bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Examine the Pharmacodynamic Effects of GSK1034702 on Neurophysiological Biomarkers of Cognition in Nicotine Abstained Otherwise Healthy Smokers
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a double blind, randomised, placebo controlled, cross over study in which up to
      20 otherwise healthy male nicotine abstinent smokers will be tested following 3 acute
      treatment conditions (placebo, 4 and 8mg of GSK1034702). Each subject will undergo screening
      assessments within 30 days prior to administration of the first dose of study medication.
      There will be 3 treatment sessions and dosing will be separated by a minimum 1 week washout
      period. There will be two testing days (day 1 and day 2) per treatment session. On each
      treatment session subjects will be admitted on day 1. On day 1, subjects will be administered
      placebo and approximately 3 hours later, there will be a Baseline EEG/ERP recording,
      neuropsychological (Cogstate battery) testing and mood/craving/dependence questionnaire
      assessments . Subjects will be allowed to smoke until approximately midnight on day 1. On day
      2, subjects will undergo a pre-drug neuropsychological (Cogstate battery) testing and
      questionnaire assessments of mood/craving. This will be conducted approximately 1 hour prior
      to dosing. Subjects will be randomized to one of six treatment sequences. Post dose EEG/ERP
      recording, neuropsychological (Cogstate battery) testing and mood/craving measurements will
      be conducted between 3 and 6 hours post treatment to coincide with peak pharmacokinetic
      effects. This testing will be performed approximately at 12pm following at least 12hrs of
      nicotine abstinence. Blood samples will be collected at baseline (pre-drug) and following
      drug administration to quantify exposure levels.
    


Intervention name(s): Drug; Drug
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; 4mg and 8mg Study drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia
Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone
      Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder
      Inhaler in COPD
    


Intervention name(s): CHF 5993 DPI; CHF5993 pMDI; CHF 1535 pMDI; Placebo DPI; Placebo pMDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BDP/FF/GB DPI; BDP/FF/GB pMDI; BDP/FF pMDI; CHF 5993 DPI matched placebo; CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Condition: Cesarean Section; Complications; Placenta Previa; Placenta Accreta
MeSH terms: Placenta Accreta; Placenta Previa
Study type: Interventional

Summary: 
      Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology
      Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S
      (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in
      subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,
      ...) are very important issues. Classically Kerr incision is repaired with continuous locked
      suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in
      turn may reduce short and long term complications. For this reason, the investigators aimed
      to compare two closure techniques.
    

Detailed description: 
      In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into
      the study and agreed to participate in the study will be randomized into two groups
      (computer-assisted randomization method will be used.) In the first group of patients
      classical closure method of Kerr incision(double layered continuously locked suturing) will
      be used. In the second group of patients double layered purse string closure technique will
      be used.

      Women will be followed for a subsequent pregnancy in the next 4 years. If they become
      pregnant again they will be followed up during pregnancy for comparison of long-term effects
      of the two suture techniques. Patients will be followed especially from the aspects of
      placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta
      previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or
      complete rupture will be compared between two groups.
    

Intervention name(s): Purse string closure technique; Continuously locked closure technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Uterine incision will be closed with purse string closure technique.; Uterine incision will be closed with continuously locked closure technique
Other intervention name(s): Uterine incision in C/S; Uterine incision in C/S
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean section; Kerr incision; Purse string suturing in CS; Continuous locked suturing in CS
Examining a Text Message Intervention for Smoking Cessation
Condition: Tobacco Use Disorder; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The primary goal of this study is to use qualitative interviews and focus groups to aid us in
      adapting a face-to-face smoking cessation intervention for delivery through text messaging.
      After design is completed, the intervention will be pilot tested with a sample of young
      adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of
      treatment) and both 3 and 6 month follow up.
    


Intervention name(s): text messaging for smoking cessation; Generic text messages
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 7-week program of daily text messages; non-smoking related text messages will be given on the same daily schedule as matches the active intervention to establish a control for contact time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tobacco; smoking; text message; therapy
The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Aim of the current study is to evaluate the effect functional electrical stimulation and
      therapeutic exercise on traumatic spinal cord injured participants'skeletal muscle
      characteristics, sitting balance, lung function and quality of life.
    


Intervention name(s): FES+TE; TE; REF-FES+TE; REF-TE
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Group receive FES+therapeutic exercise during 6 weeks (twice a week). Altogether 8 exercises are conducted, each done 3 sets and 12 repetitions during first three weeks and 4 sets during last three weeks of intervention).; Group perform only therapeutic exercise. Exercises are the same between all 4 groups.; Group perform FES+TE, but only participate in 1 session to collect reference data.; Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).
Condition: Unspecified Disorder of Bone Density and Structure
MeSH terms: Bone Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The
      main storage place for magnesium is in the bone. Magnesium is direct under calcium in the
      periodic system making it possible to interact with the crystal structure. Some small studies
      have shown beneficial effects of magnesium substitution on osteoporosis. Evidence has shown
      improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It has been
      uncertain however, which of these factors can contribute to such a change. The effect of
      magnesium substitution 240 mg daily as therefore studied in two parallel groups where both
      received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the
      other received magnesium. This was studied on various expressions for bone metabolism after
      zero, seven and 28 days in elderly females aged 70 years old.
    

Detailed description: 
      Elderly 70 year old ladies who had been to an outpatient X-ray investigation were invited to
      participate in this study. They were all healthy without any signs of osteoporosis, or
      fractures.They were stimulated to participate by having done bone density measurements free.
      Patients who had used biphosphonates, oestrogens, glucocorticoids , diuretics,
      immunomodulating agents, or prolonged use of heparin were excluded.

      Patients with possible secondary osteoporosis due to primary hyperthyroidism or chronic lung
      disease were also excluded. The participants were randomized into placebo or Mg-treatment
      groups. They were seen by the dietician, and blood and urine samples were taken at day 0, 7
      and 28 at the same time these days. Medicine was prepacked for intake twice daily. They
      received medicine for 30 days and should only take for 28 days. The number of tablets which
      should be left was controlled the last day. The participants were informed about the results
      of the bone density measurements taken the first and the last day. All the patient contacts
      were undertaken by the same dietician.
    

Intervention name(s): Oral magnesium substitution; Placebo tablets without magnesium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The elderly was given tablets two times daily with calsium and vitamin D. They were further given magnesium tablets 120 mg two times daily for 28 days.; The elderly was given tablets two times daily with calsium and vitamin D. They were further given placebo without magnesium two times daily for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: calcium; magnesium; vitamin D; bone turnover markers
Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
Condition: MEDI3902 for Prevention of P. Aeruginosa Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy
      adult subjects 18 to 60 years of age.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy
      adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4
      fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting
      a screening period of up to 28 days, 1 day of investigational product administration, and a
      60 day safety follow up period.
    

Intervention name(s): MEDI3902 - Dose 1; MEDI3902 - Dose 2; MEDI3902 - Dose 3; MEDI3902 - Dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.; Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.; Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.; Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.; Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
Other intervention name(s): MEDI3902; MEDI3902; MEDI3902; MEDI3902
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: MEDI3902; Safety,; Pharmacokinetics,; Healthy Volunteers
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The combination of docetaxel+epirubicin is highly effective and well tolerated as first line
      treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in
      women with MBC pretreated with taxane and anthracycline. Docetaxel increases the
      intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine.
      The combination of docetaxel plus capecitabine is highly active and superior to docetaxel
      monotherapy in women with MBC pretreated with an anthracycline
    

Detailed description: 
      This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus
      capecitabine combinations as first line treatment in women with MBC
    

Intervention name(s): Docetaxel; Capecitabine; Epirubicin; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles; Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Other intervention name(s): Taxotere; Xeloda; Farmorubicin; Taxotere
Intervention MeSH terms: Docetaxel; Capecitabine; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer;; First line chemotherapy;; Docetaxel;; Epirubicin;; Capecitabine
Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria
Condition: Proteinuria
MeSH terms: Proteinuria
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the impact of proteinuria on the
      pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.
    


Intervention name(s): ALXN1720
Intervention type(s): Drug
Intervention description(s): All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proteinuria; Glomerular Disease; Chronic Kidney Disease; Lupus Nephritis; Immunoglobulin A Nephropathy; Primary Membranous Nephropathy; Focal Segmental Glomerulosclerosis; Diabetic Nephropathy; Hypertensive Nephrosclerosis; Minimal Change Disease; Thin Basement Membrane Nephropathy; Membranoproliferative Glomerulonephritis (all forms)
Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block
Condition: Hip Fractures; Anesthesia Local; Pain, Perioperative
MeSH terms: Hip Fractures
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the trial is to complete a double-blinded randomized controlled trial
      with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift
      technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel
      Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator
      nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.
    

Detailed description: 
      The main objective of the trial is to complete a double-blinded randomized controlled trial
      with crossover design of a one-injection nerve block of the lower part of the lumbar plexus
      and the upper part of the sacral plexus (Suprasacral Parallel Shift, SSPS) to achieve
      analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve
      L1 with SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound by estimating
      sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the
      terminal nerves in healthy volunteers.

      The secondary objective is to estimate a) preparation and b) procedure time, c) injection
      site and d) depth, e) discomfort, f) change in MAP, g) plasma lidocaine pharmacokinetics, h)
      motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine
      added gadotorate meglumine on MRI, and l) cost-effectiveness of SSPS guided by ultrasound/MR
      image fusion vs. SSPS guided by ultrasound.

      The investigators hypothesize that block success is higher for SSPS guided by ultrasound/MR
      image fusion than for SSPS guided by ultrasound.
    

Intervention name(s): Lidocaine-epinephrine added gadoterate meglumine
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine; Epinephrine; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip surgery anesthesia; Perioperative analgesia
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Condition: Primary Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Although liver resection, liver transplantation, a-interferon, Transarterial Chemo
      Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation
      therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the
      high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous
      Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection
      and TACE Therapy will be evaluated.
    

Detailed description: 
      The study is a single center,open label trial. To obtain safety information on toxicities and
      adverse events attributable to the subcutaneous injections of autologous dendritic cells
      incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients
      with HCC.
    

Intervention name(s): DC-TC+GM-CSF
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DC; Immunotherapy; TC
Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients
Condition: Stroke; Immunoregulation; Inflammation; Vinpocetine
MeSH terms: Stroke; Ischemic Stroke; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke.
      Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration.
      Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the
      outcomes of stroke. For this multi-center study, investigators recruited 60 patients with
      anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but
      lasted less than 48 hours. These patients, after randomly division into two groups, received
      either standard management alone (controls) or standard management plus vinpocetine (30 mg
      per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).
    


Intervention name(s): vinpocetine; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg of the drug by intravenous infusion once daily, for fourteen consecutive days, beginning within one hour after the baseline MRI and no later than 48 hours after the onset of symptoms.; 100mg, once daily, oral medication
Other intervention name(s): Cavinton
Intervention MeSH terms: Aspirin; Vinpocetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in
      both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on
      hemodialysis) populations, and several lines of evidence point to their contribution in the
      development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive
      protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in
      these two populations. The uremic state is characterized by retention of oxidized solutes
      including reactive aldehyde groups and oxidized thiol groups. It has recently been
      demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of
      oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the
      atherosclerotic uremic metabolic state. In this study we hypothesize that administration of
      antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress
      in patients with Stage III and IV CKD.
    


Intervention name(s): Alpha, gamma, beta, and delta (mixed) tocopherols; alpha lipoic acid; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): approximately 666 IU daily (1 pill) for 4 months; 600 mg daily (2 pills 300 mg each) for 4 months; placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months; placebo for alpha lipoic acid; 2 pills daily for 4 months
Other intervention name(s): Vitamin E
Intervention MeSH terms: Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment