bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three way three sequence two treatment partial replicate
      crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from
      Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead
      Sciences, USA) in Healthy Human Volunteers Under Fasting Condition.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Soviredia; Harvoni (first dose); Harvoni (Second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir; Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir; Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Other intervention name(s): Harvoni; Harvoni; Harvoni
Intervention MeSH terms: Ledipasvir, sofosbuvir drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Partial replicate crossover study
Masking: None (Open Label)
Primary purpose: Other
G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Design

      50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B)

      Investigations:

      Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function
      testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology:
      total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper
      studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection (
      blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake
      Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis
      CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by
      transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2
      staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in
      hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of
      proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers
      of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous
      pressure gradient ( HVPG)
    


Intervention name(s): G-CSF+EPO; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO)
G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).
Arms: G-CSF+EPO Drug: Placebo
Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).; Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Assessment of the Cosmetic Benefit of a Skin Cream in Healthy Females With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a Glycolic Acid Facial Peel Procedure
Condition: Skin Care
Study type: Interventional

Summary: 
      To evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in
      healthy female participants with mild to advanced photo-damaged facial skin who have
      undergone a 70% Glycolic Acid facial peel procedure.
    

Detailed description: 
      This will be a randomized, evaluator-blind, single-center and two-arm clinical study designed
      to evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in
      healthy female participants with mild to advanced photo-damaged facial skin who have
      undergone a 70% Glycolic Acid facial peel procedure.
    

Intervention name(s): Test Product; Cleanser; Sunscreen
Intervention type(s): Other; Other; Other
Intervention description(s): Restoring lipid balm; Moisturizing facial cleanser; SPF (Sun Protection Factor) 50 sunscreen
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of Connected Diabetes Technology
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To test the hypothesis that remote sharing of health data - including measured blood glucose
      values as well as patient-reported carbohydrate counts and insulin doses - with the UC Davis
      Pediatric Diabetes team via connected health applications is feasible for pediatric patients
      with newly diagnosed type 1 diabetes.
    


Intervention name(s): Application Use
Intervention type(s): Behavioral
Intervention description(s): Use applications after initial diagnosis to share information with study team.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Use of applications to share data
Masking: None (Open Label)
Primary purpose: Health Services Research
Lithium Cannabis Withdrawal Study
Condition: Cannabis Dependence; Substance Withdrawal Syndrome
MeSH terms: Marijuana Abuse; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will examine the efficacy of lithium in providing symptomatic relief from the
      withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular
      use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can
      be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from
      such symptoms may be important in helping some clients achieve a period of abstinence and
      facilitate subsequent entry into a relapse prevention program.
    

Detailed description: 
      There are currently no accepted pharmacotherapies for the management of cannabis withdrawal.
      A recent study by Cui et al (2001) investigated the effects and mechanism of lithium on
      cannabinoid withdrawal in rats. The researchers found that lithium administration prevented
      the development of withdrawal symptoms, and suggested that increased oxytocin secretion
      resulting from lithium dosing prevented the withdrawal syndrome from occurring. Although
      caution should be exercised in generalising the results of an animal study, preliminary
      results of a small pilot study in humans are consistent with the potential utility of lithium
      in the management of human cannabis withdrawal (Zhang, personal communication). Furthermore,
      human use of lithium is well established and the addition of a readily available drug such as
      lithium carbonate would be a useful clinical tool should it prove efficacious in a series of
      clinical trials.
    

Intervention name(s): Lithium carbonate
Intervention type(s): Drug
Intervention MeSH terms: Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cannabis withdrawal; lithium; Cannabis withdrawal syndrome
Acute Nutritional Ketosis in GSD IIIa
Condition: Glycogen Storage Disease IIIA
MeSH terms: Glycogen Storage Disease; Metabolic Diseases
Study type: Interventional

Summary: 
      The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can
      boost muscle mitochondrial function in vivo.
    

Detailed description: 
      Glycogen Storage Disease type IIIa (GSD IIIa) is an inborn error of carbohydrate metabolism
      caused by impaired glycogen debranching enzyme (GDE) activity. The ageing GSD IIIa cohort
      shows that muscle involvement -despite dietary management- is a common disabling phenotype in
      adulthood. Currently, no specific therapy has been established for muscle problems in adult
      GSD IIIa patients.

      However, it could be hypothesized that nutritional ketosis (NK) will be highly beneficial to
      patients. Amongst others, ketone bodies could take on the role of primary energy source in
      exercising muscle. Recently, acute NK in exercise was studied in humans. NK was found to
      enhance muscle mitochondrial function in athletes.

      The investigators will study if acute NK in adult GSD IIIa patients can boost muscle
      mitochondrial function in vivo.
    

Intervention name(s): physical exercise
Intervention type(s): Other
Intervention description(s): In session II and III participants will perform an exercise test on a bicycle inside and outside the MR scanner.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: glycogen storage disease type IIIa; exercise; ketone esters; magnetic resonance spectroscopy
Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
Condition: Depression; Depression, Anxiety; Inflammation
MeSH terms: Inflammation; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This pilot study aims to measure the effects of an intervention of 22.5 grams of freeze-dried
      whole blueberry powder in water drunk daily. Measures are on outcomes of depression,
      biological markers of inflammation and oxidative stress, and microbial populations in the
      intestines.
    

Detailed description: 
      A 29 week double-blind, placebo-controlled, crossover intervention assessing the effect of a
      blueberries on behavioral symptoms related to depression, biological markers of inflammation
      and oxidative stress, and gut microbiome measures. A total of 45 participants will be
      randomly assigned to either a blueberry-first or placebo-first group; participants will take
      22.5 grams of either freeze-dried blueberry powder or matched placebo powder mixed with water
      daily for 12 weeks. This period is followed by a 4 week washout period at the beginning of
      which all participants will stop the assigned intervention. After this washout the
      participants will start their crossover intervention.
    

Intervention name(s): Freeze Dried Blueberry Powder - 71717; USHBC Blueberry Placebo Formula #114
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption.; Blueberry flavor- and color-matched placebo powder.
Other intervention name(s): Tifblue/Rubel 50/50 Blend
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study will utilize a randomized, double-blind, placebo-controlled, crossover design. 60 participants with depression will be randomized into either the placebo first or blueberry first group. Randomization will be based on outcomes from behavioral measures (Major Depression Inventory and GAD-7) and a physiological measure (C-reactive protein levels) in appointment 0. The first arm will consist of 12 weeks of daily treatment and baseline (pre-intervention), mid-intervention and post-intervention assessments. Next there will be a four week washout period, after which patients will switch treatments, and the second arm will commence--identical to the first in structure. Further, the study is a repeated measures design with each participant's baseline measures serving as her or his own control.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; inflammation; anxiety; blueberries
Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease
Condition: Charcot Marie Tooth Disease
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The object of this research is to test the effectiveness of Coenzyme Q10 (CoQ10) on symptoms
      of weakness, fatigue, and pain in persons with Charcot-Marie-Tooth disease (CMT).In this
      study we also intend to examine the impact of daily supplementation on overall quality of
      life.We are also interested in identifying any differences in serum ratios of CoQ10 in the
      oxidized and reduced forms.
    

Detailed description: 
      CoQ10 is an integral part of the electron transport chain in the mitochondria, or the energy
      production centers of cells. Within recent years, there has been expanding interest in the
      potential benefits of CoQ10 supplementation on a variety of neuromuscular diseases, some of
      which involve mitochondrial dysfunction, such as CMT. Daily supplementation may have
      cytoprotective and neuroprotective properties, which may improve symptoms of weakness,
      fatigue, and pain, as well as increase quality of life (QOL) among persons with CMT.

      With regards to within group comparisons we hypothesize that daily supplementation of CoQ10
      taken as a 300 milligram wafer twice a day for 3 months will produce a statistically
      significant reduction in weakness, fatigue, and pain, along with a significant improvement in
      QOL as indicated from scores in both standardized physiological and scale measures.

      The addition of serum level analysis will help to contextualize clinical results. We
      hypothesize the ratios of the oxidized and reduced forms of CoQ10 will be modified upon
      supplementation.
    

Intervention name(s): Coenzyme Q10; Coenzyme Q10
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 300 mg CoQ10 twice a day for 48 weeks; 300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study
Other intervention name(s): CoQ10; Ubiquinone; CoQ10; Ubiquinone
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CMT; Charcot-Marie Tooth; CoQ10; Coenzyme Q10
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125
      in healthy female subjects on combination oral contraceptives (COC).
    


Intervention name(s): AQX-1125; Combined Oral Contraceptive
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Drug; COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study was designed as a randomized, single blind, placebo-controlled, study to
      evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and
      associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d
      for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat
      cutaneous leishmaniasis ulcers.
    

Detailed description: 
      This is a randomized, single blind placebo-controlled study in which the groups were selected
      from the cases presenting to the health post. The inclusion criteria were: age between 15 and
      50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The
      diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower
      limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to
      Leishmania antigen.
    

Intervention name(s): GMCSF plus Antimony reduced dose; Meglumine antimoniate
Intervention type(s): Drug; Drug
Intervention description(s): 400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days); 20mg/daily for 20 days
Other intervention name(s): Sargramostim; pentavalent antimony
Intervention MeSH terms: Meglumine Antimoniate; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
Condition: Autistic Disorder; Attention Deficit and Disruptive Behavior Disorders; Anxiety Disorders; Mood Disorders; Conduct Disorder; Oppositional Defiant Disorder
MeSH terms: Anxiety Disorders; Mood Disorders; Autistic Disorder; Mental Disorders; Problem Behavior; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether an exergaming, aerobic physical education
      (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and
      classroom functioning among children with behavioral health challenges attending a
      therapeutic day school. After following an approved consent/assent process, children
      attending the school were randomized by classroom to take part in either 7 weeks of the
      experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout
      period, children then crossed over into the other arm.
    


Intervention name(s): Aerobic Exergaming PE Curriculum; Standard PE
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sustained aerobic exercise.; Non-aerobic skill building.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determinants of Balance Recovery After Stroke - Retrospective Study
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward
      after a first hemispheric stroke. Postural and gait disorders in relation to referential of
      verticality have been analyzed in routine care.
    

Detailed description: 
      300 consecutive patients, admitted in our department for neurorehabilitation after a first
      hemispherical stroke, have been enrolled retrospectively. During their hospitalisation, all
      patients have been routinely evaluated with clinical scales, evaluating motor and cognitive
      deficits. Postural and visual vertical (VV) assessments have been performed 1 to 4 times
      during in-patient-stay.

      The objective was to analyse the determinants of balance recovery after stroke, in particular
      the impact of wrong referential of verticality.

      Data collection was performed by means of medical records. Observation period covered from
      january 2012 to february 2018.
    

Intervention name(s): Postural Assessment Scale for Stroke (PASS)
Intervention type(s): Behavioral
Intervention description(s): Postural Assessment Scale for Stroke (PASS)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke
      
Keywords: lateropulsion; pusher syndrome; posture; balance; PASS; verticality perception; gait
CMX001 in Post-transplant Patients With BK Virus Viruria
Condition: Viruria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was a randomized, double-blind, multiple-dose placebo-controlled study of oral
      brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients
      with BK virus viruria.
    

Detailed description: 
      This was a randomized, double-blind, multiple-dose placebo-controlled study of oral
      brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients
      with BK virus infection.

      Subjects received blinded study medication for a total of 5 doses in 1 of the following
      regimens:

        -  10 mg BCV administered twice weekly (BIW) on Days 0, 3, 7, 10, 14.

        -  20 mg BCV administered once weekly (QW) on Days 0, 7, and 14 and placebo administered on
           Days 3 or 10.

        -  Placebo administered BIW on Days 0, 3, 7, 10 ,14.

        -  40 mg BCV administered QW on Days 0, 7, 14, 21, and 28.

        -  Placebo administered QW on Days 0, 7, 14, 21, and 28.
    

Intervention name(s): Placebo; Brincidofovir
Intervention type(s): Drug; Drug
Other intervention name(s): BCV; CMX001
Intervention MeSH terms: Brincidofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CMX001; Kidney transplant; HSCT transplant; BK Virus; Post kidney transplant patients with BK virus viruria > 10^4; Post HSCT transplant patients with BK virus viruria > 10^4
Serum Zinc, Peptic Ulcer Disease and H. Pylori Infection
Condition: Peptic Ulcer Disease
MeSH terms: Peptic Ulcer
Study type: Observational

Summary: 
      Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included.
      All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal
      endoscopy and rapid urease test. Measurement of serum zinc level was done for all the
      included patients in addition to twenty five age and sex matched healthy control subjects.
    


Intervention name(s): Upper gastrointestinal endoscopy
Intervention type(s): Procedure
Intervention description(s): Thorough examination of the esophagus, stomach and duodenum to the second part was done to all patients using Olympus CV-150 or Pentax EPM-3500.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia,
        heartburn who were candidates for upper gastrointestinal endoscopy.