cyrilzakka/clinical-trials huggingface dataset:
Natural History Study of Patients With Canavan Disease (CANinform Study)

This study uses medical records that allow retrospective data extraction of critical milestone and motor function data. In addition, prospective assessments collect data relevant to the natural history of Canavan disease in children.

The CANinform natural history study is the first multinational effort to rigorously gather both retrospective and prospective data from this patient population. Data collection includes extraction of retrospective data from medical records of living and deceased patients, and collection of prospective, longitudinal data from living patients and their parent(s)/caregiver(s). Motor function assessments are performed remotely in the home via video or in the clinic by qualified study team members. Families will be invited to attend clinic visits and/or will be followed remotely by the clinical site for approximately 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Meet age criteria of a specific cohort.
2. Confirmed clinical and biochemical diagnosis of Canavan disease.
3. Available medical records since birth that permit documentation of disease characteristics and developmental milestones.
4. Parent and/or legal guardian is able to read, understand, and sign the informed consent.

Exclusion Criteria:

1. Patient does not meet the Inclusion Criteria.
Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.

For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0).
* Distance from the lower bound of tumor to the anal verge is less than 12 cm.
* KPS score not less than 70
* Can be tolerated chemotherapy and radiotherapy.
* No history of radiation therapy to the pelvis.
* Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
* Full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. -

Exclusion Criteria:

* Other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
* Pregnant or lactating patients.
* Fertility but did not use contraceptive measures.
* Existing active infection.
* Merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
* Concurrent treatment with other anticancer drugs.
* Can not complete treatment or follow-up
Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders

The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive learning and training. They are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function.

The SG is expected to improve asthmatic children's behaviour by providing a positive psychosocial experience with positive effects on asthma outcomes.

Participants will be subjected to SG as part of routine medical care, and researchers will study the effect of SG.

The aim of the study is to evaluate the impact of an innovative SG on neurobehavioural patterns through a randomised controlled pilot study in adolescents with controlled asthma and on the modulation of the expression pattern of CTRA 'Conserved Transcriptional Response to Adversity'.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of controlled asthma according to GINA recommendations (http://ginasthma.org)

Exclusion Criteria:

* flare-ups requiring oral corticosteroids within the last four weeks
* use of leukotriene receptor antagonists or therapy as required in the last four weeks
* respiratory infections within the last four weeks
* immunological, metabolic, cardiac or neurological diseases
* obesity
* preterm birth
* major malformations of the respiratory system
* active smoking
* pregnancy
Behavior of Valve Leaflets Following Aortic Valve Implant

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU)
2. The subject has signed the informed consent.
3. The subject is at least 18 years of age at the time of implant and consent signature
4. The subject will be available for post-operative follow-up through one year

Exclusion Criteria:

1. The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position
2. The subject has any medical condition requiring long term (\> 6 months) anticoagulation or dual antiplatelet therapy
3. The subject has any clinical condition precluding the use of CT imaging with contrast
4. The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
5. The subject has active endocarditis, myocarditis, or sepsis
6. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
7. The subject is already included in another clinical trial that could confound the results of this clinical investigation
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.

This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.

Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components.

Calcium hydroxide is a synthetic medication which is antibacterial

Eligibility Criteria:
Inclusion Criteria:

* Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
* Teeth with favorable root morphology.
* Teeth with closed apex.

Exclusion Criteria:

* Teeth with PAI index 1 and 5.
* Patients who are on antibiotics.
* Patient with recent trauma to the jaw.
* Teeth with open apex
* Multi-rooted teeth.
* Vital teeth.
* Non-restorable teeth.
* Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
* Teeth associated with soft tissue abscess or swelling.
* Teeth with external or internal root resorption
* Re-treatment cases.
* Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).
* Teeth requiring endodontic surgery.
* Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant.
* Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language.
* Patients allergic to bee pollen or honey products.
Postoperative Effects of Preoperative Anxiety

INTRODUCTION Patients who will have obesity surgery have about %48 psychiatric illnesses like anxiety disorder. Studies which analyze the relationship between preoperative anxiety level and postoperative pain had reported conflicting results. The aim of this study is to search the relationship between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy surgery.

MATERIAL AND METHODS Our prospective double-blind study is planned to require 86 female patients aged between 18-65 years old, American Society of Anesthesiologists (ASA) I-II and Body mass index (BMI) ≥40 kg/m\^2. Patients having a psychiatric or neurologic disease, brain damage, using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol, known allergy to medications used in the study protocol, inability to provide informed consent will be excluded. Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.

EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy. Morbidity rate related with pain may be decreased and patient satisfaction may be increased.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18-65 years old
* ASA I-II
* BMI ≥35 kg/m\^2

Exclusion Criteria:

* Having a psychiatric or neurologic disease
* Brain damage
* Using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol
* Known allergy to medications used in the study protocol
Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.

We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.

The actual protocol used in aorta evaluation consist of two CT-scans on the same study. The first scan that detects calcifications is using parameters with low-dose current, non EKG-gated and without contrast. The second scan uses iodine-contrast, EKG-gating and higher current dose to obtain higher image quality of diagnostic value.

The study will optimize the first scan parameters and compare the measures of the aorta diameters from the standard protocol.

By modifying the first scan parameters, we would demonstrate that the follow-up of an aortic aneurysm can safely be made with lower radiation exposure.

Eligibility Criteria:
Inclusion Criteria:

* 60 years old and more
* 85 bpm or less

Exclusion Criteria:

* aortic material
* EKG gating not possible
* aorta pathology (thrombus, dissection)
"KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON POLYCYSTIC OVARIAN ADOLESCENTS"

study was designed to determine the effect of ketogenic Mediterranean diet versus hypocaloric balanced diet on adolescent female with polycystic ovary disease.

this study wsa designed to investigate the effect of the ketogenic Mediterranean diet in comparison with hypo-caloric diet on obese adolescent female's patients with polycystic ovary disease trying to find out a new physical therapy approach that had positive effect in the treatment and care for such cases which could enhance the physical therapy field.

Eligibility Criteria:
Inclusion Criteria:

1 - All patients were adolescent females. 2- All patients ages ranged from 16 to 21years old. 3- Their BMI ranged from 25kg/m² to 35kg/m². 4- All patients were suffering from hormonal disturbances confirmed by their lab tests and cysts in the ovaries that confirm their diagnosis with polycystic ovary disease.

5- They were conscious and free from any other medical disease.

Exclusion Criteria:

Patients were examined by a gynecologist before the study and excluded if they have:

1. Cardiac problems, epileptics and implanted pacemakers.
2. Pregnancy.
3. Malignancy and cardiovascular disease.
4. Women with skin infection.
5. Dysesthesia.
6. Cerebrovascular disease.
7. Uncontrolled diabetes.
8. Severe uncontrolled cardiac patient.
9. Liver and kidney dysfunction.
Management of Childhood Obesity

The significant increase in the prevalence of obesity can also be attributed to various social changes, in which the environment (political, economic, social, cultural), and not only the individual and his choices, takes a strategic place in the analysis of the problem and proposed interventions. The food environment can influence the choice and consumption of foods that promote obesity, such as ultra-processed foods (UPA). It is suggested that to intervene to effectively change behavior and eating habits, intensive interventions are needed that consider multiple levels that include the family, school, and community rather than one-off interventions that may not be effective in changing behavior and lifestyle. Regarding the family environment, parents or guardians can assist in the adoption of obesity-related behavioral patterns. It is known that the context of Primary Health Care (PHC) is ideal for actions to prevent diseases and promote children's health, since the PHC professional team is closest to the reality of life of the child, family, and community. We emphasize the importance of this study from the perspective of treatment of childhood obesity, in order to generate scientific evidence and practical subsidies for the implementation of interventions focused not only on the individual, but also in the context of the Unified Health System (SUS). The hypothesis of the study is that there will be a decrease in the consumption of ultra-processed foods (UPA) among children, aged 6 to 10 years, living with obesity and who are treated in primary health care. In addition to encouraging healthy habits such as physical activity and the consumption of in natura and minimally processed foods. The management of childhood obesity is one of the priority topics on the national agenda of SUS's food, nutrition, and health promotion policies.


Eligibility Criteria:
Inclusion Criteria:

* child classified as obesity by values equal to or greater than z-score +2 for BMI/age

Exclusion Criteria:

* children with severe mental disorders
* children on weight loss medication and with comorbidities associated with obesity
* children participating in any diet and physical activity program for weight loss/maintenance
* parents/guardians who do not agree to participate and do not sign the informed consent form
Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption

After being informed about the study and potential risks, all participants giving written informed consent who meet the eligibility requirements will take Drospirenone-only pills (4 mg, once daily). Between the 21st and 28th day of Drospirenone taking, pharmacokinetics will be measured. Pre-bariatric surgery pharmacokinetics study will be compared with post-bariatric surgery pharmacokinetics study.

Eligibility Criteria:
Inclusion Criteria:

* Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital
* Need contraception
* Able to use non-hormonal contraception during the study
* Giving consent

Exclusion Criteria:

* Pregnancy or history of giving birth within 3 months
* Breastfeeding within the 6 months
* History of using DMPA within 12 months
* History of using other types of hormonal birth control pills within 4 weeks
* History of bilateral oophorectomy or hysterectomy
* Suspected ovarian tumor or pathological ovarian cyst
* Regular cigarette smoking
* Contraindications to Drospirenone
Preventing Post-Stroke Depression

This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.

The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.

Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Stroke within the last 120 days

Exclusion Criteria:

* DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
* Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
* Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
* Pre-existing dementia or aphasia with severe language comprehension deficits
* Alcohol or substance abuse or dependence within the last 12 months
* Recurrent unipolar or bipolar disorder prior to the stroke
Cryoballoon Atrial Fibrillation Ablation Registry

This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label

The purpose of this Registry is to describe characteristics of patients undergoing cryoballoon ablation, diversity of cryoablation techniques among different centers; to evaluate efficacy and safety of the procedure in the centers with different levels of experience.

Eligibility Criteria:
Inclusion Criteria:

* The indications for catheter ablation of atrial fibrillation
* Signed informed consent to participate in the Register
* Patients undergoing cryoballoon ablation

Exclusion Criteria:

* Left atrial thrombosis
Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma

This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.


Eligibility Criteria:
* Age greater than or equal to 18.
* Histologically or cytologically confirmed diagnosis of advanced or metastatic renal cell carcinoma for which no effective therapy is available or that is unresponsive to conventional therapy.
* Measurable disease. To be considered measurable, a lesion must be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
* Karnofsky performance status of greater than or equal to 70.
* Be able to have a central venous like access maintained throughout the study.
* Provide written informed consent prior to the initiation of protocol therapy.
* Appropriate organ function.
To Assess the Anti-adhesive Effect and Safety of Protescal

This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.

The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.

Eligibility Criteria:
Inclusion Criteria:

* a woman who is over 20 years old
* a woman who needs a laparoscopic myomectomy

Exclusion Criteria:

* a pregnant woman and a nursing mother
Digital Tracking With Auto Data Reporting

Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families.

The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease.

However, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals.

In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.

Patients are enrolled to a prospective, observational Post-Market clinical Follow-up study. This is a pilot study.

The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes mellitus
* Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
* Patients using a glucose monitoring system
* Patients who are able to complete the study questionnaires
* Patients who are able to handle the application on a smart mobile phone.
* Informed consent is obtained from the patient.

Exclusion Criteria:

* Patients who, in the opinion of the investigator will not be able to commit to carrying out the follow-ups or do not have adequate technological skills
Feasibility and Acceptability of Culturally Adapted Group Psychosocial Intervention for Depressed Fathers

The study is a feasibility trial with a pre and post-experiment design in Karachi, Pakistan's most populous city. The intervention comprises of twelve sessions of learning through play (LTP) plus during the three month period.


Eligibility Criteria:
Inclusion Criteria:

* Depressed fathers of children 0-30 months
* Given written informed consent

Exclusion Criteria:

* Not willing to participate
* Out of trial catchment area