bioihbjkbjnl/mcl2 huggingface dataset:
A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
Condition: HPV Vaccine Acceptability
Intervention: HPV vaccine acceptability
Intervention description: One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Male
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV; College men; HPV vaccine; Health belief model; HPV vaccine acceptance

Summary:

      The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV)
      vaccine acceptability among college men based on the Health Belief Model through focus
      groups, (2) triangulate focus group results with a prior quantitative study in developing an
      intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3)
      test the efficacy of the above intervention based on the Health Belief Model by comparing it
      to a knowledge-based intervention. Approximately five focus groups with ten participants in
      each group with college students in the ages 18-25 years will be conducted at a large
      Midwestern University for the qualitative piece. Data will be analyzed for categories and
      triangulated with previous study to develop a theory based intervention. For the quantitative
      piece a randomized controlled design with 45 participants in each arm (theory based
      intervention and knowledge based intervention) will be implemented.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males

          -  English speaking

          -  18-25 years

          -  Undergraduate or graduate student at the University of Cincinnati

        Exclusion Criteria:

          -  Females

          -  Under 18 years, or above 25 years

          -  Non- English speaking individuals

          -  Non-university attending students

          -  If already received HPV vaccination
Delayed Start to Ovarian Stimulation
Condition: Diminished Ovarian Reserve; Infertility; In Vitro Fertilization
MeSH terms: Infertility
Intervention: Ganirelix acetate
Intervention description: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
Intervention MeSH terms: Ganirelix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DOR; Infertility; IVF; ART; GnRHa; GnRH Antagonist Protocol; Ganirelix

Summary:

      In couples with infertility secondary to Diminished Ovarian Reserve, the investigators
      hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist
      (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal
             ultrasound (TVUS), or

          -  Cancellation of a prior IVF cycle due to poor ovarian response.

          -  Patients will receive an antagonist stimulation protocol for IVF, or IVF with
             Intracytoplasmic Sperm Injection (ICSI).

        Exclusion Criteria:

          -  Severe male factor infertility requiring surgical intervention to obtain sperm

          -  Major uterine abnormality,

          -  Preimplantation genetic diagnostic (PGD) testing,

          -  Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate
             cycles).
The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Pain, Postoperative
Intervention: Placebo saline injection; Ropivicaine 0.5%
Intervention description: 20 cc of sterile, injectable saline; Ropivicaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to use a new combination of anesthesia techniques in an attempt
      to minimize early pain after surgery and improve the patient's ability to participate more
      fully with physical therapy. Total knee replacement patients who participate will receive the
      standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The
      study is looking at the added benefits of including an injection of numbing medication
      (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to
      compare the outcomes we will also have a group of patients who will receive a saline
      injection as opposed to the numbing medication. Patients are randomly assigned to a group.
      Outcomes are measured up until twenty-four hours following the surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is scheduled to undergo elective total knee replacement at Duke University
             Hospital.

          -  The subject has signed the written consent form.

        Exclusion Criteria:

          -  Known allergy to ropivacaine or hydromorphone.

          -  Known history of narcotic abuse or alcohol abuse.

          -  Known history of chronic pain.

          -  Known diagnosis of peripheral neuropathy or complex regional pain syndrome.

          -  Significant impediment to physical therapy participation.

          -  The surgery is a revision case.

          -  Patient is undergoing bilateral Total Knee Replacement.
Antidepressant Therapy in Treating Bipolar Type II Major Depression
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Venlafaxine; Lithium Carbonate
Intervention description: 75 to 375 mg; 300 to 2400 mg
Intervention MeSH terms: Lithium Carbonate; Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar Type II Disorder; Hypomania; Antidepressant; Mood Stabilizer; Venlafaxine; Lithium Carbonate; Major Depressive Episode; Hypomanic Episodes; Prevention of Depression Relapse

Summary:

      This study will compare the safety and effectiveness of antidepressant therapy versus mood
      stabilizing therapy in treating people with bipolar type II major depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for Axis I bipolar II disorder

          -  Meets DSM-IV criteria for Axis I major depressive episode

          -  Score of 16 on 17-item HAM-D rating scale

          -  Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study
             entry

          -  Willing to use an effective form of birth control throughout the study

        Exclusion Criteria:

          -  History of mania

          -  Current primary Axis I diagnosis other than bipolar II disorder

          -  Alcohol or drug dependence within 3 months prior to study entry

          -  Contraindication to treatment with venlafaxine or lithium

          -  Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)

          -  Pregnant or breastfeeding

          -  Experiencing suicidal thoughts

          -  Requires hospitalization

          -  Requires concurrent neuroleptic or MS therapy

          -  Requires concurrent AD therapy

          -  Current psychotic features

          -  Inadequate trial of therapy at the time of initial screening visit

          -  History of intolerance to either venlafaxine or lithium

          -  Unlikely to participate in a 36-week trial

          -  Presence of apparent secondary gain
Nebulized Hypertonic Saline for Inpatient Use in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: hypertonic saline; standard saline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline
      (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale
      scores after 4 treatments within 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age

          -  Admitted to Doctors Hospital with a clinical diagnosis of COPD

          -  Documented obstruction on spirometry from prior records available at the time of the
             study.

        Exclusion Criteria:

          -  Patients younger than 18 years of age

          -  Spirometry data not available

          -  History of smoking less than twenty pack-years

          -  Possibility of other primary cause of the patient's change in dyspnea or cough (e.g.
             pneumonia, congestive heart failure with pulmonary edema, myocardial infarction)

          -  Patient is found to have a different primary cause after initial enrollment

          -  Non-English speaking subjects
Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?
Condition: Neuromuscular Block
Intervention: Sugammadex; Rocuronium
Intervention description: Reversal of deep neuromuscular block; Maintenance of deep neuromuscular block
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: deep neuromuscular block; sugammadex; stability of anesthesia; suppression of EMG activity; PQRS; General Anesthesia; Quality of Recovery

Summary:

      The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular
      block throughout the entire surgical procedure followed by sugammadex reversal, would
      suppress EMG activity and result in improved anesthetic stability by reducing the variability
      of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the
      anesthetic drugs propofol and remifentanil required to maintain an adequate level of
      anesthesia (BIS between 40 and 60).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ASA I-III

          -  Between 18 - 80 years old

          -  Scheduled for routine cervical surgery

          -  Minimum duration of surgery is 90 minutes and performed with total intravenous
             anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the
             neuromuscular relaxant rocuronium

          -  Patients that are able to and do provide a signed informed consent form

        Exclusion Criteria:

          -  Patients with neuromuscular diseases and severe cardiac and respiratory pathologies

          -  Contra indication for any of the drugs used

          -  Not able to complete the baseline PQRS test.

          -  Indication to perform tracheal intubation using fibroscopy

          -  Patients who are pregnant or nursing
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
Condition: Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Intervention: hydrocortisone 100mg.; mannitol 20% intravenous fluid
Intervention description: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours; group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Mannitol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower
      abdominal and pelvic surgery under spinal anesthesia were included in this randomized
      double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received
      intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received
      intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours.
      Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment
      was assessed using visual analog scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 18-50 years old.

          -  both sex.

          -  ASA physical status I and II.

          -  70-90 kg body weight.

          -  height 160-180 cm.

          -  Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of
             incisional hernia, varicocele and hydrocele.

        Exclusion Criteria:

          -  Patients with impaired kidney or liver functions.

          -  history of cardiac or central nervous system disease.

          -  uncontrolled medical disease (diabetes mellitus and hypertension)

          -  history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h
             before surgery

          -  allergy to the used medications

          -  patient's refusal

          -  duration of surgery more than 120 minutes.
A Placebo-Controlled, Cross-Over Trial of Aripiprazole
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole; placebo
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenia; Diabetes; Obesity; Olanzapine; Insulin Resistance

Summary:

      This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of
      the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated
      patients with schizophrenia or schizoaffective disorder. The advantage of the crossover
      design is that each subject will act as their own control and fewer subjects will be required
      than a between-group design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Age 18-65

          -  Diagnosis of schizophrenia, any subtype, or schizoaffective disorder, any sub-type

          -  Body mass index > 30 Kg/m2 or >27 Kg/m2 with other risk factors (HTN, Lipid
             abnormalities)

          -  Well established compliance with outpatient medications.

          -  Maintained on a stable dose of olanzapine for at least one month.

        Exclusion Criteria:

          -  Serious medical or neurological illness (unstable cardiac disease, malignancy, liver
             or renal impairment, etc.)

          -  Current substance abuse

          -  Psychiatrically unstable, which is defined as a score on the CGI's severity of illness
             question of 5 or greater or a baseline Total PANSS score > 75

          -  Pregnancy, nursing, or unwilling to use appropriate birth control measures during
             participation if female and fertile

          -  Serious suicidal or homicidal risk within the past three months
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin 10mg then Placebo Oral Tablet; Placebo Oral Tablet then Dapagliflozin 10mg
Intervention description: SGLT2 inhibitor - Dapagliflozin then Placebo; Placebo then SGLT2 inhibitor - Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Post renal transplant type 2 diabetes mellitus patients and non-diabetic mellitus patients after renal transplant with a control group of type 2 diabetes mellitus who have not undergone renal transplant
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose
      concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal
      denervation) or in subjects after renal sympathectomy (63) can add insight about the possible
      role of a neural arc which mediates the changes in plasma glucagon and/or insulin
      concentration in response to glucosuria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age = 18-70 years

          -  BMI = 18.5-40 kg/m2

          -  HbA1c ≥ 7.0% and ≤10.0% for type 2 diabetics

          -  males or females

          -  Must be at least 3 months post renal transplantation and be on a stable dose of
             prednisone (≤5 mg/day), tacrolimus, and mycophenolate mofetil

          -  Not taking any antidiabetic medications or who are treated with metformin,
             sulfonylurea, dipeptidyl peptidase 4 (DPP4) inhibitor, thiazolidinedione or some
             combination

          -  Must be in good general health as determined by physical exam, medical history, blood
             chemistries, CBC, TSH, T4, EKG and urinanalysis

        Exclusion Criteria:

          -  Subjects who are taking insulin or SGLT2 inhibitor are excluded

          -  Only subjects whose body weight has not been stable (± 3 lbs) over the preceding three
             months and/or who participate in an excessively heavy exercise program will be
             excluded.

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males (and eGFR <45ml/min.1.73m2), or 24-hour urine albumin
             excretion > 300 mg will be excluded.
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
Condition: Type 2 Diabetes
Intervention: Insulin Aspart; Insulin Aspart 30; Insulin Aspart 70
Intervention description: Patients received insulin aspart before breakfast and before lunch.; Patients received biphasic insulin aspart 30 before breakfast and before lunch.; Patients received biphasic insulin aspart 70 before breakfast and before lunch.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: insulin aspart 30; insulin aspart 70; insulin aspart; postprandial glucose and lipid metabolism; consecutive mixed meals

Summary:

      The aim of the study is to investigate meal-related treatment with either premixed Insulin
      Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free
      fatty acids excursions after a standard breakfast and lunch.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type-II Diabetes

          -  BMI > 27 kg/m2

          -  age 35 to 75 years

          -  HbA1c < 8.5%

          -  informed consent

          -  treatment with pre-mixed insulin

          -  stabile dose of insulin for at least 4 weeks

        Exclusion Criteria:

          -  Type-I Diabetes mellitus

          -  HbA1c > 8.5 %

          -  Serum Creatinine > 1.7 mg/dl

          -  Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal

          -  treatment with sulfonylurea or gliptins

          -  treatment with glitazones

          -  manifest clinical infections

          -  treatment with glucocorticoids or antipsychotic drugs

          -  psychiatric diseases

          -  alcohol abuse

          -  myocardial infarction or stroke within the previous 3 months

          -  surgery within the previous 3 months