bioihbjkbjnl/mcl2 huggingface dataset:
Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      PF-04287881 after a single oral dose in healthy adult volunteers.
    


Intervention name(s): PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo; PF-04287881; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 75 mg oral dose (prepared solution) given once; placebo to match 75 mg oral dose (prepared solution), given once; 150 mg oral dose (prepared solution) given once; placebo to match 150 mg oral dose (prepared solution), given once; 300 mg oral dose (prepared solution) given once; placebo to match 300 mg oral dose (prepared solution), given once; 750 mg oral dose (prepared solution) given once; placebo to match 750 mg oral dose (prepared solution), given once; 1000 mg oral dose (prepared solution) given once; placebo to match 1000 mg oral dose (prepared solution), given once; 1250 mg oral dose (prepared solution) given once; placebo to match 1250 mg oral dose (prepared solution), given once; 1500 mg oral dose (prepared solution) given once; placebo to match 1500 mg oral dose (prepared solution), given once; 300 mg oral dose (prepared solution) given once; placebo to match 300 mg oral dose (prepared solution), given once; 750 mg oral dose (prepared solution) given once; placebo to match 750 mg oral dose (prepared solution), given once; 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once; placebo to match 1000 mg oral dose (prepared solution), given once
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety tolerability pharmacokinetics PK first in human FIH
Safety and Immunogenicity of the RSV D46cpΔM2-2 Vaccine in RSV-Seropositive Children and RSV-Seronegative Infants and Children
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2
      vaccine in RSV-seropositive children and RSV-seronegative infants and children.
    

Detailed description: 
      Human RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in
      infants and children under 5 years of age worldwide. This study will evaluate the safety and
      immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and
      RSV-seronegative infants and children. The vaccine will be evaluated in a stepwise fashion
      beginning in RSV-seropositive children (Group 1), and then in RSV-seronegative infants and
      children (Group 2). In each group, participants will be randomly assigned to receive a single
      dose of D46cpΔM2-2 vaccine or placebo at study entry (day 0).

      Participants will be enrolled in the study between April 1 and October 31, outside of the RSV
      season. Group 1 (RSV-seropositive children) will attend several study visits and will be
      followed for 28 days. Group 2 (RSV-seronegative infants and children) will remain on study
      until they complete the post-RSV season visit between April 1 and April 30 in the calendar
      year following enrollment. Participants in Group 2 will also attend several study visits
      during the time they are enrolled in the study. Study visits for all participants may include
      clinical assessments, blood collection, and nasal washes.
    

Intervention name(s): D46cpΔM2-2 vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Delivered as nose drops; Delivered as nose drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Tolerance Evaluation of an Injective Treatment for the Area Around the Eyes
Condition: Under-eyes Dark Circles
Study type: Interventional

Summary: 
      Efficacy and tolerance evaluation of an intradermal injective HA and aminoacids based
      treatment for the area around the eyes
    

Detailed description: 
      Primary end point of this study was to evaluate clinically and by non-invasive instrumental
      measurements the aesthetic performance on the area around the eyes of the"SUNEKOS® 200"
      injective treatment. Precisely three micro-injection sessions with an interval of 15 days
      were performed by a specialized dermatologist using periosteal and subepidermal injection
      techniques, on the area around the eyes of female volunteers with dark circles.

      An additional aim of this study is to evaluate the product tolerance by both the investigator
      and volunteers.
    

Intervention name(s): SUNEKOS® 200
Intervention type(s): Device
Intervention description(s): The intradermal injection procedure was performed bilaterally, on the area around the eyes including the eyelids, using periosteal and subepidermal injection techniques. This injective procedure consists of micro-wheals of 0.2 ml just above the periosteum and micro-wheals of 0.1 ml very superficially, just under epidermis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether duloxetine is an effective treatment of
      attention deficit disorder in adults.
    


Intervention name(s): duloxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg capsule once per day for 6 weeks; one capsule of placebo taken one a day for 6 weeks
Other intervention name(s): cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Disorder with Hyperactivity; Duloxetine; Adult; ADDH; ADHD
Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
Condition: Acute Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with
      conventional neurologic intensive care in patients with acute moderated to severe brain
      injury in early stage - A randomized controlled study.
    

Detailed description: 
      This study adopted a prospective, randomized controlled design. All eligible patients
      included in the study agreed to participated and signed the informed consent from and the
      study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital
      (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi
      general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in
      this study and randomized into intervention group and control group. All patients of both
      groups were enrolled within 14 days after episode and a follow-up interview until 6 months
      from the onset. The intervention group mean regular neuro-intensive care combined TCM and the
      intervention group mean only neuro-intensive care. But there are 7 patients in intervention
      group and 12 patients in control group quit out this study
    

Intervention name(s): Wendan decoction combination in acute brain injury
Intervention type(s): Drug
Intervention description(s): In the intervention group, traditional Chinese medicine was given between 14 days of onset and TCM was used 1 month at least in intervention group.
Intervention model: Single Group Assignment
Intervention model description: randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: traditional chinese medicine combination treatment
Effect of Kinesiotaping on Force Irradiation
Condition: Healthy
Study type: Interventional

Summary: 
      The study is assessed the electromyographic activity response of non-dominant biceps brachii
      muscle during unilateral-dominant concentric, eccentric and isometric biceps brachii muscle
      contractions under kinesiotaping and non-taping conditions. The aim of the study is to
      determine the synergistic effect of kinesiotaping which is applied on non-dominant biceps
      brachii muscle on force irradiation.
    

Detailed description: 
      Fourty healthy subjects with no history of neurological or recent musculoskeletal injury will
      participate the study.

      Healthy subjects are arranged in two groups of stimulation: kinesiotaping group
      (kinesiotaping and force irradiation) and control group (only force irradiation). The
      electromyographic response of the resting arm (non-dominant) will be assessed during the
      dominant arm movement for all subjects. Additionally, in kinesiotaping group, kinesiotaping
      will be applied 24 hours before the experiment.

      The electromyographic response of the resting arm will be assessed under three contraction
      type movement (isometric, eccentric and concentric contractions) The SEMG signals are
      analysed by using MATLAB®, suitable signal proccessing techniques (linear envelope, Root Mean
      Square etc) are chosed. The statistical analysis are done by using SPSS®, according to data
      distribution, "Independent Sample T Test" or "Mann-Whitney U Test" is utilized for comparing
      outcomes of control and KT groups.
    

Intervention name(s): Force Irradiation; Kinesiotaping
Intervention type(s): Other; Other
Intervention description(s): For the force irradiation, while the subjects perform dominant elbow flexion at an angular velocity of 60°/s for concentric contractions, 30°/s for eccentric contractions, at 90° elbow flexion position for isometric contractions with a maximal effort level, electrical activity of the non-dominant biceps brachii and triceps brachii muscles are recorded.; For kinesiotaping, the elbow positioned in 30°-45° flexion and kinesiotaping facilitation technique is applied origin to insertion of non-dominant biceps brachii muscle before 24 hours the experiment.
Other intervention name(s): Force Irradiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Force Irradiation; Kinesiotaping; EMG
Composites and Urinary Bisphenol-A Study
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The Composites and Urinary Bisphenol-A Study (CUBS) is a clinical study of dental composite
      for its effects on urinary bisphenol-A levels. The study will enroll approximately 139
      children recruited from study-affiliated clinical sites in New England.The primary aim of
      CUBS is to test the hypothesis that urinary bisphenol-A (BPA) concentrations increase after
      composite restoration placement. BPA is a chemical used in the synthesis of matrix monomers
      and has been shown to have harmful effects in toxicological studies in laboratory animals.
      Currently it is unknown whether dental composite restorative materials containing monomers
      that are derived from BPA result in chronic low-dose BPA exposure in children.
    

Detailed description: 
      Study subjects will be new or existing patients of the clinical sites who are in need of
      dental restorations, meet all eligibility criteria, and provide informed consent/assent to
      participate. Subjects will be asked to provide two pre-treatment urine samples and three
      post-treatment samples. Urine collections occur next-day and 14 days after treatment, with
      one final urine collected approximately 6 months later (marking the end of the subject's
      active study participation). Data will be collected from the clinician's standard oral
      examination (including new and existing dental treatments), the data collector's measurements
      of height and weight and interviews administered to the parents/guardians to assess
      sociodemographic and other relevant factors (e.g., recent food/beverage consumption).
      Confidentiality will be maintained by assigning each subject a unique number and using only
      this number or aggregate data in all study reports. All study records will be securely
      maintained with access limited to essential study personnel only.
    

Intervention name(s): Restoration of dental caries with dental composite
Intervention type(s): Procedure
Intervention description(s): Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
Other intervention name(s): Composite to be used is Z100 by 3M ESPE (St Paul, MN, USA).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental Caries; Dental Restorative Materials; Dental Composite; Bisphenol-A
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      To assess the effect of a probiotic product, when co-administered with antibiotics, on
      gastrointestinal symptoms following antibiotic treatment in children.
    


Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether the combination of nifedipine GITS and valsartan is more effective in
      reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine
      whether nifedipine GITS is comparable to valsartan
    


Intervention name(s): Nifedipine (Adalat, BAYA1040) and Valsartan; Nifedipine (Adalat, BAYA1040); Valsartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily; Nifedipine 60mg, Once daily; Valsartan 160mg, Once daily
Intervention MeSH terms: Valsartan; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Central blood pressure; Nifedipine; Valsartan
Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab
      produced by the original manufacturing process (Process A) compared to a second manufacturing
      process (Process B)

      The secondary objectives of the study are:

        -  Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2
           manufacturing processes

        -  Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes
    


Intervention name(s): Pozelimab
Intervention type(s): Drug
Intervention description(s): Single subcutaneous (SC) injection
Other intervention name(s): REGN3918
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relationship Between Muscle Mass and Muscle Relaxation Time
Condition: Anesthesia
Study type: Interventional

Summary: 
      Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis
      of the affected skeletal muscles. There have been several studies reported positive
      relationship between muscle mass and amount of neuromuscular junction. The purpose of this
      study is to find relationship between muscle mass and muscle relaxation time.
    

Detailed description: 
      Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis
      of the affected skeletal muscles. There have been several studies reported positive
      relationship between muscle mass and amount of neuromuscular junction. Until now, dose of
      rocuronium has been judged by patient's weight and height. However, height and weight do not
      represent exact muscle mass. The purpose of this study is to find relationship between muscle
      mass and muscle relaxation time. Measurement of muscle mass will be obtained using
      bioelectrical impedence analysis.
    

Intervention name(s): Inbody
Intervention type(s): Device
Intervention description(s): Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. After measurement, patient is induced anesthesia. Rocuronium dose is 12mg for male, and 9mg for female.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Lower Limbs Symmetrical Loading on Risk of Fall
Condition: Total Hip Replacement
Study type: Interventional

Summary: 
      Objective: To assess the impact of total hip arthroplasty (THA) on functional outcomes and
      fall risk in patients with hip osteoarthritis. The objective was to investigate the
      effectiveness of physical therapy in postoperative rehabilitation and identify fall risk
      factors to guide fall prevention strategies after THA.

      Methods: A non-randomized, interventional clinical trial was conducted with 30 patients
      scheduled for THA. Functional outcomes were evaluated using the Harris Hip Score (HHS),
      40-meter fast-paced walk test (40mFPWT), 30-Second Chair Test, and Western Ontario McMaster
      Universities Osteoarthritis Index (WOMAC). Balance and fall risk were assessed using the
      Single-Leg Standing Test and a posturography device (TETRAX). The Nottingham Health Profile
      (NHP) was used to measure subjective health status and quality of life. Assessments were
      performed preoperatively, at 6 weeks postoperatively, and at 3 months postoperatively.
    


Intervention name(s): postoperative rehabilitation
Intervention type(s): Other
Intervention description(s): 30 patients took postoperative rehabilitation after total hip arthroplasty surgery, 3 times a week, for 6 weeks. They took conventional rehabilitation (hip range of motion exercises, progressive strengthening exercises for hip and knee muscles, balance and proprioceptive exercises and gait training).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total hip arthroplasty; static balance; postoperative rehabilitation
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind,
      placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4
      NASH.
    


Intervention name(s): EFX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine if PD-0299685 is effective and safe in the
      treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.
    


Intervention name(s): PD-0299685
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
Condition: Pain; Inflammation
MeSH terms: Cataract; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled
      study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will
      be randomized (2:1) in to one of two treatment groups: N-PPDS or p-PPDS, which are inserted
      in the lower punctum of the subject's scheduled surgical eye. All plugs will remain in the
      study subject's lower punctum for a period of 2 weeks following cataract surgery.
    

Detailed description: 
      This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled
      study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will
      be randomized (2:1) in to one of two treatment groups:

      Group A: A total of 50 study subjects (50 eyes) will have an N-PPDS inserted in the lower
      punctum of their scheduled surgical eye.

      Group B: A total of 25 study subjects (25 eyes) will have a p-PPDS inserted in the lower
      punctum of their scheduled surgical eye.

      All plugs will remain in the study subject's lower punctum for a period of 2 weeks following
      cataract surgery.
    

Intervention name(s): Nepafenac PPDS; Placebo PPDS
Intervention type(s): Combination Product; Combination Product
Intervention description(s): A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.; A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
Intervention MeSH terms: Nepafenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment of pain and inflammation after Cataract Surgery
Safety and Tolerability Study With Single Ascending Doses of ORM-12741
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating doses of
      ORM-12741 in healthy volunteers.
    


Intervention name(s): ORM-12741
Intervention type(s): Drug
Intervention description(s): Alternating panel single dose escalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteer study