bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MSB2311 in Advanced Solid Tumors
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a
      humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified
      subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease
      progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs
      first. The maximum treatment duration is 2 years. During the study, subjects will be
      evaluated for safety and toxicity, PK/PD, immunogenicity and anti-tumor activity of MSB2311.
    


Intervention name(s): 10 mg/kg Q2W; 20 mg/kg Q3W
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/kg MSB2311 every two weeks; 20 mg/kg MSB2311 every three weeks.
Other intervention name(s): MSB2311 10 Q2W; MSB2311 20 Q3W
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: MSB2311 IV at 10 mg/kg Q2W, 20 mg/kg 3QW
Masking: None (Open Label)
Primary purpose: Treatment
Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Bronchial asthma is a common disease and frequently encountered disease of respiratory
      apparatus. It has very complex mechanism and multiple inducing factors. This study will focus
      on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal
      and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice.
      The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial
      asthma, and provide an effective therapy for this disease.
    


Intervention name(s): warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum; clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum; securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum; Theophylline Sustained-release Tablets and budesonide suspension
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): warming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day; clearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day; securing origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day; Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day
Intervention MeSH terms: Budesonide; Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bronchial asthma; cold type; heat type; Asthenia type; TCM syndrome; symptoms; physical signs
Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Risperidone Tablet 1 mg of Ipca Laboratories Limited, India and the corresponding Reference
      Product: Risperdal® (Risperidone) Tablets 25 mg of Janssen Pharmaceutica Products, USA, under
      fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 1 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 16 days including washout period of at
      least 10 days between administrations of study drug in each study period.
    

Intervention name(s): Risperidone Tablet 1 mg; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg tablet once a day; 1 mg tablet once a day
Other intervention name(s): Test Product; Risperdal®
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Self Monitoring of Blood Glucose With Finger Tip vs. Alternate Site Sampling: Effect on Long Term Glycemic Control
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to assess the effect of using ASBG (alternate site blood glucose) versus
      FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since
      ASBG measurements appear to lag behind FSBG measurements at times of changing glucose
      concentration, it is possible that ASBG measurements will yield lower postprandial readings
      than FTBG, potentially causing a negative impact on long-term control. It is also possible
      that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve
      adherence to testing and improve long term control.
    

Detailed description: 
      Patients undergo an initial screening visit. Inclusion criteria include adults 18 -70 years
      of age with type II diabetes currently using insulin and recording SMBG measurements.
      Exclusion criteria include history of severe hypoglycemic episodes, current use of ASBG
      measurements, serious co-morbid illness or pregnancy. For eligible subjects baseline data
      including HbA1C is obtained. The goal for enrollment is 176 subjects. Subjects are randomized
      into either a fingertip or an arm-testing group within strata of baseline HbA1C. Each subject
      who does not already have one receives a One Touch Ultra® SMBG device. All subjects receive
      training in the use of this device, but for those in the arm-testing group this includes
      training on obtaining samples from the forearm. Arm- testing subjects are encouraged to use
      arm testing as much as possible but to use finger testing if they are not able to obtain a
      sample from the arm. All subjects are asked to perform SMBG testing before breakfast, before
      dinner and 2 hours after dinner and to complete diaries of all SMBG readings. At 1, 3 and 5
      months after the training visit subjects see a diabetes provider who makes adjustments in the
      therapeutic regimen based on the SMBG measurements, as they would during routine diabetes
      management. Diary sheets are then collected and the data they contain is entered into a
      database. At months 2, 4 and 7 subjects present for a visit to drop off their diary sheets.
      At months 4 and 7 they have blood drawn for HbA1C measurement. The principal outcome variable
      is level of diabetic control as measured by 7-month HbA1c. The means for each group will be
      compared, and we will test the hypothesis that glycemic control as represented by 7-month
      HbA1C is not worse for the ASBG group than the FTBG group. Secondary outcome variables are
      compliance with testing and number of hypoglycemic episodes.
    

Intervention name(s): Alternate site blood glucose testing
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alternate Site; Blood Glucose Testing; Blood Sugar Testing; Hemoglobin A1C
Exercise as a Behavioral Treatment for Cocaine Dependence
Condition: Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of exercise on cocaine use, fitness, and
      cravings for cocaine and nicotine. This study is part of an effort to develop treatments for
      cocaine abuse.
    

Detailed description: 
      This proposal represents an important research effort with considerable public health
      significance in that it will provide detailed behavioral and physiological data for a
      non-pharmacological intervention to treat stimulant addiction. Regular exercise is known to
      promote better mental and physical health, however the effects of exercise on cocaine use and
      craving in cocaine-dependent individuals has not been previously assessed. The Specific Aims
      include: 1) To evaluate the effects of regular exercise (running and walking) versus placebo
      (sitting) on basic fitness measures; 2) To evaluate the effects of exercise on objective and
      subjective measures of cocaine and nicotine use and craving. Participants will also receive a
      total of 12 sessions of a standardized series of computerized cognitive behavioral therapy
      (CCBT) modules, which are specifically designed for the treatment of cocaine addiction.
    

Intervention name(s): Sitting; Running; Walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).; Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.; Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cocaine; Exercise
Bioequivalence Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose oral bioavailability of metformin
      hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of
      Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and
      female volunteers under fed conditions
    

Detailed description: 
      This was an open-label, balanced, randomised, two-treatment, two-period, two-sequence,
      single-dose crossover bioavailability study performed on 36 healthy adult male and female
      non-smoking or light smoking volunteers and 2 alternates. A total of 36 subjects completed
      the clinical phase of the study. In each period, subjects were housed from the evening before
      dosing until after the 24-hour blood draw. Single oral 1000 mg doses were separated by a
      washout period of 7 days Of the 36 healthy adult non-smoking or light-smoking (10
      cigarettes/day) volunteers and 2 alternates (19 males, 19 non-pregnant females) enrolled in
      the study, two did not complete the clinical phase of the study. Subject No. 11 was withdrawn
      from the study by the on-duty Physician after a positive pregnancy test prior to dosing in
      Period 2 and Subject No. 20 was withdrawn from the study by the Clinical Study Manager after
      she failed to complete her breakfast prior to dosing in Period 2. Thus a total of 36 subjects
      completed the clinical phase of the study
    

Intervention name(s): metformin hydrochloride liquid 500 mg per 5 mL
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence metformin hydrochloride
Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Condition: Cardiovascular Diseases; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the feasibility, tolerability, safety, and image
      quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected
      ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims
      include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either
      SPECT or invasive angiography.
    


Intervention name(s): Lexiscan
Intervention type(s): Drug
Intervention description(s): Coronary vasodilator
Intervention MeSH terms: Regadenoson
Intervention model: Single Group Assignment
Intervention model description: Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Computed Tomography
Intranasal Dexmedetomidine Sedation at Dose of 2 mcg/kg Versus 4 mcg/kg in Children Undergoing MRI
Condition: Anesthesia; Deep Sedation; Magnetic Resonance Imaging; Pediatric ALL
Study type: Interventional

Summary: 
      This study aimed to compare the effectiveness of intranasal Dexmedetomidine sedation at Dose
      of 2 mcg/kg and 4 mcg/kg in Children Undergoing MRI at Cipto Mangunkusumo Hospital
    

Detailed description: 
      Ninety-four pediatric subjects who would undergo MRI with sedation were recruited. Subjects
      aged between 1-10 years old, ASA I-II, weighed between 1-30 kg were included in this study
      and assigned into two groups randomly. One group received 2 mcg/kg (IND2 group) and the other
      group received 4 mcg/kg (IND 4 group) of intranasal dexmedetomidine.

      Randomization was done by the third party, who was not participated in the data collection,
      by using randomization tool from www.randomizer.org.

      Dose of intranasal dexmedetomidine for each participant was concealed using closed envelope
      and was opened preprocedure by the second party who prepared the sedation drugs. The doctor,
      who gave sedation drug to the patient and recorded the data, was also blinded. All patients
      were blinded to data collection. Patients were allowed to drink clear fluid until 2 hours and
      required to fast for 6 hours before the procedure. Baseline heart rate, SpO2 was recorded
      premedication.

      Subjects in IND 2 and IND 4 group received 2 mcg/kg and 4 mcg/kg intranasal dexmedetomidine.
      Intranasal drugs were given 45 minutes before the MRI procedure through both nostrils using a
      1 mL syringe. Patient was maintained in supine position for 1-2 minutes to maximize
      absorption. After the patient was sedated, peripheral intravenous access was performed. The
      level of sedation was assessed using RSS. Heart rate, oxygen saturation, and RSS are recorded
      every 10 minutes until the procedure was done. After the target sedation has been reached,
      MRI started immediately. If the sedation target was not reached and/or the child moved, 0.5
      mg/kg rescue dose of propofol would be given. After completing the MRI procedure, the patient
      was then transferred to the recovery room to record the recovery time. Outpatients were
      allowed to go home when they reached Aldrete score of 9-10.
    

Intervention name(s): Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg
Intervention type(s): Drug
Intervention description(s): Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
Condition: HPV-related Cytological Abnormalities on PAP Smear (LSIL)
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Aim: In this project proposition the investigators would like to examine the effect of immune
      modulation by probiotics on the clearance of HPV-infections.

      This study provides a model for viral infection but also for cancer precursors. This would be
      an excellent model (and the only possible short-term model) to examine an effect on cancer
      precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically
      accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.

      Research question: Does daily intake of probiotics lead to a better immune-response in
      HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of
      cytological lesions?
    


Intervention name(s): probiotic drinkers
Intervention type(s): Dietary Supplement
Intervention description(s): HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine
      Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and
      Company for single dose in healthy male subjects, as well as to evaluate the similarity of
      the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects
    


Intervention name(s): 14028 injection; dulaglutide injection
Intervention type(s): Biological; Biological
Intervention description(s): 14028 injection, single dose, s.c. injection; dulaglutide injection(TRULICITY®), single dose, s.c. injection
Other intervention name(s): TRULICITY®
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diabetes-Specific Formula on Long Term Glycemic Control
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a
      (partial) meal replacement on long-term glycemic control and short-term glycemic variability
      in individuals with type 2 diabetes.
    

Detailed description: 
      This is a randomized, controlled, parallel study. Eligible participants will be randomly
      allocated (at 1 :1 ratio) to one of two groups: DSF group or control group.The total expected
      duration of the study is 97 days.

      There are two periods in the study:

      i) "Run-in Period" (Study Days -6 to -1): participants will wear the CGMS:Continuous Glucose
      Monitoring System (FreeStyle Libre Pro) and will be asked to follow and track their diet and
      physical activity on a daily basis.

      ii) "Intervention Period" (Study Days 0 to 90): participants will be randomized into one of
      the two groups (n = 125 per group): DSF group or control group.
    

Intervention name(s): Diabetes-Specific Formula; Standard Of Care
Intervention type(s): Other; Other
Intervention description(s): Diabetes-Specific Formula and Standard of Care; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Determine the effects of a diabetes-specific formula [1-2 servings per day as a (partial) meal replacement] in addition to standard of care on HbA1c level, in comparison with the standard of care only
Masking: None (Open Label)
Primary purpose: Supportive Care
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Condition: Androgenetic Alopecia; Male Pattern Baldness
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 2

Summary: 
      Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and
      regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at
      low level through regulation by GSK-3, multifunctional serine/threonin kinase. After
      phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore,
      inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce
      growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for
      decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been
      studied yet.
    


Intervention name(s): Valproic Acid; Control placebo
Intervention type(s): Drug; Drug
Intervention description(s): spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks; spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of MgSO4 for Pain After Bariatric Surgery
Condition: Therapeutic Opioid Induced Constipation (Disorder)
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of magnesium sulfate on pain
      management for pain after sleeve gastrectomy operation
    

Detailed description: 
      The purpose of this study is to investigate the effect of magnesium sulfate on pain
      management for pain after sleeve gastrectomy operation.

      Design: A prospective, randomized, controlled clinical study.

      Setting: University hospital.

      Participants: Eighty patients undergoing sleeve gastrectomy.

      Measurements and Main Results: Visual analog scale for pain score, sedation score, mean
      arterial pressure, heart rate, and valid and invalid analgesic demand will record. Serum
      magnesium levels will determined at preoperative evaluation, postanesthesia care unit
      admission and at 24 hours. Side effects will also record.
    

Intervention name(s): Magnesium
Intervention type(s): Drug
Intervention description(s): The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients undergoing sleeve gastrectomy.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: sleeve gastrectomy; magnesium sulfate; postoperative pain; bariatric surgery