cyrilzakka/clinical-trials huggingface dataset:
A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study

Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while inhaling. Children and adolescents with VCD may experience multiple symptoms, including difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited information on optimal management of VCD. In our proposed study, we will use cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity will be examined prior to and following a series of four therapy sessions with a clinical psychologist that are focused on teaching patients strategies to decrease symptom reactivity.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent patients presenting to West Virginia University, Charleston Division Sub-specialty Clinic for Pediatric Pulmonology with a clinical diagnosis of vocal cord dysfunction.
* Diagnosed with VCD within 12 months prior to study enrollment. between the ages of 13 and 18 years old.
* Currently symptomatic for VCD.
* Must have a baseline PFT to reference at the time of diagnosis. Additionally in patients who were diagnosed with VCD 6 months or more prior to study enrollment, current PFT results as part of routine care, are required.
* A parent or guardian must agree to participate in the four behavioral therapy sessions with his or her child.

Exclusion Criteria:

* Severe psychiatric disorders (ex. psychosis, suicidal ideation)
* Developmental delay
* Previous speech therapy for the treatment of VCD.
* Currently receiving psychological counseling.
* In open Child Protective Services cases.
A Dose Escalation Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration

This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
2. Male or female patients ≥ 50 yrs. of age.
3. Active CNV lesions secondary to neovascular AMD.
4. BCVA score of 19-78 letters using ETDRS charts in the study eye.
5. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.

Exclusion Criteria:

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
2. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
3. Active ocular or periocular inflammation/infection in either eye;
4. Prior any treatment of following in the study eye:

   1. Anti-VEGF therapy within 90 days prior to screening;
   2. Intraocular glucocorticoid injection within 180 days prior to screening;
   3. Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
   4. Intraocular surgery within 90 days prior to screening;
   5. Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
5. Glycated hemoglobin (HbA1c) \> 8% within 28 days prior to screening;
6. Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg);
7. Systemic administration of steroids within 30 days prior to screening;
8. Systemic administration of anti-VEGF drugs within 90 days prior to screening;
9. History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
10. Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study;
11. Other conditions unsuitable for enrollment judged by investigators.
Effect of Pre-cooling on Whole-body Heat Loss During Exercise-heat Stress

Endurance exercise performance declines in hot environments as core body temperature increases. To enhance performance, body pre-cooling strategies, such as cold-water immersion have been employed to lower resting core temperature thereby increasing the body's heat storage capacity. In turn, the increase in body core temperature associated with exercise in the heat is blunted, allowing the individual to exercise at higher intensity and or for a longer period of time. However, the mechanisms by which pre-cooling impacts heat exchange during exercise remain unclear. While existing research has focused on the performance benefits of pre-cooling the body, relatively little is known about the impacts of pre-cooling on whole-body heat exchange during an exercise-heat stress. Investigators will therefore evaluate whole-body heat exchange (dry ± evaporative heat loss as assessed using a direct air calorimeter) during a prolonged (1-hour) moderate-intensity cycling bout in the heat (wet-bulb globe temperature of 29°C; equivalent to 37.5°C, 35% relative humidity) performed with and without pre-cooling by cool-water (\~17°C) immersion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young males (18-30 years)
* Non-smoking
* English or French speaking
* Ability to provide informed consent

Exclusion Criteria:

* Presence of chronic diseases (e.g., hypertension, diabetes)
* Acute illness (e.g., flu, COVID-19)
* Physical restriction limiting physical activity
* Use of medication judged by the patient or investigators to make participation in this study inadvisable.
* Sedentary
Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms

Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.


Eligibility Criteria:
Inclusion Criteria:

Screening Criteria

1. Female

   1. age 18 years or older who is a candidate for breast reconstruction (primary or revision) with Allergan silicone implants or saline breast implants (controls) OR
   2. age 22 or older who is a candidate for breast augmentation (primary or revision) with Allergan silicone implants or saline breast implants (controls)
2. Exhibit fluency and literacy in English or Spanish

Enrollment Criteria

1. Have satisfied all the inclusion and none of the exclusion criteria
2. Have completed the implant surgery
3. Have only one breast implant or have matching breast implants (i.e., both Round Responsive, both Style 410, or both saline) following their qualifying surgery. In the case of silicone, the device(s) must be manufactured by Allergan.
4. Are free of all target diseases at baseline (410 arm only)
5. Have signed the informed consent form, documenting agreement to participate in all required follow-up interviews by internet, phone, or mail and authorizing health care providers to release medical records to study personnel, and have completed the baseline questionnaire prior to implant surgery (prospectively enrolled subjects)

For retrospectively enrolled subjects into the 410 arm, in addition to the above, these criteria also apply:

1. Received 1 or 2 Style 410 implants between 2015 and 2019
2. Willing to complete baseline questionnaire at time of enrollment

Continuation Criteria (BIFS Arm Only)

1. Have completed baseline and years 1, 2, 3 and 4 follow-up questionnaires available (including the Satisfaction with Breasts and Psychosocial Well-Being modules of the BREAST-Q)
2. Met all enrollment criteria, specifically the minimum age requirements for silicone implants (18 or older for reconstruction subjects and 22 or older for augmentation subjects), and were free of all target diseases at baseline
3. Were enrolled at a site that was selected in the cluster sampling to continue in the BIFS arm

Exclusion Criteria:

1. Are transgender
2. If a saline implant subject, have a current or past unilateral or bilateral silicone gelfilled breast implant
3. Investigator decision that subject is not a suitable candidate for a long-term observational study
Impact of Energy Drinks on Cardiovascular Endpoints

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between ages 18-40 years
* ONLY "as needed" use of ibuprofen or acetamenophen
* Active duty military
* DoD beneficiary or Civilian Government Employees

Exclusion Criteria:

* No other co-morbid conditions
* No active prescription or OTC drug use
* Not pregnant or planning to become pregnant during study participation
Objective Sleep Disturbances in Orthostatic Intolerance

We wish to study sleep architecture in patients with chronic orthostatic intolerance. We will test the null hypothesis that there is no difference in time during the various phases of sleep between patients and healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with chronic orthostatic intolerance (or healthy subject)

Exclusion Criteria:

* overt cause or acute orthostatic intolerance
* pregnancy or lactation
A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and at least 18 years of age
* Female patients must be of either:

  * Non-childbearing potential, post-menopausal
  * Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria:

* Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area
* Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks
* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area
A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men

A double-blind, randomised, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male volunteers

Part A - Single Ascending Dose (SAD) Double-blind, randomised, placebo-controlled, single ascending dose study.

Each study subject will participate in a screen visit, three identical treatment periods, in each of which they will receive a single oral dose of V81444 or placebo in accord-ance with the randomisation schedule, and one post-study visit.

In each treatment period, subjects will be admitted the day before dosing (Day -1) and, subject to satisfactory medical review, discharged in the morning, 4 days later (Day 4).

Part B - Multiple Ascending Dose (MAD) Double-blind, randomised, placebo-controlled, parallel group, multiple ascending dose study

Each study subject will participate in a screen visit, one treatment period in which they will receive repeated oral doses of V81444 or placebo in accordance with the randomisation schedule, and one post-study visit.

In each treatment period, subjects will be admitted the day before dosing (Day -1), dosed daily on Days 1 to 14 and, subject to satisfactory medical review, will be discharged in the morning, 3 days after the final dose (Day 17).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers: aged 18 to 45 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication. Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history.

Exclusion Criteria:

* have a history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-oesophageal reflux disease or gastritis
* any known malformations that would make OGD difficult or unsafe(Part B only)
* have taken V81444 in any previous investigational study
* have taken any restricted concomitant medication
* have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo or midazolam (Part B only)
* in the 4 calendar months before study drug administration have smoked more than 5 cigarettes per day have consumed more than 28 units of alcohol per week have donated blood or plasma in excess of 500 mL been exposed to any new investigational agent or any other adenosine A2A receptor antagonist used non-steroidal anti-inflammatory drugs regularly had a new tattoo or body piercing
* have any clinically relevant abnormal findings at screening and/or admission
* intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication
A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge

This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.

Each subject will be given an Ariva® Silver Wintergreen lozenge or a Placebo Wintergreen lozenge on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult smoker
* smoking for at least 5 years
* smoking at least one (1) pack of cigarettes a day
* interest in quitting smoking

Exclusion Criteria:

* known allergy to silver or silver salts
* pregnant or breast-feeding
* current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA

This outcome evaluation effort provides the opportunity to learn what programmatic approaches effectively address two of the most difficult hurdles in HIV health services delivery: (1) getting people who would benefit from health care to use it and (2) getting people who do use health care to do so more consistently and effectively. The New York HIV Planning Council (through MHRA) has funded 23 agencies to achieve these objectives for people of color with HIV disease.

All clients are assessed upon entry into the program, have their service utilization tracked, and then are reassessed at three, six, and twelve months following program entry.

The main client-level data elements collected during baseline and follow-up interviews are the following:

* Biological markers (including HIV status, viral load, t-cell count)
* Demographic characteristics
* Adherence to treatment
* Barriers to care
* Social support
* Substance use and treatment
* Functional health status

Functional Health Status is used in this evaluation as the primary measure of final client "outcomes." The Functional Health Status items we use are from the ACTG SF-21 (a modified version of the Medical Outcomes Study instrument).

The overall evaluation objectives are to:

* Describe the change in functional health status for different populations and groups of clients.
* Identify services or constellations of services and intensity of services associated with change in functional health status.
* Assess whether programs meet intermediate objectives (decreased drug use, increased service use, improved housing stability).
* Identify barriers to access to and maintenance in care.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Not in HIV care, or difficulty being maintained in HIV care
* HIV-negative but at high risk of HIV infection

Exclusion Criteria:

* HIV-negative and not at high risk of HIV infection
Effectiveness of a Brief Psychological Mindfulness Based Intervention for the Treatment of Depression in Primary Care

The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks) psychological intervention for the treatment of depression in Primary Care between different groups: a mindfulness intervention applied face to face in group format, a control group that will receive treatment as usual (TAU) consisting of medical treatment and the same mindfulness intervention applied by Information and Communication Technologies (ICTs). The principal hypothesis is that face to face intervention will be more effective than TAU

The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks) psychological intervention for the treatment of depression in Primary Care between different groups: 1) a face-to-face mindfulness intervention in group format (10-12 people/group), 2) a control group which will received primary care TAU (usual medical treatment) and 3) the same mindfulness intervention applied by Information and Communication Technologies (ICTs) (Internet-based program). All participants in the two psychological intervention groups will also receive usual medical treatment managed by their general practitioner. Each group will be composed of 40 participants with a total sample of 120. The principal hypothesis is that face to face intervention will be more effective than TAU. Secondary hypothesis, are: 1) The online computerized program will be more effective than TAU; 2) The differences between face-to-face and online format will be analyzed. Finally, a qualitative study will be conducted in order to analyze the feasibility, acceptance, barriers and causes of drop-outs and success, expectations, experiences and attitudes that could be obstacles or facilitators in the interventions, both in patients and in health professionals. This study will allow us to understand the experiences of depressed patients with these interventions and their differences.

Eligibility Criteria:
Inclusion Criteria:

* Be adult
* Willingness to participate in the study and signing informed consent
* Ability to understand and write Spanish.
* DSM-5 diagnose of Major Depression or Dysthymia, mild or moderate depression expressed as score lower than 14 in the Patient Health Questionnaire (PHQ)
* Duration of depressive symptoms 2 months or more
* To have and to handle the computer and internet

Exclusion Criteria:

* Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.), except for anxious pathology or personality disorders
* Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk
Identification of Admission High Risk Elderly

Objective: The study aim to establish high risk admission model and readmission model for elderly in Taiwan.

Method: Investigators compare the clinical, epidemiological, and socioeconomic characteristics of admitted patients during 1 August,2011 to 31 July,2012. All patients will follow up to end of study to identify 14 days readmission and 30 days readmission to geriatic ward.

Expected Outcomes: (1) To compare the prediction value of derivation cohort and validation cohort. (2) To identify high risk indicators of admission and readmission for elderly. (3) To determine the risk factors in admission elderly association with quality indicators.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with age 65 year old above
2. Patients admission to geriatric ward

Exclusion Criteria:

1. Patients with unstable vital sign
2. Patients or dependants reject to sign inform consent.
Sucralose Effects on Glucose Metabolism and Gut Microbiota

Hypothesis:

1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.
2. Long-term consumption of sucralose may alter food behaviour in healthy adults.

Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without underlying disease
* Normal oral glucose tolerance test
* Agree to participate by written informed consent

Exclusion Criteria:

* Shift workers
* History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
* Malabsorption problem
* Regular consumption of nonnutritive sweeteners
* Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3-folds upper normal limit)
* Renal impairment (serum creatinine \>1.5 mg/dL)
* Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen
* Pregnant and lactating woman
* Smoking within 6 months
Management of Placenta Accreta Spectrum

placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.

placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.

1. surgical management of placenta accreta
2. short term follow up to the outcomes
3. long term follow up

Eligibility Criteria:
Inclusion Criteria:

* All placenta accreta e high possibility of placenta accrete
* consent
* easy follow up visits

Exclusion Criteria:

* bleeding tendency
* associated medical disorder hypertension, diabetes, preeclapsia..