bioihbjkbjnl/mcl2 huggingface dataset:
Translation and Reliability of FAAM-U
Condition: Foot Injuries; Ankle Injuries
MeSH terms: Wounds and Injuries; Ankle Injuries; Foot Injuries
Study type: Observational

Summary: 
      This study is designed to translate and validate the FAAM questionnaire to the Urdu language,
      to interpret its psychometric properties, and to determine the reliability of scores obtained
      from the population of Pakistan. The translated version of the gold standard tool will be
      used by the local population as well as Urdu-speaking immigrants across the globe to better
      understand and report the severity of their symptoms. Hence, to improve quality of life
      across cultures, there is a need of standard outcome measures in Urdu language.
    


Intervention name(s): FAAM
Intervention type(s): Other
Intervention description(s): The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        With a time, span of 3 days after the primary recording, a total of the 175 patients whose
        conditions were relied upon to stay stable were approached to complete the forms again in
        the retest meeting; no treatment was given during this time-frame.
Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly
      other bone disorders. Recent results suggest that relacatib interacts with the way our bodies
      metabolise drugs and so some drugs which are commonly prescribed to the intended target
      patient population could be affected by giving relacatib at the same time. The purpose of
      this study is to evaluate the effect of repeat dose administration of relacatib on the way
      subjects bodies metabolise three commonly prescribed medications in the osteoarthritis
      population: ibuprofen, acetaminophen, and atorvastatin.
    


Intervention name(s): Relacatib; Acetaminophen; Ibuprofen; Atorvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will administer 60 or 120 mg tablets in Session 2; Acetaminophen will be administered orally; Ibuprofen will be administered orally; Atorvastatin will be administered orally
Intervention MeSH terms: Acetaminophen; Ibuprofen; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Osteoarthritis; Postmenopausal; Osteoporosis
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain
      after a bunionectomy.
    


Intervention name(s): VX-548; HB/APAP; Placebo (matched to VX-548); Placebo (matched to HB/APAP)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Capsules for oral administration.; Placebo matched to VX-548 for oral administration.; Placebo matched to HB/APAP for oral administration.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction
Condition: Coronary Disease; Myocardial Infarction
MeSH terms: Myocardial Infarction; Coronary Disease; Coronary Artery Disease; Infarction
Study type: Observational

Summary: 
      The investigators want to compare blood microbiota profile between patients with documented
      coronary lesions and patients free of coronary disease.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        case : patients who have had a myocardial infarction within one month to one year before
        the inclusion controls : patients without history of myocardial infarction, free of
        coronary disease in the view of one of the following tests performed within one year before
        the inclusion Effort test Echocardiographic stress test Myocardial perfusion scintigraphy
        Coronarography with >= 2 major cardiovascular risk factors:

          -  Treated hypertension,

          -  Treated dyslipidemia

          -  Current smoking

          -  Diabetes mellitus
      
Biospecimen description: 
      blood sample
    
Keywords: blood microbiota; coronary disease; myocardial infarction
A Modified Calculation Formula for Meibomian Gland Grading
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Observational

Summary: 
      The meibomian gland (MG) is a modified sebaceous gland located in the upper and lower
      eyelids. The grades of MG loss (i.e. meiboscore) is calculated as the ratio between the area
      of the MGs and the eyelids, and this calculation is based on the two-dimensional digital
      infrared images.In the current formula, the area of the eyelid is the denominator. However,
      because the eyelids need to be flipped over for the examination and evaluation, and there may
      be interobserver variability in the measurement of the area of the eyelids. Aging and
      involutional eyelid disorders, such as ptosis, ectropion, and entropion, may lead to laxity
      or deformation of eyelids, and impact the shape and area of eyelid area consequently.These
      factors could cause inaccuracy in current evaluation method, and impact the grading and
      evaluation of treatment efficacy of MGD, especially in self-controlled studies, such as in
      clinical trials.

      In this study, the investigators propose to use a modified calculation formula for the
      grading of MGs. The investigators could measure the white to white (WTW) distance of cornea,
      and then calculate the area of cornea (i.e. corneal base area) accordingly.Unlike the eyelid,
      the WTW distance does not change significantly during aging or between sexes.Thus, the
      investigators hypothesize that using the corneal base area as the new denominator in the
      formula for the grading of MG loss is a better way comparing with the conventional method.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatient population
A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes
Condition: Healthy Volunteers; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is investigating the safety and tolerability of the new medicine NNC0472-0147, its
      concentrations in the blood and its effect on blood sugar for the treatment of diabetes.
      Another goal of the study is to determine an effect of NNC0472-0147 on cholesterol. The first
      part of the study is conducted in healthy people, while the second part involves people with
      type 2 diabetes (T2DM). The study will test how NNC0472-0147 is tolerated by the body, how it
      is taken up in the blood, how long it stays there and how much blood sugar is lowered. In
      part 1, participants will either get the new medicine NNC0472-0147 or placebo (an injection
      that does not contain active medicine) - which treatment is decided by chance. In part 2,
      participants will either get the new medicine NNC0472-0147 or insulin glargine - which
      treatment is decided by chance. It is the first time that NNC0472-0147 is tested in humans.
      Participants will get once daily injections of either NNC0472-0147 or insulin glargine for a
      treatment period of fourteen days. The injections will be given under the skin
      (subcutaneously, s.c.) of the left thigh. Participants will be in the study for about 7
      weeks. There will be 15 visits with the study doctor. People cannot be in the study if the
      study doctor thinks that there are risks for their health. Only women who cannot become
      pregnant are allowed to participate.
    


Intervention name(s): NNC0472-0147; insulin glargine; Placebo (NNC0472-0147)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.; Part 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.; Part 1: A single dose of placebo, dose increased in each cohort.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1: Single ascending dose, placebo control. Part 2: Multiple ascending dose design, active control.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PBP Versus Halsted's Model: the PROVESA Trial
Condition: Educational Problems
Study type: Interventional

Summary: 
      This randomized controlled trial aims to compare the effectiveness of Halsted's
      apprenticeship approach to training with the PBP approach for teaching the robotic suturing
      of a VUA on a chicken model.
    

Detailed description: 
      In a prospective, randomized and blinded study robotic naïve (urology (n = 12), surgery (n =
      12) and gynecology (n = 12)) residents (n = 36) from the KU Leuven and University of Gent
      residency training programs will be randomized (in equal discipline numbers) to Traditional
      Halstedian apprenticeship type training or proficiency based progression (PBP) training to
      learn to perform a vesico-urethral anastomosis (VUA) on a chicken model. Both groups will
      receive the same e-learning (on how to perform the VUA on the chicken model) and skills
      laboratory robotic training curriculum. The PBP trained group will however be required to
      demonstrate quantitively defined proficiency benchmarks for training progression (i.e., from
      e-learning to the skills lab). The PBP group will also have a defined benchmark to
      demonstrate before training is deemed completed. The Traditional trained group will train in
      the same skills laboratory for a case-matched period of time as the PBP group, with the same
      level of supervising faculty proctors and using the same training resources but with no
      proficiency benchmarks or metric-based feedback. Both groups will be required to perform a
      VUA on the chicken model before skills training proper and at the end of training.
      Investigators will be trained in pairs to assess VUA performance from a pre-defined set of
      explicitly defined binary metric events reliably (inter-rater reliability > 0.8). They will
      also be blinded as to the identity of the trainee performing the procedure, how they were
      trained (i.e., group) and procedure order.

      H1 It is hypothesized that implementation of PBP training in teaching the robotic suturing of
      VUA leads to better surgical training outcomes (i.e., lower number of performance errors)
      when compared to Halsted's method.
    

Intervention name(s): Vesico urethral anastomosis on chicken model
Intervention type(s): Procedure
Intervention description(s): Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: surgery; robotics; training; vesico-urethral anastomosis; Proficiency Based Progression; Basic skills training
A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of BNC210 compared to placebo on PTSD
      symptom severity as measured by CAPS-5 Total Symptom Severity Scores.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study
      with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3
      weeks before randomization to confirm eligibility. Approximately 200 participants will be
      randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched
      placebo. Participants will then complete 12 weeks of treatment with their allocated study
      intervention. Participants will return to their study site at 4-weekly intervals to receive
      study intervention and complete safety and efficacy assessments. Participants are then
      requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study
      intervention is administered).
    

Intervention name(s): BNC210; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BNC210 900 mg twice daily (b.i.d.) for 12 weeks; Placebo twice daily (b.i.d.) for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Irinotecan Study For Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin
      as first-line chemotherapy for advanced or recurrent cervical cancer
    


Intervention name(s): Irinotecan
Intervention type(s): Drug
Intervention description(s): An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan (60mg/sqm, D1, 8, 15) Plus Cisplatin (60mg/sqm, D1) As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
Intervention MeSH terms: Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix
A Phase I Study of Famitinib Malate in Patients With Solid Tumor
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and
      antiangiogenic activities. This study is designed to evaluate the safety and tolerability of
      Famitinib in patients with solid tumor
    

Detailed description: 
      1. To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose
           (MTD) and dose-limiting toxicity (DLT).

        2. To determine the pharmacokinetic profile of Famitinib and its metabolites .

        3. To assess preliminary antitumor activity .

        4. To determine preliminary dose and regimen for phase II study .
    

Intervention name(s): Famitinib Malate Capsule
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Famitinib; Advanced Solid tumor; Phase I
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the investigators study was to investigate the safety and efficacy of autologous
      ADSCs for the clinical treatment of liver cirrhosis.
    

Detailed description: 
      One milliliter of cell suspension will be injected intrahepatically under sonographic
      guidance using a gauge-18 needle.
    

Intervention name(s): ADSCs
Intervention type(s): Drug
Intervention description(s): autologous ADSCs
Other intervention name(s): hADSCs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the safety, tolerability and pharmacokinetics
      (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older
      male volunteers.
    

Detailed description: 
      VVZ-149 injection, an investigational product (IP) in this clinical study, is a multi-target
      analgesic drug candidate against glycine transporter type II (GlyT2) and serotonin receptor
      2A (5HT2A). The target receptors have been known to play important roles in the induction and
      transmission of pain signals in the pain-related neural system. There have been efforts to
      develop new drugs that selectively antagonize the GlyT2 or 5HT2A, but it was unsuccessful due
      to limitations of single-target drugs. VVZ-149 showed morphine-comparable analgesic and
      gabapentin-comparable anti-allodynic effects in various rat models of pain.
    

Intervention name(s): VVZ-149 injection; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Colorless, transparent liquid in water for injection; water for injection
Other intervention name(s): VVZ-149 injection or water for injection; VVZ-149 injection or water for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers
Condition: Healthy; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether supplementation with phosphatidylcholine
      lowers plasma homocysteine concentrations in healthy men.
    

Detailed description: 
      A high homocysteine concentration is a potential risk for cardiovascular disease. Plasma
      homocysteine concentrations can be lowered through betaine supplementation. However, effects
      of choline supplementation, the precursor for betaine, on plasma homocysteine concentrations
      in healthy humans are unknown. If supplementation with choline or phosphatidylcholine, the
      form in which choline occurs in foods, lowers homocysteine concentrations, then extra intake
      of these compounds may lower cardiovascular disease risk in humans.

      Comparison: We compared the effects of supplementation with phosphatidylcholine to the
      effects of a placebo on fasting and post-methionine concentrations of plasma homocysteine in
      healthy men.
    

Intervention name(s): supplementation with phosphatidylcholine
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: phosphatidylcholine; choline; homocysteine; cardiovascular disease prevention; human; cardiovascular health
Craniosacral Therapy in Patients With Chronic Low Back Pain
Condition: Low Back Pain; Musculoskeletal Manipulations
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the current randomized clinical trial was to analyze the effectiveness of
      craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric
      endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac
      index, and biochemical estimation of interstitial fluid in individuals with chronic low back
      pain.
    

Detailed description: 
      Objective: To analyze the effects of craniosacral therapy on disability, pain intensity,
      quality of life, and mobility in patients with chronic low back pain.

      Design: A single blinded randomized controlled trial. Setting: Clinical setting. Subjects:
      Sixty-four patients (42 females) with chronic low back pain. Interventions: Patients were
      randomly assigned to an experimental group (craniosacral therapy group) or a control group
      (classic massage group).

      Main measures: Self-reported disability (Roland Morris Disability Questionnaire - primary
      outcome; and Oswestry Disability Index), pain intensity (a 10-point Numerical Pain Rating
      Scale), scale of kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk
      flexor muscles (McQuade Test), lumbar mobility in flexion, and oxygen saturation, blood
      pressure, cardiac index, and biochemical estimation of interstitial fluid.
    

Intervention name(s): Craniosacral therapy; Classic Massage
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; Craniosacral; Disability Evaluation; Randomized Controlled Trial
Osteopathic Treatment in Patients With Low Back Pain: Stabilometry
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Determine the improvement in nonspecific low back pain patients with osteopathic techniques
      (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a
      stabilometric platform (Footscan®).
    

Detailed description: 
      Fifty patients participate in this study (25 experimental group with body adjustment protocol
      of osteopathy and 25 control group). For a first objective of this study, all the patients
      determine if the osteopathic approach to the body adjustment approach will improve low back
      pain (Oswestry Questionnaire). For the second aim, the investigators want to know if there
      are changes in the distribution of body weight in lower limbs in group experimental and
      control group, analyzed with a stabilometric platform (Footscan®).

      The experimental group is treated with osteopathy, three sessions (20 minutes/session) and a
      frequency one session/week. The treatment osteopathic is the body adjustment protocol. In the
      other hand, the control group made 2 stretching global postures once a week (10 minutes for
      each posture) for three weeks: the first was for the anterior muscular chain and the second
      posture to stretch the posterior muscle chain. Before treatment, immediately after the last
      session and a month later, are measured stabilometric parameters, height and Oswestry.

      The analysis will be made with Statistical Package for the Social Sciences (SPSS Statistics)
      22.0
    

Intervention name(s): Osteopathic; Auto Stretching
Intervention type(s): Other; Other
Intervention description(s): Body adjustment in three sessions (20 minutes/session).; The patients realize auto stretching in three sessions (20 minutes/session).
Other intervention name(s): Manual Therapy; Muscle chains; Muscle chains
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NON SPECIFIC LOW BACK PAIN; OSTEOPATHY; FOOT PRESSURE PLATFORM; POSTURAL BALANCE