bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the effect of selonsertib (formerly
      GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic
      kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1
      of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.
    


Intervention name(s): Selonsertib; Placebo to match selonsertib
Intervention type(s): Drug; Drug
Intervention description(s): Tablets administered orally once daily; Tablets administered orally once daily
Other intervention name(s): GS-4997
Intervention MeSH terms: Selonsertib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Kidney Disease; Gilead
Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding
      frequency (number of bleeds per year) and on joint damage.
    


Intervention name(s): Recombinant Factor VIII (Kogenate FS, BAY14-2222); Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention type(s): Biological; Biological
Intervention description(s): Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.; Treated according to the Kogenate FS package insert indications and study physician recommendations
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      Evaluation of the human eye irritation potential of a test sunscreen formulation.
    


Intervention name(s): BAY987521; Control
Intervention type(s): Drug; Drug
Intervention description(s): 10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).; 10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Comparative A1 vs A2 Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant
Condition: Intestinal Absorption
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk
      based formula on alimentation and gastrointestinal digestion. The impact of the study
      products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory
      immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and
      infant growth were also evaluated.
    


Intervention name(s): Oral consumption of Nutricia Aptamil Stage 1 formula; Oral consumption of a2® Platinum Stage 1 formula; Oral consumption of breast milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily oral consumption of Nutricia Aptamil Stage 1 formula; Daily oral consumption of a2® Platinum Stage 1 formula; Daily oral consumption of breast milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Nerve Transfer for Finger Sensory Reconstruction With Dorsal Branch of the Digital Nerve
Condition: Sensory Restoration of the Reconstructed Finger Pulps; Cold Intolerance of the Reconstructed Finger; Pain of the Reconstructed Finger
Study type: Interventional

Summary: 
      A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger
      pulp, which results in functional disability.The dorsal branch of the PDN can be transferred
      for reconstruction of such nerve defects.In this study, the investigators modified the
      Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN
      defects. For comparison, the investigators collected a consecutive series of 32 patients with
      finger PDN defects treated using a traditional sural nerve graft from February 2005 to
      October 2008.
    


Intervention name(s): Nerve transfer
Intervention type(s): Procedure
Intervention description(s): the dorsal branch was used as a pedicle nerve for reconstructing PDN defects
Other intervention name(s): Local pedicle nerve transfer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: defect; dorsal branch of the proper digital nerve; proper digital nerve; nerve transfer; finger sensory reconstruction
Health-Smart for Weight Loss at UF Jax Clinics
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The study will test the effectiveness of a culturally sensitive, evidence-based,
      multi-component, behavioral program for treating obesity called Health-Smart. This program is
      being implemented by Community Health Workers at the primary care centers and followed by
      either of two physician-implemented behavioral counseling programs to prevent weight
      gain--programs that are implemented quarterly over 12 months.
    


Intervention name(s): Health Smart for Weight Loss
Intervention type(s): Behavioral
Intervention description(s): We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Women's health
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
Condition: Distal and Lateral Subungual Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of a topical antifungal
      formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the
      toenails.
    


Intervention name(s): Luliconazole Solution, 10%; Vehicle Solution
Intervention type(s): Drug; Drug
Intervention description(s): Topical; Topical
Intervention MeSH terms: Luliconazole; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Onychomycosis; Toenail Fungus; luliconazole; Antifungal; Topical
Effect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
Condition: Hyperglycemia, Postprandial
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether drinks containing Salvia hispanica L
      (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy
      individuals.
    

Detailed description: 
      Dietary fibre has been implicated in improving many risk factors associated with Type 2
      Diabetes and Cardiovascular Disease (CVD). However, on average, Norther Americans consume
      less than half of the recommended amount set by health agencies. It has been proposed that
      the health benefits of dietary fibre may be attritbuted to rheological characteristics such
      as viscosity. Salvia hispanica L (Salba) and Flax are nutritionally similar. The primary
      objective of this research trial is to study the effects of Salba and Flax on postprandial
      glycemia and appetite in healthy individuals.
    

Intervention name(s): Salba; Flax; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): Salvia hispanica L; Glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: postprandial glycemia; subjective appetite; Salba; Flax
Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
Condition: In Vitro Fertilization
Study type: Observational

Summary: 
      Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET)
      cycles performed after the embryos are cryopreserved in the base study P05690 in order to
      estimate the cumulative pregnancy rate for each treatment group.
    

Detailed description: 
      This is a follow-up protocol to collect the outcome of FTET cycles, performed after the
      embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the
      cumulative pregnancy rate for each treatment group.
    

Intervention name(s): corifollitropin alfa; recFSH (follitropin alfa); 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; Biological; Drug; Drug; Biological; Drug; Drug; Biological
Intervention description(s): Single injection of 100 μg corifollitropin alfa administered under protocol P05690; Daily recFSH administered under protocol P05690; GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690; hCG 5,000 IU or 10,000 IU administered SC under protocol P05690; Under protocol P05690, 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 at the equivalent volume of 150 IU/day administered under protocol P05690; Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690; Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590
Other intervention name(s): Org 36286; Puregon®/Follistim®
Intervention MeSH terms: Hormones; Progesterone; Follicle Stimulating Hormone; Ganirelix
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women from whom embryos have been cryopreserved in base study P05690
      
Keywords: In-vitro fertilization; Controlled Ovarian Stimulation; Cumulative pregnancy data; Follow-up
Facilitating Assessment of At-Risk Sailors Using Technology
Condition: Psychological Distress
Study type: Interventional

Summary: 
      Randomized clinical trial with individuals being allocated to experimental (Cogito Companion)
      or Active Control arms. Those in the latter will receive information regarding widely
      available mobile self-help apps via a custom mobile app built in MyCAP. This same platform
      will be used to collect data regarding symptoms. Randomization will be stratified by gender,
      force (Surface, Aviation), and smartphone model (Android, I-Phone), as Cogito algorithms
      differ based on smartphone platforms. Participants will be willing Naval personnel being
      redeployed to CONUS. Data is also being collected (feasibility/acceptability) to inform
      future implementation..
    


Intervention name(s): Experimental - Cogito Companion; Active Control
Intervention type(s): Device; Behavioral
Intervention description(s): Cogito Companion; Use of MyCAP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
A PHASE I, SINGLE-CENTER, MIXED METHODS STUDY ON THE HEALTH OUTCOMES OF VISUAL SELF EXPRESSION
Condition: A Healthcare Professional, a Patient or Caregiver in the Radiation Oncology Department at the University of Pennsylvania
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      To gain understanding about the impact of visual art making on biomarkers, such as cortisol,
      alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in
      levels of stress and immune function in patients and caregivers adults (including family
      caregivers and medical professionals)
    


Intervention name(s): Art therapy
Intervention type(s): Behavioral
Intervention description(s): Art Therapy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A healthcare professional, a patient or caregiver in the Radiation Oncology Department at
        the University of Pennsylvania
A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
Condition: Obesity; Overweight; Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The
      primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics,
      and pharmacodynamics, of multiple oral doses of PF-04620110.
    


Intervention name(s): PF-04620110; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.; Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: - Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms
Clinical Trial of Chemosensitivity Test
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant
      cancer chemotherapy after gastric surgery
    

Detailed description: 
      Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained
      before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients.
      Chemosensitivity test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be
      tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and
      dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on
      duty.

      Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks
      followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year
      after operation.

      Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall
      survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff
      condition will be determined based on the accumulated data of CD-DST and mRNAs.

      Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable
      survival outcome comparing with resistant cases.
    

Intervention name(s): S-1
Intervention type(s): Drug
Intervention description(s): S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: gastric cancer; S-1; chemosensitivity; adjuvant
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen
      arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese
      healthy adult participants. The secondary purpose of this study is to assess the
      pharmacokinetic and safety profile of the test and reference preparations.
    

Detailed description: 
      The bioequivalence study adopts a single-center, randomized, open-label, single-dose,
      two-treatment, two-sequence, two-period, two-cohort, two-way crossover design with at least
      2-day washout period, under both fasting and fed conditions in Chinese healthy adult
      participants. It will be planned to enroll approximately 84 participants out of which the
      first 34 participants for the fasted cohort and the subsequent 50 participants for the fed
      cohort receiving ibuprofen arginine granules 400 mg. Participants will be randomly assigned
      to either one of the 2 treatment (Test or Reference product) sequences in a 1:1 ratio within
      fasted cohort and fed cohort.
    

Intervention name(s): Ibuprofen arginine granules 400 mg; Ibuprofen arginine granules 400 mg (Spedifen)
Intervention type(s): Drug; Drug
Intervention description(s): Experimental- Ibuprofen arginine granules 400 mg, one sachet administration containing 400 mg ibuprofen granules.; Marketed drug- Ibuprofen arginine granules 400 mg (Spedifen), one sachet administration containing 400 mg ibuprofen granules.
Intervention MeSH terms: Ibuprofen; Ibuprofen arginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design
      in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt
      tablet formulations relative to the current CAB sodium salt formulation being used in the
      phase IIb studies under fasting conditions. All treatments will be administered as single 30
      mg doses of CAB. Safety evaluations and serial PK samples will be collected during each
      treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study
      drug. Treatment period doses will be separated by a 14 day washout. Participation in this
      study will be approximately 12 weeks.
    


Intervention name(s): Cabotegravir 30 mg current formulation; Cabotegravir 30 mg micronized new formulation 500 M; Cabotegravir 30 mg unmicronized new formulation 500 U; Cabotegravir 30 mg micronized new formulation 650 M; Cabotegravir 30 mg unmicronized new formulation 650 U
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cabotegravir 30 mg current formulation (Treatment A) is a film coated tablet with a weight of 824 mg; Cabotegravir 30 mg micronized new formulation 500 M (Treatment B) is a film coated tablet with a weight of 515 mg; Cabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) is a film coated tablet with a weight of 515 mg; Cabotegravir 30 mg micronized new formulation 650 M (Treatment D) is a film coated tablet with a weight of 670 mg; Cabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) is a film coated tablet with a weight of 670 mg
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cabotegravir; Human Immunodeficiency Virus; Bioavailability; Pharmacokinetics
Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following
      oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)
    


Intervention name(s): BI 1026706; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety of an investigational combination
      drug/immunotherapy for the treatment of Stage III/IV melanoma.
    

Detailed description: 
      This study will examine the effects of an oral Activator Ligand administration to modulate
      the timing of gene expression of human IL-12 by adenovirus-transduced dendritic cells
      injected into tumors.
    

Intervention name(s): INXN-1001; INXN-3001
Intervention type(s): Drug; Biological
Intervention description(s): Capsules given once daily for 14 days for 3 treatment cycles.; Intratumoral injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: melanoma; biologic; immunotherapy; cancer