bioihbjkbjnl/mcl2 huggingface dataset:
Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
Condition: Gastritis; H Pylori Infection; Dyspepsia
MeSH terms: Gastritis; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans
      Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule ,
      Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus
      Coagulans may have some positive effect on H. pylori eradication.
    

Detailed description: 
      The study will include three phases: screening, treatment and follow-up. Screening: during
      this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy
      and Urea Breath test will be performed in addition to the baseline routine evaluations.

      Treatment: Subjects are randomly assigned to treatment and will be treated for 8weeks.

      Follow-up: includes one visits. Eradication of H. Pylori will be confirmed through urea
      breath test(UBT).
    

Intervention name(s): Clostridum Butyricum Capsule; Bacillus Coagulans Tablets; Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks; Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks; Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastritis; H Pylori Infection
The Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, multicenter, open-label, multiple-dose Phase I study to investigate
      the safety, tolerability, and initial efficacy of HX009 in subjects with advanced malignant
      tumors. The study will consist of a dose-escalation and dose-finding component to establish
      the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and to evaluate the
      preliminary antitumor activity of HX009.
    

Detailed description: 
      The study will follow a 3+3 dose-escalation scheme enrolling cohorts of at least 3 subjects
      sequentially at escalating doses. During study treatment, subjects will receive HX009
      treatment via intravenous infusion once every 2 weeks. Dose escalation will continue until
      identification of an MTD or the maximum dose is reached. Dose-limiting toxicities (DLTs) will
      be assessed from the first dose of study treatment (Day 1) until 28 days later (Day 29).

      The study is divided into a screening period (28 days before first dose), treatment period
      (up to 24 months), and survival follow-up period. Safety will be evaluated throughout the
      study up until 90 (±7) days after the last dose of study treatment. Blood samples will be
      collected at regular intervals for pharmacokinetics (PK) and immunogenicity evaluation. Tumor
      evaluation (assessed by the Investigator in accordance with Response Evaluation Criteria in
      Solid Tumors Version 1.1 [RECIST 1.1] and immune RECIST [iRECIST]) to assess efficacy will
      start from the first dose and occur every 8 weeks in the first 12 months and every 12 weeks
      in the second 12 months and during the survival follow-up period.
    

Intervention name(s): HX009
Intervention type(s): Drug
Intervention description(s): During study treatment, subjects will receive HX009 treatment via IV infusion once every 2 weeks at doses of 0.1, 0.3, 1, 2, 3, 5, and 7.5 mg/kg.
Other intervention name(s): anti-PD-1/CD47 infusion protein
Intervention model: Single Group Assignment
Intervention model description: HX009
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction
Condition: Sinus Node Dysfunction
MeSH terms: Sick Sinus Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Providing ideal rate response to patients should improve their quality of life and ability to
      execute activities of daily living.

      Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to
      specify an "activities of daily living" (ADL) response rate and an "exertion" response rate.
      There is much data to support the target heart rate for an exercise response but the data to
      support the programming of the ADL rate is lacking.
    

Detailed description: 
      Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to
      specify an "activities of daily living" (ADL) response rate and an "exertion" response rate.
      There is much data to support the target heart rate for an exercise response but the data to
      support the programming of the ADL rate is lacking.

      Unpublished Holter data from our center indicates that the ADL rate for most patients in our
      practice is between 50-70bpm rather than 95bpm. Moreover, this increased ADL rate may impact
      diastolic filling times and adversely impact cardiac output.
    

Intervention name(s): Reprogramming dual chamber pacemaker
Intervention type(s): Device
Intervention description(s): Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
Other intervention name(s): Medtronic dual chamber pacemaker
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or
        chronotropic incompetence defined as exercise heart rate less than 100 beats per minute
      
Keywords: Sinus Node Dysfunction
Investigation of Awareness Levels of Women Living in Turkey About Kegel Exercises and Pelvic Floor Muscles
Condition: Female Sexual Dysfunction
Study type: Observational

Summary: 
      Pelvic floor disorders affect millions of women and their lives in our country and around the
      world. Along with many factors such as age, obesity, menopause, smoking, number of births and
      mode of delivery, there is an increase in the prevalence of pelvic floor disorders. Pelvic
      floor disorders (urinary/fecal incontinence, pelvic organ prolapse, chronic pelvic pain,
      sexual dysfunction) negatively affect women, their families, caregivers of individuals who
      cannot meet their own needs, and society in many ways. Treatment of pelvic floor disorders is
      very costly on a community basis. An effective process is carried out with the use of
      non-pharmacological traditional and complementary therapies instead of invasive or
      pharmacological treatment in the early period of the treatment of symptoms of pelvic floor
      disorders.
    

Detailed description: 
      Pelvic floor muscle training has a positive effect on voiding functions by strengthening the
      urogenital sphincter muscle. One of the commonly used methods for pelvic floor muscle
      training is the so-called Kegel exercise.

      Sexual life, with its personal and social aspects, is an inseparable part of human beings in
      general, it is one of the most important factors in human life and happiness, especially in
      family life. Sexuality positively integrates and enriches the somatic, emotional,
      intellectual and social aspects of individuals, and develops personality, communication and
      love.

      Kegel exercises; It is a method for strengthening the muscles that fix the bladder,
      intestines and genital organs in the pelvis and control their movements. These are tightening
      and relaxation exercises that strengthen the pelvic muscles. Like all voluntary muscles, the
      pelvic floor muscles are muscles that get stronger and develop as they work. Women of all
      ages need to have strong pelvic floor muscles.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Individuals who will participate in the study will be reached through online platforms. A
        questionnaire will be sent to the participants via the Google search engine and they will
        be asked to fill it out.
      
Keywords: exercise; kegel exercise
Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section
Condition: Hysterotomy Closure
Study type: Interventional

Summary: 
      Prospective single blinded trial comparing standard synthetic suture material to a synthetic
      barbed suture in closure of uterine incision, during Cesarean section procedures.
    

Detailed description: 
      Cesarean section is one of the most common medical procedures women of child bearing age
      undergo, in the United States and the world. This trial is designed to provide information
      and possible recommendation as to suture material used during closure of the uterus during
      that procedure. Our intent is to provide data relating to time of uterine closure, blood
      loss, and post operative pain. These conclusions may provide substantiated recommendations as
      to self locking and tying suture material in the performance of cesarean section as related
      to readily available synthetic suture material, which has the need for standard suture knot
      placement.
    

Intervention name(s): Stratafix synthetic barbed suture
Intervention type(s): Procedure
Intervention description(s): hysterotomy closure in Cesarian section
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery
Condition: Cataract; Anterior Chamber Inflammation; Pain, Postoperative
MeSH terms: Cataract; Inflammation; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the
      EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with
      implantation of a monofocal posterior chamber intraocular lens (IOL).
    

Detailed description: 
      This will be a Phase 2b, double-masked, multi-site study, in which a total of up to 100 eyes
      of up to 100 subject will be enrolled at up to 8 clinical sites in the United States. The
      study has 2 different treatment arms consisting of the following iontophoresis treatment
      regimen:

      Treatment Arm 1, up to 50 subjects will receive the following study treatment:

      40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of
      4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours'
      post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for
      subjects who have ≥11 AC cells per high-power field on slit lamp examination.

      Treatment Arm 2, up to 50 subjects will receive the following study treatment:

      100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment
      consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1
      (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be
      administered for subjects who have ≥11 AC cells per high-power field on slit lamp
      examination.

      Subjects will come in for 6 visits over 28 days.

      The primary efficacy endpoint (PEP) will evaluate 1) the proportion of subjects with an AC
      cell count of zero on Day 7 and 2) the proportion of subjects with a pain score of zero on
      Day 1.
    

Intervention name(s): Dexamethasone phosphate; Placebo
Intervention type(s): Combination Product; Other
Intervention description(s): Ocular iontophoretic delivery of a steroid; Ocular iontophoretic delivery of a placebo
Other intervention name(s): Sodium Citrate Buffer
Intervention MeSH terms: Dexamethasone; Sodium Citrate; Dexamethasone 21-phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-masked, randomized, placebo-controlled, multi-center, Phase 2b clinical trial designed to evaluate the efficacy and safety of transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients having undergone cataract surgery with implantation of a monofocal posterior chamber IOL.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laparoscopy-Assisted Transgastric ERCP
Condition: Biliary Obstruction
Study type: Observational

Summary: 
      We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a
      laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the
      common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. The
      presentation of the case is presented as well a review of the literature.
    

Detailed description: 
      The exclusion of the stomach after Roux-en-Y-Gastric bypass (RYGB) makes access to the
      biliary tree very challenging for the surgeon or the endoscopist. There are different
      techniques described to overcome this downside, being laparoscopic assisted trans-gastric
      endoscopic retrograde cholangiopancreatography (ERCP) approach an outstanding method to
      access the remnant stomach for reaching the duodenal papilla, with a high rate of success
      reported. We describe a case of a 57-year-old patient with altered RYGB anatomy, who
      underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone
      on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully
      performed, introducing the duodenoscope through a gastrostomy without the need of an
      intra-gastric trocar. The patient evolved favorably and was discharged on his second
      postoperative day without complications.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with altered Roux en Y Gastric Bypass anatomy
      
Keywords: biliary disease; gallstones; obesity
Assessment of Chiropractic Treatment: Strength and Balance
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study is a randomized controlled trial designed to compare the effects of 4 weeks of
      chiropractic care to a waitlist control group on measures of strength, balance, and endurance
      in military personnel experiencing non-surgical low back pain.
    

Detailed description: 
      This study will assess three functional outcomes (strength, balance and endurance) and
      patient-reported outcomes in participants with low back pain (LBP) treated with chiropractic
      care, providing evidence that may enhance our understanding of the relationship between
      functional outcomes and chiropractic care. The findings from this study may support the use
      of chiropractic care for military personnel as an effective, conservative treatment for low
      back pain that may also help preserve or improve functional outcomes and thus, allow active
      duty personnel to better perform the physical demands required of them.
    

Intervention name(s): Chiropractic manipulative therapy
Intervention type(s): Procedure
Intervention description(s): We will set an a priori treatment schedule of 8 visits at a frequency of 2 visits per week over a 4 week period. CC participants will receive chiropractic manipulative therapy (CMT). CMT procedures can be broadly divided into two types, thrust and non-thrust. Thrust CMT is a high-velocity low-amplitude procedure characterized by a single, short duration thrust (ranging from 100 to 500 ms) of low amplitude force applied to a target joint that often results in an audible sound, or cavitation. Non-thrust CMT employs low-velocity and often repeated joint movements of varying amplitude. In the event that no CMT treatment is clinically indicated, treatment will not be provided.
Other intervention name(s): Spinal manipulative therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chiropractic Manipulative Therapy; Low back pain; Trunk muscle strength; Balance; Active military personnel
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose
      combination and co-administration of the individual components under fasting conditions in
      healthy Korean volunteers.
    

Detailed description: 
      40 healthy subjects are administered the corresponding drug for each period, and the drug
      wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours.
      Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety
      are evaluated.
    

Intervention name(s): SIPS-2209-1; SIPS-2209-2, SIPS-2209-3
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; Fixed-dose combination; Bioequivalence
Fluid Kinetics in Patients With Diabetic Ketoacidosis
Condition: Diabetes
MeSH terms: Ketosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      The purpose with the study is to follow the fluid shifts that occur during fluid
      resuscitation of patients with diabetic ketoacidosis.

      In the study measurements of changes in blood and urine concentrations of Sodium and Chloride
      as well as blood hemoglobin are used to mathematically calculate changes in distribution
      volumes of these different endogenous markers.
    

Detailed description: 
      Patients treated for diabetic ketoacidosis receive 1000 ml of Sodium Chloride during the
      first 30 minutes of treatment.

      Before, during and after this infusion regular blood samples(and urine) are collected (0, 10,
      20, 30, 35, 40, 45, 50, 60, 120, 180 and 300 minutes after infusion start).

      B-Hemoglobin, P-Albumine, B-Glucose, P-Sodium, P-Potassium. P-Chlorides, U-Sodium, U-Chloride
      and U-Glucose. Hourly volume of urine is measured.

      The 30 minute infusion can be used to calculate the urine extracellular volume. Thereafter
      during infusion of Ringers acetate changes in electrolytes in blood as well as urine volume
      and in the urine excreted electrolytes can be used to calculate the fluid shifts between the
      different fluid compartments.

      Eventually 8 to 12 hours later a second infusion of SodiumChloride is as a control performed.
    

Intervention name(s): SodiumChloride
Intervention type(s): Drug
Intervention description(s): Infusion of SodiumChloride, blood samples to calculate extracellular volume.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes; Ketoacidosis; fluid shift
Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  This trial is conducted to assess pharmacokinetic characteristics of valproic acid when
           valproic acid single treatment and valproic acid & ertapenem combination treatment

        -  This trial is performed to evaluate safety of the combination treatment compare with
           single treatment

        -  The investigators carry this trial out to study mechanism of combination treatment
    


Intervention name(s): Valproic acid and Ertapenem
Intervention type(s): Drug
Intervention MeSH terms: Ertapenem; Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: valproic acid; ertapenem
Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the
      management of subjects with type-II-diabetes mellitus and to determine the minimal effective
      dose of DLBS 32 for subjects with type-II-diabetes mellitus.
    


Intervention name(s): DLBS-32; DLBS-32; DLBS-32; DLBS-32; Placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): DLBS-32 50 mg once daily and lifestyle modification; DLBS-32 100 mg once daily and lifestyle modification; DLBS-32 200 mg once daily and lifestyle modification; DLBS-32 300 mg once daily and lifestyle modification; Placebo capsules once daily and lifestyle modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes mellitus; DLBS-32; fasting plasma glucose; insulin resistance
Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Condition: Degeneration of Lumbar Intervertebral Disc
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study is designed to evaluate the feasibility of recombinant human bone morphogenetic
      protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® )
      for anterior lumbar interbody fusion in patients with degenerative disc disease.
    


Intervention name(s): rhBMP-2/ACS/LT-CAGE® Device; Autograft/LT-CAGE® Device
Intervention type(s): Device; Device
Intervention description(s): rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGE® device.; LT-CAGE® device filled with autogenous bone taken from the patient's iliac crest
Other intervention name(s): Recombinant human bone morphogenetic protein-2; Autogenous bone graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative Disc Disease; Symptomatic Degenerative Disc Disease
Golden Black Seed: Support of Metabolic Health and General Wellness.
Condition: Hyperlipidemias; Hyperglycemia
MeSH terms: Hyperglycemia; Hyperlipidemias
Study type: Interventional

Summary: 
      To document effects of consuming Golden Black Seed (brand: New Chapter Inc.) on metabolic
      health and wellness in human subjects.

      Golden Black Seed contains extracts from the turmeric root (Curcuma longa) and black cumin
      seeds (Nigella sativa). Both botanicals have been used traditionally in Asian cooking, and
      also in herbal medicine for reducing inflammation.
    

Detailed description: 
      For this clinical study, human participants will be tested over a period of 8 weeks. Below is
      a simplified diagram illustrating the involvement of each human subject, where all study
      participants will be tested on three different clinic days.
    

Intervention name(s): Golden Black Seed
Intervention type(s): Dietary Supplement
Intervention description(s): 1 capsule per day for 8 weeks.
Intervention model: Single Group Assignment
Intervention model description: Open-labeled 8-week study design with evaluation at baseline, 4, and 8 weeks.
Masking: None (Open Label)
Primary purpose: Basic Science