bioihbjkbjnl/mcl2 huggingface dataset:
SR-45023A in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have
      advanced solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally
      advanced or metastatic solid tumors that are refractory or for which no standard therapy
      exists. II. Determine the quantitative toxic effects of SR-45023A in these patients. III.
      Assess the pharmacokinetic profile of SR-45023A in these patients. IV. Identify the antitumor
      activity of SR-45023A in these patients.

      OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A twice daily for 14
      days, followed by 7 days rest. On day 14 of course 1, patients receive only one dose of
      therapy due to pharmacokinetic sampling. Treatment continues every 21 days in the absence of
      disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
      doses of SR-45023A until the maximum tolerated dose (MTD) is reached. The MTD is defined as
      the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients
      are followed until death.

      PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
    

Intervention name(s): apomine
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral
      consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.
    

Detailed description: 
      In this double-blind, randomized and placebo-controlled trial, twenty participants
      experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of
      either ZSO or soy bean oil (SBO) as placebo for 10 weeks. All participants completed the
      study. Follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress
      markers, and blood lipid analysis were performed.
    

Intervention name(s): Zanthoxylum Schinifolium Seed Oil(4g/day); Soy Bean Oil;placebo(4g/day)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): parallel design; parallel design
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Zanthoxylum schinifolium seed Oil; soy bean oil; omega-3 fatty acid; dry eye disease
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in
      patients with atopic dermatitis.
    


Intervention name(s): S-777469 400 mg; S-777469 800 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): S-777469 400 mg BID; S-777469 800 mg BID; Placebo BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis
Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      purpose of the study: to determine the effectiveness of cervical mobilization with PIR in
      reducing pain and improving neck ROM and function in people with mechanical neck pain
      associated with MTrPs
    

Detailed description: 
      This study will be based on a randomized controlled design which will be comparative in
      nature. Participants will be recruited using the convenience sampling method and will be
      randomly divided into two groups A and B respectively. Thirty participants of mechanical neck
      pain associated with upper Trapezius trigger point pain will be recruited from the
      Physiotherapy department, at the Najran University, Saudi Arabia. Study objectives and
      procedure will be properly explained and written informed consent will be obtained at the
      beginning of the study. All the participants will be randomly assigned into two equal groups
      A and B.

      Group A will be receiving the hot pack, active Stretching, isometric exercise intervention,
      and PIR technique while group B will receive the hot pack, active Stretching, isometric
      exercise intervention, and cervical Mobilization.
    

Intervention name(s): Post Isometric relaxation Technique (PIR); Cervical Mobilization (CM); conventional treatment
Intervention type(s): Other; Other; Other
Intervention description(s): In PIR intervention, the patients were requested to lie down in a supine position and their neck was in a lateral flexion to the opposite side so that the target upper Trapezius muscle fibers would be in a lengthened position. The therapist performed a moderate isometric contraction (approximately 75% of maximal) of upper Trapezius muscles, held it for 5 seconds, then relaxed for 3 seconds before moving the cervical spine into the new barrier. In each session, this technique was repeated for four times, on alternate days for three weeks.; Cervical Mobilization was delivered in prone lying with their foreheads resting comfortably on his hands, and the chin was tucked in.The treatment session was done on alternate days (3 days a week) for 3 weeks, hence the total number of sessions were 9.; Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10-second relaxation) were given, and isometric exercise of the neck((10 repetitions of two sets with 10 seconds hold) alternate days for three weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Favipiravir Treatment of Patients With COVID-19
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      To verify that the efficacy of favipiravir exceeds that of the actual supportive care
      (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) with mild
      pneumonia, using the time required to improve clinical symptoms as the primary endpoint.
    


Intervention name(s): Favipiravir
Intervention type(s): Drug
Intervention description(s): Name: AVIGAN Generic name: Favipiravir Content: T-705a tablets [200]
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cranberry Juice and Cardiovascular Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Previous studies have shown that consumption of a low calorie cranberry beverage imparts a
      favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men.
      However, these studies were not well controlled. Thus, it is important to confirm these
      effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify
      the cardioprotective effects of cranberries by conducting a dietary intervention trial with
      healthy subjects in a controlled environment.
    


Intervention name(s): Cranberry juice; Placebo
Intervention type(s): Other; Other
Intervention description(s): base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day; base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: cranberry; cardiovascular; adhesion; polyphenol
Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      In traditional Chinese medicine (TCM), examination of the tongue plays an important role in
      diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur,
      teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of
      the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia,
      which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing
      hyperglycemia can also be associated with buccal alteration. The purpose of this study was to
      survey on tongue diagnosis and other examinations associated with diabetic mellitus.
    


Intervention name(s): clinical evaluation
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators recruited the control group , the pre-DM group, and the DM group.
      
Keywords: tongue diagnosis; heart rate variability; nailfold videocapillaroscopy
Effect of the Level of Dietary Protein on Infant Growth
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether infants fed a formula with protein levels
      different than a standard infant formula have similar growth and development.
    


Intervention name(s): Standard infant formula; Infant formula with different level of proteins
Intervention type(s): Other; Other
Intervention description(s): From 3 to 12 months of age. As per standard requirement; From 3 to 12 months of age. As per standard requirement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Infant formula; Protein metabolism
Stress Intervention for Chronic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional

Summary: 
      Stress and chronic urticaria has been linked. The purpose of the study is to evaluate a
      patients chronic urticaria and stress levels before and after he/she goes through six
      sessions designed to help that participant manage his/her stress.
    

Detailed description: 
      The purpose of this single-arm, interventional pilot study is to evaluate the effect of
      psychological stress intervention for patients with chronic urticaria, as many of these
      patients report heightened levels of stress before and/or after the onset of the urticaria.
      Participants will meet individually with a University of Mississippi Medical Center
      psychiatry resident for one hour once a week for six consecutive weeks to be educated on
      psychological stress intervention techniques. There is no control group for this pilot study.
      All participants will complete a packet of psychological and dermatological questionnaires
      before the first session with the psychiatry resident and one week after the final session.
      All participants will record daily 1) their urticaria symptoms and 2) the type and number of
      medications taken for his/her chronic hives. If psychological stress intervention proves to
      be effective, then this therapeutic modality would benefit patients with chronic urticaria,
      while avoiding addition and/or continuation of medications that may have significant adverse
      side effects.
    

Intervention name(s): Stress intervention
Intervention type(s): Behavioral
Intervention description(s): To evaluate psychological stress, participants will complete the Perceived Stress Scale, Beck Depression Inventory-Fast Screen, Anxiety Sensitivity Index-III, Posttraumatic Stress Diagnostic Scale and the Depression Anxiety Stress Scales; to evaluate cognitive and behavioral aspects of emotional avoidance, participants will complete the Emotional Avoidance Questionnaire as well as the Acceptance and Action Questionnaire, Difficulties in Emotion Regulation Scale, Illness Attitudes Scale and the Five Facet Mindfulness Questionnaire; and to evaluate quality of life in regards to his/her skin condition, participants will complete the Dermatology Life Quality Index questionnaire.
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Urticaria; Hives; Stress
Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate antiretroviral activity of up to five different oral
      doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced
      patients, who have documented genotypic resistance to at least one major mutation from the
      IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be
      monitored for side effects, and the pharmacokinetics of bevirimat will be determined.
    

Detailed description: 
      Bevirimat (PA103001-04) represents a new class of antivirals that blocks HIV replication by
      disrupting virus maturation; specifically, by inhibiting a late step in the Gag processing
      cascade. Short term (7-10 days) functional monotherapy studies (conducted in patients with
      detectable viral loads on a failing regimen)help in determining the potency of the drug, and
      enable dose finding. This is a two part (A and B)randomized, placebo-controlled,
      double-blind, multiple-dose, dose-escalation study in HIV treatment-experienced patients on a
      failing regimen (harboring resistance mutations to at least one member of the NRTI, NNRTI or
      PI classes. The antiretroviral activity, safety, and pharmacokinetics of up to 5 different
      dose levels of bevirimat will be compared to placebo when added to a failing approved
      antiretroviral regimen. The study is conducted in two parts: A and B. In Part A following 14
      days of daily dosing patients commenced a new optimized ART regimen in addition to their
      randomized treatment. In Part Part B dosing with the randomized treatment ends after the
      initial 14 days of daily dosing.
    

Intervention name(s): matching placebo; Bevirimat
Intervention type(s): Drug; Drug
Other intervention name(s): PA103001-04; PA-457N
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV; treatment experienced; AIDS
Effects of Fish Oil on the Colon Mucosa
Condition: Physiological Effects of Fish Oil
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see what effects the dietary supplement called Omega-3 or
      "Fish Oil" and it has on your colon, if any. Omega-3 (Fish Oil) is available in many forms
      (pills, capsules, liquid) in grocery stores, health food/vitamin stores and drug stores and
      from eating fish. We would like to learn if different amounts of Fish Oil specifically chosen
      for you individually change your colon tissue (large intestine). We hope that Fish Oil may be
      useful in the future as something that may help to prevent colon cancer, but we don't have
      any research in humans that shows that yet. We have to do this study first to see if Fish Oil
      effects the colon. One type of Fish Oil is has been approved by the U.S. Food and Drug
      Administration (FDA) to reduce the risk of heart disease. We are going to test a different
      Fish Oil supplement made by a company called Nordic Naturals.

      The colon lining or "mucosa" comes in contact with all the undigested things we eat or drink
      as it passes out to waste (stool). Animal studies suggest that fish oil may help the colon
      lining by reducing colon polyps and therefore colon cancer. We think this happens through
      chemical changes in the colon lining and also in the blood. The chemicals that we are looking
      at are called "fatty acids". We want to see if taking different amounts fish oil chosen for
      you changes these chemicals (fatty acids) in your colon or your blood. We will assign you a
      personal "low dose" of fish oil to take for 2 weeks, followed by a "high dose, or maximum"
      dose for 2 weeks. We will calculate your basal Metabolic Rate (BMR) from your height, weight,
      age and assess your activity factor. We have a table that then tells us your target low and
      high dose. Then, based on your blood samples, we figure out which target dose is the one for
      you that will change these chemicals (fatty acids) by about ½ (50%). We will check how well
      this process worked by collecting small pieces of colon tissue (biopsies) of the colon before
      any fish oil and after all the fish oil is consumed. We will also use blood samples to test
      for these fatty acids and a few others. We are going to collect diet information at several
      times throughout the study so we can see if the food you eat makes a difference too.

      We hope to learn a lot about how fatty acids are metabolized (broken down or used) in the
      colon directly in combination with Omega-3 supplements.
    


Intervention name(s): Fish OIl
Intervention type(s): Dietary Supplement
Other intervention name(s): Omega-3 Fatty Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fish Oil; colon health; fatty acid metabolism
A Study of Clofarabine in Japanese Patients With Acute Myeloid Leukemia (AML)
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the
      safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered
      to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia
      (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.
    

Detailed description: 
      This is a Phase I, open-label, multi-center study of Clofarabine administered to Japanese
      patients with Acute Myeloid Leukemia (AML) who are relapsed/refractory or elderly untreated
      AML for whom standard induction chemotherapy is unlikely to be of benefit.

      Cohort 1 will receive 20 mg/m2/day of Clofarabine once daily for five consecutive days,
      Cohort 2 will receive 30 mg/m2/day, and Cohort 3 will receive 40 mg/m2/day. Patients will
      receive one cycle as a rule. However, if there is evidence of some hematologic response after
      one cycle of treatment with Clofarabine, patients may receive up to a maximum of three
      cycles. If patients fail to achieve CR or CRp after two cycles of treatment with Clofarabine,
      further dosing for such patients should be stopped.

      Three patients constituting a cohort will receive Clofarabine and will then be assessed for
      dose limiting toxicities (DLT) at Cycle 1. If none of these three patients develops DLT, the
      next cohort will be introduced. If one of them develops DLT, three new patients will be added
      to the cohort, so that six patients in total are included in the tolerability assessment. In
      this case, treatment of the next cohort is allowed only in the case the number of patients
      who develop DLT is still one in this six-patient cohort. If two of the six patients develop
      DLT, however, the tolerability is ruled out. However, if two DLTs are observed at the
      20mg/m2/day dose cohort, new patients will be enrolled at cohort -1 15mg/m2/day; and if no
      more than one of six patients in the cohort develop DLT, it will be considered as the last
      cohort for this study.
    

Intervention name(s): clofarabine
Intervention type(s): Drug
Intervention description(s): Intravenous, 20 mg/m2, 30 mg/m2, 40 mg/m2
Other intervention name(s): Evoltra, Clolar, JC0707
Intervention MeSH terms: Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examination of B Cell Responses in Human Blood
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.
    

Detailed description: 
      Groups of patients with different immune competencies will be examined. The impact of HIV
      infection on immune response will be assessed.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV patients and controls attending specialised clinics, Germany
      
Biospecimen description: 
      peripheral blood
    
Keywords: HIV; B-lymphocyte
Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade
Condition: Retinal Detachment
MeSH terms: Retinal Detachment
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil
      on retinal saturation with Oxymap.
    

Detailed description: 
      Silicone oil is the first choice treatment for long-term vitreous replacement in complicated
      cases of retinal detachment. However, it will cause various problems for permanent tamponade,
      such as keratopathy, glaucoma, cataracts, and silicone oil emulsification3. In addition,
      silicone oil has the potential to cause retinal toxicity. Moreover, the gravity and
      mechanical pressure of the silicone oil on the retina may influence retinal blood flow and,
      and the presence of silicone oil in the vitreous cavity may block the oxygen exchange between
      the retinal surface and the vitreous humor, resulting in the metabolic disturbance of the
      retina. In this study, the investigators utilized a noninvasive measurement (Oxymap,
      Reykjavik, Iceland) to evaluate the effect of silicone oil tamponade on oxygen saturation and
      diameter in retinal vessels in complicated retinal detachment cases.
    

Intervention name(s): Silicone oil removal
Intervention type(s): Procedure
Intervention description(s): The patients in each group will receive the same procedure of silicone oil removal.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: silicone oil; retinal saturation; retinal blood flow; retinal detachment