bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women
Condition: Menopause; Dietary Supplements; Quality of Life
Study type: Interventional

Summary: 
      This study was designed to evaluate the beneficial effects and safety of a standardised
      botanical extract combination containing soy isoflavone extract, grains of paradise seed dry
      extract and pomegranate skin dry extract on health-related Quality of Life in healthy Spanish
      menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported
      and validated Cervantes Scale.
    

Detailed description: 
      Fifty-seven outpatient women (45-65 years) with menstrual problems associated with
      climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a
      prospective, placebo-controlled, double-blind study. Women were randomized to receive
      treatment with either the botanical combination (250 mg daily divided into two doses) or
      placebo for eight weeks. At the beginning and end of the study, health-related Quality of
      Life was assessed using the Cervantes Scale.
    

Intervention name(s): Botanical dry extracts combination; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg); Filler agent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Hot flushes; Isoflavones; Aframomum melegueta extract; Punica granatum extract; Cervantes Scale
Early Outcome of Mechanochemical Endovenous Ablation
Condition: Varicosis
Study type: Observational

Summary: 
      More than 25 percent of the general population suffers from varicose veins, which has a
      considerable impact on quality of life. Nowadays endovenous treatment modalities for great
      saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new
      tumescent-less technique, that combines mechanical endothelial damage using a rotating wire
      with the infusion of a liquid sclerosant. The current study aims at evaluating short and long
      term outcome after mechanochemical endovenous ablation.
    


Intervention name(s): ClariVein
Intervention type(s): Device
Intervention description(s): Using the ClariVein device, the GSV will be occluded.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with insufficiency of the greater saphenous vein will be included.
      
Keywords: GSV; insufficiency; ClariVein device; safety; efficacy; QOL
Upper Limb Ergometer on Pulmonary Function Among Patients With Spinal Cord Injury.
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Randomized Control Trial, To determine the effects of arm ergometer exercise on pulmonary
      function of Spinal Cord Injury.
    

Detailed description: 
      The spinal cord is a tubular structure contained nervous tissue. This acts as a transmission
      channel of nerve signals within the brain and spinal cord. It contains grey and white matter.
      The grey matter consists of cell bodies of different sensory and motor neurons and white
      matter consists of oriented spinal tracts.

      By 2007, a prospective observational study had been conducted after a disaster occurred in
      Pakistan which was the most cataclysmic natural disaster in country's history as a result
      73000 people were lost their lives and 126000 were harmed. There was no Spinal Cord Injury
      (SCI) registry existed in the country but according to different estimates 650-750 had been
      effected of SCI.

      In United States SCI incidence mainly due to higher percentage of violence-related SCIs
      (18%)which is higher compared to the western Europe (8%) Australia (2%). In Pakistan the most
      common traumatic cause of SCI was falling from different cause followed by road traffic
      accident (RAT) (25.2%) and functional aerobic impairment (FAI) (8.4%). The way that SCI is
      associated with fantastic expenses and human sufferings , yet careful statistics of SCI are
      not accessible in dominant of developing countries including Pakistan.

      Total lung capacities become abnormal in chronic spinal cord injury patients. Changes in
      chest wall compliance and decreased respiratory muscle strength leads to abnormal changes in
      overall lung capacities.
    

Intervention name(s): Conventional Treatment; Upper Limb ergometer training
Intervention type(s): Other; Other
Intervention description(s): Conventional Treatment:
Deep breathing: 10-15 reps, twice a day (BD)
Assisted coughing 10-15 reps, BD
range of motion (ROM)+ stretching 10 reps, BD
Tilt table standing; Conventional Treatment + upper limb (UL) ergometry exercise UL ergometry exercise 15 to 20 mints , 2 times ,five days per week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Function; Spinal Cord Injury; Spirometry; Ergometer
Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in
      treating elderly patients who have metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal
      cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the
      toxicity profile of this regimen in this patient population. III. Compare response rates
      obtained in this study with those observed in recent phase III studies in younger patients.

      OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every
      8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or
      disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3
      years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.
    

Intervention name(s): leucovorin calcium; tegafur-uracil
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leucovorin; Tegafur; Calcium; Levoleucovorin
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
Effects of Blueberry-polyphenols on Endothelial Function, Absorption and Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in
      epidemiological studies.

      Dietary intervention studies with certain micronutrients have shown promising effects on
      surrogate parameters of vascular risk including blood pressure, endothelial function and
      cholesterol levels. Wild blueberries have gained attention due to their high content of
      phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular
      function and health when given over relevant time periods and in relevant populations is not
      known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption
      of wild blueberries can improve endothelial function, a prognostically validated surrogate of
      cardiovascular risk.
    


Intervention name(s): Blueberry Group; Placebo Group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water; Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: blueberry polyphenols; Polyphenol metabolites; endothelial function; Molecular mechanisms of action; Vascular function; Healthy men
An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Condition: Unresectable Stage III; Stage IV Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the objective response rate of lenvatinib in
      previously treated participants with American Joint Committee on Cancer (AJCC) unresectable
      Stage III or Stage IV melanoma and disease progression.
    

Detailed description: 
      This was a Phase 2, multicenter, open-label, 2-cohort, 2-stage study that assessed the ORR of
      lenvatinib in previously treated participants with AJCC unresectable Stage III or Stage IV
      melanoma and disease progression. Cohort 1 enrolled participants not harboring the V600E BRAF
      mutation with disease progression following up to 2 prior systemic anticancer regimens
      (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma, and is referred to as
      Cohort 1 or V600E BRAF negative. Other less common BRAF activating mutations were allowed as
      long as the participant did not receive a BRAF-targeted therapy. Cohort 2 enrolled
      participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease
      progression following BRAF V600E-targeted therapy, and is referred to as Cohort 2 or V600E
      BRAF positive. Eligible participants had measurable disease according to RECIST 1.1.
    

Intervention name(s): Lenvatinib
Intervention type(s): Drug
Intervention description(s): Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
Other intervention name(s): E7080
Intervention MeSH terms: Lenvatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diplegic Cerebral Palsy and Action Observation Training
Condition: Diplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      In this study, video-based action observation training and live action observation training
      in children with spastic diplegic cerebral palsy; It was aimed to examine the effect on motor
      function, activity participation and secondary outcome measures.
    

Detailed description: 
      The study was designed as a single-blind randomized controlled trial. Patients aged 5-14
      years with spastic diplegic cerebral palsy will be included. Children will be assigned to
      groups through stratified randomisation; The patients will be divided into 3 groups as
      experimental and control groups. Group 1 (experiment): video-based action observation
      training in addition to the conventional rehabilitation program, Group 2 (experiment): live
      action observation training in addition to the conventional rehabilitation program, Group 3
      (control) will receive only the conventional rehabilitation program. The experimental group
      will receive 20 minutes of action observation training after a conventional physiotherapy
      program for 20 minutes for 8 weeks, 40 minutes 2 days a week. The control group will receive
      40 minutes of conventional treatment. Evaluations will be made for each group, before and 8
      weeks after the start of the study. GMFM for gross motor function; Pediatric berg balance
      scale for balance function; Timed Up and Go Test for functional mobility assessment; Gillette
      Functional Assessment Questionnaire and 1-min walk test to assess functional walking; sit and
      stand test for functional muscle strength and to evaluate activity participation; The Child
      and Adolescent Participation Questionnaire (CASP) will be used.
    

Intervention name(s): Video Based Action Observation; Live Action Observation; Conventional physiotherapy program
Intervention type(s): Other; Other; Other
Intervention description(s): Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.; Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.; Individuals in this group will only receive a conventional physiotherapy program.
Other intervention name(s): Conventional physiotherapy program; Conventional physiotherapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental, Randomized Controlled Study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Action Observation Therapy; Diplegic Cerebral Palsy; Mirror Neuron System; Motor Function; Activity Participation; Secondary Outcome Measures
Tenecteplase in Patients With COVID-19
Condition: COVID-19; Respiratory Failure; ARDS
MeSH terms: COVID-19; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a placebo-controlled, double blind, randomized, Phase II dose escalation study
      intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of
      COVID-19 associated respiratory failure. The hypothesis is that administration of the drug,
      in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.
    

Detailed description: 
      Patients with COVID-19 who suffer from acute hypoxemic respiratory failure have a poor
      prognosis. COVID-19 has been associated with a hyperinflammatory and hypercoagulable state,
      leading to a range of thromboembolic complications from pulmonary embolism to ischemic
      stroke. Furthermore, emerging data suggest that the associated acute respiratory failure is,
      at least in part, due to pulmonary vascular disease caused by micro- and/or macro-emboli,
      creating pulmonary vascular shunting and dead-space ventilation. In this placebo-controlled,
      double blind, randomized, Phase II dose escalation study, we plan to evaluate the clinical
      efficacy and safety of low-dose IV bolus tenecteplase together with anticoagulation compared
      with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed
      with COVID-19 respiratory failure with elevated D-dimer. We believe these patients can be
      successfully treated without significantly increasing the risk of major bleeding while
      improving recovery rates, shorten hospitalization time, and perhaps ultimately prove to
      improve survival.
    

Intervention name(s): Tenecteplase; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): First 20 patients randomized to treatment arm will receive 0.25 mg/kg of tenecteplase. Next 20 patients randomized to treatment arm will receive 0.50 mg/kg of tenecteplase. Both will receive concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.; Patients will receive placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Intervention MeSH terms: Tenecteplase
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects will be randomized in a 2:1 ratio to treatment or control in blocks of 15, performed twice per dose (low and high) with randomization stratified by site.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; ARDS; thrombolysis; tenecteplase
Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1
Condition: HTLV-I Infections
MeSH terms: Infections; Communicable Diseases; HTLV-I Infections
Study type: Observational

Summary: 
      Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The
      two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis
      /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM
      in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM have a HTLV-1
      proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic.

      Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its
      rapid evolution is partly attributed to the failure of the immune system that regulates viral
      replication and expression.

      It has recently been shown that different versions of Single Nucleotide (human leukocyte
      antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced the
      severity of infection with hepatitis C and effectiveness of treatment.

      By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single
      nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT
      genotype was statistically more frequent in the group TSP / HAM than in asymptomatic patients
      (80% versus 20%) and was associated with HTLV-1 proviral load higher.

      We propose a broader group of patients in our population and Afro-Caribbean, to confirm the
      results of the latter study was conducted in a predominantly Latin American population.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HTLV-1 infected patients :

        Adult, followed in consultation of Neurology of the University Hospital of Fort-de-France
        for their HTLV-1 infection.

        Blood Donors ; Adult, age 18 to 70 years coming to give their blood in one of building or
        mobile collection facilities of Martinique French Blood Establishement
      
Keywords: HTLV-I
Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus
Condition: Skin Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by
      comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific
      Corporation in patients with dermal pruritus.
    


Intervention name(s): PAC-14028; Vehicle
Intervention type(s): Drug; Other
Intervention description(s): Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks; Participants received topical Vehicle twice daily for 4 weeks
Other intervention name(s): PAC-14028 Cream 0.3%; PAC-14028 Cream 1.0%; Vehicle of PAC-14028 Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about cancer and the development of drug resistance in patients.

      PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid
      leukemia to learn more about drug resistance in these patients.
    

Detailed description: 
      OBJECTIVES:

        -  Ascertain whether assessments of P-glycoprotein (P-gp) status using the accumulation
           assay find greater than 10% positive specimens among 30 specimens (collected from
           patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999) found to be
           negative using only the efflux assay.

      OUTLINE: This is a multicenter study.

      Cryopreserved bone marrow specimens are examined for P-glycoprotein (P-gp) by the
      accumulation assay and the efflux assay using DiOC_2 dye. Flow cytometry is used for
      measuring activity in both assays.

      PROJECTED ACCRUAL: A total of 40 specimens will be accrued for this study.
    

Intervention name(s): flow cytometry; immunological diagnostic method; laboratory biomarker analysis
Intervention type(s): Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E3999
      
Keywords: adult acute monocytic leukemia (M5b); adult acute megakaryoblastic leukemia (M7); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); secondary acute myeloid leukemia; untreated adult acute myeloid leukemia; adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b)
Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The overall objective is to investigate, whether retinal blood vessel diameter change during
      the energy consuming dark adaptation process and if responses vary between low and high blood
      glucose.
    

Detailed description: 
      All subjects are being studied using the same procedure. The study schedule takes place from
      8 a.m. to 12 a.m. every time. Each subject shows up on one single day. Subjects are to show
      up fasting overnight with a break in insulin and/or oral antidiabetic treatment.

      The study eye of each subject will be selected by randomisation. We seek to have an equal
      distribution of right and left eyes overall.

      A first set of images will be taken after 5 minutes in "standardised daylight", in a room
      without light from outside, which eliminates any concerns about weather variations. After
      this the room is completely darkened. 2 set of images will be taken in the dark adapted state
      after 20 and 40 minutes. Subsequently the patient ingests the OGTT and will reach maximum
      blood glucose level after about 60-90 minutes. At this time, the subjects undergo the same
      "photo session" as above with high blood glucose levels.
    

Intervention name(s): Oral Glucose Tolerance Test (OGTT)
Intervention type(s): Dietary Supplement
Intervention description(s): 75 g of glucose dissolved in 250 mL water.
Other intervention name(s): OGTT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with diagnosed Type 2 diabetes mellitus with none or minimal diabetic retinopathy.
      
Biospecimen description: 
      Venous blood sample. Na+, K+, Crea, HbA1c. Capillary glucose measurement. Samples will be
      analysed and destructed according to normal laboratory practice at the Glostrup Hospital.
    
Keywords: Diabetes Mellitus; Retinal Vessels; Physiology