bioihbjkbjnl/mcl2 huggingface dataset:
Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effect of disease-modifying anti-rheumatic drugs
      (DMARDs) dose reduction in patients with rheumatoid arthritis (RA).

      Remission is the treatment target in RA, but knowledge about the best way to treat RA
      patients who achieve sustained remission is limited. DMARDs have potential serious adverse
      events, and biologic DMARDs are costly to the society. The objectives for ARCTIC REWIND are
      to assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients
      in sustained remission, to study predictors for successful tapering and withdrawal of DMARDs
      in this patient group, and to study cost-effectiveness of different treatment options in RA
      remission.

      ARCTIC REWIND is a randomized, open, controlled, parallel-group, multicenter, phase IV,
      non-inferiority strategy study. Patients with less than five years of disease duration and
      stable remission for at least 12 months are randomized to either continued stable treatment
      or tapering and withdrawal of DMARDs, including tumor necrosis factor (TNF) inhibitors and
      synthetic DMARDs. Patients are assessed by clinical examination, patient reported outcome
      measures, ultrasonography, MRI and X-ray, and monitored for adverse events. The primary
      endpoint of the study is the proportion of patients who are non-failures (have not
      experienced a flare) at 12 months. Secondary endpoints include composite disease activity
      scores and remission criteria, joint damage and inflammation assessed by various imaging
      modalities, work participation, health care resource use and health related quality of life.
    


Intervention name(s): TNF inhibitors; Synthetic DMARD(s); Co-medication: Synthetic DMARDs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Synthetic DMARDs given as co-medication for TNF inhibitors as appropriate.
Intervention MeSH terms: Tumor Necrosis Factor Inhibitors; Antirheumatic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Carcinoma in Situ
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
      during surgery followed by external-beam radiation to the entire breast may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery
      followed by whole-breast radiation therapy in treating women who have undergone lumpectomy
      for ductal carcinoma in situ or invasive breast cancer
    

Detailed description: 
      OBJECTIVES:

        -  Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute
           complications after lumpectomy (before whole breast irradiation) in women with ductal
           carcinoma in situ or invasive adenocarcinoma of the breast.

        -  Determine the local recurrence rates in patients treated with this regimen.

        -  Determine the cosmetic outcome in patients treated with this regimen.

      OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of
      radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy
      to the entire breast 5 days a week for 5-6 weeks.

      Patients are followed at 1 month and then every 3 months for 2 years.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
    

Intervention name(s): adjuvant therapy; conventional surgery; intraoperative radiation therapy
Intervention type(s): Procedure; Procedure; Radiation
Intervention description(s): Patients undergo excisional biopsy or surgery.; Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; ductal breast carcinoma in situ; breast cancer in situ
Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison
      with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The participants were selected from patients admitted to three different medical hospitals
        namely Mahatma Gandhi Hospital, New Pargaon, Sub district Government Hospital, Kodoli and
        Yeshwant Chavan Hospital, Kodoli
      
Keywords: chlorhexidine; gingivitis; periodontitis
Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery
Condition: Caudal Block
Study type: Interventional
Phase: Phase 1

Summary: 
      One of the most commonly used regional anesthetic techniques in pediatric surgeries is the
      caudal epidural block. Its main disadvantage remains the short duration of action. Hence,
      different additives have been used. Dexmedetomidine as an additive to the local anesthetic
      bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so
      is dexamethasone. The investigators aimed to study the effect of combining both additives in
      the duration of analgesia, decreasing side effects and decreasing anesthetic doses
    

Detailed description: 
      Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21)
      (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine
      0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and
      groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine
      0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and
      sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic
      request was recorded.
    

Intervention name(s): Dexamethasone; Dexmedetomidine; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs; Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics; local anesthetic agent
Other intervention name(s): decadron; precedex; plain marcaine
Intervention MeSH terms: Dexamethasone; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Sixty-three patients with ASA I-II aged from 1-6 years scheduled for hypospadias surgery in Abu El-Resh pediatric Hospital-Cairo university, were included in this prospective randomized double-blinded clinical study. Patients with contraindication to caudal anesthesia, cardiovascular diseases, drug allergy, type I diabetes, clotting disorders, mentally retarded children or those whose families did not approve inclusion in the study were excluded from the study.
Patients were randomly divided on the morning of surgery into three groups group I( dexamethasone 21 patients), Group II ( Dexmedetomidine 21 patients) and group III(Dexmedetomidine and dexamethasone 21 patients).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study was to compare the efficacy of escitalopram with that of
      duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment.
      The study hypothesis was that there were clinically important differences between the two
      drugs in terms of efficacy and adverse event profiles.
    

Detailed description: 
      Depression is a common mental disorder that presents with depressed mood, loss of interest or
      pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and
      poor concentration. The lifetime prevalence of Major Depressive Disorder (MDD) in community
      samples is 10-25% for women and 5-12% for men. Depression may become chronic or recurrent and
      lead to substantial impairments in an individual's ability to take care of his or her
      everyday responsibilities. At its worst, depression may lead to suicide. Depression is
      recurrent in 75-80% of patients and becomes chronic in 15-20% of depressed patients.

      The selective serotonin reuptake inhibitors (SSRIs) have become the leading class of
      antidepressants throughout the world. The efficacy and safety of SSRIs in the treatment of
      depression has been demonstrated in several clinical trials. With respect to safety, the
      studies show an advantage for the SSRIs over the older antidepressants. If the prescribing
      physicians are to make a well-founded judgement in their choice of drug factors like
      efficacy, safety, quality of life, and health economics must be taken into consideration. The
      primary aim of this study is to compare the efficacy of escitalopram with that of the
      serotonin norepinephrine reuptake inhibitors (SNRIs) duloxetine in the treatment of MDD.
    

Intervention name(s): Escitalopram; Duloxetine
Intervention type(s): Drug; Drug
Intervention description(s): 20mg once daily; orally; 60mg once daily; orally
Other intervention name(s): Cipralex, Lexapro; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depressive disorder, major; Randomized controlled trials; Antidepressive agents
Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury
Condition: Orthostatic Intolerance
MeSH terms: Spinal Cord Injuries; Orthostatic Intolerance
Study type: Observational

Summary: 
      This project aims to evaluate the physiological effects of Midodrine administration during
      orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown
      to improve orthostatic symptoms in those with spinal cord injury but the physiological
      mechanisms influenced have not been identified. The investigators will examine key
      physiological components influencing orthostatic tolerance. The investigators will do this,
      by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain
      brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one
      before Midodrine administration, and one after administration of a 10mg dose of Midodrine.
    


Intervention name(s): Midodrine
Intervention type(s): Drug
Intervention description(s): Single 10 mg dose
Other intervention name(s): Amatine, ProAmatine, Gutron
Intervention MeSH terms: Midodrine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with spinal cord injury currently in primary care (less than one year post
        injury)
      
Keywords: Orthostatic intolerance in people with spinal cord injury
Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the
      pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when
      administered with rifampin in healthy subjects
    

Detailed description: 
      -  In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145

        -  In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral
           doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg
           IPI-145 concomitantly administered with 600 mg of rifampin
    

Intervention name(s): IPI-145; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg oral capsule; 2x 300 mg oral capsule
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy subjects; DDI; CYP3A
177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer
Condition: Metastatic Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a pilot study to assess the safety and measure image-based absorbed dose of
      177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer
      (mCRPC) who will undergo radioliagnd therapy using 177Lu-P17-087/177Lu-P17-088. All patients
      underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with
      single dose 1.1 GBq (30 mCi) of 177Lu-P17-087/177Lu-P17-088 within one week, then monitored
      at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours after
      177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT
      imaging.
    

Detailed description: 
      Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific
      membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors
      which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound,
      provide an effective target for the treatment of metastatic castration-resistant prostate
      cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short
      half-life and fast rate of clearance. The investigators designed and synthesized a new
      radiopharmaceutical based on PSMA-11, P16-093. 68Ga-P16-093 showed higher tumor uptake and
      clear blood clearance than 68Ga-PSMA-617. Then, the investigators shynthesis a new
      therapeutic radiopharmaceutical based on P16-093, P17-087; and the investigators added a
      selected albumin binder into P17-088 to synthesis another new radiopharmaceutical, P17-088.
      This study was designed to investigate the safety, dosimetry and preliminary effects of
      177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer.
    

Intervention name(s): 1.1 GBq (30 mCi) of 177Lu-P17-087; 1.1 GBq (30 mCi) of 177Lu-P17-088
Intervention type(s): Drug; Drug
Intervention description(s): All patients were intravenous injected with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087 then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours post-injection.; All patients were intravenous injected with single dose 1.1 GBq (30 mCi) of 177Lu-P17-088 then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours post-injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of an additional distal rectus femoris
      transfer carried out as a part of single-event multilevel surgery in children with spastic
      diplegic cerebral palsy.
    


Intervention name(s): Distal rectus femoris transfer
Intervention type(s): Procedure
Intervention description(s): Transfer of the distal rectus femoris tendon to the semitendinosus tendon.
Other intervention name(s): rectus tendon transfer; rectus femoris transfer; rectus transposition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; distal rectus femoris transfer; stiff knee gait pattern; gait analysis; single event multilevel surgery; randomized trial; crouch gait
Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active
      immunization, in subjects with mild to moderate Alzheimer's disease.
    


Intervention name(s): ACC-001 + QS-21; QS-21; Diluent: Phosphate Buffered Saline; ACC-001
Intervention type(s): Biological; Biological; Other; Biological
Intervention description(s): IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52; IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52; IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52; IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Intervention MeSH terms: Saponin QA-21V1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study,
      which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC
      administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend
      and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm,
      all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed
      by 10 weeks during which PK, safety, and immunogenicity measurements were made. The
      randomization to treatment assignment was stratified by body weight (≥80 kg vs. <80 kg) as
      measured on baseline (Day -1), gender (male vs. female) and study center.
    


Intervention name(s): CT-P17; CT-P17
Intervention type(s): Biological; Biological
Intervention description(s): subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks; subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Condition: Degenerative Arthritis; Knee Osteoarthritis
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous Adipose
      Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee
      Osteoarthritis.
    

Detailed description: 
      JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal
      stem cells. As it does not use allogenic tissues and is cultured without additional genetic
      modification, it is classified as 'autologous cell therapy' and is completely free of
      immunologic rejection.

      It primarily aims to improve joint function. The intra-articular injection of JOINTSTEM is
      expected to stimulate the regeneration of cartilage, and to innovatively improve joint
      function with cartilage regeneration.

      The subjects of this therapy were patients with K&L grade 3 aged 20 or older.

      This study is a double-blind, randomized, placebo controlled study with two arms to evaluate
      JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening
      period, approximately 260 patients will be randomly assigned into one of the following two
      arms in a 1:1 ratio (1 JointStem : 1 placebo control). After each patient completes 6-month
      visit (Visit 5) and the data management team confirms all data have no issue, the individual
      database will be locked and the blinding will be open for the statistical analysis.
    

Intervention name(s): JOINTSTEM; saline
Intervention type(s): Biological; Drug
Intervention description(s): JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection; saline, 1 time injection
Other intervention name(s): Autologous Adipose Tissue derived MSCs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stem Cell; Adipose tissue derived mesenchymal stem cell; osteoarthritis; degenerative arthritis; biostar; Rbio
Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization
Condition: Safety of Native vs. Micellar 6-PN After Oral Intake; Pharmacokinetics of Native vs. Micellar 6-PN After Oral Intake; PBMC Activity After Native vs. Micellar 6-PN Oral Intake
Study type: Interventional

Summary: 
      Micellar encapsulation will be tested to increase the oral bioavailability in humans of
      6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250
      mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design
      with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals
      up to 24 h after intake of the native compound, the micellar formulation or placebo. The
      safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be
      investigated.
    


Intervention name(s): Placebo; Native 6-prenylnaringenin; Micellar 6-prenylnaringenin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Mannitol and silicon dioxide capsules; 250 mg native 6-PN plus mannitol and silicon dioxide capsules; 250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: 6-prenylnaringenin; Bioavailability; Pharmacokinetics; PBMC