bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Postural Control After Exercise in Athletes Using Tetra Axial Posturography (tetrax1)
Condition: Healthy
Study type: Observational

Summary: 
      Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of
      electronic signals emitted by four footplates, one for each heel and toe, respectively. These
      are sensitive to vertical pressure produced by a subject standing straight but in various
      positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields
      additional parameters not obtained by the traditional monoplate stabilometers, namely,
      weight-distribution patterns and correlation among six combinations of paired outputs from
      the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric
      synchronizations).

      Most athletic injuries occur at the end of an activity, when the participant is fatigue. It
      is likely that significant portion of the injuries result from instability of the lower
      extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue
      increase postural sway, impaired muscle control, and increase the onset delay of movement.
      Comparing pre-exercise with post-exercise results for each athlete, should detect significant
      and clinically meaningful differences with the Tetra-ataxiametric measures of stability,
      interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and
      synchronizations of toe parts. The method is suitable for young subjects, and the equipment
      is portable and tests can be conveniently carried out in a child's familiar training setting
      and right before/after exercise.

      The goal of the present study is to measure the balance of the athletes after different types
      of exercises, to measure the ability of the athletes to recover different types of exercises,
      and to measure the influence of increasing physical fitness on balance ability. Fifty
      basketball and football players between the ages of 12 and 18 years old will be examined
      following informed consent from the children and their legal guardian. Each participant would
      be measured three times during the year (pre-season, middle-season, and post-season), three
      times each (before-training, after aerobic warming-up, and after-training) on the Tetrax.
      Additionally, physical parameters (as height, and weight), anatomical parameters (as leg
      length), and joint range of movement, would be record.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty basketball and football players between the ages of 12 and 18 years old.
      
Keywords: Normal young athletes
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD),
      multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in
      healthy volunteers.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under Section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      Sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): DNL151; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral dose(s); oral dose(s)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Halophyte-based Cream on Pain and Itch
Condition: Pain, Acute; Itch
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      In this study the investigators wish to investigate whether halophyte-based cream applied to
      the skin can reduce itch applied by means of small needles from the plant mucuna pruriens
      (also called cowhage) or by histamine (an itch-evoking substance formed in the human body).
      Further, the investigators wishes to investigate whether long-term application of
      halophyte-based cream has a pain-relieving effect on heat/cold and pinprick stimulations.
    

Detailed description: 
      Salt-tolerant plants (also called halophytes) can grow in saline soil or directly in salt
      water (e.g. along coasts). For centuries, these plants have been used in folk medicine, and
      among other things they are believed to have pain-relieving and anti-inflammatory effect.

      Even though experiments have already investigated halophytes as a pain relieving substance,
      the mechanisms in relation to pain and/or itch are still unknown. Therefore, the
      investigators wish to investigate whether halophyte-based cream applied to the skin can
      reduce itch applied by means of small needles from the plant mucuna pruriens (also called
      cowhage) or by histamine (an itch-evoking substance formed in the human body). Further, the
      investigators wishes to investigate whether long-term application of halophyte-based cream
      has a pain-relieving effect on heat/cold and pinprick stimulations.
    

Intervention name(s): Halophites-based cream 24 hours; Halophites-based cream 48 hours; Vehicle cream 24 hours; Vehicle cream 48 hours; Histamine 1%; Cowhage
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): The concentration of active aqueous extract will be in the range of 2% to 30% (v/v) by cold emulsification. A 2 gram amount of Halophytes-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.; The concentration of active aqueous extract will be in the range of 2% to 30% (v/v) by cold emulsification. A 2 gram amount of Halophytes-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.; A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.; A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.; To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction.; The insertion of cowhage spicule(s) rapidly and consistently produces itch with no or very little flare reaction. This insertion is conducted by forceps using a stereo-microscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
Intervention MeSH terms: Histamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Development of a Celiac Safe Food Additive
Condition: Gluten Intolerance
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      The goal of this clinical trial was to investigate if intestinal deamidation of gliadin from
      wheat bread could be hindered by adding a E304i/zinc additive. The study was a randomized
      double-blind 4-week crossover intervention in 20 healthy volunteers in which the participants
      ingested 2 bread rolls a day during the intervention weeks.

      The question it aimed to answer was if there was a difference in blood levels of deamidated
      gliadin peptides after ingestion of the reference wheat bread compared with the wheat bread
      containing the food additive.
    


Intervention name(s): Breakfast rolls consisting of wheat flour with and without a E304i/zinc additive
Intervention type(s): Other
Intervention description(s): The participants were provided with two Breakfast rolls (a 40 g) a day during the intervention week. In addition, they were provided with gluten-free foods during the whole trial.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised double-blind crossover intervention
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose
      study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers
    

Detailed description: 
      The subjects who are adequately eligible to attend this clinical trial via screening will be
      assigned to four cohorts (five if necessary) and administered a single dose of GX-I7 solution
      or placebo drug for intravaginal injection at the visit 3 (Day0) and 7 (Day28). After
      completing scheduled tests at the visit 6 (Day 14), safety-related data of each cohort will
      be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed
      under the principal investigator, medical monitor, and the sponsor's mutual approval,
      referring to SMC's evaluation.
    

Intervention name(s): GX-I7; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.; This is the placebo of GX-I7 described above.
Other intervention name(s): IL-7-hyFc; GX-I7 vehicle (formulation buffer)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HPV
Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study objective is to explore the safety and tolerability of STX209 in subjects with
      Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in
      treating irritability. We hypothesize that STX209 will be safe and well-tolerated.
    


Intervention name(s): Arbaclofen
Intervention type(s): Drug
Intervention description(s): variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Other intervention name(s): STX209
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorders; irritability; aberrant behavior
A Study to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of ritonavir, on the single-dose
      pharmacokinetics (PK) of JNJ-61393215 in healthy participants.
    


Intervention name(s): JNJ-61393215; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension.; Participants will receive 100 mg of ritonavir tablet orally.
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause
Condition: Perimenopausal Bone Loss
MeSH terms: Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      Study Objective: To determine whether Natto supplementation in women immediately after
      menopause might prevent severe bone loss

      Study population: Women 50 - 60 years, 1-5 years after menopause

      Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II"
      clinical trial.

      Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer

      Study Treatment Group: Daily supplementation with Vitamin K2, "NATTO"

      Study Control Group: Identically-looking placebo medication

      Duration of treatment: 12 months

      Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response:
      Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the
      minimum clinically significant difference between the groups is 0.3 percentage points. The
      trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage
      points in the treatment group.

      Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334
    


Intervention name(s): Natto capsules (food suppl.) cont. 360 microg. vit K2/day; Placebo capsules
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Women; Bone density; Menopause; Dietary Supplements; Vitamin K2
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain
      following bunionectomy surgery.
    


Intervention name(s): diclofenac potassium (XP21L); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg capsule, every 6 hours; Oral placebo capsule, every 6 hours
Other intervention name(s): Zipsor Liquid Filled Capsule; XP21L
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bunionectomy; Bunion surgery; Post-operative pain
A Clinical Trial to Evaluate Tolerability and Pharmacokinetics of HL217 Eye Drop in Healthy Male Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and PK parameters in
      healthy subjects.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability and PK parameters of HL217
      after single eye drop administration at different doses in healthy subjects.
    

Intervention name(s): Cohort 1: HL217 Ophathalmic Solution QD; Cohort 2: HL217 Ophathalmic Solution BID; Cohort 3: HL217 Ophthalmic Solution QID; Placebo Ophthalmic solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cohort 1 (Once a day); Cohort 2 (Twice a day); Cohort 3 (Four times a day); Placebo
Other intervention name(s): 3mg/mL; 3mg/mL; 3mg/mL; Placebo
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of
      Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
    

Detailed description: 
      Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted
      conditions
    

Intervention name(s): 20 mg HC-ER; 20 mg HC-ER; 20 mg HC-ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1-72 hours; 1-72 hours; 1-72 hours
Other intervention name(s): Zohydro ER; Zohydro ER; Zohydro ER
Intervention MeSH terms: Hydrocodone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily
      recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the
      higher circulating FSH activity during the first days of stimulation. For this reason, the
      use of corifollitropin alfa might be beneficial in poor responders in whom the number of
      oocytes retrieved is crucial for success.

      The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment
      compared to daily recFSH in terms of the number of oocytes retrieved in a defined population
      of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using
      gonadotrophin releasing hormone (GnRH) antagonists.
    


Intervention name(s): Corifollitropin alfa; rFSH
Intervention type(s): Drug; Drug
Other intervention name(s): Elonva; Puregon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
AZD5423 Single Ascending Dose Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male
      subjects.
    


Intervention name(s): AZD5423; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.; Solution for nebulisation, inhaled. Each subject will receive a single-dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Healthy; Inhalation
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318
      in healthy subjects following up to 28 days dosing, where F901318 is given orally . The
      effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the
      pharmacokinetics of midazolam will also be assessed.
    

Detailed description: 
      Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be
      conducted in a sequential manner such that the dose level can be optimised upon review of
      emerging safety, tolerability and PK data.
    

Intervention name(s): F901318
Intervention type(s): Drug
Intervention description(s): F901318 tablet
Intervention MeSH terms: Olorofim
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Different Designs of Space Maintainer
Condition: Early Tooth Exfoliation
Study type: Interventional

Summary: 
      Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs
      versus standard one.

      Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st
      primary molar were selected for this study. The whole sample was divided into four groups (13
      each). In Group I, Band and loop (B&L), Group II: Single-sided band and loop (Ss B&L), Group
      III: Direct bonded wire (DBW), Group IV: Tube and loop (T&L). children were recalled at 3, 6,
      9, 12,15-month.
    

Detailed description: 
      Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs
      versus standard one.

      Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st
      primary molar were selected for this study. The whole sample was divided into four groups (13
      each). In Group I, Band and loop (B&L), Group II: Single-sided band and loop (Ss B&L), Group
      III: Direct bonded wire (DBW), Group IV: Tube and loop (T&L). children were recalled at 3, 6,
      9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier
      method with log rank test. Cumulative survival rates of SMs were estimated by means of
      Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated
      using Sampsize application with anticipated success on treatment with conventional band and
      loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power,
      and significant level 0.05.
    

Intervention name(s): Fixed space maintainer
Intervention type(s): Device
Intervention description(s): Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other intervention name(s): Bonded or/ Banded space maintainers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone
      cements.
    

Detailed description: 
      The fixation of components in total hip arthroplasty has a significant effect on the
      long-term survival of the prostheses. Bone cement in total joint replacement acts as an
      anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into
      bone surfaces. However, there are significant differences in cement behaviour among differing
      types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated
      that there is an increased rate of revision due to aseptic loosening of femoral components
      implanted with low-viscosity cement compared with that of high-viscosity.

      Studies have shown that high early migration for certain designs of femoral prosthesis can be
      a predictor for clinical loosening. RSA is a technique enabling calculation of the
      three-dimensional translational and rotational movements of the implant relative to the bone,
      and therefore provides an ideal technique to detect early micromotion of implants.
    

Intervention name(s): Bone cement 1; Bone cement 2
Intervention type(s): Device; Device
Intervention description(s): Bone cement SmartSet® HV; Bone cement Palacos R
Other intervention name(s): SmartSet HV; Palacos R
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total hip arthroplasty; Charnley stem; RSA; non-inflammatory arthritis