cyrilzakka/clinical-trials huggingface dataset:
Web-based Daily Care Training of Children With Cerebral Palsy

Purpose:Effect of web-based daily care training on the quality of life of caregivers of children with cerebral palsy.

study design: Single-blind clinical trial. study population: Caregivers of children with cerebral palsy. Inclusion criteria: caregiver -Mother of a child with cerebral palsy who spent most time on child care- Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records. Moderate and severe cerebral palsy (gross motor function levels 3 to 5). caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week). exclusion criteria: taking care of two or more children with disability. participated in previous face to face training programs.

Sample size: 100. Intervention: Web-based daily care training. intervention time: 12-week. Outcome of the study: the quality of life of caregivers

step1: web development and design

1. development of educational content (4 weeks)
2. Create a paper version of the site (2 weeks)
3. Create a web-based version of the site (4 weeks)
4. pilot study (6 weeks) step 2: RCT (12 weeks)

Eligibility Criteria:
Inclusion Criteria:

* caregiver_ Mother of a child with cerebral palsy who spent most time on child care Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records
* Moderate and severe cerebral palsy (gross motor function levels 3 to 5)
* caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week)

Exclusion Criteria:

* taking care of two or more children with disability
* participated in previous training programs
Polish Revision Obesity Surgery Study

Bariatric surgery is well established method of treating patients with obesity. Obesity is well-documented risk factor for many health conditions including some cancer, cardiovascular diseases, pulmonary diseases and type-2 diabetes. Bariatric surgery is associated with improved comorbidities, quality of life and survival in severe obesity. However, the rate of conversion or revisional bariatric surgeries is increasing nowadays. Recent date estimate the rate of revisional procedures between 8-25% of all bariatric surgeries performed worldwide.

Weight recidivism or fail to achieve a significant weight loss (estimated 10-20% of operated patients) remains a challenge for surgeons and patients. This has economic and health implications, leading to reduction in quality of life and increased prevalence of obesity-related comorbid conditions. Therefore, the aim of this study is to identified patients with failure after primary bariatric procedure in population of Poland.

All participating medical institutions performing metabolic and bariatric surgeries from Poland can register patients via online questionaries. The database will include all patients with full preoperative history regarding the status of comorbidities, maximum weight and BMI. Details regarding initial surgery will be collected: type of procedure, time of procedure, length of the procedure, technical aspects (type of anastomosis, location of the anastomosis, type and amount of staplers used, length of bypassed jejunum, type of gastric band), length of hospital stay, short-term complications. The outcomes of initial surgery will be noticed: %TWL, minimum weight and BMI, remission of comorbidities, improvement of comorbidities, reduction of pharmacological treatment. Long-term postoperative complications in example de novo reflux, stenosis of anastomosis, stricture of gastric pouch will be included in analysis. The cause of revisionary surgery will be analyzed. The secondary bariatric procedure will be analyzed in terms of time, type and its length. Detail information of technical aspects will be collected. The complications and outcomes of revisional surgery will be acquired from hospitals registers, as well as, informations received from clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

Patients after revisional bariatric surgery, male and females over 18 years old, any type of primary bariatric surgery.

Exclusion Criteria:

Lack of follow-up, lack of anthropometric details at any point of a study.
Determination of Glycemic Index of Six Greek Honey Grades

This study determined the glycemic index and glycemic load of six Greek honey varieties

This randomized, double-blind, cross-over study investigated the glycemic response to six Greek honey grades differing in floral source and carbohydrate composition. Isoglucidic test meals (50g available carbohydrate) and 50g glucose reference were given to 11 clinically and metabolically healthy, fasting individuals (27±7 years; 9 women; BMI 24±4kg/m2), in random order. GI was calculated using the FAO/WHO method. Capillary blood glucose samples were collected at 0,15,30,45,60,90-and-120min. Salivary insulin samples were collected at 0,60-and-120min. Subjective appetite ratings (hunger, fullness and desire to eat) were assessed by visual analogue scales (VAS, 100mm) at baseline and 120min.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smoking
* individuals with normal body mass index (between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

* coronary heart disease
* diabetes mellitus
* kidney disease
* liver conditions
* endocrine conditions
* gastrointestinal disorders
* pregnancy
* lactation,
* competitive sports
* alcohol
* drug dependency
Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions

Patients with high standards of oral hygiene frequently search for buccal gingival recession (GR) treatment due to cervical wear, root sensitivity and compromising aesthetics. The cervical lesion (NCCL) is commonly produced by improper toothbrushing techniques, sharing the same etiology of GR. Many different surgical approaches have been described. The association of a graft to the coronally advanced flap had demonstrated the best long-term outcome for root coverage. But, substitutes for the autogenous graft must be studied. Therefore, the aim of this clinical trial was to investigate the effectiveness of the acellular dermal matrix graft (ADMG) in root coverage associated with a previous restored cervical lesion or not.

Material and methods: Seventeen individuals with bilateral GR were included in the study. At one side, the GR must present a previously restored cervical lesion, as the test group (TG). The contralateral arch, must present GR with an intact root surface (CG). All patients were treated with the extended flap technique associated with the ADMG. All clinical parameters were assessed at baseline and 6-months postoperative.


Eligibility Criteria:
Inclusion Criteria:

* CEJ without significant damage;
* localized bilateral RT112 gingival recession ≥3 mm in the same arch, in which one had a non-carious cervical lesion (NCCL) restored with composite and the opposite one was intact

Exclusion Criteria:

* previous periodontal surgical treatment on the involved sites;
* smokers
* pregnants or lactating
* compromised systemic health and contraindications for periodontal surgery
TCI vs Manually Controlled Infusion of Propofol

Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion.

The aim of the study is to verify differences in time to extubation and amount of drugs used.

anesthetize


Eligibility Criteria:
Inclusion Criteria:

- Patients to laparoscopic surgery

Exclusion Criteria:

-
Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion

The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary supplement on skin radiance (clinical assessment) for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Female volunteers:
* Age: 40-70 years
* Who have a dull complexion evaluated by clinical scoring
* Phototype II to IV (annex 5)
* Non-smoking or smoking less than 5 cigarettes per day
* Did not change her eating habits, within one month before the start of the study and agreeing not change during the study
* With no history of facial skin care (peeling, mask...) 15 days before the beginning of the study and agreeing not to perform during the study
* Volunteers accepting not changing their local treatment on face
* Who agree to avoid UV exposure (sun or tanning booth) during the study
* Who have a fixed address and are entitled to Social Security or a similar National Insurance scheme
* Who sign a written informed consent

Exclusion Criteria:

* Pregnant, nursing, or intending to become pregnant in the course of the study
* With a history of allergy or hypersensitivity to the products or one of their components
* Having use oral nutritional supplements and/or vitamin supplementation less than one month before and/or refusing not consuming nutritional supplement during the study
* Having used cosmetics and/or topical preparations containing ingredients claiming efficacy on skin radiance less than 15 days before and/or during the study
* With a dermatosis, systemic disease or treatment susceptible to interfere with the evolution of the parameters of the study or with taking the nutritional supplement
* Participation in another clinical trial evaluating skin radiance during the last month before the study
* Participation in another clinical trial or volunteers being in the exclusion phase of such a trial, thus being unable to participate in any other one
* Who have forfeited their freedom by judiciary decision or are deemed legally incompetent
* Having perceived more than 4500 € as indemnification fees for participation in clinical trials during the preceding 12 months (including participation in this clinical trial)
* Unable to comply with the protocol constraints
* Who cannot be contacted by phone rapidly
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - \<36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children
* Aged ≥6 to \<36 months on Day 1
* Born at a gestational age ≥37 weeks
* Written informed consent
* No previous influenza vaccination

Exclusion Criteria:

* Acute respiratory infection or other acute disease
* Acute febrile illness (≥38.0 °C)
* Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus
* Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)
* Known hypersensitivity to any vaccine component
* Known history of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed)
* Known immunodeficiency (including leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period
* Participation in another clinical trial
* Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee
* Suspected non-compliance
Uterine Elastography: a Potential Predictor of Embryo Transfer Success

To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer
2. Patients planning to undergo single embryo transfer (SET) of a euploid embryo by Preimplantation genetic testing for aneuploidy (PGT-A)
3. Uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year
4. Egg recipients

Exclusion Criteria:

1. Gestational carriers
2. BMI \> 35
3. Diagnosis of a uterine anomaly
4. History of uterine surgery, excluding polypectomy, c-section, D\&C
5. Communicating hydrosalpinx
6. Transfer of an embryo of unknown ploidy status or embryos of undetermined safety
7. Surgically retrieved sperm
8. Embryos that were cryopreserved on day 7 of development
9. Poor quality embryos defined by modified Gardner grading criteria used in the embryology lab
10. Sonographically abnormal appearing uteri, including distortions from leiomyomas and thin endometrium
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.


Eligibility Criteria:
Inclusion Criteria :

* American Society of Anesthesiologists physical status (ASA) \< III
* Age 18-40 year
* Body Weight \<110 kg
* Height between 160 and 175 cm
* Gestational age\>37 SA
* Elective cesarean delivery
* Singleton pregnancy
* Non complicated pregnancy
* Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

* Twin pregnancy
* History of 2 cesarean section or more
* Diabetes and gestational diabetes
* Placenta praevia
* Congenital foetal abnormality
* Intrauterine growth retardation
* Patient in labour
* Membrane rupture
* Known allergy to local anaesthetics
* Standard contraindications to neuraxial block.
* Disagreement of the patient
* Neurological impairment
* Gestational low blood pressure
* Pre eclampsia and eclampsia
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Basal-bolus treatment for at least 3 months
* Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2
* HbA1c (glycosylated haemoglobin) less than or equal to 12.0%

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
* Receipt of any trial drug within 1 month prior to this trial
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury

Background: Cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. Recently a new instrument, a stress radiographic device and knee stability test (DYNEELAX), were produced to objectively measure these displacements.

Objective: To assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee.

Material and method: The MRI, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.


Eligibility Criteria:
Inclusion Criteria: Patients are diagnoed as ACL/PCL injury or suspect ligament sprain at Kaohsiung veteran general hospital.

Exclusion Criteria: Unable receing MRI exam, any op history of knee or fracture history on the impaired knee.
Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes

The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone.

This Phase 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.

Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Have been diagnosed with Type 2 diabetes mellitus
* Have followed dietary and exercise interventions for at least 8 weeks prior to screening
* If used any glucose-lowering drugs within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
* Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
* Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
* Have a body mass index ≥19.0 kg/m\^2 to ≤35.0 kg/m\^2

Key Exclusion Criteria:

* Have type 1 diabetes
* Have had any acute diabetic complications within 12 months prior to screening
* Have had any Grade 3 hypoglycemic event within 12 months prior to screening
* Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
* Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening
* Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
* Have used any hypoglycemic drug during the 4-week run-in period prior to randomization
* Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis

Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application


Eligibility Criteria:
Inclusion Criteria:

* 10 years or older
* AIS diagnosis
* Risser 0-2
* Primary curve angles 20 degrees - 40 degrees
* If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria:

* Patients with a pre-existing cardiovascular condition
* Patients with symptom of a neurological disorder
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs,
Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).

The study will include patients with stone related cholecystitis that are not adequate surgical candidates that will be treated with EUS guided cholecystoenterostomy with endoscopic stone extraction. Patients will be randomized to stent removal immediately after gallstones have been removed or to observation for 1 year with the stent in place. Outcomes to be measured include recurrence of stone disease and rate of complications from the procedure in both groups

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-100 years or age
2. Both genders
3. Diagnosis of acute cholecystitis by TG13 criteria.
4. Patients who are able to give consent
5. Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team.

Exclusion Criteria:

1. Unable to provide informed consent
2. Cardiorespiratory dysfunction that precludes sedation
3. Pregnant females
4. Presence of ascites (distance between duodenum and GB \> 1 cm) and/or coagulopathy (INR \> 3, PLT \<20K)