cyrilzakka/clinical-trials huggingface dataset:
Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy

Approximately 75,000-150,000 patients each year in the United States undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. These patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term reductions in pain intensity. However, no studies have compared the effects of these two treatments on measures of pain, suffering, and disability at post-treatment and over a one-year follow-up period.

Our investigation is a 16-week, randomized controlled outcome study of these interventions and their respective placebo control procedures. One hundred and sixty patients are being recruited for this study. We will assess the effects of our interventions on patients' pain levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our treatment effects as well as their statistical significance.


Eligibility Criteria:
Inclusion Criteria:

* Substernal chest pain at least 2X per week for at least 3 months;
* Angiographic evidence of normal or non-obstructive (\<50% luminal diameter narrowing) coronary arteries among subjects \> 40 years of age; OR Normal exercise stress tests, normal echocardiogram, and cardiologist evaluation that symptoms are not cardiac in origin among subjects \< 40 years of age;
* Gastroesophageal reflux disease ruled out by 24-hour pH monitoring, endoscopy, or 1-month trial of anti-reflux therapy with omeprazole 20 mg bid;
* Pain threshold levels for esophageal balloon distention must be 12 ml.

Exclusion Criteria:

* Mitral valve prolapse
The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.

The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.

The patients will be divided into two groups, as diabetics and non-diabetics. The diagnosis of diabetes mellitus will be extracted from the medical records and medical history of the patients hospitalised with COVID-19.

The COVID-19 patients medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for COVID-19

Exclusion Criteria:

* Patients with known malignancy
* Pregnant patients
Sprint Interval Training in Patients With Chronic Obstructive Lung Disease

Exercise therapy is a cornerstone in the management of patients with Chronic Obstructive Pulmonary disease (COPD), and supervised walking exercise three times a week over 12 weeks improves walking ability and quality of life. Despite this, very few patients exercise on a regular basis. The underuse of exercise in COPD patients can partly be explained by discomfort during exercise because it evokes dyspnea, and thereby explain lack of participation in exercise. If the goal is to offer the best medical therapy to these patients, new and effective exercise training methods must be explored and defined since exercise training is an important part of pulmonary rehabilitation.

Intention is to study a new training method called sprint interval training (SIT), which consists of high intensity bouts with very short duration. The idea behind SIT is to avoid the dyspnea associated with traditional endurance training, thus maximizing exercise power without excessive discomfort. The investigators will study training adaptations in patients with COPD and compare the results with age-matched controls.

It is expected that both COPD-patients and healthy elderly will improve exercise cycle time until exhaustion after SIT training, and also that the improvement will be larger in the healthy group due to higher absolute training intensity.


Eligibility Criteria:
Inclusion Criteria (patients):

* stable CPOD stage 3 and 4 according to GOLD guidelines (www.goldcopd.org)
* post bronchodilator FEV \< 50%

Exclusion Criteria:

* having participated in a pulmonary rehabilitation program during the last 3 months.
MyoSure Hysteroscopic Tissue Removal System Registry Study

The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.

Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy female between 18 and 65 years of age
2. Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her
3. Subject is indicated for myomectomy or polypectomy
4. Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:

   * All polyps
   * All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter
   * Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter

Exclusion Criteria:

1. Subject is pregnant
2. Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure
3. Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
4. Active pelvic inflammatory disease or pelvic/vaginal infection
5. Subject has a known or suspected coagulopathy or bleeding disorder
6. Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
7. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study
Effects of Reciprocal Inhibition Versus Post Facilitation Muscle Energy Technique Along With Conventional Physical Therapy in Patients With Piriformis Syndrome: a Randomized Controlled Trial

This study is a randomized controlled trial and the purpose of this study is to compare the effects of reciprocal inhibition versus post facilitation muscle energy technique along with conventional physical therapy in patients with piriformis syndrome in terms of pain, range of motion at hip joint and functional disability.

This study aims to compare the effects of reciprocal inhibition with post facilitation muscle energy technique along with conventional physical therapy in terms of pain, functional disability and range of motion at hip joint in patients with piriformis syndrome to find the best suitable and effective treatment for it based on the outcomes.

Males and females between the age of 20-50 years, having buttock pain of ≥ 3 on NPRS since 3 months or more and a score of ≥ 8 on a 12-point clinical scoring system as well as any two of the positive screening tests will be recruited in this study as patients of piriformis syndrome.

These subjects will be selected via non-probability purposive sampling technique, followed by randomization into two groups using blocked randomization method.

A total of 6 treatment sessions will be given to each participant over the duration of 2 weeks with a total of 3 follow-ups after every 2 sessions.

TENS and hot pack followed by reciprocal inhibition technique will be given to the experimental group A, while the active comparator group B will be given TENS and hot pack followed by post-facilitation muscle energy technique.

Both the groups will be guided about the strengthening exercises given as a home plan.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-50 years
* Both Genders
* Chronic pain in buttock and hip area (≥ 3 on NPRS) lasting more than 3 months.
* Shortened piriformis muscle (Internal rotation less than 30°) on muscle length assessment.
* A score of ≥ 8 on a 12-point clinical scoring system.
* At least two positive screening tests.

Exclusion Criteria:

* Active infection
* Lower lumbar radiculopathy
* Sacroiliac joint dysfunction
* Malignancies
* History of trauma
* Hip Arthroplasty
* Rheumatoid/ Osteoarthritis
* Any neurological dysfunction
Cognitive Rehab for Parkinson's

This study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (CCT) software. Data will also be collected to determine if this program improves thinking and memory as well as everyday function. The hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.

The objective of this study is to examine feasibility of an at-home cognitive rehabilitation program that incorporates both prospective implementation intentions strategies (PRIIS) and an existing web-based executive function (EF) computerized cognitive training (CCT) software for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS, compared to CCT alone and an active control group, will lead to greater improvements in cognitive performance and daily function. This innovative study uses a set of on-line training games that target aspects of EF susceptible in PD and trains the transfer of cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive impairment in executive function. Additionally, training is conducted at home allowing for convenience and flexibility for participants.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who seek services at Hines VA Hospital
* Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
* Meet criteria for having mild cognitive impairment
* Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
* 50 years or older
* Speak and read English

Exclusion Criteria:

* Dementia
* Failure to demonstrate decision making capacity
* Cholinesterase inhibitor medication
* History of deep brain stimulation surgery
* Severe depression
* Severe anxiety
* Severe apathy
Sun Protection Factor Assay (SPF Assay 202/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Digital Literacy Intervention to Address Support, Literacy and Communication in Older Adults

The investigators propose a person-directed, values-based digital literacy intervention to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home. This intervention will be a way to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home.

This is a one-arm pilot trial to test the feasibility and acceptability of the intervention Digital Literacy Pilot Intervention to Address Support, Literacy and Communication in Older Adults. Each participant will receive 4-6 home visits with 3-4 interim phone calls based on the participant's individual digital literacy needs and goals. Each participant will receive internet connectivity (if not already available), a tablet (if not already available) and tailored action plans co-developed by the participant and the interventionist. In each participant will also have pre and post-intervention visits with the research team.

In earlier phases, research team members conducted preliminary activities to design the intervention using Human-Centered Design techniques.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years old or older
* English proficient
* Willingness to improve digital literacy

Exclusion Criteria:

* Severe cognitive impairment as defined by a 6-item Callahan Cognitive Screener
* Hospitalization overnight more than 3 times in the last 12 months by self-report.
Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210).

Both approaches combined with Vocal Hygiene Program (Behlau, 2007).The target population are female teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Vocal Functional Exercises and Voice Amplification are equally effective at improving vocal functioning in teachers with voice disorders. The Fiberoptic endoscopic evaluation will be done before randomization. All the participants will complete before and after a 6-week treatment phase (a) Voice Activity and Participation Profile (PPAV), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders to assess the impact of voice disorders on daily activities (b) Audio voice recording for later acoustic analysis, through the Kay Elemetrics Multi Dimensional Voice Program (c) Audio recording for later perceptual analysis through Consensus Auditory-Perceptual Evaluation of Voice (CAPE_V). It is believed that the search for evidence in clinical studies like this can contribute to awareness programs and vocal training for teachers.

Eligibility Criteria:
Inclusion Criteria:

* Female teacher
* 21-50 years old.
* Full or part time elementary to middle school teacher ( Prefeitura Municipal de Belo Horizonte).
* Minimum 20 hour weekly workload.
* Medical reference to speech therapy due to behavioral dysphonia

Exclusion Criteria:

* Physical education or daycare teachers.
* Professional singers.
* Neurological and/or psychiatric voice disorders
Weight Management in Mothers and Adult Daughters

The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.

Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.

Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.

Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Body mass index of 25-50 kg/m2
* Mexican or Mexican-American

Exclusion Criteria:

* Pregnancy or plans to become pregnant in the next year
* 5% weight loss in the last 3 months
* History of bariatric surgery
* Serious medical condition or psychological disorder
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).


Eligibility Criteria:
Inclusion Criteria:

General Requirements:

* Ability to provide Informed Consent
* 18 years of age or older
* English language proficiency
* Willingness to participate in all scheduled procedures outlined in the study investigational plan
* Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

Ear to be Implanted:

* Severe-to-profound sensorineural hearing loss (\> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
* CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
* Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) \>3 months and ≤10 years in the ear to be implanted only

Contralateral (non-implanted) ear:

* Up to a moderate sensorineural hearing loss (\<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
* CNC word recognition score \>30% (tested in subject's everyday listening condition for that ear)

Exclusion Criteria:

* Previous experience with a cochlear implant
* Cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
* Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
* Active middle-ear disease/infection in the ear to be implanted
* Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
* Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.

The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands.

The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays.

Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary Sjogren Syndrome according criteria american european 2002.
* Salivary flux non stimulated \< 0,1 ml/min.

Exclusion Criteria:

* hepatitis B and/or C
* radiotherapy in the glandular area (previous)
* other connective diseases
* thyroidopathy non compensated
* GVHD graft-versus-host disease
* HIV
* Sarcoidosis
Neurological Consequences of Perinatal Listeriosis Infection

The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, Listeria monocytogenes.

Perinatal listeriosis is defined by the occurrence of maternal listeriosis at birth and/or of early-onset listeriosis in the neonate (defined by the positive culture of any sample of maternal or neonatal origin).

Neurological involvement is defined by the presence of inflammation of the cerebrospinal fluid of positive culture or the cerebro-spinal fluid.

Evaluation is performed at the age of 5 years, and includes WPPSI evaluation of the Intelligence Quotient (IQ), NEPSY evaluation of the executive functions and clinical evaluation checking for any motor, sensorial or other focal deficiency among 90 cases and 270 controls matched for gestational age.

Eligibility Criteria:
Inclusion Criteria:

* Children from the MONALISA cohort (culture proven-maternal listeriosis)
* Or Children from the EPIPAGE cohort (control group)
* Written consent from the parent(s) or legal representative

Exclusion Criteria:

* Children whose parents or legal representative would deny their consent