bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms
Condition: Stress
Study type: Interventional

Summary: 
      Two unique proprietary formulations of adaptogens VL-G-E12 formulation and an herbal blend
      containing VL-G-A57 is one of the most well-known adaptogens that has been used for years to
      enhance positive mood states, deepen sleep, and improve memory. The product has been proven
      to have a role in improving depression, enhancing work performance, eliminating fatigue and
      treating symptoms of asthenia subsequent to intense physical and psychological stress. The
      extract was tested on antidepressant, adaptogenic, anxiolytic, nociceptive and locomotor
      activities at doses of 10, 15 and 20 mg/kg, using predictive behavioral tests and animal
      models. The results show that this product extract significantly, but not dose-dependently,
      induced antidepressant-like, adaptogenic, anxiolytic-like and stimulating effects in mice.
      Studies reveal that this shrub has antimicrobial (including antibacterial, antiviral,
      antifungal, antiprotozoal, antimalarial, anthelmintic), anti-inflammatory, anti-diabetic,
      anti-hypercholesterolemia, anti-hypertensive, anti-carcinogenic, and immunomodulatory
      effect.The aim of the current study is to assess the adaptogenic effects of two potential
      investigational products VL-G-A57 and VL-G-E12 Their adaptogenic effect shall be investigated
      by assessing several clinical symptoms of HPA axis dysfunction such as stress, anxiety, sleep
      quality, fatigue, mood etc.
    


Intervention name(s): VL-G-A57; VL-G-E12; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days; Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days; Dose: 700mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Products: VL-G-A57 (Arm 1), VL-G-E12 (Arm 2) & Placebo (Arm 3) Dose: 700 mg daily Route: Oral Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food Duration: 60 days
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of the Effectiveness of Dry Needling Versus Foam Roller
Condition: Myofascial Pain Syndromes; Dry Needling
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      To compare the effects of dry needling and Foam roller in myofascial trigger points. Needling
      has been shown to decrease pain in the short term; however, its effects on muscle force
      production are unclear. There are differences between dry needling and foam roller after
      treatment?
    

Detailed description: 
      Background: It has been shown that the decrease of the range of motion in the ankle, due to
      the presence of latent trigger points in the gastro-sole complex, can affect performance, as
      well as being a predisposing factor to injury. Objective: To compare the effects of Dry
      Needling and Foam roller in healthy athletes with limited dorsal ankle flexion by the
      presence of latent trigger points. Material and methods: This is a clinical trial,
      single-blind experimental study. The sample will have a total of 44 students, volunteers,
      healthy of the degree of physiotherapy of the the investigator's university (UCV).
      Participants who meet the inclusion criteria will be randomly assigned in two groups: Group 1
      or Dry Needling (N = 22) and Group 2 or Foam Roller (N = 22). The range of motion of ankle
      will be assessed through the Leg Motion system (Check Your Motion®, Albacete, Spain).
      Assessed thought Ankle Test (post-intervention and 24 hours later). The reference values to
      consider the decreased ankle ROM will be <11.5 cm, <35º measured with Easy Angle® digital
      goniometer (Meloq AB, Sweden) and/or if it has a difference of 1.5 cm between both
      extremities. Thus, the effect on previous activity performance will be assessed thought the
      Counter Movement Jump. Data analysis: Once the distribution of the sample is determined, a
      descriptive analysis of the data will be carried out and an ANOVA of repeated measures. Will
      be used to compare the data found in the two groups that make up the study taking into
      account a 95% CI and an error less than 0.05.
    

Intervention name(s): Dry needling
Intervention type(s): Procedure
Intervention description(s): Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dry needling; Myofascial pain syndromes; Ankle joint
Visual Outcomes After Implantation of a New Multifocal Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective nonrandomized study comprised patients with cataract, corneal astigmatism,
      and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular
      Lens will be implanted in the capsular bag. Three months postoperatively, distance,
      intermediate, and near visual acuities; spherical equivalent; residual refractive
      astigmatism; defocus curve; and contrast sensitivity will be evaluated. A
      patient-satisfaction and visual phenomena questionnaire will also be administered.
    

Detailed description: 
      Postoperative evaluation was performed at 3 months. The uncorrected and corrected distance
      visual acuity were assessed using the 100% contrast Early Treatment Diabetic Retinopathy
      Study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual
      acuity at 40 cm; a binocular defocus curve was constructed using the ETDRS chart at 4 m and
      adding to the patient's manifest refraction +2.50 to -5.00 D sphere in 0.50 increments. The
      cylinder axis of the Intraocular lens (IOL) was measured at the slitlamp using the beam
      protractor after full mydriasis. The mean of the absolute values of degrees the intraocular
      lens was off axis was determined.

      Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.),
      which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12
      and 18 cycles per degree. The background illumination of the translucent chart does not
      depend on room lighting. All measurements were obtained under mesopic (5 cd/m2) and photopic
      (85 cd/m2) conditions. The examinations were performed unilaterally at a distance of 2.5 m
      with Best-corrected visual acuity (BCVA) and an undilated pupil. All measurements were
      performed under the same conditions.

      Patient satisfaction and quality of life were assessed by a simple questionnaire. Patients
      were interviewed 3 months postoperative. Patients were asked about visual disturbances,
      visual lifestyle activities, spectacle use, and satisfaction with the procedure.
    

Intervention name(s): Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)
Intervention type(s): Device
Intervention description(s): Multifocal IOL implantation
Other intervention name(s): RAYNER M-FLEX T TORIC IOL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cataract; Vision; Intraocular lens; Multifocal; Toric
Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study investigators are studying the effects of a drug called ketamine on the
      symptoms of Obsessive-compulsive disorder (OCD).
    

Detailed description: 
      Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%
      of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as
      obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only
      medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with
      SRI treatment, most patients continue to experience significant OCD symptoms, impaired
      functioning, and diminished quality of life. Recent evidence suggest that a different
      neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target
      glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from
      OCD. In this study the investigators are recruiting patients to receive the drug ketamine,
      which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate
      (NMDA), in a 2-week placebo controlled study.
    

Intervention name(s): Ketamine infusion; Saline
Intervention type(s): Drug; Other
Intervention description(s): 0.5mg/kg IV over 40 minutes; saline infusion
Other intervention name(s): Ketamine hydrochloride
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: OCD
Food Effect Study of AG120 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of
      AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a
      2-period crossover design. PART 2 is an open-label study to determine the safety and PK
      parameters of a single 1000-mg oral dose of AG-120.
    


Intervention name(s): AG120
Intervention type(s): Drug
Intervention description(s): AG120 in fed and fasted conditions. Part 2- AG120 single dose exposure
Intervention MeSH terms: Ivosidenib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers
A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Current literature has only limited information on the natural history of acute ischemic
      stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from
      symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from
      this trial will advance our knowledge on this important topic and may serve as a bench mark
      for future trials
    


Intervention name(s): Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies
Intervention type(s): Other
Intervention description(s): The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. Patients with current standard of care other than IV rtPA or IA therapies will be studied.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom
        onset and with an imaging-defined large cerebral vessel occlusion and a known infarct
        volume will be enrolled and followed for 90-days.
      
Keywords: acute ischemic stroke, large vessel occlusion, natural history, functional outcome
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to understand the safety and tolerability of INCB018424 in
      patients with rheumatoid arthritis
    


Intervention name(s): INCB018424; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis
Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The purpose of the study is to examine the effect of alpha-neurofeedback while subjects
      listen to a noise on tinnitus.
    


Intervention name(s): Neurofeedback
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
Condition: Burns; Ulcers; Giant Nevi
Study type: Interventional

Summary: 
      The aim of this work was to present the investigators experience in the use of autologous
      three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes,
      melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents
      a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers
      and giant nevi.
    

Detailed description: 
      Background and Objective:

      Permanent wound closure remains a limiting factor in the closure of extensive, full-thickness
      loss of substance. The aim of this work was to present our experience in the use of
      autologous three-cellular cultured skin substitutes (CSS) consisting of cultured
      keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This
      method represents a surgical alternative in the treatment of a variety of pathologies,
      including burns, ulcers and giant nevi.

      Methods:

      CSS were obtained from full-thickness skin biopsies collected after enrollment of 11 patients
      in a study protocol approved by the local Institutional Review Boards of the "La Sapienza"
      University of Rome. CSS consisted of a structure characterized by the presence of a
      pluristratified epithelial cell surface with melanocytes (relation 1/20) and a basement of
      fibroblasts kept together by an esterified hyaluronic acid scaffold that can be surgically
      manipulated, and is gradually reabsorbed after implantation and substituted by the host
      connectival stroma.
    

Intervention name(s): CSS grafting
Intervention type(s): Procedure
Intervention description(s): grafting of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid (HYAFF11® and HYAFF11p80®) obtained from full-thickness skin biopsies to repair full-thickness loss of substance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioengineered; ski; keratinocytes; fibroblasts; skin; culture; autologous; CSS; full-thickness loss of substance from:; burns; ulcers; giant nevi; cicatricial outcomes
Assessment of Renal Physiology by Magnetic Resonance Imaging (MRI) in Normal Volunteers
Condition: Glomerular Filtration Rate; Renal Blood Flow
Study type: Interventional

Summary: 
      Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients
      with renal disease. Although serum creatinine based GFR and nuclear medicine based
      estimations are routinely used in clinical practice, GFR estimation by Inulin is the
      recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.

      A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease
      in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome
      para-aminohippuric acid (PAH) clearance method.

      MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most
      of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH
      clearance which are ther gold standards . In this study we propose to estimate MRI based GFR
      estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI
      is an accurate test of kidney function.
    


Intervention name(s): Inulin and PAH clearance and MRI
Intervention type(s): Procedure
Intervention description(s): GFR and renal blood flow estimation by Inulin and PAH clearance will be performed in the Renal Physiology Lab for approximately 2.5 hours;
The MRI test will be performed afterwards at Medical Imaging department and last about 45 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Glomerular Filtration Rate; Renal Blood Flow; MRI; Inulin; Para-Aminohippuric Acid
Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
Condition: Recurrent Glioblastoma Multiforme; Recurrent Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective - to determine the 6-month progression free survival (PFS) of adult
      patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly
      temozolomide plus (Avastin) bevacizumab.

      Secondary objectives - to determine radiographic response including specialized MRI
      sequences, safety and overall survival of adult patients with with recurrent glioblastoma
      multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin).
      Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.
    

Detailed description: 
      This is a phase II study of the combination of Avastin and temozolomide for patients with
      recurrent glioblastoma multiforme. Avastin is administered intravenously at a dose of 10
      mg/kg on days 1 and 15 every 28 days and temozolomide is administered at a dose of 100 mg/m2
      on days 1-5 and 15-19 every 28 days (one cycle). Patients will have a baseline MRI, an MRI
      scan after the first cycle and every other cycle after that. If there is no evidence of
      disease progression or unacceptable toxicity, patients will receive one year of therapy. If
      there is evidence of added benefit (eg: tumor regression), patients can stay on treatment
      longer than one year, per investigator discretion.
    

Intervention name(s): temozolomide and bevacizumab
Intervention type(s): Drug
Intervention description(s): oral temozolomide 100 mg/m2 days 1-5 & 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 & 5 every 28-day cycle
Other intervention name(s): Temodar; Avastin
Intervention MeSH terms: Bevacizumab; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: temozolomide; bevacizumab; Temodar; Avastin; glioblastoma multiforme; gliosarcoma; glioma; GBM; brain tumor
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Condition: Lung Cancer
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The prognosis of patients with unresectable, locally advanced non-small cell lung cancer
      (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer
      drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern
      targeted therapies have enhanced the outcomes of lung cancer treatment, especially for
      advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is
      bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF).
      Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy
      may change the previous treatment modality. It allows some lung cancer patients to be
      downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be
      improved.
    

Detailed description: 
      This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in
      unresectable, locally advanced lung adenocarcinoma.
    

Intervention name(s): Neoadjuvant Bevacizumab
Intervention type(s): Drug
Intervention description(s): Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection
Other intervention name(s): Pemetrexed (Alimta); Bevacizumab (Avastin)
Intervention MeSH terms: Bevacizumab; Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; lung adenocarcinoma; bevacizumab; adjuvant chemotherapy; surgical resection rate; safety; feasibility
A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial will study the
      safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with CKD due
      to multiple etiologies at risk of rapid disease progression. Approximately 70 patients will
      be enrolled and randomized 1:1 to either bardoxolone methyl or placebo. Patients with CKD
      secondary to varying etiologies will be enrolled from age 18-70 years with eGFR ≥ 20 to < 60
      mL/min/1.73 m2, and other risk factors for rapid progression of kidney disease.

      The maximum target dose will be determined by baseline proteinuria status. Patients with
      baseline urine albumin to creatinine ratio (UACR) ≤ 300 mg/g will be titrated to a maximum
      dose of 20 mg, and patients with baseline UACR > 300 mg/g will be titrated to a maximum dose
      of 30 mg. Qualified patients will be randomized 1:1 to receive either bardoxolone methyl or
      placebo once daily (preferably in the morning) throughout a 12-week dosing period.

      Patients in the study will follow the same visit and assessment schedule. Patients will be
      assessed during treatment at Day 1, Weeks 1, 2, 4, 6, 8, and 12 and by telephone contact on
      Days 3, 10, 21, 31, 35, and 45. Date of last dose and the end-of-treatment assessments mark
      the end of the treatment period. Patients will not receive study drug during a 5-week
      off-treatment period between Weeks 12 and 17. The off-treatment (OT) period includes 5 visits
      requiring various assessments to characterize eGFR from the time of study drug
      discontinuation through Day 35 off-treatment.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Bardoxolone methyl oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status; Capsule containing an inert placebo
Other intervention name(s): RTA 402
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Advanced CKD; Chronic Kidney Disease; Bardoxolone methyl; RTA 402; eGFR; Advanced Chronic Kidney Disease