bioihbjkbjnl/mcl2 huggingface dataset:
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical trial objectives are to investigate the efficacy and safety of a single injection of
      100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for
      controlled ovarian stimulation (COS), using daily recFSH as a reference.
    

Detailed description: 
      This is a randomized, double-blind, active-controlled, equivalence clinical trial
      investigating the efficacy and safety of a new treatment regimen with Org 36286, a
      recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for
      Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection
      of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of
      triggering final oocyte maturation. In the reference group patients receive daily injections
      of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two
      treatment groups in the number of oocytes retrieved is the primary objective of this trial.
    

Intervention name(s): corifollitropin alfa (Org 36286); recFSH (follitropin beta); gonadatropin releasing hormone (GnRH) antagonist (ganirelix); human chorion gonadatropin (hCG); progesterone; placebo-recFSH (follitropin alfa); placebo-corifollitropin alfa; open-label recFSH
Intervention type(s): Drug; Drug; Drug; Drug; Biological; Drug; Drug; Biological
Intervention description(s): 100 µg corifollitropin alfa subcutaneous (SC) injection; 150 IU recFSH SC injection; GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day; hCG 5,000 IU or 10,000 IU administered SC; Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.; Placebo-recFSH administered at the equivalent volume of 150 IU/day.; Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.; Open-label recFSH administered up to a maximum dose of 200 IU/day.
Other intervention name(s): Org 36286; recFSH (Puregon/Follistim AQ Cartridge)
Intervention MeSH terms: Hormones; Progesterone; Follicle Stimulating Hormone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: In vitro fertilization; Pharmacological effects of drugs; Hormones; Hormone Substitutes and Hormone Antagonists; Pharmacological Actions; Randomized; Multi-center; Multi-national; Double-blind; Active-controlled; Equivalence
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Detailed description: 
      A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability,
      pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445
      after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in
      healthy volunteers.
    

Intervention name(s): PRT064445/Edoxaban; Placebo/Edoxaban; Placebo
Intervention type(s): Combination Product; Combination Product; Drug
Other intervention name(s): Andexanet
Intervention MeSH terms: Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GSK962040 Drug-drug Interaction Study With Ketoconazole
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a
      single dose of GSK962040. The results from this study will help to estimate the maximum
      increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also
      contain an exploratory investigation of biliary secretion of GSK962040 and or its
      metabolites.
    


Intervention name(s): GSK962040; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): GSK962040. Planned doses per cohort as follows:
Cohort 1 planned dose = 10 mg; Cohort 2 to be determined based on data from Cohort 1; 400 mg
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ketoconazole; GSK962040; Drug-Drug Interaction; Phase I
Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
Condition: Healthy Newborn Infants
Study type: Interventional

Summary: 
      The primary objective of this trial is to demonstrate that infants receiving an infant
      formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the
      first 4 months of life, stools that are softer than those of infants receiving a control
      formula.
    

Detailed description: 
      Human milk is considered as the golden standard for infant formula. In human milk and infant
      formula lipids provide about 55% of energy for the infant and represent as such a major
      nutrient for the baby. The vast majority of the lipids in human milk is composed of
      triacylglycerols (98% of total lipids) and the remainder percent are phospholipids.
      Triglycerides are composed of the glycerol backbone to which three fatty acids are bound. In
      human milk, palmitate (16:0) is the major long chain saturated fatty acid representing 22% to
      26% of total fatty acids, esterified to approximately 70% in sn-2 position on the glycerol
      backbone. Unsaturated fatty acids such as oleic acid (18:1) and linoleic acid (18:2n-6) are
      preferentially esterified at the 1 and 3 position. In infant formulas the major source of
      palmitic acid is palm oil or palm olein where palmitate is, however, preferentially in the
      external 1,3 positions, and mono- and polyunsaturated fatty acids are usually esterified at
      the 2-position of the triacylgycerol.

      The aim of this study is to assess the safety and efficacy of infant formula containing 40%
      and 50%, respectively, of palmitic acid in sn-2 position.
    

Intervention name(s): Whey predominant starter formula; Whey predominant starter formula + 40% palmitic acid; Whey predominant starter formula + 50% palmitic acid
Intervention type(s): Other; Other; Other
Intervention description(s): Milk powder product given to babies between 1 week and 4 months; Milk powder product containing 40% of palmitic acid; Milk powder product containing 50% of palmitic acid
Intervention MeSH terms: Palmitic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Perceived Fitness to Drive While Intoxicated
Condition: Alcohol Drinking; Alcohol Intoxication; Perception, Self; Drinking, Alcohol; Driving Under the Influence; Drinking Behavior
MeSH terms: Alcoholic Intoxication; Alcohol Drinking; Drinking Behavior
Study type: Interventional

Summary: 
      The goal of this study is to conduct a laboratory-based pilot randomized control trial of
      smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among
      intoxicated adults. The study team will enroll up to 30 adults aged > 21-44 who are frequent
      drinkers without dependence who drive more than four times per week to complete a
      standardized alcohol drinking protocol in a monitored setting collecting breathalyzer
      measurements. The protocol involves consuming three weight-based doses of alcohol with a
      target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of
      0.03 is reached. The control group will complete a visual analog scale on their perceived
      fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro
      breathalyzer device, while the intervention group would do the same, but be shown their
      breath alcohol readings on the paired BACtrack smartphone application. The research team's
      previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC
      within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood
      test.
    


Intervention name(s): Participants Shown their Breath Alcohol Content Measurement
Intervention type(s): Behavioral
Intervention description(s): Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Objective: To investigate effects of home-based somatosensory stimulation associated with
      motor training on improvement in performance of the paretic upper extremity in patients in
      the chronic phase after stroke.
    

Detailed description: 
      Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based
      rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke.
      Interventions: Patients will be randomized to an active and a control group. In both groups,
      treatments will be performed at home, daily, over four weeks. Patients in the active group
      will be instructed to use a device that provides somatosensory stimulation in the form of
      electrical stimulation of the median nerve for two hours. Patients in the control group will
      also be instructed to use the device for two hours, and sham stimulation will be
      administered. In both groups, patients will be instructed to train activities with the
      paretic hand immediately after nerve stimulation.

      Main measures: The primary outcome will be improvement in performance of the paretic hand
      evaluated by the Jebsen-Taylor test at end of treatment and four months after end of
      treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the
      interventions, assessed through a daily written log, and oral reports of the patients; 2)
      safety profile of the interventions.
    

Intervention name(s): Relief band (Somatosensory stimulation); Placebo stimulation
Intervention type(s): Device; Device
Intervention description(s): Electrical median nerve stimulation; Placebo stimulation
Other intervention name(s): Relief band; no stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this research study is to find out ways to help pre-teens and teens and their
      families to improve diabetes control and to help with the burden of diabetes management.
      Specifically, the study aims to find out if coming to diabetes clinic more frequently and for
      a longer period of time helps adolescents with diabetes, and if adolescents who wear a
      continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.
    

Detailed description: 
      Good glycemic control is critical in preventing chronic complications of type 1 diabetes.
      However, achieving good glycemic control remains elusive for many adolescents. This study
      evaluates two clinic-based approaches for improving glycemic control in adolescents with
      poorly controlled type 1 diabetes - an intensive diabetes support and education program alone
      and the same intensive diabetes support and education program together with continuous
      glucose monitoring - in comparison with standard diabetes care.
    

Intervention name(s): Diabetes related psychological counseling and education; Continuous Glucose Monitor
Intervention type(s): Behavioral; Device
Intervention description(s): The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.; Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
Other intervention name(s): Diabetes Education; Diabetes Psychological Counseling; Medtronic Minimed iPro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Glucose Monitor; Adherence; Adolescents; Diabetes Education
Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease
Condition: Parkinson's Disease.
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Objective: To evaluate the effects of technical-Breath Stacking (BS) and incentive spirometry
      (IS) on the volume of the chest immediately after and within thirty minutes after the
      techniques in patients with Parkinson's disease (PD). Methods: This is a study of cross-over.
      The study investigated 14 patients with mild to moderate PD. The subjects performed the
      technique Breath-Stacking, incentive spirometry volume and participated in a phase control
      according to randomization. The volunteers were evaluated by opto-electronic plethysmography
      in four stages: before, immediately after fifteen and thirty minutes after the completion of
      the techniques. The investigators used a repeated measures ANOVA with post-hoc Tukey test for
      parametric variables, and the Friedman test with post-hoc Dunns for nonparametric variables.
      The level of significance was set at 5%, p <0.05.
    


Intervention name(s): Breath-Stacking; Incentive spirometry; 5000 Voldyne ® Sherwood Medical, USA; Silicone face mask
Intervention type(s): Other; Other; Device; Device
Intervention description(s): We used a silicone face mask, connected to a unidirectional valve which allowed only inspiration and is connected to a spirometer showed that the volume inspired by the individual. The face mask was attached to the appraised performed successive breaths until the researcher realized the lack of volume of air being inhaled and this time it was allowed to expire (Baker et al., 1990; Feitosa et al., 2012).; We used an incentive spirometer volume (5000 Voldyne ® Sherwood Medical, USA). Subjects performed slow, deep inhalations from functional residual capacity to total lung capacity, seeking to sustain the inspiration for at least three seconds (Restrepo et al., 2011).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is
      in treating HIV-1 infected people who have failed treatment with lamivudine.
    

Detailed description: 
      Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line
      treatment of HIV infection. Although effective initially, many people later on develop
      resistance to some or all of the drugs (including lamivudine) leading to virological failure.
      Resistance is associated with characteristic mutations, which for lamivudine is the M184V
      mutation. A change to new, active drugs must take place when patients fail their current
      regime, to regain control of the virus. Although there are other types of drugs available for
      second line treatment, there is currently no fully active, well tolerated cytidine analogue
      that can replace lamivudine in a second-line regimen when patients fail first line treatment.
      This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with
      activity against HIV resistant to other nucleosides) as part of a new regimen to treat
      patients who have failed treatment containing lamivudine, compared to the best alternative
      new regimen which continues to include lamivudine.
    

Intervention name(s): AVX754; 3TC
Intervention type(s): Drug; Drug
Intervention description(s): apricitabine, 600mg BID or 800mg BID; 3TC, 150mg BID
Other intervention name(s): apricitabine; lamivudine
Intervention MeSH terms: Lamivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus; anti-retroviral therapy; nucleoside analogue; reverse transcriptase; lamivudine; resistance mutation; Treatment Experienced
Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients
Condition: Chronic Hepatitis C; Renal Transplant
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a distinct lack of published literature on the effect of combination treatment of
      PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients.
      Small case series have been published utilizing conventional interferon and/or ribavirin and
      the available data is extremely preliminary in nature. A small retrospective series of
      patients treated with Pegylated interferon and ribavirin published recently suggests that the
      treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi
      Arabia also suggest a good safety profile and reasonable efficacy from this form of
      combination treatment.

      The investigators aim to prospectively study the safety and efficacy of PEG-interferon and
      ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40
      patients with histological evidence of liver disease will be recruited and the efficacy of
      the above medications studied.

      The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin
      combination therapy in the treatment of chronic HCV in renal transplant patients in a way
      that will allow management of such patients in an optimized manner.
    


Intervention name(s): Pegylated interferon alfa-2a plus ribavarin
Intervention type(s): Drug
Intervention description(s): PEG-interferon alfa-2a and ribavirin. Pegylated interferon alfa-2a - standard dose; plus ribavirin - standard dose (determined by creatinine clearance); for 24 to 48 weeks (genotypes 1 & 4: 48 weeks; genotypes 2 & 3: 24 weeks)
Other intervention name(s): Pegasys®, F. Hoffman-LaRoche; Copegus®, F. Hoffman-LaRoche
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis c; Renal transplantation; Pegylated interferon
The Effects Of I-PRF On Gingivectomy and Gingivoplasty
Condition: Wound Heal
Study type: Interventional

Summary: 
      The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF)
      applications on early wound healing after gingivectomy and gingivoplasty surgery. In this
      randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were
      performed on 46 patients. The postoperative I-PRF-applied surgery areas were compared with
      control regions. The surgical areas were stained with Mira-2 tone and evaluated in the ImageJ
      program. Wound healing was evaluated by using the Modified Manchester Scar (MMS) scale and
      Landry, Turnbull, and Howley (LTH) index. Vascular endothelial growth factor (VEGF) and
      fibroblast growth factor 10 (FGF-10) concentrations were assessed by enzyme-linked
      immunoabsorbent assay (ELISA). The seven-day Visual Analog Scale was used to assess pain
      level.

      Considering the results found, I-PRF applications revealed positive effects on epithelial
      wound healing after gingivectomy and gingivoplasty operations.
    


Intervention name(s): İnjectable platelet rich fibrin; Gingivectomy anad gingivoplasty
Intervention type(s): Other; Procedure
Intervention description(s): I-PRF is a type of platelet-rich fibrin (PRF) product obtained from the patient's own blood. PRF is a kind of tissue regeneration product of blood, rich in platelets, growth factors and cellular components.; leveling and regulation of the gingiva
Other intervention name(s): i-prf
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: VEGF, FGF-10, I-PRF,gingivectomy
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      Lamotrigine formulations after administration of single doses to non-smoking, healthy males
      and females under fed conditions
    

Detailed description: 
      A single-dose, two-way, bioequivalence study in up to 24 normal, non-smoking, healthy males
      and females will be utilized to evaluate the pharmacokinetics and bioequivalence of
      Lamotrigine chewable dispersible formulations under fed conditions.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine Tablets (chewable, dispersible), 25 mg
Other intervention name(s): Lamictal
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Lamotrigine (chewable, dispersible)