bioihbjkbjnl/mcl2 huggingface dataset:
Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil
Condition: Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia
Study type: Interventional

Summary: 
      Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern
      anesthesia. The purpose of this study is to compare two methods of administering desflurane,
      an volatile anesthetic during balanced anesthesia. The investigators hypothesized that
      administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia
      will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth
      than administering desflurane according to the patient's BIS (bispectral index) value.
    


Intervention name(s): Administering desflurane according to the patient's BIS value; Administering desflurane at 1 MAC
Intervention type(s): Drug; Drug
Intervention description(s): Administering desflurane according to the patient's BIS value; Administering desflurane at 1 MAC
Intervention MeSH terms: Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Cumulative Irritation Potential of 828 Ointment
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Cumulative Irritation Patch Test
    

Detailed description: 
      Single site study that will evaluate the relative cumulative irritation potential of
      HP828-101 ointment compared to a negative control, Johnson's baby oil, and a positive
      control, 0.2% SLS v/v, following 21 daily applications to the skin of normal, healthy
      volunteers.
    

Intervention name(s): HP828-101
Intervention type(s): Device
Intervention description(s): 21 day patches
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: cumulative irritation; healthy adult volunteers
Injury Incidence in Professional Soccer
Condition: Injury
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The winter break within the German Professional Football Leagues will be shortened as for the
      season 2009/2010 from 6.5 to 3.5 weeks. That might have repercussions on injury incidence in
      either way, positive or negative. On the one hand, recovery time during the winter will be
      shorter, which might lead to an increased risk of injury. On the other hand, it will allow a
      better spread of games in the second round, thus reducing the amount of the so-called
      "English weeks", which in turn could reduce the number of injuries. This study compares
      injury incidence between the season 2008/2009 (long winter break) and the season
      2009/2010(short winter break) via questionnaires in accordance with UEFA/FIFA injury
      evaluation criteria.
    


Intervention name(s): shortened winter break
Intervention type(s): Other
Intervention description(s): winter break shortened by 3 weeks (from 6.5 to 3.5) within the German Professional Soccer League in season 2009/2010
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        German professional male soccer players
      
Keywords: injury incidence; male professional soccer; Change of injury incidence in professional soccer
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
      conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on
      symptom reduction related to lactose intolerance.
    


Intervention name(s): RP-G28; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): powder for reconstitution for oral administration; powder for reconstitution for oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US). The study is comprised of 4 study periods.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lactose Intolerance
Effect of Surgical Smoke on Air Quality
Condition: Air Quality; Volatile Organic Compounds; Occupational Health
Study type: Observational

Summary: 
      This study; It was planned to (1) determine the effect of surgical smoke on indoor air
      quality and (2) examine its effect on physical symptoms and throat culture results in
      operating room employees and compare it with those working in internal units.
    

Detailed description: 
      Background:This study is a experimental study. The aim of this study is; to determine the
      effect of surgical smoke containing toxic chemicals on indoor air quality and to examine the
      physical symptoms of employees in the operating room.

      Method:It was carried out in general surgery operating room between June 2020 and July 2020
      In the study, 45 air samples were taken from the with active sampling method before, during
      and after surgery. Physical complaints of 19 people working in the operating room were asked
      and throat cultures were taken before and after surgery. These results were compared with
      those working in internal units. Data were analyzed using a statistics program.
    

Intervention name(s): exposure to surgical smoke during surgery
Intervention type(s): Other
Intervention description(s): No intervention was made. During the surgery, complaints and throat cultures were taken before and after exposure to surgical smoke. Simultaneously, 45 air samples are taken in the operating room before, during and after the operation.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Health workers in hospital
A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion in Adults of Atopic Dermatitis.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      This study will evaluate the safety and efficacy of a moisturizer body lotion: the study aims
      to determine the tolerance of this product by the study population, and its effects on atopic
      dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy.
      Participants will receive the product to use it at home for 21 +/- 2 days.
    


Intervention name(s): Moisturizer Body Lotion
Intervention type(s): Other
Intervention description(s): Moisturizer Body Lotion
Other intervention name(s): The body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Melatonin and Adiponectin in Hypertensive Kidney Transplant
Condition: Hypertension; Kidney Transplant
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome.
      We have also demonstrated that exogenic melatonin supplementation can improve blood pressure
      profile in nondipper patients.

      The aim of this study is to find whether there is a difference between melatonin secretion in
      hypertensive kidney recipients versus "normal" hypertensive patients. Secondly, to ask if
      there is any correlation between melatonin secretion and adiponectin levels.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        group1- patients from the kidney transplant unit, sheba medical center group2- patients
        from hypertension unit,sheba medical center
      
Keywords: hypertension; kidney transplant; melatonin; adiponectin
Evaluation of Web-Based CBT for Rape Victims
Condition: PTSD
Study type: Interventional

Summary: 
      Rape is unfortunately a common experience among women, affecting between 13 and 20%. In
      addition, up to 50% of all rape victims experience significant and persistent psychological
      distress. While cognitive-behavioral interventions have been found to be successful at
      alleviating distress among victims; the majority do not seek out these services, often
      because of feelings of stigma and self-blame. One potential method for circumventing these
      barriers is through online administered treatment. Thus, the current project is designed to
      conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media,
      cognitive-behavioral, online intervention tailored specifically for rape victims. The
      effectiveness of this program at ameliorating distress among college women who have
      experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated.
      Reductions in psychological distress was the primary outcome and was assessed at
      post-intervention and at three and six month follow-up periods. The effectiveness of the
      intervention was compared to a psycho-educational website.
    


Intervention name(s): Online intervention; Psycho-educational website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD; Psycho-educational self-help website about rape-related PTSD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
Condition: Postprandial Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      This study assesses the glycemic responses to several nutritional products.
    

Detailed description: 
      During a study visit fasted subjects will consume one serving of the reference product or of
      the test products. Venous blood samples will be taken at baseline and at several time-points
      over a 6-hr period.
    

Intervention name(s): First concept product (containing 50 grams of carbohydrates); Second concept product (containing 50 grams of carbohydrates); Reference product (containing 50 grams of carbohydrates)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fasted intake of First concept product (randomised); Fasted intake Second concept product (randomised); Fasted intake of Reference product (randomised)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, controlled, double-blind, cross-over, single-centre, Proof of-Concept study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: nutritional product; glucose response; carbohydrate metabolism
Impact of Duloxetine on Male Fertility
Condition: Infertility, Male; Depression
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are conducting a placebo-controlled, randomized control trial with
      duloxetine in healthy, fertile men not previously on any antidepressants. Participants will
      be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will
      assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes
      measured will include semen parameters (sperm concentration, motility, morphology), hormone
      levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)
      surveys.
    

Detailed description: 
      Antidepressant medications are commonly prescribed in the USA not only for depression, but
      also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive
      disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain.
      Despite being widely prescribed in the United States in men of reproductive age, the impact
      of antidepressants on fertility has not been extensively studied.

      After noticing worsened semen parameters in men on anti-depressants, the investigators
      performed the first prospective study to demonstrate a deleterious impact of selective
      serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to
      reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs
      on male fertility, as assessed by semen parameters and/or sperm DNA integrity.

      No studies have examined the impact of a newer, but similar, class of antidepressant - the
      serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of
      serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to
      their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is
      one of the most commonly prescribed anti-depressants in the United States.

      The investigators are conducting this trial to determine whether or not the administration of
      duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.
    

Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week; Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
May Metformin be Used in Renal Failure?
Condition: Renal Disorder Associated With Type II Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to treat metformin dose-escalation diabetic subjects of all stages of renal
      failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a
      possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients
      by stage is considered, 60 patients in total.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin (Glucophage ®), oral antidiabetic, will be administered as it is usually recommended: engaged during or at the end of the meal in the evening for the single dose 500 mg (Phase 1), the evening and morning for total doses of 1000 mg, 2000 mg and 3000 mg (with, respectively, 2 tab. 500 mg, 2 tab. to 1000 mg, 1 tab. to 1000 mg and 2 tab. to 1000 mg), a fourth dose is also scheduled to stage one (3000 mg / d)
Other intervention name(s): phase1 : 500 mg/d; phase2 : 2 x 500 mg/d; phase3 : 2 x 1000 mg/d; phase4 : 3 x 1000 mg/d
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether PF-03654746 is effective in the treatment
      of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized,
      double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment
      with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg),
      and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants
      will be required to washout of prior ADHD medication before entering the study. Participants
      will be required to come to the site for 10 visits over approximately a 10-week period.
    


Intervention name(s): PF-03654746; Placebo capsules; PF-03654746
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21; Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.; Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study performed in Irritable Bowel Syndrome (IBS) subjects and healthy
      patients is to demonstrate the ability of composite score of frequency of gastrointestinal
      symptoms to discriminate healthy subjects and IBS patients. The properties of this
      questionnaire of composite score of gastrointestinal symptoms frequency will be compared to
      other validated questionnaires (severity of IBS symptoms and HRQoL).
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult healthy subjects and adult IBS patients (Rome III criteria, all subtype)
      
Keywords: Gastrointestinal symptoms; healthy subjects; IBS; HRQoL; questionnaires
PEPPER : PErcePtion of Pre-anesthesia Visit With or Without Robot
Condition: Satisfaction, Personal; Anesthesia
Study type: Observational

Summary: 
      Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit,
      patients should be informed of the different available technics of anesthesia (i.e. general
      or loco-regional) and of their own risks .

      Nowadays, many informations are given through written paper and leaflets, just before the
      consultation. In addition, patients need usually to wait for the doctor. This time may be
      used to give information, and new information's support, such as videos, may be used.

      The aim of this study is to evaluated if a robot (PEPPER), who is able to answer to patients
      and to give informations, may increase the satisfaction of patients having a pre anesthesia
      visit for a scheduled surgery.
    

Detailed description: 
      Before- after observational study.

      All adult patients (age≥18 yrs) coming for a pre-anesthesia visit will be proposed to fulfill
      a questionnaire regarding their satisfaction and the quality of information they received.

        -  in the first period, patients will receive paper informations before the anesthesia
           visit.

        -  in the second period, they will have the same paper informations but a robot PEPPER will
           also stand in the waiting room and propose to the patients to give them informations
           about anesthesia, patients journey, risks, blood transfusion etc...
    

Intervention name(s): PEPPER robot
Intervention type(s): Other
Intervention description(s): Presence of a Robot (PEPPER Robot), designed and programmed to give informations, using a screen and vocal. All the patients in the second period will have access to,the robot, while waiting for the visit.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients scheduled for a pre-Anesthesia visit during the study period (for
        orthopedic, general, urologic, ophthalmologic surgeries or for endoscopic examination under
        anesthesia).
Study Evaluating Hot Flashes in Hormone Sensitive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The validation of the HFRDIS questionnaire in French will allow the use in common practice of
      this questionnaire in consultation in order to have a concrete and reproducible assessment of
      the impact of hot flashes on the daily life of patients. This validation will also allow this
      questionnaire to be used in therapeutic trials to assess the effectiveness of a symptomatic
      treatment under study.

      The use of this questionnaire in patients on hormone therapy will allow for an overall
      assessment of the impact of hot flashes in their daily lives.

      There are no risks induced by participation in this research, it is only an observational
      study without change on the monitoring of participants in both cohorts.
    

Detailed description: 
      The main objective is to assess the impact of hot flashes on the daily lives of patients on
      adjuvant hormone therapy for hormone-sensitive breast cancer.

      The primary test of judgment is composite. The first step is a French validation of the
      HFRDIS questionnaire assessing the impact of hot flashes on daily life in a control
      population free of breast cancer (validated in English). The second step is a comparison of
      the impact of hot flashes on the quality of life of patients in both populations (control and
      hormone therapy adjuvant for hormone-sensitive breast cancer) via the HFRDIS questionnaire.

      In the first part of the study (control population): Patients will be seen in a city
      gynecology consultation. Patients between the ages of 40 and 60 will be offered participation
      in the study consecutively. If patients answer "yes" to the question "Do you have hot
      flashes?", they will then be included in the study and will have access to the study
      questionnaire. Upon their 2nd connection on the website (D15), patients will answer the
      HFRDIS Questionnaire again.

      In the second part of the study (patients on hormone therapy for breast cancer): Patients at
      the Institut Curie Saint Cloud aged 40 to 60 years included on hormone therapy adjuvant
      therapy who will be seen in a monitoring consultation will be offered participation in the
      study consecutively.
    

Intervention name(s): HFRDIS questionnaire completion
Intervention type(s): Diagnostic Test
Intervention description(s): HFRDIS Questionnaire (Hot Flash Related Daily Interference Scale) completion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Group for control population: Patient aged 40 to 60 included.

          -  Group for Hormone therapy for breast cancer: Patient aged 40 to 60 included management
             for RH breast cancer under hormone therapy adjuvant therapy: