bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the safety of & immune response to a single dose of
      GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed,
      egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
    


Intervention name(s): Trivalent influenza vaccine GSK 138842A; Fluarix
Intervention type(s): Biological; Biological
Intervention description(s): IM injection on Day 0; IM injection on Day 0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cell culture; Safety; Influenza; Humans; Adults; Immunogenicity; Influenza vaccine; Vaccine
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study will determine whether acute and chronic consumption of a beverage containing
      erythritol will improve endothelial function in patients with type 2 diabetes mellitus.
    


Intervention name(s): Erythritol-containing beverage
Intervention type(s): Dietary Supplement
Intervention description(s): Orange flavored beverage containing erythritol
Intervention MeSH terms: Erythritol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelium; diabetes mellitus; oxidative stress
Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery
Condition: Degenerative Joint Disease; Osteoarthritis; Knee Injury, Trauma; Connective Tissue Disorder; Pain; Loss of Function
MeSH terms: Osteoarthritis; Joint Diseases; Connective Tissue Diseases; Knee Injuries
Study type: Observational

Summary: 
      This study is to determine the relevancy of clinical scales for outcome measures as compared
      to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee
      Society Score and the WOMAC Score will be obtained from patients. Gait data will also be
      obtained from total knee replacement (TKR) patients at pre-operative and post-operative
      times. Gait data will be measured on unaffected normal controls as a second baseline.

      The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait
      dependent outcomes amd functional performance of the total knee replacement.
    

Detailed description: 
      Patients scheduled to undergo unilateral total knee replacement (TKR) surgery will be the
      subjects of the study. A control group of Healthy volunteers, will serve as a control group.
      The control group will be matched as close as possible by age and gender to the TKR group.
      Both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be
      performed on the TKR group.

      A Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to record body
      motion, the sensors for the IDEEA device will be placed on the patient and secured with
      adhesive tape(if not allergic) once the IDEEA device is properly placed on the patient,
      measuring and calibrating can start.

      The patient will be required to perform tasks, walking at a normal pace for approximately 100
      feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8 steps,
      sit and rise from two chairs. Parameters will be measured on each subject, knee flexion
      angle( walking, stair climbing and sitting), velocity ( walking and stair climbing), Stride
      length (walking), Energy (walking, stair climbing, and sitting), other parameters will be
      added as needed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients that are healthy and patients that need a unilateral total knee
        replacement.
      
Keywords: Total knee replacement
Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Giving belotecan together with cisplatin may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well belotecan works when given together with
      cisplatin in treating patients with previously untreated extensive stage small cell lung
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the antitumor efficacy, in terms of objective response rate, of belotecan
           hydrochloride and cisplatin in patients with previously untreated extensive-stage small
           cell lung cancer.

      Secondary

        -  To assess additional evidence of antitumor activity as measured by overall and
           progression-free survival of these patients.

        -  To determine the safety and tolerability of this drug combination in these patients.

      OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days
      2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.
    

Intervention name(s): belotecan hydrochloride; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Belotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer
Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Condition: Breast Cancer
MeSH terms: Carcinoma; Carcinoma in Situ
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can
      stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast
      cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if
      radiation therapy is more effective than observation, with or without tamoxifen, in treating
      ductal carcinoma in situ.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with
      that of observation, with or without tamoxifen, in treating women who have ductal carcinoma
      in situ.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of whole breast radiotherapy vs observation with or without
           optional tamoxifen in decreasing or delaying the appearance of local failure (both
           invasive and in situ) and preventing the need for mastectomy in women with good-risk
           ductal carcinoma in situ (DCIS) of the breast.

        -  Compare distant disease-free survival of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
      (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm),
      mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei
      grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2
      treatment arms.

        -  Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily
           (at the discretion of the physician) for 5 years.

        -  Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to
           the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive
           optional tamoxifen as in arm I.

      Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
    

Intervention name(s): tamoxifen citrate; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer in situ; ductal breast carcinoma in situ
Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 1

Summary: 
      Methamphetamine dependence is a serious public health problem, with methamphetamine abusers
      being at risk for significant morbidity and mortality, including HIV. To date, no medication
      or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder.
      This clinical trial will examine whether lisdexamfetamine shows promise in alleviating
      withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent
      methamphetamine dependent individuals. Findings of this study will not only shed light on
      whether lisdexamfetamine may improve upon treatment for this disorder but also inform future
      medication development strategies for improving treatment for drug dependence disorders.
      Discovering efficacious limited risk interventions that show more robust, longer-term
      outcomes would be beneficial both to the individual and society.
    


Intervention name(s): Lisdexamfetamine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Early Medication Change (EMC) Trial
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The EMC trial investigates for the first time prospectively whether Major Depression Disorder
      patients with non-improvement after 14 days of antidepressive treatment with EMC are more
      likely to become remitters compared to patients treated according to current guidelines,
      i.e., with a medication change after 28 days of treatment in case of non-response.
    


Intervention name(s): Escitalopram, venlafaxine, lithium; Escitalopram, venlafaxine
Intervention type(s): Drug; Drug
Intervention description(s): oral application, highest tolerable dose, once daily; oral application, highest tolerable dose, once daily
Intervention MeSH terms: Dexetimide; Citalopram; Venlafaxine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major; Depression; Disorder
Research Evaluating the Value of Augmenting Medication With Psychotherapy
Condition: Depression; Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This 24-week study, with a 12-month follow up period, will compare the effectiveness of
      antidepressant medication alone to the combination of psychotherapy and antidepressant
      medication in patients with chronic depression.
    

Detailed description: 
      Chronic depression affects approximately 5% of adults in the United States and is associated
      with significant functional impairment and high health care utilization. The combination of
      drug treatment and psychotherapy may be most effective in treating depression. This study
      will determine the effects of adjunctive psychotherapy in depressed patients who have failed
      to respond or have responded only partially to an initial trial medication.

      Participants receive an initial trial of antidepressant medication for 8 to 12 weeks.
      Participants who continue to have depressive symptoms are randomly assigned to add Cognitive
      Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication
      regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are
      made at 6 and 12 months post-treatment.
    

Intervention name(s): Brief Supportive Psychotherapy; CBASP; Medication Only
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): brief supportive psychotherapy; psychotherapy developed for chronic depression; antidepressant medication
Other intervention name(s): Cognitive Behavioral Analysis System of Psychotherapy; one of five antidepressants
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dopaminergic Modulation of Choroidal Blood Flow Changes During Dark/Light Transitions
Condition: Regional Blood Flow; Ocular Physiology
Study type: Interventional

Summary: 
      There is evidence from a variety of animal studies that choroidal blood flow is under neural
      control. By contrast, only little information is available from human studies. Recent results
      indicate that a light/dark transition is associated with a reduction in choroidal blood flow
      due to an unknown mechanism. We have shown that during unilateral dark/light transitions both
      eyes react with choroidal vasoconstriction strongly indicating a neural mechanism responsible
      for the blood flow changes.

      Dopamine has been discussed as a chemical messenger for light adaptation. However,
      dopaminergic effects in the eye are not restricted to synaptic sites of release, but dopamine
      also diffuses to the outer retinal layers and pigment epithelium. Accordingly, dopaminergic
      effects also include a modulatory role on retinal vessel diameter and animal studies provide
      evidence for vasodilatory effects in the choroid. There is evidence that during darkness
      retinal and choroidal dopamine levels decrease. Accordingly, dopamine could provide a
      modulatory input to the light/dark transition induced changes of choroidal circulation. The
      aim of the present study is to test this hypothesis.
    


Intervention name(s): Quetiapine (drug); Sulpiride (drug); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Quetiapine (Seroquel 100mg-film-coated tablet, AstraZeneca Vienna, Austria) Dose: 100 mg tablet oral single dose; Sulpiride (Dogmatil 200mg-tablet, Synthélabo Groupe, Le Plessis Robinson, France) Dose: one half of 200 mg tablet oral single dose; Placebo
Intervention MeSH terms: Quetiapine Fumarate; Sulpiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sulpiride; Quetiapine; Light/dark transition; Choroidal blood flow
Safety and Acceptability Study of a Non-Hormonal Ring
Condition: Contraception
Study type: Interventional

Summary: 
      This is a feasibility, multi-center, open-label, non-significant risk device study for a
      non-hormonal contraceptive ring.
    

Detailed description: 
      The purpose of this clinical trial is to assess the ability of Ovaprene™ to prevent sperm
      from penetrating midcycle cervical mucus. In addition, safety, release of ingredients,
      acceptability and fit will be assessed.
    

Intervention name(s): Ovaprene
Intervention type(s): Device
Intervention description(s): non-hormonal contraceptive ring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, first-in-human dose-escalation study of SHJ002
      Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration
      of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional
      children will receive the highest tolerated concentration for 28 days.
    


Intervention name(s): SHJ - Low concentration; SHJ - Mid concentration; SHJ - High concentration; SHJ - Maximum tolerated
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical ophthalmic; Topical ophthalmic; Topical ophthalmic; SHJ - Maximum tolerated
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Single-center, Open-label, first-in-human dose-escalation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia
Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
Condition: Pityriasis Rubra Pilaris
MeSH terms: Pityriasis; Dermatitis, Exfoliative; Pityriasis Rubra Pilaris
Study type: Interventional
Phase: Phase 2

Summary: 
      15 patients with PRP will be treated with ixekizumab for 24 weeks to determine safety and
      efficacy. Participants are required to travel to Portland, OR only for the first visit and
      week-24 visit. 5 visits in between these times and one follow up visit may be performed by
      secure videoconferencing.
    

Detailed description: 
      Pityriasis rubra pilaris (PRP) is a rare and poorly understood severe inflammatory skin
      disease characterized by widespread (often full-body) redness and flaking of the skin,
      painful thickening and cracking of the palms and soles, hair loss, crumbling nails, and
      severe skin itching and burning.

      There is no FDA-approved therapy for this rare disease and the commonly used medications do
      not work for many patients. There is some evidence that IL-17 may be too high in the skin of
      PRP patients. Ixekizumab is an injectable medication that blocks IL-17 and is FDA-approved
      for psoriasis.
    

Intervention name(s): Ixekizumab
Intervention type(s): Drug
Intervention description(s): Treatment at the FDA-approved psoriasis dosing
Other intervention name(s): Taltz; IL-17A inhibitor
Intervention MeSH terms: Ixekizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ixekizumab; IL-17; Pityriasis Rubra Pilaris (PRP)
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
Condition: Methamphetamine Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help
      methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible
      participants will attend research visits twice per week, and will receive individual
      counseling sessions once per week for all 9 weeks. 50% of the participants will receive the
      active medication while the other 50% will receive the placebo (sugar pill). Neither the
      participant or the study team will know if the participant is receiving the placebo or active
      drug.
    


Intervention name(s): Dextroamphetamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 week placebo and 8 weeks 60mg d-AMP QD.; 9 weeks of placebo 60mg capsules QD.
Intervention MeSH terms: Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methamphetamine; Drug Abuse; Drug Treatment; Addiction; Meth; Treatment for Methamphetamine Dependence
Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma
Condition: Esophageal Neoplasms
MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with
      radiation therapy, and to document the adverse events for further clinical trial.
    

Detailed description: 
      Although preoperative chemoradiation therapy followed by surgery is the most common approach
      for patients with resectable esophageal cancer, the considerable number of esophageal cancer
      patients received operation as the first treatment modality. Accordingly, postoperative
      treatments have been playing an important role because of the poor survival rates of the
      patients with pathologically positive lymph nodes who have been treated with resection alone.
      The investigators have proved the value of prophylactic radiation therapy after radical
      esophagectomy for esophageal carcinoma with positive lymph node metastases under the
      conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized
      clinical trial. For patients with positive lymph nodes, 5 year survival after surgery alone
      was 28.4%, median overall survival was 24 months, recurrence occurred 34.6% in mediastinal
      lymph nodes，13.3% in supraclavicular lymph nodes，10% in abdominal lymph nodes. Distant
      metastases occurred in 21% patients. Adjuvant radiotherapy significantly reduced the
      recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). However
      distant metastases rate increased to 30.7%. Chemotherapy may be vital for these patients.
      Chen reported that the 5 year overall survival rates for the chemoradiotherapy group and
      radiotherapy group were 47.4% and 38.6% (P=0.03). Based on the investigators' studies,
      treatment failure occurred in 8% patients because of celiac metastases. Small radiation field
      by omitting celiac axis lymph node basin may ensure 5-6 cycles of concurrent chemotherapy for
      lower toxicity.
    

Intervention name(s): Paclitaxel; Cisplatin; Radiation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): starting dose 20mg/m2 qw; dose 25mg/m2 qw; 60Gy/2Gy/30f
Other intervention name(s): taxel; platimum
Intervention MeSH terms: Paclitaxel; Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chemoradiation; dose escalation
A Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers
Condition: Shoulder Injury
MeSH terms: Shoulder Injuries
Study type: Observational

Summary: 
      Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a
      reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points
      the injury risk, because an alteration in biomechanics can turn lead to clinical findings of
      impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in
      swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive
      stretch could reduce glenohumeral rotation restriction after swimming competition.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Swimmers from the winter national trials who competed at state, national or international
        level, performed at least five swim sessions per week and intended to continue this
        training level during the following 24 months were eligible to participate in this study.
      
Keywords: Shoulder; glenohumeral; stretching