bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin B12 Supplement to Prevent Cognitive Decline
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic
      people. Vitamin B12 deficiency in older people is associated with cognitive impairment and
      Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in
      older diabetic people.

      Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively
      normal older diabetic people reduces the incidence of cognitive decline.

      Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal
      diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in medical
      and family medicine/ general outpatient clinics.

      Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and
      without family member who can reliably inform on cognitive functioning (personal contact at
      least once a week), eligible patients will be invited to participate in this clinical trial.
      After obtaining written consent, research assistant (RA) will record demographic and clinical
      information from the subjects and perform neuropsychological tests - 1. Clinical dementia
      rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini mental state
      examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be taken for
      serum methylmalonic acid (MMA). Those with cognitive impairment and significant comorbidities
      will be excluded.

      264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram
      or two identical looking placebo tablets once daily for 27 months.

      All subjects or family caregivers are reviewed in the research clinic every 12 weeks in which
      the research assistant performs a pill count and dispenses the trial tablets. At 9 monthly
      intervals, the subjects will have neurocognitive test battery repeated at research clinic.
      CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and vitamin B12
      will be repeated.
    


Intervention name(s): Vitamin B12; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 tablets; 2 tablets
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Preventing Youth Suicide in Primary Care: A Family Model
Condition: Suicide
MeSH terms: Suicide
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based
      Family Therapy) for youth presenting in primary care with suicidal ideation and depressed
      mood.
    

Detailed description: 
      Youth suicide is a serious public health problem and clinical challenge for medical and
      behavioral health providers, yet few preventive interventions have been tested for this
      population. This project addresses this deficit by testing the efficacy of a brief family
      therapy for adolescents presenting with serious risk for suicide in a primary care setting.
      Several innovations characterize the study. First, patients will be identified and treated
      directly in the primary care setting. Integrating behavioral health services into primary
      care may a) reduce burden on physicians by promoting parents as safety monitors, b) increase
      behavioral health treatment adherence, and c) address many underlying family problems
      associated with suicide. Second, to identify seriously at risk adolescents, we will assess
      for severe and persistent suicidal ideation and co-occurring depression. Patients will need
      to score above clinical cutoffs on both ideation (SIQ-JR > 31) and depression (BDI-II >20) at
      two consecutive appointments (generally within 3 days of each other). Third, treatment will
      target two of the most critical suicide risk factors: depression and family conflict.
      Depression is the most consistently associated risk factor for suicide and family conflict is
      the most common precipitant of completed suicide (20%) and non-fatal suicidal episodes (50%).
      Fourth, we will use Attachment Based Family Therapy (ABFT; Diamond et al., 2002) as the
      intervention approach, an efficacious and manualized family therapy model specifically
      designed for adolescent depression. ABFT has been successful in reducing suicidal ideation,
      hopelessness, depression, anxiety, and family conflict. Participants will be recruited from
      the primary care centers at The Children's Hospital of Philadelphia. Eighty-seven percent of
      patients are African American and 60% are girls. One hundred adolescents will be randomized
      to 6 to 10 weeks of either ABFT or Enhanced Usual Care (EUC). Patients will be evaluated at
      baseline 6, 12, 24, and 52 weeks.
    

Intervention name(s): Attachment-Based Family Therapy; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-16 week family-based therapy; Rapid referral to community outpatient care with weekly monitoring of symptoms by study team
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: youth suicide; family therapy; primary care; intervention
A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
Condition: Insulin Resistance; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this clinical research study is to examine the acute hormonal and metabolic
      effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The
      hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2)
      rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by
      having volunteers undergo two glucose tolerance tests in a crossover study design.
    


Intervention name(s): Olanzapine 10 mg po qhs for 3 days; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): (1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets); (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
Other intervention name(s): Zyprexa; Sugar pill
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Insulin Resistance; Diabetes mellitus; Antipsychotic
Restasis for Treatment of Brittle Nails
Condition: Brittle Nails
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of this study is to assess the safety and effectiveness of Restasis® ophthalmic
      emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle
      nails and for the enhancement of normal nail growth and texture. The investigators think that
      daily application of Restasis® to nails and nail beds in patients with brittle nails will
      enhance nail growth and improve nail texture in both affected and unaffected nails.
    

Detailed description: 
      This is a single center, investigator-blinded (investigator masked), head to head comparison
      of Restasis® and its vehicle, Refresh® Dry Eye Therapy in 24 patients. Three target
      fingernails will be identified in each subject. Two of the target nails will be the two nails
      that have the most severe signs of brittle nail syndrome. The third target nail will be a
      normal nail or, in the absence of a normal nail, the patient's second-healthiest appearing
      nail. The patients most normal-appearing nail will be untreated so that growth in the treated
      nails can be compared to growth in an untreated normal nail, this will be the fourth target
      nail. Study medication will be applied to target nails (the subjects may also apply to all
      nails if they wish, except one nail which will be untreated in order to determine the
      subject's baseline rate of fingernail growth) for 24 weeks. The target nails will be assessed
      at each visit, every four weeks. There will be a 12-week follow up period after treatment is
      completed.

      This 36 week study will be conducted at one center. Adult male and female patients meeting
      the inclusion and exclusion criteria will be screened for eligibility. The principal
      investigator or his/her designee will obtain informed consent from all patients before any
      protocol specific procedures are performed.
    

Intervention name(s): Restasis (cyclosporine ophthalmic emulsion) 0.05%; Refresh® Dry Eye therapy
Intervention type(s): Drug; Drug
Intervention description(s): cyclosporine ophthalmic emulsion 0.05%; Emulsion contains glycerin 1% and polysorbate 80
Other intervention name(s): Restasis®; Refresh®
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Efficacy and Safety of Temozolomide in Patients With MPPGL
Condition: Pheochromocytoma, Metastatic; Paraganglioma, Malignant; Pheochromocytoma Malignant
MeSH terms: Pheochromocytoma; Paraganglioma
Study type: Interventional
Phase: Phase 2

Summary: 
      Metastatic pheochromocytoma / paraganglioma (MPP) are rare while the prognosis was poor.
      Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. TMZ has been
      recommended in National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2019 for
      treating MPP patients.However, studies investigating TMZ efficacy in MPP patients are
      extremely limited. The largest study involved only 15 patients till date. The safety and
      efficacy of TMZ treatment in MPP patients need to be verified in larger studies.
    

Detailed description: 
      Patients with histologically or radiologically confirmed MPP were enrolled. TMZ was
      administered orally at an initial daily dose of 150 mg/m2 per day for 5 days, every 28 days.
      In patients with a good tolerance during the first cycle, the dose was increased to 200 mg/m2
      per day for 5 days, every 28 days. Plasma normetanephrine and metanephrine (MNs), 24-hour
      urinary catecholamine excretion (24hCA) and neuron specific enolase (NSE) were measured at
      baseline and every 1-3 cycle. Contrast-enhanced computed tomography（CT ）of chest, abdomen and
      pelvis were used to assess measurable target lesions at baseline and every 3 cycles. For
      patients who only had bone metastases or no measurable target lesions, TMZ efficacy was
      evaluated by 18F-fluorodeoxyglucose (18F-FDG-PET/CT). The primary endpoint was objective
      response rate (ORR) per Response Evaluation Criteria In Solid Tumors（RECIST) 1.1/PERCIST1.0.
      Secondary endpoints included biochemical (catecholamine levels) response rate (BRR),
      progression-free survival (PFS) and safety. The investigators will try to explore which
      patients are more suitable for TMZ treatment.
    

Intervention name(s): Temozolomide capsule
Intervention type(s): Drug
Intervention description(s): Temozolomide was given orally per day for 5 days, every 28 days until disease progression or intolerable toxicities.
Other intervention name(s): Temozolomide
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pheochromocytoma or Paraganglioma; metastasis; Temozolomide
Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain
Condition: Neck Pains
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy
      on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical
      basis for the chronic neck pain treatment and evaluation of efficacy.
    

Detailed description: 
      According to statistics, the incidence of chronic neck pain has significantly increased year
      by year, particularly tending to younger people, as social competition increase fiercely and
      the pace of people's daily work and life accelerate. Studying the effective treatment and
      prevention of chronic neck pain has obvious medical, social and economic significance.
      Purpose of this trial is to observe and objectively evaluate electroacupuncture (EA) therapy
      on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical
      basis for the chronic neck pain treatment and evaluation of efficacy.
    

Intervention name(s): acupuncture; comprehensive treatment
Intervention type(s): Device; Other
Intervention description(s): 56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral Jiaji (EX-B2) of cervical positive reaction plane (taking two pairs). Besides, bilateral Jianzhongshu (SI15) and bilateral Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.; Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
Other intervention name(s): electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: electroacupuncture therapy; neck pain; McGill Pain Questionnaire; Acupuncture Therapy; Electroacupuncture; Meridians
Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis
Condition: Seasonal Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the oral administration of grass pollen
      peptides to treat allergic rhinitis is safe and well tolerated.
    


Intervention name(s): gpASIT+TM
Intervention type(s): Biological
Intervention description(s): oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Experimental Biomarker Study for Pain Thresholds
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in
      primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and
      mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by
      UVB (ultraviolet B) irradiation and topical capsaicin.
    


Intervention name(s): V116517 aqueous suspension; Celecoxib capsules; Placebo; Capsaicin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose; 400 mg (2 capsules of 200 mg each) taken orally x 1 dose; Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose; 1% administered topically
Other intervention name(s): Celebrex®; Celebra®
Intervention MeSH terms: Celecoxib; Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Condition: Heterozygous Familial Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and efficacy of fluvastatin in children
      diagnosed with heterozygous familial hypercholesterolemia
    


Intervention name(s): Fluvastatin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heterozygous familial hypercholesterolemia; mixed dyslipidemia
Are You in a Poor Country; HIPEC is Still in Reach
Condition: HIPEC
Study type: Interventional

Summary: 
      Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies
      either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC
      is mostly considered as a very bad prognostic sign hence it affects the overall survival with
      very poor response to systemic chemotherapy.

      On introduction of the new concept of combined optimal cytoreduction (CRS) followed by
      hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.

      A major obstacle which may face application of HIPEC manoeuvre is the cost either of the
      machine or the disposable kit used in handling the chemotherapy, heating it and delivering it
      to the patient, hence we established our machine design with its disposable kits making it
      available for use in poor places.
    

Detailed description: 
      As aforementioned the use of HIPEC technique offered a promising results in dealing with
      peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor
      places so we inented a machine with considerably lower costs both in the machine composition
      and its disposable kit used for every patient we used it for six years in a trial to find any
      shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the
      published data of the standard machines
    

Intervention name(s): HIPEC device
Intervention type(s): Device
Intervention description(s): To report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
Condition: Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of
      two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high
      triglycerides).
    

Detailed description: 
      The duration of treatment is 18 weeks.
    

Intervention name(s): MK0653, ezetimibe; Comparator: fenofibrate monotherapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ezetimibe; Fenofibrate
Primary purpose: Treatment
Keywords: mixed hyperlipidemia; high cholesterol; high triglycerides
Dexmedetomidine to Prevent Agitation After Free Flap Surgery
Condition: Agitation; Delirium
MeSH terms: Delirium; Psychomotor Agitation
Study type: Interventional
Phase: Phase 4

Summary: 
      Reconstruction using microvascular free tissue flap has been an important management in
      patients with maxillofacial tumor. It is often characterised as long operation time, more
      traumatic and require restriction of patient's head movement postoperatively in order to
      prevent disruption of microvascular anastomosis. Agitation and delirium are common in
      patients with free flap surgery, which may lead to serious consequences such as self
      extubation, injury or even failure of the flap.

      Dexmedetomidine is a sedative and co-analgesic drug with high specificity for
      α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after
      free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on
      preventing delirium has not been proved.

      The investigators hypothesized that the use of Dexmedetomidine would reduce emergence
      agitation and prevent delirium in patients after free flap surgery.
    


Intervention name(s): Dexmedetomidine; Saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.; Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: agitation; delirium; dexmedetomidine; head and neck surgery; microvascular free tissue transfer; flap
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
Condition: Vulvar and Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the therapeutic equivalence of the Test
      formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace®
      Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and
      compare the safety of Test, Reference and Placebo treatments in patients with vulvar and
      vaginal atrophy.
    


Intervention name(s): Estrace® Cream; Estradiol Vaginal Cream; Vehicle Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estrace® Cream; Estradiol Vaginal Cream; Vehicle Cream
Other intervention name(s): Estradiol Vaginal Cream; Placebo
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaginal Dryness; Vaginal and/or Vulvar Irritation/Itching; Dysuria; Vaginal Pain and Bleeding
BAX 855 PK-guided Dosing
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855
           targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)

        2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX
           855
    


Intervention name(s): PEGylated Recombinant Factor VIII; PEGylated Recombinant Factor VIII; PEGylated Recombinant Factor VIII
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Pharmacokinetic (PK) evaluation; Standard treatment; Intensified treatment
Other intervention name(s): BAX855; BAX 855; BAX 855; BAX855; BAX855; BAX 855
Intervention MeSH terms: Factor VIII; BAX 855
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention