bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a national, multicenter, interventional, non-randomized, non-controlled,
      open-label study to assess the effectiveness of pirfenidone in participants with IPF in
      Russian clinical practice.
    


Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.
Other intervention name(s): Esbriet, RO0220912
Intervention MeSH terms: Pirfenidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pirfenidone, UIP, IPF, FVC
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
Condition: Neurobehavioral Disinhibition
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Psychomotor Agitation; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the
      treatment of neurobehavioral disinhibition including aggression, agitation, and irritability
      in participants with traumatic brain injury (TBI).
    

Detailed description: 
      Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition
      including aggression, agitation, and irritability that persists after brain injury.

      This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of
      treatment.
    

Intervention name(s): Placebo; AVP-786-28; AVP-786-42.63
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as capsules; 28 mg of d6-DM and 4.9 mg of Q; 42.63 mg of d6-DM and 4.9 mg of Q
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aggression; agitation; irritability; non-penetrating brain injury; traumatic brain injury; TBI; AVP-786
Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
Condition: Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two methods in the treatment of
      excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections.
      Suction-curettage is a method in which the doctor will insert a suction tool into two small
      incisions in order to suction out the sweat-producing glands. It is similar to liposuction,
      but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where
      the sweat glands are located. This method has been shown in some studies to effectively
      reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA)
      approved drug that in small doses, paralyses muscles. It is most commonly and famously used
      in the treatment of facial wrinkles. However, it has also been approved to treat excessive
      sweating. When injected in areas that sweat excessively, sweating can be significantly
      reduced in that area for months at a time. This study is a pilot study designed to determine
      feasibility of these procedures.
    


Intervention name(s): Botulinum Toxin Type A; Suction-Curettage
Intervention type(s): Drug; Device
Intervention description(s): Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.; The doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
Other intervention name(s): botox; liposuction
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sweating; sweat; underarm; axillary; hyperhidrosis; botox; liposuction; suction-curettage; suction; curettage
Effect Evaluation of Independent Medical Evaluation (IME) in Norway
Condition: All International Classification of Primary Care 2 Diagnoses
Study type: Interventional

Summary: 
      A randomized controlled trial comparing independent medical evaluation (IME) to treatment as
      usual (TAU). Participants will be individuals reaching six months uninterrupted sickness
      absence. Treatment as usual (TAU) is normal follow-up by a general practitioner (GP).
    

Detailed description: 
      A randomized controlled trial in a Norwegian context, involving an effect evaluation, a
      cost-benefit evaluation and a qualitative evaluation. Independent medical evaluation (IME)
      will be compared to treatment as usual (TAU). Independent medical evaluation (IME) will
      comprise a consultation with an independent general practitioner (IME GP) who will assess
      whether the sick listed worker has been given eligible and available opportunities in return
      to work follow-up in Norway. The independent medical evaluation general practitioner (IME GP)
      will write a short report that is sent to the treating general practitioner as input from a
      colleague. The report can be used in the follow-up of the sick listed participant. The
      participants in the treatment as usual (TAU) group will not receive any other follow-up than
      normal follow-up by the treating general practitioner. The qualitative evaluation will be
      conducted to gain insight into the experiences of the general practitioners and the
      participants.
    

Intervention name(s): Independent medical evaluation
Intervention type(s): Other
Intervention description(s): The independent medical evaluation (IME) will be performed by specialists in general medicine, temporarily hired by the county welfare service. The independent medical evaluation (IME) procedure is developed by the Research Unit for General Practice at Uni Research Health in Norway.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: independent medical evaluation; sick leave; sickness absence; physician primary care; general practitioner; family physician
Fractional Laser and Ultrasound for Striae Distensae
Condition: Stretch Marks
MeSH terms: Striae Distensae
Study type: Interventional

Summary: 
      This was a prospective randomized controlled study comparing the efficacy of micro-focused
      ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus
      1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch
      marks).

      Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment
      every 2 weeks for a total of 4 treatments on one side and the contralateral side received
      micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks
      for a total of 4 treatments with site-match control area of baseline striae on each side.

      The primary outcome measure by two dermatologists blindly compared the two areas of striae
      distensae on each side from live subjects using a questionnaire and quartile rating scale on
      the final follow-up visit.

      This study was a pilot study designed to determine the feasibility of these procedures.
    

Detailed description: 
      The secondary outcomes were qualitative measurements of the mean striae width in the
      treatment area before(week0) and after treatment(week10) and subject satisfaction was
      determined by a satisfaction questionnaire.
    

Intervention name(s): Combination treatment; 1550-nm erbium-doped fractionated laser
Intervention type(s): Device; Device
Intervention description(s): The contralateral side received the combination of micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.; Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stretch marks; Striae distensae
The Effect of Smartphone Addiction and Mental Fatigue on Working Memory in University Students
Condition: Smartphone Addiction; Mental Fatigue
MeSH terms: Fatigue; Mental Fatigue; Behavior, Addictive; Internet Addiction Disorder
Study type: Observational

Summary: 
      The aim of this study is to investigate the effects of smartphone addiction and mental
      fatigue on working memory in university students.
    

Detailed description: 
      University students who meet the inclusion and exclusion criteria will be informed about the
      study and the participants who agree to participate in the study will be given the Turkish
      version of "Smartphone Addiction Scale", ''Mental Fatigue Scale'' and "Working Memory
      Questionnaire" tests, respectively. 120 university students will included in the study. To
      evaluate between correlation of tests will used to correlation analysis tests. In addition,
      it will be investigated whether there is a difference between 1.2.3 and 4th grades in terms
      of Smartphone Addiction, Mental Fatigue Scale and Working Memory Questionnaire
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        120 university students
      
Keywords: working memory; mental fatigue; smartphone addiction
Treatment of Primary CNS Lymphoma ( FTD )
Condition: Primary CNS Lymphoma (PCNSL)
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of FTD regiment
      (fotemustine, temozolomide and dexamethasone ) for patients with primary CNS lymphoma.
    

Detailed description: 
      Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is
      confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for
      patients with PCNSL remains challenging and at present there is no universally accepted
      therapeutic approach for patients with newly diagnosed disease. The purpose of this study is
      to evaluate the efficacy and safety of FTD regiment(fotemustine, temozolomide and
      dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.
    

Intervention name(s): HD-MTX-Ara-C regimen; FTD regimen
Intervention type(s): Drug; Drug
Intervention description(s): HD-MTX-Ara-C regimen high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine
1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles; FTD regimen(fotemustine, temozolomide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,temozolomide 150mg/m2 d1-5 po,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 28 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
Other intervention name(s): high-does metrotrexate and cytarabine; fotemustine, temozolomide and dexamethasone
Intervention MeSH terms: Cytarabine; Dexamethasone; Temozolomide; Fotemustine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary CNS lymphoma; chemotherapy; RR; PFS; OS
Female Upper Genital Tract in HIV-infected Women
Condition: HIV
Study type: Observational

Summary: 
      The female upper genital tract is a unique compartment involved in HIV pathogenesis.
    

Detailed description: 
      The persistent detection of HIV in the female genital tract in spite of ART is unexplained,
      and it is possible the uterine endometrium serve as a reservoir. There are limited data
      regarding the interaction between HIV expression, antiretroviral therapy (ART) and host
      immune system in the uterine endometrium.
    

Intervention name(s): Endometrial biopsy
Intervention type(s): Procedure
Intervention description(s): Endometrial biopsy (EMB) specimens were collected via a 3 mm diameter plastic pipelle that was inserted into the uterus following EML. A sample of tissue was obtained by retracting the pipelle's plunger leading to negative suction and rotating the cannula for approximately 15 seconds.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We enrolled HIV-1 positive menstruating women between ages 25-48 years.
      
Biospecimen description: 
      Endometrial and cervical lavage specimens
    
Keywords: HIV; female; genital tract
The Effect of Nasal Carbon Dioxide (CO2) Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of as-needed treatment with nasal carbon
      dioxide in patients with Seasonal Allergic Rhinitis symptoms.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, multi-center, parallel group, pilot study
      will evaluate the efficacy and safety of as-needed with nasal, non-inhaled administration of
      CO2 (nasal CO2) in patients with SAR. Approximately 50 patients who meet the eligibility
      criteria will be enrolled into this study at up to 4 sites to ensure that approximately 30
      patients complete the study.

      Patients will be randomized to one of two treatment groups and be provided with either an
      active or placebo dispenser.

      All patients will administer study drug for 10 seconds to each nostril once on Day 0 in the
      clinic then as-needed up to 6 times a day during waking hours (doses must be at least 2 hours
      apart) for 14 days. Patients will assess their nasal and non-nasal symptoms in a patient
      diary. Each patient's participation in the study may last up to 72 days.

      There will be a total of 5 scheduled clinic visits:

        -  Visit 1 Screening

        -  Visit 2 Enrollment (within 42 days of Visit 1)

        -  Visit 3 Randomization (after the completion of a 3-7 day run-in period)

        -  Visit 4 Mid-Treatment (Day 7 ± 1 day)

        -  Visit 5 End of Treatment (within 1-3 days of last study drug administration)

      Sites will follow-up with randomized patients via telephone 7 ± 1 days after the last study
      drug administration.
    

Intervention name(s): Nasal CO2; Inactive Placebo Gas
Intervention type(s): Drug; Drug
Intervention description(s): As-Needed during the 14 day Treatment Period; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Double-Blind; Multi-Center; Phase II; Nasal Carbon Dioxide; Carbon Dioxide; Efficacy; Safety; Total Nasal Symptom Score
Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)
Condition: Prediabetic State; Diabetes type2; Dysglycemia
MeSH terms: Prediabetic State; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts,
      consumed at the daily regimen of three times per day on glucose and lipid homeostasis in
      dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior
      to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of
      consumption.
    


Intervention name(s): TOTUM-63 3 intakes per day; Placebo 3 intakes per day; TOTUM-63 2 intakes per day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner); Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner); 5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes (4 in the morning and 4 at dinner)
Other intervention name(s): Active product 3 intakes per day; Comparator product 3 intakes per day; Active product 2 intakes per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dysglycemia; Prediabetes; Type 2 diabetes; Hyperglycemia; Insulinemia; Diabetes risk; Diet supplement; Plant extracts; Health condition; Hygiene and dietary recommendations; Diet
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled
      seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an
      open-label proof-of-concept study.
    

Detailed description: 
      The purpose of this proof-of-concept study is to evaluate ganaxolone as adjunctive therapy
      for uncontrolled seizures in female children with PCDH19 mutations and other rare genetic
      epilepsies. After establishing baseline seizure frequency, qualifying subjects will enter the
      study and be treated with open-label ganaxolone for up to six months.
    

Intervention name(s): Ganaxolone
Intervention type(s): Drug
Intervention description(s): oral suspension or capsules
Other intervention name(s): CCD 1042
Intervention MeSH terms: Ganaxolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PCDH19; ganaxolone; neurosteroid; CDKL5; LGS; CSWS
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Condition: Metabolic Acidosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study
      will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney
      disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12
      weeks once daily.

      The maximum study duration is anticipated to be up to 16 weeks.
    


Intervention name(s): TRC101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral suspension; Oral suspension
Other intervention name(s): Veverimer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: blood bicarbonate, kidney disease
Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety
Condition: Insulin Sensitivity; Lipid Metabolism; Resistant Starch; Potato
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The objective of this study is to assess whether intake of baked and then chilled potatoes
      over a 24-h period, compared to intake of isocaloric, carbohydrate (CHO)-matched foods low in
      fiber and resistant starch (RS), will increase insulin sensitivity, breath hydrogen and
      satiety, and decrease hunger and free fatty acid (FFA) levels in overweight or obese men and
      women at risk for metabolic syndrome and diabetes mellitus.
    

Detailed description: 
      This randomized, two-period crossover study will include one screening/baseline visit (visit
      1) and two 24-h treatment periods (treatment period 1: visits 2 and 3 and treatment period 2:
      visits 4 and 5). A minimum 7-d washout will occur between the treatment periods.
    

Intervention name(s): Potato (Resistant Starch); CHO-matched (Low-fiber, RS-free)
Intervention type(s): Other; Other
Intervention description(s): Potato lunch and dinner meals, and an evening snack containing 100 g potatoes and 5 g resistant starch (RS) per meal, providing a total of 300 g/d potatoes, equivalent to roughly two whole potatoes, and 15 g/d RS.; Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Resistant Starch; Free Fatty Acids; Potato; Insulin sensitivity; Lipid Metabolism
Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases
Condition: Giant Thoracic Herniation; Myelopathy
MeSH terms: Spinal Cord Diseases; Hernia
Study type: Observational

Summary: 
      Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment
      is indicated when there are signs of spinal cord injury. To date, several surgical techniques
      have been described in the treatment of this condition on small patient series. The main
      objective is to evaluate the long-term results of a series of 53 patients treated with a
      minimally invasive endoscopic procedure. The secondary objective is to explain our
      pre-operative planning and the technical details of our procedure. METHOD: Retrospective
      monocentric study on a cohort of patients treated in our department. The following medical
      data from our database are analyzed: Morbidity of operative gesture (duration of procedure,
      bleeding, postoperative complications), clinical results at the last follow-up visit
      (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability
      to walk, wish to carry out the same intervention again if necessary). On the radiological
      level, we evaluated the quality of the resection (total, subtotal, incomplete and
      impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the
      presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are
      collected and analyzed anonymously. Expected Results: We believe we can demonstrate that
      thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation
      responsible for spinal cord compression. This with a low morbidity given the minimally
      invasive nature of the approach.
    


Intervention name(s): Thoracoscopy
Intervention type(s): Procedure
Intervention description(s): Thoracoscopy surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient operated on giant thoracic thoracic disc herniation between May 2001 and October
        2016
      
Keywords: spinal thoracic herniation; surgery; endoscopic approach; thoracic spine; minimal invasive access