bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of multiple-dose administration of
      BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.
    

Detailed description: 
      Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover
      study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated
      by a washout of 10 or more days. During each of the treatment periods the volunteers received
      either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo,
      concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8:
      0.25 mg/day).
    

Intervention name(s): BIA 2-093; Placebo; Digoxin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BIA 2-093 1200 mg once-daily; matching placebo; Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
Other intervention name(s): ESL, Eslicarbazepine acetate; PLC, Placebo; Lanoxin™
Intervention MeSH terms: Digoxin; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eslicarbazepine acetate; BIA 2-093
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way
      cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102
      (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
    

Detailed description: 
      The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day
      (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.
    

Intervention name(s): Active comparator: Modafinil + placebo; THN102 300/3; THN102 300/27
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Modafinil 300 mg; Flecainide Placebo; Modafinil 300 mg; Flecainide 3 mg; Modafinil 300 mg; Flecainide 27 mg
Intervention MeSH terms: Flecainide; Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors
Condition: Orbital Tumor
MeSH terms: Solitary Fibrous Tumors; Hemangiopericytoma
Study type: Observational

Summary: 
      Orbital solitary fibrous tumors are rare tumors with an intermediate potential of malignancy.
      Orbital solitary fibrous tumors' prognostic criteria are still poorly understood.

      Some patients with orbital solitary fibrous tumors have been treated at the Adolphe de
      Rothschild Foundation Hospital. This cohort will be studied to describe the recurrence rate
      and to identify predictive factors of recurrence or metastasis.
    


Intervention name(s): Phone call
Intervention type(s): Other
Intervention description(s): Patients will be asked to complete a questionnaire via a phone call
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with an orbital solitary fibrous tumor
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
Condition: PTSD
MeSH terms: Disease; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12-week, multicenter, open-label extension study to evaluate the safety and
      efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD
      or related condition. Patients recruited into this trial are those who have successfully
      completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made aware
      of the therapy they received during the double-blind study.
    

Detailed description: 
      The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which
      is anticipated to be the same date as the final visit in the lead-in P201 study) and visits
      after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for
      refraining from the use of certain concomitant medications and trauma-focused psychotherapies
      will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or
      they may utilize other medications as needed to help them sleep, per the judgment of the
      investigator.

      Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily
      at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to
      receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the
      lead-in study. No patients, investigators, or study staff will know the assigned study
      treatment from the lead-in study, P201, at the time of entry into the extension study.
      Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used
      as one of the baseline values for this study.
    

Intervention name(s): TNX-102 SL
Intervention type(s): Drug
Intervention description(s): TNX-102 Sublingual tablets
Other intervention name(s): cyclobenzaprine HCI
Intervention MeSH terms: Cyclobenzaprine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Military-related PTSD and other related conditions; open-label extension
COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction; Ventricular Remodeling
Study type: Interventional
Phase: Phase 2

Summary: 
      Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury
      in ST-segment elevation myocardial infarction. They add additional damage to the myocardium
      and are associated with clinical adverse events (heart failure and cardiovascular death) and
      poor myocardial recovery. All the different anti-inflammatory approaches to reduce
      reperfusion injury have been disappointing.

      Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent
      pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary
      intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase
      release) with a short course treatment of colchicine in comparison to placebo.

      One mechanism to explain this effect could be the reduction of adverse left ventricular (LV)
      remodelling. LV remodelling is part of the healing process of myocardium after MI. It is
      defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV
      remodelling is increased by inflammation and ultimately leads to heart failure.

      Our main hypothesis is that colchicine with its anti-inflammatory properties significantly
      reduces the initiation of adverse LV remodelling, together with a significant reduction of
      infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients
      referred for PPCI.

      After inclusion and randomisation, patients will receive the first part of their experimental
      treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5
      days. They will be followed up during their hospitalization and until one year. In order to
      evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during
      their participation: one during their hospitalization and a second at 3 months. At 1 year,
      adverse events will be collected by phone.
    


Intervention name(s): Colchicine group (experimental arm); Placebo group (control arm)
Intervention type(s): Drug; Drug
Intervention description(s): In the experimental group, patients will receive colchicine, starting with a loading dose of 2 mg at the time of revascularization and continuing with 0.5 mg twice daily (b.i.d) for 5 days.; In the placebo group, patients will receive placebo, starting with a loading dose of 2 mg at the time of revascularization and continuing with 0.5 mg twice daily for 5 days.
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial Infarction; STEMI; Inflammation; Left ventricular remodeling; Colchicine; CMR
Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis; Eczema
Study type: Interventional

Summary: 
      Up to 30 participants with mild to moderate atopic dermatitis/eczema will be enrolled to
      apply study Investigational Product for 4 weeks.
    

Detailed description: 
      This will be a 4-week single arm study. This study will be executed by one clinical research
      company in one research center accruing 30 subjects with mild to moderate Eczema/atopic
      dermatitis. Patients ages 18-75, will be enrolled. Subjects that are enrolled will be placed
      on Locus's Over The Counter cream "Arctiva" twice per day for 4 weeks.
    

Intervention name(s): Arctiva
Intervention type(s): Other
Intervention description(s): A colloidal oatmeal cream designed to stimulate healing and repair of damaged tissue naturally, working with the body instead of against it.
Intervention model: Single Group Assignment
Intervention model description: Open label, single arm
Masking: None (Open Label)
Primary purpose: Treatment
Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The aim of this study is to evaluate the quality of life of patients undergoing colorectal
      resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre
      operative status have been submitted retrospectively, while post operative questionnaires
      have been submitted prospectively during last follow up visit
    

Detailed description: 
      All patients fit for the study will be asked to complete a visual analogue scales (VAS) for
      dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients
      will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being
      questionnaires Bristol Stool Chart, GSCG (Gastrointestinal Symptom Rating Scale), STAY (1 and
      2), the Psychological General Well-Being Index (PGWBI), Generalized Self-Efficacy, CD-RISC -
      Connor-Davidson scale about their pre operative and actual status.

      Surgery includes laparoscopic resection of all visible endometriosis, including resection of
      the affected bowel with primary anastomosis Perioperative and post-operative complications
      will be collected using the Extended Clavien-Dindo classification of surgical complications
      divided in early (within 30 days after surgery onset) and late (over 30 days after surgery
      onset).
    

Intervention name(s): colorectal resection
Intervention type(s): Procedure
Intervention description(s): Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis
Other intervention name(s): ileostomy creation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and
        candidate to colo-rectal resection
      
Keywords: deep infiltrating endometriosis; colorectal resection; quality of life
Substrate Metabolism, Growth Hormone Signaling, and Insulin Sensitivity During Fasting
Condition: Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Background: Calorie restriction increases longevity in many species and attenuate the
      development of chronic disorders including type 2 diabetes, cardiovascular diseases and
      cancer. In mice reduced activity of insulin-like growth factor I (IGF-I) and/or insulin is
      associated with extended longevity. Growth hormone (GH) is the main regulator of IGF-I
      production, but the molecular mechanism whereby GH switches from IGF-I stimulation (protein
      anabolism) to fatty acid oxidation (fatty acid catabolism) as well as induction of insulin
      resistance during fasting remains enigmatic.

      Hypotheses: The changes of the global set of metabolites, induction of insulin resistance,
      and the shift in metabolism from protein anabolism to lipolysis together with the potentially
      favorable effect of calorie restriction during fasting depend on preserved fasting-induced GH
      secretion.

      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in
      signaling pathways that take place at the transition to the fasting state among healthy
      overweight and obese subjects. Furthermore the investigators wish to determine the effect of
      GH on the adaption of the metabolism to a fasting state.
    


Intervention name(s): Fasting; Saline; Pegvisomant
Intervention type(s): Other; Drug; Drug
Intervention description(s): 72 hours of fasting; Concomitant saline during fasting; Concomitant Growth hormone receptor blockade with Pegvisomant during fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC
Condition: Locally Advanced Lung Carcinoma
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of
      hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent
      consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced
      non-small cell lung cancer (LA-NSCLC).
    


Intervention name(s): Hypofractionated radiotherapy; Concurrent chemotherapy; Consolidation immunotherapy
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): Split-course adaptive HRT-CHT is administered at the following three dose levels:
Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.; weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT; Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally advanced non-small cell lung cancer; Definitive hypofractionated chemoradiotherapy; Fraction dose escalation; Consolidation immunotherapy
Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
Condition: Parkinson's Disease; With Inclusion Criteria for STN Deep Brain Stimulation; Presenting a Contraindication to Intracerebral Electrode Implantati
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in
      Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but
      presenting also with clear contraindications to the implantation of the deep brain
      electrodes.
    

Detailed description: 
      Subthalamic nucleus (SNT) deep brain stimulation (DBS) is the reference treatment for severe
      drug resistant Parkinson's disease, responsible to dopaminergic therapy, to the state of
      complication. The efficacy of this therapeutic approach has transformed the functional
      prognosis of these patients. Unfortunately, those of the patients presenting with
      contraindications for anaesthesia or electrode implantation are excluded of these therapeutic
      hope.

      Gamma Knife radiosurgery is a neurosurgical procedure going to operate in the brain of the
      patients without opening the skull without infection or bleeding risk.

      Gamma Knife radiosurgical treatment will be done in two separate times (GK1 and GK2).
      Treatment of the second side (GK2) will be done at least 12 months after the treatment of the
      first side (GK1), in the same methodology as the first treatment. The major risk of onset of
      acute ballism although low is planned to be managed by the standard protocol by the
      recruiting team involved in the trial.
    

Intervention name(s): Gamma Knife radiosurgery
Intervention type(s): Procedure
Intervention description(s): For patients presenting a contraindications for anaesthesia or electrode implantation, operate their brain without opening the skull without infection or bleeding risk.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson; contraindication to Intracerebral electrode implantation; Gamma Knife radiosurgery
Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Onychomycosis is a fungal infection that affects fingernails and/or toenails.

      The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of
      patients with fungal infection of the toenails.
    


Intervention name(s): MOB015
Intervention type(s): Drug
Intervention description(s): Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal subungual onychomycosis
Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II study is to provide data regarding the safety and immunogenicity
      for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative
      for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for
      MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will
      provide long-term immune response data.

      This study was originally performed by MedImmune. However, GSK is now responsible for the
      clinical development of the HPV vaccine.
    

Detailed description: 
      This is a Phase II double-blind, randomized, dose-comparison, multicenter study in the United
      States of three different dose levels of MEDI-517 (HPV-16/18 VLP AS04 vaccine) and one dose
      of MEDI-517 formulated with aluminum hydroxide, with doses administered at 0, 30 and 180
      days. Healthy female volunteers 18 through 30 years of age will be entered into 4 treatment
      arms. The objectives of study are to evaluate reactogenicity, safety and immunogenicity.
    

Intervention name(s): MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1); MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2); MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3); MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): IM injection; IM injection; IM injection; IM injection
Other intervention name(s): MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2); MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3); MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV, Vaccine
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study investigated the clinical efficacy and safety of a 10-day course of therapy with
      daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in
      patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2
      parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug
      will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic
      acid will be given orally, once daily throughout the study duration of 90 days as basic
      treatment. The clinical observation period for each patient will be 3 months and will include
      six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.
    


Intervention name(s): Cerebrolysin; 0.9% Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): 30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.; 30 ml will be given once daily by intravenous infusion for 10 consecutive days.
Other intervention name(s): NaCl
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment