bioihbjkbjnl/mcl2 huggingface dataset:
High-dose Dual Therapy With Different Administration Frequencies
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a single center, randomized controlled clinical study. The enrolled patients
      are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea
      breath test. According to the declaration of Helsinki, 327 patients will be included in this
      study. After obtaining the written informed consent of the patients, HP culture and drug
      sensitivity test will be conducted on all the selected patients with the success rate,
      adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
    

Detailed description: 
      According to relevant literature research, amoxicillin TID groups (including before meal
      group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0
      TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given
      Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei
      biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital.
      The three groups were treated for 14 days respectively, and 13C urea breath test was
      performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.
    

Intervention name(s): vonoprazan; Amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): Potassium competitive acid blocker; Antibiotics for H. pylori eradication
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Dual Therapy
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to compare the absorption of four different inhalation products
      with the reference product in healthy volunteers.
    

Detailed description: 
      Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products
      and one reference inhalation product according to a five-period cross-over design. Plasma
      tiotropium levels will be measured pre-dose and over 8 hours post-dose.
    

Intervention name(s): tiotropium pMDI
Intervention type(s): Drug
Intervention description(s): inhalation
Other intervention name(s): Spiriva Respimat
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inhalation; LABA; corticosteroid
Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional

Summary: 
      OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal
      neuralgia.

      II. Evaluate the safety and tolerance of L-baclofen in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, parallel study.

      Patients are randomized to receive either L-baclofen or placebo orally at increasing daily
      doses for 1 week. Patients then continue to receive the maximum dosage acceptable for a 1
      week maintenance period.

      Patients, thereafter, may enroll in a long term open label study with L-baclofen.

      Patients are followed at 1, 3, 6, 9, and 12 months.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): L-baclofen
Intervention type(s): Drug
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: neurologic and psychiatric disorders; rare disease; trigeminal neuralgia
Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
Condition: Healthy Subjects; Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins
      in the brain and how much stays in the blood over a range of different doses. This study will
      use a medical imaging technique called Positron Emission Tomography (PET) which uses an
      imaging agent called [11C]-WAY100635.
    


Intervention name(s): GSK163090
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PET scan; healthy males
Antimicrobial Activity of Two Mouthwashes
Condition: Periimplantitis; Dental Plaque; Periodontal Diseases; Caries; Oral Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Periodontal Diseases; Dental Plaque; Peri-Implantitis; Surgical Wound
Study type: Interventional

Summary: 
      This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of
      chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the
      oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to
      control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile
      saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed
      to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to
      polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth
      with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva
      will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be
      plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be
      processed by a blinded microbiologist.
    


Intervention name(s): chlorhexidine; Polyhexamethylene biguanide; Sterile saline solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0.12% chlorhexidine solution. Samples of saliva will be collected immediately before the mouth wash and after 30, 60 and 180 minutes.; The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0,07% solution Polyhexamethylene biguanide. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.; The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of a sterile saline solution. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
Intervention MeSH terms: Biguanides; Chlorhexidine; Polihexanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: anti-infective agents; local/therapeutic use; chlorhexidine; dental desinfectants; polyhexamethylene biguanide; mouthrinse
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
Condition: Adult Attention Deficit Hyperactivity Disorder; Cocaine Dependence
MeSH terms: Hyperkinesis; Cocaine-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the
      safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine
      dependence. Since this medication has independently shown promise in helping with ADHD and
      cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD
      and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives
      of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and
      improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.
    

Detailed description: 
      Specific Aim 1: To determine the efficacy of ER-MAS in promoting cocaine abstinence and ADHD
      improvement among comorbid ADHD and cocaine-dependent patients.

      Primary Hypothesis: benzoylecgonine positive urine screens will decrease with greatest to
      least reductions from 80mg>60mg>PBO (placebo).

      Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from
      80mg>60mg>PBO.

      Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and
      impulsivity among comorbid ADHD and cocaine-dependent patients.

      Hypothesis 4: There will be greater improved CGI (clinical global impression scale) scores in
      participants receiving d-AMPH (d-amphetamine) compared to PBO.

      Hypothesis 5: ER-MAS will decrease impulsivity as measured by several self-report (Barratts
      Impulsivity Scale) and behavioral measures (Card Sort, IMT (immediate memory task), DMT
      (delayed memory task), BART) compared to PBO.

      This 14-week, three arm (two medication doses versus PBO), prospective, parallel groups,
      randomized PBO-controlled trial with a lead-in as well as medication run-up and run down
      weeks, will provide clear data on efficacy and safety for definitive Phase III trials, which
      if successful will lead to improved treatment for A-ADHD/S-SUD.
    

Intervention name(s): Placebo; Adderall-XR; Adderall-XR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo group; Adderall-XR 60mg/day; Adderall-XR 80mg/day
Other intervention name(s): Extended-Release Mixed Amphetamine Salts (Adderall-XR); Extended-Release Mixed Amphetamine Salts (Adderall-XR)
Intervention MeSH terms: Amphetamine; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Cocaine; Treatment
The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC
Condition: Head and Neck Squamous Cell Carcinom; Nasopharyngeal Carcinoma
MeSH terms: Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to
      evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of
      JS004, define the RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered
      IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated
      until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0,
      withdrawal of consent, or end of the study, whichever occurs first.Disease progression must
      be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of
      progression.
    


Intervention name(s): JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; JS001 and JS004
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; 600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      Hepatitis C Virus is constantly evolving genetically, particularly in response to the immune
      system. This is an observational study to examine if immunosuppressants particularly
      calcineurin inhibitors taken by transplant patients in order to avoid organ rejection causes
      predictable changes in the genetics of this virus that might be important in order to treat
      it effectively.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        solid organ transplant patients
      
Biospecimen description: 
      viral RNA
A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this trial is to select an optimum dose may be selected based on bronchodilator
      efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.
    


Intervention name(s): Tiotropium bromide; Tiotropium bromide; Tiotropium bromide; Tiotropium bromide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): inhalation solution administered via Respimat in 3 different doses; inhalation solution administered via Respimat in 3 different doses; inhalation solution administered via Respimat in 3 different doses; inhalation solution administered via Respimat in 3 different doses
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women
Condition: Vertical Disease Transmission; HBV
MeSH terms: Hepatitis B
Study type: Observational

Summary: 
      Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral
      therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual
      activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical
      HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The
      study hypothesis is a major reduction of the risk of HBV vertical transmission.
    

Detailed description: 
      Mother-to-Child HIV transmission has been dramatically reduced by the use of combined
      antiretroviral therapy in HIV-infected pregnant women, both in developed and in developing
      countries. Among the most often used drugs, several have dual activity, against HIV and HBV:
      lamivudine, emtricitabine, tenofovir; they can be used as a combo, as tenofovir+emtricitabine
      for instance. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women
      are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV
      vertical transmission in this context, justifying this retrospective study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All children born in the Maternity Department, Lariboisiere Hospital, Paris, France, from
        HIV-HBV co-infected women
Study of the Effect of Food Intake on the Bioavailability of XC221 100 mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective of the study: evaluation of the effect of food intake on the
      bioavailability of XC221 100 mg tablets after a single oral administration in fed or fasted
      condition.

      Additional objective of the study: evaluation of pharmacokinetic parameters, safety and
      tolerability of XC221 100 mg tablets in healthy volunteers after single oral administration
      in fed or fasted condition.
    


Intervention name(s): XC221 100 mg tablets
Intervention type(s): Drug
Intervention description(s): XC221, 3 discrete doses separated by 7-day wash-out periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser
Condition: Capsulorhexis
Study type: Interventional

Summary: 
      The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of
      centration of the capsulorhexis- scanned capsule centration and pupil centration. It is
      hypothesized that scanned capsule centration provides more uniform(25% better) overlap of
      capsulorhexis margin over IOL optic compared to pupil centration.
    

Detailed description: 
      50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned
      capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs
      will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping
      the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be
      calculated.

      Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs
      or poor quality images.
    

Intervention name(s): capsulorhexis
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: capsulorhexis; IOL centration
First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of
      BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy
      male volunteers
    


Intervention name(s): BCD-147
Intervention type(s): Biological
Intervention description(s): Bispecific anti-HER2 monoclonal antibody
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of D-serine in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine whether increasing D-serine within the body will improve negative
      symptoms and cognitive impairments in people with schizophrenia.
    

Detailed description: 
      Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans
      each year. Schizophrenia can be extremely disabling, causing people to hear voices,
      experience paranoia or hallucinations, believe that others are controlling their thoughts,
      and even fail at maintaining a job or caring for themselves. Current medications help to
      relieve most of these symptoms, but not all. Some people with schizophrenia still suffer from
      negative symptoms, such as difficulty with talking, expressing emotions, and motivation; they
      may also suffer from cognitive impairments, such as decreased concentration and memory loss.
      D-serine, an amino acid found within the body, activates brain cell receptors that appear to
      play a role in learning and memory. This study will determine whether adding a D-serine
      solution to a stable antipsychotic medication regimen will decrease negative symptoms in
      people with schizophrenia.

      Participants in this open-label study will remain on their regular medication regimen for at
      least 2 weeks. During this time and before starting treatment, participants will be
      interviewed about their emotional problems, marital status, education, family background,
      employment history, and any drug or alcohol problems. Participants will also undergo a
      physical exam, an electrocardiogram (EKG), vital sign measurements, psychological tests,
      cognitive tasks, and an electroencephalogram (EEG). Participants will then begin 4 weeks of
      treatment with D-serine. In addition to participants' regular medication regimen, they will
      drink a D-serine powder mixed with water twice daily. Every 2 weeks, participants will
      undergo a physical exam and an interview about any changes in symptoms or emotional problems
      that they may be experiencing. Blood and urine samples will be taken throughout the study.
      After 4 weeks, participants will undergo an EKG, EEG, and the same psychological tests and
      cognitive tasks completed prior to treatment. A follow-up visit will occur 2 weeks
      post-treatment to monitor any changes in negative symptoms.
    

Intervention name(s): D-serine; D-serine; D-serine; D-serine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Negative symptoms; NMDA; Glutamate; Glycine