bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1a/b Study on Safety of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers
Condition: Helicobacter Pylori Infected Subjects; Helicobacter Pylori Naive Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate
      the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected
      healthy volunteers.

      The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each
      containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts
      will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to
      one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each
      cohort.

      Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in
      each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the
      DSMB, as soon as the results of the safety and efficacy analyses are available.

      Up to 72 subjects collectively in Phases A & B will be recruited. depending on immunogenicity
      status.
    


Intervention name(s): CTA control; IMX101 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.; Sublingual and intradermal application of a vaccine, drug product is not yet on the market.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Schistosoma Mansoni in Mwanza Region, Tanzania
Condition: Schistosoma Mansoni
Study type: Interventional

Summary: 
      The objective of this study is to determine the strategy for mass drug administration (MDA)
      which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in
      school-aged children after 4 years of intervention.
    

Detailed description: 
      Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni.
      Despite the increasing focus on the use of praziquantel against schistosomiasis infections
      for the last three decades many areas in Sub-Saharan Africa still have high prevalences and
      intensities of schistosomiasis especially among school-age children. This is true for the
      area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and
      includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12
      years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are
      included, diagnosed and treated with praziquantel using strategies composing of a mixture of
      community wide treatment (CWT), school-based treatment (SBT) and years without treatment
      (-T). The 100 school children provided stool specimens on three consecutive days, while the
      100 first year students and 50 adults with few exceptions only provided one specimen. The
      treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT,
      CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT;
      Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.
    

Intervention name(s): Praziquantel
Intervention type(s): Drug
Intervention description(s): Six different treatment strategies with praziquantel
Other intervention name(s): no other drugs
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosoma mansoni; treatment; school children; adults
Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed
      sequentially in Axial Spondyloarthritis patients according to the internationally accepted
      guidelines to determine serum creatinine change with NSAIDs use.
    

Detailed description: 
      The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into
      2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100
      mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine
      and responded with the drug were followed up to 24th week. Those who did not respond were
      excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and
      indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again
      followed up to 24th week.
    

Intervention name(s): Indomethacin SR, 75 Mg Oral Capsule, Extended Release; Indomethacin 25 Mg Oral Capsule; Etoricoxib 90 mg; Etoricoxib 60 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily; Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily; Etoricoxib 90 mg once daily orally; Etoricoxib 60 mg once daily orally
Other intervention name(s): indomethacin; indomethacin; Etoricoxib; Etoricoxib
Intervention MeSH terms: Indomethacin; Etoricoxib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topiramate Trial for Compulsive Buying
Condition: Compulsive Shopping
Study type: Interventional
Phase: Phase 2

Summary: 
      It is a double blind controlled study to test the hypothesis that Topiramate is more
      effective than placebo in the treatment of compulsive buying, during a period of 12 weeks
    

Detailed description: 
      Compulsive buying is a prevalent disorder with no approved pharmacological treatment.
      Previous reports suggest that topiramate could be useful in reducing impulsivity in
      pathological gambling and other impulse control disorders, as well as craving in substance
      addictions. The goal of this study was to investigate the effectiveness of topiramate
      combined with brief cognitive restructuring in treating compulsive buying, compared with just
      cognitive restructuring treatment+placebo.
    

Intervention name(s): Topiramate; Cognitive restructuring intervention
Intervention type(s): Drug; Behavioral
Intervention description(s): 4 sessions of a manualized cognitive restructuring intervention for compulsive buying
Other intervention name(s): behavioral
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: compulsive buying, compulsive shopping, topiramate
Voclosporin in Healthy Japanese Volunteers
Condition: Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single-centre, double-blind, placebo controlled, randomized, ascending
      multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic
      profiles of voclosporin.
    

Detailed description: 
      Ten subjects will be randomized into each of four treatment groups to receive approximately
      0.25, 0.5, 1.0, 1.5mg/kg/dose of voclosporin vs placebo. For Day 1, subjects will be given
      oral treatment once a day; Day 2, subjects will not be given any oral treatment; Day 3-12,
      subjects will be given oral treatment twice a day; Day 13, subjects will be given oral
      treatment once a day. The duration of the study takes about 21 days (including follow up
      assessments).
    

Intervention name(s): Voclosporin
Intervention type(s): Drug
Other intervention name(s): ISA247
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Calcineurin inhibitor; Voclosporin
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
Condition: Acute Leukemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human
      umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg
      in subject for the promotion of an engraftment and prevention of graft rejection and
      Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for
      children with acute leukemia.
    

Detailed description: 
      -  Hematopoietic stem cell transplantation (HSCT) is a procedure in which progenitor cells
           capable of reconstituting normal bone marrow function are administered to a patient.
           This procedure has been used to treat adults and children with life-threatening
           hematological malignancies and congenital immunodeficiency disorders.

        -  In HSCT, therapeutic goal is an elimination of disease and enrichment of regenerating
           capacity to achieve engraftments resulting in continued generation of functional blood
           elements from the engrafted living cells. Transplantation of unrelated hematopoietic
           stem cells originating either from adult bone marrow or from peripheral blood often
           leads to graft-versus host-disease (GvHD), opportunistic infections and graft failure
           after transplantation.

        -  In HSCT, MSC have been used as a therapy for GvHD and other complications. The aim of
           MSC infusions in HSCT is to use the cells' immunomodulatory effects to promote
           engraftment and to reduce the immunological reactions giving rise to GvHD.

        -  There is a growing interest in co-transplantation of MSC and HSC to improve the donor
           outcome in the unrelated HSCT condition.
    

Intervention name(s): Human umbilical cord blood-derived mesenchymal stem cells; Human umbilical cord blood-derived mesenchymal stem cells
Intervention type(s): Biological; Biological
Intervention description(s): 1x1,000,000 hMSC/kg, IV after unrelated HSCT; 5x1,000,000 hMSC/kg, IV after unrelated HSCT
Other intervention name(s): PROMOSTEM; PROMOSTEM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cells; Allogeneic Transplantation; Engraftment; GvHD; Childhood; unrelated HSCT
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
Condition: Hypertensive Heart Disease
MeSH terms: Heart Diseases; Bradycardia
Study type: Interventional

Summary: 
      72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and
      randomly divided into research group and control group. The research group received regular
      medication against hypertension and the personalized formulas based on syndrome
      differentiation, meanwhile the control group only received the regular medication. The five
      symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and
      used for evaluation of treatment.
    

Detailed description: 
      To test the effect of Chinese herb against the hypertensive heart disease, we designed this
      randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive
      bradyarrhythmia were selected and randomly divided into research group and control group. The
      five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded.
      The research group received regular medication against hypertension and the personalized
      formulas based on syndrome differentiation, meanwhile the control group only received the
      regular medication. 2 weeks after treatment, all the symptoms were graded again.
    

Intervention name(s): Safflower (Carthamus Tinctorius) IgG4 &#X7C; Serum &#X7C; Allergy; Atropine Sulfate
Intervention type(s): Drug; Drug
Intervention description(s): The designed Chinese herb formulas; The basic treatment for heart disease
Other intervention name(s): Xuefuzhuyu
Intervention MeSH terms: Atropine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, single-center study to evaluate the mass-balance and
      pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single
      oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991.
      Subjects will be checked in to the research unit from approximately 12 hours prior to dosing
      and remain in house until greater than 90% of the administered radioactivity is collected
      from bodily excreta or until less than 1% of the administered radioactivity is recovered from
      excreta on consecutive days. This study will investigate the extent of involvement of the
      renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the
      compound's major metabolites.
    


Intervention name(s): [14C]-PD-0332991
Intervention type(s): Radiation
Intervention description(s): A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of [14C]-PD-0332991.
Intervention MeSH terms: Palbociclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Mass Balance study; Radio-labeled dose; PD-0332991
A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose
      study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL)
      and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2
      treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing
      potential) participants will be enrolled in the study so that approximately 6 participants
      will be enrolled in each treatment sequence. Each treatment sequence will consist of 2
      periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4
      nights (including Period 1 and Period 2).
    


Intervention name(s): Tofacitinib tablet; Tofacitinib Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of tofacitinib 5 mg tablet; Single 5 mL dose of tofacitinib oral solution (1 mg/mL)
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial
      fibrillation.
    

Detailed description: 
      Patients who are undergoing or who have undergone minimally invasive surgery for atrial
      fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery
      follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month,
      and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be
      documented during this time. The overall efficacy of the procedure will be assessed based on
      the freedom from atrial fibrillation at the time of transtelephonic monitoring.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible subjects will be male or females age 18-85 that have elected to undergo or have
        undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation
      
Keywords: surgery; ablation; radiofrequency; minimaze; transtelephonic monitoring
Effects of Joint Integrity Exercises Verses Mirror Therapy in Hemineglect Stroke Survivors
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of joint integrity exercises and mirror
      therapy to evaluate that which intervention is more effective to improve proprioception and
      motor function of upper limb in hemineglect stroke survivors. This will be randomized
      clinical triall study. Data will be collected from Lahore General Hospital by using
      non-probability convenient sampling technique. Patients will be divided into two groups,
      (Group A and Group B). Group A will include patients that will be treated with joint
      integrity exercises of upper limb by applying tactile stimulation, kinaesthetic stimulation
      and stereognosis. and Group B will include those patients which will be treated with mirror
      therapy of upper limb. Session will be 3 days per week. Data will be collected pre
      (baseline=0 week) and post intervention (after 6 weeks) from two groups using Nottingham
      sensory assessment, Fugl Mayer Assessment and Motor assessment scale. SPSS for windows
      software, version 25 will be used to analyze the data.
    


Intervention name(s): Joint integrity exercises; Mirror therapy
Intervention type(s): Other; Other
Intervention description(s): patients with three strokes followed by 3 sec rest period. Kinaesthetic stimulations will be given to the patients to increase proprioception proprioception in neglected limb in sitting position, the limb on the affected side of the body is supported and moved by the examiner in various directions but movement is only at one joint at a time. Stereognosis by placing the object in the patient's hand for a maximum 30 seconds with close eyes. Identification is by naming, description or by pair matching with an identical set.; A 5 cm × 35 cm mirror will be placed vertically between the upper limbs on the table, with the reflecting surface facing the uninjured limb. Patients will be asked to observe the motion of the upper limb on the uninjured side and imagine that the limb on the affected side was in motion, imagine the motion of the affected limb the same as that observed on the uninjured side, and complete 6 movements including shoulder joint forward flexion, elbow joint flexion and extension, forearm forward and backward rotation, wrist joint flexion and extension, finger extension and grasping, and thumb abduction. The participants will be asked to perform each movement for 5 min and try to reach the maximum range of motion of the joints. Training will be completed for 30 min per day) Session will be 3 days per week. Per day session will be for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Joint integrity ,Proprioception, Mirror therapy, Hemineglect
Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block
Condition: Brachial Plexus Block; Ultrasound, Interventional
Study type: Interventional

Summary: 
      In this prospective randomized controlled observer-blinded study we aimed to compare the
      efficacy of a single operator technique so called Jedi Grip and conventional technique
      requiring double operator in ultrasound guided axillary brachial plexus block.
    

Detailed description: 
      Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical
      status I to II ) undergoing elective hand, wrist and forearm surgery were prospectively
      enrolled. Patients were randomly assigned to Group C (conventional technique) or group J
      (Jedi technique). In both groups, axillary plexus blockage was provided by applying 5cc of a
      mixture of 10 cc 0.5% bupivacaine and 10 cc 2% prilocaine to the ulnar, radial, median and
      musculocutaneous nerves. Parameters such as performance time and the number of needle passes
      were recorded during procedure. Subsequently, a blinded observer evaluated and recorded
      parameters related to the success of blockage. The main outcome variable was performance time
      and success rate (surgical anesthesia).
    

Intervention name(s): conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage
Intervention type(s): Procedure
Intervention description(s): on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the patients were randomly allocated to one of the two groups as Group C (conventional two-operator axillary brachial plexus blockage) and Group J (axillary brachial plexus block with single operator using Jedi grip)
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Brachial Plexus Block, Ultrasound-Guided, Jedi Grip, Double operator peripheric nerve block
Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic
      Solution in subjects with mild to moderate dry eye disease.
    

Detailed description: 
      This is a single-center, dose escalation, randomized, double-masked, placebo-controlled,
      Phase 1/2a trial designed to evaluate the safety and tolerability of P-321 Ophthalmic
      Solution in subjects with mild to moderate dry eye for up to 4-weeks of treatment and up to 8
      scheduled in clinic visits. This study will conduct a consecutive dose escalation of the
      following concentrations of P-321 Ophthalmic Solution given two times a day via ocular
      instillation: 0.0005% (Cohort 1), 0.0015% (Cohort 2), 0.005% (Cohort 3), and 0.01% (Cohort
      4). Up to 48 subjects will be enrolled in four consecutive cohorts. Subjects will be
      randomized to P-321 Ophthalmic Solution or placebo in a 3:1 ratio.

      Safety and tolerability assessments, drug plasma concentrations and drug urine concentrations
      will be evaluated throughout the study in all cohorts.
    

Intervention name(s): P-321 Ophthalmic Solution; P-321 Ophthalmic Solution placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to match P-321 Ophthalmic Solution
Other intervention name(s): P-321; placebo
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry eye disease