cyrilzakka/clinical-trials huggingface dataset:
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. However, not all patients do better with a device. Currently, there is not a way to identify which patients will benefit from the device. The purpose of this study is to determine if using medical tests, Echocardiogram, can help in predicting which patients will improve. The types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe heart failure

  * Ejection Fraction ( measurement of blood pumped out of the heart) less than 35%
  * Wide (greater than 130 milliseconds) QRS duration for US patients only.
  * May include patients with less than 130 millisecond QRS duration if they have mechanical dyssynochrony (uncoordinated heart contractions) in Europe.
  * All patients enrolled should be stable on medications that include at least an ACE inhibitor or Angiotensin Receptor Blocker (ARB) and at optimal level for at least one month prior to surgery

Exclusion Criteria:

* Patients that are not eligible for this study are those that have a mechanical right heart valve or are experiencing the following medical conditions within the last 3 months:

  * Chest pain / unstable angina
  * Acute heart attack
  * Chronic or permanent atrial arrhythmias such as atrial fibrillation
  * Contrary artery bypass graft (CABG)
  * Percutaneous transluminal coronary angioplasty (PTCA)
  * Patients who have had intermittent or continuous Inotropic drug therapy are not eligible for this study.
  * Patients who have had heart transplant or a prior Cardiac Resynchronization Therapy device are not eligible for this study.
  * Patients who are pregnant or are of child-bearing potential are not on a form of birth control may not participate in this study.
Correlation Between Maximal Inspiratory Pressure and Hand Grip Force

This study aimed to examine the possible relationship between hand grip strength (HGS) and maximum inspiratory pressure (MIP) in healthy individuals.

This study aimed to examine the possible relationship between hand grip strength (HGS) and maximum inspiratory pressure (MIP) in healthy individuals. All individuals underwent assessment of inspiratory muscle strength by maximum inspiratory pressure, and evaluation of hand grip strength. MIP was measured using a U-type water manometer calibrated in centimetre of water (cmH2O), while the HGS was measured with hydraulic hand dynamometer calibrated in Kg.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* age \<20 years old,
* pregnancy,
* official diagnosis with lung disease such as Chronic obstructive pulmonary disease (COPD),
* body mass index (BMI) \> 40,
* known pre-existing causes of neuromuscular weakness,
* median entrapment neuropathy such as carpal tunnel syndrome
Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women

Liposuction is the most popular aesthetic surgery in Brasil and worldwide. Evidence showing that adipose tissue is a metabolically active tissue led to the suggestion that liposuction could be a viable method for the improvement of metabolic profile through the immediate loss of adipose tissue. Studies about the effects of liposuction on metabolic profile are conflicting. A few studies report the improvement of insulin sensitivity, inflammatory markers and lipid profile, others observe no changes and a few report the worsening of metabolic profile. In addition, animal studies show a compensatory growth of intact adipose tissue in response to lipectomy. Physical exercise improves insulin sensitivity, lipid profile, inflammatory balance, adipose tissue distribution and increases or preserves free fat mass. Therefore, liposuction and physical exercise seem to act on similar tissues of the body. To the investigators knowledge, there are no studies about the associated effects of liposuction and exercise in humans. However, one can suggest that exercise training associated with liposuction could: \[1\] attenuate or block the possible fat recovery or compensatory growth; \[2\] block or reverse the possible harmful effects of liposuction; or \[3\] exert an additive or synergistic effect to the possible beneficial effects induced by liposuction on metabolic and hormonal profile and inflammatory balance.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 35-year old healthy subjects with a BMI of 22 to 28 Kg/m2;
* Non-smokers;
* Present stable body weight for 6 months (without variations exceeding 4 kg);
* Be in use contraceptive pill for at least 6 months;

Exclusion Criteria:

* Health problems that impede surgery or exercise training;
* Be in chronic use of antibiotics or antiinflammatory medication.
Assessing the Impact of Probiotic Supplementation in Children Diagnosed with Autism Spectrum Disorder: the PROBI-O-TISM Study

Children with autism spectrum disorder (ASD) present with stereotyped behaviors and often with comorbidities including gastrointestinal symptoms and sleep disturbances. These affect the quality of life of both children and parents. As of now, interventions available to manage ASD-related behaviors rely heavily on the services of professionals who are often difficult to access. What is even more striking is that there are currently no approved medications to treat the core symptoms of ASD. There is an important need for additional strategies to manage severity of ASD and to develop new treatments.

Targeting the bacteria living in the intestine, named 'gut microbiota', by using probiotics is an avenue that has been proposed by other groups to improve behaviors associated with ASD and gastrointestinal symptoms. However, these studies have important limitations, pressing the need for robustly designed interventions.

Previously, the PROBI-O-TISM pilot study was conducted at CHU Sainte-Justine. The investigators confirmed that the Bio-K+ probiotic beverage is acceptable and safe for autistic children and that the proposed study protocol is feasible. The study also led to promising preliminary results suggesting a beneficial effect of the probiotics on behaviors, gastrointestinal symptoms and sleep.

The proposed study will answer the question: ''Does supplementing with Bio-K+ probiotics reduce the severity of autistic behaviors and comorbidities in children with a diagnosis of ASD? '' The investigators will use a solid study design, a double-blinded randomized controlled-trial with placebo, to test the efficacy of a 14-week treatment with daily Bio-K+ probiotic supplement in children aged 4 to 11 years old. The investigators will also study the impact of the supplementation on other parameters such as quality of life, gut microbiota and brain signaling.

This is a unique opportunity to test a simple approach to improve behaviors and comorbidities in autistic children.


Eligibility Criteria:
Inclusion Criteria:

* Being an autistic child with normal intelligence as documented by a neuropsychology assessment at the time of ASD diagnosis based on the ADOS score and the clinical impression of a multidisciplinary team of experts in autism diagnosis in the Department of Psychiatry;
* Being between the ages of 4 and 11 years;
* Acceptance and ability of the child to consume the probiotics product.

Exclusion Criteria:

* Epilepsy;
* Autism in the context of a genetic syndrome such as Fragile X or Bourneville sclerosis;
* Known presence of cancer, diabetes, celiac disease or inflammatory bowel disease (Crohn's disease or ulcerative colitis);
* Genetic disorder such as trisomy 21 or 14;
* Immune system disorder;
* Intolerance or allergy to Bio-K+ pea-based probiotics;
* Having taken antibiotics or probiotics in the previous 3 months
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.

The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.

FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.

Eligibility Criteria:
Inclusion Criteria:

* Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (\>1cm)
* Undergoing thyroid surgery (histology of index nodule)

Exclusion Criteria:

* Not undergoing thyroid surgery
Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital

assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease.

assess the impact of albumin level on clinical course and outcomes of HE.

sample size calculation will be performed based on anticipated incidence rates of HE and variability in serum albumin levels, aiming for a study population of 100-150 patients to achieve adequate statistical power.

- All patients included in the study will be subjected to : Glasgow Coma Scale (GCS) score. Clinical Assessment: Baseline evaluation of patients to confirm chronic liver disease diagnosis and determine clinical characteristics.

History of prior episodes of HE, presence of ascites, variceal bleeding, and other complications of chronic liver disease .

Age, gender, etiology of cirrhosis (e.g., viral hepatitis, alcohol), comorbid conditions (e.g., diabetes, hypertension)

* Laboratory investigation :

Serum albumin level AST ALT Total bilirubin and direct CBC Serum creatinine Proth time and concetntration

Eligibility Criteria:
Inclusion Criteria:

* patients aged \>18 years.
* Confirmed chronic liver disease (by imaging ,
* liver function tests , and clinical history).
* Diagnosed with hepatic encephalopathy based on clinical criteria.
* Patients able to provide informed consent.

Exclusion Criteria:

* Patients age less than 18 years old
* Acute liver failure.
* Chronic renal failure on dialysis.
* Pregnant women.
* Patients with active malignancy.
Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health

The goal of this clinical trial is to investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. The main questions it aims to answer are:

* How does consuming personalized innovative fritters affect the nutritional health of overweight and obese individuals?
* What is the mechanism underlying the impact of personalized innovative oil bars on nutritional health?

Participants will be randomly assigned to one of two groups: a trial group consuming personalized innovative fritters and a control group consuming traditional fritters with equal energy content. Over the course of 6 months, participants will undergo two phases of intervention separated by a two-month washout period. During the intervention, participants will be assessed comprehensively for sensory ratings and nutritional health status through biological indicators, physical examinations, and other relevant measures.

Researchers will compare the trial group to the control group to determine if personalized innovative fritters lead to improvements in nutritional health compared to traditional fritters.

Participants entered the trial with a 1-week equilibration period during which baked and fried foods were prohibited. The test group will consume personalised innovative Youtiao and the control group will uniformly consume traditional Youtiao of equal energy, 45 g 4 times per week for 8 weeks, during which time we will periodically measure biological indicators and collect biological samples to gain insight into the effects of the personalised innovative Youtiao on the participants. After completion of the 8-week intervention, a washout phase is entered. During this phase, participants will no longer ingest the Youtiao to see how they trend after stopping the intervention. Participants then enter the second phase of the trial, where the intervention process described above is continued with appropriate consumption adjustments based on the initial results of the first phase of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-70 years old (women need to be menopausal);
* BMI\>24 kg/m2;
* Consumption of fritters more than once a week.

Exclusion Criteria:

* history of diabetes mellitus, cardiovascular disease, dyslipidaemia, renal disease, -
* liver disease or cancer;
* surgical treatment within 3 months;
* allergy/intolerance to the study food or any of its ingredients;
* breastfeeding or pregnancy;
* \>10% weight loss in the past 6 months;
* smoking or alcohol abuse;
* participation in another clinical study within the past 6 months
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration

Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

This study is a "N of one" trial where the patient is their own control. We will provide the quality of life questionnaire, the MOS-HIV questionnaire; ISR questionnaire and a satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide for at least one month. As well, demographics and laboratory data will be collected. The same procedures will be given 1 month after the use of Biojector in a follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria:

Patients with hemophilia
Diet and Nutritional Status of Adolescent Girls in Zambézia, Mozambique

Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique was collected. A cross-sectional study was carried out in 2010 in two seasons, January-February and May-June. Participants (total n=551) were recruited from Quelimane (the provincial capital), Maganja da Costa district and Morrumbala district.


Eligibility Criteria:
Inclusion Criteria:

Girls in the target age range who were able to visit the study centre and didn't have any significant illness preventing participation were considered eligible.

Exclusion Criteria:•

* age not between 15 and 18 years
* any apparent significant illness, disability or unstable medical condition which could lead to difficulty participating in the study
* unwillingness to participate in the study
* unwillingness or inability to arrive at the study location at the requested time.
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression

The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.

This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR\*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR\*D study.

The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.

Eligibility Criteria:
Inclusion Criteria

* Subjects whose depressive symptoms have not remitted during their participation in the "Pharmacokinetics and Pharmacodynamics of Citalopram and Escitalopram" study or the "Pharmacokinetics and Pharmacodynamics of Duloxetine" study
* Must be able to continue to take same dose of duloxetine through the course of the study

Exclusion Criteria

* A history of failure for respond to Electroconvulsive Therapy (ECT)
* Any metal in the head (except in mouth)
* Implanted medication pump or cardiac pacemaker
* Have had prior brain surgery
* Have unprovoked seizure disorder or family history of treatment resistant epilepsy
* Pregnancy
* Psychiatric hospitalization within the past two weeks
* Suicide attempt with hospitalization within past three months
Clinical Trial Tobacco Marijuana

Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly smoke tobacco. Combining tobacco with cannabis has become a common method of smoking cannabis. Similarities of use, and using together, can make quitting difficult. Stopping tobacco simultaneously with cannabis may be beneficial. Little scientific information currently addresses how to best target tobacco smoking during treatment for CUDs. Our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes.

This protocol reflects the planned Stage 1, proof-of-concept study that will compare a combined cannabis and tobacco intervention to one that targets CUD only. Hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts. If the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will inform future development of prevention and intervention strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals must be 18 years or older
2. Individuals must meet criteria for the current Diagnostic and Statistical Manual -IV diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
3. Individual must indicate that they have at least some interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale)

Exclusion Criteria:

1. Current dependence on alcohol or any drug other than tobacco and cannabis
2. Use of non-tobacco nicotine
3. Current participation in structured treatment for substance abuse
4. Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder)
5. Report of a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking NRT, we will consider enrolling them
6. Legal status that would interfere with participation
7. Living with someone currently enrolled in the project
8. Not being fluent in English
9. Not living within 45 miles of the research site
Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

This study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. Half of participants will receive visual perceptual training using the Nu.T. The other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.


Eligibility Criteria:
Inclusion Criteria:

* Intermittent Exotropia patients aged 6 to 15
* Patients with decreased stereopsis above 50 arc seconds in Titmus Dot Test
* Able to use the Virtual Reality(VR) device
* Patient or legally authorized representative has signed the informed consent form

Exclusion Criteria:

* Incomitant strabismus patient with impaired eye movement
* Patients with amblyopia (Maximal corrective vision of one eye is less than 0.8 or maximal corrective vision both eyes more than two lines of difference)
* History of ophthalmic surgery
* Patient who has undergone or is currently undergoing cover treatment within one month for the purpose of treating strabismus or amblyopia
* Scheduled for ophthalmic surgery during the clinical trial participation period (8 weeks in the treatment group as of the registration date, Maximum 16 weeks in the control group as of the registration date)
* Difficult to understand and perform the stereopsis test.
* Abnormal Retinal Correspondence
* Patient with neurological abnormalities other than strabismus
* History of premature birth
* Participating in other clinical trial
* Any other condition that, in the opinion of the investigator, precludes participation in the trial
Perfusion Index and Pleth Variability Index in Cesarean Section.

The aim of this study is to investigate the predictability of hypotension by using PI and PVI in pre-and post-spinal anesthesia periods in cesarean section cases in the sitting position.

Spinal anesthesia has been widely used all over the world due to its superiority to general anesthesia in cesarean section. However, as a result of the sympathetic blockade in spinal anesthesia, vascular tone decreases and hypotension occurs. The incidence of hypotension increases up to 70% in pregnant women due to increased sensitivity to local anesthetics and increased intraabdominal pressure. Improper management of postspinal hypotension may lead to maternal and fetal complications. Predicting the risk of hypotension in patients undergoing spinal anesthesia may allow applications such as volume loading or prophylactic vasopressor use. The perfusion index, measured by pulse Oximeters, correlates with blood flow changes at the tip of the finger so that it can detect hypotension and thus decrease in blood flow after spinal anesthesia. Pleth variability index (PVI) is a non-invasive value found in the new generation pulse oximeters. It is a parameter used in the dynamic measurement of response to fluid therapy in intensive care units. PVI can dynamically give an idea about the fluid status of the pregnant woman. Previous studies have shown that PVI may be a marker for predicting hypotension following spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who will undergo elective cesarean section

Exclusion Criteria:

* Preeclampsia
* Cardiovascular disorder
* Fetal abnormality
* Patients who failed spinal anesthesia or switched to general anesthesia during operation.