bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Esophagogastric Varices
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined
      with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with
      esophagogastric varices (EGV) and seek out predictors associated with survival.
    


Intervention name(s): transarterial chemoembolization combined with endoscopic therapy
Intervention type(s): Procedure
Intervention description(s): TACE: The tip of the catheter was advanced into tumor-feeding artery based on the tumor location and size. 5-Fu was injected. Then the chemolipiodolization was performed, using oxaliplatin, epirubicin and lipiodol. If stagnant flow did not realized, then injected pure lipiodol. If the tumor-feeding artery still cannot be completely embolized, several absorbable gelatin sponge particles would be injected. Endoscopic therapy: After the site of esophageal varices was identified by the gastroscopy, spiral ligation using the EVL device (COOK, MBL-6-F) was performed and ensure the varices were fully inhaled, 1-3 rubber bands were used totally. After EVL, water was sprayed to the ligation sites to check for bleeding. If gastric varices were found, EIS was performed using the 'sandwich method' of hypertonic glucose-tissue adhesive-normal saline. Make sure the needle entered the varieose vein before inject drugs, and repeated the injection if necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
Condition: Barrett's Esophagus; GERD
MeSH terms: Barrett Esophagus
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure
      comparable to patients with erosive esophagitis. A significant proportion of patients with BE
      who are not symptomatic on treatment continue to have persistent acid reflux. High dose
      esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on
      Barrett's esophagus stroma is currently unknown.

      It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced
      by acid reflux. The specific aim of this proposal will be: To assess the association between
      acid reflux and subepithelial fibroblasts in Barrett's esophagus.
    

Detailed description: 
      We will conduct a prospective cohort study to assess the degree of stromal activation in
      patients with LSBE (without dysplasia) who have adequate and inadequate control of acid
      reflux in the distal esophagus. The study will be conducted in two phases.

      Phase 1 (Pilot): 20 patients with LSBE without dysplasia will undergo endoscopy with biopsies
      and a 24 hour pH study on treatment. Patients will then be divided into 2 groups:

        -  Group A (GER): Those with ongoing acid reflux (characterized by either presence of
           esophagitis [LA classification B,C or D1] on endoscopy, and/or a positive pH study on
           treatment defined using standard criteria)

        -  Group B (NGER): Those with controlled acid reflux (negative endoscopy and pH study on
           treatment).

      Stromal markers that will be assessed and compared between the 2 groups will include:
      presence of activated myofibroblasts (detected by immunohistochemistry for vimentin and
      smooth muscle actin).
    

Intervention name(s): Endoscopy and pH study
Intervention type(s): Procedure
Intervention description(s): endoscopy and PH study done one time
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Barrett's esophagus; GERD
Contact Sensitization Potential of 828 Ointment
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Contact sensitization by patch applications.
    

Detailed description: 
      Single site study that will evaluate the contact sensitization potential of 828 ointment by
      repetitive patch applications to the skin of normal, healthy volunteers.
    

Intervention name(s): HP828-101
Intervention type(s): Device
Intervention description(s): Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: Contact sensitization; Healthy Adult Volunteers
Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid
Condition: Bleeding
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations
      such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few
      studies in laminectomy had conflicting results and varying in doses. The objective is to
      compare perioperative bleeding in major laminectomy between patients receive doubles doses of
      tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).
    

Detailed description: 
      78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels
      laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to
      tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD),
      pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0
      mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first
      dose, patients will receive study drug or placebo intravenously. The standard anesthesia and
      monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique
      will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood
      pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the
      begining and every two hours. Blood will be given if the hematocrit is below 30%. The
      perioperative fluid will be managed by anesthesiologist who will not know the patients'
      groups. The next morning, the hematocrit and blood creatinine will be checked and if the
      hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and
      blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and
      signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations
      will be done for the definite dignosis and the appropriate treatment will be started
      immediately.
    

Intervention name(s): tranexamic acid; 0.9% NaCl
Intervention type(s): Drug; Drug
Intervention description(s): Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo); 0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid
Other intervention name(s): transamine (Daiichi-Sankyo, Japan); NSS
Intervention MeSH terms: Tranylcypromine; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tranexamic acid; bleeding; blood transfusion; spine surgery
Open Label Pharmacokinetic Study of OZ439 and Piperaquine on Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in Healthy Volunteers
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      A healthy volunteer study to characterise the exposure of the two study medications,
      following administration of OZ439 + TPGS granules with piperaquine phosphate granules
      (intended for children) and with piperaquine phosphate tablets (intended for adults).
      Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.
    

Detailed description: 
      A Phase 1 open label parallel group, four arm study conducted in healthy male and female
      subject aged 18 to 55 years of age. Subjects will receive either treatment A, B, C or D as
      described below:

        -  Treatment A: 1440 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension

        -  Treatment B: 960 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension

        -  Treatment C: 960 mg PQP granules for oral solution and 800 mg OZ439 + TPGS granules for
           oral suspension

        -  Treatment D: 800 mg OZ439 + TPGS granules for oral suspension
    

Intervention name(s): 1440mg PQP tablets; 960mg PQP tablets; 800mg OZ439 + TPGS; 960mg PQP granules
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Piperaquine phosphate tablets (1440mg); Piperaquine phosphate tablets (960mg); OZ439 (800mg) + TPGS granules for oral suspension; Piperaquine phosphate granules for oral solution (960mg)
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open label; healthy volunteers; pharmacokinetic; parallel group
Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Condition: Thoracic Surgery
MeSH terms: Aortic Dissection
Study type: Interventional
Phase: Phase 4

Summary: 
      Desflurane and its effect on postoperative morbidity and mortality in patients undergoing
      thoracic surgery.

      Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a
      group of general anesthetics. Because of the hypnotic effects of these agents, attention has
      mainly focused on the central nervous system. In the last 10 years, however, numerous studies
      have reported that volatile anesthetic agents interact with membrane structures of the
      myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural
      abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced
      preconditioning has become a main topic in cardiac research worldwide

        -  Trial with medicinal product
    


Intervention name(s): Desflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): 4-6 Vol %; TIVA to achieve BIS value of 40-60
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
Condition: Hyperuricemia; Gout
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a dose block-randomized, double-blind, active and placebo controlled, single and
      multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic /
      pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and
      laboratory tests will be conducted for safety/tolerability evaluation and serial blood
      samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be
      conducted at specified time points.
    


Intervention name(s): LC350189
Intervention type(s): Drug
Intervention description(s): Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY)
Condition: Vitamin D Deficiency
MeSH terms: Overweight; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations
      on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.

      Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations
      on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation
      (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours
      Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.
    


Intervention name(s): Cholecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): The participants will be randomized into one of the four groups. Group 0 will be placebo group, group 1 will receive monthly supervised dose of 18,000 IU (equivalent to 600 IU/day), group 2 will receive monthly supervised dose of 60,000 IU(equivalent to 2000 IU/day), and group 3 will receive 120,000 IU (equivalent to 4000 IU/day) vitamin D3 supplementation for 4 months (16 weeks).
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented
      and results from previous studies suggest the association between OMT and length of stay
      (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of
      the present study is to show the effect of OMT on LOS in a sample of premature infants.
    


Intervention name(s): osteopathic manipulative treatment; Usual care
Intervention type(s): Other; Procedure
Intervention description(s): Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.; Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopathic manipulative treatment; alternative medicine; complementary medicine; neonatology; neonatal care; prematurity; allied health care
Serotonin and the Upper Airway in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if a certain medication, alone or combined with
      another medication, will increase muscle activity in the upper airway in people who do and
      people who do not have sleep apnea. The medications being studied are paroxetine, a commonly
      used antidepressant, and 5 hydroxy-tryptophan (5HTP), which also can be used as a dietary
      supplement without a prescription. Because the effects of paroxetine in previous studies were
      not very large, we will also study it combined with 5HTP to see if the effect on the upper
      airway muscles is greater.
    


Intervention name(s): Paroxetine; 5HTP
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Serotonin; Sleep Apnea Syndrome; Pharyngeal Muscles
Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
Condition: Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to
      diagnostic and patient discomfort.

      METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be
      randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC)
      or and endocervical brush. All samples will be submitted for histological study.
    


Intervention name(s): Curette v/s endocervical brush
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Clinical Safety for the Inspiratory Muscle Training
Condition: Heart Diseases; Lung Disease
MeSH terms: Lung Diseases; Heart Diseases
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic
      responses during an inspiratory muscle training session during a single cardiopulmonary
      rehabilitation session program. An electrocardiogram will be continuously recorded and the
      heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately
      after a single inspiratory muscle training (IMT) session, consisting of two series of 15
      cycles, with one-minute intervals between sets and an initial load of at least 30% of the
      initial maximal inspiratory pressure (MIP).
    


Intervention name(s): Inspiratory Muscle Training
Intervention type(s): Other
Intervention description(s): Each session The session itself consisted of the following: two sets of 15 breathe cycles without removing the breathing promoter from the mouth and with the aid of a nose clip and 1-minute interval between sets. For training, we used the breathing promoters Power Breathe® Plus Light and Medium Resistance, possessing 10 levels of load gradation ranging from 17 to 186 cm H2O, which were adjusted for each patient and allowed for the individualized prescription of IMT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients regularly attending a supervised exercise program
      
Keywords: Blood Pressure; heart rate; electrocardiogram; Cardiac arrhythmias; respiratory exercise
Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Condition: Pain, Chronic; Pain, Postoperative
MeSH terms: Pain, Postoperative; Chronic Pain
Study type: Interventional

Summary: 
      Interventional study that evaluate dermatomal distribution and its demographic determinants
      in patients who underwent to Erector Spinae Plane (ESP) block
    

Detailed description: 
      Interventional study that evaluate dermatomal distribution with pinprick and cold, and its
      demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with
      20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper
      abdomen.
    

Intervention name(s): Erector Spinae Plane Block
Intervention type(s): Procedure
Intervention description(s): In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.
Intervention model: Single Group Assignment
Intervention model description: Assignment interventional
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erector Spinae Plane; Erector Spinae Plane Block
The Safety of ahSC in Chronic SCI With Rehabilitation
Condition: Spinal Cord Injury; Paraplegia; Quadriplegia; Tetraplegia
MeSH terms: Spinal Cord Injuries; Paraplegia; Quadriplegia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC)
      transplantation in participants with chronic SCI.

      This trial design is phase I, open label, unblinded, non-randomized, and non-placebo
      controlled multiple injury cohorts.
    

Detailed description: 
      For humans with chronic SCI, we hypothesize that axons might show improved function if myelin
      repair is induced with the implantation of ahSC. In addition spinal cord cavitation may be
      reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects. In
      this trial, subjects will receive fitness conditioning and rehabilitation prior to
      transplantation in order to validate the stability of their neurological baseline and enhance
      their ability to undergo surgery with few complications. They will also receive fitness
      conditioning and rehabilitation post-transplantation to maintain health and promote neuronal
      activity and potential neuroplasticity.

      Trial enrollment will target 2 cohorts. The first cohort will be thoracic (T) level 2-12 ASIA
      Impairment Scale (AIS) grade A, B, or C (n = up to 4), the second cohort will be cervical (C)
      level 5 through T1 AIS A, B, or C (n = up to 6). Two (2) participants with AIS grade A will
      be enrolled prior to enrolling a participant with AIS B or C, applicable to both cohorts.

      Participants will be monitored throughout a 6 month post-transplantation evaluation period
      for occurrence of AEs (acute, delayed, and/or cumulative), as well as for changes in clinical
      status and neurological status. Safety and efficacy assessments will be performed at weeks 1
      and 2 post-transplantation and months 2 and 6 post-transplantation.
    

Intervention name(s): Autologous human Schwann cells
Intervention type(s): Biological
Intervention description(s): Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schwann cells
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine and compare the rate and extent of absorption of gemigliptin/metformin
      hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and
      coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and
      metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual
      tablet in healthy subjects under fasting conditions
    


Intervention name(s): Gemigliptin tartrate sesquihydrate and metformin; gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release
Intervention type(s): Drug; Drug
Intervention description(s): Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.; Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.
Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base).
Other intervention name(s): Zemimet® SR Tab. 50/1000 mg; Zemiglo Tablet 50 mg and Glucophage XR 1000 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment