bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and
      multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.
    

Detailed description: 
      This is a single-center, sequential-cohort, double-blind, placebo-controlled, single- and
      multiple-ascending dose study. Eligible adult subjects will be assigned sequentially to 1 of
      10 cohorts, at successively higher single doses, followed by successively higher multiple
      doses.

      Single IV Doses: 5 subjects per cohort, aged 18-55, will be randomized in a 4:1 manner to
      receive active drug (6, 30, 90, 180, 360, and TBD µg/kg) or to receive matching placebo
      (Cohorts 1-6).

      Multiple IV Doses: 8 subjects per cohort, aged 18-55, will be randomized in a 3:1 manner to
      receive active drug (90, 180, 360, and TBD µg/kg) or to receive matching placebo every 12
      hours for 5 doses (Cohorts 7-10).

      Single-Dose Cohorts Subjects receiving a single dose will be confined in a Phase 1 unit for
      12 hours prior to dosing, during dosing, and for 24 hours after dosing (Study Day 1-2) for
      observation and PK sampling. Subjects will return on Study Day 4 (~72 hours after infusion)
      and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be
      made to subjects to collect AEs that occur within 28-days of the dose.

      Multiple-Dose Cohorts Subjects receiving multiple doses will be confined in a Phase 1 unit
      for 12 hours prior to dosing through 24 hours following the last dose (Study Day 1-4) for
      observation and PK sampling. Subjects will return on Study Day 6 (~72 hours after last
      infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call
      will be made to subjects to collect AEs that occur within 28-days of the last dose.
    

Intervention name(s): 3K3A-APC, diluted in 0.9% sodium chloride in water; 0.9% NaCl in water
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: APC, 3K3A, 3K3A-APC, volunteer, healthy
Laparascopic Assisted Colonoscopic Polypectomy
Condition: Colon Polyps
MeSH terms: Colonic Polyps
Study type: Observational

Summary: 
      Study Objective: To compare the hospital costs between the standard surgical procedure and
      the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with
      advanced polyps in the colon.
    

Detailed description: 
      All patients being referred for possible LACP to the Division of Colorectal Surgery at Stony
      Brook University Medical Center will be randomized in a 1:1 fashion using a computer
      generated system to undergo either partial colectomy (performed by means of laparoscopy when
      possible), or LACP for the treatment of advanced polyp(s). Our research assistant will be
      present in the operating room to record the data.Patients will then undergo standard clinical
      management while hospitalized at Stony Brook according to the procedure performed.
    

Intervention name(s): Laparoscopic Assisted Polypectomy
Intervention type(s): Procedure
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        GI clinic
      
Keywords: polypectomy; laparoscopic
The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td
Condition: Tetanus
MeSH terms: Tetanus; Tetany
Study type: Observational

Summary: 
      The investigators want to determine whether TIG influences the formation of tetanus antibody
      after simultaneous tetanus vaccination according to age and the time-interval of the last
      tetanus vaccination.
    

Detailed description: 
      When an injured patient visits the ED, unnecessary injection of tetanus immunoglobulin (TIG)
      may cause side effects and also increase the medical expense.5 Further, the opportunity of
      assessing a rising tetanus antibody titer may be missed after simultaneous injection of
      tetanus-diphtheria vaccine (Td) and TIG. According to age, the elevation of the tetanus
      antibody titer after tetanus prophylaxis might be not equivalent because of different levels
      of basal immunity and the time-interval of the last tetanus vaccination. Therefore, we wanted
      to determine whether TIG influences the formation of tetanus antibody after simultaneous
      tetanus vaccination according to age and the time-interval of the last tetanus vaccination.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adult over twenty
      
Biospecimen description: 
      serum
3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst
Condition: Laparoscopy
MeSH terms: Ovarian Cysts
Study type: Interventional

Summary: 
      Lack of depth perception and spatial orientation are drawbacks of laparoscopic surgery. The
      advent of the three-dimensional (3D) camera system enables surgeons to regain binocular
      vision. The aim of this study was to gain subjective and objective data to determine whether
      3D systems are superior to two-dimensional (2D) systems in terms of surgical outcomes.
    

Detailed description: 
      Elective laparoscopic ovarian cystectomy is established as the treatment of choice for benign
      ovarian cysts. The advantages of laparoscopic surgery over conventional open surgery are less
      pain, shorter recovery time, shorter hospital stay, and consequently faster return to normal
      activity as well as better cosmetic effects. However, laparoscopic surgery is more
      challenging compared with open surgery, partly because surgeons must operate in a
      three-dimensional (3D) space through a two-dimensional (2D) projection on a monitor, which
      results in loss of depth perception and consequently more cognitive workload on the surgeon.
      In traditional 2D laparoscopic procedures, the surgeon has to mentally transform and process
      the 2D image into a 3D image using motion parallax through movement of the laparoscope,
      relative position of instruments, and shading of light and dark. During the past 3 decades,
      3D imaging systems have been introduced in and attempt to improve in-depth perception and
      spatial orientation during minimally invasive surgery. The anticipated advantages for the
      surgeon are greater accuracy and speed in manual skills, translating to decreased operative
      time, a reduced learning curve, and enhanced safety.

      Nevertheless, studies, to date, examining the potential advantages and disadvantages of 3D
      versus 2D imaging systems have produced contradictory results. Moreover, there have been no
      studies exploring the advantage of 3D imaging system in patients undergoing laparoscopic
      ovarian cystectomy. The aim of this study was to gain subjective and objective data to
      determine whether 3D imaging systems in the treatment of ovarian cyst are superior to 2D
      systems in terms of surgical outcomes.
    

Intervention name(s): 3D laparoscope; 2D laparoscope
Intervention type(s): Procedure; Procedure
Intervention description(s): For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.; For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A 35 Day Study to Investigate the Effects of GSK1521498 on Bodyweight in Obese Subjects With Over-Eating Behaviours.
Condition: Obesity
MeSH terms: Hyperphagia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese
      but otherwise healthy subjects with over-eating behaviours.
    

Detailed description: 
      This study is to test a new drug which may be used for treating over-eating behaviours and
      patterns that some overweight and obese people find difficult to control. The drug works by
      inhibiting the effects of messenger molecules called opioids. These opioids are naturally
      produced within the human body, and are involved in controlling how much we eat, and the
      pleasure we get from eating. We believe that GSK1521498 might be effective in the treatment
      of obesity because it is well known that drugs working on similar binding sites in the brain
      reduce the pleasure we get from eating, especially high fat or high sugar food. We also
      believe the effects of GSK1521498 will be greater in obese individuals with greater severity
      of over-eating behaviours, as measured for example by existing questionnaire scales for
      binge-eating or compulsive eating behaviour. We will perform a variety of simple tests using
      a computer, questionnaires and eating assessments to examine effects on behaviour. We will
      also ask people to complete questionnaires so that we can see if there are any effects on
      their mood.
    

Intervention name(s): GSK1521498; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly; Placebo will be given for up to 35 days and subjects will be assessed weekly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Opioid receptors; Body weight; Over-eating behaviour; Obesity; Fat mass
Beta-alanine and Elder Endurance
Condition: Physical Endurance
Study type: Interventional

Summary: 
      The purpose for this study is to determine if beta-alanine supplementation combined with
      endurance-based resistance training can increase gains in muscular endurance to a greater
      extent than endurance-based resistance-training alone in older adults.
    


Intervention name(s): Beta-alanine; Placebo; Muscular endurance exercise
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuromuscular; Supplementation; Elderly
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this
      has not been carefully studied. This research is being done to learn more about sleep
      function in heavy marijuana users, and to determine whether a medication approved for
      treating insomnia can help restore normal sleep function during brief periods of abstinence.
    


Intervention name(s): eszopiclone; Placebo; ramelteon; zolpidem
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral capsule at dose recommended for adults; Participants receive placebo prior to sleep; ramelteon; zolpidem
Intervention MeSH terms: Zolpidem; Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: marijuana; cannabis; dependence; withdrawal
Relationship Between Nutrition and Sexual Activity
Condition: Sexual Dysfunction; Mediterranean Diet; Aphrodisiac Foods; Obesity; Healthy Eating Index
Study type: Observational [Patient Registry]

Summary: 
      Sexuality is integral to personality, influencing feelings, thoughts, actions, and physical
      and mental health. Female sexual dysfunction is a fairly common condition that covers four
      main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and
      sexual pain disorder. Although incidence and prevalence rates vary, it has been reported that
      women range between 30% and 50%.

      Male sexual dysfunction is not a single disease. Male sexual arousal refers to the entire
      process of sexual activity for men, including penile erection, penile penetration,
      ejaculation, and any obstruction in a single connection. It is a significant psychological
      distress for affected men, their sexual partners, and their health-related quality of life.
      Sexual dysfunctions are common among men of all ages and ethnic and cultural backgrounds. It
      is reported in the literature that 52% of men between the ages of 40-70 experience various
      degrees of sexual dysfunction.

      Cardiovascular disease, smoking, obesity, sedentary lifestyle, diabetes, hypertension,
      hyperlipidemia, and metabolic syndrome are risk factors for sexual dysfunction. Although the
      positive effects of adopting healthy lifestyle changes and dietary habits in reducing the
      risks of these diseases have been proven, few studies have evaluated the impact of these
      treatment approaches on sexual dysfunction.

      Studies evaluating the relationship between diet and erectile dysfunction have focused more
      on men with diabetes. Some small studies have also shown that lifestyle modification and
      weight loss interventions improve erectile dysfunction in men with significant cardiovascular
      risks. The same is valid for female sexual dysfunction. The Western diet and its components
      are indirectly associated with sexual morbidity. The Western diet has processed foods,
      refined carbohydrates, and high sodium and monounsaturated fat content, which have been
      widely linked to the development of MetS, obesity, and diabetes. These comorbidities are also
      risk factors for female sexual dysfunction as well.

      This study aims to evaluate the relationship between the eating habits of obese and non-obese
      men and women and their sexual functions.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was selected among adult obesity patients who were followed up and treated in
        the last six months of 2015 at Istanbul University Istanbul Medical Faculty Obesity
        Polyclinic. 185 patients aged 18 years and over were included in the study.
      
Keywords: SHIM; IEFF; Sexual Dysfunction; Aphrodisiac foods; Mediterranean Diet; Healthy Eating Index
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose
      escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody,
      being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary
      fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and
      immunogenicity of PMG1015 after Single ascending doses (SAD).
    

Detailed description: 
      Participants will be enrolled and randomized into 1 of 7 cohorts in a double-blind manner.
    

Intervention name(s): PMG1015 Dose 1; PMG1015 Dose 2; PMG1015 Dose 3; PMG1015 Dose 4; PMG1015 Dose 5; PMG1015 Dose 6; Placebo; PMG1015 Dose 7
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose level 1 of PMG1015; Dose level 2 of PMG1015; Dose level 3 of PMG1015; Dose level 4 of PMG1015; Dose level 5 of PMG1015; Dose level 6 of PMG1015; Placebo to match; Dose level 7 of PMG1015
Other intervention name(s): PMG1015; PMG1015; PMG1015; PMG1015; PMG1015; PMG1015; PMG1015
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems
Condition: Constipation; Postoperative Care; Nursing Care
MeSH terms: Constipation
Study type: Interventional

Summary: 
      One of the most common nursing care problems after surgery is defecation problems and the
      risk of constipation. The aim of the study was to determine the effectiveness of the
      squatting position with footstool on the constipation severity and defecation problems in the
      postoperative period in patients with hernia surgery.
    

Detailed description: 
      In this study, after the surgical procedure, the patients were placed in a squatting position
      by placing a stool under their feet in the toilet.
    

Intervention name(s): Squatting position by footstool
Intervention type(s): Other
Intervention description(s): Before the study, the height of the toilet bowls in the patient rooms was measured as 42 cm. The stools to be used for the study are manufactured by ordering laminated with white medium density fiberboard and synthetic resin resistant to harsh chemicals. Stools are made of high quality non-slip materials for patient safety.
After the first postoperative ambulation, stable patients whose bowel movements resumed met their initial defecation needs with the squatting position created using a stool at the appropriate height on the water closet type toilet.
The patients used footstools throughout a week after discharge at home and in the hospital for defecation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: pretest-posttest time series model with the different control group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Squatting Position; Constipation; Defecation problems; Clinical Nursing Research
HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma (ECTOP-1008)
Condition: Adenocarcinoma of Lung
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Observational

Summary: 
      This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1008). It aims to
      evaluate the correlation between radiological diagnosis based on HRCT and pathological
      invasiveness.Investigators observe the radiological features and the correlation with the
      postoperative pathological findings.
    

Detailed description: 
      Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured
      lung adenocarcinoma is important for selection of appropriate surgical extent. Whether
      thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic
      tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be
      enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor
      invasion (invasive adenocarcinoma [IAD] versus adenocarcinoma in situ [AIS]/minimally
      invasive adenocarcinoma [MIA]) would be evaluated according to radiologic parameters of HRCT
      before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic
      tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic
      parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        East Asian population
      
Biospecimen description: 
      Lung surgical specimens
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores
Condition: Hypothermia; Anesthesia; Fragility
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      The goal of this observational study is to compare frequency of intraoperative hypothermia
      between fragilitly groups of eldery patients who underwent orthopedic surgical procedures.

      It aims to answer those questions:

        -  İs there any difference between fragility groups in terms of hypothermia frequency
           during orthopedic surgical procedures?

        -  Are there any other factors that influence the frequency of hypothermia such as age,
           body mass index, room temperature etc. ? Participants body temperature before anestesia
           application,and before surgery had started was measured and measurament was done during
           whole procedure. Measuraments had been done by tympanic thermometer.
    


Intervention name(s): body temperature measurament
Intervention type(s): Diagnostic Test
Intervention description(s): body temperature of every patient was measured with tympanic thermometer during surgical procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Our candidates was choosen from patiens who scheduled for elective orthopedic surgeries in
        Kirsehir education and research hospital. We have enrolled patients who accepted to be a
        partician for this study after obtaining their informed consent. Elective Orthopedic
        Surgery. All of our participants were 65 years old or older.