bioihbjkbjnl/mcl2 huggingface dataset:
TAK-653 Escalating Single and Multiple Dose Study in Healthy Participants
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      TAK-653 when administered as single and multiple oral doses at escalating dose levels in
      healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-653. TAK-653 is being tested to treat
      people who have depression. This study will look at the tolerability and PK of TAK-653 in
      healthy participants.

      The study may enroll up to 112 participants and each cohort will enroll 8 participants. This
      study consists of 2 parts: Part 1- single rising dose (SRD) consisting of at least 6 cohorts
      and Part 2- single rising dose and multiple rising dose (SRD/MRD) consisting of at least 5
      cohorts. Additional cohorts may be added depending on the emerging safety and PK data.
      Participants will be randomly assigned (by chance, like flipping a coin) within each cohort
      to receive TAK-653 or placebo which will remain undisclosed to the participants and study
      doctor during the study (unless there is an urgent medical need). Participants enrolled in
      Cohort 1 to 5 of Part 1 will receive TAK-653 0.3 mg, 1.0 mg, 3.0 mg, 5.0 mg and 9.0 mg or
      TAK-653 placebo-matching tablet. Subsequent dose escalation in Part-1, from Cohort 6 onward
      will occur after the full availability of safety, tolerability, PK, and PD data from
      preceding cohorts. Participants in Part-2 Cohorts 1 to 3 will receive TAK-653 0.3 mg, 1.0 mg
      and 3.0 mg respectively. Dose for Part 2, from Cohort 4 onward will be based on review of
      safety, tolerability, and available PK and PD data from previous cohorts. All participants
      will be asked to take the drug at the same time each day on Day 1 for Part 1 and Day 1 and
      Days 6 to 18 in Part 2.

      This single-center trial will be conducted in the United Kingdom. The overall time to
      participate in this study is approximately 14 days for Part 1 and 31 days for Part 2.
      Participants will be admitted to the clinic for 6 days in Part 1 and 22 days in Part 2.
      Participants will be followed up 14 days after last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): TAK-653 Placebo; TAK-653
Intervention type(s): Drug; Drug
Intervention description(s): TAK-653 placebo-matching tablets.; TAK-653 tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug therapy
Characters of Epiretinal Membranes in Patients With Previous Vitrectomy for Retinal Detachment
Condition: Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)
MeSH terms: Retinal Detachment; Epiretinal Membrane
Study type: Interventional

Summary: 
      31 patients were included in the study,15 cases with ERM in silicone filled eyes and 16 eyes
      with idiopathic ERM
    

Detailed description: 
      This is a prospective study that included 31 patients and was performed in Tanta University
      Eye Hospital in cooperation with the Pathology Department, Tanta University, between January
      2018 and June 2019. The approval of the ethical committee of the Faculty of Medicine in Tanta
      University was obtained, and the study was conducted in accordance with the 1964 Helsinki
      Declaration and its later amendment. A detailed informed written consent was signed by all
      study participants. The research is not funded by the university or any organization or
      entity.

      Fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months
      earlier with ERM detected by OCT one day before silicone oil removal. The other 16 cases
      matched for age and gender with idiopathic ERM and were included as a control.
      Histopathological features of the ERMs were compared between the two groups.

      All patients have undergone complete ophthalmic evaluation including: best corrected visual
      acuity (BCVA) by Snellen chart that was converted to log MAR for statistical analysis,
      anterior segment examination by slit lamp, posterior segment examination by slit lamp
      bimicroscopy using +78 D lens and indirect Ophthalmoscopy, and Spectral domain optical
      coherence tomography (SD-OCT) (Spectralis; Heidelberg Engineering,Heidelberg, Germany) was
      performed for all patients before surgery.

      The investigators excluded patients with previous intraocular surgery (except cataract
      surgery) for the control group, diabetes mellitus/diabetic retinopathy, coincident retinal
      pathology as choroidal neovascular membrane and age related macular degeneration, previous
      laser photocoagulation, intravitreal injection of Triamcinolone Acetonide or antivascular
      endothelial growth factor (anti-VEGF) agents, prior intra-ocular inflammation, retinal
      degenerations, neovascularization or rubeosis and vascular disorders e.g. retinal vein or
      artery occlusion.
    

Intervention name(s): Surgery; Vitrectomy machine
Intervention type(s): Procedure; Device
Intervention description(s): Removal of epiretinal membrane and ILM; Pars plana vitrectomy
Other intervention name(s): Invasive procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Comparison of the Efficacy of High Intensity Laser Therapy and Low Level Laser Therapy in the Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome; Electromyography; Low-Level Laser Therapy; Ultrasound Imaging
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome is the most common entrapment neuropathy and is frequently encountered
      in clinical practice. Although there is no standard protocol for its treatment, conservative
      treatment methods are preferred. In our study, we aimed to clinically compare the efficacy of
      high and low intensity laser treatments in patients with carpal tunnel syndrome. By using
      methods such as electromyography and ultrasound, we aimed to provide a more objective
      evaluation
    

Detailed description: 
      Our study was designed as a prospective, randomised, controlled, single-centre trial. A total
      of 63 patients aged 18-65 years with electrophysiologically diagnosed mild to moderate carpal
      tunnel syndrome and 114 hands were included in the study. Patients were divided into 3
      groups. Patients in all three groups wore a neutral wrist splint of appropriate size. The
      second group included patients who additionally received low level laser therapy (LLLT), and
      the third group included patients who additionally received high intensity laser therapy
      (HILT). All groups underwent clinical, electrophysiological, and ultrasonographic
      examinations at the beginning of the treatment, at 1st month, and at 3rd month after the
      treatment.
    

Intervention name(s): low level laser treatment; High intensity laser treatment; wrist splint
Intervention type(s): Device; Device; Other
Intervention description(s): The laser device from Mectronic Medicale was used for LLLT. LASER treatments were to be performed every other day for a total of 10 sessions.; The laser device from HIRO TT (ASA, Italy) was used for HILT. LASER treatments were to be performed every other day for a total of 10 sessions.; wrist splints of an appropriate size in a neutral position for at least 8 hours at night for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a positive correlation between serum's cholesterol levels and death from
      cardiovascular disease, especially coronary artery disease. The reduction of plasma lipids
      levels is one of the main goals of prevention. Research has shown that green tea has
      beneficial effects on health due to the polyphenolic substances (catechins) that it contains.
      Studies have shown that prolonged consumption of polyphenols has a positive effect on factors
      related to cardiovascular risk such as obesity, dislipidemia and various indicators of
      oxidative stress.

      The aim of this study was to examine the possible effects of catechin supplementation, in
      combination with the classic treatment for the reduction of hypercholesterolemia, statin
      therapy, on the treatment's effectiveness and in the reduction of classic side effects.
    

Detailed description: 
      This is a randomized, double - blind placebo controlled trial. The patients will be divided
      randomly in two groups; one group will receive statin and catechin, while the other statin
      and placebo for 12 weeks. The experimental group will receive 20 mg atorvastatin (Lipitor)
      daily and 600 mg of catechin in capsules, while the control group will receive 20 mg
      atorvastatin (Lipitor) and Placebo in identical capsules of 600 mg for the same time period.

      The patients will undergo biochemical evaluation in which the serum lipids, the levels of
      oxidative stress and the antioxidant capacity will be assessed. Body composition will be
      calculated with anthropometric measurements, while the levels of visceral fat, the
      subcutaneous fat, as well as the level of liver fat infiltration will be examined with the
      use of computed tomography images. Factors related to the patients' quality of life will be
      assessed by a series of questionnaires.

      The investigators hypothesized that the combination treatment with statin and green tea
      extract (catechins)will improve in a greater extent the lipidemic profile, increase
      antioxidant capacity, reducing significantly visceral fat and intrahepatic lipids content.
    

Intervention name(s): Green Tea Extract - Catechins; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks; Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Green Tea Extract; Catechins; Statin; atorvastatin; body composition; visceral fat; steatosis; oxidative stress; quality of life; OGTT; OGIS; ISI matsuda
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study to assess early markers of cardiovascular disease in women with
      polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and
      chlormadinone acetate alone or associated with Spironolactone.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is associated with comorbidities that may contribute to
      increased risk of cardiovascular disease (CVD). Oral contraceptives (OC) have been the
      mainstay of PCOS pharmacological therapy for decades. However, in non-hyperandrogenic women,
      OC use is associated with higher risk of cardiovascular disease, raising concern about a
      possible worsening of the unfavorable metabolic and cardiovascular profile of PCOS patients.
      There is lack of evidence about the impact of PCOS pharmacological therapies on
      cardiovascular risk markers and the long-term safety of these drugs in PCOS has not been
      established. The aim of this study is to compare the effect of an OC alone or associated with
      an anti-androgenic drug (spironolactone) on echografic cardiovascular risk markers, metabolic
      and hemostatic variables.
    

Intervention name(s): oral contraceptive; Oral contraceptive plus spironolactone; Oral contraceptive plus metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months; The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.; Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin
Other intervention name(s): Belara; Belara; Spironolactone; Belara; Metformin
Intervention MeSH terms: Metformin; Spironolactone; Contraceptive Agents; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; Oral Contraceptives, Hormonal; Cardiovascular Disease; Endothelium
A Randomized, Open-label, Two-way Crossover Study to Assess the Pharmacokinetics and Safety of CK-30 600 mg (Compound K)
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red
      ginseng extracts 2.94 g after a single oral dose in healthy male volunteers
    


Intervention name(s): CK-30; Red ginseng extracts
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Compound K 600 mg; Red ginseng extracts 2.94 g
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Extracorporeal Shock Wave Therapy in Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The present study has examined the effectiveness of extracorporeal shock wave therapy along
      with conventional physical therapy on functional ability in grade IV knee osteoarthritis.
      Intervention program was performed for four weeks. Conventional physical therapy included
      ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip
      adductor strengthening exercises. Functional ability was assessed using the Lower Extremity
      Functional Scale (LEFS) score.
    


Intervention name(s): Extracorporeal Shock Wave Therapy; conventional physical therapy
Intervention type(s): Other; Other
Intervention description(s): The ESWT was performed by an ESWT instrument (Chattanooga) once a week for four consecutive weeks (a total of four sessions).; Conventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group experimental-control design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical therapy; Lower Extremity Functional Scale score; Ultrasound therapy; Exercises; Quadriceps
Lipoic Acid as a Treatment for Acute Optic Neuritis
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if oral lipoic acid can safely help relieve
      permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also
      explore how the body absorbs and breaks down the study drug, and what effects it has on the
      immune system.
    

Detailed description: 
      Oral lipoic acid is an antioxidant that helps proteins work in the body. It is available in
      oral and intravenous formulations and has been used in the past to treat nerve damage like
      that seen in diabetes and some other metabolic disorders. It is available as a dietary
      supplement in the United States.

      Patients with a diagnosis of acute optic neuritis who are enrolled in the study will undergo
      medical and nervous system examinations, and blood draws. The study doctor will take a
      medical history and perform physical examinations. Research assistants at the MS Center, who
      are trained in blood draws, will perform the blood draws. Patients will also undergo Optical
      coherence tomography (OCT) examination at Casey Eye Institute, and receive two MRIs at Oregon
      Health and Science University (OHSU). Because it is a placebo-controlled trial, subjects will
      have a 50:50 chance of receiving either placebo (inactive) or study drug. If enrolled in the
      study, patients will take two gel capsules of the study drug or placebo at the same time
      every day for six weeks.
    

Intervention name(s): Lipoic Acid
Intervention type(s): Drug
Intervention description(s): Lipoic acid will be administered orally, in two 600mg capsules, for a total 1200mg dose. The dose will be administered daily for a 6-week treatment period.
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Optic Neuritis; Lipoic Acid; Multiple Sclerosis; Antioxidant; OCT; Acute
Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)
Condition: Mild Traumatic Brain Injury; Post-Concussive Symptoms
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome
Study type: Observational

Summary: 
      The purpose of this project is to explore the degree to which performance consistency on
      neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation
      Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with
      persistent self-reported symptoms.
    

Detailed description: 
      Mild TBI outcome studies are traditionally limited to single administration or
      baseline/post-injury assessment models and they often fail to show enduring deficits among
      persons complaining of such problems. It may be the case that our standard approach to
      deficit measurement in mTBI has confounded our ability to elicit the actual impairment. The
      proposed study could generate an assessment paradigm shift (performance over time) and afford
      professionals the direction to better assess and ultimately serve persons with mTBI.
      Additionally, research on the impact of PTSD symptoms on throughput and cognitive performance
      has been mixed (Bremner et al., 1995; Brenner et al, 2010; Vasterling et al., 1998, 2002,
      2006) and the proposed study will yield additional data in that area.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of
        mild traumatic brain injury (mTBI) with persistent self-reported symptoms.
      
Keywords: Deployment Acquired Mild Traumatic Brain Injury; Persistent Post-Concussive Symptoms; Repeated measures
Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects
Condition: Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction (DDI)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the
      concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the
      safety and tolerability of the combined administration of solifenacin, mirabegron and
      tamsulosin HCl.
    

Detailed description: 
      This study is comprised of two study sequences with 2 investigational periods in each
      sequence. There will be a wash-out period between each investigational period. Patients will
      be admitted to the clinic until discharged after each investigational period.
    

Intervention name(s): Mirabegron; Solifenacin succinate; Tamsulosin HCl; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral; Oral
Other intervention name(s): Myrbetriq; Betmiga; Betanis; solifenacin; Vesikur; Vesicare; Flomax
Intervention MeSH terms: Tamsulosin; Mirabegron; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy subjects; Mirabegron; Solifenacin; Tamsulosin HCl
Clifutinib Food Effect Study in Healthy Subjects
Condition: Acute Myeloid Leukemia in Children
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate to determine the effect of food on the PK of a
      single dose of 40 mg Clifutinib in healthy subjects.
    


Intervention name(s): Clifutinib with fed state; Clifutinib with fasted state
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg Clifutinib with food; 40 mg Clifutinib without food
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Analysis of Procedural Times Using Colpassist for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning
      device during robotic-assisted sacrocolpopexy.
    

Detailed description: 
      The purpose of this research study is to evaluate the efficiency of the Colpassist (Boston
      Scientific, Natick, MA) vaginal positioning device used during robotic-assisted
      sacrocolpopexy. Traditionally, vaginal positioning during robotic-assisted sacrocolpopexy is
      done using a device that was not designed specifically for sacrocolpopexy, commonly a
      vaginally placed endo anal sizer. It is possible the Colpassist device will result in shorter
      operative times because Colpassist is flat which makes it easier to sew against. Also, the
      width of the device is designed to be similar to the width of the vagina which should improve
      visibility during surgery.

      Enrolled patients will be randomized to undergo their planned robotic-assisted sacrocolpopexy
      using either a vaginally placed endo anal sizer or a vaginally placed Colpassist vaginal
      positioning device. Both surgeon and patient will be blinded to which device was used at the
      time of surgery. Length of time to complete each step of the sacral colpoexy that involves
      use of a vaginal positioning device (dissection of the anterior and posterior vaginal walls,
      attachment of anterior and posterior vaginal mesh, attachment of sacral mesh) will be
      recorded during the surgery to measure operative efficiency. Surgeon and surgical-assistant
      satisfaction will be recorded with each device.
    

Intervention name(s): Traditional vaginal positioning device; Colpassist vaginal positioning device
Intervention type(s): Procedure; Procedure
Intervention description(s): A vaginally placed endo-anal sizer will be used to position the vagina during surgery.; A vaginally placed Colpassist will be used to position the vagina during surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: robotic; sacrocolpopexy; Colpassist; vaginal positioning device