bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Condition: Female Sexual Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Additional testosterone undecanoate can improve female sexual function in postmenopausal
      women which one aspects of quality of life. The dose adjustment can reduce incidence of
      adverse effects and low cost of treatment with effective outcome.
    

Detailed description: 
      Research Question:

      " Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type
      Research:Clinical research

      Study design:

      Randomized double-blinded placebo controlled trial
    

Intervention name(s): Testosterone undecanoate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): testosterone undecanoate 40 mg orally twice a week; placebo orally twice a week with progynova 1 mg oral daily
Other intervention name(s): Andriol
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: female sexual function; postmenopause; testosterone
High Fat Diet: Oxidative and Cardiovascular Effects
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the effects of a modified Atkins high fat diet on endothelial function, insulin
      resistance and energy balance.
    

Detailed description: 
      To test the effects of a modified Atkins high fat diet on endothelial function, insulin
      resistance and energy balance.
    

Intervention name(s): Placebo; MUFA; PUFA; SFA
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo; MUFA; PUFA; SFA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Preoperative Octreotide Treatment of Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether 6 months preoperative treatment with the
      somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.
    

Detailed description: 
      After a baseline evaluation, patients are randomized separately for each study center in
      blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with
      octreotide.

      To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide
      is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three
      times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR
      (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months.
      Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are
      delayed, an extra octreotide LAR injection is given before surgery.
    

Intervention name(s): Octreotide; Direct surgery for acromegaly
Intervention type(s): Drug; Procedure
Intervention description(s): First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months; Direct transsphenoidal surgery
Other intervention name(s): Sandostatin; Sandostatin LAR
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly
A Pilot Exercise Study for PTSD in Women Veterans
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity
      exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans.

      Specific aims of the study are to;

        1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity
           exercise

        2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome
           data will include posttraumatic and depressive symptoms.

        3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on
           comorbid pain syndrome and quality of life.
    


Intervention name(s): Aerobic Exercise
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of brisk walking
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; PTSD; Aerobic Exercise; Women; Veteran
Bone Metastasis and Surgery in Breast Cancer
Condition: Breast Cancer; Surgery
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Observational [Patient Registry]

Summary: 
      A registry trial evaluating resection of the primary breast tumor in women presenting with de
      novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected
      patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may
      result in improved survival, but this remains unproven. The early results of our ongoing
      trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with
      distant metastases at presentation who receive loco-regional treatment for intact primary
      tumor compared with those who do not receive such treatment) showed that patients with bone
      metastasis only have a trend toward improved survival with initial surgery.
    

Detailed description: 
      This registry trial evaluating resection of the primary breast tumor in women presenting with
      de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully
      selected patients presenting with stage IV breast cancer suggest that surgery on the primary
      tumor may result in improved survival, but this remains unproven. The early results of our
      ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women
      with distant metastases at presentation who receive loco-regional treatment for intact
      primary tumor compared with those who do not receive such treatment) showed that patients
      with bone metastasis only have a trend toward improved survival with initial surgery. Our
      goal is to test if primary surgery improves overall survival in bone only metastasis.
    

Intervention name(s): Surgery; Systemic therapy
Intervention type(s): Procedure; Drug
Intervention description(s): Surgery to primary tumor; Systemic therapy based on tumor phenotype
Other intervention name(s): mastectomy, lumpectomy; Chemotherapy, hormone therapy, biphosphanetes
Intervention MeSH terms: Hormones
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All female patients diagnosed with de novo stage IV breast cancer
      
Keywords: Metastatic breast carcer; Bone metastasis; surgery
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to
      placebo. Investigational product will be administered as intravenous infusion in double-blind
      period, and as a subcutaneous injection in open-label period
    

Detailed description: 
      This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled,
      treatment period followed by a 100-week, open label, treatment period to evaluate short-term
      efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to
      severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the
      investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially
      receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the
      12-week, double-blind, placebo-controlled, treatment period. At the completion of the
      double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option
      to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070
      (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28
      weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after
      their last dose of IP for safety.
    

Intervention name(s): MEDI2070; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 iv infusion on Week 0 and Week 4; 1 iv infusion on Week 0 and Week 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI2070; inflammatory bowel disease; moderate to severe Crohn's disease
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV
      immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.

      Passive antibody therapy has been used with limited success in treating advanced HIV disease
      in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic
      donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced
      HIV-positive children.
    

Detailed description: 
      Passive antibody therapy has been used with limited success in treating advanced HIV disease
      in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic
      donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced
      HIV-positive children.

      Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose
      levels, then are followed for 3 months after the final infusion.
    

Intervention name(s): Anti-HIV Immune Serum Globulin (Human)
Intervention type(s): Drug
Intervention MeSH terms: Immune Sera
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Immunoglobulins, Intravenous; Immunization, Passive
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
Condition: Vitamin B12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      This study was designed to determine whether elderly residents of long term care facilitated
      who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to
      have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal
      spray improved these subjects' vitamin B12 status.
    

Detailed description: 
      Subjects had serum creatinine <1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious
      anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and
      methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with
      those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray
      for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with
      baseline concentrations.
    

Intervention name(s): blood collection; treatment (cyanocobalamin nasal spray)
Intervention type(s): Other; Drug
Intervention description(s): blood collection; cyanocobalamin nasal spray -- 500 mcg q week for eight weeks
Other intervention name(s): baseline
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin B12 deficiency; cyanocobalamin deficiency; proton pump inhibitors; omeprazole
Vegans Health Status and Exposure to Pesticides and Nitrate
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      This research concerns nutritional and toxicological health risk evaluation among long-term
      vegans. Research focus is in cumulative exposure to pesticides.
    

Detailed description: 
      The main objective of the study was nutritional and toxicological health risk evaluation
      among long-term vegans with emphasis on cumulative exposure to pesticides. Main research
      methods include: measurement of food intake by using three days food record, measurement of
      nutritional and toxicological bio-markers on blood, serum and plasma. Nutritional biomarkers
      include following plasma/ serum measurements: concentrations of vitamins (vitamin E, D2, D3,
      B12 and beta-carotene), iron, iodine, selenium, fatty acids and polyphenols. Toxicological
      measurements include nitrate, pesticides and DNA-adducts.

      We recruited the participants (n = 41) through an advertisement published in the Finnish
      Vegan Association's monthly newspaper and via an online discussion forum. The selection
      criteria were as follows: the participants had to (1) have followed a vegan diet for at least
      a year, (2) be between 18 and 50 years of age, (3) be apparently healthy, and (4) be nonusers
      of regular medications (except oral contraceptives or hormone replacement therapy). Further,
      we matched the non-vegetarian participants by age and sex. The study was approved by the
      Ethical Committee of Kuopio University Hospital (69//2011)

      We assessed the consumption of foods at baseline with a three-day food record using household
      measures. The participants received the instructions on how to complete this record, and a
      dietician checked the completed food records. The participants also filled out a health
      questionnaire inquiring into their long-term healthy eating habits, including vitamin
      supplementation.

      We collected fasting peripheral venous blood samples, plasma and serum, and stored them at
      -70 °C before the analysis. Further, urine samples 24 hours were collected prior to
      phlebotomy and divided into aliquots. For one of the subjects, only a spot urine sample was
      available. We carried out the hematological and chemical analyses at laboratory
      (hematological data), Helsinki University Central Hospital (folate, vitamin B12, vitamin D,
      and homocysteine), and the National Institute for Health and Welfare (alfa-tocopherol,
      beta-carotene, selenium, iodine, fatty acid profile, and polyphenols). Nitrate, nitrite were
      measured by capillary electrophoresis and DNA adducts by ELISA at Finnish Food Safety
      Authority.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Vegans and non-vegans
      
Keywords: nutritional status; pesticides; nitrate
Minimum Current for Train-of-four Monitoring
Condition: Anesthesia; Anesthesia Recovery Period; Neuromuscular Blockade
Study type: Interventional

Summary: 
      Neuromuscular monitoring during general anesthesia is important to make sure adequate muscle
      relaxation during operation and adequate recovery of muscle power and spontaneous breathing
      during emergence from general anesthesia. The neuromuscular monitoring is usually using
      electrical stimulants and the method called train-of-four (TOF) is representative. Because it
      uses electrical stimulants, the patients could be uncomfortable and feel pain during the
      monitoring when the patients are conscious. Lowering the current of the stimulants would be
      helpful in reducing the pain, but there is a concern that the TOF results performed in lower
      current would be underestimated or inaccurate. Therefore, the investigators want to find the
      minimal current for TOF monitoring that shows adequate TOF results.
    


Intervention name(s): Train-of-four (TOF)
Intervention type(s): Device
Intervention description(s): Give 4 electrical stimulants on the ulnar nerve to see if the 4 responses (T1 ~ T4) of adductor pollicis fade or not. If there's no neuromuscular block, it shows no fade, or it fades. When an operation is over under general anesthesia, we use the ratio of the height of T4 to T1, and the ratio is over 90%, the neuromuscular block is recovered enough to extubation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the safety and efficacy in subjects with moderate to severe
      psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA),
      Dermatology Life Quality Index (DLQI) and other assessments.
    


Intervention name(s): VB-201 80mg; VB-201 160mg; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Body Weight
Study type: Interventional
Phase: Phase 1

Summary: 
      The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery
      disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose
      in higher body weight (HBW) patients.
    


Intervention name(s): prasugrel; clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally, daily for 12 days; Administered orally, daily for 12 days
Other intervention name(s): Efient; Effient; LY640315; CS747
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet function
"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."
Condition: PITS AND FISSURE SEALANT
Study type: Interventional
Phase: Phase 3

Summary: 
      Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant,
      Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first
      permanent molar in children at 9 months follow ups.

      Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and
      study was Split mouth randomized controlled clinical trial.

      Sample size- Total number of 42 patients will be recruited in the study, with 42 first
      permanent molars in each group.

      Methods-Patients were seated in supine position on the dental chair and cotton rolls will be
      applied for isolation. The first permanent molar in each group was treated as follows:

      Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled
      resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 -
      ¬Intervention with Unfilled resin sealant. Patients and their parents were received
      instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was
      evaluated at 3, 6 and 9 month recall visit.

      OUTCOME MEASURES:

        1. Primary outcomes: To evaluate sealant retention, anticaries effect and marginal
           integration.

        2. Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
    


Intervention name(s): Sealant, Fissure
Intervention type(s): Drug
Intervention description(s): FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Resistance exercise is effective in improving glycemic control in diabetes patients. The
      effectiveness of a home-based resistance exercise program has not been establish.
    

Detailed description: 
      Exercise play an important role in diabetes control. The American Diabetes Association (ADA)
      approved of resistive exercise as an effective method in controlling blood sugar of type 2
      diabetes patients. Few community-based intervention has been establish. So the authors
      developed the low-cost community based resistance exercise program to promote exercise in of
      type 2 diabetes patients.
    

Intervention name(s): Resistance Exercise Training Program With Rubber Bands
Intervention type(s): Behavioral
Intervention description(s): Resistive exercise consist of 5-min warm up, at least 30 min resistive exercise using rubber band as recommendation (8-12 times per set, at least 3 sets per day and at least 3 days per week) and 5-min cool down
Other intervention name(s): elastic band
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: resistive exercise; Resistance Exercise Training Program; Rubber Bands; Glycemic Control; Type 2 Diabetes Mellitus
Preliminary Evaluation of Safety and Efficacy by [14C] AC0010 Trail and Subsequent AC0010 Treatment
Condition: Carcinoma，Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced
      NSCLC who participant in [14C] AC0010 ADME.
    

Detailed description: 
      The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced
      NSCLC who participant in [14C] AC0010 ADME (absorption, distribution, metabolism and
      excretion) trial and subsequent receiving AC0010 treatment.
    

Intervention name(s): AC0010
Intervention type(s): Drug
Intervention description(s): Oral dose of 300mg bid,the two doses are advised to be administered at an interval of 12 hours
Other intervention name(s): AC0010MA
Intervention MeSH terms: Abivertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment