cyrilzakka/clinical-trials huggingface dataset:
Impact of an Online Behavioral Weight Loss Program

This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12 weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after 12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.

This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.

Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index (BMI) of 25 to 40;
2. age 18 to 65 years;
3. blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
4. caffeine intake 100-400 mg/d; and
5. ability to participate in physical activity for a minimum of 150 min/week.

Exclusion Criteria:

1. pregnancy, lactation or actively trying to become pregnant;
2. medical illnesses or medications that could affect body weight;
3. cigarette smokers;
4. weight loss of 10 or more pounds in the last 3 months;
5. fasting blood glucose greater than 126mg/dl;
6. participation in a clinical research study that would conflict with the purpose of the current trial; and
7. other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
Safety Study of Entocort for Children With Crohn's Disease

A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Eligibility Criteria:
Inclusion Criteria:

* All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
* Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology.
* Subjects with mild to moderate Crohn's disease.
* All subjects must have a stool analysis negative for Clostridium difficile toxin, Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days prior to visit 1.
* All subjects must have had laboratory assessments within 7 days prior to visit 1.
* All subjects must weigh \>= 15 kg at time of enrollment

Exclusion Criteria:

* Subjects who have had any previous intestinal resection proximal to and including the ascending colon
* Subjects with evidence of severe active Crohn's disease and/or, stricturing and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
* Subjects who do not have a negative stool analysis, within the 30 days prior to visit 1
* Subjects who have been screened/or enrolled in this study previously within the last 30 days
* Subjects with morning cortisol level \<150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder

This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.

Part A of the study is an open-label design with dosing of SAGE-217 for 14 days.

Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to SAGE-217 or placebo for 14 days.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

* Participant has a history of suicide attempt
* Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
* Participant has active psychosis
* Participant has a medical history of seizures
* Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Tumor Regression Grade As Predictor of Adjuvant Therapy

Neoadjuvant therapy followed by surgery is preferred for locally advanced esophageal squamous cell carcinoma, but the necessity of adjuvant therapy remains controversial. Tumor regression grade reflects the response to neoadjuvant therapy and may predict patient prognosis, yet its role in guiding adjuvant therapy remains unexplored.

We aim to explore the role of TRG and other clinical characteristics in predicting the efficacy of postoperative adjuvant therapy in ESCC patients receiving neoadjuvant therapy. This study Includes patients who underwent R0 esophagectomy for thoracic ESCC after neoadjuvant therapy. Patients will be assessed by TRG and divided into good responders (TRG 0-1) and poor responders (TRG 2-3). The main variable of interest is adjuvant therapy, and the primary outcome is OS, defined as time from diagnosis until death. Cox proportional hazards regression models will be used to calculate hazard ratios and 95% confidence intervals to assess the impact of various variables on survival time.

Eligibility Criteria:
Inclusion Criteria:

(I) underwent R0 resection with either two-field or three-field lymphadenectomy (II) received neoadjuvant therapy such as preoperative radiotherapy, chemoradiotherapy, or combined immunotherapy (III) had esophageal squamous cell carcinoma pathology.

Exclusion Criteria:

(I) Patients with incomplete clinical data or follow-up information (II) Diagnosed with multiple primary malignancies
Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy

Spastic Hemiparetic Cerebral Palsy (SHCP) uses to limit the manual function. Using anodic transcranial direct current stimulation, it is possible to activate certain cerebral areas depending on where the electrodes are. This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects.

It has been designed a single-arm prospective longitudinal quasi-experimental pilot clinical study following the SPIRIT 2013 statement. It will value the time that the children spend doing the bimanual activities described by the Children's Hand-Use Experience Questionnaire (CHEQ), it will also value the subjective experience doing those activities; it will analyze the active movement (Fugl-Meyer for upper limb), spasticity (modified Ashworth), manual strength (dynamometry) and the recruitment improvement (surface electromyography) too.

This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 session per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper limb. Another evaluation will be realized 3 weeks after the last session of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term.

Eligibility Criteria:
Inclusion Criteria:

* Children between 14-18 years old.
* Children with spastic hemiparetic cerebral palsy diagnosis.
* Children with a cognitive level high enough to understand and to do the activities to value them.
* Children hemodynamically stable.
* Children forming part of levels II-IV of the Manual Ability Classification System (MACS).

Exclusion Criteria:

* Children with defibrillator.
* Children with pacemaker.
* Children with cerebral stimulator.
* Children with intracranial metallic implants.
* Children with opened cranial after clambering.
* Children that receive another treatment (pharmacological or physiotherapical) that could interfere or disrupt the results.
* Another circumstance where the electrotherapy treatment is contraindicated.
Patient Convenience Study (RE-SONANCE)

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).


Eligibility Criteria:
Inclusion criteria:

Cohort A:

1. A. Written informed consent prior to participation
2. A. Female and male patients \>= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
4. A. Patients switched to Pradaxa according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

1. B. Written informed consent prior to participation.
2. B. Female and male patients \>= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
3. B. Stroke prevention treatment initiated with Pradaxa or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria:

1. Contraindication to the use of Pradaxa or VKA as described in the Summary of Product Characteristics (SmPC).
2. Patients receiving Pradaxa or VKA for any other condition than stroke prevention in atrial fibrillation.
3. Current participation in any clinical trial of a drug or device.
4. Current participation in an European registry on the use of oral anticoagulation in AF.
Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria

Exclusion Criteria:

* Allergy to Bacillus clausii spores
* Prior treatment with antibiotics or probiotics (4 weeks)
* Not willing to fulfill symptom diary
* Pregnancy or breastfeeding
* Clinical suspicion of organic disease
Effect of Cimetidine on the PK of Imeglimin

The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.


Eligibility Criteria:
Inclusion Criteria:

* BMI : 18.5-29.9
* Body weight ≥ 60 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
* Clinically relevant abnormal findings at the screening assessment
* Clinically significant vital signs outside the acceptable range at screening
* Clinically relevant abnormal medical history, surgery or concurrent medical condition
* Acute or chronic illness
* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
* Severe adverse reaction to any drug or sensitivity to the trial medication or its components
* Significant food allergy; vegetarian or vegan
* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* Drug or alcohol abuse
* Smoking of more than 5 cigarettes daily
* Possibility that subject will not cooperate
* Positive test for hepatitis B \& C, HIV
* Objection by a General Practitioner
Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain

We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).

A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.

Eligibility Criteria:
Inclusion Criteria:

* having no abnormal results in routine blood tests
* having no known acute or chronic inflammatory disease
* an education level required for understanding the applied treatment, interventions

Exclusion Criteria:

* malignancies
* active infection
* history of common inflammatory rheumatic disease
* trauma in spinal area, skin lesion, presence of infection or open wounds
* radiculopathy
* peripheral circulation disorder
* use of warfarin due to coagulopathy
* arthropathy
* congenital or acquired spinal pathology
* pregnancy
A Comprehensive Registry Study of the Whole Life Cycle of Patients With CHD

This observational study aims to collect data on the prevalence, intervention, and prognosis of congenital heart disease (CHD) in Chinese patients across their entire lifecycle. From the diagnosis of CHD in fetuses, to early treatment of severe CHD in neonates, to standardized perinatal diagnosis and treatment of CHD patients with concurrent pregnancy, the study employs a cyclical model consisting of evaluation, training, improvement, and re-evaluation. The goal is to enhance the diagnostic and treatment capabilities of participating hospitals, especially for complex CHD cases, and promote standardized clinical practices in cardiovascular disease treatment among these hospitals. This will ultimately improve the quality of medical services provided to cardiovascular patients and serve as a basis for exploring CHD treatment guidelines suitable for China.

The project will be implemented by Capital Medical University Affiliated Beijing Anzhen Hospital and the National Clinical Research Center for Cardiovascular Diseases. The plan is to involve more than 20 hospitals over the next five years. An independent website will be created for data collection, education and training, as well as experience sharing among participating hospitals. Starting from January 1, 2024, each hospital will continuously collect CHD inpatient cases on a monthly basis. The project team will regularly analyze and report on the completion of key medical quality evaluation indicators for each hospital. They will provide guidance measures such as education, training, experience sharing, and on-site investigations to address identified issues, helping hospitals improve medical quality. Hospitals that demonstrate excellence and significant improvement will be recognized and commended, driving overall improvement in the quality of cardiovascular medical care in China.


Eligibility Criteria:
Inclusion Criteria:

* Patients with various congenital heart diseases

Exclusion Criteria:

* None
Development and Validation of Interpretable Machine Learning Models Incorporating Paraspinal Muscle Quality for to Predict Cage Subsidence Risk Followingposterior Lumbar Interbody Fusion

The study focuses on identifying risk factors for cage subsidence after posterior lumbar interbody fusion (PLIF) and developing an interpretable machine learning model to predict these risks. It analyzes patients from two large teaching hospitals, using clinical, radiographic, and surgical parameters, including paraspinal muscle indices and bone density markers. A web-based application was developed to facilitate real-time clinical risk assessments using the machine learning model, enhancing surgical planning and reducing subsidence risks.


Eligibility Criteria:
Inclusion Criteria:

1. confirmed lumbar disc herniation, spinal stenosis, or spondylolisthesis based on clinical and imaging findings;
2. patients who failed conservative treatment for ≥3 months or experienced recurrence and underwent surgery for the first time;
3. minimum 12-month follow-up.

Exclusion Criteria:

1. prior spinal surgery;
2. spinal deformity or severe instability;
3. lumbar tuberculosis, infection, tumor, or severe bone destruction;
4. incomplete or lost follow-up.
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
* Capable of self-care but may be unable to carry out any work activities.
* No prior anticancer therapy for SCLC

Exclusion Criteria:

* have previously participated in a study involving pemetrexed
* have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant

RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by infusion and then by mouth may be effective treatment for cytomegalovirus that has become active after donor bone marrow transplant.

PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth works in treating patients with cytomegalovirus after donor bone marrow transplant.

OBJECTIVES:

* To determine the feasibility of using oral ganciclovir (GCV) following induction with intravenous GCV in the setting of cytomegalovirus (CMV) reactivation after bone marrow transplantation.

OUTLINE: Blood cultures for cytomegalovirus (CMV) are obtained periodically after the planned bone marrow transplantation (BMT). Patients showing reactivation of CMV receive induction ganciclovir (GCV) IV twice a day on days 1-7. Patients then receive maintenance oral GCV three times a day for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacokinetic studies.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Undergoing allogeneic transplantation, including unrelated donor bone marrow transplantation (BMT) and/or allogeneic donor leukocyte infusion, for any indication
* Patients or their donors must have had a positive pre-BMT cytomegalovirus (CMV) antibody titer as measured by enzyme-linked immunosorbent assay (ELISA)

PATIENT CHARACTERISTICS:

* Able to comply with study requirements

Exclusion criteria:

* Signs or symptoms of documented CMV infection, including any positive CMV culture from any site and/or any suspected or documented CMV-associated clinical syndrome, at the time of study entry
* History of symptomatic CMV-associated clinical syndrome

PRIOR CONCURRENT THERAPY:

* Receiving concurrent investigational antiviral agents

PATIENT CHARACTERISTICS:

* History of hypersensitivity to ganciclovir or acyclovir
Heat Waves and the Elderly With COPD

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

Heat waves are the leading cause of death among natural disasters in the United States.

Elderly individuals are disproportionately more likely to become ill or die during heat waves. While the elderly have a reduced ability to regulate their body temperature,8-10 hospitalizations and deaths in this population during heat waves are primarily due to cardiovascular and/or respiratory complications, not solely hyperthermia. While previous research has primarily focused on the thermal and cardiovascular consequences of healthy aging, very little research has focused on the physiological responses to heat exposure in older individuals with chronic disease, such as chronic obstructive pulmonary disease (COPD). Notably, epidemiological data suggests that pulmonary complications are a leading cause of heat wave-related hospitalizations in older adults with a diagnosis of COPD, yet nothing is known regarding the physiological mechanisms by which those with COPD are most susceptible to heat waves. To fill this important gap, the investigators will identify the physiological responses that occur in this population, relative to healthy age-matched individuals, during two unique heat wave simulations.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older
* Diagnosis of COPD

Exclusion Criteria:

* Known heart disease
* Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc
* Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram
* Current smokers
* Participant with a body mass index ≥31 kg/m2
Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital

Design online program for language sessions for cochlear implanted children in arabic and monitor its validity and reliability to improve language outcome

Design online program for teletherapy and coach parents to improve language of their children with cochlear implant and evaluate language outcome before and after teletherapy and compare it with control group who will take classical face to face sessions

Eligibility Criteria:
Inclusion Criteria:

* Cochlear implanted children with non verbal intelligence quotient 80 or above
* parents are compliant to the sessions

Exclusion Criteria:

* cochlear implanted children who have non verbal intelligence quotient less than 80 using the Arabic version of Stanford Binet intelligence scale 5th edition
* parents are non compliant to sessions