cyrilzakka/clinical-trials huggingface dataset:
Mindfulness Based Stress Reduction for High Blood Pressure

Nearly 60 million adults in the United States have high blood pressure (BP) in the pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8 deaths in the world, and in the US the direct and indirect costs of high BP are estimated to reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for prehypertension, followed by antihypertensive medication if BP progresses to Stage I hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice that has been purported to alleviate stress and treat certain health conditions. Some stress management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP. When added to lifestyle modification advice, MBSR may be an appropriate complementary treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR for prehypertension and/or hypertension, pilot data is necessary to provide preliminary evidence of a treatment effect and to evaluate feasibility. This feasibility randomized clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR as a complementary treatment for high BP and by documenting any treatment effect. Sixty patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive muscle relaxation training matched for therapist contact and homework. Patients BP will be assessed prior to randomization and following treatment by researchers blind to treatment assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment fidelity, and patient satisfaction with treatment will be evaluated.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* prehypertension
* 30-60 years of age

Exclusion Criteria:

* normal BP
* hypertension
* pregnancy
* smoking
* use of antihypertensive medication
Satisfaction Survey for Amyotrophic Lateral Sclerosis (ALS) Patients Comparing Rooms With and Without Assistive Technology

The purpose of this study is :

1. To assess the ALS patient's satisfaction related to a hospital stay on the neurology floor of Hahnemann Hospital.
2. To compare the reported satisfaction of those individuals who stayed in a standard hospital room with those who stayed in Room 1455. Room 1455 is a room specifically set up with assistive technology related to environmental controls for individuals with disabilities.
3. To look at frequency of use of the various pieces of adaptive equipment.


Eligibility Criteria:
Inclusion Criteria:

* In-patients with probable or definite ALS, ages 18 - 90, staying on the neurology floor of Hahnemann Hospital

Exclusion Criteria:

* In-patients who do not meet the criteria of the diagnosis of ALS.
Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

Altered gamma activity has been observed in several neurological and psychiatric disorders, including a reduction in gamma synchronization in patients with disorders of consciousness. Modulation of gamma oscillations with rhythmic stimulation has been used as a possible therapeutic tool. Hence, we try to use acoustic and electric stimulation at gamma frequency to restore brain oscillation and thereby to improve conscious awareness in patients with disorders of consciousness.

We propose a matched-pair parallel study in patients with disorders of consciousness to investigate whether combined acoustic and trigeminal nerve stimulation can modulate brain oscillations, as measured by electroencephalography (EEG), and whether the brain activity changes are coupled with improvements in consciousness.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of disorders of consciousness based on CRS-R
* Time post-injury ranging from one to twelve months
* No history of acquired brain injury or psychiatric or neurological diseases

Exclusion Criteria:

* Not medically stable
* Any contraindication to electric stimulation
* Hearing impairment before brain injury
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older

This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination.
2. In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedures.

Exclusion Criteria:

1. History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
2. Receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine within 4 weeks prior to Study Day 1, or planning to receive some other vaccination before the final study visit (about Day 29 after vaccination).
3. Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
Evaluation of Liquid vs. Tablet Buprenorphine - 6

The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.

Eligibility Criteria:
Inclusion Criteria:

* ED of more than 6 months
* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
* Positive response to PDE-5 inhibitors
* IIEF-5 domain score of 12-20 denoting mild to severe ED
* Non-Neurological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* NPT - normal/flat
* Prior prostatectomy surgery
* Any cause of ED other than vascular related
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Cardiovascular conditions that prevent sexual activity
* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
* Cancer within the past 5 years.
* Anti-androgens, oral or injectable androgens
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
An Observational Study of Patients Treated With Bimatoprost 0.03% (Latisse®) for Hypotrichosis of the Eyelashes

This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at least 12 months for hypotrichosis of the eyelashes.


Eligibility Criteria:
Inclusion Criteria:

* Hypotrichosis of the eyelashes
* Using bimatoprost ophthalmic solution 0.03% (Latisse®) for at least 12 months

Exclusion Criteria:

* Use of any over-the-counter medication(s) for eyelash growth
CT for Pulmonary Thromboembolic Disease

Examine the feasibility and efficacy of individually optimized uniform contrast enhancement in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.

Patient characteristics, qualitative image quality scores, and quantitative contrast enhancement and CNR will be described using mean values and standard deviations for continuous variables, and frequencies and percent for categorical variables. Difference between the two patient groups will be compared using Wilcoxon signed rank tests and chi-square statistics for continuous and categorical variables, respectively. All statistical tests will be performed at a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or older
* Patients who have been recommended for CTPA scan for the diagnosis of pulmonary; thromboembolic disease (PE) in the Department of Diagnostic Radiology and Nuclear Medicine at the University of Maryland-Patients whose body mass index (BMI) is greater than 30 kg/m2.
* Patients whose body mass index (BMI) is greater than 30 kg/m2
* Patients who signed the University of Maryland Medical Center Consent for Intravenous Contrast Administration

Exclusion Criteria:

* Pregnant or breast-feeding women; Female participants of childbearing age (10 - 60 years) will be screened for their pregnancy status prior to study registration, by following the Department of Diagnostic Radiology and Nuclear Medicine CLINICAL STANDARD Procedure DI-AOP-003 "Pregnancy Screening Documentation"; - Patients with decreased renal function34-36. This is evaluated by blood work checked within 30 days prior to the CTPA scan with contrast. Patients cannot receive contrast if their BUN index is not within \[7-20\] or creatinine is not within \[0.5 - 1.4\] mg/dL
* Patients with decreased renal function34-36. This is evaluated by blood work checked within current admission for inpatients or within 30 days for outpatients prior to the CTPA scan with contrast. Patients cannot receive contrast if their serum creatinine level exceeds 2.0 mg/dL
* Patients with known moderate or severe allergic reactions to contrast, including but not limited to: shortness of breath, a change in baseline vital signs, such as a change in blood pressure, tachycardia, increased respirations that can progress to major respiratory distress, laryngeal edema, bronchospasm, arrhythmias, convulsions, and cardiopulmonary arrest.
The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS

To determine safety and tolerance of administering aerosolized recombinant interferon gamma (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of IFN-gamma can activate alveolar macrophages in AIDS patients.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Diagnosis of AIDS with one or more opportunistic infections.
* Kaposi's sarcoma with prior history of opportunistic infection.
* Stable dose of zidovudine (AZT) therapy.
* Preserved pulmonary, renal and hepatic function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Presence of active infection.
* Active opportunistic infections.
* Cardiac disease.
* Central nervous system disorders.
* History of seizures.
* Irreversible airway disease.

Patients with the following are excluded:

* Co-existing conditions and symptoms listed in Patient Exclusion Co-existing Conditions.

Prior Medication:

Excluded within 4 weeks of study entry:

* Immunosuppressive therapy.
* Cytotoxic therapy.
* Excluded:
* Interferon gamma therapy.
Maribavir for Prevention of CMV After Stem Cell Transplants

Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic stem cell transplant recipient
* Recipient CMV seropositive
* Have transplant engraftment
* Able to swallow tablets

Exclusion Criteria:

* CMV organ disease
* HIV infection
* Use of other anti-CMV therapy post-transplant
Comparison Between the Efficacy of CIMT and NDT Along With Conventional Physiotherapy Treatment on Upper Extremity Rehabilitation Among Patients of Stroke

To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation

This research aims to provide a comprehensive comparison of CIMT and NDT, supplemented by conventional physiotherapy, in the rehabilitation of upper extremity function among stroke patients. The findings will inform clinical practice, guiding the development of optimized, patient-centered rehabilitation strategies.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be aged 40-65 years and will have experienced either a hemorrhagic or ischemic stroke with hemiplegic presentation within the past 1 to 6 months. Additionally, they must have a Mini-Mental State Examination (MMSE) score of 23.

Exclusion Criteria:

* Participants with visual or auditory deficits, musculoskeletal (MSK) disorders, mental impairments, or a history of surgery will be excluded from the study.
A Study of Econazole Foam 1% in Athlete's Foot

This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.

Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years or age and of either sex.
* Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
* Be willing to give informed consent.
* Be willing and able to give informed consent.
* Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
* Be in good health and free of any disease or physical condition which might, in the investigator's opinion, expose the subject to an unacceptable risk by study participation.
* Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).

Exclusion Criteria:

* Is nursing or planning a pregnancy during the study.
* Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 days prior to the start of the study.
* Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
* Has a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
* Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
* Has any other skin disease which might interfere with the evaluation of tinea pedis.
* Is currently enrolled in an investigational drug or device study.
* Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study
* Is unreliable, including subjects with a history of drug or alcohol abuse.
* Has known hypersensitivity to any of the components of the study medications.
Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion

Hypothesis

Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.

Study Design

Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUC, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.

This Randomized Controlled Trial will be offered to women choosing to have a LNG-IUC or CuT380 after an abortion for gestational ages from 12 to 24 weeks. \[delete next insert\]"and a non intervention control group offered to all others having abortions at this gestational age". Participants choosing an LNG-IUC or CUT380 will be randomly assigned to immediate or interval insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups \[delete next insert\] and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6, 12, 24, 36, 48 and 72 months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.

Eligibility Criteria:
Inclusion Criteria:

1. Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and
2. Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and
3. Residents of British Columbia, registered with the Medical Services Plan health care system.

Exclusion Criteria:

1. Intention to move from BC within the next year
2. Intention to conceive within the next year.
3. Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC
4. Post Randomization Exclusion:

uterine perforation at the time of abortion

bleeding of more than 500 cc during abortion

any of the above exclusions detected at time of abortion
Establishing the Clinical Significance Values of the Lysholm Knee Score

The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* What is the minimal clinically important difference value of the Lysholm Knee Score?
* What is the substantial clinical benefit value of the Lysholm Knee Score?
* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the minimal clinically important difference value?
* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the substantial clinical benefit value?


Eligibility Criteria:
Inclusion Criteria:

* to be over 18 years old
* to undergo surgery for a ruptured anterior cruciate ligament

Exclusion Criteria:

* to have metabolic or autoimmune diseases
* to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair
* to have cognitive issues that will hinder the completion of the study forms
* to lack sufficient proficiency in Turkish
Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans

RATIONALE: An interactive computer program may be more effective than a brochure in increasing colorectal cancer screening among African Americans.

PURPOSE: This randomized clinical trial is studying an interactive computer program to see how well it works compared with a brochure in increasing colorectal cancer screening among African Americans.

OBJECTIVES:

* Compare rates of participation in fecal occult blood testing and endoscopic screening (colonoscopy or sigmoidoscopy) among African-Americans who receive an interactive computer intervention (ICI) versus a non-tailored colorectal cancer screening brochure.
* Examine mediators and moderators of intervention effectiveness as depicted in the conceptual model.

OUTLINE: This is a multicenter study.

Participants are stratified according to site, age (≤ 65 years old vs \> 65 years old) and gender. Participants are randomized to one of two arms.

* Arm I (non-tailored colorectal cancer screening brochure): Participants undergo a baseline interview via telephone and receive a colorectal cancer screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.
* Arm II (interactive computer intervention \[ICI\]): Participants undergo a baseline interview via telephone and complete an ICI in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently being seen in the primary care clinics of Wishard Memorial Hospital (Indianapolis, IN), Roudebush Veterans Affairs Medical Center (Indianapolis, IN), IU Health Family Medicine Center (Indianapolis, IN) or Norton Louisville Primary Care Clinic (Louisville, KY)
* African-American who is currently non-adherent to screening guidelines, meeting all of the following criteria:

  * No fecal occult blood test in the past 12 months
  * No sigmoidoscopy in the past 5 years
  * No colonoscopy in the past 10 years
* Patients with average and increased risk for colorectal cancer are eligible
* No personal history of colorectal cancer

PATIENT CHARACTERISTICS:

* Participants must have a telephone
* English-speaking
* Able to read at a 5th grade reading level
* No medical condition that prohibits colorectal cancer screening

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics