bioihbjkbjnl/mcl2 huggingface dataset:
Taste Perception Pre and Post Bariatric Surgery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      The investigators wish to study the effects of three forms of bariatric surgery, gastric
      bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If
      your insurance does not cover the procedure, then the patient is responsible for payment of
      the surgical process. The investigators are doing pre and post surgery testing to provide a
      better understanding of the effect of bariatric surgery-induced weight-loss on taste
      perception.
    

Detailed description: 
      Bariatric surgery is the most effective weight loss therapy for obesity. However, the
      mechanisms responsible for decreased food intake are incompletely understood. One possible
      mechanism that could account for decreased food intake is changes in taste perception.
      Therefore, the primary goal of this proposal is to provide a better understanding of the
      effects of bariatric surgery-induced weight-loss on taste perception.
    

Intervention name(s): Gastric bypass; Gastric banding; Sleeve gastrectomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Roux-en-Y gastric bypass; Laparoscopic adjustable gastric banding; Sleeve gastrectomy surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 41 morbidly obese (BMI>=35 kg/m²) subjects scheduled for bariatric surgical
        procedures will participate in this study.
      
Biospecimen description: 
      Tongue tissue
    
Keywords: obesity; gastric bypass; gastric banding; sleeve gastrectomy; weight loss; taste perception
Relationship Between Dopamine Genetics, Food Reinforcement, Energy Intake and Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of the study is to determine whether the presentation of various foods produces
      an increase or decrease in responses on a motivational computer task. In addition, the study
      determines if energy intake or motivation to obtain food is related to the dopamine receptor
      genotype.
    

Detailed description: 
      One of the most important research areas in obesity is developing a better understanding of
      individual differences in factors that influence excess energy intake and positive energy
      balance. One key to understanding these individual differences is determining what factors
      underlie the motivation to eat. We have demonstrated in a series of studies that obese adults
      and children are more motivated to work for palatable, favorite foods than leaner peers and
      that those high in food reinforcement consume more food in an ad libitum eating task than
      those who do not find food as reinforcing. Dopamine (DA) is one of the major
      neurotransmitters involved in establishing the reinforcing value of food, and low levels of
      dopamine activity and a reduction in the number of DA receptors is associated with obesity.
      The general aim of the proposed research is to build upon this research to examine
      relationships between food reinforcement, obesity, and polymorphisms of genes within the
      dopaminergic system.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects will be recruited from newspaper ads, posters on campus and in community settings,
        web based recruitment (ads on Craig's list and on the department's website) and direct mail
        targeted to community residents between 18-50 years of age.
      
Biospecimen description: 
      Saliva DNA samples will be collected from all participants
    
Keywords: Food Reinforcement; Energy Intake; Obesity; Dopamine
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to
      placebo and eplerenone in participants with resistant hypertension.
    


Intervention name(s): LCI699; Eplerenone; LCI699-matching Placebo; Eplerenone-matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): LCI699 oral capsules; Eplerenone oral capsules; LCI699-matching placebo oral capsules; Eplerenone-matching placebo oral capsules
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood Pressure; Hypertension; Resistant Hypertension
Prospective Study Assessing Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Removal of the Cervix Versus Removal of the Uterus,Ovaries and Fallopian Tubes For Treatment Of Early Stage Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to will help us understand how two treatments impact women with
      early stage cervical cancer: a radical hysterectomy, which removes the entire uterus, the
      ovaries, and fallopian tubes versus a radical trachelectomy which removes the cervix, which
      is the bottom part of the uterus. The second leaves the rest of the uterus, the ovaries, and
      fallopian tubes. This means that there is a chance that the woman might be able to get
      pregnant in the future with this type of treatment. We believe that these two operations need
      further study to see how they impact women. This study will look at emotions and issues of
      fertility. The study will also ask about quality of life and sexual functioning. What we
      learn from this study will help us give better information to women considering these
      treatments.
    

Detailed description: 
      This project will prospectively assess and describe the emotional, sexual and quality of life
      impact of radical trachelectomy in comparison to the standard treatment of radical
      hysterectomy in women with early stage cervical cancer over a two year time period. Women
      being considered for radical trachelectomy with laparoscopic pelvic lymphadenectomy or
      radical hysterectomy (abdominal, laparoscopic or schauta) will be approached for study
      participation prior to undergoing surgery. After providing informed consent, participants
      will be given a survey questionnaire pre-operatively and asked to complete follow-up surveys
      post-operatively at follow up medical appointments at 3 months, 6 months, 12 months, 18
      months and 24 months. We will assess the following domains in these women; mood, sexual
      functioning, and quality of life in addition to issues of fertility and treatment choice. The
      survey will take approximately 30 minutes to complete. The findings will be used to provide
      additional information to women considering these procedures and enable future interventions
      to be designed to meet any identified needs. In addition, the findings of this study will
      also be presented for consideration of a multi-center feasibility study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with early stage cervical cancer undergoing either radical trachelectomy or radical
        hysterectomy
      
Keywords: cervical cancer; quality of life assessment; behavioral
Long Term Study With B2036-PEG
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients
      with acromegaly.
    


Intervention name(s): Pegvisomant
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset
Condition: Stroke; Cerebral Infarction
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to explore safety and efficacy of Salfaprodil administration for
      patients with acute ischemic stroke within 6 hours of onset.
    

Detailed description: 
      The present study is to investigate safety and efficacy of Neu2000, a multi-target
      neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent
      antioxidant, in acute ischemic stroke patients within 6 hours of onset. Compared to NMDA
      antagonists or antioxidants, improved efficacy and therapeutic time window of Neu2000 have
      been well documented in four animal models of stroke. Notable Safety of Neu2000 has been
      demonstrated in 168 human subjects conducted in the US and China as well as animals.

      In the present phase II study, patients with acute ischemic stroke within 6 hours of onset
      would be assigned randomly to one of four groups as follows:

        -  Group A receiving 2.75g Neu2000KWL for 5 days

        -  Group B receiving 5.25g Neu2000KWL for 5 days

        -  Group C receiving 6.00g Neu2000KWL for 5 days

        -  Group D receiving placebo for 5 days

      Patients will receive intravenous infusion of the clinical study drug twice a day at 12±1
      hour intervals for 5 days.
    

Intervention name(s): Neu2000KWL; Neu2000KWL; Neu2000KWL; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours; 1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours; 1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours; 1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours
Other intervention name(s): Salfaprodil for injection; Salfaprodil for injection; Salfaprodil for injection
Intervention MeSH terms: Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Stroke; the Salfaprodil for injection; Neu2000KWL; Neuroprotection; glutamate; free radical
Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The investigators propose to evaluate the relationship between PTSD, mood, craving and
      withdrawal symptoms and factors associated with relapse in the context of a randomized
      clinical smoking cessation trial. The use of supplemental nicotine administration (SNA)
      during a "pre-treatment" phase before a targeted quit date is an innovative development in
      smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad
      lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional
      dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation.

      Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions
      (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All
      participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard
      nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and
      withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to
      the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date.
      The study is designed to address the following aims:

      Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal
      through electronic diary assessment.

      Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment
      period as compared to the placebo patch condition.

      Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms
      associated with smoking behavior.

      Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal
      symptoms following the quit-date.

      Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD.

      Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific
      Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood,
      anxiety sensitivity, distress tolerance, and self-efficacy.

      Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect,
      increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each
      will independently be associated with shorter abstinence from smoking.
    


Intervention name(s): nicotine patch; placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine patch, 7-21 mg.; placebo patch used from weeks 4-6
Other intervention name(s): Nicoderm, Habitrol
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PTSD; smoking cessation; nicotine patch
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This interventional device study aims to compare mainly standard Multiple Daily Injection
      (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction.
      In addition, a third arm is included to compare to only similar product on the market which
      is OmniPod. The third arm is for data collection purpose.
    


Intervention name(s): Accu-Chek® Solo micropump system; mylife™ OmniPod® Insulin Management System; Multiple Daily Injections (MDI) therapy
Intervention type(s): Device; Device; Other
Intervention description(s): Medical device for subcutaneous delivery of insulin in a personalized way.; A patch pump system delivering insulin.; Injecting insulin as per participant's need.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluating the Well-being Among Dental Students With Warwick-Edinburg Mental Well-Being Scale
Condition: Well Being
Study type: Observational

Summary: 
      The present study was conducted to measure the mental well-being amongst dental students by
      using Warwick-Edinburg Mental Well-being Scale (WEMWBS) and investigate factors affecting
      well-being among dental students.
    

Detailed description: 
      The survey schedule was planned to be independent of the students' assessment period and the
      questionnaire was administered to the students when they were attending a lecture together.
      After the lecture, a researcher explained to the students the purpose of this survey and
      assured them of confidentiality. Participation in this study was also voluntary, and all
      participants remained anonymous. The questionnaire was given to all participants after
      explaining the purpose of the study. The questionnaire included demographic details (age,
      gender, year of study), social background (parents' education levels, family income, first
      choice for admission, living accommodation) and lifestyle behaviors (smoking status, presence
      of regular sport activity and hobby). In addition, Warwick-Edinburg Mental Well-Being Scale
      was applied to the participants of this study.
    

Intervention name(s): dental students
Intervention type(s): Other
Intervention description(s): WEMWBS and a questionnaire included demographic details and social background, lifestyle behaviors was applied to the participants.
Other intervention name(s): no intervention was made
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All students in the faculty of dentistry, Baskent University
Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the absorption, metabolism, and excretion of
      [14C]-evobrutinib in healthy participants
    


Intervention name(s): Evobrutinib
Intervention type(s): Drug
Intervention description(s): Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain [14C]-evobrutinib.
Other intervention name(s): M2951
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: [14C]-evobrutinib; Healthy; Pharmacokinetics; Metabolism; Excretion
Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      It is believed that imiquimod 5% cream has the potential to be an effective treatment for
      actinic keratoses. The purpose of this study is to evaluate the duration of the effect of
      topical imiquimod 5% topical cream for the treatment of actinic keratoses.
    

Detailed description: 
      This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic
      keratoses on the head to reduce the size of lesions. The objective is to analyze the effect
      of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is
      applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is defined
      as the proportion of subjects with no clinically visible AK lesions in the treatment area at
      the end of cycle 1 or the end of cycle 2.
    

Intervention name(s): imiquimod
Intervention type(s): Drug
Intervention MeSH terms: Imiquimod
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: actinic keratoses; imiquimod; pre-malignant; squamous cell carcinoma; immunosuppression
Nutraceutical Combination in Patients With Low-grade Systemic Inflammation
Condition: Atherosclerosis; Inflammation; Hypercholesterolemia
MeSH terms: Atherosclerosis; Hypercholesterolemia; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators tested if a nutraceutical combination with red yeast rice, berberine and
      policosanol (NC) can significantly modify inflammation, lipid profile and markers of
      endothelial injury (endothelial microparticles) in subjects with elevated levels of
      high-sensitivity C-reactive protein (hsCRP).
    

Detailed description: 
      Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL
      100-160 mg / dL) and hsCRP levels> 2 mg / L, divided into two groups of equal numbers,
      matched by by sex and age, randomized to receive a nutraceutical combination containing red
      yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a
      low-cholesterol diet (<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).

      All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a
      period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed
      randomization in the two intervention arms: NC + SOC or SOC.
    

Intervention name(s): Nutraceutical Combination; Standard of Care; Placebo
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily; low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule; placebo
Other intervention name(s): Armolipid Plus, Rottapharm-Madaus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: C-Reactive Protein; Endothelial Microparticles; Endothelium; Nutraceutical; Cholesterol
EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is a randomized multi-center study being done to measure the ability of a new medical
      device, Maestro System, to safely reduce body weight over five years in people who are
      considered obese.
    

Detailed description: 
      The Maestro System is a neuromodulation system that consists of implantable and external
      components.

      Implantable components: two leads (one electrode each for the anterior and posterior
      intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.

      External components: one programmable, battery-powered, ambulatory external controller
      connected via a small, flexible cable to a cutaneous transmit coil that is positioned
      externally over the neuroregulator. A clinician programmer that transmits information to the
      controller and uploads data from the controller.

      All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF
      groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to
      therapy ON or therapy OFF groups.

      All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects
      will participate in a medical weight management program.
    

Intervention name(s): Therapy ON; Therapy OFF
Intervention type(s): Device; Device
Intervention description(s): Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON); Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)
Other intervention name(s): Maestro System; Maestro System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Bariatric surgery; Excess weight loss; Vagus nerve; Vagal blocking; vBloc(TM) therapy
Master Mind Program Evaluation Study
Condition: Substance Abuse; Mindfulness
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial to evaluate the
      efficacy of the Master Mind program, a mindfulness education substance abuse prevention
      program. The program has the goal of enhancing coping strategies and decision-making skills
      and preventing substance abuse in late elementary school students.
    


Intervention name(s): Master Mind
Intervention type(s): Behavioral
Intervention description(s): Master Mind is a 25-lesson elementary school mindfulness education substance abuse prevention program. Each lesson takes approximately 15 minutes and is designed to be taught by trained teachers every day for 5 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention