bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy
      rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic
      radical excision of deep infiltrating colorectal endometriosis with a bowel resection.
    

Detailed description: 
      Patients

      All women (n=45) who had undergone fertility sparing CO2 laser laparoscopic radical excision
      of deep infiltrating endometriosis with bowel resection were selected retrospectively from
      the list of all patients (n=more than 500, of whom slightly more than 50% with endometriosis)
      operated at the Leuven University Fertility Centre (LUFc) between September 2004 and
      September 2006.

      Questionnaires

      All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire
      (27), a sexual activity questionnaire (28), visual analogue scales (VAS) for dysmenorroe,
      chronic pelvic pain and deep dyspareunia, and to answer questions about medication and
      fertility, to compare their status before surgery and at the moment of the evaluation
      (December 2008).
    

Intervention name(s): multidisciplinary laparoscopy; Questionnaires
Intervention type(s): Procedure; Other
Intervention description(s): Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.; All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire, visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep
        infiltrating endometriosis with active involvement of the colorectal surgeon performing a
        bowel resection were selected retrospectively from the list of all patients (n=more than
        400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and
        July 2006.
      
Biospecimen description: 
      The diagnosis of endometriosis was confirmed by histologic examination of resected lesions.
    
Keywords: colorectal endometriosis; deep infiltrating endometriosis; dysmenorroe; dyspareunia; quality of life
Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Condition: Chronic Venous Insufficiency; Lipedema
MeSH terms: Foot Deformities; Venous Insufficiency; Lipedema
Study type: Observational

Summary: 
      Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum
      of clinical manifestations occurring with symptoms and/or signs that vary in type and
      severity. The pathophysiological mechanisms of CVD start from the development of venous
      hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is
      subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities.
      Previous studies showed that foot deformities such as pes planus or cavus are at a high
      prevalence in CVD patients, and the authors indicated that foot disorders are an important
      risk factor that negatively affects venous disease. To the best of our knowledge, there is
      only one study investigating plantar arch abnormalities in lipedema patients based on
      clinical observation. Therefore, the study aimed to investigate plantar foot distribution and
      foot deformity in patients with CVD and lipedema.
    


Intervention name(s): Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease.
Intervention type(s): Other
Intervention description(s): Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease and lipedema.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patients were divided into two groups: Patients with only CVD and patients with CVD
        accompanied lipedema.
      
Keywords: Foot deformity; venous insufficiency; pressure; Lipedema
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334
Condition: Healthy Volunteers; Cryopyrin Associated Periodic Syndrome
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD
      followed by a MAD study of IZD334 conducted in healthy adult participants as well as an
      open-label cohort in adult patients with CAPS. The study is designed to evaluate the safety,
      tolerability, PK, PD, and food effect of IZD334 in healthy adult participants, and to
      evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of IZD334 in
      adult patients with CAPS.
    


Intervention name(s): IZD334; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Placebo to Match
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine
      F 18, may be effective in finding recurrent disease in patients with gliomas.

      PURPOSE: This clinical trial is studying how well positron emission tomography using
      fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety of fluorothymidine F 18 for visual and dynamic brain tumor images
           in patients with glial neoplasms.

        -  Determine, preliminarily, the efficacy of this drug.

      Secondary

        -  Compare, preliminarily, the efficacy of this drug to fludeoxyglucose F 18 in
           differentiating tumor recurrence from radiation necrosis.

        -  Determine the optimal time to image post injection of this drug.

      OUTLINE: This is a pilot, nonrandomized study.

      Patients receive fluorothymidine F 18 IV over 1 minute and then undergo positron emission
      tomography (PET) scanning of the brain over 2 hours.

      After completion of the PET scan, patients are followed for at least 1 month.

      PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
    

Intervention name(s): fluorine F 18 fluorothymidine; positron emission tomography
Intervention type(s): Other; Procedure
Intervention MeSH terms: Fluorides
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: adult anaplastic astrocytoma; adult anaplastic ependymoma; adult anaplastic oligodendroglioma; adult diffuse astrocytoma; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma; adult ependymoma; adult oligodendroglioma; recurrent adult brain tumor; adult mixed glioma
Smoking Cessation in Groups and With Tobacco Pastils
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to examine if smokeless tobacco combined with group support
      might increase smoking cessation rate compared with groups support in smokers.
    

Detailed description: 
      The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with
      group support (15-20 per group) might increase smoking cessation rate compared with groups
      support cold turkey in smokers.The test product should be used for 7 weeks. Seven group
      meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12
      months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight,
      carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and
      plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.
    

Intervention name(s): Oliwer Twist smokeless tobacco (tobacco)
Intervention type(s): Drug
Intervention MeSH terms: Lobeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation,; nicotine,; smokeless tobacco,; cigarettes
Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug
      interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL
      ER).
    

Detailed description: 
      This is a single-center, open-label, single-sequence, crossover, drug-drug interaction study
      in healthy subjects.

      Primary Objectives:

      Safety

      - To evaluate the safety of a single dose of INX-08189 (50 mg) alone and combined with
      verapamil HCL ER (240 mg) after subjects receive verapamil HCL ER QD for 6 days

      Pharmacokinetic

      - To evaluate the effect of multiple doses of verapamil HCL ER (240 mg) on the
      pharmacokinetic (PK) profile of INX-08189 and the metabolite INX-08032, and the effect of a
      single dose of INX-08189 on the PK profile of verapamil and the metabolite norverapamil
    

Intervention name(s): INX-08189 50 mg; 240 mg verapamil HCL ER; 50 mg dose of INX-08189 and 240 mg verapamil HCL ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study Day 0: Single 50 mg dose of INX-08189 in the morning; Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning; Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pharmacokinetics; PK; INX08189; Verapamil; Inhibitex
Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting
      drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).
    

Detailed description: 
      A randomized, double blind, placebo-controlled, 12-week cross-over study (5-week treatment
      periods with 2-week washout) of adjunctive riluzole in 12 persons with ASD and DRI between
      the ages of 12 and 25 years.
    

Intervention name(s): Riluzole; placebo
Intervention type(s): Drug; Other
Other intervention name(s): Other name: Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Evaluation in Healthy Volunteers of CARDIOSPACE II
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this project is to test the CARDIOSPACE II system that integrates several medical
      devices. This system is dedicated to physiological studies in space environment.

        -  Electrocardiogram

        -  Vascular doppler

        -  Laser doppler with iontophoresis

        -  Continuous blood pressure recording at the finger level

        -  Brachial blood pressure

        -  Ultrasound

        -  Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder
    


Intervention name(s): Test of the different devices integrated in cardiospace II
Intervention type(s): Device
Intervention description(s): The different devices included in CARDIOSPACE II will be tested
Electrocardiogram
Vascular Doppler
LaserDoppler and iontophoresis
Brachial blood pressure
Continuous blood pressure recorded at the finger level
Ultrasound
Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
Condition: Healthy Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence of improved and current orally
      disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each
      of two administration methods (with/without water).
    


Intervention name(s): Donepezil Hydrochloride; Donepezil Hydrochloride; Donepezil Hydrochloride; Donepezil Hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): improved orally disintegrating E2020 10 mg tablet without water.; current orally disintegrating E2020 10 mg tablet without water.; improved orally disintegrating E2020 10 mg tablet with water.; current orally disintegrating E2020 10 mg tablet with water
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects; Donepezil
Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia, Myeloid, Acute; Neutropenia; Febrile Neutropenia
Study type: Interventional

Summary: 
      Febrile neutropenic patients are at high risk for developing sepsis and other infections
      which often necessitates acute admission to the Intensive Care Unit (ICU) and are associated
      with high mortality. Neutropenic fever is a medical emergency and early detection of fever
      allows for prompt infectious work up. In this study, the investigators will collect pilot
      data from outpatients utilizing a remote outpatient continuous temperature monitoring device
      to compare the incidence of ICU admission and severe sepsis to historical data for prior
      patients who did not receive at home monitoring device.
    


Intervention name(s): Remote monitoring of temperature
Intervention type(s): Device
Intervention description(s): The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional group will be compared with historic group of patients
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HiDAC; Neutropenia; Fever; AML; Leukemia
Influence of Oxytocin on Resting State Neurophysiological Measures
Condition: Oxytocin
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the investigators will explore the influence of oxytocin administration on
      several neurophysiological responses (EEG, skin conductance and heart rate) during rest.
    

Detailed description: 
      Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG
      and skin conductance during specific tasks (e.g., emotion recognition, fear learning and
      extinction). However, not much is known about the influence of oxytocin on those measures
      during rest. Therefore, in this randomized, placebo controlled, double blinded study, the
      investigators will investigate the influence of oxytocin during a resting period of 5
      minutes. Heart rate, skin conductance, respiration and EEG will be measured before and after
      oxytocin or placebo administration. The investigators expect that oxytocin will increase the
      heart rate variability and decrease the skin conductance levels. Exploratory, the
      investigators will conduct a cross-frequency analysis of band power and asses the
      relationship between distinct indexes of sympathetic / parasympathetic balance.

      Please note that this study is part of a larger study in which the investigators also asses
      the influence of oxytocin on neurophysiological responses elicited by direct gaze
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Syntocinon nasal spray; Placebo nasal spray
Other intervention name(s): syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: resting state; EEG; skin conductance; heart rate; oxytocin
Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to characterize the safety and immunogenicity of a' pandemic influenza
      (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received
      influenza vaccination.
    


Intervention name(s): GSK Biologicals' FluLaval®; Placebo (saline); GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A; GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injections; Intramuscular injections
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pandemic; GSK Bio's influenza vaccine GSK2340274A; H1N1; Influenza
Effect of Interferential l Therapy on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Background: Chronic non-specific low back pain is defined as unknown mechanical
      musculoskeletal pain lasting more than 3 months. Electrotherapy is a non-pharmacologic,
      non-invasive and simple method back pain treatment that is mainly applied using
      interferential (IF) therapy. The current study was designed to investigate the effect of IF
      on pain, range of motion, and quality of life in patients with chronic non-specific low back
      pain. Materials and methods: 61 patients suffered from chronic non-specific low back pain
      (CNLBP) were randomly assigned to IF group (n=30) and placebo IF (n=31). The entire patient
      received suggested exercise 3 times per week for 4 weeks. The outcome measures were visual
      analogue scale (VAS), lumbar range of motion (ROM) in terms of flexion& extension and the
      Short Form-36 (SF-36) health questionnaire to evaluate the quality of life (QOL).
    

Detailed description: 
      Participants The study was conducted in outpatient clinics in Cairo University Hospitals. 60
      patients (29 males and 31 females) were invited to participate in the current study. Subjects
      were included in the study if they had LBP of at least three months duration and aged between
      25 and 60 years. Patients with spinal pathology (tumor, nerve root, fracture, and
      compromise), cardiopulmonary conditions, pregnancy, and received physiotherapy in the last
      eight weeks or any contraindications to the use of electrotherapy were excluded.
    

Intervention name(s): Interferential therapy
Intervention type(s): Other
Intervention description(s): Exercise therapy
Other intervention name(s): Exercise therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain,; Interferential Therapy; Quality of Life
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Condition: Menopause; Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring
      compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women
      who have recently gone through menopause.

      Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally
      occurring spinal bone loss and improve biological and other emotional changes of menopause.
    

Detailed description: 
      The risks of bone loss and osteoporosis increase significantly after menopause. Although
      hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms,
      Women's Health Initiative (WHI) findings indicate significant potential health risks
      associated with HT. This has prompted women to switch from HT to naturally occurring
      compounds similar to estrogen, such as those derived from soy, in the hope that estrogens
      from plant sources can provide benefits while sparing adverse effects caused by prescribed
      estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This
      study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary
      source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes
      associated with estrogen deficiency in young menopausal women. The "Soy Phytoestrogens As
      Replacement Estrogen (SPARE)" study will provide a foundation of knowledge from which
      menopausal women and their doctors can begin to make more informed decisions regarding HT and
      other treatment options.

      Enrollment into the study will occur over 3 years, with each participant taking part in the
      study for a total of 2 years. Participants will be randomly assigned to one of two groups;
      the first group will receive a 200 mg dose of soy isoflavones daily and the second group will
      receive placebo daily. There will be 10 study visits: screening, study entry, randomization
      at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end
      of active participation at Month 24. At each study visit, participants will have blood drawn,
      provide urine samples, answer questionnaires, and have mammograms and bone density tests.
    

Intervention name(s): Soy isoflavones; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.; Placebo soy isoflavones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment