bioihbjkbjnl/mcl2 huggingface dataset:
Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Most mental health problems emerge by age 14, often leading to chronic impairments and
      adverse impacts for individuals, families, and societies. Any action-focused path to reducing
      the need-to-access gap will require moving beyond the dominant settings, formats, and systems
      that have constrained intervention delivery to date. In a fully-online trial, youths ages
      13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a
      behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset,
      targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's
      relative benefits, versus the control, on depressive symptoms and proximal outcomes such as
      hopelessness. Results will reveal whether SSIs that were designed to address behavioral
      versus cognitive symptoms differentially benefit adolescents with elevated depressive
      symptoms.
    


Intervention name(s): Supportive Therapy SSI; Behavioral Activation SSI; Growth Mindset SSI
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Online, 30-minute self-administered program for youth; Online, 30-minute self-administered program for youth; Online, 30-minute self-administered program for youth
Other intervention name(s): Sharing Feelings SSI; ST-SSI; Activate Action; BA-SSI; Project Personality; GM-SSI
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to the Behavioral Activation SSI (BA-SSI), Growth Mindset SSI (GM-SSI), or the Supportive Therapy SSI (ST-SSI; each 30 minutes in length).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: single-session interventions
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Africa, Asia and North America. The aim of this trial is to
      compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin
      glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
    


Intervention name(s): insulin glargine; insulin degludec; insulin degludec; insulin degludec; metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Treat-to-target dose titration scheme, s.c. injection.; Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily; Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily; Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly; Tablets, 1500-2000 mg/day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor
Condition: Hallux Limitus; Movement, Abnormal; Back Pain Lower Back Chronic
MeSH terms: Hallux Limitus; Hallux Rigidus; Dyskinesias; Back Pain; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      Foot disorders have been recognized as being linked to chronic low back pain
    

Detailed description: 
      Foot disorders have been recognized as being linked to chronic low back pain (CLBP), To
      improve knowledge of the relationship between the limitation of the movement range of hallux
      (HROML) is important about it can affect the back biomechanical . The aim of this research is
      to investigate if the HROML may appear as a risk factor of CLBP

      HROML affect the foot position, and consecuently may induce to alter as compensatory
      mechanism the normal biomechanical of the leg, hip and back.
    

Intervention name(s): Case control
Intervention type(s): Diagnostic Test
Intervention description(s): Is a case-control research
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Males and females between 18 and 65 years old
      
Keywords: foot; hallux; limitus; back
Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Condition: Dry Eye; Tear Film; Lipid Layer; Liposic; Tears Naturale Forte
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been
      developed in which phospholipid liposomes are delivered to the tear film via the surface of
      the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte
      application on the lipid and stability of the tear film in dry eye patients
    


Intervention name(s): Liposic; Tears Naturale Forte
Intervention type(s): Drug; Drug
Intervention description(s): one eye of the participant recieved Lipoic; the other eye of the participant recieved Tears Naturale Forte
Other intervention name(s): Carbomer; DEXTRAN/HYPROMELLOSE/GLYCERIN
Intervention MeSH terms: Dextrans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a piolt single-arm trial of Jiu-wei-zhen-xiao Granule, extracted from nine kinds of
      Chinese medicnie, for the treatment in patients with advanced, unresectable hepatocellular
      carcinoma(HCC). The primary objective is to assess its therapeutic efficacy in patients with
      unresectable HCC. The primary endpoint is overall survival (OS) after the use of 12-week
      drug. Secondary endpoints include progression-free survival (PFS) after the use of 12-week
      drug, the improvement of the score of the European Organization for Reasearch and Treatment
      of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), the changes of the liver
      function, coagulation function, the size of solid tumors,"Du-tan-yu-jie Zheng" in Chinese
      medicine, pain Visual Analogue Scale and toxicity profile of Jiu-wei-zhen-xiao Granule.
    


Intervention name(s): Jiu-wei-zhen-xiao Granule
Intervention type(s): Drug
Intervention description(s): Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
Condition: Subarachnoid Haemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH)
      affects 7000 patients each year in the UK and is a source of considerable death and
      disability, even in young adults. Recent observations indicate that these bleeds can cause
      reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability
      occur, and are particularly prevalent when low cerebral blood flow results in stroke.
      Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target
      of modern therapy. Candidate drugs include statins which have an impeccable safety record and
      multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory
      processes, reduce adverse blood coagulation) following SAH.

      The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow
      and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated
      potential benefits for acute statin therapy following SAH, and the investigators now wish to
      conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger
      population (n=1600). The purpose is to see whether the positive effects of statins seen in
      our phase II study translate into clinical benefits - both short term (e.g. reduced need for
      intensive care) and long term (outcome and wellbeing at 6 months).
    


Intervention name(s): placebo; simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): one tablet a day for up to 21 days; simvastatin 40mg once a day for a maximum of 21 days
Other intervention name(s): placebo tablet; ritechol
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: intracranial aneurysm
Experimental Study Measuring Power and Execution Speed in 44 Athletes in Push-up Exercise.
Condition: Power
Study type: Interventional

Summary: 
      Investigation of power and speed in relation to the increasing instability in a group of
      untrained athletes and a group of expert athletes. In this way, the effectiveness of unstable
      training for different types of athletes can be tested.

      Our hypothesis is that as instability increases there is a gradual decrease in power and
      speed of execution, but not too relevant in the expert group.
    

Detailed description: 
      Introduction

      Strength training using devices that induce varying degrees of instability is widely
      practiced in numerous contexts and has been credited with benefits in prevention,
      rehabilitation and general health. Several studies have found a progressive decrease in power
      as the degree of instability increases. However, it is not known how mildly unstable
      situations are affected, nor are the differences between trained and untrained subjects.

      The purpose of the present study was to compare the effect of different degrees of
      instability on power and speed of execution in a push-up or arm-bottoms exercise, in trained
      and untrained subjects.

      Method

      Maximum power (MP) and mean power (BP), and maximum speed (MV) and mean propulsive speed (VA)
      of push-up were analyzed in 44 subjects, 24 untrained (176.38±5.35 cm, 76.38±6.85 kg, 2.5±1.5
      months experience) and 20 trained (178.45±5.91 cm, 83.4±21.56 kg, 15.5±5.3 months
      experience), under six conditions of increasing instability: 1) stable, 2) device in
      suspension: rings, 3) monopodal, 4) device in suspension: TRX®, 5) with hands-on Bosu® and 6)
      with hands-on TRX® and feet on Bosu®.
    

Intervention name(s): Power and Speed
Intervention type(s): Behavioral
Intervention description(s): Analysis of the power and speed of execution in 6 conditions of increasing instability Situation 1 is stable and basic execution. Condition 6 is the most unstable.
The participants performed 2 series of 3 repetitions in each of the situations. All the exercises were executed on the same day.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Core; Unstable Devices; Suspension Training; Resistance Training; Strength
A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the potential inhibitory/inducing effects of
      JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a
      cocktail, containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A4/A5, CYP2C9,
      CYP1A2, CYP2D6, CYP2B6, and CYP2C19) in healthy adult subjects.
    


Intervention name(s): JNJ-54175446 150 mg; JNJ-54175446 600 mg; Midazolam 2 mg; Warfarin 10 mg; Caffeine 50 mg; Dextromethorphan 30 mg; Bupropion 150 mg; Omeprazole 20 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive JNJ-54175446 150 mg capsules orally (1*100 mg + 1*50 mg) under fasted conditions on Day 7, 9, 10 and 11.; Subjects will receive JNJ-54175446 600 mg (6*100 mg capsules) orally on Day 8.; Subjects will receive midazolam 2 mg oral emulsion [2 (milligram per milliliter (mg/mL)] as a drug cocktail on Day 1, 7 and 11.; Subjects will receive warfarin 10 mg tablets (2*5 mg) orally as a drug cocktail on Day 1, 7 and 11.; Subjects will receive caffeine 50 mg tablet (1*50 mg) orally as a drug cocktail on Day 1, 7 and 11.; Subjects will receive dextromethorphan 30 mg capsule (1*30 mg) orally as a drug cocktail on Day 1, 7 and 11.; Subjects will receive Bupropion 150 mg tablet (1*150 mg) orally as a drug cocktail on Day 1, 7 and 11.; Subjects will receive omeprazole 20 mg capsule (1*20 mg) orally as a drug cocktail on Day 1, 7 and 11.
Intervention MeSH terms: Midazolam; Dextromethorphan; Caffeine; Bupropion; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Characterise the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Activity in Patients Affected by Benign Prostatic Hyperplasia (BPH) and Storage Urinary Symptoms
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity
      in patients with LUTS suggestive of BPH and relevant storage symptoms
    


Intervention name(s): Tamsulosin HCl controlled release capsules; Matching placebo capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
French National Cohort of Children With Port Wine Stain
Condition: Port Wine Stain; Klippel Trenaunay Syndrome; Parkes Weber Syndrome
MeSH terms: Hemangioma, Capillary; Sturge-Weber Syndrome; Brain Stem Infarctions; Klippel-Trenaunay-Weber Syndrome; Port-Wine Stain; Syndrome
Study type: Interventional

Summary: 
      Port Wine Stain on a limb can be either isolated or associated with complications (venous or
      orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes
      (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).

      Little is known about epidemiology of port wine stains: their evolution during the growth of
      the child, the frequency of complications, genetic data, and prognostic factors.

      This prospective french national cohort will help for : description of the evolution of port
      wine stain and possible complications; prognostic factors for complications ; association
      with mutations of RASA1 gene; quality of life of these children. It will also help for global
      appreciation of the management of this disease in France.
    

Detailed description: 
      Prospective national study, including 16 Pediatric and Dermatologic Departments.

      Methods : each children with a port wine stain on a lower limb will be followed up for 5
      years.

      Collected data : demographic data, clinical features, alterations of RASA1 gene, vascular
      evaluation by ultrasonographic and orthopedic evaluation by X rays, quality of life with a
      questionnaire.

      Inclusion period = 3 years Follow up period = 5 years Population = 150 children
    

Intervention name(s): search for polymorphisms of RASA1 gene
Intervention type(s): Genetic
Intervention description(s): Blood sample ( 5 mL) at tne inclusion of the child DNA extraction and genetic analysis of the 24 exons of RASA1 gene after specific consent
Intervention MeSH terms: GTPase-Activating Proteins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: port wine stain of a limb
Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects
Condition: Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC
      capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of
      these two formulations in healthy male Japanese subjects.
    

Detailed description: 
      A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study
      Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of
      D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
    

Intervention name(s): D961H Sachet 20 mg; D961H HPMC capsule 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.; Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.
Other intervention name(s): esomeprazole sachet; esomeprazole; capsule 20 mg
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence,; pharmacokinetics,; safety,; esomeprazole,; Japanese,; healthy subject,; homo-EM
Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to compare the pharmacokinetic characteristics, safety and tolerability of
      two formulations of lamotrigine in healthy male and female volunteers
    


Intervention name(s): Lamotrigine; GI267119
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine; 25 mg ODT
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tolerability; safety; Pharmacokinetic characteristics
Simultaneous MEG or fMRI And INtracranial EEG
Condition: Epilepsy; Healthy Volunteers
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with
      either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients
      suffering from drug-resistant partial epilepsy, and 2) define the functional organization of
      neural networks underlying human perception and cognition in order to prevent inadvertent
      deficits resulting from neurosurgical resection. In particular, high-frequency activity
      (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for
      both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG
      require further investigation. This will be a pioneering effort in several respects, as the
      first to directly measure high-frequency neural activity in tandem with fMRI, and among the
      first to do so with MEG. In addition to their attractiveness as noninvasive imaging
      techniques, fMRI and MEG have the potential to examine whole-brain networks that are not
      accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of
      simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the
      two noninvasive techniques, providing compelling evidence for the links between all three
      measurements with respect to underlying high-frequency neural activity in both health and
      disease. This project will therefore lead to improved selection of epilepsy surgery
      candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and
      healthy brain networks. The same techniques will be immediately applicable to functional
      mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of
      neurological and psychiatric populations.
    


Intervention name(s): MEG or fMRI And INtracranial EEG; fMRI
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Epilepsy surgery; High frequency activity; icEEG; fMRI; MEG
Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term
Condition: Induced Vaginal Delivery
Study type: Interventional

Summary: 
      This study evaluates the intervention for induction of labor with low bishop scores . One
      group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other
      group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at
      term.
    

Detailed description: 
      An unfavorable cervix during induction decreases the success rate of labor induction and
      vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable
      cervices. Application of transcervical Foley catheter is an effective mechanical method and
      has the advantages of lower cost and lowest rate of fetal heart rate changes due to
      tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1
      and PGE2 are reported to be more effective than mechanical methods to achieve vaginal
      delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and
      transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley
      balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon
      catheter. Early amniotomy is another effective method to ripen cervix. we aim to evaluate
      which method is superior to another.
    

Intervention name(s): early amniotomy; foley catheter balloon placement
Intervention type(s): Procedure; Device
Intervention description(s): 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.; an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix
Other intervention name(s): mechanic and medical method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dinoprostone; early amniotomy; labor induction; foley bulb