bioihbjkbjnl/mcl2 huggingface dataset:
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who
      had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH
      (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The
      investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the
      control groups regarding the results of IVF in these patients.
    

Detailed description: 
      1. Aim

           -We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH
           (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH
           (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We
           evaluated and compared the addition of rLH, increasing the dose of rFSH and the control
           groups regarding the results of IVF in these patients.

        2. Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with
           infertility to the unit of Assisted Reproduction Techniques- of the Department of
           Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for
           ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function,
           who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation)
           with rFSH were included in the study. 52 patients were considered responsive to
           stimulation and composed the normal control group (Group 1). On the 7th day of
           stimulation transvaginal ultrasonography was carried out. Patients who had at least 6
           follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250
           pg / ml were considered to have suboptimal response to stimulation and were divided into
           two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3
           (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between
           the groups.
    

Intervention name(s): fix dose r-FSH (Gonal-f); r-LH supplementation; r-FSH (Gonal-f)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): recombinant follicle stimulation; recombinant luteinizing hormone; recombinant follicle stimulation hormone
Other intervention name(s): puregon; luveris; puregon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ICSI; Suboptimal Ovarian Response; rLH
Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures
Condition: Depth of Anesthesia
Study type: Observational

Summary: 
      As part of the clinical routine of the Department of Anesthesiology and Operative Intensive
      Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum
      intraoperative electroencephalography data and clinical routine data are recorded and
      evaluated in surgical children (<=1 year).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children <= 1 year undergoing surgery procedure with Electroencephalography Monitoring.
A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the
      population at high risk of overstimulation associated with signs and symptoms of PCOS and
      examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for
      individualized controlled ovarian stimulation (iCOS).
    


Intervention name(s): Gonal-f®; Long GnRH agonist; GnRH antagonist
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Recombinant human follicle stimulating hormone (r-FSH) will be administered subcutaneously (SC) for about 10 to 20 days along with the ART regimen as routinely practiced by Investigators and according to licensed summary of product characteristics (SmPC label) for the ovarian stimulation.; As a part of the ART regimen GnRH-agonist will be administered for about 14 to 20 days until down regulation is satisfied as judged by investigator.; As a part of ART regimen GnRH-antagonist will be initiated and regimen will be as routinely practiced by Investigators and according to licensed SmPC label.
Other intervention name(s): Recombinant human follicle stimulating hormone
Intervention MeSH terms: Prolactin Release-Inhibiting Factors; Follicle Stimulating Hormone
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Infertile women undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol
        using Gonal-f® new pen who are expected to be normal or high responders.
      
Keywords: Polycystic Ovary Syndrome; Gonadotropin releasing hormone agonist (GnRH-a); Gonal-f; Assisted Reproductive Technology
A Genetic Linkage Study of Schizophrenia
Condition: Schizophrenia Sib-Pairs
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical
      assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To
      conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell
      repository and data management centers. We will attain these goals by achieving the
      following: 1) From Taiwan and China, we will collect 900 Han Chinese sib-pairs having DSM-IV
      schizophrenia. 2) We will examine all family members using the Diagnostic Interview for
      Genetic Study and the Family Interviews for Genetic Study. The PI participated in the
      development and field testing of these interviews and has an already established training
      program for their use. They have been translated into Mandarin by the Taiwanese
      investigators, who have used them in prior studies. 3) Blood samples will be sent to the NIMH
      designated cell repository for creation of lymphoblastoid cell lines. 4) Clinical Data will
      be entered using the database software created for the NIMH Human Genetics Initiative. Data
      will be vetted and sent to the NIMH designated data management center. 5) We will complete a
      genome scan using 450 markers spaced at an average of 10 cM intervals using markers that have
      been optimized for use in the Han Chinese population. The scan will be completed with no cost
      to the NIMH through an agreement with Millennim Pharmaceuticals, a biotechnogy company in the
      the Boston area that the PI has worked with on a prior genetic linkage study of
      schizophrenia. All genetic analyses will be approved by our consultant, Eric Lander, PhD. 6)
      All clinical data will be made available to the scientific community by the end of the
      funding period. All genotypes wil be available one year after they are created but no later
      than a year after the funding period. This project as feasible because 1) The PI has already
      coordinated one multi-site genetic linkage study of schizophrenia and has participated in a
      second. 2) We have a long-standing relationship with our Taiwanese collaborators and an
      effective, albeit, more recent working relationship with our Chinese collaborators. 3) We
      have conservatively estimated that each site has access to more than enough available
      families having two schizophrenic siblings. 4) The PI's Harvard team has had prior experience
      collaborating on genotyping and linkage analysis projects with Millennium Pharmaceuticals.
      This, and Millennium's prior genotyping experience shows that the genotyping phase of the
      work is feasible.
    


Observational model: Defined Population
Time perspective: Other
Keywords: Schizophrenia; linkage; Taiwan; Han Chinese population
Surface Electromyography in Stratifying Chronic Low Back Pain.
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Surface Electromyography can be utilised to detect normal muscle electrical activity during
      maximum forward flexion termed Flexion Relaxation Response (FRR)
    

Detailed description: 
      In this study, our primary objective is to assess FRR and disability (ODI) correlation
      protocol as an objective tool in stratifying Chronic LBP. We also would like to evaluate the
      relationship between FRR with pain intensity and lumbar range of motion as our secondary
      objective.
    

Intervention name(s): Surface Electromyography
Intervention type(s): Procedure
Intervention description(s): will be applied Surface Electromyography to assess Flexion Relaxation Response
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with low back pain who were being referred to the rehabilitation outpatient in
        University Malaya Medical Centre between November 2019 until July 2020.
Early Intervention in Preterm Infants: Short and Long Term Developmental Outcome After a Parental Training Program
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period
      of stressful environment, which may negatively impact early brain development and subsequent
      neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in
      reducing stressful experiences early in life and in enhancing brain development and long term
      developmental outcomes.
    

Detailed description: 
      Very preterm birth is associated with motor, cognitive and behavioral problems.

      Micro-structural brain abnormalities, even in the absence of focal lesions, have been
      documented by neuroimaging studies in preterm infants at term corrected age and later in
      childhood. These alterations in brain maturation occurring during the neonatal period may be
      implicated in long-term neurobehavioral disorders later experienced by preterm babies.

      However, there is increasing evidence that also negative environmental factors (intensive
      care, excessive sensory stimulation, paucity of parental contact etc.) can affect later
      outcomes.

      Potential benefits of early dyadic interaction and preterm baby massage in reducing the
      effects of the NICU stressor environment have been demonstrated. More recently, few studies
      have investigated visual function in preterm infants focusing on the potential role of early
      visual interaction to enhance attention and improve later neurodevelopment.

      The role of early intervention strategies to improve neurodevelopment has been recently
      emphasized.

      Early intervention programs based on the concept of "individualized care" have proved to be
      effective in promoting brain maturation and neurodevelopmental outcome. In this context,
      early interventions as the Mother Infant Transaction Program (MITP) and the Premie Start,
      both targeting parenting, have the greatest potential to have sustained effects on child
      development.

      In addition, recent studies have shown that exposure to stressful events in the neonatal
      period can cause epigenetic modifications in children born preterm; in particular alteration
      of serotonergic tone was observed, associated with methylation of the serotonin transporter
      gene, which could be implicated in the etiology of behavioral disorders observed in these
      children. In animal models these epigenetic effects appear to be influenced by maternal care
      that can epigenetically modulate the offsprings' stress response.
    

Intervention name(s): Early Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Early intervention; Brain Development; Neurodevelopment
Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women
Condition: Vaginal Delivery
Study type: Interventional
Phase: Phase 4

Summary: 
      A case control trial Patients who meet the inclusion criteria were asked to participate in
      the study and a written consent was obtained from each patient after explaining thoroughly
      the nature and the scope of the study.

      Patients were divided into three equal groups:

      Group A: included 40 pregnant patients. They received two ml of normal saline intravenously
      as a placebo.

      Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml
      HBB+ one ml saline) intravenously.

      Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide
      intravenously (HBB).
    

Detailed description: 
      A case control trial Patients who meet the inclusion criteria were asked to participate in
      the study and a written consent was obtained from each patient after explaining thoroughly
      the nature and the scope of the study.

      For each patient:

        1. Complete history was taking to exclude allergy to hyoscine butylbromide, medical
           disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease …etc.) and any
           contraindication for vaginal delivery.

        2. General examination of the patients including (pulse, blood pressure, temperature).

        3. Obstetric Abdominal examination including fetal lie, fetal presentation, head station
           and uterine contractions.

        4. Vaginal examination including cervical dilatation, effacement and position, state of
           fetal membranes, presenting part, position of fetal head and pelvic adequacy.

        5. Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of
           liquor, site of placental attachment and fetal heart rate.

      Patients were divided into three equal groups:

      Group A: included 40 pregnant patients. They received two ml of normal saline intravenously
      as a placebo.

      Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml
      HBB+ one ml saline) intravenously.

      Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide
      intravenously (HBB).
    

Intervention name(s): hyoscine butylbromide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of hyoscine butylbromide during first stage of labor; 2ml of saline intravenous
Other intervention name(s): Dospa; saline
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: hyoscine butylbromide; progress of labor; duration of labor
Viral Activation Transfusion Study (VATS)
Condition: Acquired Immunodeficiency Syndrome; Blood Transfusion; Cytomegalovirus Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Infections; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      The purpose of the trial was to determine if transfusion of allogeneic blood to HIV-1
      infected persons led to immune activation and consequent induction of HIV-1 or /or
      Cytomegalovirus (CMV) replication, and whether this adversely affected clinical prognosis.
    

Detailed description: 
      BACKGROUND:

      The initiative was approved by the NHLBI AIDS Ad Hoc Working Group and given concept
      clearance by the September 1993 National Heart, Lung, and Blood Advisory Council. The
      initiative was released in January 1994.

      DESIGN NARRATIVE:

      Patient enrollment started in August 1995. Patients scheduled for transfusion were entered
      into the study at the time of their first transfusion and randomized to receive leukopoor red
      cells filtered within 24 hours of collection or unmanipulated blood components. Patients
      received blood as per their treatment arm as needed for one or two years. Patients were
      stratified to those with CD4 counts below 50 /MM3 (most patients) and those with CD4 counts
      above that level. Primary endpoints were overall survival and a change in HIV viremia after
      the 1st transfusion. The secondary endpoint was the occurrence of a new AIDS-defining
      complication. A substudy looked at donor lymphocytes in the immunosuppressed recipients to
      help determine why AIDS patients don't seem to get post-transfusion graft-vs-host disease.
      The patient recruitment time was extended for one year because of low accrual. With new
      drugs, especially protease inhibitors, the proportion of patients needing transfusion has
      decreased. The patients are less severely ill and their disease produces less anemia.
      Furthermore, the new drugs don't have anemia as a side effect. The trial ended in January,
      2000.

      The study completion date listed in this record was obtained from the "Completed Date"
      entered in the Query View Report System (QVR).
    

Intervention name(s): blood transfusion
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Prevention
TMS for Improving Response Inhibition in Adolescents With OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using
      transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits,
      improves response inhibition, and reduces compulsions in adolescents with OCD.
    


Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of The Step Up Wellness Program for People With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This randomized pilot study will evaluate the feasibility and acceptability of a phone-based
      wellness program for improving mood, physical activity, and smoking abstinence rates among
      people with depression who also are physically inactive and smoke cigarettes.
    

Detailed description: 
      This pilot study will evaluate the feasibility, acceptability, and potential effectiveness of
      the Step Up Wellness Program among people with depression who also are physically inactive
      and smoke cigarettes.

      Participation in this study will last 6 months. All participants will complete a baseline
      survey and then be assigned randomly to receive the Step Up Wellness Program or usual care
      for 3 months. Participants in the Step Up program will receive weekly phone calls from a
      study health coach. During these calls, the coach will discuss ways to improve and manage
      mood, increase physical activity, and prepare to quit smoking. Participants will also be
      given materials to review and homework assignments between calls. Participants in the usual
      care group will receive standard care which includes referrals for treatment of depression
      and nicotine dependence, as well as self-help information on physical activity. All
      participants will be surveyed at 4 and 6 months post-enrollment. Participants will also
      provide qualitative feedback on the program.
    

Intervention name(s): Step Up Wellness Program; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the Step Up Wellness program will receive weekly phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking.; Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Smoking; Physical Activity
Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus
Condition: Pain
Study type: Interventional

Summary: 
      A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in
      a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and
      BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml).
      Pupillary reflex dilation is recorded after each stimulation.
    


Intervention name(s): Remifentanil; propofol; TCI; Tetanic stimulation; Algiscan
Intervention type(s): Drug; Drug; Device; Procedure; Device
Intervention description(s): Pupillometry
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: analgesia; pupillometry; general anesthesia
Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      Spectrailis optical coherence tomography has come with a new posterior pole asymmetry
      analysis for glaucoma diagnosis. The aim of the investigators study was to assess its
      applicability in diagnosing early glaucoma patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive 80 eyes of 80 normal subjects and 76 eyes of 76 patients with early glaucoma
        were included for the study.