bioihbjkbjnl/mcl2 huggingface dataset:
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Condition: Intervertebral Disk Degeneration
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not
      inferior in effectiveness and safety to local autologous bone (control device) when applied
      in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural
      allograft ring in patients with degenerative cervical disc disease..
    

Detailed description: 
      Anterior Cervical Discectomy and Fusion (ACDF) is a common surgical treatment option for
      symptomatic degenerative cervical disk disease in patients who fail conservative treatment.
      i-FACTOR bone graft is a unique anorganic bone mineral (ABM) and small peptide, P-15™. P-15
      is a synthetic fifteen amino acid polypeptide that mimics the cell-binding domain of Type I
      human collagen and is responsible for osteogenic cell attachment via alpha2-beta1 integrins.

      This is randomized, controlled, multi-center, prospective FDA IDE study conducted to assess
      the safety and effectiveness of i-FACTOR bone graft (Cerapedics, Inc. Westminster, CO) in
      patients treated with single level ACDF. Patients received i-FACTOR bone graft or local
      autologous bone inside a structural allograft.
    

Intervention name(s): P-15 Synthetic osteoconductive bone substitute; Autologous bone
Intervention type(s): Device; Other
Intervention description(s): Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery; Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Other intervention name(s): i-Factor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Degenerative disc disease; P-15 Bone Putty; Bone graft; Cervical discectomy; Cervical spine
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Condition: Covid19; SARS (Severe Acute Respiratory Syndrome); SARS Pneumonia; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Pneumonia; Pneumonia, Viral
MeSH terms: COVID-19; Pneumonia; Coronavirus Infections; Severe Acute Respiratory Syndrome; Pneumonia, Viral
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to
      evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
    

Detailed description: 
      The primary objective of this study is:

      To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC)
      in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by
      days on oxygen.
    

Intervention name(s): Fostamatinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fostamatinib (150 mg twice daily) for 14 days and Standard of Care; Placebo (twice daily) for 14 days and Standard of Care
Other intervention name(s): Fostamatinib disodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID19; SARS-Associated Coronavirus Pneumonia; Pneumonia, Viral
Endpoint Validation Study (0524A-015)
Condition: Flushing
MeSH terms: Flushing
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the most effective daily dose of MK0524A when compared with placebo after the
      8-week treatment period for Niacin Induce Flushing (NIF).
    


Intervention name(s): MK0524A, /Duration of Treatment : 8 Weeks; Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A First-in-Human Study of BNZ132-1-40
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single ascending dose study to characterize the safety and PK/PD
      profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2
      family.
    

Detailed description: 
      This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy
      adult subjects. Subjects are followed for 30 days after treatment for collection of safety,
      PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.
    

Intervention name(s): BNZ132-1-40
Intervention type(s): Biological
Intervention description(s): pegylated peptide inhibiting IL-2, IL-9 and IL-15
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cytokines; interleukin-2; Safety Issues
Clinical Trial of AVL-3288 in Schizophrenia Patients
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase,
      cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of
      AVL-3288 each compared to placebo, in patients with schizophrenia.
    

Detailed description: 
      This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective
      disorder. Subjects will complete three treatment phases, each involving 5 straight days of
      taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in
      which subjects do not take the study drug to ensure that the drug is completed eliminated
      from the body before the next phase.
    

Intervention name(s): AVL-3288; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): daily for 5 days; daily for 5 days
Other intervention name(s): Anvylic-3288
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the combined effect of physical activity and
      adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative
      stress in obese patients enrolled in the weight management reduction program.
    


Intervention name(s): Weight reduction program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline
      pharmacokinetics in healthy subjects.
    

Detailed description: 
      Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose
      periods separated by a washout of 14 days or more
    

Intervention name(s): rasagiline; BIA 9-1067
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg rasagiline (single-dose); 50 mg BIA 9-1067 (single-dose)
Intervention MeSH terms: Opicapone; Rasagiline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
ABO-GLYC in Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Evaluation of the improvement of the overall glycemic control after 6 months of treatment
      with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
    


Intervention name(s): ABO-GLYC; ABO-GLYC Placebo
Intervention type(s): Device; Other
Intervention description(s): 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.; 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
Other intervention name(s): Libramed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
Condition: Altitude Hypoxia
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Altitude Sickness; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating the effect of acetazolamide on sleep
      disordered breathing in lowlanders older than 40 years travelling from 760 m to 3'100 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of preventive acetazolamide intake on the sleep disordered breathing in lowlanders older than
      40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m),
      will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and
      stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before
      departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay
      at 3'100 m.

      An interim analysis will be carried out when 80 participants will have completed the study or
      after the first year. The Peto's method will be used and the trial will be stopped when
      pre-specified futility boundaries were crossed.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: healthy participants older than 40 years; sleep disordered breathing; periodic breathing; prevention; acetazolamide
Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given
      as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp
      setting in subjects with type 1 diabetes.

      Secondary Objectives:

      To compare the metabolic activity characteristics of single doses of insulin glargine given
      as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in
      subjects with type 1 diabetes.

      To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in
      subjects with type 1 diabetes.
    

Detailed description: 
      Total study duration for each subject is between 3.5 and 12 weeks.

      Two overnight stays at the unit in each of 3 treatment periods.
    

Intervention name(s): insulin glargine U200 HOE901; insulin glargine U500 HOE901; insulin glargine U100 HOE901
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: subcutaneous; Pharmaceutical form:solution for injection Route of administration: subcutaneous; Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioavailability of teduglutide administered as a
      single subcutaneous (SC) fixed dose (depending upon participant weightband assignment)
      delivered by a syringe injection and the same fixed dose delivered by the pen injector in
      healthy participants.
    

Detailed description: 
      This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of
      participant's with greater than or equal to (>=) 40.0 kilogram (kg) to lesser than or equal
      to (<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (>) 75.0
      kg to <= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2
      treatment sequences AB or BA. Randomization will be stratified by injection site (i.e.,
      thigh, abdomen, and arm) within each cohort.
    

Intervention name(s): Teduglutide; Syringe Injection; Pen injector
Intervention type(s): Drug; Device; Device
Intervention description(s): Participants received 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of Treatment Periods 1 and 2.; Teduglutide was administered using syringe.; Teduglutide was administered using pen injector.
Other intervention name(s): TAK-633
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Single Ascending and Multiple Dose Study to Evaluate Safety, Tolerability, and PK of MYMD1 in Healthy Male and Female Adult Subjects
Condition: Hashimoto Disease
MeSH terms: Hashimoto Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, placebo-controlled, single ascending and multiple dose study. Approximately 32
      healthy adult male and female subjects will be given a single capsule of MYMD1 to determine
      its safety, tolerability, and pharmacokinetic properties. The study data will guide the
      establishment of an optimum therapeutic dose.
    

Detailed description: 
      A single-center, double-blind, placebo-controlled, single ascending and multiple-dose study
      to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of MYMD1
      capsule in healthy male and female adult subjects. Each subject will participate in the study
      for approximately 7-8 weeks, including a Screening period of up to 30 days, a confinement
      period of 2 or 5 days, and a follow-up period of approximately 5 days. In each of Cohorts
      1-3, 8 subjects will be administered a single dose of either MYMD1 (N=6 in each cohort) or
      Placebo (N=2 in each cohort), under fasted conditions. Subjects in Cohort 4 will be
      administered either MYMD1 (N=6) or Placebo (N=2) on Days 1, 2, 3, 4, and 5. Each subject will
      participate in only 1 of the 4 cohorts during the study. Anticipated dosing levels will be
      150mg (Cohort 1); 300mg (Cohort 2); 250mg (Cohort 3); and 600mg (Cohort 4).
    

Intervention name(s): MYMD-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg capsule; Matching in appearance to MyMD-1 150mg capsule
Other intervention name(s): Isomyosamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, placebo-controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial to Optimally Show the Pharmacological Action of Z-100
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical trial is to evaluate the change of the immunological parameter
      levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100
    


Intervention name(s): Z-100; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days; Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled,
      multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis
      HN019 supplementation on stool frequency and on other constipation parameters in adults
      suffering from functional constipation according to ROME III criteria. The hypothesis is that
      Bifidobacterium lactis HN019 is superior, in comparison with a placebo, for the increase of
      stool frequency of at least 1 stool per week.
    


Intervention name(s): Active product; Control product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Bifidobacterium lactis HN019 (probiotic powder). One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.; Placebo. One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stool frequency; Probiotic; Lactic bacteria; Bifidobacteria; Transit; Quality of life; Constipation symptoms; Diet supplement
A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to learn about the safety, pharmacokinetics and antiviral
      activity of the study medicine (called sisunatovir/RV521) for the potential treatment of
      respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the
      treatment period. RSV is a highly contagious virus that can lead to serious lung infections
      in patients with reduced ability to fight infection. Most vulnerable populations include
      babies, the elderly and patients that have received a bone marrow transplant.

      This study is seeking healthy participants who are:

        1. Aged 18 to 45 years old and will agree to the use of highly effective methods of
           contraception.

        2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts
           of 33 participants each. In both cohorts participants will be exposed to the challenge
           virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo
           (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5
           days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5
           days. Participants will start taking the study medicine upon confirmation of RSV
           infection (or evening of Day 5 if not positive to RSV). The study medicine will be
           administered 12 hours apart (or twice daily). Each participant will remain in the
           quarantine unit until discharge on Day 12.
    


Intervention name(s): RV521; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RV521 drug in capsules; Placebo in capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the vaginal health between premenopausal and
      postmenopausal women before and after using oral "estradiol" for 14 days then "estradiol" and
      "progesterone" for 14 days.
    

Detailed description: 
      This research project recruits 10 healthy, premenopausal women (aged 20-40 years-old) with
      regular menstrual cycle with interval of 24-35 days and duration of 2-7 days and 10 healthy
      postmenopausal women (aged 45-60 years-old) with an intact uterus and at least 12 months but
      not more than 36 months of spontaneous amenorrhea.

      Premenopausal women will not receive any study medication(s). Postmenopausal women will be
      assigned the intervention described below.

      • Oral "estradiol" 1.0 mg tablet for 14 days, then oral "estradiol" 1.0 mg tablet and
      "progesterone" 100 mg capsule for 14 days
    

Intervention name(s): oral estradiol 1.0 mg; oral progesterone 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): one tablet of oral estradiol 1.0 mg once a day for 28 days; one tablet of oral progesterone 100 mg once a day for 14 days
Other intervention name(s): Estrace; Prometrium
Intervention MeSH terms: Estradiol; Progesterone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vaginal cytokine
Nonmyeloablative Allogeneic Transplant
Condition: Aplastic Anemia; Paroxysmal Nocturnal Hemoglobinuria; Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma; Multiple Myeloma; Waldenstrom Macroglobulinemia; Breast Cancer; Renal Cell Carcinoma; Melanoma; Sarcoma; Ovarian Cancer; Thymoma
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Lymphoma, Mantle-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Waldenstrom Macroglobulinemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Thymoma; Hemoglobinuria; Myelodysplastic Syndromes; Anemia, Aplastic; Hemoglobinuria, Paroxysmal
Study type: Interventional

Summary: 
      Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses
      including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative
      syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
    

Detailed description: 
      same
    

Intervention name(s): Nonmyeloablative Allogeneic Transplant; Nonmyeloablative Allogeneic Transplant
Intervention type(s): Procedure; Procedure
Intervention description(s): Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day; Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonmyeloablative transplant; Allogeneic transplant; Transplant