bioihbjkbjnl/mcl2 huggingface dataset:
eNeura SpringTMS Post-Market Observational US Study of Migraine
Condition: Headache
MeSH terms: Headache
Study type: Observational

Summary: 
      A multi-center, prospective, non-randomized, single arm, open label, post-market,
      observational study to evaluate the use of the eneura, springtms system in reduction of
      migraine headache symptoms.
    

Detailed description: 
      A prospective, non-randomized, single arm, multi-center observational study designed to
      evaluate the use of the SpringTMS system in reducing the frequency of headache days.

      Note: This is a NON-SIGNIFICANT RISK (NSR) study of a NON-SIGNIFICANT RISK (NSR) Device. It
      is a post market study of a NSR device cleared by FDA through the 510(k) pre-market
      notification process. The cleared indications for use are provided above. This NSR study is
      designed to collect information on additional applications of the SpringTMS device. These
      additional applications include:

        1. Use of the device to evaluate the potential for regular use of sTMS to reduce the
           frequency, severity, and/or duration of migraine.

        2. Delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of
           breakthrough migraine attacks with and without aura.
    

Intervention name(s): eNeura SpringTMS
Intervention type(s): Device
Intervention description(s): Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete
        headache-free days/month)
A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to demonstrate that dupilumab treatment improves
      exercise capacity in patients with moderate-to-severe asthma.

      The secondary objectives of the study are:

        -  To demonstrate that dupilumab treatment increases physical activity of daily living in
           patients with moderate-to-severe asthma

        -  To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in
           patients with moderate-to-severe asthma
    


Intervention name(s): dupilumab; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pre-filled syringe administered by subcutaneous (SC) injections; Pre-filled syringe administered by subcutaneous (SC)
Other intervention name(s): Dupixent®; SAR231893
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cerebral Blood Flow Effects of Resveratrol and Piperine in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Resveratrol is associated with a plethora of physiological effects in humans, including
      modulation of cerebral blood flow, despite apparently poor bioavailability. This study
      investigated whether the physiological effects of resveratrol could be affected when
      co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability
      of resveratrol.
    


Intervention name(s): Trans- resveratrol; Placebo (silica)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.; All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Keywords: Resveratrol; Piperine; Cerebral blood flow; Near- infrared spectroscopy; Bioavailability
Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To determine the effects of anodal transcranial direct current stimulation on mobility and
      balance in post stroke patients.
    

Detailed description: 
      Stroke is characterised as sudden onset of neurological dysfunction of central anxious
      framework that contain cerebral infarction, intra cranial haemorrhage & subarachnoid
      haemorrhage. Around the globe stroke is the chief cause of incapacity and passing.

      The trans-cranial direct current stimulations (tDCS) could be a non-invasive,low cost and
      capable brain stimulator utilised within the treatment of brain disorders.Two modes of tDCS
      is utilised is stroke patients,anodal stimulation (increased in excitability) of the lesional
      half of the globe and cathodal stimulation (decreased in excitability) of the contralesional
      hemisphere. The transcranial direct current stimulation induced polarity-dependent changes in
      membrane excitability, with Anodal-tDCS causing depolarisation and cathodal-tDCS causing
      hyper polarization of membrane potential in neurons of the stimulated area.

      The role of Trans-cranial Direct Current Stimulation as a catalyst of recovery in stroke
      population and found that it's a safe,portable,non invasive brain stimulation technique.
      T-DCS is able to modulate the excitability of specified brain areas by varying the neuronal
      membrane potentials that based on the polarity of the current transmitted through the scalp
      via sponge electrodes. Trans-cranial direct current stimulation is clinically potential for
      use in stroke recovery because of its ease of use, non invasive-ness and safety.
    

Intervention name(s): Anodal Transcranial Direct Current Stimulation Group; Conventional Training Exercises Group
Intervention type(s): Other; Other
Intervention description(s): Experimental group were received anodal transcranial direct current stimulation and conventional training exercises for 3 days a weeks for 6 consecutive weeks on alternate days.
Anodal tDCS were given through:
i. Anodal electrode:It has been placed over primary motor cortex(ipsilesional) ii. Cathodal electrode: It has been above contralateral eye. iii. Intensity: 2mA iv Density: 0.07C/cm2 iv. Duration:20 min vi Rectangular electrodes(25cm2 ) inserted in saline soaked sponge used; Conventional physical exercises were given for 3 days a week on alternate days upto 6 weeks. It includes: progressive Conventional Training Exercises : From Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balance; Stroke; Anodal Transcranial Direct Current Stimulation
Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the
      end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)

      Secondary Objectives:

      To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following
      parameters:

      Randomization/Crossover phase:

        -  Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus
           vial and syringe

      Re-randomization phase:

        -  Change in Fasting Plasma Glucose (FPG) from week 4 to week 10

        -  Percentage of patients achieving FPG<110 mg/dL at week 10

        -  Change in Lantus dose injected per day (U) from week 4 to week 10

      Observational phase:

        -  Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40

        -  Time to first observation of HbA1c<7% during the observational phase

        -  Percentage of patients who discontinue Investigational Product (IP) during the
           observational phase due to dissatisfaction with their current device

      All phases:

        -  Percentage of patients who discontinue IP during each phase of the study

        -  Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)
    

Detailed description: 
      This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a
      6-week Re-randomization Phase, followed by a 30 week Observational Phase.

      The total duration of study participation was up to 41 weeks with a total treatment duration
      of up to 40 weeks of Lantus exposure.
    

Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Indoor Allergen Exposures in Northern Manhattan and the South Bronx
Condition: Asthma; Allergy
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Controlled trial of an intervention to reduce indoor exposures to cockroach allergens among
      asthmatic children in NYC.
    


Intervention name(s): Integrated Pest Management
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Allergen; Cockroach
Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)
Condition: Schizophrenia
MeSH terms: Neutropenia; Schizophrenia
Study type: Interventional

Summary: 
      Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia
      (SZ). Despite the overwhelming evidence of superior efficacy, CLZ is infrequently prescribed
      in the US, at a considerably lower rate than the estimated prevalence of treatment-resistant
      SZ, especially for African-Americans (AA). Recent evidence suggests that low Absolute
      Neutrophil Counts (ANC), either at baseline or during treatment are a significant barrier to
      CLZ use in AA patients in the US, where guidelines mandate CLZ discontinuation if ANC drops
      below 1500 cells/mm3. The investigators group has found that discontinuation of CLZ in AA
      patients is over twice that in European-American (EA) patients (N~400; 42% vs.19%, P=0.041)
      and initiation rates are 50% lower. In a Statewide study (N=1875), the investigators reported
      that discontinuation was more frequently due to neutropenia in the AA sample, though no AA
      had developed agranulocytosis (8 cases in EA). Benign Ethnic Neutropenia (BEN) in people of
      African ancestry, including AAs, identifies a group (50% of AA) with low ANCs but no
      increased risk of agranulocytosis or infection. Low baseline or in-treatment fluctuations
      requiring CLZ discontinuation under current prescribing guidelines are common in CLZ-treated
      persons with BEN. In the investigators recent pilot study of N=12 AA patients with BEN,
      treatment was safely and successfully continued with CLZ despite low baseline ANC (outside
      current guidelines). Recent evidence implicates a polymorphism in the Duffy Antigen Receptor
      Chemokine (DARC) gene in the pathophysiology of BEN. In homozygotes (FY-/-) for the DARC null
      allele, mean within-subject neutrophil counts are reduced, resulting in sporadic ANC <1500
      cells/mm3 in 10-15% of people with the allele. In population studies, the FY-/- genotype is
      found in 0.01% of EAs, 99.3% of sub-Saharan Africans (SSA), and 68% of AAs. Further, a
      missense DARC mutation has been reported to interact with the DARC FY-/- in determining low
      WBC in AAs. Normal patterns of week-to-week fluctuation in ANC levels in individuals of
      African ancestry with BEN and the DARC null genotype are not known, and no published research
      has examined variation in ANC in African ancestry CLZ-treated SZ patients with BEN and the
      DARC null genotype (FY-/-). Such data are also lacking on individuals with BEN without the
      DARC null genotype. Conducting such research will generate genetic marker and safety data
      that could be used to expand access to CLZ for AA patients who otherwise are eligible to
      receive this superior treatment option.
    


Intervention name(s): Clozapine
Intervention type(s): Drug
Intervention MeSH terms: Clozapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TEL and Clam Shell Exercises Affect After ACL
Condition: Knee Ligament Injury
Study type: Interventional

Summary: 
      The purpose of this study to determine the effects of the addition of isolated hip
      strengthening exercises to traditional rehabilitation after Anterior cruciate ligament
      reconstruction (ACLR). Clamshells exercises unique in scene because it mainly focuses on the
      muscle surrounding the hip whereas the traditional exercises mostly paid attention on quads
      and hams exercise
    

Detailed description: 
      In 2020, researcher conducted a randomized controlled clinical trial to determine "Does
      six-weeks of Hip-focused exercises has the effects on Time to Stabilization after Anterior
      Cruciate Ligament Reconstruction". The purpose of these study to determine the relationship
      between muscle strength and time taking to increase the performance of knee. The main
      findings suggesting that rehabilitation program targets on strengthen the hip muscles in
      comparison with traditional exercises of knee demonstrate an improvement of knee functions in
      individual with Anterior cruciate ligament reconstruction (ACLR).

      In previous studies there is very less literature regarding determining effects of the
      clamshells exercises on extension lag after anterior cruciate ligament reconstruction.
      Therefore there is a dire need to explore the effect of the clamshells exercises on post
      anterior cruciate ligament reconstruction extension lag. This study aims in the management of
      pain disability and functional impairment in persons with extension lag with clamshells
      exercises after ACL reconstruction.
    

Intervention name(s): goniometer; clamshells exercises; traditional physical therapy
Intervention type(s): Device; Other; Other
Intervention description(s): to measure the range of motion; clamshells exercises; traditional physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: anterior cruciate ligament reconstruction
Acute Treatment of Bipolar II Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the medications lithium and lamotrigine (Lamictal®) in treating
      depression in individuals with bipolar II disorder.
    

Detailed description: 
      Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic
      episodes. The disability and suicide risk associated with BDII is equal to bipolar I
      disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII
      addressed in current treatment guidelines. Data suggest that Li and LTG may be effective
      treatment options for BDII. This study will determine the safety, effectiveness, and
      tolerability of the two drugs in people with BDII.

      Participants in this study will be randomly assigned to receive either Li or LTG for 16
      weeks. Participants will be assessed every 2 weeks. One week after study completion,
      participants will have a follow-up visit. Measures of depression, mania, quality of life,
      functioning, and participant satisfaction will be taken.
    

Intervention name(s): Lithium; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive lithium.; Participants will receive lamotrigine.
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Depression
Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose of this study is to evaluate the clinical response and safety of CMAB009
      plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and
      oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients
    

Detailed description: 
      CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds
      specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a
      murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is
      expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab
      (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other
      post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology
      Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed
      well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to
      determine whether adding CMAB009 to irinotecan increased the response rate and prolongs
      survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously
      treated with fluoropyrimidine and oxaliplatin.
    

Intervention name(s): CMAB009 plus Irinotecan; Irinotecan-only and sequential-CMAB009
Intervention type(s): Drug; Drug
Intervention description(s): Combined with irinotecan 180 mg/m2 every 2 weeks, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression; First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression.
Other intervention name(s): YiMaiLin for irinotecan; YiMaiLin for irinotecan
Intervention MeSH terms: Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KRAS wild-type; Metastatic Colorectal Cancer; CMAB009 Plus Irinotecan; Phase II/III
Pulmonary Hypertension, Quality of Life and Psychosocial Factors
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The investigators aim to :

        -  describe and analyse psychological characteristics, cognitive factors and
           representations in patients with Pulmonary Hypertension, a rare disease.

        -  assess the psychological characteristics impact on quality of life, check the
           association between disease and QoL evolution, and the variability of QoL parameters
           over severity class changes and follow-up
    

Detailed description: 
      PAH is a rare, and severe disease, potentially mortal, affecting preferentially young
      subjects. The knowledge and the international literature, as regards the quality of life, the
      expectations, the needs and the psychosocial characteristics of patients with PAH, are
      non-existent. But it is known that the persons affected by rare diseases are more vulnerable,
      on the psychological, social, economic and cultural planIn all the stages of the treatment,
      patients with PAH are confronted with heavy psychosocial situations, in a context of vital
      risk, with exceptional medicinal treatments (intravenous administration at home).

        -  QoL might be differently affected by these changes according to situational and
           dispositional psychological dimensions.

        -  the predictive role of these characteristics on the current and later quality of life,
           as well as the impact of diverse cognitive mediators and strategies to cope with the
           disease, should be investigated.The respiratory diseases department of the Montpellier
           hospital is regional competence center for PAH in Languedoc-Roussillon, under the aegis
           of the national reference center (the respiratory diseases department of Antoine Béclère
           hospital, Le Petit-Clamart).
    

Intervention name(s): Evaluation of quality of life
Intervention type(s): Behavioral
Intervention description(s): -Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological
        follow-up at the competence center.
      
Keywords: Pulmonary Hypertension; Quality of life; Coping; Depression; Anxiety; Social support; Control beliefs