bioihbjkbjnl/mcl2 huggingface dataset:
Anti-aging Repairing Serum: Efficacy and Tolerability Study
Condition: Anti-aging
Study type: Interventional

Summary: 
      The study aimed to evaluate the effectiveness and tolerability of a dermocosmetic serum
      containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water
      in reducing skin aging signs. The experimental clinical trial involved 34 participants aged
      45 to 65 years who applied the serum twice a day for 84 days.
    

Detailed description: 
      This experimental, mono-centric, open clinical trial was conducted in accordance with the
      principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil, ethical
      principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical
      Practice (GCP).

      Quality control was applied to each stage of data handling to ensure that clinical data were
      generated, collected, processed, analyzed and reported according to the protocol, Standard
      Operating Procedures (SOP) and requirement of GCP.

      Descriptive Statistics: Quantitative parameters, or those that can be reasonably treated as
      such, were summarized using measures of central tendency as mean and median and dispersion
      measures as standard deviation at each time of evaluation. Quantitative variables were
      summarized using frequencies and percentages. For each parameter (clinical evaluation scores
      and parameters derived from the Primos®) and each region (frontal, periocular, peri-oral and
      neck), graphical representations of means ± 95% Confidence Interval (CI) were elaborated for
      visual assessment of evolution over time.
    

Intervention name(s): Topical serum
Intervention type(s): Other
Intervention description(s): Participants are asked to apply the topical serum twice daily for 84 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anti-aging; skin barrier; dermocosmetic; wrinkles
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
Condition: Malignant Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the toxicity and tolerance of Myocet® in children
      and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20%
      of the dose recommended for adults and a dose recommended for adults, administered in single
      dose in 1-hour perfusion each 21 days.

      Other purposes are to determine the recommended dose of Myocet and to assess the response to
      drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite
      doxorubicinol during 72 hours after Myocet administration will also be studied.
    


Intervention name(s): Doxorubicin
Intervention type(s): Drug
Other intervention name(s): MYOCET
Intervention MeSH terms: Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of transvenous vagus nerve stimulation
      (tVNS) on the immune response.

      In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide
      [LPS]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as
      TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute VNS
      using a minimally invasive delivery method.
    


Intervention name(s): Vagal Nerve Stimulation; Sham Stimulation
Intervention type(s): Device; Device
Intervention description(s): 30 minutes of vagal nerve stimulation using a catheter in the IJV; Catheter placed in the IJV without stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: inflammation; vagus nerve stimulation; chronic heart failure; Systemic Inflammatory Response Syndrome; sepsis; auto-immune diseases
Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of multiple oral
      doses of BMS-779788 in healthy subjects
    


Intervention name(s): BMS-779788; BMS-779788; BMS-779788; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral Solution, Oral, 1 mg, Once daily, 7 days; Oral Solution, Oral, 2 mg, Once daily, 7 days; Oral Solution, Oral, <= 4 mg, Once daily, 7 days; Oral Solution, Oral, 0 mg, Once daily, 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Study of 3 Investigational Products on the Microbiome and Scalp Attributes in Children With Curly Hair
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the topical safety (tolerability/acceptability) of a
      kit of cosmetic products (shampoo, conditioner, and combing cream), the presence of residues
      on the scalp through visual assessment and image capture, the skin barrier, pH, and sebum
      level. All these evaluations will be performed before and after 28 plus minus (+-) 2 days of
      use under normal conditions, under the supervision of dermatologist and pediatrician.
    


Intervention name(s): Investigational Shampoo; Investigational Conditioner; Investigational Combing Cream
Intervention type(s): Other; Other; Other
Intervention description(s): Parent/LAR will bathe the child participant with the investigational shampoo at least 3 times a week for up to 28 days.; Parent/LAR will bathe the child participant with the investigational conditioner at least 3 times a week for up to 28 days.; Parent/LAR will apply investigational combining cream to wet and previously moistened hair at least 3 times a week for up to 28 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of a Pilot Phase (to assess safety and the local tolerability of highest
      AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and
      tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement of
      blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG,
      blood pressure and adverse events).
    

Detailed description: 
      A single centre prospective, randomized, double blind study consisting of a local safety
      Pilot Phase and a triple-cross-over Main Study Phase.

      In the pilot phase, 3 subjects will be administered a bolus with AOP LDLA202 vs. placebo
      (0.9% saline) simultaneously (same vein on the other body side). Following treatment of the
      first subject per cohort and assuming no safety concerns arise, second and third subjects
      will be treated in safety intervals of at least 3 hours between doses in individual subjects.
      On Day 3 after dosing a safety follow-up assessment will be done and all adverse events will
      be reported to the sponsor's medical monitor. Assuming no safety concerns arise, the
      sponsor's medical monitor will give green light for conduct of the Main Treatment Phase in
      writing.

      In the main phase, 12 subjects will be treated with AOP LDLA202, ONO LDL50 and esmolol. Three
      doses per subject and day (=treatment period), all administered via big superficial veins,
      are planned with at least 1 hour observation period after each bolus injection. Each subject,
      if confirmed eligible, will complete three treatment periods in total in the main phase of
      the study.

      ECG, blood pressure, local tolerability and adverse events will be monitored.
    

Intervention name(s): LDLA202; ONO LDL50; Esmolol hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Comparison of 3 different doses LDLA202, 40 PK samples, 40 BP and ECG measurement time points, 23 local tolerability measurement time points; Comparison of 3 different doses ONO LDL50, 40 PK samples, 40 BP and ECG measurement time points, 23 local tolerability measurement time points; Comparison of 3 different doses Esmolol, 40 PK samples, 40 BP and ECG measurement time points, 23 local tolerability measurement time points
Intervention MeSH terms: Esmolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PK
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
Condition: High Risk Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients
      (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint
      will be overall survival.
    


Intervention name(s): CPX-351; 7+3 (cytarabine and daunorubicin)
Intervention type(s): Drug; Drug
Intervention description(s): First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.; First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.
Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
Other intervention name(s): cytarabine and daunorubicin
Intervention MeSH terms: Cytarabine; Daunorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; Acute Myeloid Leukemia; high risk AML; secondary AML; AML in elderly
Hypertrophic Cardiomyopathy Pilot Study
Condition: Hypertrophic Cardiomyopathy; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Observational

Summary: 
      This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in
      comparison to patients with well-understood arrhythmogenic substrate (ischemic
      cardiomyopathy), as well as to individuals free from arrhythmogenic substrate
    


Intervention name(s): Observational: Arrhythmogenic Substrate
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular
        arrhythmias in comparison to three Controls groups
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin
      is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative
      treatment when Oxytocin isn't available. The aim of this study is to compare the safety and
      efficacy of Oxytocin and misoprostol for prevention of PPH.
    

Detailed description: 
      In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at
      Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc
      ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc
      ringer.
    

Intervention name(s): Misoprostol; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): 400µg oral misoprostol; 20 IU Oxytocin
Other intervention name(s): Cytotec; Syntocinon
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Misoprostol; Oxytocin; Post Partum Hemorrhage (PPH); Third stage of labour
Comparing Two Techniques of Haemostasis After Cervical Conization
Condition: Cervical Intraepithelial Neoplasia; Cervix Neoplasm
MeSH terms: Neoplasms; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The LEEP conization is commonly used for cervical pathologies treatment. The techniques for
      hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is
      no consensus about the best technique and there is not much information that validates the
      use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after
      LEEP conization for management of cervical lesions.
    

Detailed description: 
      A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer
      Hospital for patients with indication of LEEP conization. After local IRB approval, patients
      were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with
      vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative
      and postoperative outcomes will be evaluated: operative time, intraoperative and
      postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as
      well as short-term outcome were recorded and compared using Chi-square test, Fisher exact
      test and t-test where appropriate.
    

Intervention name(s): Vaginal Packing
Intervention type(s): Procedure
Intervention description(s): This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cervical intraepithelial neoplasia; haemostasis; vaginal pack; Loop electrical excision procedure; randomized clinical trials; uterine cervical neoplasm
Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells
Condition: Osteoarthritis, Knee; Arthritis of Knee; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),
      obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial
      is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We
      propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and
      controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay
      consists of two arms with 15 patients each one. Patients in the experimental arm will be
      given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our
      GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as
      in NCT01183728). In the control arm a standard treatment with intra-articular injection of
      hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of
      life and quantitative changes in structure and composition of cartilage determined by
      T2-weighted MRI relaxation (Cartigram) for one year.
    


Intervention name(s): Allogenic mesenchymal stromal cells injection; Hyaluronic Acid
Intervention type(s): Other; Drug
Intervention description(s): Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency; Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
Other intervention name(s): MSV; Mesenchymal Stem Cells; MSC; Hyaluronic acid, durolane, CE mark:516407
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee degenerative disease; osteoarthritis; gonarthrosis; stem cell; cellular therapy; regenerative therapy; Mesenchymal stem cells; Bone marrow; musculoskeletal Diseases; Mesenchymal Stromal Cells (allogenic)
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The overall goal of this study is to develop and evaluate a brief, video-based, group-level
      intervention designed to reduce sexual risk taking among culturally diverse English- and
      Spanish-speaking Latino men who have sex with men (MSM).
    


Intervention name(s): Video (group-delivered video-based intervention); HCT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): group-delivered video-based intervention; Offer of HIV counseling and testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV risk behavior; Unprotected sex; men who have sex with men; gay; Latino; unsafe sex; high risk sex
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
Condition: Hepatitis C Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable
      tablets.

      Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg
      tablet
    


Intervention name(s): Daclatasvir; Daclatasvir; Asunaprevir; Daclatasvir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A= single oral dose of Daclatasvir (DCV) tablet and Treatment B= single oral dose of DCV pediatric chewable tablet; Treatment C= single oral dose of Daclatasvir (DCV) pediatric chewable tablet and Treatment D= single oral dose of DCV pediatric chewable tablet; Treatment E= single oral dose of Asunaprevir (ASV) tablet and Treatment F= single oral dose of ASV pediatric chewable tablet and Treatment G= single oral dose of of ASV pediatric chewable tablet; Treatment H= single oral dose of Daclatasvir (DCV) tablet and Treatment I= single oral dose of DCV tablets
Intervention MeSH terms: Asunaprevir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Insulin Detemir Action in Cerebro
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis that subcutaneous administration of insulin
      detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose
      metabolism and/or cerebral blood flow in brain regions associated with appetite regulation,
      to account for the reported difference in weight.
    


Intervention name(s): Insulin detemir; Insulin NPH
Intervention type(s): Drug; Drug
Intervention description(s): 100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID; 100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
Other intervention name(s): Insulin Levemir; Insulin Insulatard
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Insulin; Detemir; Brain; Glucose metabolism