cyrilzakka/clinical-trials huggingface dataset:
Effect of an Innovative Online Ayurveda Program on the Mental and Physical Health of Home-Based Adults

The overall objective of this study is to evaluate the effects, feasibility, and safety of a comprehensive online Ayurveda whole-systems (WS) intervention that targets the underlying etiological factors influencing mental and physical health symptoms. The primary hypothesis is that home-based adults who participate in the Ayurveda Program for Detox and Lifestyle will experience a decrease in anxiety and depression symptoms over 4 months.

Two Ayurveda-trained medical doctors will lead the Online Ayurveda Program for Detox and Lifestyle, which comprises eight interactive live webinars over ten days. Each 1.5-hour session includes online group meetings focused on addressing the etiological factors contributing to mental and physical ill-health. The program is easily replicable and includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices, all based on traditional Ayurvedic medicine principles. After the ten-day detoxification, participants will continue to follow the diet and lifestyle recommendations and the herbal program for mental and physical health for up to four months. Outcome measures will be assessed at baseline and once a month for four months.

Eligibility Criteria:
Inclusion Criteria:

* Scored ≥ 5 on the GAD-7
* Scored ≥ 5 on the PHQ-9
* Scored ≥ 5 on the PHQ-15
* Age 18-80 years
* No other psychiatric disorders
* Not receiving specialized treatments for anxiety or depression, nor participating in another clinical trial
* Stable psychiatric medication regimen for more than two months
* No acute or severe medical conditions
* Individuals who are not pregnant or breastfeeding
* Provided informed consent

Exclusion Criteria:

* Scored \< 5 on the GAD-7
* Scored \< 5 on the PHQ-9
* Scored \< 5 on the PHQ-15
* Age under 18 or over 80 years
* Other psychiatric disorders (e.g., suicidal risk)
* Currently undergoing specialized treatments for anxiety and depression, or participating in another clinical trial
* Psychiatric medication regimen for less than 2 months
* Acute or severe medical condition (e.g., stroke, surgery)
* Individuals who are pregnant or breastfeeding
* Inability to provide informed consent
A Postural Study Comparing Sitting on the Floor Versus Sitting in a Chair While Playing Video Games.

To determine if sitting in a chair or sitting on the floor lends itself to better posture while playing video games.

Upon completion of the parental consent form, each test subject will be instructed to flip a two-sided coin to determine the sitting position of the test subject. If the flip reveals a "heads", the child will be instructed to sit in a chair; chairs will be appropriately sized to allow the child to rest his/her feet on the ground. If the flip reveals a "tails", the child will be instructed to sit on a small carpet piece that measures 2-feet by 2-feet. Each test subject will be taken to their gaming station which will sit approximately 8 feet away from a 55-inch flat screen television that will be on a 30-inch table and handed a wireless controller. Two gaming stations will be available with one featuring the game Lego Batman and the other featuring Lego Indiana Jones with both gaming stations testing simultaneously. The test subjects will be told they can play for 5 minutes with a Physical Therapist at each station to monitor and record the test subjects' positioning.

Eligibility Criteria:
Inclusion Criteria:

* English and Spanish Speaking

Exclusion Criteria:

* Non-english or non-spanish speaking
Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia

This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia

This clinical trial is designed to assess the long-term safety and activity of intra-parotid administration of AAV2hAQP1 in subjects with radiation-induced parotid salivary hypofunction and xerostomia.

After completion of their Month 12 Follow-Up visit in Study MGT016, subjects will be invited to enroll in this 4-year follow-up study during which they will be assessed for up to 60 months following study drug administration. This follow-up trial is a non-interventional study designed to collect data on longer-term safety and activity at 18, 24, 36, 48, and 60 months following study drug administration.

Over the course of the study, subjects will undergo physical and oral examinations; vital sign measurements; weight measurements; AE assessments; concurrent medication assessments; sample blood collection for hematology and chemistry; urinalysis; ear, nose, and throat (ENT) screening for malignancy; imaging assessments (if indicated); salivary flow assessments; and questionnaire assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Are willing and able to provide informed consent
2. Received AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in the prior open-label, Phase 1, dose-escalation study (Study MGT016)
3. Are willing and able to adhere to the protocol and long-term follow-up

Exclusion Criteria:

1. Subjects unwilling or unable to meet with the requirements of the study will be excluded
Teletechnology-assisted Home-based Exercise Program for Severe COVID-19

The aim of this study is to investigate the efficacy of a home-based pulmonary rehabilitation program with the support of teletechnology in COVID-19 survivors. The main questions it aims to answer are:

* The change of six-minute walk distance
* The change of time of one-minute sit-to-stand test
* The change of maximal strength of upper-limb, lower-limb and respiratory muscle
* The change of quality of life Participants in the home-based pulmonary rehabilitation group will receive teletechnology-assisted consultations (either by videotelephony or telephone calls) for every 1-2 weeks during the intervention period, and participants in the usual care group will not receive teletechnology-assisted consultations during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Patients are 20 years or more with severe (severe pneumonia) to critical (acute respiratory distress syndrome, sepsis, or septic shock) COVID-19 during hospitalization after deisolation.
* Patients are 65 years or more, or ever receiving oral antiviral treatment after deisolation.
* Patient have the ability to ambulate on level surface without direct contact of another person, have telecommunication device(s), and provide consent to receive teletechnology-assisted rehabilitation.

Exclusion Criteria:

* Patients are pregnant or planning for pregnancy.
* Patients have cognitive dysfunction, learning disability, uncontrolled arrhythmia or hypertension, or any medical diagnosis other than COVID-19 that would prominently influence their ability to follow instructions and perform exercise.
Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform enough cases to grasp this technique. The methods of ERCP training include hands-on teaching, training on different kinds of simulators, training on ex-vivo or live anesthetized porcine stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.

Selective cannulation is considered the most difficult and challenging part of learning ERCP. There is not an optimal time for trainees to attempt cannulation during hands-on ERCP training. The time used for attempting cannulation by trainees was 5min or 10min in several centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt cannulation for about one year. The incidence of post-ERCP pancreatitis, the major complication related to cannulation, was 4.0%, which was comparable with previous studies.

The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation would increase success rate of selective cannulation and help to improve skills more quickly. At the meantime, with actively verbal or hands-on assistance from the instructor during performance of trainees, the risk of complications would not increased with a longer time to attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study was designed to evaluate the effects of different periods of time for trainees to attempt selective cannulation on success rate of cannulation, self-satisfaction of performance and post-ERCP pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years old;
* Without prior EST.

Exclusion Criteria:

* History of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
* Duodenal stricture (benign or malignant);
* Ampullary carcinoma;
* Previously failed selective cannulation;
* Chronic pancreatitis with PD stone;
* Minor papilla cannulation;
* Papilla fistula;
* Severe diseases of heart, lung, brain and kidney;
* Hemodynamical unstability;
* Pregnant women;
* Refusal or unable to give written informed consent.
Effect of Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma

Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.

Interruption of radiotherapy on the one hand affects the efficacy of tumor treatment, on the other hand seriously affects the quality of life of patients.

Investigators intend to conduct a randomized, controlled clinical study of multidisciplinary nutritional and psychological care for patients receiving radiotherapy for head and neck carcinoma, with a view to reducing the rate of radiotherapy interruption and improving the quality of life of patients with radiotherapy for head and neck carcinoma through a whole-course multidisciplinary care model.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is willing and capable of signing the informed consent;
2. Patient age ≥18 years;
3. Non-metastatic head and neck tumors (including nasopharyngeal carcinoma) were confirmed by pathology;
4. Patients need to receive postoperative adjuvant radiotherapy or radical radiotherapy;
5. Expected survival ≥6 months;
6. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-3;
7. Good cognitive and reading skills, able to complete the questionnaire survey.

Exclusion Criteria:

1. The patient has malignancies other than head and neck malignancies (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);
2. The patient had previously received radiotherapy;
3. Previous history of mental illness or cognitive impairment (MMSE score \< 27 points);
4. There are contraindications to radiotherapy for head and neck, such as grade 3 or 4 suppression of bone marrow function and active head and neck infection.
5. The presence of uncontrolled systemic diseases that seriously affect the quality of life, such as poorly controlled diabetes, heart failure (NYHA grade III-IV), interstitial lung disease, etc.;
6. Pregnant women or lactating women.
Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for Rescue Treatment of Hp Infection

Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori eradication.

The aims of this study are:

1. to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;
2. to compare the patient adherence and adverse effects of these treatment regimens;
3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.

If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:

group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);

group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);

All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.

Eligibility Criteria:
Inclusion criteria:

1. Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.

Exclusion criteria:

1. pregnant or nursing woman
2. serious concomitant illness and malignant tumor of any kind
3. history of hypersensitivity to test drugs
4. serious bleeding during the course of the ulcer
5. previous gastric surgery
6. receiving bismuth salts, PPIs, or antibiotics in the previous month.
Mindfulness-based Stress Reduction for Pediatric Mental Health

Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Our study purpose is to develop and conduct a pilot mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and brain imaging to assess the impact of the intervention on children with mental health challenges.

This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 12 and 18
* residents of study site
* communication and comprehension of English
* not currently abusing substances

Exclusion Criteria:

* participants diagnosed with psychosis, as meditation has rarely been associated with precipitation of psychosis and/or psychotic episodes in individuals with pre-existing schizophrenia or significant thought disorders
Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)

To study, prospectively, the association between dietary patterns and risk of health outcomes (cardiovascular, metabolic, endocrine, neurological, skeletal muscular, cancer) in cohort study of 116,671 women age 24 to 44 years at baseline in 1989 (the Nurses' Health Study II; NHS II).

Health status and lifestyle information was self-reported on a questionnaire at baseline, and on questionnaires distributed to participants biennially thereafter. Dietary intake data was collected in form of a comprehensive, 131-item food frequency questionnaire (FFQ), distributed among participants every four years. The response rate remained over 90%. Dietary data was validated using biomarkers, health status data using medical records.

Dietary pattern scores were derived from FFQs using cumulative average whenever possible from years preceding the outcomes.

Multivariable Cox proportional hazards models were used to evaluate associations between dietary pattern scores and health outcomes, except in case of pregnancy complications (such as gestational diabetes mellitus/GDM and hypertensive disorders of pregnancy/HDPs) where multivariable logistic regression models with generalized estimating equations, with an exchangeable working correlation structure to account for correlated outcomes between pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* All women without history of chronic disease and/or primary outcome at the time of recruitment. Women contribute person-time until a first diagnosis of the primary outcome or until the end of follow-up.
* All women who reported a singleton pregnancy between 1991-2001 (data on pregnancy outcomes was collected on biennial questionnaires until 2001, since majority of women exited the reproductive age by then) (only for maternal outcomes)

Exclusion Criteria:

* women with a history of chronic disease (type 2 diabetes, cardiovascular disease, or cancer) or other disease studied as the primary outcome
* women with a missing or incomplete FFQ (more than 70 out of 131 items missing, or with caloric intake \<800 kcal/day or \>3500kcal/day) prior to endpoint.
* women with missing data on the primary outcome on biennial questionnaire.
* twin/multiple pregnancy (only for maternal outcomes)
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus

The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18
* Other protocol-defined exclusion criteria may apply.
Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period.

Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.


Eligibility Criteria:
Main Observational Study:

Inclusion Criteria:

1. Able and willing to provide written consent
2. Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314

Exclusions Criteria:

1. None

Fellow Eye Substudy:

Inclusion Criteria

1. Age ≤ 93 years
2. Currently or previously enrolled in the main observational study
3. Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration
4. Active nAMD in the fellow eye
5. BCVA between ≤ 80 and ≥ 20 letters in the fellow eye

Exclusion Criteria:

1. CNV or macular edema in the fellow eye secondary to causes other than nAMD
2. Subfoveal fibrosis or atrophy in the fellow eye
3. Advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma
4. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
5. History of intraocular surgery in the fellow eye within 12 weeks of screening
6. History of intravitreal therapy, such as intravitreal steroid injection or investigational product, other than an intravitreal therapy for nAMD, in the fellow eye within 6 months of screening
Resting Energy Expenditure Using a Handheld Calorimeter

High prevalence of obesity in children has increased associated complications such as type 2 diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts caloric intake by estimating the resting and total daily energy expenditures.Estimation of energy needs is most commonly done using predictive equations. Reliable and valid energy requirements can be obtained using a traditional metabolic system, however this is an expensive option. Handheld indirect calorimeters may be a good alternative to measure energy needs. Several studies have been conducted to determine the validity and accuracy of handheld calorimeters in adults and health children, however, to the best of our knowledge, there are no such studies in the overweight and obese pediatric population.

The purpose of this study is to validate a handheld indirect calorimeter against a traditional metabolic system in overweight and obese children.

If handheld calorimeters can accurately measure resting energy expenditure in overweight and obese adolescents, dietitians will have an opportunity to tailor pediatric weight management interventions based on parameters that are unique to each individual.


Eligibility Criteria:
Inclusion Criteria:

* 13-18y of age
* BMI 85th percentile or more
* No severe illness, neurological and development issues
* not on insulin
* Able to fast overnight

Exclusion Criteria:

* not 13-18y of age
* BMI under 85th percentile
* ill or have neurological and development issues
* on insulin
Rehabilitation in Patients With Progressive Supranuclear Palsy

The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary rehabilitation treatment, previously conceived for Parkinson's disease, is effective for patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat) can provide further benefits.


Eligibility Criteria:
Inclusion Criteria:

a) diagnosis of PSP in accordance to the NINDS-SPSP International Criteria (Litvan et al., 1996), b) age between 55 and 85 c) ability to walk unassisted for at least 6 meters, d) stable dopaminergic drugs dosage in the month preceding the admission to the study

Exclusion Criteria:

a) any others significant neurological or orthopedic disorders, b) osteoarthritis, osteoporosis, cutaneous lesions and/or other pressure wounds, c) body weight exceeding 135 kg (the weight limit for the use of Lokomat®), respiratory and cardiovascular diseases.