bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is
      non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during
      the first week of ovarian stimulation in terms of the number of vital pregnancies (ie,
      presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days
      after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation
      (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
    


Intervention name(s): SCH 900962 / Corifollitropin alfa / Org 36286; RecFSH / follitropin beta; Placebo for SCH 900962; Placebo for recFSH
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning.; RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days.; Supplied as a pre-filled syringe containing an identical solution when
compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall.; Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days.
Other intervention name(s): MK-8962; Follistim® AQ Cartridge
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reproductive Techniques, Assisted; Follicle Stimulating Hormone, Human; Fertilization In Vitro
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the effectiveness of oral risperidone versus long-acting injectable
      risperidone in treating people with first-episode schizophrenia.
    

Detailed description: 
      Schizophrenia is a severely disabling brain disorder. People with schizophrenia often
      experience hallucinations, delusions, thought disorders, and movement disorders. Proper
      treatment of first-episode schizophrenia may increase the chances of controlling disease
      progression on a long-term basis. People experiencing their first episode of schizophrenia
      are more responsive to treatment than those with chronic schizophrenia, but are also more
      susceptible to adverse treatment side effects. Atypical antipsychotic medications have been
      shown to produce fewer adverse side effects than older "typical" antipsychotics. Risperidone
      is a type of atypical antipsychotic medication that is used to control the symptoms of
      schizophrenia. This study will determine the effectiveness of oral risperidone versus
      long-acting injectable risperidone in treating people with first-episode schizophrenia.

      Participants in this open label study will be randomly assigned to receive either orally
      administered risperidone or long-acting risperidone administered via injection. Participants
      assigned to oral risperidone will receive medication in doses that are determined to be
      optimal by the study psychiatrist. Participants assigned to long-acting risperidone will
      receive an injection of risperidone once every 2 weeks. Dosages will begin at 25 mg and will
      be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve
      outpatient risperidone dosage stabilization, the randomized medication conditions will begin
      and participants will be monitored for 1 year. Study visits will occur once weekly throughout
      the study. They will include group therapy meetings focused on everyday living skills; family
      education about schizophrenia; assessments of medication response; and individual meetings
      with a case manager for counseling and evaluations of schizophrenia symptoms.
    

Intervention name(s): Oral Risperidone; Risperidone in Long-Acting Injectable Form (Consta)
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.; Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.
Other intervention name(s): Risperdal; Risperdal Consta
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizoaffective Disorder, Depressed Type; Schizophreniform Disorder; First-episode Schizophrenia; Injectable Risperidone
Strong Women Study
Condition: Oxidative Stress; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice
      powder concentrate on oxidative stress, inflammation and blood flow before and post exercise
      in overweight, middle-aged, women.

      Main hypotheses (H1):

        -  The nutraceutical has an impact on oxidative stress reduction.

        -  The nutraceutical has an impact on inflammation.

        -  The nutraceutical has an impact on blood flow and microcirculation.

        -  Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation
           markers.

        -  Walking exercise for 30 minutes has an impact on blood flow and microcirculation

        -  The combination of nutraceutical supplementation + walking exercise for 30 minutes has
           an impact on oxidative stress- and inflammation markers, and on blood
           flow/microcirculation.
    


Intervention name(s): nutraceutical group
Intervention type(s): Dietary Supplement
Intervention description(s): 6 capsules of supplement or placebo for 8wk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxidative stress; inflammation; blood flow
Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      The aim of this study is to characterise the use of clinical nutrition support, especially of
      parenteral nutrition that is administered directly into a vein, in adult patients with
      critical illness. The study wants to assess nutritional balance (that means the ratio of
      calories and protein prescribed to calories and protein actually received). Furthermore, it
      wants to evaluate whether the nutrition received has influence on the patients' clinical
      outcome, with focus on measures of physical function, such as capability of conducting daily
      living activities. As the study is "observational", no specific medications or treatments
      will be provided as part of the study to the patients.

      Study patients will be observed during their stay on an intensive care unit, for a maximum
      duration of 15 days. Furthermore, questions on the well-being of the patients will be asked
      via telephone interviews 30 and 90 days after their admission to the intensive care unit.

      Data of approximately 1250 patients will be collected and evaluated in this study, from
      approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic,
      France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will include adult male and female patients with critical illness
        (i.e. patients requiring pharmacological and/or technical support to treat a vital threat)
        who are hospitalised in a medical, surgical, or trauma ICU for at least 5 consecutive
        calendar days.
      
Keywords: ICU; parenteral nutrition; enteral nutrition; energy intake; protein intake
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to
      tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
    


Intervention name(s): EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention type(s): Drug; Procedure
Intervention description(s): Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000
      suicide attempts every year. SB management is therefore a major public health issue.

      Evidence associated dysregulation of the serotonergic system and the
      hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these
      abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity.
      There is a need to better understand the physiopathology and develop diagnostic and
      therapeutic tools in SB.

      The investigators hypothesize that increased peripheral biomarkers of inflammation would
      correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially
      in suicidal patients.

      Our aim is to compare rates of cerebral metabolites, in particular the complex
      glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior
      cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with
      and without suicidal attempt.
    

Detailed description: 
      69 patients : 23 with suicidal thoughts and attempt, 23 with suicidal thoughts without
      attempt and 23 healthy volunteers.

      2 visits :

        -  Inclusion visit (V0) : (Day 1)

           o Clinical interview : self and hetero assessment questionnaire

        -  Visit V1 (as soon as possible, day 1 if available) :

             -  MRI (spectroscopy)
    

Intervention name(s): Magnetic Resonance Imaging (MRI) and biological samples
Intervention type(s): Other
Intervention description(s): Participants will have to do a MRI and biological samples.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Psychiatry; Suicidal behaviour; Cerebral metabolites; MRI; Inflammatory markers
The Problem of Colorectal Anastomosis Safety
Condition: Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Adenocarcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a prospective cohort pilot study. The investigators are planning to develop an
      original, standardized colorectal anastomosis inspection method, which will systemically
      inspect the anastomosis vascularity using the indocyanine green fluorescent angiography
      intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension
      in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation
      will determine the final anastomotic leak risk.
    


Intervention name(s): Indocyanine green fluorescent angiography intraluminally and intraperitoneally
Intervention type(s): Procedure
Intervention description(s): The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
Other intervention name(s): Air leak test; Methylene blue test
Intervention MeSH terms: Methylene Blue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      The aim in this study is to determine the Turkish version validity and reliability of the
      Fonseca Anamnestic Index.
    

Detailed description: 
      Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased
      pain intensity from midlevel to severe. This was seen at the end of the intervention or work
      related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is
      very important to reduce the economic cost. Fonseca Anamnestic Index (FAI) is an easy and
      understandable questionnaire. This questionnaire consists of 10 questions that provide a
      versatile evaluation of the temporomandibular joint (TMJ) in the head and neck, whether there
      is pain during chewing, the presence of parafunctional habits, range of motion, joint sounds,
      malocclusion, and emotional stresses. The participants give one of the answers to the
      questions "Yes = 10 points, Sometimes = 5 points, No = 0 points". As a result of the total of
      the points, the participants are evaluated as "TMD-None = 0-15 points, Mild-TMD = 20-40
      points, Moderate TMD = 45-60 points, Severe-TMD = 100 points". The aim of this study was to
      evaluate the validity and reliability of the Turkish version of FAI. The study of validity
      and reliability is planned with 50 individuals with TMD. The sociodemographic characteristics
      of the individuals will be questioned by the investigators and then the patients will be
      evaluated with FAI, Craniofacial Pain and Disability Inventory (CF-PDI), Neck Disability
      Index (NDI), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache
      Impact Test-6 (HIT-6), Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual
      Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview
      technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer
      package program.
    

Intervention name(s): Questionnaire application
Intervention type(s): Other
Intervention description(s): Patients will complete the mentioned questionnaires.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with temporomandibular disorders between the ages of 18-50
      
Keywords: Validity; Reliability; Temporomandibular Joint Disorders
Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; CIN3; VaIN1; VaIN2; VaIN3; Genital Wart; VIN 1; VIN 2; VIN 3; AIS
MeSH terms: Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV
      recombinant vaccine in Chinese healthy females 20 to 45 years of age.
    


Intervention name(s): 4-valent HPV Vaccine; 9-valent HPV Vaccine; GARDASIL®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.; Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.; Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Acute Effects of R- and S-MDMA in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and
      prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and
      closeness to others. These acute subjective effects of MDMA may be helpful to assist
      psychotherapy and MDMA is currently investigated in phase 3 trials as a possible treatment in
      post-traumatic stress disorder.
    

Detailed description: 
      MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA.
      Preclinical research indicates that S-MDMA mainly releases dopamine, norepinephrine,
      serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release
      prolactin. Animal studies also indicate that the two enantiomers act synergistically to
      produce the subjective effects of MDMA and that S-MDMA is mainly responsible for
      psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial
      effects. However, acute effects of S- and R-MDMA have never been validly examined in a human
      study. Therefore, the present study compares acute responses to R-MDMA, S-MDMA, MDMA, and
      placebo in a cross-over study in healthy subjects.
    

Intervention name(s): 3,4-methylenedioxymethamphetamine; S-3,4-methylenedioxymethamphetamine; R-3,4-methylenedioxymethamphetamine (125 mg); R-3,4-methylenedioxymethamphetamine (250 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): A dose of 125 mg racemic MDMA will be administered.; A dose of 125 mg enantiomeric S-MDMA will be administered.; A dose of 125 mg enantiomeric R-MDMA will be administered.; A dose of 250 mg enantiomeric R-MDMA will be administered.; Placebo (Mannitol)
Other intervention name(s): MDMA; S-MDMA; R-MDMA; R-MDMA
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 5-period random order, placebo-controlled, double-blind cross-over study with four active substance conditions and placebo:
1. MDMA (125 mg), 2. S-MDMA (125 mg), 3. R-MDMA (125 mg), 4. R-MDMA (250 mg), 5. Placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).
Condition: Relapsing-remitting Multiple Sclerosis (rrMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the
      Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and
      participants with relapsing and remitting multiple sclerosis.
    


Intervention name(s): Arm 1 - GEH120714 (18F) Injection
Intervention type(s): Drug
Intervention description(s): Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Other intervention name(s): GEH120714 (18F)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Assessment of Color Vision in Diabetic Patients
Condition: Retinopathy, Diabetic
MeSH terms: Diabetic Retinopathy
Study type: Observational

Summary: 
      Assessment of color vision in diabetic patients before and after the use of anti-vegf in the
      treatment of diabetic macular edema
    


Intervention name(s): lucentis
Intervention type(s): Drug
Intervention description(s): Use of lucentis and other anti-vegf in patients with diabetic retinopathy
Intervention MeSH terms: Ranibizumab
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Assessment of color vision in diabetic patients before and after the use of anti-vegf in
        the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible
        visual loss.
Study of Blood and Tissue Samples From Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Treated With Bevacizumab, Carboplatin, and Paclitaxel
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory
      may help doctors learn more about changes that occur in DNA and identify biomarkers related
      to cancer. It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is looking at blood and tissue samples from patients with
      locally advanced, metastatic, or recurrent non-small cell lung cancer treated with
      bevacizumab, carboplatin, and paclitaxel.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine whether germline polymorphisms (DNA) of genes involved in DNA repair (e.g.,
           XPD, ERCC-1, and others) and angiogenesis (e.g., vascular endothelial growth factor
           [VEGF], interleukin-8, CXCR2, adrenomedullin, leptin, and others) are associated with
           toxicity and clinical outcome in patients with non-small cell lung cancer enrolled on
           protocol ECOG-4599.

      OUTLINE: Blood samples previously obtained from patients on protocol ECOG-4599 are analyzed
      for the association of germline variations of genes involved in DNA repair (XPD and ERCC1),
      angiogenesis (VEGF and IL-8), and clinical outcome (overall survival, response,
      progression-free survival, and toxicity).

      Tumor cells are collected from paraffin-embedded tissue using laser-capture microdissection
      and normal tissue is collected from the specimen. Polymorphisms in ERCC-1, XRCC-1, XRCC-3,
      GST-P1, TGF-β, and IL-8CXCR are assessed using Taqman assays.
    

Intervention name(s): bevacizumab; carboplatin; paclitaxel; gene expression analysis; polymerase chain reaction; polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Biological; Drug; Drug; Genetic; Genetic; Genetic; Other
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E4599
      
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer