bioihbjkbjnl/mcl2 huggingface dataset:
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for
      the acute treatment of a migraine attack.
    


Intervention name(s): rizatriptan benzoate (MK0462); Comparator: sumatriptan; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose 5 mg rizatriptan p.o.; single dose 50 mg sumatriptan p.o.; Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
Other intervention name(s): MK0462
Intervention MeSH terms: Sumatriptan; Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of a Video Explaining Epidural Analgesia in Obstetrics
Condition: Difficulty Processing Information
Study type: Interventional

Summary: 
      The aim of this study was to investigate the impact of multimedia information on epidural
      anesthesia. Pregnant women were randomly assessed to get a video information in addition to
      an oral and written information on epidural anesthesia. Maternal satisfaction concerning the
      quality of the information as well their anxiety and understanding of the procedure were
      assessed and compared in both groups.
    

Detailed description: 
      The information in anesthesia consultation is mandatory. Few studies have investigated the
      impact of multimedia preoperative information in terms of satisfaction, comprehension and
      anxiety, with conflicting results. None have evaluated the contribution of a video explaining
      epidural analgesia in obstetrics. This study compared two types of information given in
      anesthesia consultation: an oral and written information (group P) versus oral, written and
      video information (group V). The main objective was maternal satisfaction, the secondary
      objectives were understanding and anxiety.

      This is a common care, prospective and randomized study, conducted between September 2015 and
      February 2016 in the Creteil Intercommunal Hospital Center (CHIC) and accepted by the ethics
      committee Paris V. After information, not opposition of women who accepted to participated
      was collected. Oral information on epidural analgesia was provided in consultation by the
      anesthesiologist, with delivery of a written information sheet. The video made at CHIC in
      2015, was transmitted, in addition, by email to patients randomized in the group V for she
      could look it at their convenience. Satisfaction and anxiety were evaluated by numerical
      scale from 0 to 10 and comprehension by multiple choice questions with a final score of 10.
      These three criteria were also evaluated in an emergency context in which women received oral
      and written information (group U). Evaluation questionnaires were given during the anesthesia
      consultation and recovered during the hospitalization after childbirth.
    

Intervention name(s): Written Information; Video Information
Intervention type(s): Other; Other
Intervention description(s): A written information on peridural anesthesia is delivered; A link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Video Information; Satisfaction; Anxiety; Epidural Analgesia; Comprehension; delivery
Sedative-Anxiolytic Effects on Simulated Driving Performance
Condition: Psychomotor Impairment
MeSH terms: Psychomotor Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car
      the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed
      or in the morning before using a driving simulator to assess impairment.
    


Intervention name(s): Alprazolam 2mg (2ALP/PLC); Alprazolam 1mg (1ALP/PLC); Alprazolam 0.5mg (0.5ALP/PLC); Zolpidem 10mg (ZOL/PLC); Placebo (PLC/PLC); Alprazolam 1mg (PLC/ALC)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2mg alprazolam administered at night, placebo administered in the morning.; 1mg alprazolam administered at night, placebo administered in the morning.; 0.5mg alprazolam administered at night, placebo administered in the morning.; 10mg alprazolam administered at night, placebo administered in the morning.; Placebo administered at night, placebo administered in the morning.; Placebo administered at night, 1mg alprazolam administered in the morning.
Intervention MeSH terms: Zolpidem; Alprazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Investigation of DHA Intake in Pregnant and Lactating Women in China
Condition: Nutrient Intake Disorder
Study type: Observational

Summary: 
      This is a multi-center, cross-sectional, non-interventional, observational study--an
      investigation carried out in 816 pregnant (pregnant week 17±2 group and pregnant week 39±2
      group; 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group)
      from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1 lake
      regions) in China to study the correlation between DHA intake and DHA concentrations in blood
      and breast milk.
    

Detailed description: 
      This is a multi-center, cross-sectional, non-interventional, observational study in 816
      pregnant (gestation week 17±2 group and gestation week 39±2 group 408 cases in each group)
      and 408 lactating women (post-natal lactation day 42±7 group) from a total of 4 sites in 3
      typical areas (1 coastal regions, 2 inland regions and 1 lake regions) in China to study the
      correlation between DHA intake and DHA concentrations in blood and breast milk. Investigators
      are mainly physicians majoring in gynaecology and obstetrics, etc. During visits, the study
      physician will record the patient's social demographic data, disease and relevant medication
      history, review her medical records, assess DHA intake by the DHA Screener, and determine DHA
      concentrations in erythrocyte membrane, plasma and breast milk, so as to validate the
      feasibility of DHA Screener as DHA intake assessment tool for determining DHA concentrations
      in the body.

      Subjects meeting inclusion criteria and non of the exclusion criteria will be informed of
      relevant information of the study. Subjects should be voluntarily consent to participate in
      the study and sign the informed consent form.

      Screening of the study is scheduled for as long as 5 months. In this study, additional
      examinations or other interventions are not required.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        816 pregnant (pregnant week 17±2 group and pregnant week 39±2 group; 408 cases in each
        group) and 408 lactating women (post-natal lactation day 42±7 group)
      
Biospecimen description: 
      1. Collection of venous blood, pretreatment of blood sample, take the plasma and
           erythrocyte respectively.

        2. Collection of breast milk (only for women having lactated for 42±7 days)
    
Keywords: DHA intake;; Plasma;; Erythrocyte;; Breast milk.
Rwanda Vaginal Microbiota Restoration Study
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial
Study type: Interventional

Summary: 
      A pilot randomized controlled clinical trial of intermittent use of two different vaginal
      lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis
      recurrence.
    

Detailed description: 
      This is a pilot study to prepare for larger clinical trials. Sixty-eight HIV-negative,
      non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV, by modified
      Amsel criteria and/or Nugent score) and/or Trichomonas vaginalis (TV, on wet mount or by
      culture) will be treated using oral metronidazole for 7 days. After successful treatment, and
      when they are free of vaginal candidiasis, other curable sexually transmitted infections
      (STIs) and urinary tract infection (UTI)), they will be randomised to 4 different vaginal
      microbiome (VMB) maintenance interventions (17 per group) within 3 days of completing oral
      metronidazole treatment: 1) Behavioral 'vaginal practices cessation and safer sex'
      counselling only (control); 2) Behavioral counselling plus 500mg metronidazole pills twice
      per week for two months; 3) Behavioral counselling plus Ecologic Femi vaginal capsule, once
      per day for 5 days immediately after oral metronidazole treatment followed by thrice weekly,
      for two months; 4) Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every
      4 days for two months. Vaginal probiotic use may be ceased temporarily during menstruation.
      Participants will be asked to adhere to the interventions for 2 months, and VMB assessments
      will take place before (screening and enrolment visits), during (Day 7, Month 1 and Month 2
      visits), and after the interventions (Month 6 visit).
    

Intervention name(s): Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence; Prophylactic use of metronidazole pills (500 mg); Vaginal Lcr35-containing probiotic for prevention of BV recurrence
Intervention type(s): Biological; Drug; Biological
Intervention description(s): Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV; Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV; Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV
Other intervention name(s): Ecologic Femi+ vaginal capsule; Tricozole; Gynophilus LP vaginal tablet
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Oral Testosterone for the Treatment of Hypogonadism in Males
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.
    

Detailed description: 
      The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone
      after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men.
      This will be determined by blood sampling at specified times during the study. The study is
      also intended to evaluate the PK parameters of the testosterone metabolite,
      dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study
      consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study
      duration is approximately 9 weeks.
    

Intervention name(s): TSX-002
Intervention type(s): Drug
Intervention description(s): TSX-002 are capsules with testosterone as the active ingredient.
Other intervention name(s): Testosterone
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypogonadism; Gonadal Disorders; Endocrine System Diseases; Testosterone; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Androgens; Hormones; Hormones,; Hormone Substitutes,; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Therapeutic Uses; Anabolic Agents; dihydrotestosterone
Use Of Three Commercial Preparations Of Injectable Hyaluronic Acid In Hands Rejuvenation
Condition: Injuries to the Wrist and Hand
Study type: Interventional
Phase: Phase 4

Summary: 
      Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with
      Emervel® Touch and Emervel® Deep Lidocaine combined or not with Emervel® Touch in female
      patients with loss of fatty tissue in hands.
    

Detailed description: 
      This is a single center, phase IV, randomized, investigator-blind study of three different
      hyaluronic dermal filler injections for volume enhancing in the dorsum of the hands. As an
      investigator-blind study, only the investigators are unaware of which dermal fillers were
      injected in the dorsum of each hand.
    

Intervention name(s): Emervel® Touch; Emervel® Volume Lidocaine and Emervel® Deep Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Emervel® Touch will be injected only in the intervention group.; Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hands Rejuvenation, fillers
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
Condition: Perennial Allergic Rhinitis; Obstructive Sleep Apnea; Sleep Disorder
MeSH terms: Rhinitis; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind
      study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with
      Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak
      Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations,
      and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age
      with symptomatic PAR (with or without SAR) will be selected and randomized at one study site.
      The anticipated duration of subject participation in the study is approximately 39 days.
      Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening
      period. Following the run-in period, subjects who meet the qualifications at the Baseline
      Visit will be treated with study medication for 4 weeks.
    


Intervention name(s): Mometasone furoate nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.; Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
Other intervention name(s): Nasonex
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypopnea Syndrome
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy
      with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
    

Detailed description: 
      A surgical resection is currently the preferred treatment for esophageal cancer if the tumor
      is considered to be resectable without evidence of distant metastases.A higher percentage of
      radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery
      versus surgery alone.The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant
      chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has
      shown effectively.Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and
      practically eliminates the risk of hypersensitivity reactions associated with solvent-based
      paclitaxel.We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with
      nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
    

Intervention name(s): albumin-bound paclitaxel plus cisplatin
Intervention type(s): Drug
Intervention description(s): neo-chemotherapy program:Albumin-bound paclitaxel:100 mg/m2, IV (in the vein) on days 1,8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle.Number of Cycles: 2 cycles before operation.If it is effective ,2 cycles will be given in 6 weeks after radical resection.
Other intervention name(s): nab-paclitaxel
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal squamous cell carcinoma; neoadjuvant chemotherapy; albumin-bound paclitaxel; cisplatin
Fibromyalgia in Patient With Impaired Fasting Glucose
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      To assess the frequency of fibromyalgia among women with impaired fasting glucose.
    

Detailed description: 
      Objective: To assess the frequency of fibromyalgia among women with impaired fasting glucose.

      Materials and Methods: The sample was selected from the patients who applied to the Internal
      Medicine clinic and whose fasting blood glucose level were ≥100 and <126 mg/dL in their
      routine examination [Group1 ] and patients whose fasting blood glucose were less than 100
      constituted the control group [Group2 ]. Oral glucose tolerance test [OGTT ] has been applied
      to patients with impaired fasting glucose and whose 2nd hour OGTT levels were under 140 has
      been included. Patients were evaluated in terms of fibromyalgia according to modified 2010
      ACR Fibromiyalgia Criteria. Functional status was assessed by using the Fibromyalgia Impact
      Questionnaire [FIQ ].
    

Intervention name(s): oral glucose tolerance test (OGTT)
Intervention type(s): Diagnostic Test
Intervention description(s): Implementation of OGTT: The patient was seated in a quiet room after 10-12 h of overnight fasting, and blood samples were drawn. Thereafter, 75 g glucose solution dissolved in 300 mL of water was administeredwithin 5 min. Two hours after this,another blood sample was drawn. During the test, the patient wasn't allowed to rest and eat, but not smoke.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18-65 years female patients
Study to Evaluate DNL201 in Subjects With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of multiple oral doses of DNL201 in subjects with Parkinson's disease.
    


Intervention name(s): DNL201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral repeating dose; Oral repeating dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LRRK2; Parkinson's Disease; Movement Disorders
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Condition: Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Observational

Summary: 
      To compare the positivity rate of the investigational assay to the currently approved
      QuantiFERON-TB Gold In-Tube assay.
    


Intervention name(s): CST001
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have either a low risk or known risk for TB exposure.
      
Keywords: Tuberculosis; TB
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many
      countries, including the United States. In singleton gestations a short cervical length (CL)
      on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of
      cervical pessary has been assessed in several populations including singletons with short CL,
      unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical
      trials (RCTs) have been published, and several are ongoing. However, no consensus on the use
      of cervical pessary in pregnancy or guidelines for management have been assessed.
    


Intervention name(s): Cervical pessary
Intervention type(s): Device
Intervention description(s): The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects
Condition: Chronic Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the safety, tolerability and pharmacokinetics of single and repeated
      doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical
      positive comparative patch.
    

Detailed description: 
      Eligible subjects will be randomly assigned to Treatment goup A, B and C.

      In the experiment group A, 12 subjects with a ratio of 10:2 will receive one patch of AB001
      or placebo batch on Day 1 of period 1, respectively, after a wash-out period of 14 days, 10
      subjects received AB001 patch will be administered with an oral capsule of active ingredient
      on Day 20 of period 2.

      In the experiment group B, 12 subjects with a ratio of 10:2 will receive two patches of AB001
      or two placebo batches on Day 1 respectively, and then two patches daily from Day 8 to Day
      20.

      In the active comparator group C, 10 subjects will receive one patch of positive comparative
      patch on Day 1, and then once patch every two days from Day 8 to Day 20.

      The tolerability, safety and pharmacokinetics of topical AB001 patch will be assessed in this
      study.
    

Intervention name(s): AB001; oral capsule; positive comparative patch; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single and repeated dosing; single dose; single and repeated dosing; single and repeated dosing
Other intervention name(s): topical patch; active ingredient; topical patch; topical patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment