bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Interventional, multicenter, and longitudinal study, of a cohort of patients with
      schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12
      months interval.
    

Detailed description: 
      The main objective is evaluation and validation of social cognition battery, characterizing
      the psychometric properties (validity, sensitivity to change) measures in a cohort of
      schizophrenic patients. Other objective is to demonstrate that the various components
      operating at T0 and T12 months of schizophrenic patients, as an external validator, are
      significantly explained by social cognition performance given the third known factors :
      neuropsychological, sociodemographic, disease course, and clinical status. Search and model
      relationships between the measured variables.
    

Intervention name(s): Assessment battery A; Assessment battery B
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Social cognition tests version "A" are administered to the patients; Social cognition tests version "B" are administered to the patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: schizophrenia
Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study will be to examine the safety and efficacy of modafinil in
      increasing number of methamphetamine non-use weeks in subjects with methamphetamine
      dependence.
    

Detailed description: 
      To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects
      with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will
      be associated with an increase in the number of methamphetamine non-use weeks over time as
      measured by quantitative urine analysis for methamphetamine.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg or 400 mg /daily; Placebo / daily
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Methamphetamine Dependence
Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke
Condition: Ischemic Stroke; Cerebral Infarct; Sleep Apnea; Periodic Limb Movement Disorder
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Movement Disorders; Nocturnal Myoclonus Syndrome; Ischemia; Infarction
Study type: Observational

Summary: 
      Ischemic stroke is a major public health issue, likely to cause functional disability. It is
      well known that sleep has an impact on brain plasticity, and after an ischemic stroke,
      studies have shown subjective sleep quality alterations and sleep architecture abnormalities.

      Furthermore, there is no clear guideline showing the usefulness of a systematic sleep
      investigation following an ischemic stroke.

      The aim of the study is to identify retrospectively correlation between polysomnographic
      abnormalities (sleep apnea, periodic limb movements, disturbed sleep architecture…) and
      functional recovery after an ischemic stroke. The study also assesses the impact of sleep
      abnormalities on survival, and the risk of new cardiovascular event.
    

Detailed description: 
      This study is a retrospective observational study, from a cohort of patients who had a sleep
      recording (polysomnography or ventilatory polygraphy performed in Montpellier University
      Hospital) following an ischemic stroke.
    

Intervention name(s): Sleep recording (already done)
Intervention type(s): Other
Intervention description(s): Sleep recording (already done)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients selected with computer codes of disease and examination corresponding to the
        criteria : sleep recording and ischemic stroke
      
Keywords: Functional recovery; Ischemic stroke / cerebral infarct; Sleep; Polysomnography
Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most
      aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults
      and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune
      activation with increased numbers of T-cells, dendritic cells (DCs), and increased expression
      of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased skin, and 3)
      defective barrier function with increased trans-epidermal water loss (TEWL) and decreased
      lipids, reflecting underlying alterations in keratinocyte differentiation. AD is
      predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a
      "T22" (IL-22) polarized disease.

      ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD.
      This study is being done to assess the safety, tolerability, clinical efficacy, and mechanism
      of action of ILV-094 in patients with AD.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, study of six IV infusions of ILV-094
      administered to subjects with atopic dermatitis. Sixty subjects will be randomly assigned in
      a 2:1 ratio to one of the two treatments arms (ILV-094 vs placebo). Forty patients will be
      enrolled in the ILV-094 treatment arm and 20 in the placebo-treatment arm, accordingly. A
      loading IV dose of 600 mg of ILV-094 or placebo will be given at baseline (Day 0), followed
      by five additional IV doses of 300 mg of ILV-094 or placebo every two weeks (Weeks 2, 4, 6,
      8, and 10). We will continue to follow the patients every two weeks for an additional 10
      weeks after the last IV dose (20 weeks post baseline).
    

Intervention name(s): ILV-094; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of ILV-094; Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Other intervention name(s): Placebo
Intervention MeSH terms: Fezakinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
Condition: Muscle Strength
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of experimental knee pain on the muscle
      strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized
      that experimental knee pain will reduce the muscle strength gain following strengthening
      exercises in healthy volunteers.
    


Intervention name(s): Experimental knee pain; Non-painful control injections
Intervention type(s): Other; Other
Intervention description(s): Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad; Injection of isotonic saline into the infrapatellar fat pad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
Condition: Hypogonadal Males
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum
      testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the
      pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand
      application
    


Intervention name(s): Testosterone Gel (FE 999303)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
Condition: NSCLC (Non-small Cell Lung Cancer)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single
      agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in
      First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer
      Patients. The objective of the study is to demonstrate that Crizotinib is superior to
      first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging
      Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose
      tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma
      Kinase) gene locus.
    


Intervention name(s): Crizotinib; Pemetrexed/Cisplatin; Pemetrexed/Carboplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 mg two times daily [BID], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods.; Option 1: Pemetrexed/Cisplatin; Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Cisplatin, 75 mg/m^2 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and cisplatin will be repeated every 3 weeks for a maximum of 6 cycles.; Option 2: Pemetrexed/Carboplatin. Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Carboplatin, at a dose calculated to produce an AUC of 5 or 6 mg.min/mL will be administered by infusion according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and carboplatin will be repeated every 3 weeks for a maximum of 6 cycles.
Intervention MeSH terms: Carboplatin; Pemetrexed; Crizotinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crizotinib; ALK positive; ALK; Anaplastic Lymphoma Kinase; NSCLC; Non-Small Cell Lung Cancer; Frontline; 1L; Previously Untreated; East Asian; Non-Squamous
Mood Effects of Serotonin Agonists Extended
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study we are examining the effects of repeated very low doses of serotonin agonists
      on mood individuals with negative mood.
    

Detailed description: 
      Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide
      (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood,
      cognitive performance and responses to emotional tasks
    

Intervention name(s): Placebo; Serotonin agonist - 13ug; Serotonin agonist - 26ug
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug will be administered in solution form; 13ug lysergic acid diethylamide; 26ug lysergic acid diethylamide
Other intervention name(s): LSD; LSD
Intervention MeSH terms: Serotonin; Serotonin Receptor Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and
      access the efficacy and safety of GX-188E according the protocol in patients with Cervical
      Intraepithelial Neoplasia 3 (CIN3).
    

Detailed description: 
      Subjects who are eligible for this study are allocated to one of the two treatment groups of
      GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on
      alternating deltoid muscles which will be performed totally three times during the study
      period.
    

Intervention name(s): GX-188E
Intervention type(s): Biological
Intervention description(s): DNA vaccine administered via IM route using TDS-IM electroporation device
Other intervention name(s): DNA therapeutic vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CIN3; Cervical Intraepithelial Neoplasia; High-Risk HPV; HPV Infection; Neoplasm; Precancerous Diseases; Uterine Diseases; Genital Diseases, Female
A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as
      nausea and vomiting after laparoscopic surgery.
    

Detailed description: 
      With IRB approval and informed consent, 100 female ASA 1 and 2 outpatients who were scheduled
      for elective gynecologic laparoscopic surgery were randomly allocated to either the current
      standard (control group) or to additional efforts to remove residual CO2 at the end of
      surgery (intervention group; power analysis yielded 45 patients necessary per group). In the
      control group, CO2 was removed by passive deflation of the abdominal cavity through the holes
      of the trocar. In the intervention group, CO2 was removed by means of Trendelenburg position
      (> 30 degrees) with 5 manual pulmonary recruitment maneuvers. Postoperative shoulder pain was
      assessed prior to discharge and 12, 24, 36 and 48 hours later using a visual analog scale
      (VAS). In addition, positional characteristics of the shoulder pain and incidence of
      postdischarge nausea and vomiting (PDNV) were recorded 48 hours after surgery.
    

Intervention name(s): Recruitment manouver
Intervention type(s): Procedure
Intervention description(s): In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Laparoscopic Surgery; Shoulder pain; PDNV; Anesthesia; Residual CO2; Postoperative Pain; Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery
Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate different methods to evaluate the effect
      of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese
      but otherwise healthy subjects.
    


Intervention name(s): AZD4017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, 1200mg, once daily, for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Pharmacodynamic method evaluation
The Effective Concentration of Lidocaine With Fentanyl in Lumbar Epidural Anesthesia for Transurethral Resection of Prostate(TURP) in Elderly Patients
Condition: BPH( Benign Prostate Hyperplasia); TURP(Transurethral Resection of Prostate)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery
      because of its rapid onset. But the epidural anesthesia using high concentration of lidocaine
      may cause excessive motor block and unwanted side effects such as nausea, vomiting and
      hypotension.

      This is a study to determine the effective concentration of lidocaine with fentanyl in lumbar
      epidural anesthesia for transurethral resection of prostate in elderly patients.
    


Intervention name(s): epidural block with lidocaine and fentanyl
Intervention type(s): Drug
Intervention description(s): The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting concentration of lidocaine was 1.5 % mixed with fentanyl 75 ug. All patients receive 13mL of lidocaine with fentanyl 75ug. The concentration of lidocaine for subsequent patients is determined by the outcome in the previous patient according to up and down sequential allocation in 0.1% increments. In the case of block failure, the concentration of lidocaine was increased by 0.1%.
Conversely, block success resulted in a reduction in concentration by 0.1%.
Intervention MeSH terms: Lidocaine; Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Observational [Patient Registry]

Summary: 
      Circulating anti-beta2-glycoprotein antibodies have been associated with coronary artery
      disease and peripheral arterial disease. This auto-antibodies could activate endothelial
      cells leading to the expression of leukocyte adhesion molecules and increasing the release of
      pro-inflammatory cytokines.

      On the other hand, endothelial dysfunction of atherosclerotic patients acts as a primary
      pathogenic event, as it occur before structural changes are evident on angiogram or
      ultrasound scan. Loss of endothelial normal function causes vasoconstriction, local
      coagulation alterations and an increase arterial wall proliferation. This situation s been
      attributed to a reduction in nitric oxide bioactivity, and to an increase oxygen-free radical
      formation in the context of the pro-inflammatory status found in atherosclerosis.

      Hypothesis: Circulating Anti-beta2-glycoprotein I antibodies could be associated with
      endothelial dysfunction and nitric oxide metabolism disruption en patients with peripheral
      arterial disease.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cases: Male patients with intermittent claudication due to peripheral arterial disease
        after haemodynamic confirmation of the disease by Doppler and treadmill exercise testing.
        No previous history of autoimmune disease.

        Controls: Healthy male subjects with normal results on vascular examination and no
        cardiovascular risk factors, who were not in receipt of any pharmacological treatment,
        matched by age within two years with PAD patients.
      
Biospecimen description: 
      Serum samples of all the subjects included.
    
Keywords: Anti-beta2-glycoprotein antibodies; Peripheral arterial disease; Inflammation; Nitric oxide; Endothelial dysfunction
Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the
      pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the
      NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD.
      The purpose of this study is to confirm whether ifenprodil tartrate is effective in the
      treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these
      patients, this study contributes to the development of novel therapeutic drugs for PTSD.
    


Intervention name(s): Ifenprodil Tartrate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ifenprodil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD/ifenprodil
A Pharmacokinetic Study of TP-05 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending Dose Study Evaluating the
      Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects
    

Detailed description: 
      This Phase 1 study is a randomized, double-blind, single- and multiple-ascending dose trial
      to evaluate the safety, tolerability, food-effect, and pharmacokinetics of TP-05 in healthy
      subjects. Subjects will be enrolled in 5 sequential, ascending single dose cohorts and 3
      multiple, ascending dose cohorts. Dose escalation will be approved by a safety monitoring
      committee before beginning the next cohort. The Safety Review Committee (SRC) will evaluate
      if any dose-limiting adverse events (AEs) through Day 15 (in Cohorts 1-5) or through Day 36
      (in Cohorts 6-8) occurred in a cohort before proceeding to dosing in the next dose level. In
      addition, the SRC will review selected PK parameters after selected cohorts. Skin punch
      biopsies, and venous, capillary, and urine samples may be collected at various timepoints for
      pharmacokinetic analysis. Safety assessments include monitoring of adverse events, clinical
      laboratory testing, vital sign measurements, physical examinations, and ECGs. A blood sample
      may also be collected to evaluate tick mortality upon exposure.
    

Intervention name(s): TP-05 (lotilaner oral capsules); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TP-05 (lotilaner oral capsules); Placebo to match TP-05 (lotilaner oral capsules)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: a randomized, double-blind, single ascending dose (SAD) with Cohort 1-4 administered on a full stomach and Cohort 5 administered after a period of fasting Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation with Cohort 6-8 administered on a full stomach.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science