bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma
Condition: Diffuse Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine
      the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse
      Non-Hodgkin lymphoma.
    

Detailed description: 
      This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine
      the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse
      Non-Hodgkin lymphoma. The study will have the following sequential phases: Screening,
      Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and
      Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19
      cell infusion.
    

Intervention name(s): single dose of CNCT19
Intervention type(s): Biological
Intervention description(s): Dose A: 1.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Dose B: 2.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Dose C: 4.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine if oxycodone and naltrexone combination
      capsules (ALO-02) have the potential to be abused.
    

Detailed description: 
      Abuse Liability Study
    

Intervention name(s): Placebo; intact ALO-02 60 mg/7.2 mg; crushed ALO-02 60 mg/7.2 mg; crushed oxycodone IR 60 mg; crushed ALO-02 40 mg/4.8 mg; crushed oxycodone IR 40 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo solution + Placebo ALO-02 (intact); Placebo solution + ALO-02 60 mg/7.2 mg (intact); crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact); crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact); crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact); crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers; Chronic pain
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Condition: Drug Toxicity
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      Arm 1:

      Primary Objective:

      • To determine the safety and tolerability of multiple ascending, supratherapeutic doses of
      HPN-100.

      Arm 2:

      Primary Objective:

      • To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid
      [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead
      electrocardiogram (ECG) parameters in healthy male and female subjects with the primary
      endpoint being the time-matched change from baseline in the QT interval corrected for heart
      rate (HR) based on an individual correction method (QTcI).
    

Detailed description: 
      Assess the effects of steady-state levels of HPN-100 metabolites (4-phenylbutryic acid (PBA),
      phenylacetic acid (PAA), and phenylacetylglutamine (PAGN) on 12-lead electrocardiogram (ECG)
      parameters in health male and female subjects with the primary endpoint being the
      time-matched change from baseline in the QT interval corrected for heart rate(HR) based on an
      individual correction method (QTcl).
    

Intervention name(s): HPN-100; HPN-100 or Placebo; Placebo; Moxifloxacin; HPN-100; HPN-100
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days; single oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days; single oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days; single oral 400-mg dose on study Day 3; single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days; single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
Intervention MeSH terms: Moxifloxacin; Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
The Relationship Between Physical Activity Level and Reaction Time in University Students
Condition: Physical Inactivity
Study type: Observational

Summary: 
      Reaction time, movement and total movement time are said to affect athletic performance.

      The unit of time between giving a stimulus to the person and the beginning of the person's
      voluntary response to this stimulus is defined as the reaction time.

      Recent studies have reported that reaction time may depend on gender differences,
      neuromuscular and neurophysiological factors, force production, structural and neural
      properties of muscles, and information processing speed.
    

Detailed description: 
      In recent studies, it has been reported that reaction time can be affected by parameters such
      as gender, neuromuscular and neurophysiological factors, force production, structural and
      neural properties of muscles, and information processing speed. Reaction time measurements
      are basically for two functions. The first of these is the situations that we encounter
      during traffic lights, sportive activities or daily life activities. The other is to measure
      the duration of mental activities such as processing the stimulus from the environment,
      making decisions, programming the reaction.

      Physical activity is defined as all movements that require energy expenditure as a result of
      the use of skeletal muscles. Physical activity has positive effects on the development of
      muscle strength, balance, flexibility, posture, reaction time and motor skills. There is a
      complex relationship between physical activity and cognitive performance. Depending on the
      chosen cognitive task and the type of exercise, there is a change in cognitive load.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The 'Phalen Test' will be applied in order to eliminate the risk of finding a carpal tunnel
        for the people included in the study. The subjects included in the study will be classified
        according to their physical activity status by giving the "International Physical Activity
        Questionnaire (Short)". Records of the subjects' dominant hands will be taken and included
        in the analysis process.
      
Keywords: reaction time
To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
Condition: Androgenic Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.

      60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old
      and provide written informed consent were eligible for inclusion.

      The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of
      dosing, three times per week. Each subject received two doses of the five trial treatment
      doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as
      intradermal injections. On each volunteer, two treatment areas were placed on the head and
      the two selected doses were allocated to the respective treatment areas according to the
      randomisation scheme. The treatment areas were selected on the border between the bald
      surface and the surface with hair.

      The effect on hair growth was measured by the use of Trichoscan imaging and measuring method
      at week 8 and 12. A baseline measaure was taken at day 0.
    


Intervention name(s): FOL-005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intradermal injection; intradermal injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Assess Rotation for Femoral Version and Tibial Torsion
Condition: Rotational Malalignment of the Lower Extremity
Study type: Observational

Summary: 
      Determining the investigators ability to accurately assess rotational malalignment clinically
      compared to imaging.
    

Detailed description: 
      The objectives of this study are 1) to assess the inter/intra-observer reliability of
      rotational measurements on axial MRI images and 2) determine the correlation between clinical
      and MRI measures of femoral version and tibial torsion.

      The investigators will use previously obtained MRI images to retrospectively calculate the
      inter-observer and intra-observer reliability of our measurements. Participating physicians
      will undergo training to standardize measurement technique. Five orthopaedic surgeons and one
      radiologist will perform the measurement to calculate inter-observer reliability. To asses
      intra-observer reliability, repeat measurements will be performed by the same physicians at a
      later date (at least 2 weeks). The physicians will be blinded to previous results when
      performing the second set of measurements. A standardized rotational profile will be
      performed on all patients presenting to the investigators with patellofemoral complaints or
      rotational abnormalities warranting intervention. Internal and external hip rotation will be
      measured in the prone and supine positions. Tibial torsion will be assessed with the
      thigh-foot axis in the prone and sitting positions. Investigators will participate in a
      formal training session prior to data collection to normalize measurements. Each study
      participant will undergo MRI imaging of the femur and tibia.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study is aiming to recruit all patients with complaints of patellofemoral
        pain/instability associated with rotational malalignment. The two types of rotational
        malalignment, fibial version and tibial torsion are most common among the pediatric
        population.
      
Keywords: MRI; Lower Extremity Rotational; Femoral Version; Tibial Torsion
European Multi-center Post Market Study of the IBV Valve System
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The objective of this randomized, blinded, multicenter, controlled study is to compare the
      performance of the IBV Valve System (treatment group) to a control group receiving a sham
      bronchoscopy procedure without valve placement.
    

Detailed description: 
      The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of
      diseased and damaged lung. The devices are one-way valves that can be placed in the airways
      via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves
      are placed in airways communicating to the most diseased areas of lung tissue to re-direct
      airflow to less diseased areas. A multicenter, blinded and randomized study of these valves
      is being conducted in 7 centers in 6 European countries. The study is evaluating the
      effectiveness of this therapy for the treatment of upper lobe predominant emphysema in
      patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best
      medical management continue having poor quality of life, severe symptoms and physical
      limitations. The primary endpoints are to measure and compare responses using the St.
      George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented
      patients that meet the strict inclusion criteria have a bronchoscopic procedure and are
      randomized into treatment or control (no valves) groups. After the procedure, all patients
      stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months.
      After the 3-month evaluation, each patient is un-blinded. The treatment group is then
      scheduled for an additional follow-up at 6 months and the control group is offered valve
      treatment (rollover) and evaluated approximately 3 months later.
    

Intervention name(s): IBV Valve
Intervention type(s): Device
Intervention description(s): Placement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group.
Other intervention name(s): BLVR; Endoscopic Volume Reduction; Endobronchial Valve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD; Emphysema; Bronchoscopic Treatment; Interventional Bronchoscopy
A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg
      pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant
      administered as two separate 1 mL injections and to characterize the pharmacokinetics of the
      new 30 mg strength.
    


Intervention name(s): 1 x 30 mg/mL pegvisomant; 2 x 15 mg/mL pegvisomant
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection, 30 mg, single dose.; Subcutaneous injection, 2 injections of 15 mg, single dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this
      study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion.
      Treatment lasted for 10 days and participants were followed up for at least 40 days and a
      maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats
      CDAD as compared to vancomycin.
    


Intervention name(s): Surotomycin; Vancomycin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days; 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days; Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days
Other intervention name(s): CB-183,315
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDAD; Clostridium difficile Associated Diarrhea; CDI; Clostridium difficile Infection; Diarrhea
A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.
Condition: Cartilage Injury; Osteochondritis Dissecans
MeSH terms: Osteochondritis; Osteochondritis Dissecans
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide®
      collagen membrane either sutured or glued compared to microfracture alone in the treatment of
      symptomatic cartilage defects of the knee.
    

Detailed description: 
      -  Prospective, randomized, active treatment-controlled, open-label multicenter study (up
           to 40 sites in the US and EU).

        -  All subjects that meet preoperative screening eligibility criteria will be randomized to
           treatment with Chondro-Gide® either sutured or glued or Microfracture alone.

        -  Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized
           randomization list to receive one of the following treatments: Group I: Microfracture
           alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin
           glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane
           sutured (AMIC sutured)

        -  All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2
           and 5 years).

        -  Subjects will be required to follow a strict pre-specified post-surgery rehabilitation
           protocol specific to the defect location.

        -  Measures to assess effectiveness and safety will be conducted at all follow-ups.

        -  Safety will be assessed by the collection of adverse events at all timepoints.
    

Intervention name(s): Microfracture; Chondro-Gide sutured; Chondro-Gide glued
Intervention type(s): Procedure; Device; Device
Intervention description(s): Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot; Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy; Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microfracture; enhanced marrow stimulation; articular cartilage; Autologous Matrix-Induced Chondrogenesis; Chondro-Gide®; knee surgery; AMIC
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of
      NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under fasting
      conditions
    

Detailed description: 
      Study Type: Interventional Study Design: Single dose, randomized, two-period, two-treatment,
      two-sequence crossover study under fasting conditions comparing equal doses of the test and
      reference products.

      Official Title: A relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting
      Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Gabapentin 400 mg capsules; NEURONTIN® 400 mg capsules
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Actavis formulated products under fasting conditions; B: Active comparator Subjects received Parke-Davis's marketed product
Other intervention name(s): Gabapentin; Gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Gabapentin; Healthy subjects
Glioma and Exercising
Condition: High Grade Glioma
MeSH terms: Glioma
Study type: Interventional

Summary: 
      To investigate the influence of two physical activity and exercising (PAE) interventions,
      namely resistance training and endurance training in relation to quality of life, depression,
      fatigue, sleep, anxiety, stress and coping, body image, and social interactions
      (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion,
      inflammatory markers, and objective sleep (physiological dimensions), along with
      cancer-related dimensions
    

Detailed description: 
      Patients with high grade glioma (WHO III° and IV°) and undergoing radiotherapy, chemotherapy,
      or both radio- and chemotherapy suffer from decreased quality of life (QoL). This study is to
      analyse the influence of two adjuvant interventions of physical activity and exercising (PAE)
      (namely resistance training and endurance training) in relation to quality of life,
      depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions
      (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion,
      inflammatory markers, and objective sleep (physiological dimensions).
    

Intervention name(s): endurance training; social support and counseling; resistance training
Intervention type(s): Other; Other; Other
Intervention description(s): physical activity and exercising (PAE); social support and counseling; physical activity and exercising (PAE)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: interventions of physical activity and exercising (PAE); resistance training; endurance training