cyrilzakka/clinical-trials huggingface dataset:
Project Andale--Increasing Exercise in Hispanic Women

To determine the differential effectiveness of a culturally tailored program to shape and maintain moderate intensity physical activity and to improve cardiorespiratory fitness among low SES sedentary Latino women.

BACKGROUND:

Latino women are at high risk for cardiovascular (CVD) and other chronic diseases, in part, due to sedentary lifestyle, obesity, and poor fitness. Few studies assess long-term physical activity, fewer observe maintenance and none have demonstrated effective procedures for sustaining exercise. Only one study has demonstrated increased moderate exercise and none has demonstrated maintenance of physical activity among Latino women. Theoretically-based procedures (shaping, contingency management, relapse prevention, and social reinforcement) hypothesized as necessary to maintain physical activity had not yet been tested experimentally.

DESIGN NARRATIVE:

The 210 Latinas were assigned at random to one of three groups: one six month physical activity intervention, one physical activity plus maintenance intervention, and one safety education control. Exercise training emphasized walking. Bilingual exercise leaders, aided by peer models from the community, used shaping procedures to establish daily walking in participants. In the maintenance program, family incentives reinforced transfer to community exercise and were used to establish positive feedback loops to promote activity within the family. Peer led community exercise sessions, and community activism were also used to establish social networks which reinforced sustained physical activity.

Program support was faded out as naturally occurring social support for Community exercise was established. Four (baseline, post-intervention, post-maintenance, follow-up), repeated measures over 24 months assessed fitness (VO2max), physical activity (PAR), and CVD risk factors. Theoretically important mediating variables, such as self-efficacy, social support, stage of change for exercise, decisional balance, and home exercise environment were explored. Repeated measures analyses were used to determine significant differences among groups, time and group by time main effects. This study was the first to attempt to engineer maintenance of physical activity among minority women. Results will provide a model to be used to sustain physical activity and reduce the risk of cardiovascular and other diseases. If effective, this analysis will also serve as a model for designing programs to sustain physical activity in the increasingly sedentary general population.

The study was renewed in January 2000 to continue through December 2001.

Eligibility Criteria:
No eligibility criteria
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The experimental device will be investigated regarding Sound Quality perception ot the T-Coil program. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated within this study. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, moderate to severe Hearing loss)
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Willingness to wear Receiver in the canal hearing aids
* Informed Consent as documented by signature
* Owning a compatible smartphone

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems
* Central hearing disorders
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa

This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD. We hope to better understand how effective TLD will be in sub-Saharan Africa. If treatment failure occurs, we seek to understand the possible reasons, including drug resistance and adherence challenges.

This study is a prospective observational cohort study at three government-supported HIV clinics in rural South Africa and Uganda. We will enroll 1,000 adults living with HIV who are switched from first-line antiretroviral therapy (ART) containing non-nucleoside reverse transcriptase inhibitors (NNRTIs) to TLD. We will follow participants for one year with study visits at enrollment, 24 weeks, and 48 weeks. Study procedures include interviews, body measurements, chart review, and collection of blood and urine specimens for retrospective testing, including viral load, drug resistance testing, antiretroviral drug level testing, and tests to evaluate the effects of TLD on renal, liver, metabolic, and other organ function.

Aim 1: To determine the contributions of resistance prior to switch to TLD from a NNRTI-based regimen to risk of treatment failure after six and twelve months on TLD. Hypothesis: People living with HIV who experience virologic failure on TLD will have increased odds of NRTI mutations prior to TLD exposure, compared to controls with virologic suppression.

Aim 2: Explore pharmacologic measures of adherence to distinguish virologic failure on TLD due to suboptimal adherence versus resistance using 2a) urine tenofovir (TFV) levels and 2b) tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Hypothesis: Absence of TFV in urine and TFV-DP concentrations in DBS will distinguish ART failure with versus without resistance.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* HIV-positive and in care at one of the study clinics
* Current use of NNRTI-based, first-line ART for a minimum of 6 months
* Prescribed change to TLD by clinic staff
* Residing within 100 kilometers of the treatment clinic without plans to change permanent residence in the next 48 weeks
* Consents to participation

Exclusion Criteria:

There are no specific exclusion criteria. Both men and women will be theoretically eligible. We note that decision to use TLD in patients at the recruitment clinic will be made by clinic staff, and referral for study procedures will not be made until after this decision is made. We also note that, as of the time of this protocol draft, TLD use might be limited to men, women of non-child bearing ages, and women confirmed to be on contraception. This study will follow both national guidelines and clinician discretion about use of TLD in the clinic population.
Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection

Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. This prediction score allows early identification of patients at high risk of ARF and may support decision-making for protective kidney treatment.

To enhance and validate an already pre-existing score accurately predicting post-operative acute renal failure (ARF) after hepatic surgery

We will enhance a pre-existing score predicting ARF based on pre-operative as well as intra-operative predictors.

Development process: we will identify the strongest predictors of ARF in a multivariable logistic regression model followed by a stepwise backward logistic regression analysis and bootstrapping.

Validation process: we will perform an internal validation by calibrating the prediction model as well as by k-fold cross validation (c statistics) and bootstrapping. Additionally, we will calculate the discrimination by the area under the curve (AUC).

Decision curve analysis: Furthermore we will perform a decision curve analysis to evaluate the clinical consequences of both prediction scores whether a patient with increased ARF risk would post-operative benefit of a treatment on the ICU.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* scheduled for liver surgery
* benign as well as malignant diseases

Exclusion Criteria:

* liver trauma
* incomplete data sets
* pre-operative chronic renal failure requiring hemodialysis
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab

Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated stage II, III, or IVA histologically or cytologically confirmed squamous cell carcinoma of the head and neck
* Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx
* Macroscopic complete resection of the primary tumor must be planned
* Age ≥ 18 years
* ECOG performance status 0-1
* Adequate hematologic, renal and hepatic function
* Have signed written informed consent

Exclusion Criteria:

* Subjects who fail to meet inclusion criteria
* Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
* Prior severe infusion reaction to a monoclonal antibody
* Pregnancy or breastfeeding
* Evidence of distant metastasis
* Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast
* Prior history of head and neck cancer
* Prior therapy with motolimod, nivolumab, or other agents targeting PD-1/PD-L1
* Prior therapy targeting the EGFR pathway
* Acute hepatitis, known HIV, or active uncontrolled infection
* Patients with active autoimmune disease
* History of uncontrolled cardiac disease within prior 6 months
* Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months
* Active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study's objectives
* Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment
* Live vaccine within 30 days of planned start of study therapy
* History of pneumonitis or interstitial lung disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
Balloon Sinus Dilation In Office or OR

Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.

In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and greater
2. Both male and female patients eligible
3. Diagnosis of chronic sinusitis that is not responsive to medical management (\> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
4. Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)

Exclusion Criteria:

1. Cystic fibrosis
2. Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
3. Sinonasal tumors or obstructive lesions
4. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
5. Ciliary dysfunction
6. Pregnant females
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530

To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.

During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* ages 20 to 50
* body weight of IBM±20%

Exclusion Criteria:

* cardiovascular disease
* color-blindness or weakness
* hypotension, hypertension, orthostatic hypertension
* abmormal QTc (\>430 ms)
Comparison of the Effectiveness of Intradialytic Core Stabilization and Aerobic Exercise in Hemodialysis Patients

Purpose: To examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (HD) patients. The secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in HD patients.

Materials and Methods: Patients who received hemodialysis treatment for 4 hours, 3 days a week were planned to be included in this randomized controlled study. Patients participating in the study will be randomly divided into 2 groups. Grup 1 was planned to be given core stabilization exercises during hemodialysis three times a week for eight weeks; Group 2 was planned to be given aerobic exercise during hemodialysis three times a week for eight weeks. It aimed to evaluate the patients in the weeks before the start of the treatment and the week after the end of the treatment. Personal information form for evaluation, dialysis adequacy, quality of life questionnaire-kidney disease quality of life-36, piper fatigue scale, hospital anxiety and depression scale (hads), Pittsburgh sleep scale, five times sit and stand test, 10 m walking test , tinetti balance and walking test, and 2-minute step test were planned to be used.


Eligibility Criteria:
Inclusion Criteria:

* To receive HD treatment for a minimum of 6 months, for 4 hours per day, three days per week
* Being 18 years or older
* A score of 3 and/or below in the Sarcopenia Screening Test (SARC-F)

Exclusion Criteria:

* Having a history of myocardial infarction in the last 3 months
* Having angina pectoris, arrhythmia, or uncontrolled hypertension
* Having communication and/or cognitive issues that prevent them from meeting the requirements of the tests
* Becoming pregnant or going through infertility treatment
* Having a psychiatric diagnosis
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Eligibility Criteria:
Inclusion Criteria:

* Male or female Subjects of any race, aged 12 to 35 years inclusive
* Subjects with severe facial acne (global severity score of 4)
* Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
* Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

* Subjects with more than 3 nodules or cysts on the face,
* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
A 60-seconds Personalized Mindfulness Video Exercise for Patients With Orthopedic Illness

The purpose of this study is to determine within a randomized controlled trial the feasibility of a 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain versus usual medical care. Feasibility will be evaluated as the number of individuals approached who agree to participate and the number of individuals who drop out prior to completion of post intervention questionnaires.

The investigators aim to determine the usefulness and acceptability of the 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain as compared to usual medical care. Usefulness and acceptability will be assessed with the Client Satisfaction Scale-3 (CSQ-3).

The investigators also aim to determine whether participating in a personalized 60-second acceptance based mindfulness exercise (e.g., intervention) is associated with significantly more improvement in patients' ratings of state anxiety and pain intensity (co-primary outcomes), and to determine if Distress, Anxiety, Depression and Anger (secondary outcomes) decrease compared to a brief educational pamphlet (e.g., control).

The investigators also aim to determine whether any improvements observed will maintain within a 3 month follow up.

A cognitive behavioral therapy practice called Acceptance and Commitment Therapy (ACT) focuses on acceptance rather than control of thoughts, emotions and physical sensations, regardless of their quality. The crux of ACT is teaching patients to separate themselves from their thoughts (e.g., cognitive defusion) and thus decrease the importance placed on them. ACT has been successful in treating psychological disorders and emotional disturbances alone or when associated with physical illnesses, those that cause pain in particular. While ACT is effective, it may not be feasible for busy orthopedic practices. However, simple exercises that teach patients to deemphasize the importance they place on thoughts might be feasible in orthopedic settings where patients present with pain and strong emotions. An ACT exercise, delivered before the orthopedic appointment, has the potential to set the tone for a more positive experience for both patient and provider, by lowering a patient's pain intensity, state anxiety (e.g., anxiety symptoms in the present moment) as measured comprehensively by State-Trait Anxiety Inventory (STAI) questionnaire, distress, depression, anger, and anxiety, all four measured by 1 item emotional thermometers (visual scales used to rate different emotions). This exercise might help patients see ACT exercises as a helpful part of their recovery. Some might be motivated to learn more and to continue using them at home. This could improve their recovery from and adjustment to the medical condition.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to Hand and Upper Extremity Service at Massachusetts General Hospital
* English fluency and literacy

Exclusion Criteria:

* Pregnant women
* Significant Axis I or II psychopathology that would interfere with participation in the study
* Age \< 18 years old
A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody (ABX-IL8) to Placebo in Patients With Chronic Bronchitis and COPD

To determine if ABX-IL8 will improve shortness of breath.

Chronic Obstructive Pulmonary Disease (COPD) is defined as a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The airflow obstruction is generally progressive, may be accompanied by airway hyper-reactivity, and may be partially reversible. Inflammation in the lungs is triggered by exposure to inhaled toxic substances that can lead to tissue damage, mucous secretion, airways narrowing and tissue destruction.

Interleukin-8 (IL-8) plays a major role in elevating sputum in patients with COPD and may contribute to tissue destruction. Therefore, the highly specific antibody to IL-8 (such as ABX-IL8) may help to reduce mucous production and tissue destruction.

Eligibility Criteria:
Inclusion Criteria:

* \> 50 years old
* \> 20 pack-year of smoking
* Diagnosed with COPD and chronic bronchitis

Exclusion Criteria:

* Patients with bronchiectasis, cystic fibrosis, tuberculosis, asthma, alpha-1 antitrypsin deficiency, CHF
* Require oxygen therapy
* Uncontrolled hypertension
* HIV or Hepatitis
* Recent history of COPD exacerbation
* Patients with cancer
* Recent history of infection
A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients

The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.

This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

* To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.

Exclusion Criteria:

* Secondary hypertension
* myocardial infarction or stroke
* contraindications to beta-blocker therapy