bioihbjkbjnl/mcl2 huggingface dataset:
Endometriosis and Risk of Miscarriage
Condition: Endometriosis; Miscarriage
MeSH terms: Endometriosis; Abortion, Spontaneous
Study type: Observational

Summary: 
      The aim of this study is to compare the rate of miscarriage at first spontaneous pregnancy
      among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy
      among women without endometriosis.
    

Detailed description: 
      All women followed up for a surgical or sonographic diagnosis of endometriosis in 11 italian
      referral Centres for the treatment of endometriosis completed a questionnaire regarding their
      previous pregnancies. The same questionnaire was completed by women, attending a routine
      gynecologic visit, in whom surgery or vaginal examination and pelvic ultrasonography excluded
      endometriosis.
    

Intervention name(s): Survey on first pregnancy after endometriosis diagnosis; Survey on first pregnancy
Intervention type(s): Other; Other
Intervention description(s): rate of miscarriage was noted; rate of miscarriage was noted
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All continous women attending endometriosis clinics or undergoing a routine gynecological
        examination matching the inclusion criteria
Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      the investigators aim is to investigate and explore the effect 10 mg morphine added to local
      anesthetics in serratus anterior plane block for post mastectomy pain management after
      modified radical mastectomy in patients with breast cancer with assessment of its serum level
      if it will be absorbed systemically or not?
    


Intervention name(s): Morphine Sulfate; Bupivacaine Hydrochloride
Intervention type(s): Drug; Drug
Other intervention name(s): morphine; marcaine
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
Condition: Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the effects of 8 months of diet modification, with or without
      exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and
      quality of life in obese men.
    


Intervention name(s): weight loss counselling
Intervention type(s): Behavioral
Intervention description(s): Diet counselling with or without sports trainers, over 8 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; men; sexual function; urinary tract symptoms; endothelial function; inflammation; quality of life
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Condition: Marburg Virus Disease
MeSH terms: Virus Diseases; Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics
      of galidesivir following administration of single doses by IV infusion
    

Detailed description: 
      This single ascending dose study will evaluate the safety, tolerability, and PK of single
      doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in
      up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered
      per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching
      placebo.
    

Intervention name(s): galidesivir; placebo
Intervention type(s): Drug; Drug
Intervention description(s): galidesivir IV infusion; placebo IV infusion
Intervention MeSH terms: Galidesivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single & Repeat Escalating Doses of GSK2878175 in Healthy Subjects
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment
      of chronic HCV infection. This study represents the first administration of GSK2878175 in
      humans to define safety, tolerability, and pharmacokinetics (PK) following single and repeat
      doses of GSK2878175 in healthy subjects.

      This is a Phase 1, randomized, single-blind, placebo-controlled, dose escalation study to
      determine the safety, tolerability, and PK profile of GSK2878175 in single (Part 1) and
      repeat doses (Part 2) in healthy subjects. In addition the study will explore the effect of a
      moderate (30%) fat meal on single dose PK endpoints in healthy subjects.
    


Intervention name(s): GSK2878175; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Round tablets (5.0mg) given once daily single and repeated (to 7 days), Oral dose.; Visually matching GSK2878175
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic hepatitis C (CHC); Hepatitis C virus (HCV); NS5B; pharmacokinetics; GSK2878175; safety; FTIH; healthy subjects
Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Impingement
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      A randomized controlled trial will be conducted to examine the effectiveness of a traditional
      home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of
      overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction
      of pain and disability, and improvement in functionality and sports performance. Secondary
      outcome measures are strength, mobility, flexibility and functional performance.
    

Detailed description: 
      Participant are randomly assigned in 3 home exercise groups.

        1. The traditional program: consists of solely strengthening the rotator cuff muscles and
           scapular muscles (e.g. external rotation)

        2. Separate kinetic chain program: same exercises as the first group but they also receive
           an exercise program to separately train the core and lower body. (e.g. external rotation
           separately and squat separately)

        3. Integrated kinetic chain program: same exercises as the first group but all exercises
           are performed while simultaneously activating the kinetic chain. (e.g. external rotation
           while squatting).
    

Intervention name(s): Traditional training; Separate kinetic chain training; Integrated kinetic chain training
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are randomly assigned in 3 parallel intervention groups. They cannot participate in 2 or more intervention groups.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Shoulder impingement syndrome; Overhead athletes; Kinetic chain; Exercise treatment
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test whether Adalimumab (at two different doses) can induce
      and maintain clinical remission in subjects with active Crohn's disease when compared to
      placebo (a substance containing no medication)
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
Condition: Pectus Excavatum
MeSH terms: Funnel Chest
Study type: Interventional

Summary: 
      this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or
      orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction
      (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the
      cardiac output difference before and after intervention, measured by transthoracic
      impedancemetry, during an exercise stress test
    


Intervention name(s): surgical treatment; orthopedic treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).; orthopedic treatment by vacuum bell.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pectus excavatum; cardiac output; transthoracic impedancemetry
Role of suPAR in Periodontitis and CVD
Condition: Metabolic Disturbance; Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Observational

Summary: 
      soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial
      function and may be a link for the known interaction of periodontitis and cardiovascular
      disease (CVD). The investigators compared the impact of gingival health, periodontitis (CP),
      CHD or of both diseases (CP+CHD) on saliva and serum suPAR levels.
    

Detailed description: 
      The aim of this study was to evaluate a possible association between both saliva and serum
      suPAR levels in patients with CP and with CVD and if the serum suPAR levels are mediated by
      serum CRP.
    

Intervention name(s): Observation of suPAR plasma and salivary levels
Intervention type(s): Other
Intervention description(s): Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects (n=33) and patients with periodontitis (n=35), CVD (n=34), and a
        combination of periodontitis + CVD (n=34) were enrolled in the present study.
To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder(ADHD) Through Pharmacogenetics.
Condition: Methylphenidate Adverse Reaction
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      We plan to recruit 200 children and adolescents aged between 6 to 17 years old in two years.
      Those patients would receive clinical interview by child psychiatrists to diagnose as ADHD
      and to exclude mental retardation, major psychiatric disorders and medical disorders.
      Moreover, we excluded children who ever received ADHD medication treatment more than one
      year, or received medication in recent 30 days. Initial assessment includes collecting saliva
      sample, and complete questionnaires (SNAP-IV), clinical rating (CGI-S) and psychological test
      (CPT-II, WISC-IV, CANTAB). After 1 month methylphenidate treatment, we would evaluate
      SNAP-IV, CGI-S, CGI-I and Barkley Psychostimulants Side Effects Rating Scale. We also would
      collect saliva samples to perform appetite related gene phenotyping to see the association
      between medication side effect and polymorphism of appetite related genes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents aged between 6 to 17 years old, diagnosed as ADHD, and recieved
        methylphenidate treatment.
Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
Condition: Somatization Disorder
MeSH terms: Somatoform Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the long-term effect of cognitive-affective behavior therapy on the
      physical symptoms, functioning, and health care utilization of people with somatization
      disorder.
    

Detailed description: 
      Somatization disorder is a syndrome characterized by the presence of multiple medically
      unexplained physical symptoms. It often results in substantial functional impairment and the
      need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for
      the disease have demonstrated clinical success. People with somatization disorder may benefit
      from a treatment that integrates emotion-centered strategies into cognitive behavioral
      therapy. The long-term effectiveness of this treatment has not been established, however.
      This study will examine the long-term effect of cognitive-affective behavior therapy on the
      physical symptoms, functioning, and health care utilization of people with somatization
      disorder.

      Participants in this open-label study will be randomly assigned to receive either
      cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a
      psychiatric consultation. Treatment will last 4 months. Assessments of somatic
      symptomatology, functional impairment, and health care costs will occur at screening,
      baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits
      at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the
      treatment.
    

Intervention name(s): Augmented Standard Medical Care; Cognitive-Affective Behavior Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.; Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
Other intervention name(s): Psychiatric consultation letter sent to primary physician; Emotionally-Focused Cognitive-Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Treatment Outcome; Health Care Utilization; Somatization Disorder; Somatoform Disorder
Cortical Excitability Using Transcranial Magnetic Stimulation and Neuronavigation Device
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study has two main goals :

        -  to investigate the impact of aging on cortical excitability (CE)

        -  to investigate the impact of "state dependency" on CE, using a cognitive task and an
           emotional one.

      A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic
      response are recorded.
    


Intervention name(s): TMS "Magpro®, Magventure Inc" device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bioavailability of Lesinurad and Intravenous [14C]Lesinurad
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the absolute bioavailability of a single oral dose of lesinurad and
      evaluate the pharmacokinetic (PK) parameters of lesinurad and [14C]lesinurad in healthy adult
      male subjects.
    

Detailed description: 
      In this study a single dose of lesinurad will be administered after an overnight fast
      followed by a single 15-minute infusion of a radiolabeled intravenous micro tracer dose of
      [14C]lesinurad to assess the in vivo performance of lesinurad.
    

Intervention name(s): Lesinurad 400 mg; [14C]lesinurad (100 μg per 10 mL)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lesinurad
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population
Condition: Severe Combined Immunodeficiency; T Cell Lymphocytopenia
MeSH terms: Lymphopenia; Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The goal of the proposed research is to establish the validity of a newborn screening method
      for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis
      of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID
      patients, thus correlating with the disease
    

Detailed description: 
      To show that early diagnosis of SCID with a TREC screening assay can warrant timely treatment
      of the disease and avoid life-threatening infections on patients. Babies with SCID are unable
      to fight infections. They become severely ill in their first months of life and do not
      survive unless their immune systems can be restored. SCID can be treated by bone marrow
      transplant if recognized early. The newborn screening test to be employed in this study is
      designed to diagnose SCID before infections occur. By conducting a pilot testing program in a
      high-risk population on the Navajo Indian Reservation, where one in 2,000 infants is born
      with SCID, we hope to confirm the benefits of newborn screening for early diagnosis of SCID
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Navajo Indians
      
Keywords: TREC; T cell; Primary Immunodeficiency; PID; Navajo; SCID
Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the
      safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug)
      and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated
      doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
    


Intervention name(s): NNC 0141-0000-0100; placebo; NNC 0141-0000-0100; placebo; NNC 0141-0000-0100; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part; Single dose administered subcutaneously (under the skin) as a comparator at all dose levels; Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.; Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels; Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part; Single dose administered intravenously (into a vein), as a comparator at all dose levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is not only to explore pharmacokinetic interaction after single
      oral administration but also pharmacodynamics interaction after multiple oral administration
      of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808,
      amoxicillin and clarithromycin in healthy volunteers
    


Intervention name(s): YH4808; Nexium; Amoxicillin; clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): experimental drug; active comparator; experimental drug; experimental drug
Intervention MeSH terms: Amoxicillin; Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: safety/tolerability and pharmacokinetics/pharmacodynamics
Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
Condition: Healthy Volunteers; Safety
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      This first-in-human study will investigate the safety and tolerability of single and multiple
      doses of nebulised SoftOx Inhalation Solution (SIS) delivered via a jet nebuliser to healthy
      subjects.

      Objectives:

      The objective of the current study is to assess the safety and tolerability of single and
      multiple ascending doses of nebulised SIS in healthy subjects.

      Eligibility:

      Subjects are eligible to participate in this study if they are healthy, between 18 and 55
      years of age, and have a Body Mass Index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2.

      Subjects are not eligible to participate in this study if they have recently participated in
      another clinical trial or have donated blood, have a medical condition or a history of drug
      hypersensitivity, are using concomitant medication, or have a positive drugs of abuse test.

      Design:

      A randomised, double-blind, and placebo-controlled trial. Subjects will be enrolled into one
      of three single dose groups or into one of four multiple dose groups. The two first multiple
      dose groups will be dosed once daily (OD) for five days. The two last multiple dose groups
      will be dosed twice daily (BID) for four days plus a morning dose on Day 5, or four times
      daily (QID) for four days plus a morning dose on Day 5, respectively.

      The investigational medicinal product (SIS or placebo; IMP) will be delivered via a jet
      nebuliser and inhaled through a mask over a period of up to 15 minutes.

      Each treatment group will comprise eight subjects who will be randomised to receive SIS or
      placebo in a 3:1 ratio.

      A Safety Monitoring Committee (SMC) will review the safety and tolerability data from all
      preceding groups and decide whether the planned next dose regimen is acceptable prior to
      initiating the dosing in a new dose group.

      The dose to be administered in the multiple dose groups will depend on the results obtained
      in the single dose groups and will be decided by the SMC. The dose tested in the first
      multiple dose group will be the second highest well-tolerated single dose or lower.
    


Intervention name(s): SoftOx Inhaled Solution (SIS); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SIS consists of the active compound, hypochlorous acid (HOCl). Concentrations of SIS refer to the concentration of HOCl in parts per million (ppm).; Sterile isotonic saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment