bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of High Dose CoQ10 in ALS
Condition: Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in
      individuals with ALS for a possible future phase III study.
    

Detailed description: 
      Amyotrophic lateral sclerosis (ALS) is a progressive and devastating neurodegenerative
      disorder. Available treatment for ALS remains scarce. Oxidative stress and mitochondrial
      dysfunction have been implicated in the pathophysiology of ALS. Oxidative stress refers to
      the effects of cell-damaging reactive oxygen species, also known as free radicals. Oxidative
      stress is thought to contribute to nerve cell loss in ALS. Mitochondria are organelles within
      each cell that are sometimes called "powerhouses of the cell" because cellular energy
      metabolism is located within the mitochondria.

      Coenzyme Q10 (CoQ10), a mitochondrial cofactor known for its antioxidant properties, has
      prolonged survival in the mouse model of ALS and has slowed functional decline in another
      neurodegenerative disorder, Parkinson's disease. The goals of this double-blind,
      placebo-controlled, two-dose comparison phase II study are to obtain preliminary efficacy
      data and to select the preferred dose for a larger phase III study.

      Participants were randomly assigned to CoQ10 (at two different dose levels) or placebo in the
      first stage, then the 2,700 mg dose was selected in the second stage. Duration of the trial
      was 9 months with a total of 7 visits.
    

Intervention name(s): coenzyme Q10; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): antioxidant and mitochondrial cofactor, given in capsules three times daily; Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily
Other intervention name(s): Coenzyme Q 10; CoQ10
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; ALS; Lou Gehrig's disease; CoQ10; coenzyme Q10; antioxidants; free radicals; mitochondrial dysfunction
Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine
      extended-release oral suspension, CII) for the treatment of symptoms of
      attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
    

Detailed description: 
      This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover
      study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of
      ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.
    

Intervention name(s): amphetamine extended-release oral suspension, 2.5 mg/mL; Placebo extended-release oral suspension
Intervention type(s): Drug; Drug
Intervention description(s): 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO; 6, 7 or 8 mL PO
Other intervention name(s): Dyanavel XR
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
Condition: Chronic Hepatitis C; Hepatitis C Virus; HCV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the
      efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and
      without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1
      (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated
      cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially
      planned in the protocol, it was not administered in any of the study arms.
    

Detailed description: 
      This study consisted of two independent parts: Part 1 was conducted first followed by Part 2.
      Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled
      participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed
      or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV
      RNA to evaluate efficacy and the emergence and persistence of viral variants.
    

Intervention name(s): ABT-493; ABT-530
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Tablet
Other intervention name(s): glecaprevir; pibrentasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV GT4; Hepatitis C virus; HCV GT1; HCV; Compensated Cirrhosis; HCV GT6; Hepatitis C Genotype 4 (GT 4); Hepatitis C Genotype 1 (GT1); RBV; Cirrhotic; Hepatitis C; Interferon (IFN) Free; IFN free; HCV GT5; Chronic Hepatitis C; Ribavirin; Child Pugh A; Hepatitis C Genotype 5 (GT 5); Hepatitis C Genotype 6 (GT 6); ABT-493; ABT-530; glecaprevir; pibrentasvir
Platelet-rich Plasma in Calcific Tendinitis
Condition: Calcific Tendinitis
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific
      tendinitis which does not respond to conservative treatment. NACD is effective in
      approximately 70% of the patients.When NACD is not effective, surgery is often the only
      treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for
      diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and
      the doctors treating those patients will benefit from a more effective minimal invasive
      treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering
      its positive effect on tissue repair, be a possible solution here.Previous research
      investigating the effects of PRP on other tendinopathies did, however, show controversial
      results. The aim of this double-blind randomized controlled trial is to investigate the
      effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder
      function, tendon recovery,resorption of calcific deposits, the percentage of patients with
      persistent complaints and quality of life.
    


Intervention name(s): PRP; Control
Intervention type(s): Other; Other
Intervention description(s): platelet enriched autologous blood plasma; Regular barbotage/care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plasma, calcific tendinitis, rotator cuff, PRP
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
Condition: Alzheimer Disease; Cognitive Dysfunction; Mild Dementia
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of SAGE-718 and
      its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive
      impairment (MCI) or mild dementia due to Alzheimer's disease (AD).
    


Intervention name(s): SAGE-718
Intervention type(s): Drug
Intervention description(s): SAGE-718 oral tablets.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer
Condition: Recurrent Platinum Resistant Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, single arm, multi-center study to assess the efficacy and safety of
      the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade
      serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal
      carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not
      carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)
      mutations.
    

Detailed description: 
      The study will recruit approximately 60 patients aged ≥18 years, with histologically proven
      diagnosis of platinum-resistant relapsed high grade serous, high grade endometroid or clear
      cell ovarian, fallopian tube or primary peritoneal carcinoma who have received at least 3
      prior lines of therapy, and who do not carry a deleterious or suspected deleterious germline
      BRCA mutation. All patients should have recurrent platinum resistant disease. The receipt of
      prior antiangiogenic treatment (e.g. bevacizumab) is optional. If used, it can be in the
      first line or recurrent setting. To be eligible to enter the study, all patients should have
      measurable disease (as assessed by the Investigator).

      There is no maximum duration for taking the study treatments (cediranib+olaparib). Patients
      should continue on study treatments until objective radiological disease progression, as
      defined by RECIST version 1.1 guidelines, or they meet other discontinuation criteria.
      Following discontinuation of study treatment patients will be followed for disease
      progression (if they have not already progressed), survival and post-progression anti cancer
      therapies until the data cut-off for the primary analysis, approximately 8 months after
      enrollment of the last patient.
    

Intervention name(s): cediranib and olaparib
Intervention type(s): Drug
Intervention description(s): Cediranib tablets oral dose 30 mg once daily; Olaparib(Lynparza) tablet 200 mg twice daily
Dose reduction for both products is allowed
Other intervention name(s): Olaparib: also known as Lynparza
Intervention MeSH terms: Olaparib; Cediranib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer
Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The purpose of this multi-center post marketing surveillance study is to monitor the safety
      and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the
      L1 - S1 spinal disc.
    

Detailed description: 
      The purpose of this prospective, randomized, multicenter study is to demonstrate the
      superiority of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy
      (as described by Spengler), to limited discectomy alone, with regard to preventing
      reherniation and the recurrence of pain or dysfunction. Patients, ages 21 - 75, will have, in
      part, a positive straight leg raise (or positive femoral stretch, as appropriate), MRI
      confirmation of a disc herniation, and minimum Oswestry and VAS leg scores of 40 out of 100
      to qualify for this study. Additional patient criteria can be found in the
      inclusion/exclusion criteria section.

      Superiority of the Barricaid relative to limited discectomy alone will be based on a
      comparison of overall success rates of the Barricaid and a concurrent group (randomized) of
      control patients treated by primary lumbar limited discectomy at select European
      (approximately 15-20) sites.

      This study has two co-primary endpoints. Success of the study will be based on the Barricaid
      population achieving statistical superiority over the concurrently randomized non-implanted
      limited discectomy population at 2 years.
    

Intervention name(s): Barricaid
Intervention type(s): Device
Intervention description(s): Implanted intra-operatively during discectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hernia; Intervertebral Disk Displacement; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases
Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects
Condition: Multiple Sclerosis; MS
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to
      evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects
      with relapsing multiple sclerosis (RMS).

      Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the
      eligibility criteria during a screening period of up to 28 days will be provided with an
      electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.

      The main purpose of this study is to evaluate treatment adherence for subjects with RMS over
      24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose
      cartridge.
    


Intervention name(s): RebiSmart™; RebiSmart™
Intervention type(s): Device; Device
Intervention description(s): Electronic self-injection device (RebiSmart™) to inject Rebif®; Electronic self-injection device (RebiSmart™) to inject Rebif®
Other intervention name(s): Rebif; Rebif
Intervention MeSH terms: Interferon beta-1a
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community and Academic MS clinics
      
Keywords: RebiSmart; Rebif; Adherence; Multidose; Relapsing Multiple Sclerosis; RMS
Internal Iliac Artery Ligation and Abnormally Invasive Placenta
Condition: Placenta Percreta
MeSH terms: Placenta Accreta
Study type: Interventional

Summary: 
      This trial is set to detect the impact of bilateral internal iliac artery ligation on the
      amount of intra-operative blood loss during the hysterectomy procedure done for the
      management of abnormally invasive placenta
    


Intervention name(s): internal iliac artery ligation; Cesarean Hysterectomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and
      safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.
    


Intervention name(s): CTX-4430; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Facial Acne
A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW
      formulation administered as single and multiple doses in patients with schizophrenia.
    

Detailed description: 
      A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability,
      and safety of brexpiprazole QW formulation administered as single and multiple doses.

      The trial comprises the single-dose period (Cohort 1) and the multiple-dose period (Cohort
      2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma
      drug concentrations obtained in the single-dose period (Cohort 1).
    

Intervention name(s): 2mg conventional tablet, once-weekly tablets
Intervention type(s): Drug
Intervention description(s): In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia,brexpiprazole,open-label,linical pharmacology
Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety/tolerability and pharmacokinetic characteristics after single
      intravenous (IV) administration of hzVSF-v13 (humanized Virus Suppressing Factor-variant 13)
      in healthy male volunteers
    

Detailed description: 
      Dose blocked-randomized, double-blind, placebo controlled, single dose, dose-escalation study
      to investigate the safety/tolerability and pharmacokinetic characteristics of hzVSF-v13 after
      IV administration in healthy male volunteers
    

Intervention name(s): hzVSF-v13; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form: 10mg / 20mg / 50mg / 100mg / 200mg / 400mg / 800mg / 1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1 (single administration); Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)
Other intervention name(s): a humanized monoclonal antibody (mAb); 0.9% Normal saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lidocaine In-situ Gel Before Intrauterine Device Insertion
Condition: Pain Relief
Study type: Interventional
Phase: Phase 3

Summary: 
      Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the insertion tube, and removing the tube; and
      placement of the device in the uterus.
    


Intervention name(s): lidocaine in-situ gel; placebo in-situ gel
Intervention type(s): Drug; Drug
Intervention description(s): lidocaine in-situ gel; placebo in-situ gel
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
Condition: Overactive Bladder
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric
      parameters in patients with OAB and UUI.
    

Detailed description: 
      Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol
      LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of
      either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of
      study cystometry will be performed; daily symptom diaries will be completed during the trial
      and health-related quality of life will be measured before and after study drug treatment.
      Patients will be followed-up one week after completion of the trial. Study participation will
      include 5 visits over a period of six weeks.
    

Intervention name(s): SSR240600C; Placebo; Tolterodine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily; oral; once daily
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cystometry NK1 Antagonist SSR240600C
The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study is to investigate the effect of transcranial direct current stimulation (tDCS)
      simulation on motor learning to stroke patients compared to sham stimulation
    


Intervention name(s): Transcranial Direct Current Stimulation; Motor learning
Intervention type(s): Device; Behavioral
Intervention description(s): Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.; Sequential finger tapping task training is applied to stroke patients.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Kinetics of Plasma Fibrinogen in Cardiac Surgery
Condition: Fibrinogens, Abnormal
Study type: Observational

Summary: 
      The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and
      thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.
    


Intervention name(s): Fibrinogen plasma level
Intervention type(s): Procedure
Intervention description(s): At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing cardiac surgery with extracorporeal bypass
      
Biospecimen description: 
      Whole blood containing all components
Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the effect of the dispenser's buzzer function on
      compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP)
      containing oral contraceptive (OC) in a flexible extended regimen when administered for
      approximately 12 months to healthy female volunteers who request contraception.
    


Intervention name(s): BAY86-5300; BAY86-5300
Intervention type(s): Drug; Drug
Intervention description(s): 0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function; 0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment