bioihbjkbjnl/mcl2 huggingface dataset:
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty
Condition: Norepinephrine, Glypressin, Tourniquet Deflation; Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Pneumatic tourniquet is usually used in orthopedic surgeries, as it helps to decrease
      operative bed bleeding, and thus, maintaining a clean and dry surgical field allowing easy
      and clear identification of the anatomical structures. Despite that advantage, after its
      deflation, there is a blood volume shift towards that ischemic area, which may decrease
      cardiac preload leading to hypotension
    

Detailed description: 
      Hemodynamic changes after tourniquet deflation include; hypotension, tachycardia and increase
      in cardiac index. These changes may be insignificant for healthy individuals but, risky for
      patients with compromised cardiovascular system and geriatric population.

      Hypovolemia is a common problem in many clinical situations. The mortality of hypovolemic
      shock is directly related to the severity and duration of organ hypoperfusion.

      Management of hypotension include frequent monitoring of blood pressure, fluid therapy,
      non-pharmacological methods, and vasopressors. Fluid therapy by crystalloids or colloids has
      been the traditional approach to restore volume and can be given as preload or co-load .Non
      pharmacological methods include positioning and leg compression. Trendelenburg position can
      increase venous return to the heart. Leg compression by flexion of the hip, elastic bandages,
      or stockings. An efficient method to treat spinal hypotension is administration of
      vasopressors, either given by infusion or boluses. Vasopressor drugs act by reversing the
      circulatory effect of sympathetic blockade. They also restore vascular tone and preserve
      venous return and cardiac filling
    

Intervention name(s): Saline; Norepinephrine; glypressin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patient received normal saline 4ml/kg/hr with deflation of tourniquet; patient received noradrenaline infusion at rate 0.1 mcg/kg/min. with deflation of tourniquet; patient receive glypressin infusion at rate 2 mcg/kg/hr.
Other intervention name(s): control; noradrenaline; vasopressin
Intervention MeSH terms: Terlipressin; Vasopressins; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Optimal Exercise Regimens for Persons at Increased Risk
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess exercise training adherence and compliance over two years in subjects who were at
      relatively high risk for coronary artery disease. Also, to test strategies for improving
      adherence and compliance and to assess the effect of exercise training.
    

Detailed description: 
      BACKGROUND:

      Regular physical exercise is associated with lower coronary heart disease mortality,
      favorably affects coronary risk factors, and increases cardiovascular functional capacity.
      Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of
      men and 10 percent of women over age 45 do so. This is largely because effective strategies
      for increasing the exercise habit in a broadly-based segment of Americans have not been
      developed. This study applied physiological and behavioral knowledge derived in numerous
      laboratories over the past 10-15 years to a clinical setting.

      DESIGN NARRATIVE:

      Following stratification by gender and cigarette smoking status, subjects were randomized to
      one of four groups: home exercise of moderate intensity which was individually monitored;
      home exercise of high intensity which was individually monitored; exercise of high intensity
      which was group supervised; and a no program control group. The intervention program was
      conducted for one year followed by a one-year maintenance program. Main outcome measures
      included treadmill exercise test performance, exercise participation rates, and heart disease
      risk factors. Variables measured over two years included plasma lipids, lipoproteins,
      apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to
      psychological stress, cigarette smoking, nutrient intake, psychological status, and
      cardiovascular functional capacity.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Prevention
Influence of Paternal Age on Assisted Reproduction Outcome
Condition: We Will Retrospectively Assess Our Databases in Our Clinic; Instituto Valenciano de Infertilidad in Valencia (Spain); Searching for Assisted Reproduction Procedures; IUI Standard IVF/ICSI Cycles and Ovum Donation IVF/ICSI Cycles; Who Were Referred to Our Unit to Cryopreserve Sperm During the Period; From January 2000 to December 2006
Study type: Observational

Summary: 
      In the recent years, there is an increasing tendency to the parenthood delay in developed
      countries, and there is not enough information available regarding the influence of the
      male's age on fertility. If any, the negative impact should be acting at advanced ages.

      Our aim with this work was to determine the role of paternal age on IUI results embryo
      quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality
      oocytes (from fertile oocyte donors) and only first IVF cycles in young women were
      considered.
    

Detailed description: 
      A retrospective study has been designed with a total number of 2204 IUI, 1286 IVF cycles and
      1412 IVF cycles with donated oocytes from 2000 to 2006.

      The inclusion criteria will be for IUI: women under 38 years old, tubal patency demonstrated
      by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index
      < 27 kg/m2, and absence of polycystic ovarian syndrome and endometriosis. For normal IVF
      cycles and oocyte donation cycles only first cycles will be analyzed. Cycles will be studied
      only in couples with absence of severe male factor.
    

Time perspective: Retrospective
Keywords: male age, assisted reproduction, sperm, pregnancy outcome
the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, double-blind, placebo-controlled, dose-escalation study to
      evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose
      administration.
    

Detailed description: 
      KX-826 topical solution will be applied to the scalp of healthy male subjects with
      androgenetic alopecia.

      A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug
      and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each
      dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to
      receive placebo for a total of 4 dose cohorts).

      Cohort Dose of KX-826 Subjects

        1. 2.5 mg QD for 14 days 10 (8 active + 2 placebo)

        2. 5 mg QD for 14 days 10 (8 active + 2 placebo)

        3. 10 mg QD for 14 days 10 (8 active + 2 placebo)

        4. 20 mg QD for 14 days 10 (8 active + 2 placebo)

      Dose escalation will not occur until review of the multiple dose safety from the previous
      dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs
      (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory
      findings, 12-lead ECGs, skin irritation assessments and physical examination findings.
    

Intervention name(s): KX0826; Placebo
Intervention type(s): Drug; Other
Intervention description(s): investigational AR antagonist; Placebo of KX-826
Other intervention name(s): Pyrilutamide; KX-826
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, placebo-controlled, double-blind, dose-increasing study was
      designed to evaluate the safety, tolerability, and pharmacokinetics of multiple successive
      dosing in healthy Chinese adult subjects.In this study, 20 healthy adult subjects were
      enrolled in a multi-dose study in the 30mg and 40mg groups.
    

Detailed description: 
      In this study, subjects were given multiple doses in the corresponding dose group
    

Intervention name(s): AD16 30mg、40mg; AD16 Placebo 30mg、40mg
Intervention type(s): Drug; Drug
Intervention description(s): AD16 was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study; AD16 placebo was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-center, randomized, placebo-controlled, double-blind, dose-increasing study design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface
Condition: Healthy
Study type: Observational

Summary: 
      The goal of this study is to look at contact lens on the eye and its interaction with the eye
      during wearing.
    

Detailed description: 
      The goal of this study is to characterize the edge of contact lenses and its interaction with
      ocular surface.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        normal healthy subjects
      
Keywords: contact lens; normal
Feasibility and Reliability of Multimodal Evoked Potentials
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are
      potentially suited as a biomarker for disease progression.

      The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the
      feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an
      international multicenter setting in healthy subjects and subjects with multiple sclerosis
      (MS).
    

Detailed description: 
      Multimodal EP (mmEP) is being developed as a predictive biomarker to determine the clinical
      response to therapy. MEP and SSEP contributes significantly to the predictive value of mmEP.
      The variability of MEP and SSEP has limited its use in multicenter clinical trials. Recent
      technological advances and standardization of procedures has decreased the variability. The
      objective of this study is to evaluate the reliability of MEP and SSEP and feasibility of
      performing MEP and SSEP in an international, multicenter setting. Establishment of the
      reliability and feasibility of MEP and SSEP will allow for further development of this
      predictive biomarker in future clinical trials.
    

Intervention name(s): Acquisition of MEP und SSEP
Intervention type(s): Procedure
Intervention description(s): Acquisition of MEP und SSEP at two different time points within 1 to 30 days
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with MS will be recruited from the outpatient clinic at the University Hospital
        Basel as consecutive ongoing recruitment through project leader and Co-workers in daily
        clinical practice.

        Healthy subjects will be recruited by bulletin on notice-boards in the hospital
      
Keywords: evoked potentials (EP); motor evoked potentials (MEP); Somato-sensory evoked potentials (SSEP); multimodal evoked potentials (mmEP)
The Effect of Psychological State on Post Spinal Puncture Headache and Backache
Condition: Depression, Anxiety
MeSH terms: Headache; Depression
Study type: Observational [Patient Registry]

Summary: 
      To investigate the effect of patient mood before spinal anesthesia on post spinal puncture
      headache and backache
    

Detailed description: 
      Before spinal anesthesia patients' anxiety and depression mood will recorded with Beck
      anxiety and Beck depression scale fifteen minute before spinal anesthesia.Seven days after
      surgery post spinal puncture headache and backache will assess by a telephonic interview
    

Intervention name(s): anxiety scale, depression scale
Intervention type(s): Behavioral
Intervention description(s): post spinal puncture headache and backache will be assess by using visual analogue scale, anxiety will assess by beck anxiety scale, depression mood will assess by beck depression scale
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18-80 years old American Society of Anesthesiology (ASA) I-III patients underwent spinal
        anesthesia
The Autonomic Nervous System and the Metabolic Syndrome
Condition: Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The overall goal of this proposal is to determine the role of the autonomic nervous system in
      the insulin resistant state associated with obesity and the metabolic syndrome. Obesity
      results from an accumulation of excessive fat deposit due to increase caloric intake or
      decrease energy expenditure, this condition is usually associated with diseases such as
      hypertension or diabetes, a cluster known as the metabolic syndrome. The first step in the
      development of the metabolic syndrome is a resistance to the action of insulin. The mechanism
      underlying insulin resistance in obesity is still unknown, however some investigators have
      proposed that the autonomic nervous system, particularly the increase sympathetic activation
      in obesity may play an important role. We have extensive experience studying the role of the
      autonomic nervous system in the cardiovascular alterations associated with obesity by
      producing complete autonomic withdrawal with a drug named trimethaphan. We propose to use the
      same approach to study the role of the autonomic nervous system in the development of insulin
      resistance in obesity.
    

Detailed description: 
      The purpose of this study is to look at the role of the autonomic nervous system, an
      involuntary nervous system that controls your blood pressure, in insulin resistance and the
      metabolic syndrome. Insulin is a substance that helps your body use the sugar in the food
      that you eat. Some people's tissues stop reacting in a normal way to insulin, a condition
      known as insulin resistance. A person with insulin resistance can have other health problems,
      such as obesity, high cholesterol, and high blood pressure. These problems together are
      called the metabolic syndrome. We think that the autonomic or involuntary nervous system
      controls the way your body responds to insulin. This system is changed in obese people, and
      we think that it may cause the insulin resistance. We plan to study this with two drugs
      -trimethaphan and L-NMMA. Neither of these drugs are approved by the Food and Drug
      Administration (FDA), and they will be used for research purposes only.

      Fifty people will take part in this study.
    

Intervention name(s): Blocked; Intact
Intervention type(s): Drug; Drug
Intervention description(s): Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance; Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance
Other intervention name(s): Trimethaphan; Saline
Intervention MeSH terms: Trimethaphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Obesity; Hypertension; Autonomic Nervous System
Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of
      combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      Participants in this Phase IIIb study will either receive GSK Biologicals' combined
      diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or
      co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa)
      vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be
      administered at 2, 4 and 6 months of age. Two blood samples will be collected during the
      course of the study: prior to vaccination and one month after the third vaccine dose.
    

Intervention name(s): DTPa-IPV; DTPa; IMOVAX Polio®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 intramuscular injections; 3 intramuscular injections; 3 intramuscular injections
Other intervention name(s): Infanrix™-IPV; Infanrix™
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Condition: Peripheral T Cell Lymphoma Unspecified; Anaplastic Large Cell Lymphoma, ALK-negative; Angioimmunoblastic T Cell Lymphoma; Cutaneous T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell, Cutaneous; Immunoblastic Lymphadenopathy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The urgent need for new effective therapy for T-cell lymphoma patients and promising results
      observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the
      investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell
      lymphoma patients.

      Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy
      for newly diagnosed peripheral T-cell lymphoma patients.

      Phase I

        1. Primary objective

           : To define the maximum tolerable dose

        2. Secondary objective

             -  To evaluate the dose-limiting toxicity

             -  To evaluate the pharmacokinetics of RAD001

             -  Pharmacogenomic profiling

      Phase II

        1. Primary objective

           : To evaluate the overall response rate

        2. Secondary objective

             -  To estimate the time to progression

             -  To estimate overall survival

             -  Pharmacogenomic profiling
    

Detailed description: 
      Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 +
      CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP
      CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W
      100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO
      (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be
      continued until planned 6 cycles or disease progression
    

Intervention name(s): RAD001 (Everolimus)
Intervention type(s): Drug
Intervention description(s): Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks
Other intervention name(s): Cytoxan, Doxorubicin, Vincristine, prednisolone
Intervention MeSH terms: Prednisolone; Doxorubicin; Vincristine; Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RAD001; chemotherpy; T cell lymphoma