cyrilzakka/clinical-trials huggingface dataset:
The Role of High Resolution-Computed Tomography (CT) in Tuberculosis (TB) Outbreak Investigation

The aim of this study is to evaluate the role of high-resolution computed tomography of the chest (HRCT) in the investigation of an outbreak of TB that developed in the South Korean army.

Outbreak investigation including tuberculin skin test (TST), QuantiFERON® TB Gold In-Tube (QFT), and simple chest radiography (CXR) will be performed. For participants with any abnormal findings in these tests, HRCT will be carried out. Active pulmonary TB is diagnosed based on sputum studies or HRCT findings. In addition, participants with positive results both in TST and QTF will be treated as having a latent TB infection (LTBI). TST and QTF were repeated in participants with positive result in one of these tests. CXR will be repeated in all participants at 3 and 6 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All soldiers who assigned to the military battery where a tuberculosis outbreak occurred

Exclusion Criteria:

* Soldiers who could not complete study
Cognitive Exercise Therapy Approach (BETY) in Childhood Rheumatic Diseases

Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY), an innovative method developed for adults with rheumatism, aims to develop behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains in pediatric rheumatology. BETY also recognizes the importance of family education in achieving these goals. However, there is a need for studies on exercise approaches that fit the biopsychosocial model, such as BETY in childhood rheumatic diseases.

BETY is an innovative exercise approach based on the biopsychosocial model that aims to change the patient\&#39;s cognitions through exercise developed on patients with rheumatism. This approach includes function-oriented trunk stabilization exercises, chronic pain management, and authentic dance therapy training targeting positive cognitive displacement. It is carried out in a routinized structure that continues for years on a face-to-face basis in groups and individually.

Interventions that provide physical and psychosocial support are needed in childhood rheumatic diseases. Learning to exercise the muscles surrounding the joints at the proper traction angle through exercise with BETY, gaining the ability to manage chronic pain during the day, gaining positive cognitive displacement skills, and having the opportunity to socialize through both individual and group exercises constitute the basis of the intervention.


Eligibility Criteria:
Jia, JSpA, JPsA according to ILAR 2017 classification criteria; FMF according to Özen-Yalçınkaya classification criteria; JSLE according to SLICC 2012 classification criteria; JSSc according to ACR-EULAR 2013 criteria; JDM according to ACR-EULAR 2017 classification; and individuals followed by a pediatric rheumatologist with a diagnosis of CNO and CRMO will be included.

Inclusion Criteria:

* Patients who were followed up with a diagnosis of childhood rheumatic disease in the Division of Pediatric Rheumatology, Department of Pediatrics, Hacettepe University Faculty of Medicine
* 7-18 years old
* Individuals who volunteered to participate in the study will be included.

Exclusion Criteria:

* Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
* Having undergone major orthopedic surgery
* Not volunteering to participate in the study
Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study

The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.


Eligibility Criteria:
Inclusion Criteria:

* 45-59 yrs of age
* no neurological or psychiatric illness, dementia, or loss of consciousness \> 5 mins
* nongamers (i.e., report \<1 hour of video/cognitive training games/week over last 2 yrs)
* proficient in English (reading and writing)
* computer meets technology requirements (i.e. Windows: Windows 7 or above using Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42 and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS App: iOS 10 or higher version
* meet clinical dx criteria for Generalized Anxiety Disorder.

Exclusion Criteria:

* unable to provide informed consent
* unable to undergo randomization
* Telephone Interview for Cognitive Status-modified (TICS) score \<33, 2)
* other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD, narcolepsy, REM Sleep Behavior Disorder)
* severe untreated psychiatric comorbidity that renders randomization unethical
* psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that alter mood or sleep
* uncorrected visual/auditory impairments
* participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.
Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder

RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.

PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in preventing graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.

OBJECTIVES:

Primary

* To assess the efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease in patients who have undergone allogeneic stem cell transplantation for hematologic malignancies or bone marrow failure disorders.

Secondary

* To correlate the Ocular Surface Disease Index with clinical ophthalmologic examination.

OUTLINE: This is a multicenter study. Patients are stratified according to age, type of transplant (related vs unrelated), and intensity of transplant (ablative vs other). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
* Arm II: Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.

Patients in both arms may also receive artificial tear drops at least twice daily as clinically necessary.

Eligibility Criteria:
Inclusion criteria:

* Age greater than or equal to 18 years at time of enrollment
* Day 80-120 after first allogeneic stem cell transplant for hematologic malignancies or -marrow failure disorder at time of study enrollment
* Signed informed consent
* Willing to adhere to protocol requirements

Exclusion criteria:

* history of non-compliance
* diagnosis of ocular GVHD at time of study enrollment
* documented dry eye prior to onset of stem cell transplant
* significant non- GVHD ocular problems that precludes participation in study
* life expectancy of lesser than 6 months at time of enrollment (viz. grade 4 acute GVHD, florid progression or relapse of underlying disease)
* history of documented ocular infections prior to stem cell transplant or during transplant (i.e. history of herpetic keratitis)
* females who are pregnant or breastfeeding
Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis

The primary objective of this study is to assess the function and reliability of a non-invasive, skin-like electronic sensor.

We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively, and rapidly assess critical vital signs and other measures essential to healthcare monitoring for patients with asthma and anaphylaxis.

In clinical and home settings sensors to monitor vital parameters (including heart rate, ECG, respiratory rate, temperature, and pulse oximetry) require the application and removal of multiple, often bulky apparatuses. Furthermore, each requires constant, wired attachment to a power supply and operators, which can limit visibility and impair the ability to move a patient without interference. Serial measurements require significant time, as several devices with separate leads are applied and removed to obtain measurements. Due to the varying and often large measurement heads of different devices, readings may not be obtained at exactly the same skin location, which impairs comparability of serial measurements. Additionally, the process of measurement can disturb the skin area being measured.

Asthma and anaphylaxis are common entities in children. During exacerbations, frequent monitoring of the vital parameters described is necessary to guide medical decision-making. Asthma exacerbations are associated with mild to severe symptoms that include cough, wheeze, tachypnea, retractions, labored breathing and respiratory fatigue. Food allergy reactions are potentially severe with life-threatening symptoms of anaphylactic shock that include, choking, respiratory distress and loss of consciousness. In the most severe cases reactions can be fatal or require emergency and intensive care treatment in the hospital. Convenient, easy to use, vital signs monitors are especially important in pediatric populations as children have less ability to self-monitor or describe their physical symptoms of life-threatening anaphylaxis or asthma exacerbation.

The wearable sensors offer a new, non-invasive and easy to use way to monitor vital signs of patients with asthma and anaphylaxis. Our previous experience testing our wearable vital sign sensors in multiple pediatric and neonatal studies since 2016, have shown a strong correlation to existing standard of care monitor data outputs. Additionally, the sensors have received positive feedback from patients and physicians, on their comfort, ease of use, and application.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 1 to 17 years old
2. Patients scheduled to do an oral food challenge or managed in the ED or admitted to the hospital for asthma exacerbation.
3. For exploratory analyses of breath sounds, patients in the ED with signs and symptoms of lower respiratory tract infection (e.g., bronchiolitis, pneumonitis, pneumonia).

Exclusion Criteria

1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed (including wounds, blistering, cracked or peeling skin, burns or skin that is bandaged/covered)
Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm

Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.

A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present. Adaptations to ERGT will result in a 12 session long treatment for adolescents Emotion regulation group therapy for Adolescents (ERGT-A). A parallel parent group focused on strengthening parental skills will be given alongside ERGT-A (5 sessions)

Method: A quantitative feasibility open trial (N=20) with pre, post and 1 month follow-up assessments will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents.

Feasibility measures include recruitment rate, proportion beginning treatment, attrition, treatment credibility and satisfaction, negative effects, and alliance.

Preliminary effects measures include DSH, emotion regulation ability, anxiety and depression.

Method: A qualitative interview study. Using thematic analysis to explore participants' experience of ERGT-A and parent group

Eligibility Criteria:
Inclusion Criteria:

1. 13-17 years of age;
2. having engaged in deliberate self-harm (DSH)-behaviours ≥ 5 times the last year;
3. having engaged in ≥1 DSH episode during the past month;
4. having ongoing psychiatric treatment in the community;
5. having at least one caregiver or other significant adult, committed to participate in the parent program; and
6. stability of psychotropic medications

Exclusion Criteria:

1. a diagnosis of psychotic, bipolar I disorder or severe social anxiety disorder (SAD);
2. ongoing substance dependence;
3. the presence of co-occurring psychiatric disorders that require immediate treatment;
4. having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability;
5. insufficient understanding of the Swedish language
A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control

This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.

This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

Eligibility Criteria:
Inclusion Criteria:

* Participation in Study GS-US-312-0119
* Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119.
* Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL.
* The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.
Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients

Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring treatment response and development of lesions. Therefore, optimal performance and visualization of mucosal lesions via adequate bowel preparation is essential in such patients. In addition, the nature of the disease and the need for multiple colonoscopies throughout a patient's lifetime makes compliance to repeated procedures difficult.

It is well known that colonoscopy preparations are generally poorly tolerated, disliked and, consequently serve as an additional burden on patients.Polyethylene glycol (PEG), despite being the golden standard, is not very well tolerated. Inadequate bowel preparations are associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly, with missed pathology. A good bowel preparation would need a solution with reasonable volume, acceptable taste, minimal diet restrictions, and easy-to-follow instructions. The strict need for adherence to drinking a relatively large volume of solution preparation may result in poor compliance.

Despite the emergence of several types of low volume preparations, the evidence on the use of such solutions remains sparse. This is especially true in terms of patients' tolerability to the solution, and its relation with adequate bowel preparation during colonoscopy.

The investigator's aim is to assess how small volume preparations such as sodium picosulfate/magnesium citrate (Citrafleet®) enhance participants tolerability to the solution, compliance, and adequacy of bowel preparations when compared to 2L polyethylene glycol + ascorbic acid (MoviPrep®) in patients with Ulcerative Colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Ulcerative Colitis
* Patients undergoing elective outpatient colonoscopy
* Patients consenting to the study

Exclusion Criteria:

* Age less than 18 years
* Pregnant or lactating women
* Significant gastroparesis
* Gastric outlet obstruction
* Ileus
* Known or suspected bowel obstruction or perforation
* Phenylketonuria
* Toxic colitis or megacolon
* Having a stoma
* Compromised swallowing reflex or mental status
* Psychiatric disease or known or suspected poor compliance
* Severe chronic renal failure (creatinine clearance \<30 mL/minute)
* Severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
* Dehydration
* Laxative use or dependency
* Chronic constipation (\<3 spontaneous bm/week)
* Uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
* Prior colon resection
* Age above 65 years
* Profusely bleeding patients with severe UC
Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria

To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment \> 3 months
* The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
* Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be \<35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
* Serum creatinine \< 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
* 18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2

Exclusion Criteria:

* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
WILD 5 Wellness: A 30-Day Intervention

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative.

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention". Results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the WILD 5 program. Data will be collected to evaluate participants' adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for First Year Beloit College students.

Eligibility Criteria:
Inclusion Criteria:

* students 18 years of age or older
* students enrolled in First Year Initiative Course titled, "Habits of Mind, Habits of Body."

Exclusion Criteria:

* individuals who are pregnant or plan to get pregnant during the next 30 days
* students who are not enrolled in the First Year Initiative Course titled, "Habits of Mind, Habits of Body".
Challenge!, a Health Promotion/ Obesity Prevention Program for Teens

The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/ obesity prevention program will have a healthier BMI-for-age z-score and body composition (body fat %), will consume a healthier diet, and engage in higher levels of physical activity compared to those that did not receive the intervention over time.

Pediatric overweight is a major public health problem in the US, with the prevalence of overweight among children of all ages increasing dramatically over the past several decades. Interventions aimed at reducing the increased weight gain during adolescence have produced mixed results.

Challenge! is a randomized controlled trial for health promotion/ obesity prevention targeting low-income, urban, African American adolescents. Healthy adolescents were recruited from an urban medical center and from local middle schools. Weight status was not part of the inclusion criteria.

The intervention was home- and community-based and delivered one-on-one to each adolescent by a college-age "personal trainer". The intervention focused on goal-setting, consuming a healthy diet (increase fruits, vegetables, and water, and decrease high-fat snack and convenience foods), and increasing physical activity. We hypothesized that the teens enrolled in the intervention would have a healthier BMI-for-age z-score and a healthier body composition (body fat %) compared to those that did not receive the intervention over time. Additionally, we hypothesized that those enrolled in the intervention would consume healthier diets and have higher levels of physical activity compared to those that did not receive the intervention over time.

Eligibility Criteria:
Inclusion Criteria:

* Ages 11-16, willing to participate in a randomized controlled trial for health promotion

Exclusion Criteria:

* Outside of age range