bioihbjkbjnl/mcl2 huggingface dataset:
Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial
Condition: Infertility; Poor Ovarian Response
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      In combination with the existing literature, previous work indicates that 1) women with poor
      ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates,
      irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that
      do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing
      pregnancy rates in young patients (<40years old) fulfilling the criteria. These findings
      provide a strong rationale for a definitive large RCT. The COMPORT study will provide
      conclusive evidence regarding the superiority or not of this novel protocol with
      corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders
      fulfilling the Bologna criteria.
    

Detailed description: 
      Recently, the European Society of Human Reproduction and Embryology developed a new
      definition in order to select patients suitable for inclusion in future clinical trials as
      poor ovarian responders, the so-called "Bologna criteria". However, a limited number of
      studies has been published to date including patients with poor ovarian response according to
      the "Bologna criteria", whereas no randomized trial is published or ongoing for this
      population.

      Preliminary reports in "Bologna poor responders" highlight the limited prospects for these
      women. Natural cycle IVF has been shown to result in disappointingly low live birth rates,
      regardless of patients' age and ovarian stimulation with widely accepted treatment
      modalities, e.g. short agonist protocol, did not appear demonstrate substantial benefits.

      Nonetheless, despite the disappointing results from the vast majority of the preliminary
      studies in this population, a recent pilot study by our group has shown that a specific
      protocol may indeed be a promising option for women of younger age fulfilling the "Bologna
      criteria". Corifollitropin alfa followed by highly purified hMG in an antagonist protocol
      demonstrated an ongoing pregnancy rate of 28% in women <40years, strongly suggesting the
      conduction of a future randomized trial testing this novel treatment protocol
    

Intervention name(s): Corifollitropin alfa; recombinant FSH; Ganirelix; hp HMG
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1); recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering; Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering; hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering
Intervention MeSH terms: Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Procedure Selection in Obesity and Metabolic Surgery Based on EOSS
Condition: Postoperative Complications
MeSH terms: Obesity; Postoperative Complications
Study type: Interventional

Summary: 
      The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related
      diseases and predictor of mortality than BMI or waist circumference. EOSS is also important
      in predicting post - operative outcome and 30-day mortality after metabolic surgery.

      The aim of this study is to determine whether EOSS could be an indicator for procedure
      selection in obesity and metabolic surgery.
    

Detailed description: 
      All patients in Germany, who underwent Sleeve Gastrectomy, Roux-en Y Gastric Bypass and
      Mini/One anastomosis Gastric Bypass as a primary procedure for severe obesity, are
      prospectively registered in the German register StuDoQ MBE.

      Preoperative EOSS by Sharma et al. will be applied to all patients, who were operated between
      Februar 2015 and July 2017 by two different evaluators. Data collection will include the
      following: gender, age, body mass index, mobility, comorbidities, ASA score (American Society
      of Anesthesiologists score) perioperative complications next to Clavien Dindo, readmission
      rates and 30 - day mortality. Follow-up will be investigated in all patients up to 1 month
      after surgery.

      Complications, readmission rates and 30 day mortality will be investigated in relation to
      EOSS and the surgical procedure performed, to determine whether EOSS could be an indicator
      for procedure selection in obesity and metabolic surgery.
    

Intervention name(s): Role of EOSS
Intervention type(s): Other
Intervention description(s): The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EOSS; Obesity and metabolic surgery; postoperative outcome; procedure selection
Comparison of Three Noninvasive Ventilation Modes: a Physiological Study in Healthy Volunteers
Condition: Respiratory Failure; Non Invasive Ventilation on Healthy Volunteer
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Noninvasive ventilation (NIV) is a well established, safe, and effective technique in
      improving gas exchange while reducing dyspnea and inspiratory effort in patients with either
      hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to
      endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure,
      are the tolerance to the interface used and the ability of the interface to unload
      inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of
      NIV for longer periods, while face mask has been proved to be more efficient at iso-support
      in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT
      (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better
      compliant wall, that avoid the use of armpit braces potentially improving, compared to the
      standard helmet, both pressurization and patient-ventilator interaction and tolerance. The
      objective of this study is to compare the effects of NIV delivered via face mask, standard
      helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and
      comfort.
    

Detailed description: 
      16 Healthy volunteers will be enrolled. They will be ventilated with non invasive
      ventilation. The Work of breathing, ventilator/patient asynchrony, and ventilatory comfort
      produced between face mask, Helmet and NEXT helmet will be compared.
    

Intervention name(s): Non invasive ventilation HELMET; Non invasive ventilation facemask (Respironics)
Intervention type(s): Device; Device
Intervention description(s): The HELMET and HELMET NEXT modes will be tested by each patient.; The facemask Respironics (Herrsching, Germany) will be used by each patient.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Non invasive ventilation; Helmet; NEXT Helmet; Work of breathing; Intensive care
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Alcoholic Intoxication
Study type: Interventional
Phase: Phase 2

Summary: 
      To test the effectiveness of an smoking cessation treatment for smokers who also drink
      alcohol heavily.
    

Detailed description: 
      Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking
      cessation. This clinical trial examined whether smoking cessation treatment that incorporates
      brief alcohol intervention can improve smoking cessation outcomes (7-day verified point
      prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking
      cessation treatment were assigned by urn randomization to receive, along with 8-weeks of
      nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n
      = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention
      (ST-BI, n = 117).
    

Intervention name(s): Standard treatment plus brief alcohol intervention; Standard treatment (ST)
Intervention type(s): Behavioral; Other
Intervention description(s): Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention; Behavioral smoking cessation counseling and nicotine patch.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco; alcohol
Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
Condition: Breast Cancer; Cancer Survivor; Depression; Fatigue; Sexual Dysfunction; Sleep Disorders; Spiritual Concerns
MeSH terms: Breast Neoplasms; Sleep Wake Disorders; Parasomnias; Fatigue; Depression
Study type: Observational

Summary: 
      RATIONALE: Studying quality of life in cancer survivors may help determine the long-term
      effects of breast cancer and may help improve the quality of life for future cancer
      survivors.

      PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian
      female breast cancer survivors.
    

Detailed description: 
      OBJECTIVES:

        -  Compare disease-specific, generic, and global quality of life measures in
           African-American survivors of breast cancer with Caucasian survivors of breast cancer.

        -  Compare these quality of life measures in African-American survivors of breast cancer
           with control group of African-American women with no history of breast cancer.

      OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL)
      questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual
      Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence
      Scale, and other measures of symptoms/side effects (including sleep problems), the RAND
      Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale,
      assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed
      Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth
      Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity
      information, as well as menstrual and gynecological history, work status and insurance
      history, and a measure of health care provider communication is collected using
      questionnaires and medical chart review.

      PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this
      study.
    

Intervention name(s): study of socioeconomic and demographic variables; fatigue assessment and management; management of therapy complications; psychosocial assessment and care; quality-of-life assessment
Intervention type(s): Other; Procedure; Procedure; Procedure; Procedure
Keywords: fatigue; depression; spiritual concerns; sexual dysfunction; sleep disorders; cancer survivor; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if pumosetrag is effective in treating
      Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD
      symptoms and are currently taking an acid suppression therapy, such as a Proton Pump
      Inhibitor (PPI).
    


Intervention name(s): Pumosetrag; Pumosetrag; Placebo; Pumosetrag
Intervention type(s): Drug; Drug; Other; Drug
Keywords: Symptoms of Gastroesophageal Reflux Disease (GERD)
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response
      at the site of Candin intradermal injection in the presence of a targeted immune pathway
      inhibitor.
    


Intervention name(s): Benlysta; Candin
Intervention type(s): Drug; Drug
Intervention description(s): Benlysta injection will be administered subcutaneously.; Candin will be administered intradermally along with NaCl solution.
Other intervention name(s): Belimumab
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacodynamic and Pharmacokinetic Study of PL-ASA
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a
      novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose
    

Detailed description: 
      This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and
      pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under
      fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.
    

Intervention name(s): PL-ASA
Intervention type(s): Drug
Intervention description(s): Pharmacologic profile of different aspirin formulations
Other intervention name(s): Enteric-coated Aspirin (EC-ASA)
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
Condition: Snoring; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring
Study type: Observational

Summary: 
      Purpose:

      In a retrospective cohort the investigators will validate, the goodness of a multidimensional
      index to classified the severity of patients with sleep disordered breathing that has been
      previously developed in a prospective longitudinal cohort.
    

Detailed description: 
      Methods. In the developing study, three variables were found as predictors of mayor outcomes
      and were incorporated in a multidimensional index: the apnea-hypopnea index, the severity of
      daytime sleepiness as quantified by the Epworth questionnaire and the presence of current
      cardiovascular disease. The index (OSA-SCORE) has a value between 0 (less risk) to 5 (more
      risk). For each point, a significant increment in the risk of death was found. In the
      retrospective validation study, a number of potential variables will be recorded, all of them
      also predictors of major outcomes. Data will be recorded by trained personnel on-site at the
      respiratory Sleep Units around the country. The final cohort will include 1100 subjects aged
      > 18 years . The observation time will be considered since the time at diagnosis to fatal
      event and the patient will be censored when non-invasive ventilation was started or at the
      recorded time if the patient is alive. The primary outcome is all-cause death.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sleep Clinic
      
Keywords: snoring; sleep apnea; sleep study; cardiovascular outcomes
A Study of the Effect of RG1662 on Metformin in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, non-randomized, open-label, two treatment, two period, fixed sequence
      crossover study will investigate the effect of RG1662 treatment on the activity of key renal
      transporters in healthy male and female participants using metformin. The effect of RG1662 on
      other renal function parameters will also be explored.
    


Intervention name(s): Omnipaque 300; RG1662; metformin
Intervention type(s): Other; Drug; Drug
Intervention description(s): 647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function; Oral administration twice daily; Single 850 mg dose of metformin
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome
Condition: Knee Pain Chronic; Muscle Pain
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Myalgia; Syndrome
Study type: Interventional

Summary: 
      Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial
      trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical
      practice to manage MPS but few evidence is published about percutaneous electrolysis effects
      for the treatment of MPS.

      This is a randomized clinical trial with 3 parallel groups: 1) High intensity-short time
      percutaneous electrolysis; 2) Low intensity-long time percutaneous electrolysis; 3) dry
      needling control group.
    

Detailed description: 
      The current study aimed to evaluate changes in rectus femurs active trigger points and
      patellar tendon pain pressure thresholds and subjective anterior knee pain perception after
      application of two percutaneous electrolysis methods using a same charge (high intensity and
      low intensity) compared to a dry needling group in patients with patellofemoral pain syndrome
      (PFPS)

      Fifteen patients diagnosed with unilateral PFPS were divided in two experimental groups (high
      intensity percutaneous electrolysis and low intensity percutaneous electrolysis) and one
      active control group (dry needling. The duration of the study was 7 days with only one
      intervention. Pain pressure thresholds were assessed using an algometer before the
      intervention, immediately after the intervention and after 7 days and a Visual Analogue Scale
      was used before the treatment and after 7 days to rate the subjective anterior knee pain
      perception. Also a VAS was used to rate the pain perception during the intervention
    

Intervention name(s): Percutaneous Electrolysis; Dry needling
Intervention type(s): Procedure; Procedure
Intervention description(s): Needle emplacement with a galvanic electrical current; Needle emplacement without electrical current nor substance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patellofemoral pain syndrome; Electrolysis; Myofascial Pain Syndromes; Acupuncture
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare influenza vaccine responses in monozygotic and dizygotic twins.
    

Detailed description: 
      The investigators plan to study the response to different influenza vaccines much more
      broadly and deeply across different age groups and with different vaccine modalities and to
      probe the influence of genetics on these responses using monozygotic and dizygotic twins.
    

Intervention name(s): Fluzone® (intramuscular); FluMist® (intranasal)
Intervention type(s): Biological; Biological
Intervention description(s): Licensed seasonal trivalent inactivated influenza vaccine (IIV3); Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza vaccines; healthy participants; immunity to influenza; identical twins; fraternal twins; non-twins
Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Research has established the incidence of insomnia increases with age and the possible causes
      contributing to sleep problems in the elderly are still being explored and debated. Older
      adults use a disproportionately large share of sleep aids with non-prescription sleep aid use
      having increased over the past decade. This study is a double blind safety and effectiveness
      trial examining the response of eszopiclone co-administered with escitalopram for the
      treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two
      groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to
      treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at
      visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily
      in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep
      diaries.
    

Intervention name(s): Eszopiclone; Placebo; Escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Eszopiclone 2mg daily at bedtime; Placebo daily at bedtime; Escitalopram 10mg or 20mg
Other intervention name(s): Escitalopram 10mg or 20mg daily in the AM; Escitalopram 10mg or 20mg daily in the AM
Intervention MeSH terms: Dexetimide; Eszopiclone; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia; Major Depression; Geriatric