bioihbjkbjnl/mcl2 huggingface dataset:
Tailored Web and Peer Email Cessation Counseling for College Smokers
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      The RealU2 is a randomized controlled trial to determine the efficacy of an online health and
      wellness program for young adults with the addition of individualized peer health coaching.
    

Detailed description: 
      The RealU addresses smoking in a young adult population of occasional and daily smokers.

      Aim 1. To determine the efficacy of providing individually tailored smoking cessation
      messages as part of a general interest website for young adults.

      Aim 2. To determine the efficacy of providing individually tailored smoking cessation
      messages plus peer email, phone and online support as part of a general interest website for
      young adults.

      Participants were recruited via direct emails sent to undergraduate and graduate students at
      the University of MI as well as direct emails sent to participants from Survey Sampling
      International and National Data Group. Individuals were invited to complete an online survey
      about health and hope in young adults. Participants eligible for the full intervention were
      invited to join the RealU Study.

      Participants were asked to complete an online enrollment survey and consent form. Eligible,
      enrolled participants were randomly assigned to one of the following three study arms:

        -  an untailored general interest/lifestyle website

        -  an individually tailored web intervention about health and lifestyle

        -  an individually tailored web intervention about health and lifestyle with coaching from
           peers, including video, phone, and email

      Assessments were conducted at 7 weeks and 12 weeks post-enrollment. The primary outcome
      measure is self-reported 30-day abstinence at 12 weeks.
    

Intervention name(s): Tailored Web; Peer Coaching; Untailored Web
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The tailored website included 6 weeks of content about making healthy lifestyle choices, eating breakfast, exercising, reducing drinking and quitting smoking. Each week, participants were asked to check in with their past week's behavior, and to set goals for the next week's check-in.; Participants chose a peer coach, who reviewed the participant's check-in data and goals, and provided personalized feedback to help the participant reach those goals. Interaction took place via personalized videos recorded each week and uploaded to a participant's web profile, and through pro-active phone calls to the participants each week.; Content about lifestyle issues (music, travel, dating) was created for participants assigned to the control group. There was new web content each week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for
      cesarean section will be affected by the genetics of the woman's mu-opioid receptor

      Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most
      receive a dose of preservative free morphine with the spinal anesthetic.
      Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose
      administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.

      The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and
      opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at
      the 40th amino acid of the protein, with asparagine and asparate being present in different
      people. The less common variant (aspartate), present in 25-30% of the overall American
      population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in
      many studies to affect opioid analgesia.

      This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150
      micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women
      will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other
      genes that may affect pain and analgesic responses. The primary outcome will be the amount of
      intravenous morphine patients self-administer in the 24 hours postsurgery.

      The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each
      dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours,
      satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.

      It is anticipated that there will be an interim data analysis at 150 evaluable subjects for
      assessment of the dose response to morphine in the overall population; then a final analysis
      at 300 subjects for the genetic effect assessment.
    


Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cesarean; postoperative; morphine; genetics; opioid
Effect of a Simulated Flight in Patients With Type 2 Diabetes and Healthy Volunteers
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes is an increasingly common condition which affects millions of people in the United
      Kingdom. Patients with type 2 diabetes are at increased risk to develop severe heart disease
      and vascular complications and these can result in death. A cornerstone of the treatment is
      lifestyle and diet.

      The number of travellers is increasing quickly and there are more people than ever travelling
      by airplane. During a commercial flight the pressure of the air is lower than the pressure on
      the surface and that results in lower concentration of oxygen in the air we are breathing
      while flying. Also the humidity is very low inside an aircraft.

      The aims of this study are to show if we can use a simulated flight as a method to look at
      how the endothelial cells react and to see if this is different between patients with type 2
      diabetes mellitus and healthy volunteers.

      A sub-study is also incorporated to look at different dietary interventions in type 2
      diabetes.
    


Intervention name(s): Hypoxia; Low Humidity
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth
Condition: Neonatal Adaptation
Study type: Observational

Summary: 
      Especially in neonates non-invasive methods are required for monitoring the complex changes
      during immediate transition after birth to improve assessment of neonate and eventually
      resuscitation. During this period especially, the brain is vulnerable and monitoring the
      brain and possible influencing factors of cerebral oxygenation and perfusion are of great
      interest. To initiate and guide therapies based on cerebral oxygenation, it is important to
      define reference ranges.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates immediatley after birth
      
Keywords: percentile; cerebral oxygenation; neonate; immediate after birth
Endometrial Malignancy in Breast Cancer Patients With or Without AUB
Condition: Endometrial Neoplasms
MeSH terms: Endometrial Neoplasms
Study type: Observational

Summary: 
      In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of
      uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine
      bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or
      without AUB.
    

Detailed description: 
      20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according
      to recent studies. Many large (>2 cm) and molecularly changed uterine polyps are usually seen
      in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises
      the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies
      suggest that women who use TAM may also have an increase in the prevalence of uterine
      sarcomas. In addition, the duration of TAM administration appears to increase the risk of
      endometrial cancer and uterine sarcoma.

      This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and
      histopathologic findings in postmenopausal women treated for breast cancer with or without
      AUB in order to increase the robustness of a still ambiguous literature on the subject. It
      will estimate the risk of endometrial cancer in women with AUB according to various
      covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.
    

Intervention name(s): Ultrasound; Hysteroscopy
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Transvaginal ultrasound to carry out uterine surveillance; Outpatient hysteroscopy to carry out uterine surveillance
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing gynecological examinations for endometrial surveillance related to
        selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for
        breast cancer
      
Biospecimen description: 
      Endometrial biopsy for histopathological analysis.
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of
      NNC 0148-0000-0362 as tablets in healthy volunteers.

      The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362,
      placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC
      0148-0000-0362 administered orally or intravenously.
    


Intervention name(s): NNC 0148-0000-0362; insulin glargine; placebo; NNC 0148-0000-0362; NNC 0148-0000-0362; NNC 0148-0000-0362
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group; As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group; Subjects will receive a single dose of oral placebo within each dose group; Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period; Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period; Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Integrated Treatment of Marijuana Abuse for HIV+ Youth
Condition: HIV Infections
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This is an exploratory study that will adapt and test a combined cognitive behavioral
      treatment and contingency management intervention for alcohol and/or marijuana abuse for use
      in HIV-infected adolescents.
    


Intervention name(s): Focus Group; First Intervention Trial; Intervention Trial 2
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Focus group using and collecting feedback on the CBT/CM intervention.; Intervention will comprise of approximately 15 weekly sessions.
Exit interviews at the end of each session will assess acceptability, feasibility, and relevance of the intervention.
Quantitative assessment (ACASI) pre and post intervention will document immediate changes in substance use, sexual risk, and adherence to medical care.
Qualitative feedback from interviews with mental health providers and study coordinators will address acceptability and feasibility.; Evaluations/assessments will be similar to those involved for the first intervention trial. Study participants will return for a follow-up visit 3 months after the last intervention session to complete the ACASI.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance Abuse; Adolescent community reinforcement approach; Adolescent Risk Behavior Assessment; Child and Adolescent Services Assessment; Cognitive behavioral therapy; Cognitive Therapy Rating Scale; Individual behavior therapy; Individual cognitive problem solving; Motivational enhancement therapy; HIV-Positive Youth With Substance Abuse; Complementary Therapies
Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders
Condition: Sleep Disordered Breathing; Sleep Apnea, Central
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Central; Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining
      if the new device will treat those participants no worse than when compared to its
      predecessor device.
    

Detailed description: 
      The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will
      treat those participants no worse than when compared to its predecessor device, the BiPAP
      autoSV Advanced™, with respect to:

      • Apnea-Hypopnea Index (AHI)
    

Intervention name(s): BiPAP auto Advanced; BiPAP auto SV4
Intervention type(s): Device; Device
Intervention description(s): Auto Servo Ventilation Device; Auto Servo Ventilation Device
Other intervention name(s): BiPAP Auto SV; BiPAP Auto SV
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Drug Transporter Interaction Study PHENTRA_2015_KPUK
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the present study is to contribute to establishing in vivo phenotyping
      procedures for organic anionic transporter polypeptide 1B1 (OATP1B1), organic cation
      transporters 1 and 2 (OCT1/2), multidrug and toxic compound extrusion transporters 1 and
      2,kidney splice variant (MATE1/2K), organic anion transporters 1 and 3 (OAT1/3), and
      p-glycoprotein (P-gp) transporters via a cocktail approach. To this end, marker substrates
      for each of the respective transporters are administered as single doses in one period each
      and as a cocktail in one period to 24 healthy volunteers, and phenotyping metrics are derived
      from plasma and urine concentrations.
    

Detailed description: 
      Blood sampling: - 0:15 h pre-dose, 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 2:20, 2:40,
      3:00, 3:30, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 24:00 hours post-dose

      Urine Sampling: Pre-dose, 0-4 hours, 4-8 hours, 8-12 hours, 12-16 hours, 16-24 hours

      Drug analysis: by liquid chromatography - tandem mass spectrometry (LC-MS/MS)

      Pharmacokinetic Characteristics: Evaluation is carried out using standard noncompartmental
      characteristics including: area under the plasma concentration vs. time curve truncated at
      time t (AUC0-t), area under the plasma concentration vs. time curve extrapolated to infinity
      (AUC0-∞), peak plasma concentration (Cmax), time of occurrence of Cmax (tmax), apparent
      elimination half-life (t½), clearance over bioavailability (CL/F), renal clearance (CLr) and
      renal secretion. The evaluation may be completed by compartmental population pharmacokinetic
      approaches.

      Statistical evaluation: Pharmacokinetic characteristics are compared for cocktail
      administration vs. individual administration by standard average bioequivalence assessment.

      Safety, tolerability: Adverse events, laboratory and clinical parameters and vital signs will
      be assessed.
    

Intervention name(s): pitavastatin; Metformin; digoxin; Adefovir; sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Livazo®; Metformin-CT®; Digacin®; Hepsera®; Januvia®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Adefovir; Digoxin; Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: phenotype; transporter; cocktail
Effect of the Consumption of a Combination of Plant Extracts (BSL_EP026) on Serum Uric Acid.
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study is to evaluate the effect of the combination of a combination of
      plant extracts (BSL_EP026) on blood and urine uricemia levels in individuals with levels at
      the limit of the values considered normal or moderately high.
    

Detailed description: 
      Hyperuricemia is an abnormally high level of uric acid in the blood, resulted because of an
      increased production of uric acid, decreased excretion of uric acid, or both. This can cause
      gout and nephrolithiasis, and it has also been related to metabolic syndrome, diabetes
      mellitus, cardiovascular disease and chronic kidney disease.

      Some plant extracts have diuretic activity that could contribute to improve uric acid
      excretion. This effect would lead to a decrease in uric acid plasma levels and, secondarily,
      to an action on its metabolic pathway of endogenous biogeneration.

      On the other hand, uric acid has a double reabsorption-elimination step in the renal tubules
      and the flavonoids of both extracts impede the processes of renal resorption promoting
      urinary elimination, in addition to increase the pH of the urine (higher than pH 5.8), which
      favors the non-precipitation or formation of urate stones.

      Finally, the routine (present in the used extracts) inhibit the uric acid formation pathway
      from purines, which would act synergistically.

      In this project, the effect of the intake of a combination plant extracts on uricemia levels
      will be studied.
    

Intervention name(s): Combination of Plant Extracts (BSL_EP026); Control
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Each participant will consume 2 capsules daily, in the morning and in the evening.; Each participant will consume 2 capsules daily, in the morning and in the evening.
Other intervention name(s): Placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperuricemia; Plant extracts
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Condition: Extracorporeal Membrane Oxygenation Complication; Pediatric ALL; Anticoagulants
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a
      single pediatric Level 1 trauma center. The patients will be randomized into two arms; one
      arm will receive unfractionated heparin and the other arm will receive bivalirudin. There
      will be 15 patients in each arm for a total of 30 patients.

      Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
    

Detailed description: 
      The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a
      single pediatric Level 1 trauma center. The patients will be randomized into two arms; one
      arm will receive unfractionated heparin and the other arm will receive bivalirudin. There
      will be 15 patients in each arm for a total of 30 patients.

      The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin
      will spend more time at goal anticoagulation and will experience less hemorrhagic and
      thrombotic complications when compared to patients receiving unfractionated heparin. Primary
      aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The
      investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic
      complications in patients receiving bivalirudin during ECMO.
    

Intervention name(s): Bivalirudin; Unfractionated heparin
Intervention type(s): Drug; Drug
Intervention description(s): Continuous infusion; Continuous infusion
Intervention MeSH terms: Heparin; Calcium heparin; Bivalirudin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Dietary Phospholipids on Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      The aim of the study is to investigate the influence of a milk phospholipid enriched dairy
      product on subjects with atopic dermatitis determining parameters of the immune status, the
      plasma lipid profile and the skin texture.
    

Detailed description: 
      Based on the facts, that on the one hand milk phospholipids are characterized by a high
      sphingolipid content and on the other hand a disturbed sphingolipid metabolism in the
      epidermis of patients with atopic dermatitis was verified, a double blinded, controlled,
      randomized, cross-over study with a daily supplementation of 3 g milk phospholipids to
      subjects with a mild to moderate atopic dermatitis will be conducted.

      Forty patients will be randomized between two groups of each 20 patients. After an individual
      checkup and a run-in period of 2 weeks, the one group will receive the phospholipid enriched
      dairy product and the second group will be given a placebo dairy product over two month. A
      wash out-period of 4 weeks will follow, and the patients will consume the contrary dairy
      products over two month after a 2-week run-in period again.
    

Intervention name(s): milk phospholipid; diary product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.; The patients will consume daily 250 mL of a common dairy product.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment