bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the safety, tolerability, and therapeutic
      equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the
      efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of
      acne vulgaris.
    


Intervention name(s): GDC 268 Lotion; Clindamycin Phosphate Lotion 1%; GDC Vehicle Lotion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GDC 268 is a topical lotion; Clindamycin Phosphate Lotion is an FDA-approved drug product; GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: zits; pimples; blackheads
Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants
Condition: VLBW - Very Low Birth Weight Infant
MeSH terms: Sepsis; Body Weight; Birth Weight
Study type: Observational

Summary: 
      To explore the predictive value of peripheral perfusion index in late onset sepsis of very
      low birth weight infants , obtain the threshold by observing the perfusion index of very low
      birth-weight infants within one month after birth, this value can be used as a threshold to
      predict late onset sepsis in very low birth weight infants.
    

Detailed description: 
      From the day the very low birth weight infant was admitted to hospital, monitoring was
      recorded once a day, and continuous monitoring was recorded for 1 month. Before collection,
      the infant was confirmed to be in supine position with neutral temperature, and at the same
      time, the infant was in a quiet state, without the contact and operation of medical
      personnel. This study will first use LMS curve to fit the trend of perfusion index in very
      low birth weight infants within one month after birth.The perfusion index threshold of the
      outcome index was determined by ROC curve.
    

Intervention name(s): Not applicable (cohort study)
Intervention type(s): Other
Intervention description(s): This is a prospective observational study and does not include interventions. The exposure is peripheral perfusion index and the outcome is the incidence of late onset sepsis. From the day when the very low birth weight infant is admitted into hospital, PPI monitoring should be recorded once a day, and continuous monitoring would be recorded until 1 month after birth. Before collection, the infant will be confirmed to be in supine position with neutral temperature, and at the same time, the infant will be in a quiet state, without the contact and operation of medical personnel.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infant's birth weight <1500g
      
Keywords: Late onset sepsis; Peripheral perfusion index
Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to try a known antiretroviral combination in HIV- infected
      children with only one intake a day, in order to simplify the prescription and improve
      adherence to treatment. This is what is called a phase II clinical trial, only recruiting and
      following a small number of children (50) during one year to evaluate the quantity of drug in
      the blood just before it is taken and one to three hours after it is taken. The other
      important objective is to study the tolerance of drugs in that mode of prescription of the
      triple combination.
    

Detailed description: 
      The data relating to pharmacology tolerance and efficacy of the once-daily combination of 3TC
      + ddI + EFV have never been studied.

      This regimen may lead to a better treatment of the HIV-1 infected children in developing
      countries, as well as in Europe. Because of its simplicity it would facilitate observance
      that is one of the essential parameters of efficacy of treatments.

      The main objectives are those of a phase II clinical trial:

        -  Assess the virological and immunological efficacy of a once daily HAART regimen
           comprising lamivudine (3TC) + didanosine (ddI) + efavirenz (EFV) [pediatric reference];

        -  Analyse the pharmacological characteristics of this combination in children;

        -  Assess the tolerance;

        -  Study the appearance of resistance;

        -  Evaluate the observance to treatment.

           50 HIV-1 infected children aged 30 months to 15 years whose clinical and immunological
           state (stage B or C) requires antiretroviral treatment, will be included in the study.
           They should be naive of any ARV treatment (except the treatment received in the
           framework of PMTCT (Prevention of Mother to Child Transmission).

      Data Collection and Development of the Study:

        -  Monthly clinical examination;

        -  RNA HIV-1 and CD4 counts;

        -  Pharmacological dosages;

        -  Haematology and biochemistry surveillance;

        -  Genotypic resistance at inclusion; and, in case of unsuccess or failure,

        -  Assessment of observance according to alternate methods.

      Laboratory examinations will be carried out at Centre Muraz except for genotyping and for
      pharmacological tests sent to Montpellier Teaching Hospital (France).
    

Intervention name(s): Efavirenz (EFV); Lamivudine (3TC); Didanosine (ddI)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Efavirenz; Didanosine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HAART; once-daily; child; africa; HIV; AIDS; Treatment Naive
Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of this prospective study is to evaluate the influence of both bundles on the
      knee stability - anterior-posterior translation, internal and external rotations after the
      double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after
      single-bundle and double-bundle reconstruction using a computer navigation system.
    

Detailed description: 
      The purpose of this prospective study is to evaluate the influence of both bundles on the
      knee stability - anterior-posterior translation, internal and external rotations after the
      double-bundle reconstruction of Anterior Cruciate Ligament (ACL) and to compare the stability
      after single-bundle and double-bundle reconstruction using a computer navigation system.

      Methods Anterior-posterior translation, internal rotation, and external rotation were
      recorded in the deficient condition (without ACL), in the anteromedial-reconstructed,
      posterolateral-reconstructed, and in the whole ACL-reconstructed condition for double-bundle
      reconstructions and before and after the ACL reconstruction in single-bundle group. KT-1000
      was used to evaluate anterior-posterior translation.
    

Intervention name(s): 'biomechanic of the knee'
Intervention type(s): Procedure
Intervention description(s): 20 patients had their ACL replaced by SB reconstruction from hamstrings, 20 patients double - bundle technique with AM bundle being reconstructed first, and 20 patients with the PL bundle first.
Other intervention name(s): replacement of ACL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: ACL; double-bundle; navigation system
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications
Condition: Spinal Fusion; Transfusion; Pulmonary Complication
Study type: Observational

Summary: 
      Elective spine surgery is associated with a high incidence of perioperative complications,
      including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of
      patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs.
      However, whether it influences risk of other PPCs is unclear.
    


Intervention name(s): transfusion
Intervention type(s): Procedure
Intervention description(s): transfusion
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients were included if they underwent post vertebral column resection (e.g.
        multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of
        Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020
Recovery Guide Intervention for Recurrent Psychiatric Hospitalization
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Psychotic Depression
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Recovery Guide support services are
      effective in promoting recovery and social integration among psychiatrically disabled
      individuals who experience high rates of inpatient hospitalizations.
    

Detailed description: 
      The paradigm shift in mental health treatment from a deficit-and institution- based framework
      to a recovery and community integration frame necessitates new models of "case management"
      practices. The Recovery Guide model is just such a model. Beyond theoretical frameworks, the
      effectiveness of Recovery Guides has not been well studied. It is the intent of this study to
      conduct a randomized trial examining the effects of Recovery Guides on community tenure and
      integration. Furthermore, it is the intent of this study to to establish fidelity criteria.

      Comparison(s): Recovery Guide services in addition to treatment as usual, compared to
      treatment as usual.
    

Intervention name(s): Recovery Mentor
Intervention type(s): Behavioral
Intervention description(s): Provided Recovery Mentor services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Peer support; Psychiatric disability; Mutual support; Psychiatric Rehabilitation
Home-Based Interventions for Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Adolescents with T1D and chronic poor metabolic control are at high risk for short and
      long-term diabetes complications and are heavy users of both medical resources and health
      care dollars. The purpose of the proposed study is to collaborate with a community agency to
      develop and test an intervention, Fit Families, that uses the core components of a previously
      successful home-based family treatment, but that can delivered by lower cost community health
      workers. If successful, Fit Families could improve health outcomes in a vulnerable population
      at high risk for diabetes complications, and could be translated to real-world treatment
      settings.
    

Detailed description: 
      The proposed study is a planning grant in which MST will be adapted for delivery by community
      health workers and will be conducted in collaboration with CHASS, a community agency
      providing health care to underserved residents of Detroit with diabetes. The new
      intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in
      order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect
      sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and
      determine potential cost savings associated with reduced hospital admissions. These steps
      will allow for finalization of intervention content and other trial parameters in preparation
      for a larger R18 dissemination trial.

      The design for the proposed study is a randomized, controlled trial using a sample of 60
      adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus
      standard medical care, and the other half will be assigned to standard medical care alone.
      Families who are randomized to FF receive intensive, home-based family therapy delivered by a
      community health worker (CHW) for approximately six months.
    

Intervention name(s): Fit Families plus Standard Medical Care
Intervention type(s): Behavioral
Intervention description(s): Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insulin Dependent Diabetes Mellitus; family therapy; adolescents; regimen adherence; metabolic control
Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery
Condition: Morbid Obesity; Bariatric Surgery Candidate; Exercise; Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      In this study, our primary aim is; investigate the effect of aerobic dance based exercise
      program on lower extremity functions (walking, stair stroke climbing, etc.) in obese
      individuals awaiting bariatric surgery.
    

Detailed description: 
      In this study, our primary aim is; investigate the effect of aerobic dance based exercise
      program on lower extremity functions (walking, stair stroke climbing, etc.) in obese
      individuals awaiting bariatric surgery. . Our secondary aim is to provide the individual with
      exercise habits and increase the level of physical activity in daily life with the exercise
      program planned according to the needs of the individual.
    

Intervention name(s): Exercise treatment; Counselling
Intervention type(s): Other; Other
Intervention description(s): A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.; Only physical activity counseling will be given to the subjects in this group.
Other intervention name(s): Aerobic dance based exercise; Counseling of physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: bariatric surgey; morbid obesity; aerobic exercise; lower extremity functions
Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab
      as first line treatment of patients with metastatic colorectal cancer not previously treated
      and with three or more circulating tumoral cells.
    


Intervention name(s): modified FOLFOX6 + bevacizumab; FOLFOXIRI + Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab 5 mg/kg iv, day 1, followed by
Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, day 1, followed by
5- Fluorouracil (FU)/Leucovorin (LV), day 1 and 2, as follow:
LV 400 mg/m2 iv administered over a period of 2 hours, followed by
5-FU 400 mg/m2 iv bolus, followed by
5-FU 2.400 mg/m2 over 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).; Bevacizumab 5 mg/kg iv, followed by
Irinotecan 165 mg/m2 iv administered over a period of 30-90 minutes, followed by
Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, followed by
LV 400 mg/m2 iv administered over a period of 2 hours, followed by
5-FU 3,200 mg/m2 for 48 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; FOLFOX; Bevacizumab; FOLFOXIRI; circulating tumor cell
Phase 2 Study of KHK7580
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, placebo-controlled, double-blind (included open arm of KRN1493
      (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety
      in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for
      three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
    


Intervention name(s): Placebo; KHK7580 low dose; KHK7580 middle dose; KHK7580 high dose; KRN1493
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral administration; Oral administration; Oral administration; Oral administration; Oral administration
Other intervention name(s): cinacalcet
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam
      tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions
      using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Meloxicam
Intervention type(s): Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-inflammatory
Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone
      bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg,
      7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating
      participants with moderate to severe pain following bunionectomy.
    


Intervention name(s): TV-46763; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TV-46763 will be administered per dose and schedule specified in the arm description.; Placebo matching to TV-46763 will be administered per schedule specified in the arm description.
Other intervention name(s): Hydrocodone bitartrate/acetaminophen IR tablets
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome
Condition: Pre Diabetic
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie
      beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the
      Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones
      (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and
      satiety.
    

Detailed description: 
      Human gut microbiome appears to be involved in the regulation of metabolic processes,
      including digested food components, absorption of fat, metabolism of drugs, and conversion of
      indigestible foods or partially digested food ingredients to molecules that may signal
      physiological host mechanisms. The gut microbiome is a complex ecosystem of liquor or chime
      and microbiota. A change in that habitat may result in microbiota community shifts and
      consequential changes in brain-gut regulatory interactions. NM504 is a cobiotic formulation
      composed of 3 (generally recognized as safe; GRAS) food ingredients. One ingredient is a
      conventional prebiotic fiber. A second ingredient can be fermented but it also is included to
      change the viscosity of the biome while protecting the mucosal barrier. The 3rd ingredient is
      an antioxidant with poor bioavailability that alters the redox potential of the biome,
      selecting for some and against other microbiota growth. In a placebo-controlled
      double-blinded intervention this trial will investigate the effect of NM504 on the intestinal
      microbiota as well as markers of glucose regulation in 20 prediabetic adults. The
      intervention periods last 28 days. Examination of participants will happen at the beginning,
      weekly and at the end of intervention and will contain anthropometry; blood samples; fecal
      samples; oral glucose tolerance test; meal tolerance test; and scales to assess appetite,
      hunger, mood, and bowel habits.
    

Intervention name(s): Placebo; NM504:
Intervention type(s): Drug; Drug
Intervention description(s): Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.; Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: microbiome; prebiotic; cobiotic; NM504; GI microbiome
MK0524A Phase IIb Study (0524A-011)(COMPLETED)
Condition: Flushing
MeSH terms: Flushing
Study type: Interventional
Phase: Phase 2

Summary: 
      Part A: This study will determine that MK0524 is well tolerated and does not effect lipids
      and blood glucose when given alone.

      Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids
      and blood glucose.
    


Intervention name(s): Comparator: niacin / Duration of Treatment: 17 Weeks; MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks; Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment