cyrilzakka/clinical-trials huggingface dataset:
Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change

This is a study of patients with spasmodic dysphonia to determine how best to measure the severity of the disorder in patients. It addresses which characteristics of speech are the best indicator of whether or not a particular treatment has benefited a person with spasmodic dysphonia. We hope to recruit 20 participants each at 2 different centers. The evaluation for each participant will be done on a two visits, one just before and another several weeks after treatment.

This is a study of changes in voice and laryngeal function with treatment recorded using the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP). Persons with adductor spasmodic dysphonia will complete a questionnaire on the Voice Handicap Index (VHI) and ratings of speech effort as well as have their speech recorded and receive a nasolaryngoscopy examination prior to their usual treatment with botulinum toxin injection into the laryngeal muscles for their voice disorder. They will return for re-examination several weeks later after their injection and repeat each of the examinations. The purpose is to determine which items on the SD-DAP are sensitive to changes in the severity of their voice disorder. The items that show sensitivity would be those that would be useful for assessing voice outcomes in clinical trials. Some of the questions this study is trying to answer are

* What is the best way to measure the severity of spasmodic dysphonia?
* How does treatment of spasmodic dysphonia by botulinum toxin injection affect voice for communication in regular daily life in spasmodic dysphonia
* Is change in speaking effort related to the change in severity of spasmodic dysphonia with botulinum toxin injection?

Each participant in this study will be asked to do the following:

* Provide a copy of medical records and medical history relating to the diagnosis of spasmodic dysphonia.
* Have an examination by an otolaryngologist with a medical periscope inserted in the throat to view the voice box in action. The examination will be so it can be reviewed later by several different experts.
* Complete questionnaires regarding the severity of their disorder before and after receiving their usual treatment; an injection of botulinum toxin into the laryngeal muscles.
* Repeat a speech recording and laryngeal examination before and after treatment

Eligibility Criteria:
Inclusion Criteria:

* be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia)
* be 18 years of age or older

Exclusion Criteria:

* be diagnosed with secondary spasmodic dysphonia (laryngeal dystonia)
* be younger than 18 years of age
* unable to complete questionnaires
* not able to have a nasolaryngoscopy (examination of the voice box with a medical periscope)
The Best Parameter of Bladder Diary Correlates With the Volume at Strong Desire to Void of Filling Cystometry

To identify the bladder diary parameters that are best correlated to VSD.

To identify the bladder diary parameters that are best correlated to VSD.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with lower urinary tract symptoms who had underwent urodynamic studies

Exclusion Criteria:

* Patients without data of bladder diary
RADTOX: Measuring Radiation Toxicity Using Circulating DNA

This research study is being done to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications. This research study would allow monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that could give an initial result within a few days that would help clinicians make treatment decisions. Detection of unusual tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions that could include patient therapies that would reduce or prevent the problems that occur due to treatment of their cancer.

Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) dose are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage within 24 hours of radiation exposure and should help identify patients at higher risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity.

Patients undergoing radiation treatment for stage I to III prostate cancer, using protons or X-rays, either as primary treatment or consolidation after prostatectomy (positive margins or prostate-specific assay \[PSA\]-related indications) will be eligible. Hormone treatment will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study and a signed and dated an institutional review board (IRB)-approved consent form conforming to federal and institutional guidelines.
* ≥ 18 years of age.
* Patients must have an Eastern Cooperative Oncology Group (An ECOG) performance status of 0 or 1.
* A diagnosis of adenocarcinoma of the prostate.
* Not yet begun definitive therapy with chemotherapy or radiation but may have hormones or surgery.
* Clinically stage I to III tumors.

Exclusion Criteria:

* Metastatic disease.
* A history of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
* Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic).
* Prior pelvic radiation therapy for any reason.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the principal investigator (PI), would preclude the patient from meeting the study requirements.
NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.

Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 or above, and gender unrestricted
* Individual with pathologically diagnosed lung cancer

Exclusion Criteria:

* Patients with concomitant other tumors
* Individual with severe cardiopulmonary insufficiency and hypoproteinemia
* Women who were pregnant and were during their lactation
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329

The purpose of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8329 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects.

A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral AZD8329 after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 27 and 35 kg/m2 and a waist circumference greater than or equal to 102cm.
* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male subjects aged =20 to =50 years with suitable veins for cannulation or repeated venepuncture

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate.
* Fasting serum (S)-glucose =7.0 mmol/L or non-fasting S-glucose =11.1 mmol/L at screening.
* Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment
Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease

The purpose of this research study is to study the safety and efficacy of fenofibrate, an FDA-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment for Huntington's disease (HD). Subjects who meet the entry criteria will be randomized (3:1) to either 145mg of fenofibrate or placebo.


Eligibility Criteria:
Inclusion Criteria:

* An adult of either sex, ages 25-85 inclusive,
* Have proficiency with written and spoken English and corrected vision or hearing to complete the cognitive testing,
* Are able to give informed consent,
* Have good overall health status with no known problems anticipated over the course of the trial,
* Have a diagnosis of HD supported by positive gene test within the past 6 months.

Exclusion Criteria:

* Other major neurological disease \[e.g., multiple sclerosis, parkinson's disease, cortical stroke, etc\]
* Clinically significant hepatic or renal disease,
* Current or recent (\< 1 month) use of dopamine blocking agents such as tetrabenazine, anticonvulsants, neuroleptics, HAART, antiemetics, and antipsychotics for any reason,
* Current use of Warfarin (Coumadin). Enrollment in another investigational drug study within the prior three months.
Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein

Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells. These hidden cells contain HIV that is not active and do not produce the virus. These cells are a major challenge in finding a cure for HIV.

One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents (LRAs). This process, known as the "shock-and-kill" strategy, involves waking up the hidden virus ("shock" phase) so that it can be destroyed by the body's immune system or by the virus itself ("kill" phase).

Investigators are developing new LRAs that target and activate a viral protein called Tat, which is necessary for the virus to start producing again and for reversing its dormant state.The lead compound, named D10, is the first of its kind to target the Tat protein. This compound has been patented and has shown activity in activating the virus in lab-grown cells. Now, investigators need to test its effectiveness on real target cells from people living with HIV.

20 ml of blood (5 tubes of 4 ml each) will be collected from 24 people living with HIV who are on ART. The inclusion criteria for this study are: being HIV-positive, having an undetectable viral load for more than 12 months, and having a history of very low T-CD4 counts (nadir \< 200 cells/mm³).

In the lab, investigators will isolate immune cells (PBMCs) from the blood using a special technique. These cells will then be placed in small wells and treated with LRAs for 18-20 hours. Investigators will measure the virus produced in the cell supernatant using two methods: q-RT-PCR for viral RNA and p24 ELISA for viral protein. The results will be analyzed using conventional statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* HIV-positive
* On ART (antiretroviral therapy)
* HIV-1 RNA undetectable for more than 12 months
* Nadir CD4 count \< 200/µL

Exclusion Criteria:

* Lack of antiretroviral treatment
* Immunosuppressive treatments
* History of cancer less than 5 years old
* Pregnant or breast-feeding women
* Persons protected by law (under guardianship or curators), persons under court protection
* Participating in another research project with an ongoing exclusion period
* Refusal to participate in research
* Subject not affiliated to a social security scheme, or not benefiting from such a scheme.
Brain Gut Axis Changes After Bariatric Surgery and Their Relationship to Weight Loss

Assessing the changes in the brain-gut axis after weight loss surgery and their relationship with weight loss and changes in eating behaviors.

Obese women undergoing weight loss surgery will be recruited to participate in the study. These individuals will undergo a screening visit and 4 study visits. The study visits will occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will include evaluation of brain function (fMRI), anthropometrics, blood and stool samples and eating behaviors questionnaires.

Assessing the changes in the brain-gut axis after weight loss surgery and their relationship with weight loss and changes in eating behaviors.

Obese women undergoing weight loss surgery will be recruited to participate in the study. These subjects will undergo a screening visit and 4 study visits. The study visits will occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will include evaluation of brain function (fMRI), anthropometrics, blood samples (gut hormones, cytokines, metabolomics ) and stool samples (16S RNA and Metabolomics) and eating behaviors questionnaires (YFAS, TFEQ, food cravings/preferences scales, 3-day food food intake records)

Primary outcomes: weight loss after surgery and changes in eating behaviors scales (YFAS, TFEQ) , metabolomics, appetite related hormones and gut microbiome (16S RNA) Secondary outcomes: changes in brain function (fMRI/MRS), diet (3-day food intake records) and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Women, age 18-55 years
* Eligible and approved for undergoing laparoscopic gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) following the Guidelines for Clinical application of Laparoscopic Bariatric Surgery by of American Gastrointestinal and Endoscopic Surgeons (SAGES)
* Right-handed

Exclusion Criteria:

* Previous major gastrointestinal surgery including weight loss surgery (partial or complete resection of stomach and/or small bowel, Whipple procedure, etc)
* Use of medications known to affect hunger, satiety, or intestinal motility.
* Unwillingness or inability to give informed consent
* Any contraindication to undergo MRI
* Current or past alcohol or drug abuse problem or smoking
* Pregnancy, lactating or post partum less than 12 months
* Body weight at enrollment greater than 350 lbs.
* Current use of insulin and or insulin dependent diabetes
* Renal insufficiency, retinopathy, or neuropathy.
* Post menopausal (defined as no menses for 12 consecutive months)
The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.


Eligibility Criteria:
Inclusion Criteria:

1.Meet the definition of severe pneumonia(Comply with any of the followings):

1. Shortness of breath,RR≥30 bpm;
2. In a resting state:SPO2≤93%;
3. PaO2/FiO2≤300mmHg.

2.2019-nCoV nucleic acid test was positive.

