bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and gather additional safety
      information for Prochymal® in participants who have failed to respond to steroid treatment of
      Grades B-D acute GVHD.
    

Detailed description: 
      Approximately 6300 patients receive allogeneic hematopoietic stem cell transplants in the
      United States each year (International Bone Marrow Transplant Registry [IBMTR], 2003). Nearly
      50% (approximately 3,150) of these patients develop acute GVHD (Goker et al). A fraction of
      these patients (approximately 870) will progress to the severe stages of the disease, Grades
      III-IV. It is estimated that nearly 82% of those patients with severe acute GVHD will be
      steroid refractory (Przepiorka et al., 1995) and of these, only 50% of steroid-refractory
      patients will respond to secondary and tertiary treatments (Greinix et al., 2000). Thus,
      roughly 350 patients each year face tremendous odds against survival. In addition, most
      patients who initially responded to secondary and tertiary treatments have a high risk of
      dying within the first year (Remberger et al., 2001; Anasetti et al., 1994). Development of
      new therapeutic agents and strategies to rescue patients with steroid refractory, acute GVHD
      would provide a significant benefit in an area of unmet medical need. Participants will
      receive standard of care in addition to adult mesenchymal stem cells or placebo.
    

Intervention name(s): Prochymal®; Placebo; Standard of Care for GVHD
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 2 infusions of 2 million cells/kg per week for 4 weeks; 2 infusions per week for 4 weeks; Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy)
Other intervention name(s): Mesenchymal Stem Cells; excipients without adult human mesenchymal stem cells
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute GVHD; Steroid refractory GVHD; Severe steroid refractory acute GVHD; Steroid refractory; Steroid Refractory Acute Graft Versus Host Disease
Food Reward in Native American Women
Condition: Obesity
Study type: Observational

Summary: 
      This study aims to characterize the neurobiology of obesity in American Indians (AI) using
      functional MRIs to examine the correlation between brain response to food stimuli in AI
      women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI
      women look at images of fattening food, non-fattening food and non-food objects. Additionally
      examined is the effect of the drug naltrexone to suppress brain response to visual food cues
      and calorie intake in the women.
    

Detailed description: 
      The study looks at both obese and lean women. Each woman comes in for two visits. Each woman
      takes both the Naltrexone or placebo (one during each visit). Research staff and participants
      are blinded. Drugs are not used as treatment, but rather to provide information for possible
      future treatments.

      Hypotheses are:

        1. Compared with their lean counterparts, obese women will demonstrate more fMRI activation
           in the brain in response to visual food cues.

        2. Naltrexone will reduce the activation in reward-relevant brain sites in response to
           viewing photographs of fattening food as compared in placebo in both groups.

        3. Naltrexone will suppress spontaneous intake of food in obese and lean AI women.
    

Intervention name(s): Placebo and fMRI; Naltrexone and fMRI
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Pill form, participant dosed one time an hour before fMRI.; 50 mg pill given one time, one hour before fMRI
Intervention MeSH terms: Naltrexone
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Self-identified Native American women between ages of 18 and 45.
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Nephrosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the recommended dose of the sustained-release form
      of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular
      disease/nephrosclerosis).
    


Intervention name(s): Beraprost; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Beraprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Renal Failure; Prostaglandin; Prostacyclin; Glomerular Disease; Nephrosclerosis
Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block
Condition: Fracture of Ankle
MeSH terms: Ankle Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients scheduled to have foot and ankle surgery will typically receive a single shot
      sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal
      post-operative analgesic plan. The investigators are investigating the use of perineural
      dexamethasone together with local anesthetics can improve the quality of recovery for
      patients receiving sciatic nerve blocks for foot and ankle surgery.
    

Detailed description: 
      Patients scheduled to have foot and ankle surgery will typically receive a single shot
      sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal
      post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant
      for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be
      determined. More importantly, it is not known whether the beneficial effect of perineural
      dexamethasone on analgesia duration leads to a better quality of surgical recovery. We
      hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery
      than intravenous dexamethasone or saline control.
    

Intervention name(s): Dexamethasone; Dexamethasone; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV dexamethsone 8mg in 50mL (diluted in NS); 8mg/2mL; 2mL
Other intervention name(s): DECADRON; DECADRON; Sodium chloride
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Nerve Block; Anesthesia Recovery Period
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the single-dose pharmacokinetics of
      tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal
      hepatic function and in participants with severe hepatic impairment.
    


Intervention name(s): TAF
Intervention type(s): Drug
Intervention description(s): 25 mg tablet administered orally
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe Hepatic Impairment
National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and
      combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized
      controlled trial in women over 70 years with human epidermal growth factor receptor type-2
      (HER2) positive primary breast cancer.
    

Detailed description: 
      This study is a randomized, comparative trial of postoperative adjuvant therapies in women
      with HER2 (human epidermal growth factor receptor type-2)-positive primary breast cancer who
      are ≥70 years of age that will compare trastuzumab (Herceptin®) monotherapy (H group) and
      trastuzumab in combination with chemotherapy (H+CT group).

      The objectives of this study are as follows.

        1. To verify the clinical positioning of trastuzumab monotherapy and combined trastuzumab
           and chemotherapy as postoperative adjuvant therapies for the treatment of HER2-positive
           primary breast cancer patients who are ≥70 years of age.

        2. To evaluate the safety of trastuzumab monotherapy and combined trastuzumab and
           chemotherapy in patients who are ≥70 years of age. In particular, to evaluate cardiac
           disorders that are a characteristic adverse drug reaction of trastuzumab as well as
           geriatric-related concerns including lipid metabolism, cerebral infarction and cognitive
           disorders.

        3. To evaluate overall survival in patients who are ≥70 years of age using trastuzumab
           monotherapy or combined trastuzumab and chemotherapy.

        4. To evaluate health-related quality of life (HRQOL), cost-effectiveness (utility), and
           conduct a comprehensive geriatric assessment (CGA) in patients who are ≥70 years of age
           and using trastuzumab monotherapy or combined trastuzumab and chemotherapy.

        5. To establish and expand information networks by the participation of practitioners in
           clinical trials that are involved in general clinical practice and breast cancer.
    

Intervention name(s): trastuzumab monotherapy; trastuzumab and chemotherapy
Intervention type(s): Drug; Drug
Other intervention name(s): Herceptin; PTX; DTX; TC; AC; EC; FEC; CMF; TCb (CBDCA)
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optical Elastography of Systemic Sclerosis Skin
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Observational

Summary: 
      The goal of this study is to develop a new way to assess skin thickness in patients with
      scleroderma (systemic sclerosis). The study will test how well a new imaging method called
      optical coherence elastography (OCE) compares to the current clinical method used to estimate
      skin thickness, the modified Rodnan Skin Score (mRSS).
    


Intervention name(s): Optical Elastography; Visual Assessment
Intervention type(s): Device; Other
Intervention description(s): To image skin thickness, Optical Coherence Elastography (OCE)-scanning of 6 body surface areas will be preformed using the Phase-Stabilized Swept Source Optical Coherence Elastography (PhS-SSOCE) system.; Skin thickness will be visually assessed clinically in 6 body surface areas using the the modified Rodnan Skin Score (mRSS). The mRSS uses a 0-3 scale, where 0 = normal, 1= mild thickness, 2 = moderate thickness, and 3 = severe thickness
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen in clinic.
      
Biospecimen description: 
      skin punch biopsy
Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      the purpose of this study is:

        -  To assess the effect of BIA 5 1058 400 mg on the PK of bosentan.

        -  To assess the effect of bosentan on the PK of BIA 5 1058
    

Detailed description: 
      This study was an open label, three period, fixed sequence study in healthy male and female
      subjects performed at a single study center.

      The study comprised:

        -  Screening during Days -28 to -2 (both inclusive).

        -  Three treatment periods separated by a washout period of at least 10 days.

      Duration of Treatment:

      The duration of participation for each subject was approximately 2 months and 3 weeks
      (including the screening period).
    

Intervention name(s): BIA 5-1058; bosentan
Intervention type(s): Drug; Drug
Intervention description(s): Oral BIA 5-1058 (Zamicastat) 100 mg tablets; Oral Tracleer (bosentan) 125 mg film coated tablets
Other intervention name(s): Zamicastat; Tracleer
Intervention MeSH terms: Bosentan; Zamicastat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
Condition: Anemia; Fatigue; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Anemia; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve
      cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the
      effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or
      without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.

      PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see
      how well they work compared to epoetin alfa alone in treating anemia-related fatigue in
      patients with prostate cancer that is refractory to treatment with hormone therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effect of epoetin alfa with or without dexamethasone on the level of
           cancer-related fatigue measured by the FACIT fatigue subscale, in patients with
           hormone-refractory prostate cancer.

        -  Compare the effect of these regimens on increasing hemoglobin levels in these patients.

        -  Compare the effect of these regimens on palliation of other disease-related symptoms and
           on functional status and overall quality of life of these patients.

        -  Compare the survival rate of these regimens in these patients.

        -  Compare the toxicity profile of these regimens in these patients.

        -  Determine the incidence of adrenal suppression in these patients after receiving
           dexamethasone therapy.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual
      fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin
      level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive epoetin alfa subcutaneously once a week.

        -  Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day.

      In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

      Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks.

      Patients are followed for 3 years.

      PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this
      study within approximately 3 years.
    

Intervention name(s): epoetin alfa; dexamethasone
Intervention type(s): Biological; Drug
Intervention MeSH terms: Dexamethasone; Epoetin Alfa
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: recurrent prostate cancer; anemia; fatigue
Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to determine whether a noninvasive method of measuring certain
      aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and
      reliable method to detect changes in pregnant patients. Specifically,the investigators are
      interested in patients diagnosed with high blood pressure during their pregnancy, as compared
      with normal pregnant patients. A noninvasive, accurate method of taking these measurements in
      pregnant patients is not currently available.
    

Detailed description: 
      During pregnancy, many aspects of blood circulation, such as blood pressure, heart rate,
      cardiac output, and stroke volume, adapt to accommodate the increasing needs of a pregnant
      body. The circulatory system works harder to provide blood flow to the placenta and the
      growing fetus.

      Currently, the devices that can give physicians detailed information on the status of the
      blood circulation of normal patients and those with high blood pressure during pregnancy are
      invasive to varying degrees. However, recently, a new noninvasive hemodynamic monitor
      (NonInvasive Cardiac Output Monitoring: NICOM) was introduced to the market. In studies with
      non-pregnant patients, the NICOM has been found to be accurate, precise and reliable.
      However, it has yet to be studied in the field of Obstetrics.

      The purpose of this study is to find out if the NICOM is an effective tool for monitoring
      hemodynamic changes in pregnant women, both with normal and high blood pressure. We are
      planning to compare the hemodynamic profiles of normal pregnant patients, hypertensive
      pregnant patients, and non pregnant patients as a control group. If this monitor proves to be
      reliable in assessing these changes in the pregnant patients, this could have a great impact
      in optimizing the care of the patients with different medical conditions in pregnancy, such
      as increased blood pressure.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Our study population includes healthy non-pregnant and pregnant patients in their 3rd
        trimester, as well as pregnant patients in their 3rd trimester with pregnancy-induced
        hypertension (PIH). Both normal groups will be recruited from the outpatient day-unit
        (healthy volunteers). Patients with PIH may be sent to labour and delivery for monitoring
        by their obstetricians.
      
Keywords: PIH; pregnancy induced hypertension; pregnancy; bioimpedance; noninvasive monitoring; Cardiac Output; Blood Pressure
Acute Effects of Exercise in Women With Fibromyalgia (FM)
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have
      shown that exercise improves body functions and/or symptom severity in most patients, but not
      in all. About a third of patients with FM have been shown to have low levels of IGF-1. The
      purpose of this project is to study individual and biological factors that interact with
      outcomes of short-term (acute) exercise in FM.

      Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy
      age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer
      bicycle exercise tests will be conducted in feasting patients, separated by one month. The
      first exercise test is at a low and the second at a high intensity. Measurements comprise
      blood test, pain rating and pain threshold, conducted before and after the test. The levels
      of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health
      status and pain.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants are recruited from previous studies.
      
Biospecimen description: 
      Blood serum
    
Keywords: Fibromyalgia; Pain; Women; Exercise; IGF1
I-gel Versus Air-Q LMA for Pediatric Patients
Condition: Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA
Study type: Interventional

Summary: 
      This study targets to compare insertion facility, effect on hemodynamic parameters and
      effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing
      short-duration surgical procedures.
    

Detailed description: 
      The patient were divided into 2 groups. I gel group and Air Q group according to LMA type
      used to maintain airway ventilation.

      The patients were compared according to insertion facility, effect on hemodynamic parameters
      and effective ventilation.
    

Intervention name(s): LMA i gel
Intervention type(s): Other
Intervention description(s): insertion of LMA for maintaining airway during anesthesia
Other intervention name(s): LMA Air Q
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Physical Exercise and Diet Management in Vitamin D Deficient Females
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study was to determine if home based physical exercises protocol and Diet
      management has an effect on functional performance and depression level related to vitamin D
      deficiency in females.
    

Detailed description: 
      This is a randomized controlled trial to study the effect of home based physical exercises in
      comparison to Diet management, sun exposure and vitamin D supplements on functional
      performance and depression level in females with vitamin D deficiency.
    

Intervention name(s): Home Based Physical Exercise; Vitamin D3 Supplements; Diet Management; Sun Exposure
Intervention type(s): Other; Dietary Supplement; Other; Behavioral
Intervention description(s): Home Exercise protocol consists of one hour divided to 3 minutes warm up",9 minutes' full body (lower limbs, abdomen, back and upper limbs) exercise composed of (aerobic and strengthening) and 3 minutes cool down 4 times per day and 15 minutes for each session 6 days with one day recovery and, with every day follow up with each patient to ensure they did the whole sets and instructed them the ways to each exercise, The total duration was 36 sessions (6 weeks) for each patient. Daily communication with all subjects through sending mobile messages 3 times every day. The message was to remind the participants and confirmation of their response.; Vitamin D3 supplement (400mg) once daily.; Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.; Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment