bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this engineering trial is to develop and validate an algorithm that will
      deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using
      Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be
      evaluating the algorithm's ability to correctly distinguish between sleep and wake.
    


Intervention name(s): Paced Breathing
Intervention type(s): Device
Intervention description(s): The Paced Breathing (PB) feature(when activated) will work to relax the user and help them fall asleep by encouraging them to take deep slow breaths until they reach 10 breaths (or less) per minute. The feature will also detect when the subject has fallen asleep so the Continuous Positive Airway Pressur (CPAP) device will automatically switch from PB mode to regular CPAP mode.
Other intervention name(s): Respironics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Paced Breathing; OSA; sleep/wake detection
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
Condition: Hysteroscopy; Intrauterine Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Background: Intrauterine adhesions are a difficult clinical problem for reproductive
      infertility. The most common cause is uterine cavity surgery and post-abortion (including
      abortion and spontaneous abortion). After the abortion, the uterine cavity adhesion, when is
      the key point, the literature is not much ink, early literature has mentioned that after the
      abortion, the uterus scraping action is scraped in four days and the uterine adhesion will be
      smaller than one to four weeks. Much more, it seems that the sooner the uterine adhesion
      factor is excluded, the more it can reduce uterine adhesion, but the uterine curettage itself
      is a risk factor for uterine adhesion. This early practice, the current clinical application,
      is not used, Instead, it is a hysteroscopy. Our past clinical observations, as soon as
      possible after the abortion, outpatient hysteroscopy, can find the tissue factors that may
      cause adhesion in the uterine cavity as soon as possible, and immediately remove it with an
      outpatient hysteroscope.

      Objective: To verify the early outpatient hysteroscopy and reduce the occurrence of
      intrauterine adhesion after abortion.

      Expected benefits to patients: Abortion is likely to cause intrauterine adhesions, which may
      further cause the incidence of reproductive infertility, should be involved before the
      formation of permanent injury, reduce the adhesion of the uterine cavity. Outpatient
      hysteroscopy is a simple and easy-to-use examination procedure that is painless and does not
      require anesthesia. Although it is invasive but has few complications, it is expected to
      reduce the occurrence of intrauterine adhesion after abortion.
    


Intervention name(s): Hysteroscopy
Intervention type(s): Procedure
Intervention description(s): outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Induced abortion; Uterine adhesions; Reproductive infertility; Hysteroscopy
A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The primary purpose of this study is to evaluate clinical and serologic outcomes after the
      discontinuation of liatermin therapy as assessed by development of new clinical conditions
      beyond those expected in patients with advancing Parkinson's disease. In addition, the
      development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be
      monitored.
    


Intervention name(s): Safety observation
Intervention type(s): Drug
Intervention description(s): Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with idiopathic Parkinson's Disease
      
Biospecimen description: 
      none collected.
Adult Height Prediction in Congenital Adrenal Hyperplasia
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Observational

Summary: 
      Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal
      production of gluco and mineralo corticoïds. The treatment consists in supplementing children
      with hydrocortisone. Despite care for these children has improved substantially across
      decades, short adult height (AH) still remains an important consequence of the disease. About
      20% of patients have an AH below 2 standard deviations compared to their expected AH.

      In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH
      French patients, born between 1970 and 1991 with a known genotype. Using their age, sex,
      growth, disease, bone maturation and pubertal data, the investigators will build a model
      which allows to predict their AH using data available at 8 years of age. The growth charts
      built from this cohort have shown that currently used formula to calculate the predicted AH
      (Bayley-Pineau's formula) is not applicable to children with CAH.

      In this project, the investigators plan to compute an AH prediction model using data from
      children born between 1970 and 1993, and to validate the model using data from a different
      cohort (i.e. children born between 1994 and 1998). this choice was due to availability of
      data for computing the model first, and in a second stage, data from more recently born
      patients.
    


Intervention name(s): Collection of growth and bone maturation data
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adullts with Congenital Adrenal Hyperplasia
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      To perform a variety of assays on blood, nasal washes, and cells obtained from healthy
      children for the purposes of further investigation of immune responses generated by influenza
      virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle
      Vaccines, Marietta, PA).

      • To assess nasal swab specimens to detect vaccine virus shedding.
    

Detailed description: 
      This was a phase II, prospective, randomized, partially-blinded, placebo-controlled,
      outpatient study conducted at multiple sites throughout the US in healthy children aged 6
      months to less than 36 months. Parents/guardians of subjects were asked to read and sign the
      informed consent before any study-related procedures were performed. Subjects at each study
      site were sequentially assigned to 1 of 2 separate blood sample groups referred to as
      "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group
      were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10^7 FFU per dose,
      CAIV-T 10^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza
      vaccine (TIV).
    

Intervention name(s): CAIV-T 10^7; CAIVT 10^5; Placebo; TIV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril); a single intranasal 0.2 mL dose of CAIV-T <10^5; a single intranasal 0.2 mL dose of placebo; commercially available TIV injected intramuscularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4
Condition: Acute Myeloid Leukemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Purpose : The main objective of this study is to assess the efficacy and tolerance of the
      addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition
      with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de
      novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for
      efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates,
      cumulative incidence of relapse and overall survival. The secondary endpoints for safety are
      early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse
      events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by
      covariate interactions with respect to biological characteristics present at diagnosis (CD33
      positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual
      disease levels). This study is an exploratory study. Patients will be allocated at inclusion
      with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and
      cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by
      the ALFA group as treatment of AML patients aged >60 years.

      Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab
      ozogamicin (GO) during induction and one dose of GO during first consolidation in combination
      with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.
    


Intervention name(s): Gemtuzumab ozogamicin (GO)
Intervention type(s): Drug
Other intervention name(s): Mylotarg
Intervention MeSH terms: Gemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; untreated; 60-80 years old; favorable and intermediate karyotype
Predictors of Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of the study is to prove that pain scores generated from painful stimuli applied
      preoperatively may help identify the inter-individual variability in pain perception.
    

Detailed description: 
      Psychological factors and experimental pain models such as as electrical, pressure, heat, or
      cold stimuli have been identified as predictors of pain intensity and opioid consumption
      postoperatively. This study will investigate, in addition to the factors described above, the
      ability of pain scores generated from painful stimuli postoperatively in predicting
      postoperative pain.
    

Intervention name(s): Thermal Sensory Analyzer (Senselab)
Intervention type(s): Device
Intervention description(s): Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site.
To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C.
To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C).
Other intervention name(s): Modular Sensory Analyzer, Senselab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pain; quantitative sensory testing
Itopride in Functional Dyspepsia:a Dose Finding Study
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the
      treatment of patients with functional dyspepsia.

      The study will test in patients with functional dyspepsia the hypothesis that itopride is
      superior to placebo with regard to the improvement of symptoms.
    

Detailed description: 
      Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the
      efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with
      functional dyspepsia.

      Patients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or
      placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a)
      change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia
      Questionnaire), b) patient's global assessment of efficacy (proportion of patients
      symptom-free or markedly improved)and c) improvement of pain and/or fullness by at least one
      grade on a 5-grade scale.
    

Intervention name(s): Itopride (drug)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: functional dyspepsia; non ulcer dyspepsia; drug treatment
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent
      platelets from binding together when administered by an injection under the skin in the thigh
      or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475)
      works and if there is a difference if the drug is injected in the thigh or in the belly. This
      study will also help to find out more about the safety of this new drug.
    

Detailed description: 
      To investigate the pharmacodynamic (PD) and pharmacokinetic (PK) properties of selatogrel in
      patients with atherosclerotic disease, the present study will be conducted in patients with
      chronic coronary syndromes (CCS). Assessment in a population of patients with CCS allows
      better control and stability of concomitant treatments, and therefore more accurate
      characterization of the pharmacodynamic and pharmacokinetic profiles of selatogrel in the
      presence of background antiplatelet therapies.

      The study will have 3 periods: a screening period of up to 21 days prior to randomization, a
      treatment period of 2 days from randomization (Day 1) to 24 hours post dose (Day 2), and a
      follow-up period from Day 3 to the safety follow-up telephone call 28 to 35 days after single
      administration of study drug (End-of-Study).
    

Intervention name(s): Selatogrel; Placebo; Selatogrel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.; Matching placebo for subcutaneous administration.; Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
Other intervention name(s): ACT-246475; ACT-246575
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic coronary syndrome
Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush
Condition: Plaque, Dental
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      To evaluate and compare the plaque removal efficacy of a children's battery-powered
      toothbrush and a children's manual toothbrush following a single brushing.
    

Detailed description: 
      This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved
      research study evaluating the single-use plaque removal efficacy of a new children's
      battery-operated toothbrush and a marketed children's manual toothbrush. This study will
      accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will
      complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified
      Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.

      After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will
      brush with the assigned toothbrush and toothpaste provided for timed brushing under
      supervision, in front of mirror.
    

Intervention name(s): Battery operated toothbrush; Manual toothbrush
Intervention type(s): Device; Device
Intervention description(s): Device on plaque removal efficacy; Device on plaque removal efficacy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Two Abdominal Exercise Programs on the Interrect Distance
Condition: Postpartum Period
Study type: Interventional

Summary: 
      The objective of the research is to compare two programs of exercises in postpartum woman,
      one based in abdominal strengthening exercises and the other based in abdominal hypopresive
      exercise.
    

Detailed description: 
      Diastasis recti abdominisis the separation of the two rectus abdominis muscles along the
      linea alba with a consequent separation of fibres and widening of the same. The linea alba
      has different functions which include supporting the proximal anterior recti, guaranteeing
      the stability of the vertebral column, pelvis and the pelvic floor, and intervening in the
      function of the abdominal muscles since it serves as their anterior anchorage.

      The crunch abdominal exercise (classic abdominal) is the most studied exercise used to test
      the behaviour of the linea alba, and in most cases, a decrease in the inter-rectus distance
      is observed when compared to the resting stage. In the oder hand, Abdominal hypopresives
      exercises were designed for women in the postpartum period but the effects over the abdominal
      muscles is unknown and the authors are unaware of any study that evaluates the effect of a
      hypopressive exercise program on the interrectus distance.

      The objective of the research is to compare two programs of exercises in postpartum woman,
      one based in abdominal strengthening exercises and the other based in abdominal hypopresive
      exercise.
    

Intervention name(s): Classic abdominal strengthening exercises; Hypopressive abdominal exercises program
Intervention type(s): Other; Other
Intervention description(s): Classic abdominal strengthening exercises (Curl-up, sit-ups and leg-rise), balance exercises, general mobility and upper limb strengthening exercises.; Hypopressive abdominal exercises, balance exercises, general mobility and upper limb strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominal muscle; Interrectus distance; Abdominal hypopressive exercise; Abdominal crunch exercise
Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT
Condition: Intervertebral Disc Displacement
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 3

Summary: 
      Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained
      from survivors of disc surgery that would have considered the type of postoperative care.

      Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy
      starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental
      instability in the operated segment 12 years following lumbar disc surgery.
    

Detailed description: 
      Design: Twelve years' follow-up of a three-armed, randomized, controlled, single blinded
      clinical trial. Setting: Outpatient department of Physical Medicine & Rehabilitation.
      Participants: Of 120 patients following first-time, uncomplicated lumbar disc surgery who
      participated in the original study are invited to a 12 years follow-up examination.
      Interventions: In the original study, patients had been randomly assigned to "comprehensive
      physiotherapy", "sham intervention" (neck massage), or no therapy. Measurements: Low Back
      Pain Rating Score (LBPRS; Manniche 1993), functional X-rays of the lumbar spine. All data are
      collected by blinded students and physicians at the Department of PM&R, Vienna Medical
      University.
    

Intervention name(s): Physiotherapy Intervention; Sham neck massage
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 20x 30 min sessions of physiotherapy; 20x 30 minutes sessions of neck massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: disc herniation surgery; physiotherapy, exercise therapy; randomized; long term; follow up