bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR
Condition: Mania; Mixed Mania
MeSH terms: Mania
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the time to response, response rates, remission rates, and side effects in Bipolar
      Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.
    

Detailed description: 
      There are several studies demonstrating the efficacy of divalproex in the acute treatment of
      mania and mixed mania. In fact, the American Psychiatric Associations Practice Guidelines for
      Bipolar Disorder recommends divalproex as a first-line treatment for acute mania and acute
      mixed mania; divalproex is the treatment of choice in the treatment of acute mixed mania. The
      Food and Drug Administration (FDA) approved divalproex for the acute treatment of mania in
      the 1990's. A new formulation, divalproex, Depakote ER, was recently FDA approved for the
      treatment of epilepsy and prophylaxis of migraine headaches. In a pooled data analysis of
      nine open-labeled trials involving 321 epilepsy and bipolar disorder patients, Smith et al.
      that Depakote ER was associated with superior tolerability including less frequent tremors,
      weight gain, and gastrointestinal complaints (all p<0.001) compared with Depakote DR.
      Depakote ER was preferred by subjects and it provided improved seizure control and a greater
      reduction in psychiatric symptoms.
    

Intervention name(s): Depakote ER; Depakote DR
Intervention type(s): Drug; Drug
Intervention description(s): The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.; The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Determine the Safety, Tolerability and Pharmacokinetics of PMZ-2010 (Centhaquin) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of
      oxygen and nutrients that are necessary for cellular function. The current resuscitative
      agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses
      reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to
      be a highly effective resuscitative agent. The investigators are conducting a phase I
      clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of centhaquin citrate in normal healthy volunteers.
    

Detailed description: 
      Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of
      oxygen and nutrients that are necessary for cellular function. Common causes of shock are
      hypovolemia (excessive blood or fluid loss), sepsis, cardiac failure, dengue and
      neuroendocrine dysfunction. The current resuscitative measures include administration of
      crystalloid solutions (e.g., 0.9% saline, Ringer's lactate, or hypertonic saline) or colloid
      solutions (e.g., hydroxyethyl starch, albumin, or dextrans). These agents can extend
      patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses reduced blood
      lactate levels, improved blood pressure, cardiac output, survival and proved to be a highly
      effective resuscitative agent. The investigators are conducting a phase I clinical study in
      humans to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      centhaquin citrate in normal healthy volunteers. Successful completion of phase I studies
      will lead to efficacy studies in patients with hypovolemic shock.
    

Intervention name(s): PMZ-2010 (Centhaquin)
Intervention type(s): Drug
Intervention description(s): As per the randomization schedule, injection of PMZ-2010 or placebo (100 ml normal saline) will be administered to each subject under supervision of investigator as an intravenous infusion over one hour. PMZ-2010 will be dissolved in normal saline (100 ml) before administration.
Other intervention name(s): Placebo (normal saline)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      Lung cancer is the leading cause of cancer death in the United States. Currently it remains
      impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a
      mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and
      metabolism are a useful tool and available to use. The purpose of this study is to assess the
      variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.
    

Detailed description: 
      Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of
      lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or
      ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to
      predict which smokers will get cancer.

      Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known
      carcinogens. Most of these carcinogens require metabolic activation before they can
      negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and
      metabolic activity of carcinogens are a useful tool and available to use. The purpose of this
      study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year
      in a group of smokers.

      This longitudinal observational study will involve a repeated measure analysis of 6 different
      tobacco carcinogen biomarkers. Fifty current smokers who intend to continue smoking for the
      duration of the study will be recruited through advertisements. Participants will be
      compensated for their time. Blood samples will be collected every two months for one year.
      All samples will be analyzed for the 6 different carcinogen biomarkers and individual
      variability in biomarker levels will be assessed.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cigarette smokers
      
Biospecimen description: 
      Urine and blood samples.
Effects of GS-3K8 and GINst15 on Acute Respiratory Illness
Condition: Acute Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of GS-3K8 or
      GINst15 on acute respiratory illness (ARI) in healthy subjects.
    

Detailed description: 
      This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five
      subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15
      (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the
      incidence of ARI. The secondary clinical outcome measure was the development and duration of
      ARI symptoms.
    

Intervention name(s): GS-3K8; GINst15; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): GS-3K8 (ultrafiltered red ginseng extract) 1 g/day; GINst15 (hydrolyzed ginseng extract) 1 g/day; Placebo 1 g/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: ultrafiltered red ginseng; hydrolyzed ginseng; acute respiratory illness; clinical trial
Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy
Condition: Postoperative Pain; Post Operative Analgesia; Patient-Controlled Analgesia; Abdominal Surgeries
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination
      of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v.
      basal infusion of tramadol is a certified technique in postoperative pain management. We
      purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine
      is an effective way in treating postoperative pain.
    


Intervention name(s): Dexamethasone Sodium Phosphate Injection; 0.9% Saline
Intervention type(s): Drug; Other
Intervention description(s): Dexamethasone, 10mg, continuously infused up to 48h after surgeries.; Saline, in same volume of 2mL
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucocorticoid; Opioids; Balanced analgesia
A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine if golimumab can preserve beta-cell
      function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
    


Intervention name(s): Golimumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive subcutaneous golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area) in an OL extension period.; Matching Placebo to golimumab.
Other intervention name(s): SIMPONI
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
Condition: Retirement; Weight Gain
MeSH terms: Weight Gain
Study type: Interventional
Phase: Phase 2

Summary: 
      Advancing age in itself is associated with changes in body composition. However, during
      transitional life stages, such as retirement, detrimental changes on diet and physical
      activity may occur. This might lead to weight gain and accumulation of abdominal fat.

      To prevent these changes, participants receive a low-intensity intervention on energy balance
      and related behaviours.

      After six months, one and two years, the effects will be studied by comparing the
      intervention group with the control group.
    


Intervention name(s): Behavior change on physical activity and diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Retirement; Physical activity; Diet; Weight gain; Body composition
Study of TP-04 in Participants With Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to evaluate the safety, tolerability, and efficacy of the study
      drug, TP-04, in participants with papulopustular rosacea (PPR).
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double-blind, parallel-group, vehicle-controlled
      study evaluating the safety, tolerability, and efficacy of Lotilaner Gel, 2.0% (TP-04)
      applied BID for 12 weeks in participants with moderate to severe PPR.
    

Intervention name(s): Lotilaner Gel, 2.0%; Vehicle control gel
Intervention type(s): Drug; Other
Intervention description(s): Lotilaner Gel, 2.0% (TP-04) is an aqueous gel formulation of lotilaner, a member of the isoxazoline family of compounds and parasiticide that selectively inhibits parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels (GABA-Cls).; Aqueous gel
Other intervention name(s): TP-04; Vehicle Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigational product (Lotilaner Gel, 2.0% [TP-04]) or vehicle control gel will be applied topically on the face twice daily (BID) during the study.
Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) or vehicle control gel on the face BID for 12 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors
Condition: Failed Back Surgery Syndrome; Chronic Pain
MeSH terms: Syndrome; Chronic Pain; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      This pilot study is part of a global project that aims to better define and understand
      features of FBSS/POPS "post-operative persistent syndrome patients (shortened as "FBSS" in
      the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been
      defined as a chronic condition resulting from spinal interventions. Despite anatomically
      successful spine surgery, a significant proportion of patients is experiencing chronic
      refractory back and leg pain. In a recent multicentre study conducted on more than 100
      refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS
      diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might
      guide us to eventually develop a decision tool for identifying FBSS patients. Easing and
      helping diagnosis of FBSS should improve referral yield to specialists and accelerate patient
      flow through the care pathway. Hence, FBSS patients, who usually present a long standing
      history of pain, would have access to "appropriate" therapies earlier. This could lead to
      better outcomes. The aim of this multicentre, prospective study is to collect specific data
      that are not collected in routine in order to better define and understand the potential FBSS
      population and to accelerate the diagnostic and optimize the choice of appropriate treatment.

      A multidisciplinary approach through a pain management clinical network, as it has been
      structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and
      their care pathway will be collected. In addition, since the cooperation between orthopaedic
      and neuro spine surgeons is not a common relationship found all over Europe (as it is
      observed in Poitiers), this study also aims to better understand the development of
      interactions between physicians/professionals and the substantial advantage which would
      result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers
      to collect data and assess objectively pain surface and intensity changes, before/after any
      treatment, with quantitative measurements, will be used as the central key of this project.
    


Intervention name(s): No name
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF
      in COPD patients.
    

Detailed description: 
      A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO
      EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH
      FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE
      INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    

Intervention name(s): Glycopyrrolate; Glycopyrrolate; Glycopyrrolate; Comparator
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): comparison of different dosages of drug; comparison of different dosages of drug; comparison of different dosages of drug; comparison of different dosages of drug versus comparator
Other intervention name(s): Foster+GLyco 25; Foster+GLyco 50; Foster+GLyco 100; Foster
Intervention MeSH terms: Glycopyrrolate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics)
      of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to
      evaluate the effect of food on the PK of JTT-251 in healthy subjects.
    


Intervention name(s): JTT-251 or Placebo
Intervention type(s): Drug
Intervention description(s): Subjects will receive JTT-251 or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Food-effect; Diabetes
Management of Postoperative Pain After Total Knee Replacement.
Condition: Postoperative Pain; Knee Replacement Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two methods of postoperative pain management in
      patients undergoing total knee replacement.
    

Detailed description: 
      Patients undergoing total knee replacement will be assigned at random to receive one of two
      methods of postoperative pain management. Patients assigned to nerve block will receive
      regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot
      sciatic nerve block. Patients assigned to periarticular injection will receive periarticular
      local injection into the periarticular soft tissues at the time of knee replacement using a
      combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all
      patients will be given a standardized combination of oral analgesic medications
      preoperatively and postoperatively. All patients will receive a posterior stabilized total
      knee replacement through an medial parapatellar approach.
    

Intervention name(s): Nerve Block; Periarticular Injection
Intervention type(s): Drug; Drug
Intervention description(s): Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.; Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Other intervention name(s): Naropin; Naropin; Adrenalin; Toradol
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Transarterial chemoembolization (TACE) is considered the gold standard for treating
      intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not
      specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with
      sorafenib who showed TACE-resistant.
    


Intervention name(s): HAIC; Sorafenib
Intervention type(s): Procedure; Drug
Intervention description(s): administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries; sorafenib 400mg bid
Intervention MeSH terms: Sorafenib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; TACE failure; Sorafenib; Hepatic arterial infusion chemotherapy; Oxaliplatin, fluorouracil, and leucovorin
A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation
      cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in
      comparison to placebo.
    


Intervention name(s): rVIIa-FP; Placebo (0.9% normal saline)
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.; Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment