bioihbjkbjnl/mcl2 huggingface dataset:
AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5,
      in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to
      more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first
      phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a
      similar immunogenicity.
    

Detailed description: 
      The aims of HIV lipopeptide vaccination approach are to improve cell mediated immune
      responses in order to obtain strong, long lasting and polyepitopic responses and to focus
      these responses on highly conserved and immunogenic epitopes.

      Lipopeptides are chemically synthetized peptides, bearing HIV epitopes, covalently bound to a
      fatty acid moiety, a monopalmtoyl chain in this case. This lipid chain produces
      internalization of the lipopeptide into the cytoplasm of the antigen presenting cells.
      Combinations of several lipopeptides containing sequences from different HIV proteins are
      used in vaccination trials in order to increase polyepitopic responses. Lipopeptides have
      been synthetized by the French National Agency for Research on AIDS and Viral Hepatitis
      (ANRS) preventive program by the group of Helen Gras following a long and meticulous work of
      epitope screening performed by the team of Jean-Gérard Guillet at the Cochin Institute in
      Paris. The epitopes were selected on the basis of their strong affinity for HLA class I
      molecule, on their ability to form a stable complex with these molecules, and on the capacity
      of these epitopes to be recognized by T cells. The selected peptides are those containing the
      richest array of epitopes and those most frequently recognized by HIV infected patients. Each
      peptide has a length of 23 to 32 amino acids (AA).

      Different types of lipopeptides constructs have been tested in humans. Among these
      constructs, LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than
      50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I
      trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar
      immunogenicity.
    

Intervention name(s): LIPO-5
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Vaccines; HIV Seronegativity
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to examine the characteristics of the nerves and the small veins
      in the skin of people with fibromyalgia. The investigators will then use this information to
      identify possible processes in the skin that may help explain why some people feel pain
      relief with the study drug (duloxetine) and others do not.

      Duloxetine affects certain chemicals in the brain called neurotransmitters. An abnormality in
      these chemicals is thought to be related to fibromyalgia. Duloxetine is a selective serotonin
      and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of
      depression. Duloxetine is approved for sale in the United States by the Food and Drug
      Administration (FDA) for the treatment of fibromyalgia.
    


Intervention name(s): Duloxetine; Skin biopsy
Intervention type(s): Drug; Procedure
Intervention description(s): Subjects will be titrated onto Duloxetine over one week by taking 30 mg every day for seven days. Week 2 the subject will begin to take 60 mg per day until the end of the study. If the subject wishes to stop taking Duloxetine, she will be given 30 mg per day for one week for down titration.; 3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand
Other intervention name(s): Cymbalta; Punch biopsy
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pressurized Cold Application for Patients Total Knee Prosthesis Surgery
Condition: Knee Prosthesis; Cryotherapy; Pain; Patient Satisfaction
Study type: Interventional

Summary: 
      This study was conducted to examine the effects of pressurized cold applicatıon for patients
      total knee prosthesis surgery.
    

Detailed description: 
      The study was conducted as a randomized controlled experimental study in order to determine
      the effect of pressurized cold application applied after total knee replacement surgery on
      the level of pain and satisfaction.This study was conducted in 52 patients who applied to
      Pamukkale University Hospitals Orthopedics and Traumatology Clinic between July 2019 and
      February 2020, who met the inclusion criteria and accepted to participate in the study. The
      patients were divided into 26 in the control group (cold gel) and 26 in the study group
      (compressed cold therapy bandage) using a simple randomization method. The patients in the
      control group received 9 cold applications, in the form of 20 minutes of application and 40
      minutes of rest after surgery. The patients in the study group were applied 9 cold
      applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.
    

Intervention name(s): compressed cold therapy bandage
Intervention type(s): Device
Intervention description(s): Compressed cold therapy bandage was applied by wrapping the operated knee of the patients. The patients in the intervention group received 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a parallel group randomized controlled study
Masking: Single (Participant)
Primary purpose: Supportive Care
Epidemiology of Vascular Inflammation & Atherosclerosis
Condition: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Coronary Arteriosclerosis; Coronary Disease; Cerebral Arteriosclerosis; Cerebrovascular Accident
MeSH terms: Stroke; Intracranial Arteriosclerosis; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Arteriosclerosis; Myocardial Ischemia
Study type: Observational

Summary: 
      To investigate the relationship of vascular cell phenotypes to atherosclerosis.
    

Detailed description: 
      BACKGROUND:

      Currently, the predominant hypothesis regarding atherosclerosis is that it is in major part
      driven by two independent pathways: hyperlipidemia (the "stimulation") and inflammation (the
      "response"). Although vascular cells mediate the influence of inflammation on
      atherosclerosis, very little is known about vascular cell epidemiology and the relationship
      of vascular cell phenotypes to atherosclerosis. The main hypothesis tested in this study is
      that variation in vascular cell biology is related to the population variation in
      atherosclerosis.

      DESIGN NARRATIVE:

      The cross-sectional study will be nested within a large cohort study, the Multiethnic Study
      of Atherosclerosis (MESA). A partial sample of 1,000 individuals who have undergone other
      special laboratory analyses will be identified and new measures collected as part of their
      upcoming site visit. A number of novel cellular phenotypes describing the innate immune
      response (monocyte activation, natural killer and T cell counts), the adaptive immune
      response (TH1 and TH2 helper cells, and memory T cells), and vessel integrity (circulating
      endothelial progenitor cells) will be measured in these participants. Plasma constituents
      will also be measured that relate to the cellular phenotypes. The overall goal is to test the
      hypothesis that these novel phenotypes are associated with subclinical atherosclerosis in the
      coronary and carotid arteries assessed by quantification of coronary calcification (CAC) and
      B-mode ultrasound (CIMT), in addition to the other subclinical measures available from the
      MESA cohort.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        1,000 men and women aged 45-84 years
Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine
Condition: Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine
      and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

      Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II,
      scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each.
      Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg
      lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control
      group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol
      30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.
    


Intervention name(s): alkalinized lidocaine; Lidocaine; Placebo (for alcalinized lidocaine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF); 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Risk Evaluation for Support: Predicting Elder Life in the Community Tool (RESPECT)
Condition: Death
MeSH terms: Death
Study type: Observational

Summary: 
      To develop a mortality risk prediction model that can be applied to the wide spectrum of
      risks that are seen in the home care setting.
    

Detailed description: 
      ABSTRACT

      Introduction: Older adults living in the community often have multiple, chronic conditions
      and functional impairments. A challenge for healthcare providers working in the community is
      the lack of a predictive tool that can be applied to the broad spectrum of mortality risks
      observed and may be used to inform care planning.

      Objective: To develop a mortality risk prediction model for older adults in the home care
      setting. The final algorithm will be implemented as a web-based calculator that can be used
      by older adults needing care, as well as their informal and formal caregivers.

      Design: Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC)
      data in Ontario, Canada, from January 1, 2007, to December 31, 2013.

      Participants: The derivation cohort will consist of approximately 437 000 home care
      recipients from January 1, 2007, to December 31, 2012. A split sample validation cohort will
      include approximately 122 000 recipients from January 1 to December 31, 2013.

      Main outcome measures: Predicted survival from the time of an RAI-HC assessment. All deaths
      (N ≈ 245 000) will be ascertained through linkage to the provincial vital statistics records.

      Statistical analysis: Proportional hazards regression will be estimated after assessment of
      assumptions. Predictors will include sociodemographic characteristics, social support, health
      conditions, functional status, cognition, symptoms of decline, and prior healthcare use.
      Model performance will be evaluated for 6- and 12-month predicted risks, including measures
      of calibration (e.g., calibration plots) and discrimination (e.g., c-statistics). The final
      algorithm will be generated by combining development and validation data.
    

Intervention name(s): Home Care/RAI-HC Assessment
Intervention type(s): Procedure
Intervention description(s): Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Older adults receiving home care in Ontario, Canada, who have received a structured
        Resident Assessment Instrument for Home Care (RAI-HC) assessment between January 1, 2007
        and December 31, 2013.
      
Keywords: Frail Older Adults; Mortality; Home Care; Survival Analysis; Clinical Prediction Rule
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1
      ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers
      for up to 16 weeks.An additional objective of this study is to collect safety information
      including adverse events and clinical laboratory abnormalities.
    

Detailed description: 
      This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center
      study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in
      the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects'
      treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to
      receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study
      treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the
      wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or
      until the subject exited the study as treatment failure. After that, all subjects regardless
      of wound healing at the end of comparison period will be followed for 12 weeks to investigate
      durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for
      subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs
      for blind assessment will be monitored at each scheduled visit.

      One interim analysis is planned at around 50% of study information; the final analysis will
      be conducted at the end of the study.
    

Intervention name(s): ON101 Cream; Aquacel® Hydrofiber® dressing
Intervention type(s): Drug; Other
Other intervention name(s): WH-1
Intervention MeSH terms: Carboxymethylcellulose Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: WH-1,Diabetic Foot,Ulcer
Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in
      closure of enterocutaneous fistulae in patients with Crohn's disease.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
      Patients are stratified according to investigational site and number of fistulae (single vs
      multiple).

      Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion
      of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an
      infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients
      receive an infusion of placebo on day 1 of weeks 0, 2, and 6.

      Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.
    

Intervention name(s): monoclonal antibody cA2
Intervention type(s): Drug
Intervention MeSH terms: Infliximab; Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Crohn's disease; gastrointestinal disorders; rare disease
"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults
Condition: Older Adults; Mental Health; Mindfulness; Solution-focused Brief Therapy
Study type: Interventional

Summary: 
      The World Health Organization (WHO) reported that approximately 15% of adults aged 60 and
      above suffer from some form of mental disorder, with one of the most common neuropsychiatric
      disorders being depression. Similar trends are seen in Singapore where 11.4% of the older
      adults aged 65 and above had depressive symptoms. Another population survey conducted among
      elderly in Singapore showed that elderly with subsyndromal depression (SSD) were similar to
      or worse than elderly with Major Depressive Disorder (MDD). However being a multi-ethnic Asia
      society the mental conditions such as depression and anxiety are seen as taboo topics to be
      discussed more so to seek help or treatment for these conditions in Singapore. Additionally
      scarcity of trained psychiatrists and work load of these trained professionals in the acute
      care settings make it difficult to reach these needy older adults. Hence, it is imperative to
      support the needs of this group of community dwelling older adults to ensure that their
      emotional wellbeing, and their condition do not progress to MDD. As such, this is the first
      of its kind study that will evaluate the effectiveness of solution focused brief therapy
      delivered by the lay mindfulness practitioner and the nurses.

      If the pilot intervention is found to be feasible and effective, the large scale community
      trial will be planned to reach to more elderly in Singapore to help them age in a dignified
      way. In addition, other countries that do not involve lay mindfulness practitioners and
      nurses to provide integrated personal therapy in the community may benefit from this study as
      well.
    


Intervention name(s): Where-there-is-no-psychiatrist Integrated Personal Therapy (WIPT)
Intervention type(s): Behavioral
Intervention description(s): The WIPT include weekly face-to-face group sessions including mindfulness-based training and solution focused brief therapy (SFBT) involving psychoeducation and structured life review therapy catered to the personal needs of the participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The mechanism for increased androgen production in women with polycystic ovary syndrome
      (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by
      increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators
      hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen
      synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal
      women. To test this hypothesis, the investigators propose to conduct a dose-response study in
      which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH
      surrogate, will be assessed in PCOS and normal women.
    

Detailed description: 
      Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research
      Center (GCRC) for study on 5 occasions. All subjects will receive an intravenous injection of
      hCG dose of 1, 10, 25, 100, and 250 micrograms, each of which will be given on one of 5
      different days each separated by at least two weeks at 8 AM. Blood samples will be obtained
      at t -0.5, 0, and 24 hours after injection. All visits to the GCRC will be done as out
      patients. The total amount of blood withdrawn will be about 35 teaspoons. For normal control
      subjects this will be over a period of about 4-6 months and for PCOS subjects this will be
      over a period of about 6-10 weeks.
    

Intervention name(s): recombinant human chorionic gonadotropin
Intervention type(s): Drug
Intervention description(s): Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Other intervention name(s): Ovidrel
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: polycystic ovary syndrome; androgens; ovary; LH
An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The "CONTROL" study is an out patient based prospective observational cohort study. The main
      aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day
      under real life conditions in usual clinical practice in essential hypertensive patients in
      the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24
      weeks.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Essential hypertensive patients