bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
Condition: Colonoscopy; Endoscopy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to test the effect of a bowel preparation and boosts regimen on
      PillCam® procedure, colon cleanliness and capsule excretion time.
    

Detailed description: 
      Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm.
      Following the analysis of the first phase results, and per need, 30 more subjects may be
      enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order
      to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per
      need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).
    

Intervention name(s): PillCam® COLON 2 procedure using MgC boosts; PillCam® COLON 2 procedure using Suprep boosts; PillCam® COLON 2 procedure using reduced dose of Suprep boosts
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.; Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts; Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CE; colonoscopy; colon; Eligable for colon evaluation
Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study.
Condition: Bile Reflux Gastritis; Gastric Cancer; Helicobacter Pylori Infection; Intestinal Metaplasia; Precancerous Lesions
MeSH terms: Stomach Neoplasms; Gastroesophageal Reflux; Gastritis; Bile Reflux; Metaplasia
Study type: Observational

Summary: 
      To explore the effects of bile reflux on gastric cancer and its precancerous lesions, so as
      to better prevent the occurrence and development of gastric cancer.
    

Detailed description: 
      This study was a multicenter cross-sectional study. Patients were consecutively enrolled and
      divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis
      group, according to histopathological results. The bile reflux detection rate and
      Helicobacter pylori infection status were recorded for each group.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients are from several centers all around the China
      
Keywords: gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS
      H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia
      patients
    


Intervention name(s): deep TMS H-coil
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Condition: Menopause
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to
      compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream
      on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or
      oophorectomy.
    

Detailed description: 
      The study will include a screening period up to 4 weeks and a 12- week treatment period. The
      overall study duration for participants will be approximately 16 weeks. Study participants
      will undergo physical and gynecological exams, and blood tests for clinical laboratory
      assessments. All patients with a uterus will undergo transvaginal ultrasound.
    

Intervention name(s): DR-2041a; DR-2041b; Placebo; Placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter; 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Other intervention name(s): Synthetic conjugated estrogens, A; Synthetic conjugated estrogens, A
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vaginal atrophy; vaginal dryness; vaginal itching; vaginal pain
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
Condition: Arterio-Venous Fistula; Kidney Failure, Chronic; Kidney Diseases; Renal Failure Chronic; ESRD; Arteriovenous Fistula Thrombosis
MeSH terms: Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic; Thrombosis; Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      This is a prospective single arm study enrolling patients who are scheduled for creation of a
      new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with
      upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the
      VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up
      period in this study will be for a duration of 12 months, with follow up visits scheduled at
      1, 3, 6, 9, and 12 months.
    


Intervention name(s): VasQ
Intervention type(s): Device
Intervention description(s): VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laparscopic Hernioplasty in Recurrent Inguinal Hernia
Condition: Recurrent Inguinal Hernia
MeSH terms: Recurrence; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The purpose of this study was to compare between laparoscopic transabdominal preperitoneal
      (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal
      hernia.
    

Detailed description: 
      The primary objective in this study was to compare postoperative pain between the TAPP group
      and the TEP group. The secondary objective was to compare operative time, intraoperative
      complications (bleeding, bowel injury, vascular injury), postoperative complications
      (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with
      possible risk factors which include gender, age, BMI ,cord lipomas and location of the
      hernia.
    

Intervention name(s): Transabdominal preperitoneal (TAPP) using polyprolene mesh; Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
Intervention type(s): Procedure; Procedure
Intervention description(s): Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh; Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients diagnosed with recurrent inguinal hernia. The study population were randomly distributed into 2 groups by computer generating program; group (1) included patients who had Transabdominal preperitoneal (TAPP) approach while group (2) included patients who had Total extraperitoneal (TEP) approach.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: TAPP; TEP; Laparoscopic Inguinal Hernia; Recurrent hernia
Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma
Condition: Asthma; Children; Physical Activity
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This proposal will address the existent gaps in the literature by identifying barriers and
      facilitators to participation in physical activity in inner-city minority elementary
      schoolchildren with asthma, more that half of whom are also overweight; developing and
      refining a school-based intervention in partnership with the community to improve physical
      activity; and conducting a pilot randomized controlled trial of the intervention to determine
      feasibility and obtain preliminary data for a future large-scale trial.
    

Detailed description: 
      Four schools have been recruited for pilot wait-listed cluster randomized clinical trial to
      determine feasibility for a large-scaled trial. Community-based participatory research
      approach was utilized to develop an intervention that will be delivered to two schools. Two
      control schools will receive intervention during year 2 of the study.
    

Intervention name(s): asthma physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): School- and community-based intervention includes several components: a classroom-based physical activity program, asthma awareness week at the school, asthma education for parents and students enrolled in the study, collaboration with child's physician to ensure proper medical treatment of child's asthma asthma education for school personnel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: asthma; children; physical activity; school
Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the revascularization rate of the CE-marked Trevo device in large vessel
      occlusions in ischemic stroke patients.

        -  Revascularization, defined as at least TICI 2a in the vascular territory treated at end
           of the neuro interventional procedure.
    

Detailed description: 
      -  Clinical outcomes at 90 days

        -  Mortality at 90 days

        -  Device-related serious adverse events (DRSAEs)

        -  Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
    

Intervention name(s): Mechanical Thrombectomy
Intervention type(s): Procedure
Intervention description(s): The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Other intervention name(s): Trevo Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Ischemic; Thrombus; Embolectomy; Thrombectomy; Concentric; Embolus; Mechanical; Trevo
Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects
      or patients with COPD ventilated during exercise assisted by the single-limb circuit with a
      plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level
      of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for
      predicting CO2 rebreathing.
    

Detailed description: 
      Non-invasive ventilation circuit consists of single-limb tubing for inspiration and
      expiration, including a plateau exhalation valve. As exhaled gases was vented out the plateau
      exhalation valve at a constant rate, during exercise, with the increase of exhalation flow,
      single-limb circuit with a plateau exhalation valve might cause carbon dioxide(CO2)
      rebreathing. Therefore, our aim in the present study was to evaluate whether CO2 rebreathing
      occurs in COPD patients ventilated during exercise assisted by the single-limb circuit with a
      plateau exhalation valve and estimate a potential threshold for predicting CO2 rebreathing.
    

Intervention name(s): BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）
Intervention type(s): Device
Intervention description(s): See details from arm descriptions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: COPD; noninvasive ventilation; exercise; CO2 rebreathing
Galectin-3 and Placenta Accreta
Condition: Placenta Accreta
MeSH terms: Placenta Accreta
Study type: Observational

Summary: 
      Galectins are a family of carbohydrate-binding proteins that have a high affinity to
      galactosides, its protein portion is located in the nucleus and the cytoplasm with its
      carbohydrate recognition domain which has high ability to be glycosylated inside or outside
      the cell.

      They are expressed by vascular endothelium, immune cells (macrophages, neutrophils, and mast
      cells), uterus, placenta, cardiac muscle, liver, epithelium of the gastrointestinal tract,
      and many other tissues.

      Although some galectins have intracellular functions, the majority of them have extracellular
      activities, which facilitate their contribution to cell adhesion, cell activation, and
      inflammation. Galectin-3 (Gal-3) is a unique pentamer of the galectins family and it is
      involved in both physiological functions; cell growth and differentiation, and pathological
      conditions; inflammation, fibrosis, and metastasis.

      Regarding pregnancy, Gal-3 is proved to participate in angiogenesis, embryo developmental
      processes, and modulation of maternal immunity.
    


Intervention name(s): Galectin-3; Placental Galactin-3
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Measurement of Gal-3 in Serum which will be isolated from the blood samples by ELISA (Enzyme-Linked immunosorbent Assay) (R&D Systems, Minneapolis, MN, USA).; Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women
The Hand Osteoarthritis Exercise Trial
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a hand exercise intervention on
      function and osteoarthritis symptoms in persons with hand osteoarthritis .
    

Detailed description: 
      Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult
      population. The disease may have large influences on an individual's function, health related
      quality of life and participation in the society. In recently published clinical guidelines
      for management, non-pharmacological approaches are considered as core treatments.

      Several studies have demonstrated that exercise may reduce pain and improve function in
      persons with knee OA, and a similar effect is suggested for hip OA. Regarding effect of
      exercises in hand OA, available research results are limited, and randomised controlled
      trials (RCT) of good quality are needed.
    

Intervention name(s): Hand exercise program
Intervention type(s): Other
Intervention description(s): Hand exercise program three times/week for 12 weeks. In total four group sessions, otherwise home based. Weekly telephone calls from experienced physiotherapist/occupational therapist addressing adjustments of the exercise program and encouragement of program adherence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label phase I clinical study to investigate the effect of
      SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy
      subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the
      presence of Midazolam.
    

Detailed description: 
      This study aims to characterize the drug-drug Interactions (DDI) potential of SKLB1028 with
      the sensitive index substrate drug (Midazolam) in Healthy Subjects. The study consists of a
      screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a
      follow-up visit period.
    

Intervention name(s): SKLB1028; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): SKLB1028, capsule, oral; Midazolam Maleate, tablet, oral
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      This study is designed to find if the venoactive drug contained diosmin and hesperidin is
      able to work against chronic vein-specific inflammation by changing the level of Monocyte
      Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients
      with lower limb varicose veins.
    

Detailed description: 
      The study is a post-registration open-label observational prospective single-center study
      with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As,
      Pr will be invited to participate in the study.

      Those who agree, will be examined both clinically and by duplex ultrasound. Medical history
      of participants will be taken, demographic data will be collected. Blood will be drawn from
      the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by
      a visual-analog scale. Duplex ultrasound will be used in every resident to reveal
      pathological venous reflux in deep and superficial veins.
    

Intervention name(s): Diosmin / Hesperidin
Intervention type(s): Drug
Intervention description(s): Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms
Other intervention name(s): Venoactive drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b
Condition: Chronic Hepatitis C Genotype 1b
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and
      Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic
      hepatitis C (HCV) genotype 1b infection.
    

Detailed description: 
      To evaluate effectiveness and safety of treatment with Narlaprevir, Ritonavir and Daclatasvir
      combination will be selected 105 treatment-naїve patients with chronic HCV genotype 1b
      without genetic variants coding for the NS5A-Y93 С/H/N/S and/or L31 F/M/V/I amino acid
      substitutions, eligible as per protocol criteria.

      Each patient will participate in the trial approximately up to 38 weeks:

        -  2 weeks are expected for screening

        -  up to 12 weeks for treatment period

        -  24 weeks for follow-up period

      During treatment period all patient will receive equal drug combination.

      Efficacy and safety parameters will be assessed as per primary and secondary endpoints. Also
      Ctrough for Narlaprevir and Daclatasvir on day 14 will be evaluated as pharmacokinetic
      objective.

      The results of this study will provide new information about treatment of patients with
      chronic hepatitis C genotype 1 with Narlaprevir/Ritonavir in combination with Daclatasvir
      during 12 weeks.
    

Intervention name(s): Narlaprevir; Ritonavir; Daclatasvir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg, oval shaped, concave, yellow film-coated, tablets taken as 200 mg per os daily; 100 mg, tablets, taken as 100 mg per os daily; 60 mg, tablets, taken as 60 mg per os daily
Other intervention name(s): Arlansa; Norvir; Daklinza
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; chronic; 1b genotype; oral treatment
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg
      Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical
      Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg
      METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500
      mg tablet) in healthy adult subjects administered under non-fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): 5 mg/500 mg METAGLIP™ Tablets; 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 5 mg/500 mg, single-dose non-fasting; 1 x 5 mg/500 mg, single-dose non-fasting
Intervention MeSH terms: Metformin; Glipizide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects