bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in
      subjects with lumbar disc herniation.
    

Detailed description: 
      This study was a first-in-human, open-label, non-controlled single ascending dose study of
      KTP-001 in male and female subjects between the ages of 30 and 70 years with a single
      herniated lumbar disc. After obtaining informed consent, subjects were evaluated during a
      screening period of no more than 3 weeks (21 days). This study was conducted in 10 centers in
      the US.

      Subjects that met all screening requirements and inclusion criteria and none of the exclusion
      criteria were enrolled into the study. Overall, 24 subjects were enrolled and treated: 6
      subjects in each cohort. Cohort 1 received a 5 μg/disc dose of KTP-001 by intradiscal
      injection. Following administration of study drug, subjects were confined to the study center
      for 24 hours to collect data for safety and efficacy measures and collect blood samples for
      safety, PK evaluation, exploratory PD and anti-KTP-001 antibody and then returned for further
      assessments at various intervals from weeks 1 through to month 24.

      After all subjects in Cohort 1 had received study drug, safety measures were evaluated by a
      Data and Safety Monitoring Board (DSMB) to determine whether to escalate KTP-001
      administration to the next dose level. If appropriate, Cohort 2 subjects received 15 μg/disc
      of KTP-001, Cohort 3 subjects received 50 μg/disc of KTP-001, and Cohort 4 subjects received
      150 μg/disc of KTP-001 by intradiscal injection. All safety, PK, and exploratory efficacy
      assessments were performed for the subjects in the subsequent cohorts as were performed for
      Cohort 1.
    

Intervention name(s): KTP-001
Intervention type(s): Drug
Intervention description(s): KTP-001 is one time dose intradiscally.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Constituents in Exhaled Breath and Room Air From Use of E-vapor Products and Conventional Cigarettes
Condition: Second Hand Tobacco Smoke
Study type: Interventional

Summary: 
      An open-label, single center, three-arm observational study to examine emissions from
      e-cigarettes versus conventional cigarettes under three environmental settings of typical
      residential, office and hospitality facilities.
    

Detailed description: 
      Specific constituents will be measured in exhaled breath samples (EBS) from adult e-vapor
      product users and smokers when they are using e-vapor products or smoking conventional
      cigarettes. These constituents and particle counts (PC), will be measured in the room air
      samples (RAS) collected in the environmental exposure chamber (EEC) where adult e-cigarette
      users and smokers are using electronic cigarettes or smoking conventional cigarettes.

      All subjects will undergo a Screening Visit to assess if they meet study eligibility
      criteria. If all eligibility criteria are met and the subject signs informed consent, the
      subject will be assigned to one of three groups: Group I (JUUL), Group II (VUSE Solo), or
      Group III (Conventional Cigarettes).

      All three Groups will be sequentially observed in environmental settings 1 (residential), 2
      (office), and 3 (hospitality). The observation period allocated for each environmental
      setting will be 2-days and 2-overnights for Groups I and II, and 1-day and 1-overnight for
      Group III. Each observation period will be referred to as a "Clinic Visit".

      Subjects will move on to subsequent Environment Settings (Clinic Visits 2 or 3) after
      completion of the previous Clinic Visit (1 or 2).

      Subjects must return to the clinic for Clinic Visit 1 within 60 days of the Screening Visit.
      Clinic Visit 2 must occur 7 ± 2 days after the Clinic Visit 1, and Clinic Visit 3 must occur
      7 ± 2 days after Clinic Visit 2.
    

Intervention name(s): JUUL; VUSE Solo; Conventional Cigarette
Intervention type(s): Other; Other; Other
Intervention description(s): JUUL Virginia Tobacco; VUSE SOLO Original; Subject preferred conventional cigarette
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: E-Cigarettes; Conventional Cigarettes; JUUL; VUSE
A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, researchers were primarily interested in evaluating the level of agreement of
      cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining
      this study received one test drug tablet and were asked to chew completely before swallowing
      the drug. A questionnaire was used to collect the feedback from participants. The study
      involved only one (1) visit and participant stayed in this study for about 60-75 minutes to
      evaluate the cooling sensation as well as other sensory attributes perceived in the mouth,
      nose and throat.
    


Intervention name(s): Loratadine (Claritin, BAY76-2211)
Intervention type(s): Drug
Intervention description(s): Chewable tablet, oral, single dose
Intervention MeSH terms: Loratadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Allergy; Upper respiratory allergies
Effect of PF-00734200 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving
      metformin
    


Intervention name(s): PF-00734200 30 mg QD; PF-00734200 20 mg QD; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg QD; 20 mg QD; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Antipsychotics and Gene Expression in Soft Tissues
Condition: Schizophrenia; Diabetes
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Schizophrenia is a severe chronic and disabling mental disorder and is associated with a
      significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be
      jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid
      metabolism.

      Aim: to gain data on drug related effects on gene expression and regulation with special
      regard to glucose metabolism.
    


Intervention name(s): olanzapine; ziprasidone; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): olanzapine 10mg od + placebo od; ziprasidone 40mg td; placebo td
Intervention MeSH terms: Olanzapine; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: healthy volunteers; antipsychotics; gene expression
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2
Condition: Upper Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Observational

Summary: 
      This study will test the hypothesis that constitutionally poorer Eustachian tube function
      predisposes to middle-ear pathology during a viral upper respiratory infection.
    

Detailed description: 
      The most well supported immediate cause of Otitis media (OM) is a pre-existing or concurrent
      viral upper respiratory tract infection (vURI). However, not all vURI episodes cause OM and a
      variety of predisposing factors has been suggested to explain this selectivity. Based on our
      preliminary work using a model of experimental viral infections in adults, we hypothesize
      that the constitutional efficiency of the Eustachian tube (ET) to supply the middle ear (ME)
      with gas and thereby stabilize ME pressure at near ambient is a primary risk factor for OM
      during vURI. Here, we test the hypothesis that constitutionally poorer ET function (F)
      predisposes to ME pathology during a vURI. Specifically, we will use ETF testing protocols
      relevant to the pressure-chamber to evaluate constitutional ETF in ≈ 160 susceptible, adult
      volunteers who will be exposed to rhinovirus as part of our funded study entitled "Social and
      Psychological Risks for Infectious Disease" (PI: S. Cohen, PI: CHP subcontract: WJ Doyle) and
      document the ETF and ME responses to infection over a 5-day post-exposure, cloister period.

      Also, using protocols relevant to the pressure-chamber, we will evaluate constitutional ETF
      in 80 children who will be enrolled into our funded study entitled "Role of Virus and Genetic
      Susceptibility in Otitis Media" (PI: CM Alper) and followed for vURI and OM from October
      through April. From both data sets, we will extract measures of ETF efficiency and determine
      using logistic regression with appropriate control variables (e.g. demographic data etc) if a
      single or combination of ETF variables predicts an abnormal ME response in rhinovirus
      infected adults or OM during a rhinovirus cold in children.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Membership in one of the two identified source populations
      
Keywords: otitis; Eustachian tube; virus; Middle ear disease
Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study
Condition: Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the
      safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and
      multiple oral doses of AZD7986 in healthy volunteers
    


Intervention name(s): AZD7986, oral solution, 1 to 50 mg/mL; Placebo, oral solution
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose in single ascending dose part: 5 mg; Matching placebo
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: AZD7986, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect, First-in-human, Single Ascending Dose, Multiple Ascending Dose, Healthy Subjects
Clinical Study to Assess the Effectiveness of the Device Patello
Condition: Passiv Continuous Patella Mobilisation
Study type: Interventional

Summary: 
      The device "Patello" was designed to passively mobilize the Patella in cranial-caudal
      direction. Its application field lays in the rehabilitation of any knee pathology where knee
      range of motion may be restricted due to the Patella mobility.
    

Detailed description: 
      The effectiveness of the device Patello has not been tested so far. This clinical study aims
      to assess and proof the effectiveness of this device. The aim is to objectify the movement of
      the Patella induced by the device Patello in cranial / caudal direction. As outcome parameter
      serve ultrasound measurements of a bony reference point of the femur and the Patella and its
      displacement / distance after mobilization.
    

Intervention name(s): Patello
Intervention type(s): Device
Intervention description(s): The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.
Intervention model: Single Group Assignment
Intervention model description: One randomly selected knee is treated by the intervention device Patello
Masking: None (Open Label)
Primary purpose: Device Feasibility
TAK-329 Glucose Clamp Study
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability, pharmacokinetic and
      pharmacodynamic properties of single doses of TAK-329 with a single dose of a
      subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes
      mellitus.
    

Detailed description: 
      Type 1 diabetes mellitus (T1DM), also known as insulin-dependent diabetes mellitus or
      juvenile-onset diabetes, occurs primarily due to β-cell destruction, usually leading to
      absolute insulin deficiency. The condition is immune-mediated and is usually idiopathic.
      Tight glycemic control using intensive insulin therapy was shown in the Diabetes Control and
      Complications Trial (DCCT) to reduce rates of microvascular complications in T1DM; however,
      achieving and maintaining such control in T1DM using standard insulin therapy requires a high
      level of support and is associated with increased potential for hypoglycemia, increased
      weight gain and, in some patients, aggravation of cardiovascular risk factors including
      dyslipidemia.

      TAK-329 is being developed by Takeda Global Research & Development Center, Inc. (TGRD) as an
      adjunct treatment to improve glycemic control in patients with type 1 diabetes mellitus who
      use insulin therapy.

      This study will take place at 1 site in the United States. A total of 36 male and female
      adult participants with T1DM will take part in the study.

      The study will last about 77 days, including a 28 days screening period, 4 cross-over
      treatment periods and a follow up period. Participants will be confined to the study clinic
      for 2 days in each period. Participants will also be contacted by phone 30 days following the
      last dose of study drug.
    

Intervention name(s): TAK-329; TAK-329; Insulin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-329 50 mg, tablets, orally, single dose, one day.; TAK-329 200 mg, tablets, orally, single dose, one day.; Insulin 0.2 U/kg, subcutaneous injection, single dose, one day.; TAK-329 placebo-matching tablets, orally, single dose, one day.
Other intervention name(s): Insulin lispro; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Type 1 Diabetes Mellitus; Insulin; Glucose; Drug Therapy
A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open,
      crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval.
      Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open
      label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study
      sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis
    


Intervention name(s): PF-06700841; Placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a single oral dose of 200 mg PF-06700841; Placebo matching PF-06700841; a single oral dose of 400 mg moxifloxacin
Intervention MeSH terms: Moxifloxacin; PF-06700841
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-06700841; QT effect; concentration-QTc analysis
Epidural Catheter Location by Epidural Pressure Waveform
Condition: Anesthesia, Local
Study type: Observational

Summary: 
      The aim of this preliminary study was to evaluate the new CompuFlo instrument which allows
      pulsatile waveform recordings.
    

Detailed description: 
      30 epidural catheters previously successfully used for obstetric anesthesia or analgesia and
      about to be removed were tested. All patients were given 5 mL 2% lidocaine to test the
      catheter before its removal. After priming with 5 mL saline, the catheter was connected to
      CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during
      its removal. The epidural catheter was marked at the skin level to record the distance
      between the skin at the time of measurements. The power analysis required a sample of 30
      observations to set 80% test power and 95% significance level.
    

Intervention name(s): CompuFlo
Intervention type(s): Device
Intervention description(s): After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obstetric patients who received an epidural block and have an epidural catheter
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
Condition: AML
MeSH terms: Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The present trial will establish a prospective sequential Allogeneic Stem Cell
      Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced
      Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to
      which future innovative strategies can be compared.
    

Detailed description: 
      Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment
      failure

      * Secondary Endpoints:

        -  Feasibility of early transplantation within a multicenter trial

        -  Leukemia-free survival (LFS) at 2 years from transplantation

        -  Leukemia Response rate at day +30, +90 and 6 months

        -  Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM)

        -  Incidence and severity of acute and chronic Graft-versus-Host disease

        -  Feasibility and safety of early discontinuation of immunosuppressive therapy
    

Intervention name(s): Clofarabine
Intervention type(s): Drug
Intervention description(s): The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.
Intervention MeSH terms: Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; primary induction failure
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The aim of this study is to determine if alterations in sodium intake alter peripheral
      vascular function and exercise tolerance in young individuals.
    

Detailed description: 
      Sodium intake is a major contributor to the development of hypertension in the developed
      world. Interestingly, it has been recently revealed that, in addition to the cardiovascular
      dysfunction associated with high sodium intake-induced hypertension, individuals who have
      unaltered blood pressure after chronic high sodium intake, termed salt resistant, report
      similar reductions in cardiovascular function when compared to salt sensitive individuals.
      While the extent to which this high sodium intake negatively alters cardiovascular structure
      as well as function is currently being explored, little is known about how high sodium intake
      impacts vascular function and blood flow regulation during exercise. Therefore, this study
      will determine if alterations in sodium intake alter peripheral vascular function and
      exercise tolerance in young individuals. The investigators hypothesize that increases in
      sodium intake will reduce exercise-induced arterial dilation in response to shear and result
      in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise
      workloads. Furthermore, the investigators hypothesize that these changes in blood flow
      regulation and exercise tolerance in young individuals will be reversed following antioxidant
      supplementation, implicating the role of oxidative stress in this dysfunction.
    

Intervention name(s): Salt Pills; Placebo Pills
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day); 7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges
Condition: Sensory Processing Disorder
Study type: Interventional

Summary: 
      The multiple baseline single subject design study with replication across three participants
      in a public-school setting. The 15-week independent variable will be a direct service
      occupational therapy intervention, combined with teacher consultations, based on the STAR
      (Sensory Therapies and Research) Frame of Reference. Frequently measured dependent variables,
      as the main determinants of change resulting from the intervention, will be student's
      video-recorded performance in the areas of functional regulation and active participation in
      the classroom, as rated by a trained observer. Findings of the single subject study will be
      corroborated via semi-structured interviews with the student participants and their teachers,
      administration of systematic assessments and Goal Attainment Scaling.
    


Intervention name(s): Sensory Integration Intervention through the STAR Frame of Reference
Intervention type(s): Other
Intervention description(s): The individualized therapy program will be based on the results of the comprehensive evaluation. Intervention aligns with the STAR Frame of Reference fidelity measure and Ayres Fidelity Measure.
Intervention model: Single Group Assignment
Intervention model description: Multiple baseline design across participants
Masking: None (Open Label)
Primary purpose: Treatment