cyrilzakka/clinical-trials huggingface dataset:
Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation

The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.

Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.

Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.

Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.

Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Able to understand and read/write Swedish

Exclusion Criteria:

* No acupuncture training
Milking the Umbilical Cord for Extreme Preterm Infants

Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.

The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.

Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound
* informed consent obtained by the pregnant women prior to delivery of the infant.

Exclusion Criteria:

* pregnancy with a multiple gestation
* infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
* infants with hydrops fetalis
Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes

To present our experience in the diagnosis and management of cornual pregnancy. A systematic review was also conducted to investigate reproductive outcomes after treatment.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* patients with a diagnosis of cornual pregnancies.

Exclusion Criteria:

* All patients whose medical records did not contain the data deemed necessary for study analysis or who did not consent to the publication and use of their data;
* Other type of ectopic pregnancies.
Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial

Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several methods have been proposed to reducing pain including submucosal block, paracervical block, and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine appeared to be the most common methods used. However, from the investigators experience, there is significant pain associated with the injection itself.

Lidocaine spray is an effective measure for pain control during minor gastrointestinal and otolaryngological procedures. It is simple without pain related to application.

An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine submucosal injection by comparing pain scores at various stages of the LEEP procedure.


Eligibility Criteria:
Inclusion Criteria:

* Any degrees of cervical dysplasia detected from cervical cytology or histology
* Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment

Exclusion Criteria:

* Allergy to lidocaine
* Pregnancy
* Previous history of cervical operation including conization, LEEP, laser therapy and cryotherapy
* Cardiac arrhythmia
* Neural disease with impaired sensation
* Lower urinary tract cancer
* Coagulation defect
* Drug dependence
* Lower genital tract infection
* Obvious invasive disease of the cervix
Promoting Whistleblowing Among Nurses: A Randomized Controlled Trail

this study aims to investigate the effect of Whistleblowing intension Among Nurses by applying whistobloating education program

the study aims to assess the effectiveness of Whistleblowing intervention program on nurses'Whistleblowing intensions.

Hypotheses:

H1: Nurses participating in the Whistleblowing intervention will report, post intervention, high level of Whistleblowing intensions compared with those nurse nurses in control group

Eligibility Criteria:
Inclusion Criteria:

* licensed nurses who worked in direct contact with patients in their services had at least six month of experience in the nursing profession, agreed to participate in the study

Exclusion Criteria:

* participating in any intervention program within the last 12 months
Treatment of Epicondylitis by Ultrasound-guided Local Injections of PRP (Platelet Rich Plasma)

The purpose of this study is to assess efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared compared to two intra-tendinous injections of saline solution (placebo).

This was a prospective double-blind placebo-controlled randomized trial. Two ultrasound-guided injections of either PRP (ACP®, Arthrex) or saline solution were performed at 4 weeks interval.

Exclusion criterion was previous corticosteroid infiltration. All infiltrations were performed by Dr Bernard Montalvan. The selection of patients and the evaluation were conducted by Dr Patrick Le Goux who did not know which treatment had been allocated to which patient.

In the facility, no one apart from the investigators had access to full patient data.

An independent company represented by Mrs Amandine Ramseyer was hired to design, follow and carry the statistical analysis of the study. The data she got from the investigators were anonymous.

Patients were monitored by an independent evaluator blinded to treatment at baseline and 1, 3, 6 and 12 months follow-up.

Secondary criteria were the Roles-Maudsley score and the assessment of pain on isometric contraction of the extensor carpi radialis brevis and of the extensor digitorum communis.

The main evaluation criterion was the relative improvement from baseline to 6 months in pain score on visual analog scale (0-10).

Intragroup and intergroup intention-to-treat analyses were performed using Student's t-tests, applying the last-observation carried forward method. Differences of proportions were tested using chi-square. The sample size calculated was 22 patients per group so that this study had a power of 90% with typeI error rate α=0.05 to demonstrate a significant greater improvement of the global pain score of at least 10%, in the PRP over the placebo group with a standard deviation of 0.10. A "p" value of less than 0.05 was considered to be statistically significant. The SPSS software (version 19 for Windows) was used to perform statistics.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from tennis elbow for less than three months
* Patients having never received former medical or orthopedic treatment for tennis elbow

Exclusion Criteria:

* Patients having received any treatment for this specific pathology
* Evidence of ongoing tumoral affection (controlled by MRI)
* Tennis elbow history
* Elbow fracture history
* Associated elbow pathology
* Inflammatory rheumatic disorders
* Bleeding disorders
* Ongoing anticoagulation therapy
* Allergy to local anesthetic
* Ongoing or previous cancer affection
* Pregnancy
* Diabetes
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip replacement

Exclusion Criteria:

* general anaesthesia
* Allergy to local anesthetics of the amide type
* Revision surgery
* Bilateral surgery
* Chronic pain patient
* Women in the fertile age
App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes

The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of type 2 diabetes
* 18 years of age or older
* Ability to communicate in Swedish
* Have and be able to use a smartphone

Exclusion Criteria:

* Not being able to walk
Convulsions in Neonates With Congenital Heart Diseases

analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures during their neonatal intensive care unit admission.

Neonatal seizures are a commonly encountered neurologic condition in neonates. They are defined as the occurrence of sudden, paroxysmal, abnormal alteration of electrographic activity at any point from birth to the end of the neonatal period. During this period, the neonatal brain is developmentally immature. Thus, neonatal seizures have unique pathophysiology and electrographic findings resulting in clinical manifestations that can be different (and more difficult to identify) when compared to older age groups.

Neonatal seizures are paroxysmal, repetitive and stereotypical events. They are usually clinically subtle, inconspicuous and difficult to recognize from the normal behaviors of the inter-ictal periods or physiological phenomena. There is no recognizable post-ictal state. The most widely used scheme is of five main types of neonatal seizure.

* Subtle seizures (50%)
* Tonic seizures (5%)
* Clonic seizures (25%)
* Myoclonic seizures (20%)
* Non-paroxysmal repetitive behaviors Neonates with congenital heart disease have a high risk of cerebral lesions, seizures, and neurological impairment. By congenital heart disease, we refer to the group of congenital malformations present at birth that include cyanotic as well as non-cyanotic cardiac lesions.

Neonatal seizures are the most common clinical expression of central nervous system dysfunction in newborns and one of the most frequent neurological emergencies during this stage of life. They are usually the first sign of neurological involvement and an indicator of the risk of mortality and/ or neurological sequelae.

Eligibility Criteria:
Inclusion Criteria:

* All neonates up to 28 days of age with congenital heart diseases presented with repeated seizures admitted to Neonatology unit at Assiut university children hospital

Exclusion Criteria:

* Neonates with normal heart or infants more than 28 days of age.
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age.
* Has Fitzpatrick Skin Type IV, V, or VI.
* Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.

Exclusion Criteria:

* Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
* Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
* Is pregnant, lactating, or not using acceptable contraception.
The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients

Acetate-free citrate containing dialysate is expected to be clinically effective in maintaining hemodynamic stability during hemodialysis (HD). It has been demonstrated that citrate dialysate help produce a local anticoagulant effect by chelating ionized calcium. Moreover, citrate can improve phosphate and beta2 macroglobulin and better control of arterial hypertension and hemoglobinemia. We therefore would like to study the effect of citrate dialysate on clot formation and anemia while reducing heparin in chronic hemodialysis patients.

This is the prospective comparison study. This study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months. All the patients should have serum ferritin 200-1000 ng/L and TSAT of 15-50%. The investigators exclude patients with age more than 70 years, comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis), patients using heparin free protocol, hyperkalemia worsened by hypocalcemia, contraindication to heparin, treatment with cinacalcet or oral anticoagulant, patients using central venous catheter with blood flow less than 300 ml/min, and patients using low molecular weight heparin.

The study will be conducted in three phases over a period of 4 months. After run-in period for 2 weeks using acetate dialysate, the heparin dose will be titrated to lowest effective dose. During the first phase, citrate was replaced for acetate and heparin will be reduced to 50%. The second and third phase will be performed by reducing heparin doses to 25 % and heparin free consecutively. Each phase lasts for 4 weeks. Washout period for 2 weeks will be alternated after each phase.

Data collection: The investigators measure blood chemistries such as CBC, BUN creatinine electrolytes calcium phosphorus and KT/V at the beginning and at the end of each session. Ionized calcium will be monitored pre and post dialysis in each session. In addition, the investigators record clot score and erythropoietin dosage in each session and each phase.

Eligibility Criteria:
Inclusion Criteria:

* This study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months.
* Serum ferritin 200-1000 ng/L and TSAT of 15-50%.

Exclusion Criteria:

* age more than 70 years,
* comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis),
* patients using heparin free protocol,hyperkalemia worsened by hypocalcemia
* contraindication to heparin,
* treatment with cinacalcet, or oral anticoagulant
* patients using central venous catheter with blood flow less than 300 ml/min
* patients using low molecular weight heparin
Prevalence of Subacromial Impingement Among Egyptian Swimmers

In the available literature, there are no prevalence studies that show the incidence of subacromial impingement in swimmers in Egypt, this should be considered as it's one of the most commonly reported injuries worldwide in swimmers. There are also no available studies to show the difference in incidence of subacromial impingement between both genders in Egypt. This study is attempting to remedy both research deficits and to reduce the literature gap and to show the prevalence rate of this injury among Egyptian swimmers in different age groups, to help prevent its widespread and to provide data for further investigations. This study would give the Egyptian swimming federation and the Ministry of youth and sports a clear idea about the prevalence rate of swimmer's shoulder at different ages in Egyptian swimmers. Most importantly, this study is to provide the physiotherapy community in Egypt data about this injury, the rate of prevalence and how to prevent it and hopefully would help in further future studies and also to apply it in different countries.


Eligibility Criteria:
Inclusion Criteria:

* 440 swimmers (males and females) , their age between 12 - 25.
* Professional swimmers only.
* Complain of anterior shoulder pain while swimming or elevation of shoulder.
* BMI will be ranged from (18.5 - 24.9 kg/m2 ).
* All swimmers are under supervision and psychologically, medically stable.
* All swimmers received a good explanation of the questionnaire and the given study.

Exclusion Criteria:

* Any swimmer who refuse to participate in the study
* Uncooperative swimmers.
* Unprofessional swimmers.
* Participants who play any other sports.
* Exclude any previous traumatic lesion.
* Exclude any form of shoulder instability.
* Take any medication that affects pain perception as NSAIDS.
A Phase I Trial of ZIO-101 in Solid Tumors

A Phase I Trial of ZIO-101 (Darinaparsin) in Solid Tumors


Eligibility Criteria:
Inclusion Criteria

1. Subjects with histological confirmation solid malignancy refractory to conventional standard therapies for their condition
2. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents
3. Pediatric subjects will be eligible at the discretion of the primary investigator.
4. ECOG performance status score ≤ 2
5. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods
6. Subjects must provide written informed consent prior to treatment
7. At least 4 weeks from prior completion of prior therapy to day 1 of study drug
8. Baseline toxicity assessment ≤ grade 1 except treatment induced alopecia (NCI Common Toxicity Criteria version 3.0)
9. Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values:

   * Serum creatinine ≤ 2 times the upper normal limit OR a calculated creatinine clearance ≥ 50 cc/min
   * Total bilirubin ≤ 2 times the upper normal limit
   * Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
10. Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 /microL

Exclusion Criteria

1. Uncontrolled systemic infection (documented with microbiological studies)
2. Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Subject has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Subject experiences symptoms even while at rest
3. Concomitant therapy for solid cancer
4. Pregnant subjects and those who are breast-feeding
5. History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer
6. Documented personal or family history of prolonged QT syndrome
7. 12 lead electrocardiogram with a corrected QT interval \> 460 milliseconds
8. History of confusion or dementia
9. History of seizure disorder
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.

The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

The study also aims to collect confirmatory evidence on the safety of the device.

Eligibility Criteria:
Inclusion Criteria:

* Eligible and scheduled for full mouth fixed orthodontic treatment
* Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
* Class I or Class II by 1/2 cusp or less
* Non-extraction in both arches
* Age 11- 60
* Good oral hygiene
* Non-smokerInclud

Exclusion Criteria:

* Pregnant females
* Patient is currently enrolled in another clinical study
* Patient decided on Invisalign® rather than braces
* Periodontally involved teeth
* Use of bisphosphonates (osteoporosis drugs) during the study
* Patient plans to move over the treatment period
* Spaces between anterior teeth