bioihbjkbjnl/mcl2 huggingface dataset:
Contraceptive Awareness and Reproductive Education
Condition: Pregnancy; Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The long-term objectives of this research are to develop effective treatments to reduce
      unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served
      at-risk youth population.
    

Detailed description: 
      This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve
      contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a
      pregnancy. Those interested in becoming pregnant will be counseled in the risks associated
      with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The
      investigators will utilize Title X programs in Rhode Island to provide reproductive health
      services in the community. The investigators will recruit 325 at risk youth from Juvenile
      Justice programs, alternative schools, group homes, and Community Mental Health Centers and
      randomize them to two interventions: two sessions of personalized MI or two sessions of
      Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is
      based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically
      supported counseling technique designed to enhance readiness to change targeted behaviors.
      ASH provides didactic information about contraception, STI prevention and abstinence, and is
      intended to control for the effects of assessment and attention.
    

Intervention name(s): Motivational Intervention; Didactic Educational Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.; There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.
Other intervention name(s): Motivational Interviewing (MI); Awareness of Sexual Health (ASH)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; STI prevention; adolescents; probation
Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
Condition: Essential Hypertension; Hyperlipidemia
MeSH terms: Hypertension; Essential Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with
      essential hypertension and hyperlipidemia
    


Intervention name(s): Atorvastatin; Losartan; Placebo; HL-040XC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once daily, administered orally, 8 week; Once daily, administered orally, 8 week; Once daily, administered orally, 8 week; Once daily, administered orally, 8 week
Other intervention name(s): Lipitor; Cozaar
Intervention MeSH terms: Losartan; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atorvastatin; Losartan; Essential Hypertension; Hyperlipidemia
Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
      not yet known whether combining cyclophosphamide with fludarabine is more effective than
      fludarabine alone in treating chronic lymphocytic leukemia.

      PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without
      cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been
      treated previously.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of fludarabine with or without cyclophosphamide in terms of
           complete remission rate and overall survival in patients with previously untreated B
           cell chronic lymphocytic leukemia (CLL).

        -  Compare the toxicities of these 2 regimens in this patient population.

        -  Determine whether the expression of proteins specifically implicated in the regulation
           of DNA damage induced apoptosis of lymphoid cells (i.e., p53; mdm2; GST; Bcl-2; Mcl-1;
           Bax; p27; and caspase-3) correlates with response to chemotherapy in these patients.

        -  Determine whether there is a relationship between clinical response or resistance and
           differential expression of genes in the CLL cells either at initiation of therapy or
           following relapse and progression.

        -  Correlate mutations in immunoglobulin heavy chain variable region genes with clinical
           response or resistance in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
      of disease (O-II vs III-IV). Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.

        -  Arm II: Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on
           day 1.

      Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 6 months until disease
      progression.

      PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study over 2 to 2.5
      years.
    

Intervention name(s): cyclophosphamide; fludarabine phosphate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Fludarabine phosphate
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia
Tennis Elbow Trial
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Epi-X is a multicentered randomized controlled clinical trial of chronic lateral
      epicondylitis with parallel group design and two phases. In the first phase physical exercise
      treatment is given in the intervention group and expectance in the reference group. In phase
      2 eccentric exercise versus concentric is tested.
    

Detailed description: 
      Chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3
      months. It is a common condition in the general population and often results in long-term
      sick-leave. The etiology is unknown. A large number of treatments have been tried but none is
      generally accepted. However, in Achilles tendinitis a new treatment has been shown effective.
      It consists of eccentric exercise, i.e. work during stretching rather than shortening of the
      muscle (concentric exercise). The latter is currently the most common treatment method.

      This project is a randomised controlled clinical trial of eccentric versus concentric
      exercise in 205 patients with chronic lateral epicondylitis. Pain and muscle strength were
      recorded at start of treatment and after 1,2,3,6 and 12 months. Activities of daily life
      (ADL) and well-being were recorded at start of treatment and after 3, 6 and 12 months. In
      addition, blood specimens for a number of neural peptides have been sampled. Moreover, the
      involvement of the peripheral nervous system in the elbow area has been examined in a
      subsample of patients. A biopsy from 20 patients per treatment group and from 20 healthy
      subjects, and a positron emission tomography (PET) scan of 23 patients were performed to
      allow qualitative and quantitative examination of neural fibres, peptides and receptors. The
      health economy of the two treatments will be investigated using data from this project and
      from available registers.
    

Intervention name(s): Eccentric exercise; Concentric exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): Eccentric exercise treatment performed at home with three sets of 15 repetitions daily; Concentric exercise treatment at home with three sets of 15 repetitions daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tennis elbow; Epicondylitis; Pain; Muscle strength; Quality of life; RCT; Tendinitis; Chronic tennis elbow
An Observational Study on the Relationship Between Tear Metabolomics and POD
Condition: Postoperative Delirium
MeSH terms: Emergence Delirium
Study type: Observational

Summary: 
      To explore the correlation between tear metabolomics and POD. The purpose of this study was
      to compare the results of tear metabolomics between POD and non-POD elderly patients
      undergoing abdominal surgery, to clarify the correlation between tear metabolomics and POD,
      and to find tear markers related to POD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In the elderly patients who underwent abdominal surgery under general anesthesia, there
        were no serious systemic diseases and severe cognitive impairment before operation.
      
Biospecimen description: 
      tear was collected
Convalescent Plasma in Pediatric COVID-19
Condition: COVID
MeSH terms: COVID-19
Study type: Interventional
Phase: Early Phase 1

Summary: 
      COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been
      adequately studied in children to date. The study will determine safety of convalescent
      plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
    

Detailed description: 
      COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19
      is increasingly affecting children but convalescent plasma (CP) has not been adequately
      studied in children to date. The study will determine safety of convalescent plasma for
      pediatric patients with severe, or at high risk for severe, COVID-19 disease.
    

Intervention name(s): Convalescent Plasma (CP); Standard COVID-19 therapies
Intervention type(s): Biological; Drug
Intervention description(s): Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.; If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Pediatric; Convalescent Plasma; Safety
Propofol Effects on Mitral Valve Annular Velocity
Condition: Valvular Heart Disease; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Heart Diseases; Heart Valve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is primarily to determine the effects of propofol at different
      concentration on the mitral valve annulus by using Tissue Doppler Imaging
    

Detailed description: 
      The purpose of this study is to evaluate the effects of different concentration of propofol
      on patients who are undergoing cardiac surgery. The patients will receive infusion
      remifentanil 0.5mcg/kg/min with different target-site propofol concentration namely 1.0ng/ml,
      2.0ng/ml and 3.0ng/ml. Tissue Doppler Imaging by transesophageal echocardiography will be
      done to assess the changes in cardiac function.
    

Intervention name(s): Propofol 1.0mcg; Propofol 2.0mcg; Propofol 3.0mcg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.; Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.; Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion
Other intervention name(s): Fresofol (2% propofol, Fresinius Kabi); Fresofol (2% propofol, Fresinius Kabi); Fresofol (2% propofol, Fresinius Kabi)
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Cueing on Gluteus Maximus Recruitment
Condition: Muscle Contraction
Study type: Interventional

Summary: 
      Do specific verbal and tactile cues and instructions help people who perform bridging
      exercises to improve hip muscle strength to optimize recruitment of the gluteus maximus
      muscle?
    


Intervention name(s): Cueing
Intervention type(s): Other
Intervention description(s): Verbal and tactile cueing to enhance gluteus maximus recruitment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Electromyography; Exercise
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients
Condition: Mania; Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double blind, double dummy, multicentre, parallel-group study to
      compare the efficacy and safety of quetiapine and lithium used as monotherapy in the
      treatment of mania in patients hospitalised for an acute manic episode. After given of
      informed consent and undergoing screening procedures, the patients will be randomised into
      quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania
      will be assessed at Day 28. Patients will not permitted to use any psychoactive or
      antipsychotic medications throughout the study period other than those expressly permitted by
      the protocol. The patients are required to be hospitalised for the treatment and assessment
      defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On
      Day 15) if the investigator believes that it will be clinical appropriate to discharge the
      patient, that the patient is not suicidal or homicidal, and that the patient could reasonably
      be expected to continue in the study on an outpatient basis. The patients discharged after
      Day 15 will be given sufficient study medication for the period from discharge to the next
      visit. At each centre, the same individual will administer a specific psychiatric assessment
      for a patient at all study visits in order to reduce variability in rating scale scoring.
      Before the initiation of the study, a consistency assessment will be done among the
      investigators who conduct the scale assessment in each centre.
    


Intervention name(s): Quetiapine Fumarate; Lithium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute Mania
Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
Condition: Painful Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable
      patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6)
      inhibitor ricolinostat for painful DPN.
    

Detailed description: 
      The study includes an approximately 12 week randomized, double-blind, placebo controlled
      Treatment period in which patients will receive either ricolinostat or placebo, followed by
      an approximately 12 week open label Safety Extension period during which all patients will
      receive ricolinostat 120 mg daily.

      Prior to randomization, patients will be enrolled in a baseline Pain Observation period from
      Day -14 to Day -1, during which the NRS (average and worst pain) will be recorded daily using
      an electronic daily diary that will be completed by patients to allow patients to familiarize
      themselves with the pain rating procedures, and to establish a baseline and confirm
      eligibility to participate. Patients will also initiate daily dosing during this time to
      evaluate compliance eligibility for participation. A daily diary will be used by the patient
      to record the pain assessments and rescue medication use. A follow-up phone contact will be
      conducted at Day -7 to Day -5 to review diary and dosing compliance.

      Following the baseline Pain Observation period, patients who meet entry criteria will be
      randomized in a 1:1 ratio to receive either ricolinostat or placebo. During the 12-week
      double-blind, placebo-controlled Treatment period, patients will return for assessments in
      accordance with the schedule of assessments. At the conclusion of the approximately 12 week
      open label Safety Extension period, patients will enter a Follow-up safety washout and
      assessment period, which will incorporate 2 visits at approximately 2 and 4 weeks following
      the final Safety Extension visit, with assessments performed as outlined in the schedule of
      assessments.
    

Intervention name(s): ricolinostat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg per dose in 12 mL liquid formulation; 12 mL liquid formulation placebo
Other intervention name(s): ACY-1215
Intervention MeSH terms: Ricolinostat
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Neuropathic Pain; Neuropathic Pain; HDAC6; ricolinostat; Painful Diabetic Peripheral Neuropathy; DPN
A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR
      (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of
      panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus
      placebo.
    

Detailed description: 
      This was a single-site, double-blind, placebo-controlled (PLAC), randomized, parallel group
      (2 groups), 8-week, quetiapine extended release (XR) coadministration trial. SSRI resistance
      was determined either historically or prospectively. Patients were randomized if they
      remained moderately ill (CGI-S score ≥ 4). Change in the PDSS scale total score was the
      primary efficacy outcome measure. Responders were identified as those with a ≥50 % decrease
      from their baseline PDSS score. In the early weeks of therapy, XR was flexibly and gradually
      titrated from 50 to 400 mg/day.

      Conclusions: This proof-of-concept RCT did not support the efficacy of this treatment
      strategy for SSRI-resistant PD. Quetiapine XR was generally well-tolerated. Important
      limitations were the small sample size, and the relatively low average dose of quetiapine XR
      used.
    

Intervention name(s): quetiapine XR; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.; Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
Other intervention name(s): Seroquel SR; Seroquel XR; Astra Zeneca placebo
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SSRI Resistant; Seroquel SR; Seroquel XR; Panic Disorder; Comorbid Panic Disorder; Quetiapine SR; Quetiapine XR
Calcium Absorption in Postmenopausal Thai Women
Condition: Fractional Calcium Absorption
Study type: Observational

Summary: 
      Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis.
      However, postmenopausal Thai women consume diets which are habitually low in calcium due to
      lactose intolerance and dietary patterns which typically do not include milk-based products.
      The primary goal of this study is to measure the fractional calcium absorption from milk and
      a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with
      habitually low calcium intakes. The secondary objective is to determine associations between
      calcium absorption and biomarkers which impact vitamin D status and bone metabolism.
    

Detailed description: 
      Postmenopausal Thai women (n=22) will be recruited from the community surrounding Bangkok and
      Nakhon Pathon, Thailand. They will be invited to participate in an isotope study comparing
      the fractional calcium absorption from milk and cassia. Upon arrival, a fasting blood sample
      will be drawn on the morning of the absorption study to analyze serum markers of vitamin D
      and bone metabolism (25-hydroxy vitamin D [25OHD], parathyroid hormone [PTH], and
      beta-crossLaps) and to determine their impact on calcium absorption. Following this blood
      draw, women will receive a stable calcium isotope (42Ca) intravenously. Then for breakfast
      and lunch respectively, the women will be randomly assigned to orally ingest a stable calcium
      isotope from either the milk (44Ca) or cassia (43Ca) test meals. On day two, women will
      receive a breakfast, snack, and lunch meal. Urine samples will be collected over the entire
      28 hour period and the 24-hr urine collection will be used to measure urinary calcium
      concentration and to calculate fractional calcium absorption.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Post-menopausal Thai women
      
Keywords: Triple Stable Isotope