bioihbjkbjnl/mcl2 huggingface dataset:
Zoledronic Acid in Acute Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture
      prevention and the associated morbidity of bed rest and further secondary complications.
      Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more
      effective than other agents in reducing bone mass resorption and leg fractures in
      post-menopausal women, but has not been studied in patients with acute SCI. This will be a
      randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after
      SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus
      placebo within 21 days of an SCI.
    

Detailed description: 
      Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture
      prevention and the associated morbidity of bed rest and further secondary complications.
      Intravenous (IV) zoledronic acid (ZA) has been shown to be more effective than other agents
      in reducing bone mass resorption and fracture of the legs in post-menopausal women, but has
      not been studied in acute spinal cord injury. Two previous studies of ZA in persons with
      subacute SCI, while promising, were inconclusive. As stated in the long range plan of the
      National Institute on Disability and Rehabilitation Research (NIDRR), one goal in the area of
      health and function is to "focus on the onset of new conditions…exacerbation of existing
      conditions, or the development of coexisting conditions." This study is intended to
      demonstrate reduction in loss of bone mass at the hip and knee regions in acute SCI in a
      rigorous study of sufficient size to determine effectiveness of our intervention.
    

Intervention name(s): Zoledronic acid; normal saline 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.; Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury
Other intervention name(s): Reclast; normal saline; 0.9% saline
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injury; bone mineral density
Intravenous Stem Cells After Ischemic Stroke
Condition: Ischemia; Stroke
MeSH terms: Stroke; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of the study is to evaluate feasibility and tolerance of the intravenous
      injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke
      (less than 6 weeks).
    

Detailed description: 
      Stroke is the leading cause of acquired adult disability. Except the hospitalization in
      stroke units, only thrombolysis has been shown to be efficient to treat acute ischemic stroke
      in the first three hours after the onset. Increasing brain plasticity after stroke represents
      an important alternative strategy. Cell therapy provides a functional improvement after
      cerebral ischemia in rodent models. This "restorative" therapy aims to replace destroyed
      cerebral tissue with a stem cells graft. Despite these encouraging experiments, we do not
      know yet the best way of administration of the stem cells, the best dose and the optimal
      delay of the graft. The pioneer clinical studies failed to reproduce this benefit for
      patients probably because of the limited number of studied patients. Therefore, more
      translational studies are needed to improve our knowledge in this promising field. Among
      different cell sources, mesenchymal (or stromal) stem cells (MSC) derived from bone marrow
      offer the advantage of arising from a non tumoral and no modified source and are not sources
      of immunological or ethical problems.

      Our research project involves a development of cell therapy in a phase IIa clinical trial of
      feasibility and safety in patients (randomised, controlled, open, with 3 parallel groups).
    

Intervention name(s): Autologous mesenchymal stem cells
Intervention type(s): Genetic
Intervention description(s): Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cell therapy; Stroke; Neuronal Plasticity; Recovery; Mesenchymal Stem Cells; Transplantation
Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis
Condition: Periodontitis Complex
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Periodontal regeneration can change tooth prognosis and represents an alternative to
      extraction in teeth compromised by severe intrabony defects. The aim of this study is to
      compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a
      population with attachment loss to or beyond the apex of the root in terms of professional,
      patient reported and economic outcomes.
    

Detailed description: 
      This was a single center 10-year randomized controlled clinical trial. 50 stage III or IV
      periodontitis subjects with a severely compromised tooth with attachment loss to or beyond
      the apex were randomized to PR or TER with either an implant or a tooth supported fixed
      partial denture. Subjects were kept on a strict periodontal supportive care regimen every 3
      months and examined yearly. Survival, complication free survival, recurrence analysis, oral
      health related quality of life and patient reported outcomes analyses will be performed.
    

Intervention name(s): Enamel matrix derivative, bone replacement graft, barrier membrane; Tooth extraction and replacement
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; periodontal regeneration; tooth extraction; dental implant; fixed partial denture; survival analysis; Complication free survival; Recurrence analysis; Oral health related quality of life
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      Iron deficiency is the most prevalent nutritional deficiency and the most common cause of
      anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells
      that are abnormally small (microcytic) and contain a decreased amount of hemoglobin
      (hypochromic).
    


Intervention name(s): Iron dextran; Ferrous Fumarate
Intervention type(s): Drug; Drug
Intervention description(s): total dose infusion; oral tablets
Intervention MeSH terms: Ferrous fumarate; Dextrans; Iron-Dextran Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer
Condition: Benign Breast Neoplasm; Breast Carcinoma; Malignant Breast Neoplasm
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Interventional

Summary: 
      This trial studies how well an imaging technique called magnetic resonance (MR) spectroscopic
      imaging works in identifying breast cancer in women with benign or suspicious areas in the
      breast. Magnetic resonance imaging (MRI) is a diagnostic tool used to investigate the
      location of tumors in different organs. Since radiological pictures do not have sufficient
      information for tumor grades, invasive procedure such as biopsy is performed on patients with
      breast cancers for diagnosis. Breast tissue contains water, fat, and chemicals known as
      metabolites. MR spectroscopic imaging may help to characterize the various breast metabolite
      steady state levels and identify the differences between necrosis and tumor recurrence, which
      is difficult using radiological procedures such as MRI.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Non-uniform undersampling schemes (NUS) will be combined with 5-dimensional (5D)
      echo-planar imaging based correlated spectroscopic imaging (EP-COSI) sequence.

      II. Group sparsity (GS)-based compressed-sensing (CS) reconstruction schemes will be
      developed for accelerated acquisition and optimized to reconstruct the NUS EP-COSI data with
      better reliability.

      III. Alterations in metabolite and lipid levels will be correlated with apparent diffusion
      coefficient (ADC) changes in breast cancer patients compared to healthy women which will
      improve the diagnostic accuracy.

      OUTLINE:

      Participants undergo diffusion weighted imaging (DWI)-MRI over 15 minutes and MR
      spectroscopic imaging over 45 minutes.

      After completion of study, participants are followed up for 6 months.
    

Intervention name(s): Diffusion Weighted Imaging; Magnetic Resonance Spectroscopic Imaging
Intervention type(s): Procedure; Procedure
Intervention description(s): Undergo DWI-MRI; Undergo MR spectroscopic imaging
Other intervention name(s): Diffusion Weighted MRI; Diffusion-Weighted Magnetic Resonance Imaging; Diffusion-Weighted MR Imaging; Diffusion-Weighted MRI; DW-MRI; DWI; DWI MRI; DWI-MRI; MR Diffusion-Weighted Imaging; 1H- Nuclear Magnetic Resonance Spectroscopic Imaging; 1H-nuclear magnetic resonance spectroscopic imaging; Magnetic Resonance Spectroscopy; MRS; MRS Imaging; MRSI; MS; Proton Magnetic Resonance Spectroscopic Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Multiple Ascending Dose Study for LCB01-0371
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary

        -  To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral
           dose in healthy male subjects

        -  To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male
           subjects
    

Detailed description: 
      -  To investigate the PK characteristics of LCB01-0371 after a multiple oral dose

        -  To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
    

Intervention name(s): LCB01-0371 800mg; LCB01-0371 1200mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LCB0-0371 800mg; LCB01-0371 1200mg; Placebo
Other intervention name(s): LCB0-0371 800mg
Intervention MeSH terms: Delpazolid; Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acupuncture for Primary Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the
      adult population in Hong Kong.
    

Detailed description: 
      Acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of
      this study is to evaluate the clinical effectiveness of acupuncture treatment on primary
      insomnia. This is a randomized single-blinded controlled trial. Patients will be randomly
      assigned to the electro-acupuncture group or the placebo acupuncture group. Patients will be
      put into groups and then compared.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other intervention name(s): Acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insomnia; Acupuncture; Electroacupuncture; Randomized Clinical Trial; Traditional Chinese Medicine
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising
      single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing
      cohorts
    


Intervention name(s): AMG 557; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AMG 557 is for the treatment of sybjects with systemic lupus erythematosus; contains no active drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
Condition: Alcohol Withdrawal Syndrome
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous
      Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to
      measure the benzodiazepine amount prescribed during the withdrawal time.
    


Intervention name(s): Energetic Resonance by Cutaneous Stimulation
Intervention type(s): Other
Intervention description(s): Energetic Resonance by Cutaneous Stimulation (RESC) is a non-invasive method based on energetic Chinese medicine principles and digital contact. RESC is characterized by echo phenomena between two stimulation points.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: RESC, alcohol withdrawal syndrome
Cognitive Remediation of Schizophrenia in a Community Mental Health Setting
Condition: Experimental Condition TCT; Controlled Condition CG
MeSH terms: Disease; Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the usefulness of neuroscience-guided cognitive
      training combined with community-based supported employment for people with schizophrenia.
      The investigators will examine the effectiveness of moving our study of neuroplasticity-based
      restorative targeted cognitive training out of the laboratory and into the community setting;
      and the investigators will also investigate its utility in enhancing functional outcome in
      chronically mentally ill adults who are participating in supported employment.
    

Detailed description: 
      Neurocognitive functioning will be assessed at baseline (study entry), after cognitive
      training (6 months), and at 12 month follow-up, using the MATRICS Consensus Cognitive Battery
      (MCCB). The investigators will assess the following six constructs identified by MATRICS as
      separable, fundamental dimensions of cognitive impairment in schizophrenia, with a likely
      sensitivity to intervention [26]: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working
      Memory, 4) Verbal Learning and Memory, 5) Visual Learning and Memory, and 6) Reasoning and
      Problem Solving (executive functioning). The investigators will also administer the delayed
      memory trials of HVLT and BVMT, Trails B, and D-KEFS Color-Word Interference Test [27], and
      will make one modification to the MCCB in utilizing BACS Tower of London [28] in place of NAB
      Mazes.
    

Intervention name(s): (TCT) plus evidence-based SE; (CG) plus evidence-based SE
Intervention type(s): Other; Other
Intervention description(s): Targeted cognitive computer training (TCT) plus evidence-based SE in a community setting; (CG) plus evidence-based SE
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Targeted cognitive training (TCT) plus evidence-based SE; Computer games (CG) plus evidence-based SE
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high
      percentage of drug as the free base are equivalent to tablets with the standard percentage
      when given to participants.
    


Intervention name(s): Pantoprazole; SCH 530348 (high percentage); SCH 530348 (standard percentage)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg delayed-release tablet administered orally in the morning of Days 1-7; 2.5 mg tablet containing ~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5; 2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5
Intervention MeSH terms: Pantoprazole; Vorapaxar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin
      and hydrocodone bitartrate when they are administered alone or in combination to normal
      healthy male and/or female subjects.
    


Intervention name(s): Humibid®; Hydrocodone Bitartrate; Humibid® and Hydrocodone Bitartrate tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Humibid® 1200 mg (single extended release) tablet; Hydrocodone Bitartrate (3.33 mg q4h X 3); Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)
Other intervention name(s): Guaifenesin
Intervention MeSH terms: Phenylpropanolamine; Hydrocodone; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin
Condition: Lymphoma
MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides
Study type: Interventional

Summary: 
      RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a
      patient has mycosis fungoides/cutaneous T-cell lymphoma.

      PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis
      fungoides/cutaneous T-cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether computer-assisted, higher-order analysis of participant low molecular
           weight serum proteins can detect distinctive proteomic patterns in participants with
           normal skin vs mycosis fungoides/cutaneous T-cell lymphoma vs psoriasis.

        -  Determine whether these proteomic patterns can distinguish between various stages of
           cutaneous T-cell lymphoma.

      OUTLINE: This is a pilot study.

      Participants complete a general and skin health questionnaire and undergo a whole-body skin
      examination. Blood samples are taken and analyzed for low molecular weight serum proteins by
      mass spectroscopy.

      PROJECTED ACCRUAL: A total of 141-423 participants (47-94 each of healthy volunteers,
      psoriasis patients, and T3 cutaneous T-cell lymphoma patients and 141 T1, T2, and T4 mycosis
      fungoides patients) will be accrued for this study within 3 years.
    

Intervention name(s): proteomic profiling
Intervention type(s): Genetic
Primary purpose: Diagnostic
Keywords: recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome
Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting
      toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and
      5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness
      of the this regimen is evaluated by response rate, median survival time, and progression free
      survival.
    

Detailed description: 
      Patients with untreated measurable metastatic esophageal cancer were included in this trial.
      Patients received this combination chemotherapy repeated every 28 days until progression
      disease. Starting dose (dose level 1) were docetaxel 50 mg/m2 on day 1, fixed dose
      intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day
      1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia
      lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia
      accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea,
      appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the
      incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be
      calculated according to RECIST criteria.
    

Intervention name(s): Taxotere; 5-FU; Briplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.; 800 mg/m2, CIV (conti.in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.; 15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other intervention name(s): Docetaxel; 5-Fluorouracil; Cisplatin,CDDP
Intervention MeSH terms: Cisplatin; Docetaxel; Fluorouracil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment