cyrilzakka/clinical-trials huggingface dataset:
Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy

Cardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart transplant recipients. Although several immune-mediated and metabolic risk factors have been implicated in the pathogenesis of CAV, no effective therapy is currently available to treat established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is based on prevention and treatment of factors known to trigger its development. Although the mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV progression.

Two strategies involving administration of specific anti-CMV agents are recommended for prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros and cons of the two strategies are still debated, in the absence of randomized studies addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear evidence of superiority of either approach.

The investigators conceived this randomized prospective project to compare the effect of preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on one-year increase in coronary intimal thickening. Patients will be additionally randomized to receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV properties of everolimus.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18y
* Heart or heart-kidney combined transplant
* Positive CMV serology at the time of transplant
* Glomerular filtration rate ≥ 20 ml/min/1.73m2 with MDRD at randomization.
* Written informed consent

Exclusion Criteria:

* Panel Reactive Antibody ≥50%
* Less than 1000/mmc neutrophils at the time of randomization
* Less than 30,000/mmc platelets at the time of randomization
* Clinical significant infection in the 2 weeks prior to transplant
* Glomerular filtration rate \< 20 ml/min/1.73m2 estimated with MDRD formula at the time of randomization or hemodialysis treatment
* Intolerance towards valganciclovir, everolimus, mycophenolate or cyc-losporine
* Known contraindication to statin use
* Negative CMV serology at the time of transplant
* HIV positive testing
* Severe comorbidities that, based on investigator's judgment, contraindicate study drugs or procedures
* Potentially childbearing women who refuse to use contraceptives
* Participation to an interventional study in the 2 preceding weeks
* Unwillingness or inability to follow study procedure and to sign written in-formed consent
LGMD R1 Natural History Study

This is a 24-month, observational study of 100 participants with Limb Girdle Muscular Dystrophy type R1, also known as CAPN3.

Limb girdle muscular dystrophies (LGMD) are a group of over 30 heterogenous genetic disorders which have in common a pattern of weakness affecting proximal muscles of the shoulders and hips. LGMD type R1 (LGMDR1; also LGMD2A) is due to loss of function of the muscle structural gene calpain 3 (CAPN3) and causes progressive weakness and muscle wasting, which can lead to loss of ambulation or the ability to maintain a job. LGMDR1 is one of the most common LGMDs in the United States and has no FDA approved therapies but is amenable to gene replacement strategies, regenerative medicine approaches, or myostatin based approaches. There have been rapid advances in gene delivery therapies for Duchenne Muscular Dystrophy and for LGMDR4 that have set the stage for targeted therapeutic development for all LGMDs, and LGMDR1 in particular is at a crossroads: the pace of therapeutic development has outstripped the efforts at clinical trial preparedness.

There is a need for a more rigorous natural history study to assist in the design of clinical trials; in particular, identifying biomarkers for early phase development and clinical outcome assessments (COAs) for drug approval studies.

This study will enroll 100 subjects across participating sites in the GRASP-LGMD Research Consortium. No treatment will be administered as part of this study. A subset of 80 patients will undergo MR scans at selected imaging sites. Study visits will occur at Baseline Day 1, Baseline Day 2, Month 12, and Month 24.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 12-50 at enrollment
2. Clinically affected (defined as weakness on bedside evaluation in a pattern consistent with LGMDR1)
3. Genetic confirmation of LGMDR1 (presence of homozygous or compound heterozygous pathogenic mutations in CAPN3).
4. Must be able to provide written informed consent and be willing and able to comply with all study requirements. Note: Adult participants must be able to provide consent themselves. Legally authorized representatives are not permitted to consent on behalf of adult participants.

Exclusion Criteria:

1. Have contraindications to MRI or MRS (e.g., non-MR compatible implanted medical devices or severe claustrophobia)
2. Non-ambulatory as defined by those who are not able to walk 10 meters without assistive devices (ankle foot orthotics excluded)
3. Positive pregnancy test at any timepoint during the trial
4. Have dominantly inherited CAPN3 mutations (LGMDD4)
5. Any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator.
Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation

The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.

The tricuspid valve is often called the "forgotten valve" because its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified. In developed countries, TR is mainly functional, related to a remodeling of the right cavities in response to an increase in the load conditions. This remodeling induces a dilation of the tricuspid ring and / or a "tenting" of the tricuspid leaflets. Once TR is present, a vicious circle settles because TR increases right ventricle dilation. Transthoracic echocardiography is the key examination allowing noninvasive, quantification and assessment of hemodynamic repercussions of TR.

TR remains asymptomatic for a long time, often diagnosed with a significant delay at the stage of advanced right heart failure. At this stage, the surgical risk is important, at least more important than for left heart valve diseases and it is therefore essential to define the right time for proposing valvular surgery to patients. Indeed, TR is an independent factor of mortality and only surgical treatment improves the prognosis.

Current guidelines remain vague given the low number of prognostic studies and of their contradictory results often influenced by the significant comorbidities of patients, the presence of pulmonary hypertension or left heart valve disease. Only a minority of patients (\<1%) is referred to surgery because operative mortality is often judged unacceptable in elderly patients or in cases of advanced right ventricular dysfunction.

The constitution of a prospective and retrospective cohort will improve the state of knowledge on etiologies, natural history, prognosis and management of patients with moderate or severe TR.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 ans
* inclusion criteria: moderate or severe tricuspid regurgitation
* exclusion criteria: Refusal to participate/ prior surgery of the tricuspid valve
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. Among these,fractional flow reserve (FFR) provides validated functional insights while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the percutaneous management of patients with AICL.


Eligibility Criteria:
Inclusion Criteria:

* single vessel disease with an intermediate coronary artery stenosis
* multivessel disease with multiple intermediate coronary artery stenosis only
* multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis

Exclusion Criteria:

* age \<18 years or impossibility to give informed consent,
* female sex with child-bearing potential,
* life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
* poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
* recent (\< 7 days) ST-segment elevation myocardial infarction
* recent (\< 48 hours) Non ST-segment elevation myocardial infarction
* prior ST-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation
* severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ECG Sokolow's criteria fulfilled)
* severe valvular heart disease
* significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3)
* gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks
* history of clotting pathology
* known hypersensitivity to aspirin, heparin, contrast dye
* advance renal failure with glomerular filtration rate \< 30 ml/min
* lesions in coronary artery bypass grafts
* multivessel disease requiring coronary aortic bypass graft intervention
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B

The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
* Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
* Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.

Exclusion Criteria:

* Evidence of hepatocellular carcinoma;
* Clinical signs of liver decompensation;
* Serum creatinine more than 1.5 mg/dL;
* ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
* Lamivudine therapy within 3 months prior to screening;
* ADV therapy or any other anti-HBV therapy within the previous 6 months;
* Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.
Treatment of Binge Eating Disorder

This is a multicenter (2 sites) randomized trial evaluating three group treatment models for subjects with binge eating disorder. One model is a cognitive behavior treatment (CBT) group, one is partial self help, and one is self help only.


Eligibility Criteria:
* Meet binge eating disorder (BED) Criteria
* Not psychotic
* Not in other treatment
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Eligibility Criteria:
* Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
* Successfully completed
* OR
* Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy
PTSD Interview Regarding Future Study Design and Equipment.

To gain insight and perspective unique to individuals with a diagnosis of PTSD, this study will utilize an experiential one-to-one interview format. During the interview, an investigator will walk the participants through several aspects of an ANS battery of tests, provide a tour and information about other equipment in the research lab and discuss tools and procedures associated with the application of chiropractic care. The aim of this research is to provide insight for future study designs that assess or provide care to individuals with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as having been diagnosed with PTSD.
* Between the ages 21-65 years old.

Exclusion Criteria:

-
Descriptive Analysis: STarT Back Screening Tool: Cross-sectional Survey & Chart Review

Keele STarT Back SCreening Tool (KSB) is a practical and validated bio-psychosocial questionnaire that stratifies lower back pain patients into 3 risk groups (low, medium, high), with suggested treatment guidelines for each grouping. The 9-question KSB has been used in chiropractic practice to help guide medical decision making, but its use in chiropractic teaching environments has been limited.

All new LBP patients between the ages of 18-65 years presenting to a chiropractic teaching clinic in Dallas, TX between March 05, 2018 and April 06, 2018 were asked to complete the KSB questionnaire. No introduction of the KSB was given to students or faculty. For all patients that completed the KSB, a chart review of the first 4 weeks of care was completed to retrieve patient follow-up information and treatment provided, including: self-reported LBP on a 10-point numerical rating scale (NRS), region of spinal manipulation therapy (SMT), and active rehabilitation provided.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 18-65 years old.

Exclusion Criteria:

* None
Effects of Wearable Sensor-based Interactive Cognitive-motor Training in Older Adults.

* Based on research showing that cognitive-motor training programs help improve cognition in older adults with mild cognitive impairment, this program uses an interactive system to combine cognitive training with exercise.
* The interactive system consists of wearable sensors and has the advantage of cognitive training without space constraints, and the cognitive training program consists of a total of five developed cognitive training games.
* The program is expected to improve the cognitive abilities of the elderly and improve their physical abilities.

The proposed study will conduct a randomized controlled trial to compare the effects of a cognitive-motor training program using a wearable sensor-based interactive system on the cognitive and physical abilities of older adults in the community. Study participants will be randomly assigned to receive one of two interventions: (a) motor-cognitive training (b) cognitive training. All interventions will last 50 minutes and will be delivered twice a week for 6 weeks. To determine the effectiveness of the interventions, the primary outcome will assess PFC activity and cognition, and the secondary outcome will assess aerobic capacity, balance, upper extremity muscle strength, lower extremity muscle strength, and instrumental activities of daily living tasks. All assessments will be administered one week before and one week after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling seniors age 65 and older
* MMSE-K 18 or less

Exclusion Criteria:

* People of Hospitalized or institutionalized
* People diagnosed with Alzheimer's disease
* People diagnosed with vascular dementia
* People with musculoskeletal conditions that make physical activity difficult
* People with dizziness that makes physical activity difficult
* People with a wound or bleeding in the head
Total Neoadjuvant Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

The main goal of this study is to investigate the histopathological regression rate in patients with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:

1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT) followed by surgery.
2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

758 participants with resectable locally advanced gastric and gastroesophageal (Siewert 2, 3) adenocarcinoma (T3-4b, N1-3, M0) with no history of previous treatment will be included in this study after reading and signing the informed consent. After the initial diagnostic laparoscopy, patients will be randomized into two groups in a 1:1 ratio, with allocation to one of the two study groups.

Patients who will be randomized to the first (control) group will receive 8 cycles of perioperative FLOT chemotherapy scheme: 4 cycles before surgical treatment and 4 cycles after surgical intervention. Patients who will be randomized to the second (study) group will receive 8 cycles of FLOT total neoadjuvant chemotherapy, followed by surgery.

Primary endpoint of the study is pathomorphological tumor response rate. Secondary endpoints are: perioperative morbidity and mortality (surgical and chemotherapeutic complications); disease-free survival (DFS) and 1-, 3- and 5-years overall survival (OS); quality of life during and after the treatment; correlation between the pathohistological response and chemotherapy regimen.

Eligibility Criteria:
Inclusion Criteria:

* Tumor spread: сT3, сT4a, сТ4b (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas); сN1, сN2, сN3; сM0;
* Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;
* Histological type of tumor: adenocarcinoma;
* Differentiation grade: G0 - G4;
* Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;
* Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen;
* No history of cancer in the past 5 years;
* Absence of previous chemotherapeutic, surgical or radiation treatment for oncological disease;
* No concomitant severe comorbidity;
* Patient willing to participate.

Exclusion Criteria:

* M1 (distant metastases);
* ECOG 2 - 4;
* Age over 80 and under 18;
* Concomitant severe comorbidity;
* Refusal of the patient to participate in the study.
Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.


Eligibility Criteria:
Inclusion criteria:

* Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.
* Each participant must be willing and able to provide written informed consent.
* Each participant must have an identified external contact person or an identified responsible person.
* Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\^TM\] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview \[MINI\]) at Screening.
* Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.

Exclusion criteria:

* Uncontrolled, unstable clinically significant medical condition.
* Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.
* Current primary Axis I disorder other than bipolar 1 disorder.
* Meets the current DSM-IV-TR\^TM criteria for substance abuse or dependence (excluding nicotine).
* Imminent risk of self-harm or harm to others.
Ventilatory Effects of THRIVE During EBUS

High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing.

This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent.

A randomized, double-blinded, cross-over study is designed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COPD Gold classification 3 or 4
* Scheduled EBUS with sedation

Exclusion Criteria:

* Known neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, dementia, Multiple Sclerosis or Guillain-Barré.
* Allergy or intolerance for propofol or esketamine
* Severe pulmonary hypertension (PAPsyst \> 60 mmHg)
* Pregnancy
* upper airway obstruction, such as subglottic stenosis or obstructing tumors.