bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Bone Marrow Stem Cells in Cirrhosis Patients
Condition: Stem Cell Transplantation; Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is
      one of the only effective therapies available to such patients. However, lack of donors,
      surgical complications, rejection, and high cost are it's serious problems. The potential for
      stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently
      confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases,
      and several clinical studies have applied BMC injection to induce regeneration of myocardium
      and blood vessels. In this study we will evaluate safety and feasibility of autologous bone
      marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation
      through the portal vein in patients with decompensate cirrhosis.
    

Detailed description: 
      BM (200 ml) will be harvested from the iliac crest according to standard procedures under
      general anesthesia and is collected in plastic bags containing anti coagulant. After
      precipitation of red blood cells, Low density mononuclear cells will be collected by
      centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS
      instrument will be used. Cells are injected via portal vein under sonography monitoring.
      After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are
      analyzed for 24 weeks.
    

Intervention name(s): CD133; BM-MNC
Intervention type(s): Biological; Biological
Intervention description(s): portal vein infusion of CD133+ cells; portal vein infusion of BM-MNC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Autologous Bone marrow stem cells; Cirrhosis
Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear
Condition: Carcinoma, Basal Cell; Porokeratosis, Disseminated Superficial Actinic
MeSH terms: Carcinoma; Keratosis, Actinic; Carcinoma, Basal Cell; Porokeratosis; Keratosis
Study type: Observational

Summary: 
      The purpose of this study is to compare and evaluate the diagnostic performance of scrape
      cytology using two different cytological staining techniques, and to evaluate additional
      touch imprint cytology with that of histopathology of superficial basal cell carcinoma and
      actinic keratosis.
    


Intervention name(s): Skin scrape
Intervention type(s): Procedure
Intervention description(s): scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 BCC and 28 AK histologically verified lesions, from 41 and 25 patients, respectively
      
Keywords: Cytodiagnosis; Skin Scrape; Touch Imprint; Papanicolaou; May-Grunvald-Giemsa
Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy
Condition: Thoracic Diseases
MeSH terms: Thoracic Diseases
Study type: Interventional

Summary: 
      Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative
      pain control in these patients may cause serious morbidity related to pulmonary,
      cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described
      in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery.
      Intravenous lidocaine exhibit analgesic activity through both the peripheral and central
      nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity
      and accelerate postoperative recovery in many surgeries.

      The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane
      block on postoperative opioid consumption and pain scores.
    


Intervention name(s): Bupivacaine Hcl 0.25% Inj; Saline Solution for Block; Saline Solution intravenously; Lidocaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine; Ultrasound-guided erector spinae plane block with 20 ml saline; Same volume saline solution bolus and infusion as Group Lidocaine; 1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion
Intervention MeSH terms: Lidocaine; Bupivacaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Automated Hovering for Congestive Heart Failure Patients: A Pilot Study
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study offers remote monitoring devices for weight and medication adherence, combined
      with behavioral economic approaches, to patients with congestive heart failure (CHF). This
      pilot study aims to evaluate the feasibility of enrollment processes and intervention
      roll-out to inform a randomized controlled trial, to estimate the readmission rate of
      participants, and to assess if and how managing clinicians respond to weight gain alerts
      entered into a participant's electronic medical record.
    

Detailed description: 
      The specific aims of this study are: (1) To leverage access to the University of Pennsylvania
      Health System (UPHS) CHF clinic, PennChart (electronic medical record system) resources for
      identifying eligible patients, and the Way to Health (WTH) platform to launch a pilot study
      that will inform a randomized controlled trial; (2) to evaluate the feasibility of the
      enrollment processes and intervention roll-out to inform a randomized controlled trial; (3)
      to estimate the readmission rate of participants; and, (4) to assess if and how managing
      physicians respond to weight gain alerts entered into participant charts in PennChart. In
      this pilot study, no randomization will occur and all participants will receive the
      intervention.
    

Intervention name(s): Support partner; Engagement incentives; Electronic pill bottle; Bluetooth scale
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.; Participants will be entered into a daily lottery, for which their participation is contingent on adhering to their diuretic and to weighing-in on the previous day.; Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherent to this medication.; Participant adherence to stepping on their scale will be monitored on a daily basis and participants will be contacted if they are non-adherent to weighing-in. Participant weight gain will also be monitored, and if weight gain exceeds a specific threshold, the managing physician will be notified through the electronic medical record system. Managing providers will also be sent a weekly report of weight measurements.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Propranolol for Treatment of Cocaine Addiction - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of propanolol in the early
      treatment of cocaine dependence.
    


Intervention name(s): Propranolol
Intervention type(s): Drug
Intervention MeSH terms: Propranolol
Primary purpose: Treatment
Keywords: cocaine
Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma
      greater than 3 cm,the ablation volume of coagulation necrosis can be significantly
      increased,which may be enable effective treatment of patients with HCC greater than 3 cm.
    

Detailed description: 
      To assess whether the effectiveness of a combination of transcatheter arterial
      chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in
      treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the
      factors affecting the outcomes.

      The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this
      randomized controlled trial. The primary end point was survival, and the secondary end points
      were tumor response.
    

Intervention name(s): chemoembolization ,Radiofrequency ablation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma,treatment
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response
      at the site of Candin intradermal injection in the presence of a targeted immune pathway
      inhibitor.
    


Intervention name(s): Cosentyx; Candin
Intervention type(s): Drug; Drug
Intervention description(s): Cosentyx injection will be administered subcutaneously.; Candin will be administered interadermally along with NaCl solution.
Other intervention name(s): Secukinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Combination of Radiotherapy and SHR-1210 to Treat Patients With ESCC
Condition: Esophageal Cancer
Study type: Interventional

Summary: 
      SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label，single
      center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an
      investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the
      efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in
      patients with Locally Advanced Esophageal Squamous Cell Carcinomas。
    


Intervention name(s): SHR-1210
Intervention type(s): Drug
Intervention description(s): SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Other intervention name(s): Anti-PD-1 Antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, randomized, single-dose, three-period cross-over study
      in healthy participants. The aim of this study is to provide clinically relevant information
      on the pharmacokinetic (PK) and safety profile of a new lower dose formulation ambrisentan
      (AMB) tablet, which is intended for pediatric use. The study will compare the relative
      bioavailability of the lower dose tablet, dispersed in water and administered orally, with
      the reference marketed AMB tablet in healthy adults. The total study duration for each
      participant is expected to be approximately 9 weeks.
    


Intervention name(s): AMB new formulation (1 mg); Reference AMB (5 mg)
Intervention type(s): Drug; Drug
Intervention description(s): AMB tablets will be available at a unit dose strength of 1 mg. Participants will orally administer 5 tablets of 1 mg unit dose.; AMB reference tablet will be available as film-coated tablet at unit dose strength of 5 mg. Participants will orally administer 1 tablet of 5 mg unit dose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a three-period crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ambrisentan; Oral dosage forms; Pulmonary arterial hypertension; Bioavailability
The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether low-dose simvastatin in combination with
      ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the
      function of the endothelium after an oral fat load in patients with metabolic syndrome.
    

Detailed description: 
      Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven
      by the epidemic of obesity. High blood lipid levels after a meal may be an important risk
      factor for cardiovascular disease. In this study we will investigate whether simvastatin in
      combination with ezetimibe vs. simvastatin alone, has a beneficial effect on the lipid levels
      after a meal, but more importantly, whether we can measure a difference in function of the
      endothelium. In a small pilot study we already found that the combination had a beneficial
      effect in comparison with simvastatin alone. Now we want to solidify these findings in a
      larger study.
    

Intervention name(s): Simvastatin; Simvastatin/Ezetimibe
Intervention type(s): Drug; Drug
Intervention description(s): 6 weeks of treatment with simvastatin 80 mg; 6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
Other intervention name(s): Simvastatin (Zocor); Simvastatin/Ezetimibe (Zetia)
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postprandial hypertriglyceridemia; Metabolic syndrome; Endothelial function; Flow mediated dilatation; EndoPAT; Simvastatin; Ezetimibe
High Intensity Training to Reduce the Risk of Falls in Older People
Condition: Risk of Falls
Study type: Interventional

Summary: 
      Due to the high incidence of falls in the elderly population, this study is presented as a
      method to reduce the risk of falls through a specific type of training in people over 60
      years of age.
    

Detailed description: 
      A 16-week high intensity interval training (HIIT) program, compared to a continuous exercise
      program and one that does not perform any training program, decreases the risk of falls and
      improves the state of health, physical condition and quality of life to a greater extent than
      a group that does not perform any type of exercise in people over 60 years.
    

Intervention name(s): HIIT group, MICT group
Intervention type(s): Other
Intervention description(s): The HIIT program training:
5 minutes of heating will be done. The intervention will consist of a training in suspension (TRX) performing squats. The session will be divided into four four-minute intervals at an intensity of 90-95% of the maximum heart rate, followed by three-minute active rest intervals of 50-70%. This intensity will be assigned to each subject individually. After the training, there will be a return to calm of 10 minutes of exercises of joint range. There will be 2 weekly training, with three days between both training, for a period of 12 weeks.
The training of the MICT program:
5 minutes of heating will be done. Subsequently, participants will perform a squat training with the Suspension Training System (TRX) with an intensity close to 70% of their maximum heart rate maintained for 40 minutes. The session will conclude with a return to calm of 10 min of joint width and stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects
Condition: Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 1

Summary: 
      It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to
      evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese
      male subjects A total of 182 subjects are planned to be included and randomized at a ratio of
      1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi®
      (EU-licensed ).

      The study has a screening period of 14 days. PK blood samples will be collected from subjects
      to determine the serum concentration of Golimumab, thus to evaluate the change and similarity
      of the pharmacokinetics of the two study drugs.

      The investigator will perform safety evaluation for vital signs, physical examinations,
      injection site reaction, ECG, clinical laboratory tests and adverse events throughout the
      study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
    


Intervention name(s): Drug: BAT2506 injection Other Names: Simponi(EU-licensed)
Intervention type(s): Drug
Intervention description(s): Drug: BAT2506 injection Each subject will receive single subcutaneous injection of 50 mg BAT2506 Injection or Simponi(EU-licensed).
Other Names:
Simponi(EU-licensed)
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity; Dental Pain
MeSH terms: Toothache; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, controlled, double blind exploratory study to explore the effects of two
      different potassium nitrate concentrations and water on exposed dentine in reducing dentinal
      hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by
      visual analogue scale (VAS) scores following evaporative (air) stimulus.
    


Intervention name(s): Potassium Nitrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250 μL of Potassium nitrate solution (either 5% or 2.5%); Sterile Water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dentinal sensitivity; potassium nitrate; dental pain
Normal Values of Oxidative Stress, Taurine, and Related Markers
Condition: Oxidative Stress
Study type: Observational

Summary: 
      The role of oxidative stress in disease pathology is increasingly recognized. At present, the
      development of biomarkers of this state is in its infancy and the availability of clinically
      validated assays is lacking. This study will better determine normal values for specific
      biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural
      occurring oxidative stress protectant. A primary and specific application of this data is for
      the evaluation of oxidative stress, levels of the natural protectant taurine, and of
      associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study:
      Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).
    

Detailed description: 
      This study is a one-time collection of blood and urine samples in healthy individuals.
      Subjects have to be fasting for 3 hours prior to the blood sampling. A maximum of 7.5 mLs of
      blood (1 and 1/5 teaspoon) and a urine sample will be collected.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Individuals older than 8 years and less than 50 years
      
Keywords: oxidative stress
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study was to determine the plasma and central nervious system
      pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect
      on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers
      both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their
      efficacy in postoperative pain treatment.
    


Intervention name(s): Dexketoprofen; Etoricoxib
Intervention type(s): Drug; Drug
Intervention description(s): After total hip replacement surgery patient were given either etoricoxib or dexketoprofen; After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
Intervention MeSH terms: Etoricoxib; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dexketoprofen; Etoricoxib; hip arthroplasty; pain
Self-administered Acupressure for Knee Osteoarthritis: A Pilot Randomized Controlled Trial
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Objectives: To test the feasibility of the study design and clinical effects of
      self-administered acupressure on relieving knee osteoarthritis (OA) pain.

      Hypothesis: self-administered acupressure would have a superior beneficial effect compared to
      health education control group in terms of pain relief in patients with knee osteoarthritis
      across the 6-week study period.

      Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be
      recruited; 18 per group. All eligible subjects will be randomized to either self-administered
      acupressure or health education control group in 1:1 ratio.

      Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training
      sessions to learn self-acupressure and will practice self-acupressure every morning and night
      for 6 weeks; subjects in the education control group will receive two 1.5 hours training
      sessions to learn the health information related to knee OA.

      Main outcome measures: The primary outcome measure is the numerical rating scale for knee
      pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index,
      knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training
      course will also be evaluated.

      Data Analysis: Differences in the questionnaire scores and ROM will be examined using a
      mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect
      sizes will be computed by dividing the difference in means by the pooled standard deviation.
    


Intervention name(s): Self-acupressure; Knee health education
Intervention type(s): Other; Other
Intervention description(s): A training course will be offered to subjects in this group to train them to perform self-acupressure.; A course regarding knee health will be offered to the subjects in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis