bioihbjkbjnl/mcl2 huggingface dataset:
A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single and multiple ascending dose study of ANA001 in healthy adults to assess the safety
      and pharmacokinetics
    

Detailed description: 
      This is a Phase 1, single center, randomized, double blind, single ascending dose (SAD) and
      multiple ascending dose (MAD) study to assess the safety and pharmacokinetics of ANA001 in
      healthy adult subjects. In the single ascending dose portion of the study, subjects in 3
      cohorts of 10 subjects each will be randomized to receive a single daily oral dose of ANA001
      or matching placebo. In the multiple ascending dose portion of the study, subjects in 3
      cohorts of 12 subjects each will be randomized to receive twice or thrice daily oral dose of
      ANA001 or matching placebo.
    

Intervention name(s): Niclosamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Niclosamide is an antihelmintic with in-vitro antiviral activity; Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
Other intervention name(s): ANA001
Intervention MeSH terms: Niclosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Somatostatin on ADPKD Heart
Condition: Autosomal Dominant Polycystic Kidney Disease; Glomerular Filtration Rate > 40 ml/Min
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset
      hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with
      LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic
      function in ADPKD patients and whether they were affected by the treatment with the
      somatostatin analogue, octreotide.

      35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26
      mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide
      (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV
      mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane
      Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow
      velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler
      imaging.
    


Intervention name(s): Octeotride; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis
Condition: Atherosclerosis, Coronary
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      How safe and effective are CD34+ cell intracoronary injections for treating coronary
      endothelial dysfunction (CED)?
    

Detailed description: 
      This is an open label, phase I study to determine safety and efficacy of CD34+ cells in the
      treatment and management of CED and early atherosclerosis. Coronary endothelial function will
      be assessed in all patients by the administration of intracoronary acetylcholine. Patients
      with endothelial dysfunction who meet study inclusion criteria will receive granulocyte cell
      stimulating factor (G-CSF), followed by apheresis. The mobilized peripheral cell product will
      be processed for selection of CD34+ stem cells, and the purified CD34+ cells will be
      administered intracoronary during cardiac catheterization. The patients will undergo repeat
      endothelial function assessment 6 months post-procedure, as well as clinical assessments as
      described below either via in-person assessment by a nurse or physician, or via phone-call
      using a standardized questionnaire at 1, 3, and 6 month follow-up visits. At one month, the
      patient will undergo basic laboratory testing including troponin levels, complete blood count
      (CBC), electrolyte panel, liver function testing and ECG. At 3 months, the patients will
      receive a phone follow-up by the study coordinator who will assess the patient for any
      clinical deterioration or significant worsening in symptoms. At 6 months, the patients will
      return for a clinical visit, which will include physical examination, basic laboratory
      testing and follow-up acetylcholine study with angiography to assess for change in
      endothelial function. The first three patients will be sequentially enrolled, and subsequent
      enrollment will be held until one month follow-up. Provided there are no safety concerns at
      this time, enrollment will continue.
    

Intervention name(s): Autologous CD34+ Cells; Granulocyte Colony-Stimulating Factor (G-CSF)
Intervention type(s): Drug; Drug
Intervention description(s): The dose will be 1x10^5 cells/kg, injected at the rate of 10 ml/min; 5mg/kg twice daily
Other intervention name(s): Neupogen; Neulasta
Intervention MeSH terms: Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
Condition: Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
      PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 will be
      administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel (125 mg/m2) and
      gemcitabine (1000 mg/m2) will be administered IV on Days 1, 8, and 15 of each cycle. The
      planned dose levels of OMP-54F28 are 3.5 mg/kg and 7.0 mg/kg.
    

Detailed description: 
      Depending on safety in this study, additional lower or intermediate dose levels may be
      evaluated. Depending on emerging safety data from the Phase 1a study 54F28-001 with
      continuing dose escalation, additional higher dose levels of OMP-54F28 may be evaluated in
      this study. No dose escalation of OMP-54F28 will be allowed within a dose cohort.

      Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
      up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
      safety, tolerability and PK of OMP-54F28 combined with nab-paclitaxel and gemcitabine. Up to
      approximately 34 patients may be enrolled into the study.
    

Intervention name(s): OMP-54F28, Nab-Paclitaxel and Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer; Stage IV Pancreatic Cancer
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      This prospective, multi-center, observational study is designed to assess the real world
      effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral
      agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of
      participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and
      compensated liver cirrhosis in Russia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with chronic hepatitis C (CHC) genotype 1 (GT1b) and compensated liver
        cirrhosis will be recruited and observed in approximately 5-7 national and regional
        hospitals/outpatient services in Russia.
      
Keywords: Paritaprevir; Dasabuvir; Ombitasvir; Ritonavir; Ribavirin free; Chronic Hepatitis C genotype 1b (GT1b); Cirrhosis; Compensated liver cirrhosis; Hepatitis
Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
Condition: Glabellar Rhytides
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in
      Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated
      with facial laser resurfacing.
    


Intervention name(s): botulinum toxin Type A
Intervention type(s): Biological
Intervention description(s): 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Other intervention name(s): BOTOX®; onabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Peripheral Magnetic Stimulation
Condition: Healthy
Study type: Interventional

Summary: 
      Interventional study of the effectiveness of peripheral magnetic stimulation of the abdominal
      wall muscles in healthy individuals.
    

Detailed description: 
      Interventional 8-week study of the effectiveness of peripheral magnetic stimulation of the
      abdominal wall muscles in healthy individuals. The study will include an experimental and a
      control group.
    

Intervention name(s): Exercise with peripheral magnetic stimulation of the abdominal wall muscles; Exercise of the abdominal wall muscles
Intervention type(s): Device; Other
Intervention description(s): 8-week exercise program with peripheral magnetic stimulation, focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control.; 8-week exercise program focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental and control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: subcutaneous fat, magnetic stimulation, abdominal muscles
Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      This study evaluated the effectiveness of socket grafting material, combination of plate-rich
      fibrin and calcium sulfate. 5 subjects were grafted with this material, 5 subjects were
      grafted with combination of plate-rich fibrin and xenograft.
    

Detailed description: 
      Calcium sulfate (CS), an alloplastic material, is widely accepted as a socket grafting
      material and undergoes rapid and complete resorption. Studies have shown that CS creates an
      osteoconductive lattice that stimulates bone ingrowth into a defect. PRF poses multiple
      growth factors, anti-inflammatory cytokines and adhesion molecules. It is biologically active
      up to one week. The combination of these 2 materials will serve as good grafting material for
      tooth socket, in order to preserve vertical and horizontal dimensions.
    

Intervention name(s): platelet-rich fibrin and calcium sulfate; platelet-rich fibrin and xenograft
Intervention type(s): Combination Product; Combination Product
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: socket augmentation; platelet-rich fibrin; calcium sulfate; xenograft
Increasing Adoption of Fruits and Vegetables Into Family Diet
Condition: Diet, Healthy
Study type: Interventional

Summary: 
      The investigators are interested in maximizing the consumption of fruits and vegetables (F&V)
      in elementary school children by increasing the access to F&V by providing them in the home
      environment via direct delivery (F&V bag & recipes) and a gift card to purchase preferred
      choices. This also decreases barriers to trying F&V and switching to a more F&V-focused diet,
      e.g., access, cost, knowledge of what to do with fruits and vegetables by their families in
      household diet, and a period of time to try and get used to more F&V in the diet without
      worrying about access and cost.

      We hypothesize that at the end of 4 weeks, children in families that were given access to a
      F&V produce box with associated recipes, a gift card to purchase preferred choices, and a
      cooking incentive kit, consumed significantly better diets as measured with a diet composite
      score compared with children in families who did not receive increased F&V access.
    


Intervention name(s): Weekly produce box and gift card
Intervention type(s): Dietary Supplement
Intervention description(s): Weekly box of produce (5-10 lbs) and $10.00 gift card to a local grocery store to purchase preferred produce. If progress on self-goals completed, an additional $10.00 card provided, weekly, for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial, outcomes on reference child and reference caregiver; In the intervention arm, fruits and vegetables and vouchers cover more than 1 cup a day increase for families, using an average of 5 people as family size.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB
Condition: Tuberculosis, Pulmonary
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      SQ109 was developed with the aim of shortening TB treatment and providing new drugs for
      resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable
      safety profile in first-in-man studies. The objective of this study is to evaluate the
      extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of
      several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly
      diagnosed, uncomplicated, smear positive, pulmonary TB.
    


Intervention name(s): SQ109; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): SQ109 150 mg tablet; Rifampicin 150 mg capsules
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TB; Tuberculosis; EBA; Pulmonary; Early Bactericidal Activity
Dose-escalation Phase 1 to Evaluate the Safety and Efficacy of MG1111 in Healthy Adults
Condition: Varicella (Chicken Pox)
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether varicella live vaccine is safe and
      effective in the healthy adults.
    


Intervention name(s): MG1111; VARIVAX
Intervention type(s): Biological; Biological
Intervention description(s): Low, Medium, High Plaque-Forming Unit (PFU) of MG1111 in 0.5 mL dose is administered by subcutaneous injection; VARIVAX is administered by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
BMI Study for Children Ages 6-9 Years and Parents
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to test the Fitwits office tool and games with 6-9 year old
      children and their parents to: 1) assist parent-child dyad with correct BMI status
      identification and understanding; 2) address nutrition, portion size, and activity cues; and,
      3) track BMI trajectory over 12-month period.
    

Detailed description: 
      The investigators will study parents' perceptions of their child's BMI before and after the
      Fitwits intervention with a primary goal of improving parents' ability to identify their
      child's actual BMI status (underweight, healthy weight, overweight, or obese). Secondary
      goals are to measure changes in behaviors and BMI trajectories with repetitive use of the
      Fitwits office tool.

      The study design is a longitudinal non-randomized intervention study with four time points
      (baseline, 3, 6, and 12 months). The investigators will recruit family medicine residents,
      fellows, and faculty at the investigators' three family health centers and enroll 150
      parent/guardians and children aged 6-9 years at well child visits, regardless of initial BMI.

      The investigators will use electronic health record-generated BMI percentages, the
      physician-led Fitwits Office Tool as the intervention, and self-reported surveys for the
      parent-child dyad. Surveys will record the BMI understanding -pre- and post-Fitwits
      intervention at each visit.

      The investigators will compare the intervention to a control group residency-based family
      health center with usual care for child/parent dyads presenting at well child care and 12
      months later. At this site the investigators will survey for correct parent identification of
      the child's BMI category.
    

Intervention name(s): Fitwits office tool and games
Intervention type(s): Other
Intervention description(s): Physician-led narration of Fitwits office tool during well child and subsequent visits over one year with distribution of Fitwits games during first visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
Condition: Li Fraumeni Syndrome
MeSH terms: Li-Fraumeni Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules
      for the early detection of cancers in the population under study on cancer incidence at 3
      years.
    


Intervention name(s): whole body MRI
Intervention type(s): Other
Intervention description(s): whole body MRI at inclusion, one and two years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: patients with Li Fraumeni syndrome
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled
      ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of
      oocytes retrieved.
    


Intervention name(s): COOL-COS
Intervention type(s): Drug
Intervention description(s): Controlled ovarian stimulation will start on the second or third day of a menstrual cycle:
Oral clomiphene citrate: 100 mg/day until the day of the triggering.
Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation.
hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation.
The triggering will be performed using urinary hCG (5,000 IU subcutaneous).
1-2 days after the identification of one follicle ≥ 17 mm
0-1 days after the identification of one follicle ≥ 19 mm.
Other intervention name(s): Friendly COS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Design: Prospective interventional study. 69 women with OE were evaluated clinically and by
      transvaginal ultrasonography (TUV). AEST procedure was performed and the collected aspirate
      and pre-procedural blood samples were collected for estimation of cytokines' levels. At 6-m
      post-procedure, clinical evaluation and TUV were repeated and serum cytokines' levels were
      re-estimated.
    


Intervention name(s): Ethanol Injection
Intervention type(s): Drug
Intervention description(s): The AEST procedure was performed as follows: vaginal walls were cleansed using vaginal povidone-iodine, a 17 gauge, 30-cm length needle was inserted through the posterior vaginal fornix into the pouch of Douglas, and the cyst was aspirated till complete disappearance of the cyst on the ultrasound scanner. The collected cystic fluid was collected into a plastic tube without an anticoagulant. The needle was maintained in its place, the syringe was removed and the cyst was flushed with saline solution until obtaining a clear liquid. Then, 96% ethanol was injected as 60% of the volume of the aspirated fluid to guard against over distension or rupture of the cyst and/or ethanol diffusion into the pelvis. The collected fluid was divided into three sterile tubes for cytological and bacteriological examinations and the study investigations. Patients were allowed to be completely recovered and were discharged home.
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Colombian Screening Mammography Project
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to
      evaluate the effects of an opportunistic (hospital-based) screening program (intervention)
      vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or
      control arm (N=13). At intervention clinics general practitioners were instructed to perform
      clinical breast examination (CBE) on all women aged 50-69 years attending clinics for
      non-breast health related issues, and to refer them for mammographic screening. Physicians
      from control clinics were not specifically instructed to perform breast-screening or refer
      women for mammography, but could do so if they thought it appropriate ('usual care'). Women
      were followed for 2 years post-randomization.
    


Intervention name(s): Opportunistic Breast cancer screening; Usual Care
Intervention type(s): Other; Other
Intervention description(s): Opportunistic breast screening offered to women attending clinics for non-breast health issues; No breast screening was explicitly offered to women attending clinics for non-breast health issues, unless the health care provider felt that it was appropriate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational
      drug in obese patients after a very low calorie diet.
    


Intervention name(s): MK0557
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment