cyrilzakka/clinical-trials huggingface dataset:
Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases

The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.

The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.

Eligibility Criteria:
Neurologic disease or movement disorders affecting 2 or more family members.

No conditions in which phlebotomy is contra-indicated.
PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

The standard of care imaging of prostate cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen (PSMA) expressed on prostate cancer cells. PyL PET/CT may provide improved evaluation of clinically significant metastases in patients with prostate cancer.

This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with:

1. High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and
2. Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (CT of the chest/abdomen/pelvis and bone scan).

In both cohorts, PyL PET/CT will be obtained and evaluated by a nuclear radiologist trained in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . Pathology will be used as the reference standard for confirming malignancy.

Eligibility Criteria:
Inclusion Criteria:

1. Male ≥ 18 years of age.
2. Histologically confirmed adenocarcinoma of the prostate
3. Patients meet one of the follow criteria:

Cohort 1: High risk prostate cancer (PSA \>10, Gleason 8-10, or clinical stage \>T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) \> 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria \[18\] and no evidence of malignancy on standard of care imaging for metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
2. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
3. Change in therapy since standard of care imaging
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients

The purpose of this study is to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.


Eligibility Criteria:
key inclusion Criteria:

1. History of at least 5 attacks of migraine
2. ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
3. \>=80% diary compliance during the baseline period

Key exclusion Criteria:

1. Older than 50 years of age at migraine onset
2. History of cluster or hemiplegic headache
3. Evidence of seizure or major psychiatric disorder
4. Cardiac or active hepatic disease
5. Pregnant or nursing
Psychosocial Support for Patients With Takotsubo Syndrome

The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.

Takotsubo cardiomyopathy, sometimes termed Takotsubo syndrome and "broken heart syndrome," typically presents with symptoms remarkably similar to acute myocardial infarction (MI; heart attack): debilitating chest pain, shortness of breath, and a feeling of doom, among others. Takotsubo was first identified in 1990 in Japan. Most cases occur in older women. During the acute phase, the heart spontaneously undergoes "apical ballooning," changing shape to resemble a "takotsubo," a Japanese octopus trap. In approximately two-thirds of cases, Takotsubo is precipitated by an intense emotional or physical "trigger." Typically, the heart spontaneously reverts to its previous shape within about a month. Initially, it was thought that recurrence was rare. However, more recently, recurrences have been reported in 3-15% of cases. Many patients experience a variety of debilitating cardiac and psychological symptoms long after the initial presentation. There is no known way to prevent a recurrent event and patients are typically anxious about the possibility.

Since its inception as a diagnosis, one of the hallmarks of Takotsubo has been the absence of coronary artery plaque. In a surprising finding from 2019, a study of more than 1,000 Takotsubo patients undergoing coronary angiography reported that approximately 1/3 of patients had clinically significant plaque in their coronary arteries; 1/3 had evidence of sub-clinical atherosclerosis; and 1/3 had "clean coronaries," with no observable plaque. Hence, much needs to be learned about this syndrome that may affect as many as 5% of women who have been diagnosed with acute MI. Takotsubo is typically an emotionally challenging and life altering event. Strategies for primary and secondary prevention of coronary artery disease will be discussed in the virtual group sessions.

Currently, there is no specialized intervention for patients diagnosed with Takotsubo Syndrome at Weill Cornell Medical Center, either in hospital or after discharge.

Eligibility Criteria:
Inclusion Criteria:

- All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old.

Exclusion Criteria:

* Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or those who choose not to participate.
* Vulnerable populations such as prisoners, non-English speaking subjects, pregnant women, and subjects unable to provide written informed consent will not be included in this research.
A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome

This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101 to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if the subject does not meet randomization criteria).It is anticipated that the overall duration of the study per subject will range from approximately 16-22 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of endogenous Cushing's syndrome
* Baseline UFC 1.3 to 10 × upper limit of normal (ULN)
* If previous pituitary surgery, participants must be at least 3 months since surgery at the time of screening
* BMI between 18 and 60 kg/m2, inclusive

Exclusion Criteria:

* Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's syndrome
* Candidates for surgical treatment of Cushing's syndrome, unless surgery is not anticipated to occur during the study
* Normal late night salivary cortisol or 24-hr urine free cortisol
* Radiotherapy of the pituitary within 6 months
Ventilation Distribution in COPD Patients During Breathing Exercises

ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.

This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution.

Electrical impedance tomography will be used to verify the effect of the lateral posture and associated breathing techniques in COPD and healthy individuals. The subjects will be placed in a standardised position before the measurements begin. The subjects will be placed in a right lateral recumbency position. The protocol comprises four manoeuvres, each interrupted by a short rest phase. Each subject will begin the experiment with the spontaneous ventilation manoeuvre in order to obtain the reference ventilation distribution. This will be followed by four other manoeuvres during which ventilation was measured: 1) using an spirometer to obtain a tidal volume of 1L, 2) performing the ELTGOL technique independently, 3) performing the ELTGOL technique assisted by manual pressures applied by a physiotherapist. 4) using a positive expiratory pressure (PEP) device.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects: No acute or chronic respiratory disease, normal lung function, non-smoker.
* Patients with COPD: forced expiratory volume at one second (FEV1) ≤ 80% predicted value, in stable state.

Exclusion Criteria:

* Healthy subjects: obesity (BMI \> 35kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); thoracic skin lesion.
* Patients with COPD: obesity (BMI \> 35kg/m²); severe scoliosis; severe cardiovascular disease; neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); thoracic skin lesion.
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM).
* Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
* Have HbA1c between ≥7.0% and ≤9.5%.
* Be of stable weight (± 5%) for at least 3 months before screening.
* Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

* Have type 1 diabetes mellitus.
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
* Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m².
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Combined Motor and Cognitive Training for Older Adults With Motoric Cognitive Risk Syndrome (CMC-training)

To investigate the effects of a combined motor-cognitive intervention on the improvement of motor as well as cognitive function in community residents.

Cognitive training uses systematically designed tasks that are difficulty-adaptive for cognitive domains such as attention, memory, and logical reasoning to improve individual cognitive functioning. Internet-based Adaptive Multi-Cognitive Domain Cognitive Training is conducted 3 times per week for 30 minutes each time, and includes tasks such as delayed memory, paired memory, and inverse numerical breadth.

The exercise intervention was based on the M-Mobile multicomponent exercise program, in which older adults were instructed to complete exercise training at home at least three days per week. In all intervention groups, balance, sitting test and walking speed were assessed according to the Simple Physical Performance Battery (SPPB), and according to their scores, they were given exercise training, including flexibility, balance, aerobic training and resistance training.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 years; ≥ 9 years of education; Cognitive impairment: MMSE score 22-26; Slow gait:total walking time \>4 seconds and ≤8 seconds in a 4-meter walk test; Agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Dementia/suspected dementia; Suffering from diseases that affect cognitive function, such as cerebrovascular disease, Parkinson's syndrome, etc.; Taking medications related to cognitive improvement and psychiatric disorders, etc.; Recent heart attack, severe cerebrovascular disease, psychiatric disorders, etc.; other inability to persist in completing exercise cognitive interventions, such as suffering from severe musculoskeletal disorders; Participating in another clinical trial at the same time； Participation in an exercise and/or cognitive intervention in the past 6 months; Inability to complete content in studies such as neuropsychological scale assessments.
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed myelofibrosis with myeloid metaplasia.
* No limitations on allowable type and amount of prior therapy.
* Patients must have normal organ function.
* Must be willing to submit to blood sampling for planned PK and PD analyzes.
* Must have ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy.
* Patients with prior exposure to obatoclax.
* Uncontrolled, intercurrent illness.
* Pregnant women and women who are breast feeding.
Effects of Sitting Meditation and Hatha Yoga in Adolescents

The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined.

The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined. Participants (N = 198 adolescents) were recruited from a large public middle school in southern California. Participants were randomly assigned to sitting meditation, hatha yoga, or a waitlist control group. Participants were asked to complete a computerized working memory task, and self-report measures of perceived stress, anxiety, and mindfulness at pre- and post-intervention/waitlist, as well as one-month follow-up. A series of mixed-design analyses of variance (ANOVAs) were used to examine changes in working memory, stress, anxiety, and mindfulness between groups at pre- and post- intervention.

Eligibility Criteria:
Inclusion Criteria:

* Students currently enrolled in school
* Between the ages of 12 - 17 years old
* English speaking-to understand and complete the measures
* Able to attend the weekly hatha yoga or sitting meditation sessions
* Not reporting any injuries or health condition(s) that might limit their physical activity

Exclusion Criteria:

* hearing impairments, injuries, or physical disabilities that would hinder them from fully participating in intervention
Renal Impairment Study

The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment

Exclusion Criteria:

* History of heart disease
* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Efficacy of Salivary Bacteria and Post Brushing

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental procedures/visits
* Medical condition which precludes eating/drinking for 12 hrs.
* History of allergy to common dentifrice ingredients
* Subjects unable or unwilling to sign the informed consent form.
* Moderate or advanced periodontal disease.
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can currently affect salivary flow
* Current use of antibiotics
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 30 days prior to enrollment into this study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)

The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.

DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard.

METHODOLOGY

* The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.
* Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.

Eligibility Criteria:
Inclusion Criteria:

* age 18-85 years
* compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care
* signed informed consent

Exclusion Criteria:

* known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy
* portal thrombosis
* previous surgical or transjugular portosystemic shunt
* previous total or partial splenectomy
* presence of comorbid conditions conferring a life expectancy of less than 1 year
Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana

We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to IVM alone given annually, which is the current standard for mass drug administration (MDA), is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given twice per year is superior to IVM given once per year or twice per year.

We hypothesize that more effective combinations of dose schedules of existing antifilarial drugs for MDA against onchocerciasis could shorten the number of years needed to interrupt onchocerciasis transmission and eliminate this infectious disease in areas that previously had high disease rates. Improved treatments should also make it feasible to extend MDA into areas that are currently not being helped. These changes have the potential to completely change the game to make global elimination of onchocerciasis a feasible goal.

Participants will be randomized into 5 treatment arms with 75 subjects in each arm for a total of 375 and followed for 36 months after the initial treatment. The primary endpoint will be the percent fertile adult female worms in nodules removed 36 months after the initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana
2. Two or more assessable onchocercal nodules
3. Skin microfilaria density ≥5mf/mg.

Exclusion Criteria:

1. Prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine, suramin, ivermectin, albendazole, levamisole or \>1week of treatment with doxycycline, within 12 months before planned test article administration.
2. Pregnant or breastfeeding women.
3. Low probability of residency in the area (based on subject's assessment) over the next 36 months.
4. Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
5. Weight of \<40kg suggesting malnourishment
6. Hemoglobin levels \<7 gm/dL
7. aspartate aminotransferase, alanine aminotransferase, creatinine \> 1.5 upper limit of normal.
8. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose).
9. Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.