3.CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

1. dying state (i.e. survival time is less than 24 hours);
2. progressive malignant tumor with life expectancy less than 6 months;
3. immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
4. underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
5. pregnancy
6. patients with glucocorticoid taboos
Promoting Tobacco Control and Smoking Cessation in Workplaces [Phase I]

Previous research shows a significant proportion of smokers work in full-time employment. Given that the majority of smokers do not aware of the smoking cessation services available in Hong Kong, implementing smoking cessation policy in the workplaces may assist a considerable number of smokers to stop or reduce smoking.

This study aims to:

1. examine the employers' knowledge, attitudes and practices in promoting smoking cessation in workplace.
2. test the effectiveness of a brief and an intensive smoking cessation interventions to help workers stop smoking

In Phase I of this study, a large scale cross-sectional survey will be conducted to 3000 corporate companies in Hong Kong. The questionnaire will examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplaces.

In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a smoking cessation intervention offered by the Department of Psychology, the University of Hong Kong. Smokers from the participating companies will be interviewed before the intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and 52-week post-intervention follow-ups.

The follow-up assessments will consist of a biochemical validation for the self-reported quitters who report quitting in the past 7 days via exhaled carbon monoxide and saliva cotinine concentration tests. Participants' smoking behaviour, knowledge on smoking and satisfaction of the smoking cessation services will also be evaluated.

It is hypothesized that the smoking cessation intervention helps workers stop smoking. Employers' knowledge and attitudes are positively associated with the practices in promoting smoking cessation in workplace.

Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group will be conducted after 6-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18 or above
* Cantonese speaker and able to read in Chinese characters
* Smoke at least one cigarette per day
* Stay at Hong Kong during the intervention and follow-up periods (12 months)

Exclusion Criteria:

* Smokers who are psychologically or physically unable to communicate
* Smokers who are currently following other smoking cessation programme(s)
* Smokers with diagnosed psychiatric illnesses
Development and Validation of the GLORI-COPD Score

The objective of this study is to evaluate the diagnostic accuracy of the GLORI-COPD score in ambulatory care, to enable the screening of COPD patients at risk of complications, requiring early management

Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high prevalence in France, but which remains under-diagnosed due to the trivialization of symptoms and difficulty in accessing diagnostic investigations. It is associated with other co-morbidities, with an impact on the occurrence of complications and quality of life. Early management of the most severe patients would allow better control of these risks of complications. Our objective is to better identify patients with COPD at risk of complications in general practice, taking into account the totality of the patient, to improve their management.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 35 yo
* smoker or former smoker ≥ 10 Pack Years

Exclusion Criteria:

* Patients who have already been diagnosed with COPD by spirometry,
* have a contraindication to spirometry,
* have an estimated life expectancy of less than 5 years
* are under protective measures
Role of Oxygen for Vascular Dysfunction

Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for vascular function. For this purpose we measure capillary oxygen concentration and vascular.

Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood flow and laser doppler perfusion imaging.

We hypothesize that hypoxemia leads to impaired vascular function.


Eligibility Criteria:
Inclusion Criteria:

* stable coronary artery disease
* stable chronic obstructive pulmonary disease

Exclusion Criteria:

* acute myocardial infarction within 30 days
* acute exacerbated COPD within 30 days
* acute infections
* severe acute or chronic renal failure
* severe heart failure
* atrial fibrillation
* severe cardiac arrhythmia
* hypotension
* active malignant disease
* active rheumatic disease
* pulmonary hypertension with vasoactive therapy
Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial

Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strength and performance and increased risk of falls and fractures, physical disability and premature death. With the present project the investigator aim to assess the effect of a feasible exercise program to improve muscle strength (primary outcome), and muscle volume and performance and other measures potentially associated with sarcopenia (secondary outcomes) in elderly and people living with HIV (PLWH) with sarcopenia. The investigators plan to enroll 98 elderly and 98 PLWH in a multicentric, 48-week, randomized, parallel-group, open label, superiority trial comparing the effect of a home-based and app-monitored strength exercise intervention versus no intervention. The investigators expect that participants who exercise will improve strength and other parameters and that improvement at week 12 and week 48 will be higher than in no-exercise controls.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary
* \>60 year-old in the elderly group or \>50 year-old for the PLWH group;
* with sarcopenia, as defined by both relative loss of muscle mass by bioimpedentiometry (BIA) and low muscle strength by handgrip

Exclusion Criteria:

* Any disease requiring hospitalization in the 6 weeks before enrollment;
* Medical conditions contraindicating the proposed exercise as established by a sport medicine specialist;
* Current substance or alcohol abuse or use of drugs that may influence balance and coordination;
* Not being able to walk without assistance and to perform the prescribed exercises as by protocol.