bioihbjkbjnl/mcl2 huggingface dataset:
Outpatient Treatment of Uncomplicated Diverticulitis With Either Antibiotic or Nonantibiotic Treatment
Condition: Uncomplicated Diverticular Disease
MeSH terms: Diverticulitis; Diverticular Diseases; Diverticulum
Study type: Interventional

Summary: 
      Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional
      management includes inpatient administration of either oral or intravenous antibiotics with
      resumption of oral intake as symptoms improve. Recent literature has however questioned both
      inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are
      associated with non-negligible risks to patients. The aim of this trial is to assess the
      feasibility of a randomized controlled trial designed to determine whether nonantibiotic
      treatment of uncomplicated diverticulitis is safe in the outpatient setting.
    

Detailed description: 
      Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional
      management includes inpatient administration of either oral or intravenous antibiotics with
      resumption of oral intake as symptoms improve. Recent literature has however questioned both
      inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are
      associated with non-negligible risks to patients. The aim of this trial is to assess the
      feasibility of a randomized controlled trial designed to determine whether nonantibiotic
      treatment of uncomplicated diverticulitis is safe in the outpatient setting. It is designed
      as a pilot non-inferiority blinded randomized controlled trial. The estimated length of this
      pilot trial is 1 year. The target population is capable adults of who have a CT-diagnosed
      episode of uncomplicated diverticulitis who present to the Jewish General Hospital Emergency
      room.
    

Intervention name(s): Nonantibiotic treatment of uncomplicated diverticulitis; Antibiotic treatment of uncomplicated diverticulitis
Intervention type(s): Other; Other
Intervention description(s): Patients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.; Patients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antibiotics
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral
      administration of Exforge tab. 10/160mg, a combination formulation of valsartan and
      amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of
      valsartan and S-amlodipine as test drug in healthy male adults
    

Detailed description: 
      The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and
      S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination
      formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a
      combination formulation of valsartan and S-amlodipine as test drug in healthy male adults.
      Additionally the safety and tolerability of two drugs will be evaluated.
    

Intervention name(s): Exforge tab. 10/160mg; Lodivixx tab. 5/160mg
Intervention type(s): Drug; Drug
Other intervention name(s): amlodipine besylate; valsartan; S-amlodipine nicotinate; valsartan
Intervention MeSH terms: Niacin; Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: amlodipine; valsartan; hypertension
Dexamethasone for Preterm Labour
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators sought to determine whether the incidence of neonatal respiratory distress
      syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of
      dexamethasone.
    

Detailed description: 
      The administration of glucocorticoids to accelerate fetal lung maturity in patients with
      preterm delivery plays an important role for obstetrics and neonatal care. Many studies have
      shown that maternal administration of glucocorticoids has a significant beneficial effect in
      decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34
      weeks of gestation.
    

Intervention name(s): Dexamethasone 24 hours; Dexamethasone 12
Intervention type(s): Drug; Drug
Other intervention name(s): glucocorticoids; glucocorticoids
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Glucocorticoids; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dexamethasone; preterm labour; respiratory distress
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish bioequivalence (BE) under fed conditions between metformin in
      linagliptin/metformin fixed dose combination tablet and metformin reference product
      administered in free combination togther with linagliptin
    


Intervention name(s): Linagliptin/metformin; Metformin; Linagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FDC; single tablet Metformin; single tablet Linagliptin
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
Condition: Cerebral Palsy
MeSH terms: Hip Dislocation; Cerebral Palsy; Neuromuscular Diseases
Study type: Interventional

Summary: 
      The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in
      Patients With Severe Neuromuscular Disease
    


Intervention name(s): Hip protection orthosis
Intervention type(s): Device
Intervention description(s): Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Chest Pain Unit II Register
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Observational [Patient Registry]

Summary: 
      Multicentric, prospective, non-interventional observational study with two parts:

        1. A register of quality assurance within the recertification of clinics

        2. An extended register with scientific protocol.
    

Detailed description: 
      1. Quality assurance

           As a quality-assuring basic register, the CPU II register checks the extent to which
           certified Chest Pain Units fulfill the criteria published by the DGK. In particular, the
           following quality dimensions are evaluated:

             -  Indication quality

             -  Diagnostic quality

             -  Therapeutic quality

             -  Structural quality / networking

        2. Platform for projects with a scientific focus

      The CPU II register and the infrastructure provided are a platform for further projects with
      scientific questions (scientific protocol = WP):

      WP: Clinical history after CPU (PCI data / discharge / 12-month FUP) in patients with leading
      cardiac diagnosis
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Basic register:

        All patients who are admitted to a CPU.

        Scientific Protocol:

        All patients who are admitted to a CPU and have their consent to participate in a follow-up
        (in patients with leading cardiac diagnosis).
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
Condition: Neuroendocrine Tumors; Meningioma; Neuroblastoma; Medulloblastoma
MeSH terms: Neuroblastoma; Neuroendocrine Tumors; Meningioma; Medulloblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with
      somatostatin receptor positive tumors.
    

Detailed description: 
      This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with
      somatostatin receptor positive tumors. The somatostatin receptor targeting of the therapeutic
      will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy. Treatment consists of 3
      cycles, 6-8 weeks apart. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by
      dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the
      total renal dose.

      The goals of this project are to

        1. Demonstrate the safety and efficacy of dosimetry-guided peptide receptor radiotherapy
           using 90Y-DOTA-tyr3-Octreotide in patients with neuroendocrine and other somatostatin
           receptor expressing tumors.

        2. Monitor all adverse events associated with peptide receptor radiotherapy using
           90Y-DOTATOC.

        3. Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an
           accurate technique for diagnosis, staging, treatment targeting, and monitoring response
           to 90Y-DOTATOC therapy.
    

Intervention name(s): 90Y-DOTA tyr3-Octreotide; 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan; Amino Acids
Intervention type(s): Radiation; Diagnostic Test; Drug
Intervention description(s): 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.; 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.; This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
Other intervention name(s): 90Y-DOTATOC; Lysine and Arginine
Intervention MeSH terms: Octreotide; Edotreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and
      females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar
      disorder (type I or II) and who have met the criteria for substance abuse or dependence of
      cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a
      combination of lithium and divalproex. Once these medications are tolerated, they are
      randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in
      this study until they experience a marked bimodal response for four consecutive weeks. This
      study is sponsored by the Stanley Foundation.
    


Intervention name(s): Divalproex; Lamotrigine; Lithium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once a therapeutic blood level of lithium was achieved, Divalproex was initiated at 250 mg twice daily and increased slowly over 5 weeks to a minimum blood level of 50 μg/mL.; Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over 3 weeks to a minimum blood level of 0.5 mEqlL.; Subjects who did not respond to the combination of Lithium and Divalproex were then randomly assigned in a 1:1 ratio to adjunctive lamotrigine versus placebo after stratification by illness type (bipolar I versus bipolar II), historical response to lithium (response versus oon-response), and the length of current exposure to the combination treatment with lithium and divalproex (<2 months versus ≥2 months).
Other intervention name(s): Depakote; Lamictal; Eskalith
Intervention MeSH terms: Lamotrigine; Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Condition: Depression and Suicide
MeSH terms: Depression; Suicide
Study type: Interventional

Summary: 
      This study evaluates an accelerated schedule of theta-burst stimulation for depressive
      symptoms in psychiatric inpatients.

      A small pilot study (n=22) will be carried out to demonstrate feasibility, using the
      FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be
      offered stimulation at the anterior cingulate cortex (ACC).
    

Detailed description: 
      This study intends to investigate whether modifying stimulation parameters enables typical
      6-8 week long rTMS protocols to be compressed to only five days. The influence of this
      accelerated protocol on the length of patient stay in the hospital will be investigated.
    

Intervention name(s): Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation; Anterior Cingulate Cortex Accelerated Theta Burst Stimulation
Intervention type(s): Device; Device
Intervention description(s): Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC.
Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.; Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC).
Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit.
For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC.
If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).
Masking: None (Open Label)
Primary purpose: Treatment
Testing Mestinon and Exercise in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial was to test the combined and independent effects of 6 months of
      exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if
      Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms
      improved by the end of the trial.
    

Detailed description: 
      Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone
      when they exercise intensively. We also demonstrated that a single dose of Mestinon helped
      people make normal levels of growth hormone when they exercised in our laboratory. We wanted
      to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone
      (and related markers) normal and improve fibromyalgia symptoms.
    

Intervention name(s): Exercise; pyridostigmine; Placibo; Attention Control
Intervention type(s): Behavioral; Drug; Drug; Behavioral
Other intervention name(s): Mestinon
Intervention MeSH terms: Pyridostigmine Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; Exercise; Mestinon
Efficacy of Virtual Reality Exercises in STroke Rehabilitation: A Multicentre Study (EVREST Multicentre)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      A multicentre, randomized, two parallel group study comparing virtual reality using Wii
      gaming technology versus Recreational activities in patients receiving conventional
      rehabilitation after an ischemic stroke.

      Primary Hypothesis: Virtual reality using the Wii gaming system is more efficacious in
      improving motor function than recreational therapy among patients receiving conventional
      rehabilitation following a recent ischemic stroke.
    

Detailed description: 
      Virtual reality (VR) gaming systems are novel and potentially useful technologies that allow
      users to interact in three dimensions with a computer-generated scenario (a virtual world).
      In particular, the Nintendo Wii gaming system applies relevant concepts in rehabilitation
      (i.e. repetition, intensity, and task-oriented training of the paretic extremity) showing
      benefits in motor function improvement after stroke. While standard rehabilitation (i.e.
      physiotherapy and occupational therapy) helps improve motor function after stroke, the
      magnitude of its benefit is suboptimal. The implementation of conventional rehabilitation is
      resource-intensive and costly, usually requiring transportation of patients and affecting
      adherence. Moreover, as improvement of motor function may be achieved after multiple sessions
      over a period of rehabilitation. The duration and intensity of the rehabilitation strategy
      are important factors in its effectiveness. Some studies compared an intervention plus
      conventional physical therapy versus conventional physical therapy alone, which by necessity
      allowed for more rehabilitation time in the experimental group. This creates a bias in favour
      of the new intervention as the intensity and frequency of rehabilitation per se is known to
      directly and beneficially affect functional outcomes. Therefore, the investigators are
      proposing comparing VR Wii versus an active control [(recreational activities (RA)].
    

Intervention name(s): Recreational Activity; Wii Gaming System Arm
Intervention type(s): Other; Other
Intervention description(s): Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.; Virtual reality Wii games (tennis and bowling from Wii® Sports, and bean bag, bocce ball, ping cup, darts or shuffleboard from Wii® Game Party 3) and conventional rehabilitation.
Other intervention name(s): Virtual Reality Wii games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Stroke Rehabilitation; Ischemic Stroke; Virtual Reality; Nintendo Wii; Recreational Activity; Motor Function
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
Condition: Vulvar Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on
      postmenopausal women with vulvar vaginal atrophy.
    


Intervention name(s): Tamoxifen; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tamoxifen vaginal insert; Placebo vaginal insert
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effect of Whole Body Vibration Training on Trunk Muscle Strength, Body Composition and Performance Parameters
Condition: Health, Subjective
Study type: Interventional

Summary: 
      Whole body vibration (WBV) trainings are widely used in the field of sports medicine and
      rehabilitation. It is accepted that these trainings are a modality that can safely increase
      muscular activation and performance. However, although many exercise models have been tried
      on vibration platforms, a standard WBV program for trunk muscles has not been established. A
      total of 45 healthy individuals will be included in the study. Participants will be divided
      into 3 groups. Group 1 will perform exercises at 40hz frequency, group 2 will perform
      exercises at 25hz frequency on WBV. The control group will perform the same exercises at 0
      Hz. The training will last 6 weeks and each session consists of 5 exercises.The training
      consists of basic core exercises that the individual does with his or her own body weight.
      Each training session is approximately 30 minutes. All participants will be evaluated using
      an isokinetic strength test with a Cybex dynamometer at the beginning and at the end of the
      additional treatment protocol. In addition, balance, body composition and anaerobic
      performance of individuals will be evaluated.
    


Intervention name(s): Exercise training on whole body vibration
Intervention type(s): Other
Intervention description(s): Participants will be included in the 6-week exercise training on whole body vibration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism
Condition: Idiopathic Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Observational [Patient Registry]

Summary: 
      Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic
      hypogonadism.
    


Intervention name(s): hCG 1500 IU three times a week; Pregnyl (hCG) ampule 1500 IU/three times a week
Intervention type(s): Drug; Drug
Other intervention name(s): Pregnyl (Organon) ampule 1500 IU
Intervention MeSH terms: Chorionic Gonadotropin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Idiopathic Hypogonadotropic Hypogonadism