bioihbjkbjnl/mcl2 huggingface dataset:
Promotion of Well-being of Young Adult Brain Cancer Survivors
Condition: Brain Tumor, Pediatric
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of an Internet-based, behavioral
      activation intervention to promote well-being in a young adult survivors of childhood brain
      tumor.
    

Detailed description: 
      Participants will be recruited through the Children's Brain Tumor Foundation who will share
      the study announcement with their young adult members and social media. Eligible participants
      will complete a baseline battery survey via Qualtrics. The investigators will recruit 120
      participants. The survey will take approximately 30 minutes to complete. Participants will be
      randomly assigned to an experimental group or control group. The experimental group will take
      an Internet-based behavioral activation intervention. The intervention has four modules and
      will be administered via Qualtrics. A link to each module will be sent to the participants
      via e-mail. Participants will have one week to complete each module. Once a participant
      completes a module, the next module link will be sent after 3 days. A reminder will be sent
      at 7 days and 10 days until the module is complete. Each module will take approximately 30
      minutes to complete. The experimental group may continue to receive services as usual from
      the Children's Brain Tumor Foundation. The control group will continue to receive services as
      usual from the Children's Brain Tumor Foundation. The control group will have an opportunity
      to take the intervention once data collection is complete. Both groups will be asked to
      complete a battery of surveys at the end of the intervention and intermittently over a
      3-month period.
    

Intervention name(s): Brief Internet-based Behavioral Activation Intervention
Intervention type(s): Behavioral
Intervention description(s): A brief Internet-based behavioral activation intervention consisting of 4 sessions.
Other intervention name(s): Taking Action and Making Commitment: A Well-being Prorgram
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The experimental group will take a 4-session Internet-based behavioral activation intervention and the control group will receive no treatment and may continue services as usual as provided by the Children's Brain Tumor Foundation.
Masking: None (Open Label)
Primary purpose: Supportive Care
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to re-evaluate the therapeutic superiority and safety of
      acupuncture treatment using high quality and large sampled clinical research. The
      investigators want to provide a preferred treatment protocol, which is effective, safe, and
      easy to use in clinical practice. This research also clarifies that the insertion depth is a
      key factor in the therapeutic effect of acupuncture. The results of the study will help
      promote the development of the standardization of acupuncture.
    

Detailed description: 
      Functional constipation is a high morbidity disease. The life-long treatment of functional
      constipation can seriously impact a patient's quality of life. At present, one of the most
      frequently used treatment is catharsis, which deals with the symptom. There are three main
      problems with catharsis. First, there are no long-lasting effects once the patient stops
      taking medication. Second, there are many side effects, including abdominal pain with
      defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the
      constipation become refractory and complex; but also, this type of medicine can harm the
      enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a
      therapy that is safe with minimal side effects and good short-term and long-term effects is
      urgently needed in functional constipation treatment.

      Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture
      therapy is safe and effective and the therapeutic effects are still present several months
      after the treatment has been completed.
    

Intervention name(s): deep needling; Lactulose; shallow needling
Intervention type(s): Other; Drug; Other
Intervention description(s): Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain.
Once a day, five times a week, four weeks.; 20-30ml, once a day before breakfast, for the whole study except the run-in period; Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.
Other intervention name(s): acupuncture; electroacupuncture; Lactulose produced by Solvay Pharmaceuticals BV; acupuncture; electroacupuncture
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Functional constipation
Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
Condition: Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS); Self-Directed Violence
MeSH terms: Virus Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this project is to gather pilot data related to risk factors associated with
      suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency
      Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide
      that can be utilized by local and national providers to increase understanding regarding
      suicide risk assessment. There are no hypotheses associated with this qualitative pilot
      study.
    

Detailed description: 
      To achieve these goals, a semi-structured interview will be conducted to gather this
      qualitative information. Specifically, this study aims to gather the following information
      from Veterans with HIV/AIDS: a) information regarding disease acquisition; b) psychosocial
      stressors; c) social supports; d) protective factors; and e) previous suicidal ideation and
      behaviors. Further, additional exploratory questions will be asked regarding proposed
      modifications to the Suicide Risk Assessment Guide Pocket Card, an existing VA tool, so that
      it can be modified for use by local and national HIV/AIDS providers.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Veterans with HIV/AIDS
      
Keywords: Veterans; Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS); Self-Directed Violence
Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to investigate if treatment of obstructive sleep apnea
      syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP
      device administering a fixed air pressure, or by one automatic CPAP device ("Somnosmart2",
      Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic
      nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite
      normetanephrine) and on blood pressure.
    

Detailed description: 
      A nocturnal home cardiorespiratory recording will performed for diagnosis of OSA. During the
      same night, patients will be asked to collect their urines. Twentyfour-hour ambulatory BP
      monitoring (ABPM) will be performed starting from the next morning. After analysis of the
      polygraphic recording, subjects with AHI <15 will be excluded from the study, while CPAP will
      be proposed as a treatment to the other patients.

      Before starting treatment, a full night standard polysomnography will be performed: in
      subjects assigned to fixed CPAP for attended CPAP titration; in the other subjects during
      application of the Somnosmart2 device, to verify if obstructive events are adequately
      eliminated by it.

      After analysis of polysomnography, patients will be given a fixed CPAP or the auto-CPAP
      device for nocturnal home use. Two months later, compliance to treatment will be verified
      measured by the in-built time counter of the devices. Then, cardiorespiratory monitoring
      during application of the device used for treatment, nocturnal urine collection and 24-hour
      ABPM will be repeated.
    

Intervention name(s): Automatic (variable, automatically controlled) pressure CPAP; fixed continuous positive airway pressure (CPAP)
Intervention type(s): Device; Device
Intervention description(s): CPAP at a variable level according to instantaneous patients' needs for treatment of sleep respiratory disorders, as evaluated by machine's software.
Home nocturnal usage. Two-month treatment.; CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.
Home nocturnal usage. Two-month treatment.
Other intervention name(s): Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg Germany; fixed CPAP, constant level CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: OSAS; blood pressure; sympathetic nervous system; treatment; CPAP
Improving Bowel Cleansing With a Smart Phone Application
Condition: Cathartics; Mobile Applications
Study type: Interventional
Phase: Phase 4

Summary: 
      Getting ready for a colonoscopy is difficult and involves a lot of steps. The information
      given to patients is very important to adherence to treatment. The investigators have created
      a novel smart phone application (SPA) aimed to increased bowel preparation quality and
      patient satisfaction, using different educational tools.
    

Detailed description: 
      Background: Getting ready for a colonoscopy is difficult and involves a lot of steps. The
      information given to patients is very important to adherence to treatment. The investigators
      have created a novel smart phone application (SPA) aimed to increased bowel preparation
      quality and patient satisfaction, using different educational tools.

      Methods: The investigators have performed a prospective, endoscopist-blinded, randomized,
      controlled trial. The investigators have enrolled 260 outpatients owners of a smartphone.
      Patients were randomly allocated to two different protocols: instructions provided by SPA
      (SPA group; n=108) or written instructions with visual aids (control group; n=152). All
      procedures were performed in afternoon time and patients received the same purgative regimen
      (2-L PEG solution plus ascorbic acid), in a full-dose same-day regimen. The day before
      colonoscopy (Baseline), patients initiated low fiber diet. The study was designed to detect
      an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS)
      scale. The effect of protocol on patient satisfaction was assessed with a specific
      questionnaire at time of the colonoscopy.
    

Intervention name(s): Smart Phone Application; Written instructions with visual aids
Intervention type(s): Device; Device
Intervention description(s): Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure; written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Bowel preparation; colonoscopy; Smartphone application
Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional

Summary: 
      The purpose of the proposed clinical study is to evaluate the use of an implanted
      Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of
      the pain associated with cluster headaches.
    


Intervention name(s): Stimulation (Sub-perception); Stimulation (Full); Control
Intervention type(s): Device; Device; Other
Intervention description(s): Stimulation applied below the perception threshold; Stimulation applied above the perception threshold; No stimulation applied
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Cluster Headache
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants
      with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a
      16-week treatment period, and an 8-week follow-up period.
    


Intervention name(s): MSTT1041A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (SC) MSTT1041A; Participants will receive SC placebo
Other intervention name(s): astegolimab
Intervention MeSH terms: Astegolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
Condition: Immunologic Tests
Study type: Interventional

Summary: 
      The purpose of this study is to develop immunological assays on blood samples.
    

Detailed description: 
      This is a clinical study in which there is no vaccine administered. It is designed for
      research purposes such as developing immunological assays.
    

Intervention name(s): Blood withdrawal
Intervention type(s): Procedure
Intervention description(s): Healthy male or female adults between, and including, 18 and 50 years of age at the time of study start, having received GSK2231392A vaccine, were enrolled for blood withdrawal, at each study visit: Day 0, Day 14 and Day 180, to support the development of CD8+ T cell immunological detection assays.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Immunological assays
The STOP-HPV Trial 2: Performance Feedback Intervention
Condition: Immunization; Vaccination
Study type: Interventional

Summary: 
      Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric
      practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV
      vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness
      (and cost-effectiveness) of the addition of performance feedback (period 2) to training
      providers previously received on HPV vaccine communication (period 1) to reduce MOs and
      increase HPV vaccination rates.
    

Detailed description: 
      HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities
      (MOs) are healthcare visits during which a patient is eligible, but does not receive a
      vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This trial
      focuses on period 2, the addition of performance feedback in the presence of communication
      skills training. Arm-1 intervention study practices add performance feedback (period 2),
      building upon their prior training in communication skills (period 1); Arm-2 comparison study
      practices continue delivering standard of care. During this period, the investigators will be
      measuring captured opportunities - the inverse of MOs, or visits when an eligible patient
      receives a vaccine. Providers rarely receive feedback to track their captured opportunities,
      but feedback has been shown to be an effective tool. Performance feedback reports will pull
      from electronic health record (EHR) data, and will compare participants performance to their
      own previous performance and those of others. Throughout the intervention participants will
      also receive weekly text message mini-lessons that will remind participants of the project.
    

Intervention name(s): STOP-HPV performance feedback intervention
Intervention type(s): Behavioral
Intervention description(s): This intervention will be the addition of performance feedback (in the presence of communication skills).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cluster RCT study design will test the impact of performance feedback to reduce missed opportunities (MOs) and raise HPV vaccine rates
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HPV; Vaccination; Practice based intervention
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in
      subjects with mild, moderate and severe hepatic impairment
    


Intervention name(s): BKM120
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic impairment; Clinical pharmacology study; Volunteer study
Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)
Condition: Allergies
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study was to determine whether children ages 6-11 years prefer
      desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The
      secondary objectives of this study were to compare acceptance of the two attributes, taste
      and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets
    


Intervention name(s): Desloratadine; Zyrtec® (cetirizine)
Intervention type(s): Drug; Drug
Intervention description(s): desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day; Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day
Other intervention name(s): SCH 034117
Intervention MeSH terms: Cetirizine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
Condition: Multiple Myeloma, Relapsed; Multiple Myeloma, Refractory to Standard Treatment
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      In this phase I trial, patients with relapsed or refractory multiple myeloma will receive
      standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant
      conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3
      phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is
      reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose
      will be 9Gy.
    


Intervention name(s): Total Marrow Irradiation; Melphalan; Filgrastim (G-CSF); Autologous transplant; Total Marrow Irradiation; Melphalan; Filgrastim (G-CSF); Autologous transplant; Total Marrow Irradiation; Melphalan; Filgrastim (G-CSF); Autologous transplant
Intervention type(s): Radiation; Drug; Drug; Procedure; Radiation; Drug; Drug; Procedure; Radiation; Drug; Drug; Procedure
Intervention description(s): Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day; Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant; Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days.; Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue; Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day; Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant; Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days; Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue; Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day; Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant; Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days; Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
Other intervention name(s): Alkeran ®; Neupogen®; Alkeran ®; Neupogen®; Alkeran ®; Neupogen®
Intervention MeSH terms: Melphalan; Lenograstim
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Relapsed; Refractory; Progressive Disease; Symptomatic