bioihbjkbjnl/mcl2 huggingface dataset:
Helicobacter Pylori Eradication With a New Sequential Treatment
Condition: Helicobacter Pylori Infection; Non Ulcer Dyspepsia; Duodenal Ulcer; Gastric Ulcer; Chronic Active Gastritis; Gastritis
MeSH terms: Gastritis; Stomach Ulcer; Duodenal Ulcer; Ulcer; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are
      disappointing, and studies from several countries confirm this poor performance. The study
      aimed to assess the eradication rate of a new sequential treatment regimen compared with
      conventional triple therapy for the eradication of H. pylori infection.
    

Detailed description: 
      One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected
      patients were randomized to receive 10-day sequential therapy [rabeprazole (20 mg twice
      daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20
      mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5
      days] or standard 7-day therapy [corrected] [rabeprazole (20 mg), clarithromycin (500 mg) and
      amoxicillin (1 g), all twice daily]. H. pylori status was assessed by histology, rapid urease
      test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.
    

Intervention name(s): Sequential therapy
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication; Sequential therapy; Standard therapy
Bodyweight Interval Exercise in the Fed Versus Fasted State
Condition: Exercise
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a single session of at-home
      bodyweight interval exercise, performed in the fasted or fed state, on postprandial glycemic
      management, post-exercise fat oxidation, and overall perceptions of appetite in
      recreationally active females. This is a remote/online study and does not involve any visits
      to the laboratory.
    

Detailed description: 
      Following the acquisition of informed consent via videoconferencing, eligibility to
      participate in the study will be determined using questionnaires. If inclusion criteria is
      met, participants will undergo virtual exercise familiarization by following a pre-recorded
      instructional video.

      Eligible participants will be assigned, in a random order, to two metabolic trials at least 3
      days apart in the follicular phase of the same menstrual cycle. These visits will be online
      with an investigator on videoconferencing. The two trials involve: 1) Exercise followed by
      breakfast; and 2) Breakfast followed by exercise.

      Various outcomes will be measured throughout the metabolic trials including: blood sugar, fat
      oxidation and appetite. All research tools needed to acquire these methods will be delivered
      to participants' place of residence.
    

Intervention name(s): Fasted exercise; Fed exercise
Intervention type(s): Other; Other
Intervention description(s): Bodyweight interval exercise performed 5 minutes before the start of a mixed-macronutrient breakfast meal; Bodyweight interval exercise performed 10 minutes after the start of consuming a mixed-macronutrient breakfast meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Reproducibility Inter-session of the Measurement Elastography of the Passive Stiffness of Medial Beams of Gastrocnemius Muscle of the Hemiplegic Cerebral Child.
Condition: Gait; Child Development; Hemiplegic
Study type: Interventional

Summary: 
      Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three
      at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on
      the cerebral palsy, characterised by a modification of the structure (volume decrease) and
      the elasticity (increase of the passive stiffness). Every alterations of the muscular
      property have impact clinic and functional important. The many treatments of orthopaedic
      targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple
      recovery during the growth influences the muscular characteristics. There is a real interest
      to measure the muscular property development during children's growth.
    

Detailed description: 
      Elastography is a technical assessment of characteristic of the soft tissues. In this area,
      the method " Supersonic Shear Imaging® (SSI) " provide an important technological change
      measuring, swiftly and no invasive, a elasticity modulus reflecting the property
      visco-elastic of the muscle. A lot of ex vivo study led in isolated muscle and in vivo in
      healthy adults demonstrated the validity of the method SSI on the evaluation of the passive
      stiffness from a number of muscle group whose the gastrocnemius muscle. The main objective of
      this study must be checked the intersession reproducibility of the method SSI on the
      evaluation of the passive stiffness at the medial bundle of the gastrocnemius muscle
      therefore their passive lengthening in cerebral palsy children. The secondary objective is to
      test the correlation level of the relation elasticity modulus/ joint angle and couple
      force-angle obtained throughout the passive lengthening at the medial bundle of the
      gastrocnemius muscle in cerebral palsy children.
    

Intervention name(s): ultrasound scanner
Intervention type(s): Device
Intervention description(s): Ultrasound scanner used to the SSI technical reproducibility.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hemiplegic; Child; Elastography; paralysis
Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
Condition: Infantile Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a
      good benefit/risk profile. Based on the recent findings of encouraging results obtained with
      propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is
      expected to be of significant benefit in the management of the condition. The present study
      has been designed to confirm efficacy of propranolol in severe IH by demonstrating
      superiority over placebo and to document the safety profile of propranolol in this
      indication.
    

Detailed description: 
      Primary objective The primary objective of this study is to identify the appropriate dose and
      duration of propranolol treatment and demonstrate its superiority over placebo based on the
      complete/nearly complete resolution of target IH at W24.
    

Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Propranolol (1 or 3 mg/kg/day for 3 or 6 months); Treatment with placebo for 6 months
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infantile Hemangioma; Propranolol
Long-term Investigation of Resveratrol in Obesity
Condition: Obesity; Inflammation; Insulin Sensitivity; Osteoporosis
MeSH terms: Osteoporosis; Obesity; Insulin Resistance; Hypersensitivity; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to investigate potential metabolic effects of resveratrol in men
      with metabolic syndrome(otherwise healthy).

      The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will
      increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate
      bone-turnover.
    

Detailed description: 
      The study will be done in a collaboration between two PhD students, who focus on effects in
      adipose- and muscle- tissue, and bone tissue respectively.

      The investigators will look at changes in

        -  inflammation-markers

        -  biochemical markers of fat- and sugar-metabolism

        -  gene-expression in fat- and muscle-tissue

        -  body composition (DXA (whole body) and MR spectroscopy)

        -  biochemical markers of bone-metabolism

        -  Bone Mineral Density (DXA scans)

        -  bone structure (QCT)

        -  gene-expression and cytokines in bone marrow

      Some of the volunteers will have their insulin sensitivity measured.
    

Intervention name(s): Resveratrol
Intervention type(s): Dietary Supplement
Intervention description(s): 500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or
1 placebo 2 times daily for 4 months
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Inflammation; Metabolic Syndrome; Insulin sensitivity; Osteoporosis; Bone turnover; Ectopic fat accumulation; Resveratrol
Effects of HMB Supplementation on Recovery Following ACL Surgery
Condition: ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL
      injury occurs participation in physical activity is compromised. Reconstructive surgery is
      often necessary to repair the damage which is then followed by a regimen of physical therapy
      in order to regain full activity. Nutritional intervention after the surgery could help the
      patient maintain muscle mass during recovery, thus allowing for a quicker return to normal
      activity.
    

Detailed description: 
      Beta-hydroxy-beta-methylbutyrate (HMB) is a nutritional supplement shown to improve muscle
      mass with exercise, and also in muscle loss conditions caused by a decrease in physical
      activity. Participants will be recruited who will undergo reconstructive surgery for a
      complete ACL tear and will then enter a standard physical therapy program during a six week
      recovery period. Subjects will receive either HMB or a placebo supplement during the recovery
      period. Muscle mass will be measured two weeks prior to the surgery and again after the
      recovery period using an InBody 720 body composition analyzer. Additionally, the Knee Injury
      and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered as a measure of
      recovery and activity level during the study.
    

Intervention name(s): HMB; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): beta-hydroxy-beta-methylbutyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: HMB; beta-hydroxy-beta-methylbutyrate; ACL; surgery; muscle mass
Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Written educational materials and counseling by phone may help promote follow-up
      care in women with abnormal Pap smears.

      PURPOSE: This clinical trial is studying how well written educational information and phone
      calls work in increasing follow-up care in Hispanic women with abnormal Pap smears.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the reasons for nonadherence to follow-up in Hispanic women with abnormal Pap
           smear findings.

        -  Assess the effect of written educational information and phone calls on follow-up rate
           in these patients.

      OUTLINE: This is a pilot, cross-sectional, controlled, multicenter study. Patients are
      sequentially assigned to 1 of 3 intervention groups.

        -  Group 1 (control): Patients complete a standardized Spanish survey questionnaire,
           assessing their demographic information, knowledge, attitudes, behaviors, experiences
           with cervical screening, past medical history, and prior treatment, either in person
           (for those who kept their colposcopy appointment) or over the telephone (for those who
           did not keep their colposcopy appointment). Additional questions are added for patients
           who did not keep their colposcopy appointment to test for differences and to learn the
           reasons for not keeping their appointment.

        -  Group 2 (written educational information): Patients receive notification of their
           colposcopy appointment and an educational letter about Pap smears, cervical cancer risk,
           and the purpose and procedure of colposcopy. They complete the standardized Spanish
           survey questionnaire as in group 1.

        -  Group 3 (phone call): Patients receive notification of their colposcopy appointment and
           a personal telephone call educating them about Pap smears, cervical cancer risk, and the
           purpose and procedure of colposcopy. They complete the standardized Spanish survey
           questionnaire as in group 1.

      All patients are asked to agree to submit residual Pap smear fluid to the Comprehensive
      Cancer Center of Wake Forest University tumor bank, and be included in a tracking system to
      insure future follow-up communications.
    

Intervention name(s): educational intervention; questionnaire administration; study of socioeconomic and demographic variables; survey administration
Intervention type(s): Other; Other; Other; Other
Primary purpose: Health Services Research
Keywords: cervical cancer
Effects of Bupropion in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will investigate the role of dopaminergic neural systems in the symptoms and
      treatment of depression. 40 patients who meet DSM-IV criteria for a diagnosis of depression
      will be compared to a matched sample of healthy controls. The depressed group will receive
      open label treatment with Bupropion MR (150mg bd) for 6 weeks. The control group will receive
      no treatment. All participants will be assessed before treatment, after 2 weeks treatment and
      at 6 weeks treatment. The outcomes assessed will be 1) fMRI estimates of neural response to
      reward to emotionally valenced stimuli (1st and 2nd assessments), 2) computer based measures
      of emotional processing (all assessments) and 3) standardised questionnaire measures of
      depressive symptoms (all assessments). The primary study hypothesis is that altering central
      dopamine using Bupropion will lead to altered neural responses to rewarding stimuli in the
      depressed patients (i.e. comparing fMRI outcomes between assessment visits 1 and 2). A
      secondary hypothesis is that this neural change will predict subsequent symptom response to
      the bupropion (i.e. comparing symptom scores between assessment visits 1 and 3), Lastly, the
      study will test the hypothesis that baseline differences in reward circuitry will be
      particularly associated with symptoms of anhedonia (the inability to experience pleasure).
    


Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention description(s): Bupropion MR will be given open label to all participants in the depression group. Participants will receive 150mg od for one week. The dose will then be increased to 150mg bd for the following 5 weeks. Participants in the control group will recieve no drug. Note that the study is not assessing the safety or efficacy of buprion-- it is using bupropion to assess the neural effects of altering central dopaminergic function in depressed patients.
Other intervention name(s): Zyban
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anhedonia; Dopamine; Bupropion; fMRI; emotional processing; reward
Efficacy of Ketoprofen Before Intrauterine Device Insertion
Condition: Pain Relief
Study type: Interventional
Phase: Phase 3

Summary: 
      IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix
      and straighten the uterus for proper insertion; trans-cervical actions including measuring
      uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the
      device in the uterus.
    

Detailed description: 
      To minimize the discomfort and the hazards of an IUD insertion, several measures have been
      proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical
      gel, cervical and para-cervical block, but there have not done enough studies about their
      effectiveness. According to the review published in the Cochrane, non-steroidal
      anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.
    

Intervention name(s): Ketoprofen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral non-steroidal antiinflammatory drug
Other intervention name(s): bi profenid
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor Humanized Monoclonal Antibody Injection in Combination With Methotrexate and Jamelor ® in the Treatment of Moderate to Severe Rheumatoid Arthritis
Condition: Moderate to Severe Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, parallel-group study to evaluate the
      efficacy and safety of intravenous HS628 in combination with MTX versus Actemra in
      combination with MTX, in participants with moderate to severe active rheumatoid arthritis
      (RA) who have inadequate response to current MTX therapy. The study comprises a 24-week
      treatment phase, followed by a 4-week safety observation period.
    


Intervention name(s): HS628+MTX; Actemra +MTX
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive HS628 SC injections Q4W along with MTX orally for 24-week; Participants will receive tocilizumab SC injections Q4W along with MTX orally for 24-week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery
Condition: Gastric Cancer; Colon Cancer; Pancreatic Cancer; Duodenal Cancer; Biliary Cancer; Peptic Ulcer; Inflammatory Bowel Diseases
MeSH terms: Duodenal Neoplasms; Inflammatory Bowel Diseases; Peptic Ulcer
Study type: Interventional

Summary: 
      Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition
      due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption
      function, and/or metabolic changes after surgery. The postoperative malnutrition is
      associated with low quality of life and seems to be related long-term nutritional status.
      This study is a multicenter, open-labeled prospective randomized clinical trial to examine
      the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal
      surgery by comparing the change of body weight and other nutritional parameters between the
      experiment group that is supplied with ONS and the control group without ONS.
    


Intervention name(s): oral nutritional supplement
Intervention type(s): Dietary Supplement
Other intervention name(s): Encover
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
Condition: Healthy; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine the pharmacokinetics of favipiravir in volunteers with
      hepatic impairment and in healthy control volunteers.
    


Intervention name(s): Favipiravir; Favipiravir; Favipiravir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1200 mg BID for Day 1 + 800 mg BID for Day 2-5; 800 mg BID for Day 1 + 400 mg BID for Day 2-3; 800 mg Single Dose
Other intervention name(s): T-705a; T-705a
Intervention MeSH terms: Favipiravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy; hepatic impairment; T-705a; Favipiravir
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and
      Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment
      of female participants with mild to moderate acne vulgaris (pimples).
    

Detailed description: 
      This is a single-blind (physician does not know the name of the assigned drug) and randomized
      (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and
      EE/DSG in female participants using oral contraceptive and have mild to moderate acne
      vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months
      and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The
      efficacy will be evaluated efficacy primarily through total acne lesions count, which will be
      recorded at these evaluation visits. Unused study medications will be collected and drug
      accountability will be documented. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): Ethinyl estradiol/Norgestimate (EE/NGM); Ethinyl estradiol/Desogestrel (EE/DSG)
Intervention type(s): Drug; Drug
Intervention description(s): Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.; Ethinyl estradiol/Desogestrel oral formulation will be administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
Other intervention name(s): Tricilest; Oilezz
Intervention MeSH terms: Moxifloxacin; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Desogestrel; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Ethinyl estradiol; Norgestimate; Desogestrel; Tricilest; Oilezz