bioihbjkbjnl/mcl2 huggingface dataset:
The Healthy Eating Choices for Life Program
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this investigation is to conduct a 12-week pilot study to examine the effect
      of three different dietary prescriptions that differ on targeting reducing energy density
      (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation,
      satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a
      12-week behavioral weight loss intervention.
    

Detailed description: 
      Given the current prevalence of overweight and obesity among adults in the United States and
      the projected increase of these conditions in the future, development of effective weight
      loss and weight loss maintenance strategies is imperative. For weight loss to occur, energy
      intake needs to be reduced to incur an energy deficit, and for successful weight loss
      maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels
      due to an overall reduction in body size which reduces basal metabolic rate. One dietary
      strategy that may facilitate weight loss maintenance is consuming a diet low in dietary
      energy density (ED). This pilot study will test the effects of a dietary prescription focused
      on ED.

      All participants in the investigation will receive a standard 12-week behavioral obesity
      intervention. The intervention will include an activity goal that participants will gradually
      work to achieve over the course of the 12-week intervention along with standard behavioral
      weight loss strategies. One condition will receive a dietary prescription for weight loss
      that focuses solely on lowering the ED of the diet, another condition will receive the
      traditional dietary prescription used in behavioral weight loss interventions that reduces
      energy intake, and the third condition will receive both prescriptions. Pre and post
      intervention measurements will be taken to determine if there are differences between groups.
    

Intervention name(s): Standard Behavioral Weight Loss Intervention; Dietary Goal: Reduction in Energy Density of Dietary Intake; Dietary Goal: Reduction of Energy Intake
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies; Consume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day.; Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight; Dietary intake; Energy Density; Behavioral; Satiety; Deprivation; Hunger; Fruit; Vegetable
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis (PSC)
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is an open-label study in adults with primary sclerosing cholangitis to evaluate
      the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.
    


Intervention name(s): LUM001
Intervention type(s): Drug
Intervention description(s): LUM001 oral dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm
      Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma,
      UK) in Healthy Human Volunteers Under Fasting Condition
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Daclatasvir Zeta; Clatazev
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 60 mg Daclatasvir; 1 tablet contains 60 mg Daclatasvir
Other intervention name(s): Daklinza; Daklinza
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy
Condition: Myoma; Uterine Bleeding, Dysfunctional; Uterine Bleeding Heavy; Dysmenorrhea; Endometrium Hyperplasia
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Endometrial Hyperplasia; Metrorrhagia; Hemorrhage; Hyperplasia; Dysmenorrhea
Study type: Observational

Summary: 
      A prospective observational study on italian women undergoing ulipristal acetate (uPa)
      therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas
      architecture. We also evaluate changes in the endometrial pattern of selected women.
    


Intervention name(s): Transvaginal ultrasonographic examination
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluation of endometrial thickness; myoma size and volume
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Italian fertile women who are eligible for conservative treatment for uterine fibroids
      
Keywords: ulipristal acetate; myoma; leiomyoma; endometrial patterns; symptomatology
A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to
      evaluate the interaction between two investigational drugs by comparing and analyzing the
      pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when
      administered alone or in combination with repeated oral doses in healthy adult volunteers.
    


Intervention name(s): CTL0801 (Azilsartan); CTL0802 (Rosuvastatin); CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CTL0801 (Azilsartan), single dose, daily, repeated oral administration; CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration; CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration
Intervention MeSH terms: Rosuvastatin Calcium; Azilsartan medoxomil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer
Condition: Advanced Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pancreatic cancer is a common malignancy of digestive system with gradually increasing
      incidence, is the fourth and seventh leading cause of cancer-related mortality in the world
      (1) and China (2) according to the statistics in 2014. The vast majority of patients were
      confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated
      five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced
      pancreatic cancer is characterized by poor prognosis.
    

Detailed description: 
      Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer
      since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median
      survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend
      GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and
      GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported
      that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs.
      3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the
      significant increase of grade 3/4 adverse reactions, to some extent, limited its wide
      application. Therefore, it is necessary to continue to explore effective and safe
      chemotherapy of advanced pancreatic cancer.

      Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has
      demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound
      oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan.

      We conducted a single arm, prospective, phase II study in our center on the first-line
      treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the
      efficacy and safety of the combination regimen.
    

Intervention name(s): Nab-paclitaxel and S-1
Intervention type(s): Drug
Intervention description(s): Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
Other intervention name(s): Abraxane,Tegafur, Gimeracil and Oteracil Porassium
Intervention MeSH terms: Paclitaxel; Tegafur
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nab-Paclitaxel; S-1; Advanced Pancreatic Cancer
Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      Objective: To determine if lower paracervical intramuscular ropivacaine injection is an
      effective treatment for pediatric headache in an emergency department setting.
    

Detailed description: 
      Methods: The study will be a double-blind randomized control trial. Patients will be randomly
      assigned to receive either intramuscular injection of the lower cervical paraspinous muscles
      with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on
      each side, or no intervention at all. If randomized to an injection, the investigator and the
      patient will both be blinded as to the nature of the injection.

      The location of the child's pain as well as severity will be assessed immediately prior to
      intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient
      for discharge to home, intravenous treatment will be instituted according to current
      protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to
      assess severity will vary based on the child's age.
    

Intervention name(s): Ropivacaine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.; 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Headache; Migraine; Ropivacaine
Effect of Probenecid on Synovial Fluid ATP Levels in CPPD
Condition: Calcium Pyrophosphate Deposition Disease
MeSH terms: Chondrocalcinosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will investigate the hypothesis that probenecid, a medication currently used for
      gout, reduces levels of ATP in the joint fluid of patients with calcium pyrophosphate
      deposition disease (CPPD), another common type of crystal-related arthritis. There is good
      evidence that CPPD results from an excess of ATP in joints. The investigators will measure
      levels of ATP in joint fluid before and after 5 days of treatment with probenecid. This study
      will serve to rationalize larger studies of probenecid in CPPD.
    

Detailed description: 
      Objective: The objective of this study is to determine whether pharmacologic doses of the
      drug probenecid significantly decrease ATP and inorganic pyrophosphate (PPi) levels in the
      synovial fluid of patients with calcium pyrophosphate deposition disease (CPPD). The
      investigators have considerable evidence that synovial fluid ATP levels are high in patients
      with this disease and these high levels lead to calcium pyrophosphate (CPP) crystal formation
      which then produces acute and chronic arthritis. The investigators have identified the
      transmembrane protein known as ANK as the chief regulator of ATP levels in and around
      cartilage. Probenecid blocks function of ANK in vitro. The purpose of this study is to
      determine if probenecid used at normal doses are sufficient to block ANK function in vivo and
      whether this results in reduced ATP and PPi levels in synovial fluid.

      Research design: This is a randomized un-controlled trial of probenecid vs. no drug in
      patients with a joint effusion and known CPPD.

      Methodology: Power analysis based on an 80% chance to show a 20% difference in ATP levels in
      the treatment group resulted in a sample size of 20 patients in each group. Patients with
      known CPPD and a joint effusion will have an arthrocentesis to remove 2 ml of synovial fluid
      from their joint. Fluid will be sent to the investigators' research laboratory and ATP and
      PPi levels will be measured. Patients will be randomized to treatment with 2 grams/day of
      probenecid or no therapy. After 5 days, the remainder of the joint fluid will be removed and
      tested for ATP and PPi levels. The investigators will compare differences in ATP and PPi
      levels in the probenecid treated and the untreated group.
    

Intervention name(s): Probenecid
Intervention type(s): Drug
Intervention description(s): Treatment
Other intervention name(s): uricosuric
Intervention MeSH terms: Probenecid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ATP; Probenecid; Chondrocalcinosis
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect of severe hepatic impairment on the
      pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite),
      following administration of a single dose of TE 250 mg (1 x 250-mg tablet) compared to
      healthy, demographically-matched subjects with normal hepatic function.
    


Intervention name(s): Telotristat Ethyl
Intervention type(s): Drug
Intervention description(s): Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose
Other intervention name(s): telotristat etiprate, Xermelo
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Safety and Efficacy of SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
Condition: Asthma; Chronic Obstructive Pulmonary Disease
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has two parts. The main purpose of Part 1 of this study will be to examine how
      safe and effective two doses of SelK2 is on participants with mild asthma. Lung function and
      inflammatory cell numbers will be measured in response to the administration of an allergen
      (a compound to which the participant is allergic) into the lungs in the presence or absence
      of SelK2. Part 2 of this study will examine how safe and effective one dose of SelK2 is on
      participants with chronic obstructive pulmonary disease (COPD). Lung function and
      inflammatory cell numbers will be measured in COPD patients in the presence or absence of
      SelK2. SelK2 may block the movement of key inflammatory cells into the lungs and consequently
      improve lung function in these two patient populations.
    


Intervention name(s): SelK2 (Part 1); Placebo (Part 1); SelK2 (Part 2); Placebo (Part 2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): I.V., multiple-dose (Day 1 and Day 22); I.V., multiple-dose (Day 1 and Day 22); I.V., single-dose (Day 1); I.V., single-dose (Day 1)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 of the study will enroll patients in two arms in a 1:1 ratio to receive either SelK2 or placebo. Part 2 of the study will enroll patients in two arms in a 2:1 ratio to receive either SelK2 or placebo, respectively.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; chronic obstructive pulmonary disease; COPD; adhesion molecule; P-selectin glycoprotein ligand 1; P-selectin
Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors
Condition: Breast Cancer; Long-Term Survivors
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to learn more about how chemotherapy affects an individual's
      thinking abilities (cognition). Some research has shown that chemotherapy can cause changes
      in cognition in breast cancer survivors. However, it is not clear why this change occurs. In
      this study, the investigators will look to see if damage to DNA is related to these changes
      in cognition. Specifically, the investigators want to see 1) if women who have been treated
      with chemotherapy have more DNA damage than healthy women; and 2) if DNA damage is related to
      cognitive problems in breast cancer survivors and healthy women.
    

Detailed description: 
      The primary objective of this proposal is to obtain preliminary data regarding the
      association between DNA damage and cognitive functioning in breast cancer survivors.
      Specifically, we predict that:

        1. Breast cancer survivors treated with chemotherapy and hormonal therapy will have higher
           levels of DNA damage as measured by the Comet assay as compared to age and education
           matched survivors treated with hormonal therapy only and healthy controls.

        2. Survivors who meet criteria for cognitive impairment will have higher levels of DNA
           damage as compared to cancer survivors who do not meet criteria for cognitive impairment
           and healthy controls.
    

Intervention name(s): Mini-Mental State Exam and Blood draw; Mini-Mental State Exam and Blood Draw; Mini-Mental State Exam and Blood Draw
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage; The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage; The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Survivors Healthy women
      
Keywords: Breast cancer; survivor
Acceptance-based Care for Child Eating and Physical Activity Treatment
Condition: Pediatric Obesity; Executive Function; Self-Regulation
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to develop and pilot test a new type of patient-centered,
      family-based treatment for children aged 8-12 with obesity and their caregivers. The
      treatment will focus specifically on improving children's self-regulation (SR) skills to help
      them better manage their feelings, behaviors, and thoughts to help them live a healthier
      lifestyle.
    

Detailed description: 
      We aim to: (1) To determine the treatment needs of children ages 8-12 with obesity and their
      families with a focus on understanding cognitive function challenges that are related to
      self-regulation (using focus groups i.e. FG and feedback sessions i.e. FB). (2) To evaluate
      the feasibility and acceptability of this novel family-based treatment. (3) Explore potential
      associations between pediatric cardiovascular (CVD) risk factors and self-regulation in
      children with and without overweight or obesity. (4) To refine the F-ABT protocol and to
      maximize participant feasibility, acceptability, safety, and tolerability of F-ABT. (5) To
      provide pilot, proof-of-concept, and preliminary efficacy data of beneficial effects of F-ABT
      on SR and BMI in children with SR deficits and their caregivers.
    

Intervention name(s): Acceptance-based Behavioral Treatment (ABBT)
Intervention type(s): Behavioral
Intervention description(s): ABBT is rooted in behavioral therapy but also cultivates self-regulation skills including experiential acceptance of potentially uncomfortable internal experiences (e.g., emotions, cravings), mindful awareness of decision making (e.g., mindful eating), and values clarification and behavioral commitment (e.g., practicing daily physical activity to be a contributing member on a sports team). ABBT has been used effectively to help youth and adults manage various medical and psychological problems. Moreover, components of ABBT have been shown to improve child and adult EF including inhibitory control and cognitive flexibility. Recently, ABBT has been integrated with components of standard behavioral treatment of obesity and applied with robust efficacy to weight management in adults.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Obesity; Executive Function; Behavioral Intervention; Self-Regulation; Acceptance-Based