cyrilzakka/clinical-trials huggingface dataset:
Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-Based Intervention in Primary Care

This study will modify an existing evidence-based parental tobacco cessation intervention (the Clinical Effort Against Secondhand Smoke Exposure, or CEASE) delivered in pediatric primary care clinics to address shared tobacco use determinants and barriers to smoking cessation treatment among Somali Americans, an immigrant population facing significant combustible tobacco use disparities.

Smoking is a significant and growing concern within U.S. Somali immigrant populations, who experience unique barriers to accessing and using tobacco treatments developed for the general population. Household smoking exposes Somali families to second- and thirdhand smoke with related negative health consequences and influences children's tobacco use beliefs and future behaviors. This study will modify and then pilot test an existing evidence-based parental tobacco cessation intervention (the Clinical Effort Against Secondhand Smoke Exposure, or CEASE) delivered in pediatric primary care clinics to address shared tobacco use determinants and barriers to smoking cessation treatment among Somali Americans. This new intervention, CEASE+, will increase access to and utilization of tobacco cessation treatment for Somali parents through brief clinician- and staff-delivered messaging and tobacco cessation resources. The project will take place in two phases. In phase 1, the investigators will modify the existing intervention to develop CEASE+ by conducting focus groups with Somali parents who smoke and non-smokers who live with adults who smoke and with the help of a community advisory board. In phase 2, we will conduct a pilot study of the new intervention, CEASE+, with Somali parents in 2 pediatric primary care clinics (n=50 parents who smoke). Primary outcomes will include feasibility and acceptability of CEASE+ intervention components and study procedures.

Secondary outcomes will include cigarette smoking abstinence and total tobacco abstinence at 3 months and changes in cigarette smoking heaviness between baseline and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* self-reported 1 st or 2 nd generation Somali identity
* parent or legal guardian at least one pediatric patient within the MHF system
* self-reported use of combustible cigarettes (even a puff) in the past 30 days
* access to a telephone

Exclusion Criteria:

Clinician or staff participant:

* Inability or unwillingness to participate in implementing CEASE+
* Employees or students of the research team

Parent participant:

* Having participated in Aim 1
Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Primary Objective:

1. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and 299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by incidence of Lactobacillus plantarum bacteremia.

Secondary Objectives:

1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to children and adolescents undergoing HSCT.
2. To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum.
3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT patients who have been administered Lactobacillus plantarum.

Myeloablative regimens are the backbone of hematopoietic stem cell transplantation (HSCT) and are associated with prolonged periods of cachexia/anorexia, nausea/vomiting, mucositis, and compromised gut integrity (CGI). The toxicities associated with HSCT often lead to prolonged periods of poor oral intake and may result in overt malnutrition. CGI decreases oral tolerance to foods, reduces Quality of Life (QOL) and functional status, delays the transition from the hospital to home setting, and increases the risk of the development of gut-derived infections. Probiotics are nutritional supplements that contain a defined amount of viable microorganisms and upon administration confer a benefit to the host. Clinical trials in adults receiving organ transplants have found probiotics decrease the incidence of infection, the duration of antibiotic use, the incidence of multiorgan failure and systemic inflammation. Children and adolescents undergoing HSCT, experience similar clinical challenges suggesting probiotics may have a therapeutic value in the setting of HSCT. This study is to evaluate the safety and feasibility of administering probiotics to children and adolescents undergoing HSCT.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing myeloablative allogeneic HSCT will be eligible. The source of stem cells can be from bone marrow, umbilical cord blood or cytokine mobilized peripheral blood. Donor can be human leukocyte antigen (HLA) matched sibling or parent, a related donor mismatched for a single HLA locus (class I or II), unrelated marrow or peripheral blood stem cell donor, or unrelated cord blood at least 4/6 antigen match (Class 1 or II).
* Patients of either gender and between 2 and 17.99 years of age
* Patients receiving any type of GVHD prophylaxis are eligible.

Exclusion Criteria:

* Patients who have self-prescribed probiotics within 3 months of starting the conditioning regimen for stem cell transplant (consumption of yogurt products is allowed).
* Patients with known allergy to oats.
* Patients who have had any type of gut damage within the past three months; such as, previous bowel perforations; previous episode of Grade 4 neutropenic colitis or typhlitis.
* Patients with inflammatory bowel syndrome, short small bowel syndrome, Crohns Disease, Ulcerative Colitis, and patients with a history of bowel resections.
* Patients who have undergone a previous allogeneic HSCT.
Remote STATE Training for Insomnia in Older Adults

This study called rSTATE (Remote STATE Training for Insomnia in Older Adults) is a Phase II study to definitively evaluate the efficacy of a computerized cognitive training program (rSTATE) designed to improve sleep regulation and brain health and extend functional independence in older adults with insomnia.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who are 65 years of age or older. The inclusion age of ≥ 65 is in accordance with the FDA's Guideline for Industry Studies in Support of Special Populations (Geriatrics ICH-E7), which uses 65 as its cutoff for defining the geriatric population prone to insomnia.
2. Participants who have an Insomnia disorder diagnosis per DSM-V.
3. Participants who exhibit \> 30 minutes sleep onset latency (SOL); and/or \> 30 minutes wake after sleep onset (WASO).
4. Participants must be a US resident.
5. Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
6. Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet.

Exclusion Criteria:

1. Participants who score ≥ 4 on the Cognitive Function Index (CFI).
2. Participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks.
3. Participants with past or present psychosis, schizophrenia, or bipolar disorder. Participants with other untreated psychiatric disorder, including substance abuse/dependence disorders.
4. Participants with a seizure disorder.
5. Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome).
6. Participants with a recent hospitalization, ongoing chemotherapy or other cancer treatment.
7. Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment (CBTi) in the last 12-months that could affect the outcome of this study, or concurrent engagement in another insomnia treatment, per self-report. However, participation in standard treatments not known to affect sleep (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable if stable on medications for \> 3 months.
8. Participants who are using computer-based cognitive training programs or have used it within a month of the consent date.
Retrospective Survey of Bone Fracture in Patients With Arimidex 1mg

The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal breast cancer patients treated with Arimidex 1mg at the time of previously conducted clinical experience investigation.

Exclusion Criteria:

-
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion.

It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of degenerative disc disease
* Up to Grade I spondylolisthesis
* Eligible to undergo a single vertebral level spine fusion (L2 to S1)

Exclusion Criteria:

* Previous spinal instrumentation or previous interbody fusion procedure at the involved level
* Grade II or greater spondylolisthesis
* Systemic or local infection at the site of surgery
Age-related Changes of Shoulder Muscles

A cross-sectional descriptive study, in which the surface electromyographic activity of five shoulder muscles was compared in three populations: older adults, middle-aged adults and young adults. The evaluation of the electromyographic data offers a suitable foundation to understand aging process.

This supports that surface electromyography provide information about the aged shoulder muscles. Loss of functionality is suffered by a high percentage of older adults, which greatly limits their physical activity. In this sense, this paper presents findings that might be related with possible therapeutic approaches in subsequent studies.

The purpose of the present work was to assess neuromotor abnormalities in aging shoulder. Twenty young adults (20-42), 20 middle-aged adults (43-67) and 20older adults (\>68) were recruited. A comparative electromyography (EMG) study was performed on the upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior. The EMG measurement (root mean square (RMS)) and onset time of isometric contractions were analyzed. Body mass index and strength were also tested.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no previously manifested symptoms in the shoulder joint and/or the neck during the past year,

Exclusion Criteria:

* moderate or severe cognitive impairment, rheumatologic diseases, massive osteoarthritis, tumors, shoulder joint instability, circulatory disorders (hemophilia clotting problems) and dermatological problems exacerbated by contact with skin
Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to \>75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in protocol BAP089
* Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

Exclusion Criteria:

* Female patients who are pregnant or who want to become pregnant
* Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Severe LUTS : IPSS ≥ 20

Exclusion Criteria:

* Post voided residual urine ≥ 150mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to tamsulosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)
Effect of Audio Book Applıcatıon on Patıents Blood Pressure, Pulse Rate and Anxıety Levels Before Total Knee Replacement Surgery

Before the TDP surgery, the anxiety levels of the patients in the experimental group will be measured by listening to an audio book.

Before Total Knee Prosthesis surgery, patients will have their blood pressure, pulse and anxiety levels measured before the surgery. Patients in the experimental group will listen to an audiobook for 20 minutes. The selected book will be played via wireless headphones. The researcher will check the battery level of the headphones and charge it when necessary. In this way, the headphones will be ready for the next patient. A smartphone with Spotify mobile application installed, which the researcher is a member of, will be used for the audiobook application. The connection between the headphones and the audiobook will be provided via Bluetooth. The patient will be present from the moment they start listening to the audiobook section, and if they experience any hearing problems or if there is an attempt to stop listening, immediate intervention will be made. Necessary interventions will be made for patients who experience interruptions during listening to listen again. After each application, the headphones will be cleaned with an antiseptic solution containing chlorhexidine 2%. The patient will be asked to rest for 10 minutes after the audiobook application. At the end of 10 minutes, the patient will be filled with an AÖKÖ and the patient's blood pressure and pulse will be measured and recorded. When measuring patients' blood pressure, the same blood pressure monitor with calibrated cuff, manometer, and stethoscope will be used, and when measuring pulse, the saturation device data will be used and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 40-80 years of age,
* Patients must be conscious and able to communicate,
* Individuals who volunteer to participate in the study,
* No hearing problems,
* Individuals who will undergo TKA surgery,
* Can understand Turkish,
* Patients must have elective (planned) surgery (must have been hospitalized at least 2 hours before surgery).

Exclusion Criteria:

* Refusing to participate in the study,
* Any communication barrier,
* Cancellation of TKA surgery for any reason.
Lymphangioleiomyomatosis, a Study on Cathepsin K

This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.


Eligibility Criteria:
Inclusion criteria for patients with lymphangioleiomyomatosis

* Age ≥ 18 years
* Female carrier of lymphangioleiomyomatosis according to ERS criteria

Inclusion criteria for healthy female volunteers

* Age ≥ 18 years
* Women with no history of lymphangioleiomyomatosis, pulmonary, renal or osteoporotic disease

Inclusion criteria for tuberous sclerosis complex patients without lymphangioleiomyomatosis

* Age ≥ 18 years
* Woman followed for tuberous sclerosis complex for whom a chest CT scan less than 3 years old does not objectify a pulmonary cyst. (= without lymphangioleiomyomatosis)

Non-inclusion criteria

* Woman under judicial protection
* Woman with a urinary tract infection within 15 days
* Person who objected to the data processing
Weight Management Interactions in a Virtual Clinical Environment

This study is part of an effort to learn about interactions between doctors and patients. We aim to understand how women feel about techniques that doctors use to talk with patients about their weight. We are studying women s reactions to these techniques using a virtual reality version of a doctor s office to create as realistic a model of a doctor s visit as possible. This can help us better understand what happens during real doctor s visits.

Women between the ages of 20 and 50 who are currently overweight may be eligible for this study. Participants will be recruited from the Washington D.C. area. This is not a weight treatment study.

Participants undergo the following procedures:

* Complete an online questionnaire about themselves, their experiences, and their thoughts about their weight
* Participate in activities in a virtual reality environment in which they interact with a virtual doctor in a virtual clinical scenario. For this experiment, participants wear a head-mounted display that allows them to see the virtual world images.
* Fill out a questionnaire after completing the virtual reality activities. This questionnaire includes information on the participants' virtual reality experience, the information provided in the experience, and additional questions about themselves and their thoughts.

The primary goal of this research project is to build an evidence base related to primary care encounters that include discussions about a patient s body weight. We are particularly interested in how encounters impact patients health-related and weight-related attitudes and beliefs. Furthermore, this project aims to determine how a physician s approach to the health care encounter impacts its outcome.

The current study is a controlled experiment in which participants will be participate in a weight counseling encounter with a virtual reality-based doctor. The virtual doctor will present weight etiology information. Participants will fill out a self-report questionnaire online, prior to this encounter. They will then come in to the Immersive Virtual Environment Testing Area in the NIH Clinical Center for a visit. During this visit, they will engage in the interaction with the virtual doctor and then fill out a post-test questionnaire. Participants in the main trial will include approximately 222 healthy adult females between 20-50 years of age who have a BMI of greater than or equal to 25 and are dissatisfied with their current weight.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. being between 20 and 50 years old
  2. having a self-reported body mass index of greater than or equal to 25
  3. having the ability to read, write, and converse in English
  4. being able to come to the NIH Clinical Center for one visit

EXCLUSION CRITERIA:

1. having a vestibular or seizure disorder
2. having a high propensity for motion sickness
3. known pregnancy
4. uncorrected low vision or hearing
5. inability to complete tasks in the virtual environment
6. being an NHGRI employee
7. being or training to become a health care provider
Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

Fifty patients with pathological proof of malignant soft tissue sarcoma will receive Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily.

* The primary end point : To assess Progression Free Survival (PFS)
* The secondary end points : To assess Overall Survival (OS) and Toxicity Profile


Eligibility Criteria:
Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant soft tissue sarcoma.
2. ECOG less than or equal to 2 .
3. Measurable disease according to the requirements of modified RECIST criteria.
4. Age ≥ 19 years .
5. Estimated life expectancy of at least 12 weeks .
6. Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

1. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
2. Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
3. Serious concomitant systemic disorder incompatible with the study.
4. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
5. Pregnancy
Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome

The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients \>= 18 years of age at Visit 1
* Hypertension (systolic blood pressure \>= 140 mmHg and \< 170 mmHg and/or diastolic blood pressure \>= 90 mmHg and \< 105 mmHg
* Elevated triglycerides
* Metabolic syndrome as defined by Adult Treatment Panel III criteria

Exclusion Criteria:

* MSSBP \>= 170 mmHg and/or MSDBP \>= 105 mmHg at any time between Visit 1 and Visit 2
* Diabetes mellitus
* Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply