bioihbjkbjnl/mcl2 huggingface dataset:
Self-Weighing: an Ecological Momentary Assessment
Condition: Daily Self-weighing; Daily Temperature-taking
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The primary objective of this study is to experimentally test the momentary and more distal
      psychological effects of daily self weighing as compared to an active control group.
    

Detailed description: 
      Two significant public health problems, obesity and eating disorders, are prevalent during
      emerging adulthood, a unique stage of life between ages 18 and 25. Over half of emerging
      adults experience weight gain and/or disordered eating (e.g. overly restrictive dieting,
      binge eating); both of which contribute to obesity. Because many emerging adults attend
      college, the college community represents a viable population for implementing interventions
      to prevent weight gain, while not triggering disordered eating.

      A promising strategy for preventing weight gain during college is daily self-weighing, an
      example of behavioral self-monitoring, an evidence-based strategy for weight control.
      Self-monitoring is fundamental to behavior change: feedback allows the user to evaluate
      progress in relation to a goal and modify behavior. Despite self-monitoring being
      recommended, some evidence suggests that self-monitoring strategies, self-weighing in
      particular, may have unintended psychological consequences; the concern being that negative
      mood states could precipitate disordered eating. Alternatively, other evidence suggests
      positive psychological outcomes related to daily self-weighing in young adults.

      Technological advances have allowed for users to track personal health information in real
      time. Given that 60% of U.S. adults track weight, diet, or exercise, and 92% of adults aged
      18-34 own a smartphone, electronic self-monitoring is feasible in this population. What is
      less known is individuals' psychological and behavioral response to self-monitoring. This
      original, important study will contribute to the fields of obesity and eating disorders and
      experimentally test the psychological effects of this daily weight-control intervention.
    

Intervention name(s): daily self-weighing; daily temperature-taking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.; Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: self-weighing; weight gain; Ecological Momentary Assessment; mood; emerging adulthood; obesity; eating disorders
Evaluating Fine Needle Aspiration to Measure Hepatic Vaniprevir (MK-7009) Concentrations in Participants With Chronic Hepatitis C (MK-7009-048)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of
      liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards
      identifying a minimally invasive, reproducible platform to measure liver PK. The study will
      be done in 2 parts. In Part 1, participants will be randomized to one of five FNA/core needle
      biopsy (CNB) time-point collection sequences. In Part 2, participants will be randomized to
      one of two possible doses of vaniprevir and will be assigned to one of five FNA/CNB
      time-point collection sequences; participants in Part 2 will also receive background therapy
      with pegylated interferon alpha-2b (Peg-IFN alpha-2b) and ribavirin (RBV). The primary
      hypothesis is that there is a greater than 80% posterior probability that vaniprevir
      concentrations are successfully obtained at least 60% of the time from FNA liver samples
      collected at 2 of 3 specified timepoints.
    


Intervention name(s): Vaniprevir 600 mg; Peg-IFN alfa-2b; Ribavirin; Liver samples from FNA; Vaniprevir 300 mg; Liver samples from CNB
Intervention type(s): Drug; Biological; Biological; Procedure; Drug; Procedure
Intervention description(s): Vaniprevir capsules, were administered orally, twice per day (BID) to achieve a final daily dose of 600 mg on Days 1 through 6; and a single dose of 600 mg, orally, on Day 7.; Peg-IFN alfa-2b was administered at 1.5 µg/kg per week by subcutaneous injections on Days 1, 8, 15 and 21; Ribavirin capsules were administered on Days 1-21, orally, twice daily for a total daily dose of 600 - 1400 mg, depending on the participant's weight; Liver samples were collected from Day 7 up to Day 10 by FNA at 3 of 5 specified postdose timepoints.; Vaniprevir capsules were administered orally, twice per day to achieve a final daily dose of 300 mg on Days 1 through 6; and a single dose of 300 mg, orally, on Day 7.; Liver samples were collected from Day 8 up to Day 10 by CNB at 1 of 3 specified postdose timepoints.
Other intervention name(s): MK-7009; PegIntron™; Rebetol™; MK-7009
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon alpha-2; Liver Extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD Specifically With Executive Function Impairment
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo
      on executive function (self-regulation) behaviors in adults with ADHD who report clinically
      significant impairment of executive function behavior in their everyday environment, as
      measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version
      (BRIEF-A) Global Executive Composite (GEC) T-score.
    


Intervention name(s): SPD489; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks); 1 capsule per day, daily throughout the double-blind treatment period (10 weeks)
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
Condition: Lower Esophageal Ring; Dysphagia
MeSH terms: Deglutition Disorders; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to compare the efficacy of bougie dilation to
      electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the
      presence of rabeprazole treatment. All patients will be followed for one year for recurrence
      and/or severity of dysphagia and will be placed on rabeprazole for that time period.
    

Detailed description: 
      Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the
      University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for
      dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at
      endoscopy, the patient will be randomized to electrosurgical incision or standard bougie
      dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or
      severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).
    

Intervention name(s): Bougie Dilation; Needle-knife incision
Intervention type(s): Procedure; Procedure
Intervention description(s): Bougie dilation will be performed as standard; Needle-knife incision will be performed
Other intervention name(s): Maloney dilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lower esophageal ring; dysphagia; electrosurgical incision; bougie dilation; GERD
Drug Interaction Study Evaluating the Effect of Rifampin on PK and Safety of PF 04965842.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open label, 2 period, single fixed sequence study designed to evaluate the
      effect of repeat dose oral rifampin on single dose PF 04965842 PK after a single 200 mg oral
      dose in healthy subjects. A total of 12 healthy male and/or female subjects will be enrolled
      in the study so that at least 10 subjects will complete the study.

      Subject will report to the clinical research unit (CRU) at least 12 hours prior to Day 1
      dosing in Period 1 and will be required to stay in the CRU for 11 days and 10 nights.
      Genotyping samples for CYP2C19 and CYP2C9 will be collected predose in Period 1 only. In
      Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the
      morning on Day 1 under fasted conditions. No food will be allowed for at least 4 hours
      postdose and undergo serial blood sample collection for 24 hours postdose to characterize the
      PK profile of PF 04965842.

      In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7,
      approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight
      fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to
      administration of a single 200 mg oral dose of PF 04965842. Subjects will remain in a fasted
      state for 4 hours after dosing with PF 04965842 and undergo serial blood sample collection
      for 24 hours post PF 04965842 dosing to characterize the PK profile of PF 04965842. Subjects
      will be discharged from the CRU on Day 9 of Period 2 after all study procedures are
      completed. The subject will be required to return to the CRU for on site follow up visits 7
      14 days, and have a follow up phone contact 28 35 days after the last dose of PF 04965842.
    


Intervention name(s): PF-04965842; rifampin
Intervention type(s): Drug; Other
Intervention description(s): single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions.In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842.; In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842
Intervention MeSH terms: Rifampin; Abrocitinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: healthy volunteers
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Condition: Tuberous Sclerosis Complex; Seizures
MeSH terms: Tuberous Sclerosis; Seizures; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      open-label extension phase only will be described in this record. All participants will
      receive the same dose of GWP42003-P. However, investigators may subsequently decrease or
      increase the participant's dose until the optimal dose is found.
    


Intervention name(s): GWP42003-P
Intervention type(s): Drug
Intervention description(s): Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other intervention name(s): Cannabidiol; CBD
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this project is to use white-skinned sweet potato as the main material for
      weight control for overweight and obesity, the non-communicable diseases (cardiovascular
      diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high
      quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and
      health food that to do functional study in Shih Chien University and Taipei Medical
      University. In this study, the investigators will recruit overweight and obesity subjects
      that divide into white sweet potato group (experimental group) and no intervention group
      (control group) by using randomized, parallel and open clinical study in sixty days.
    

Detailed description: 
      All subjects will be evaluated the body weight and clinical nutrition assessment such as
      postural measurement, urine test and blood biomarker examination.
    

Intervention name(s): White sweet potato diet
Intervention type(s): Dietary Supplement
Intervention description(s): The diet were supplied 516 kcal daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Condition: Diffuse Hair Loss in Females
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The objective of this study is to assess the hair growth efficacy of a Food for Special
      Medicinal Purposes (FSMP) Pantovigar® vegan after 3 and 6 months of intake.
    


Intervention name(s): Pantovigar® vegan
Intervention type(s): Dietary Supplement
Intervention description(s): Oral application of 1 capsule three times a day (morning, noon, evening) for 6 months
Intervention model: Single Group Assignment
Intervention model description: Intra-individual comparison
Masking: None (Open Label)
Primary purpose: Treatment
Magnesium Versus High Dose Fentanyl in Endotracheal Intubation
Condition: Stress Response
Study type: Interventional

Summary: 
      this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to
      conventional anesthesia in attenuating stress response to intubation
    

Detailed description: 
      to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in
      attenuating stress response in cancer patients undergoing surgeries under general anesthesia
      requiring endotracheal intubation
    

Intervention name(s): Magnesium sulfate- Fentanyl; Fentanyl 4Mcg/kg; Fentanyl 2Mcg/kg; Lidocaine 1.5 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): drug administration before intubation; drug administration with induction of anesthesia; drug administration with induction of anesthesia; drug administaration 90 sec before intubation
Other intervention name(s): MgSo4; high dose fentanyl; Conventional anesthesia; Lidocaine
Intervention MeSH terms: Lidocaine; Magnesium Sulfate; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
Condition: Endodontically Treated Teeth; Anterior Teeth
MeSH terms: Tooth, Nonvital
Study type: Interventional
Phase: Phase 2

Summary: 
      Rehabilitation of anterior endodontically treated teeth with significant coronal damage has
      been problematic. Adopting endocrown design to treat teeth with this condition is still under
      investigation. To address this issue, the USPHS criteria were adopted to assess the anterior
      endocrown restorations manufactured using various ceramic materials and cemented with
      different protocols.
    

Detailed description: 
      40 participants with anterior endodontically treated maxillary central incisors were enrolled
      to restore their teeth with esthetic restorations Patients were divided into two groups,
      zirconia and e-max groups. Each group was, further subdivided into two groups following the
      cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical
      marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and
      18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction
      and potential postoperative discomfort were also assessed and recorded during the same
      periods. All qualitative data were displayed as frequency (N) and Percentages (%). The
      chi-square test was utilized for qualitative data comparisons.

      Results:

      As to marginal integrity and patient satisfaction, no significant difference were revealed
      regarding all scores at different intervals as P>0.05.

      Conclusions:

      According to the findings of this study, ceramic endocrowns offer a promising restorative
      solution for the rehabilitation of anterior endodontically treated teeth. Additionally,
      regardless of the presence of the MDP monomer in its composition, using adhesive resin cement
      achieved highly successful results when used with MDP-based ceramic primers.
    

Intervention name(s): resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate; Non MDP containg resin cement
Intervention type(s): Other; Other
Intervention description(s): Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max; Adhesive resin cement not containing an MDP agent
Other intervention name(s): Panavia SA; Duo-link Universal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients received their treatment at the same time. Follow-up periods were parallel for all participants.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Digital Dentistry, E-max, MDP, Zirconia
The the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XNW3009 in Health Subject
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      XNW3009 is a small molecule hURAT1 inhibitor developed independently by Sinovent Pty Ltd.,
      and is intended to treat gout-related hyperuricemia.

      Uricosuric drugs increase urinary uric acid excretion by blocking renal tubular reabsorption
      of urate. The human urate transporter 1( hURAT1) is responsible for the majority of the
      reabsorption of filtered urate, and the mutations in the hURAT1 gene have been demonstrated
      to be responsible for urate non-homeostasis.

      This is a randomized, double-blind, placebo-controlled, dose-escalation study to investigate
      the safety, tolerability, PK and PD of XNW3009 after administration of single (Part A) and
      multiple (Part B) oral doses in healthy adult subjects. Approximately six sequential dose
      panels (single oral doses of 1, 5, 10, 20, 35 and 50 mg XNW3009) will be evaluated in SAD and
      approximately three sequential dose panels (ten consecutive days for respectively daily oral
      doses of 10, 20,35 mg, QD) will be evaluated in MAD.
    


Intervention name(s): XNW3009; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): XNW3009 is a small molecule hURAT1 inhibitor; Placebo and active drug will have the same appearance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the study is to investigate the safety and tolerability of single
      ascending doses of AC-076 administered as subcutaneous injection
    


Intervention name(s): AC-076 for s.c. administration; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lyophilized AC-076A to be reconstituted with 1 mL of water for injection; Sterile 0.9% w/v sodium chloride solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Measurement of corneal temperature gives indirect information about the ocular blood flow.
      For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow.
      It can be measured by means of infrared thermography. This test, however, is not used in an
      everyday clinical routine so far. In this study is investigated if ocular blood flow
      disturbances in glaucoma patients can be diagnosed by means of infrared thermography.

      Corneal temperature are measured in normal tension glaucoma patients and healthy controls
      before and after cold provocation test. In the group of patients and the group of controls,
      subjects with and without a primary vascular dysregulation (PVD) are included. This will
      allow to analyze and compare the influence of cold provocation on corneal temperature (and
      indirectly ocular blood flow) in these study Groups.
    


Intervention name(s): infrared thermography
Intervention type(s): Device
Intervention description(s): measurement of corneal temperature by infrared thermography before and after cold provocation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic