cyrilzakka/clinical-trials huggingface dataset:
Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound

Children ages 3-17 who are undergoing port access receive both standard care, topical medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2 separate visits to the clinic. The child's pain with the access procedure is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 3-17 with subcutaneous port

Exclusion Criteria:

* Emergent need for port access
* Allergy to lidocaine sodium lauryl sulfate
Morbidity in Open Versus Minimally Invasive Esophagectomy

The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.

Esophageal resection is still associated with considerable morbidity and mortality. Standardized preoperative efforts could increase the outcome of these patients. While early reports of medical pioneers focused particularly on safety and feasibility, more recent studies showed that implementation of minimally invasive esophagectomy (MIE) was widely accepted. Since first reports of MIE, different techniques and adjustments have been discussed. A recent publication of a large prospective trial in Phase II showed the safety of a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and laparoscopy). Surgical technique however is still a subject of debate and the level of evidence remains still low. Proving feasibility does not warrant a paradigm shift, as experience is an important factor for safety and patient benefit.

The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE) versus hybrid-MIE in a randomized controlled setting.

Prior to surgery patients will be randomized either the minimally invasive surgery group (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open gastric tube formation with an open laparotomy approach). Randomizing tool is the "randomizer" of the medical university of vienna. (link is attached below)

Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the esophagus and the esophagogastric junction in (Siewert) type I and II position
* esophageal squamous cell cancer
* patients, who require esophageal resection due to above mentioned diagnosis
* patients, who gave their informed consent

Exclusion Criteria:

* individuals who did not meet the inclusion criteria were excluded from the study.
* patients with tumor localization in the upper third of the esophagus and requiring cervical resection were excluded.
* patients, presenting other than AC or ESCC or showed contraindication for laparoscopy (history of large abdominal surgery or signs of hostile abdomen)
* patients with a history or presence of any other malignancy, except carcinoma in situ or basalioma
First Trimester Resistin Levels in HG

This cross-sectional case-control study was conducted in Tuzla State Hospital Obstetrics Clinic in Turkey. The study evaluated 400 pregnant women during their first trimester of pregnancy. Many pregnant women (50-90%) experience nausea and vomiting during their first trimester; however, some patients have a disease called "hyperemesis gravidarum" (HG) characterized by very severe nausea and vomiting that may require hospitalization. resistin" is a peptide which is secreted primarily by human adipocytes and mononuclear cells. Evidence suggests that resistin increases plasma glucose concentration, reduces glucose intake by adipocytes, and promotes insulin resistance. Considering the HG effect on endocrinologic and metabolic complications, we hypothesized that resistin levels in maternal serum may change in the presence of HG; therefore, the aim of the present study was to evaluate these resistin levels during the first trimester and their correlation with HG severity.


Eligibility Criteria:
Inclusion Criteria:

Those who applied in the first trimester and had a mid-trimester OGTT result

Exclusion Criteria:

1) multifetal pregnancy, 2) fetal chromosomal or structural anomalies, 3) pregestational DM, 4) chronic hypertension or history of preeclampsia, 5) thyroid disease, 5) chronic kidney disease, 6) autoimmune disease, or 7) long-term use of aspirin or glucocorticoids 8) without OGTT results.
The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal

The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow.

This procedure is done in an outpatient clinic 3-4 weeks after the pins are placed and can be uncomfortable and cause anxiety in some patients. Therapy dogs are trained to sit calmly with a patient on or near the exam table as a distraction from procedures.

Eligibility Criteria:
Inclusion Criteria:

* presenting to clinic for elbow pin removal post elbow fracture surgery

Exclusion Criteria:

* dog allergy
* fear of dogs
Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris

Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Azadirachta Indica will be studied in the treatment of Acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 12 to 25 years of age
* Presence of inflammatory and non-inflammatory lesions
* Able to follow-up according to protocol
* Patients not taking any medication for treatment of Acne in preceding one month.

Exclusion Criteria:

* Acne Conglobata
* Pregnant or Breast feeding females or females having intention of becoming pregnant
* Significant systemic disease
* Any drug/ alcohol addiction
* History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome
Virtual Reality and Cervical Mobilization

The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain persisting for at least 3 months
* Being between the ages of 18-65,
* Being sedentary (not included in any physical therapy program in the last 6 months), -\>10 points from the Neck Disability Index

Exclusion Criteria:

* History of previous spinal surgery
* Neurological, cardiopulmonary, musculoskeletal disease affecting physical performance
* Any pathology in the shoulder joint
* Spinal trauma history
* Pregnancy
Influence of Persistent CMV-infection on Immune Senescence

Recent studies indicate that persistent viral infections particularly with Cytomegalovirus (CMV) might have a negative impact on immune senescence (i.e. immunocompetence of elderly individuals). We will test this hypothesis by performing a vaccination trial in healthy elderly individuals subdivided in two groups of CMV-seropositive and CMV-seronegative individuals. All individuals will be vaccinated with the currently licensed vaccine for the prevention of TBE (FSME Immun CC) which is recommended for the general population in our area. Vaccination efficacy will be monitored longitudinally concerning the TBEV-specific antibody (TBEV-neutralization, TBEV-specific ELISA) and T cell response (ELISpot, cytokine production).

Vaccination efficacy will be compared between CMV+ and CMV- individuals and correlated with the CMV-specific immune response in CMV+ individuals.


Eligibility Criteria:
Inclusion criteria:

* Age \> 70 years
* Healthy according to a health questionnaire (completed before screening)
* TBE-Vaccination indicated (exposure to TBEV-infested ticks possible)
* Capable to make an informed decision and to understand the informed consent form
* Informed consent signed by patient and study physician

Exclusion criteria:

* Previous exposure to TBEV (natural or vaccination)
* Immunodeficiency, history of autoimmune disease or current intake of immune-modulating drugs (corticosteroids a.s.o.)
* Persistent (\> 3 months) pharmacological treatment with more than one drug of relevance (exception: combination antihypertensives)
* Contraindication for TBEV-vaccination
* Condition that would drastically interfere with clinic attendance and/or adherence to the protocol
* Past medical history or current treatment for one of the following conditions: Chronic cardiac disease (Coronary heart disease, heart failure), chronic pulmonary disease (COPD), chronic kidney disease, diabetes mellitus, previous stroke, epilepsy, Parkinsons disease, dementia
* Hemoglobin \<12 g/l
* Random plasma glucose (RPG) \> 11.1 mmol/l OR fasting plasma glucose (FPG) \> 6.9 mmol/l (FPG required, if RPG is 7.0-11.0 mmol/l)
* Calculated Creatinin-Clearance \< 50 ml/min
* TBEV-serology positive
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder

To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration


Eligibility Criteria:
Inclusion criteria:

* Outpatient with Social Anxiety Disorder
* The subject is healthy
* Willing to restrict alcohol intake
* Capable of giving informed consent

Exclusion criteria:

* Subjects with depression or any other psychiatric condition
* Subjects positive for HIV or hepatitis
* Subjects taking drugs or other medication
* Pregnant or becoming pregnant during the study
* Subjects who have donated blood
* Subjects who are left-handed
* Subjects with claustrophobia
* Subjects with an electronic device or ferromagnetic metal foreign body
Comparison of Calcium Channel Blockers and Beta Blockers on Tourniquet-induced Hypertension During Intravenous Regional Anesthesia

The investigators aimed to investigate the efficacy of calcium channel blockers and beta blockers for controlling tourniquet induced blood pressure increase in patients undergoing carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation under IVRA were retrospectively examined in terms of demographical and hemodynamic variables.

After approval of the University Research Ethics Committee, the files of patients who have been operated under intravenous regional anesthesia (IVRA) in orthopedics clinics between January 2009 and January 2010 were retrospectively investigated. A total of 312 patients, 164 patients with carpal tunnel syndrome and 148 patients with trigger finger have been operated under IVRA. Out of 164 patients who have been operated due to carpal tunnel syndrome, 50 patients in which either calcium channel blockers or beta blockers were used for treatment of critical blood pressure increase after tourniquet inflation and in which whole data were obtained, were included to the study.The patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of diltiazem 10 mg (Group I) or calcium channel blocker 0.5mg/kg (Group II) have been administered by intravenous route constituted the study groups. Demographical characteristics and hemodynamic parameters were recorded from the patient files.

Eligibility Criteria:
Inclusion Criteria:

Patients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010.

Exclusion Criteria:

The patients that the files could not be reached
The Threshold Value of Regional Cerebral Oxygenation in Detecting Cerebral Ischemia

Using patients receiving spinal anesthesia as a model to evaluate the treshold value of cerebral oximeter to detect the symptoms of cerebral ischemia

56 patients has been recruited for the analysis of relationship between the symptoms of cerebral ischemia and the value of cerebral oximeter. All patients were recieved spinal anesthesia for the procedure of Ceserean section.

Eligibility Criteria:
Inclusion Criteria: patients who are going to undergo Cesarean section under spinal anesthesia

Exclusion Criteria: conditons contraindicated for regional anesthesia
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer

This is a prospective cohort study on the effect of Andrographis Paniculata (AP) on palliative management of patients with advanced or metastatic esophageal cancer. A total of 30 patients with locally advanced or metastatic squamous esophageal cancer will be recruited for the trial.


Eligibility Criteria:
Inclusion Criteria:

1. Aged over 18
2. Locally advanced esophageal cancer with invasion or adherent to surrounding organs including trachea, recurrent laryngeal nerves and descending aorta;
3. Presence of distant metastasis;
4. Extensive lymph node metastasis to beyond surgical therapy

Exclusion Criteria:

1. Patients who cannot receive palliative stenting for dysphagia or under other conventional treatment including chemotherapy or chemoradiotherapy
2. Patients who are not willing to receive Chinese herbal medicines
3. Patients who do not consent for the study
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs

the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）

To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)

Eligibility Criteria:
Inclusion Criteria:

* 1. NSCLC patients were confirmed by histology or cytology 2. Patients were ever treated with standard dose EGFR-TKIs(Erlotinib or Gefitinib )on which he/she achieved complete remission/partial remission,or maintained stable disease for 4 months.Disease progression at present (accord to RECISTv1.1 criteria） 3.At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 4.Have an ECOG PS of 0-2 5.At least 8 weeks of expected survival time 6.Have no serious cardiovascular,hepatobiliary or renal disorders 7.Provision of a voluntarily given, personally signed and dated, written informed consent document 8.Must be in accordance with the following laboratory biochemical data: Hgb≥80g/L，WBC≥3.0×10\^9/L，ANC≥1.0×10\^9/L， PLT≥80×10\^9/L Renal function：SCr≤ULN Liver function： if no hepatic metastases:AST/ALT≤2.5ULN if hepatic metastases:AST/ALT≤5ULN

Exclusion Criteria:

* If the subject meet any of the following exclusion criteria ,he/she is no eligible to participate in this study

  1. Have chronic toxicity reaction(above grade 2) and not recovered( hair loss not include)
  2. Have Appeared skin rashes or diarrhea(above grade 3),or have any reason lead to decrement during standard dose EGFR-TKIs treatment
  3. Female subjects who are in pregnancy or lactation，or of childbearing age but don't take any contraceptive measures
  4. Current enrollment in another therapeutic clinical study
  5. Have any symptoms of brain metastases or leptomeningeal metastases
  6. Subjects will not be eligible if they have history of prior malignancy in past 5 years
  7. Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study or known drug abuse/alcohol abuse.
Early Physical Therapy Intervention in Preterm Infants

The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).

There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.

The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.

The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants, gestational age between 28-34 weeks
* Families with ability to take care of the child, without chronic or mental illness
* Long-term parental presence in the hospital (at least 10h/day)

Exclusion Criteria:

* Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study
* Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention)
* Children with musculoskeletal deformities
P.Vivax Treatment Trial

This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).

This is a randomized, Single blind trial in G6PD normal participants with subclinical P. vivax infections in Laos. Participants with subclinical P. vivax infections and those meeting the enrolment criteria will be randomly assigned to one of two treatment arms:

* Intervention: Dihydroartemisinin-piperaquine (DP) therapy 3 days dosing plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg/day).
* Control arm: Dihydroartemisinin-piperaquine (DP) 3 days dosing therapy plus 14 days identical primaquine placebo.

Participants found to be G6PD deficient (G6PDd) will be treated with primaquine 0.75mg/kg/week for 8 weeks according to WHO recommendations. Primaquine and placebo will be administered with food (biscuits), which has been shown to reduce gastrointestinal side effects. All doses of study drugs will be supervised. If participants cannot visit the study centre, or fail to attend during the 14 days of supervised therapy, team members will visit them in their homes, schools or work to ensure complete dosing.

Findings:

The study showed that a 14-day course of primaquine added to mass drug administration with dihydroartemisinin-piperaquine prevented recurrent asymptomatic P. vivax infections (doi: 10.1186/s12936-019-3091-5)

Eligibility Criteria:
Inclusion Criteria:

* Participants with subclinical mono- or mixed P. vivax infections (uPCR) can be enrolled.
* Able to participate as decided by the investigators, and willing to comply with the study requirements and follow-up.
* A participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial.

Exclusion Criteria:

* Currently pregnant or breastfeeding (female of child-bearing age).
* Inability to tolerate oral treatment.
* Previous episode of haemolysis or severe haemoglobinuria following primaquine.
* Known hypersensitivity or allergy to the study drugs.
* Blood transfusion in last 90 days, since this can mask G6PD deficiency.
* An acute malaria episode requiring treatment.
* A febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration).
* Anaemia (Haemoglobin (Hb) \< 9 g/dL
* Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal or hepatic disease; severe malnutrition; HIV/AIDS; or severe febrile condition other than malaria); co-administration of other medication known to cause haemolysis or that could interfere with the assessment of antimalarial regimens.
* Currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs
Evaluation of Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery (CLOR_4)

Evaluation of the response of gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the surgical wound following third molar surgery.

Wound healing following third molar surgery will be evaluated at the level of the flap incision. Surgical interventions will be performed following a standardized protocol by a single operator.

After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

The patients will be allocated in one of the three distinct study groups as it follows:

Group A: administration of 0.2% chlorhexidine + anti-discoloration system + hyaluronic acid mouth rinse (test group 1) Group B: administration of 0.2% chlorhexidine + anti-discoloration system mouth rinse (test group 2).

Group C: administration of placebo mouth rinse (control group)

Post-treatment photographs of surgical incision will be taken immediately after surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Wound Healing Index - WHI (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.

At T3, T7, and T14 the following clinical parameters will be recorded for each patient: oedema, trismus and pain level. The clinical examinations will be performed by calibrated examiner blind to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* males or females of age range between 18 and 70 years,
* good health status,
* indication to perform third molar surgery,
* patients willing to give informed consent,
* compliance to the study follow-up,

Exclusion Criteria:

* pregnancy or breast-feeding,
* indication to antibiotic therapy prior to surgical treatment,
* chronic infections,
* systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
* previous therapy with the mouth rinses employed in the present study, and
* smoking habit (\>20 cigarettes per day, and/or pipe or cigar smoking).