bioihbjkbjnl/mcl2 huggingface dataset:
FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The scope of this study is to evaluate the efficacy of the addition of atezolizumab to
      FOLFOXIRI plus bevacizumab as first line treatment of patients with metastatic colorectal
      cancer in terms of Progression Free Survival.
    

Detailed description: 
      This is a prospective, open-label, multicentric phase II randomized in a 1:2 ratio trial in
      which patients initially unresectable and previously untreated mCRC will receive induction
      treatment with FOLFOXIRI plus bev up to 8 cycles followed by maintenance with 5-FU/LV plus
      bev until disease progression, unacceptable toxicity or patient's refusal (arm A) versus
      FOLFOXIRI plus bev plus atezolizumab up to 8 cycles followed by maintenance with 5-FU/LV plus
      bev plus atezolizumab until disease progression, unacceptable toxicity or patient's refusal
      (arm B). If disease progression does not occur during induction, at the treating physician's
      discretion, the reintroduction after progression of the same induction treatment (up to 8
      cycles) according to randomization arm, followed by maintenance until disease progression,
      unacceptable toxicity or patient's refusal, is recommended.

      The third- and subsequent lines of treatment will be at investigators' choice.
    

Intervention name(s): Bevacizumab; Irinotecan; Oxaliplatin; L-Leucovorin; 5-fluorouracil; Atezolizumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/kg iv over 30 minutes day 1; 165 mg/sqm iv over 60 minutes day 1; 85 mg/sqm iv over 2 hours day 1; 200 mg/sqm iv over 2 hours day 1; 3200 mg/sqm 48 h-continuous infusion; 840 mg iv over 30 minutes (60 minutes at the first infusion) day 1
Intervention MeSH terms: Leucovorin; Bevacizumab; Atezolizumab; Fluorouracil; Oxaliplatin; Irinotecan; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, open-label, multicentric phase II randomized in a 1:2 ratio
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FOLFOXIRI; Bevacizumab; Atezolizumab
Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer
Condition: Prostate Cancer; Radiation Therapy
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer is the second most incident cancer among male population worldwide. Radiation
      therapy by itself or along with surgery and chemotherapy are the main treatments for prostate
      cancer however prostate cancer cells are only modestly responsive or even unresponsive to the
      cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed
      radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in
      this area and it is not yet known whether radiation therapy is more effective with or without
      curcumin supplements in treating patients with prostate cancer.
    


Intervention name(s): Curcumin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Patients take 3 grams of BCM95 Curcumin (as 6 × 500 mg capsules); Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Patients take 3 grams of roasted rice powder (as 6 × 500 mg capsules)
Other intervention name(s): turmeric pigment
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: curcumin; radioprotective; radiosensitizer
PRimary Prevention Of Depression in Offspring of Depressed Parents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this randomised controlled trial is to see whether a group-based psychological
      intervention for families can reduce the inflated risk of depression in children and
      adolescents who have at least one parent who suffers from depression (or who has suffered
      from depressed in the child's lifetime).
    


Intervention name(s): Prevention programme
Intervention type(s): Behavioral
Intervention description(s): Based on a group- and family-based cognitive behavioural manual developed by Bruce Compas and colleagues in the USA, and adapted for a German sample. The programme is for parents and children and consists of 8 weekly sessions and 4 monthly booster sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Depression; Prevention; Adolescent; Child; Randomised Controlled Trial; Risk; Cognitive behavioural therapy; Group-based therapy
Piloting a Mobile Game for Behavioral Therapy
Condition: Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The following study aims to understand the feasibility of the mobile app and game, GuessWhat,
      to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style
      game that engages parent and child in fluid social interaction where the parent must guess
      what the child is acting out based on the prompt shown on the phone screen. Participants will
      use their own personal phone to download the study app. The app will walk participants
      through a variety of charades style games. The interactive games will be video recorded and
      all data are transferred securely to the Wall Lab for analysis. This study is enrolling
      parents of children with ASD who are at least 18 years of age and have a child between 3-12
      years old. Parents are asked to complete questionnaires before and after playing the
      GuessWhat game with their child 3-4 times per week for 4 weeks.
    


Intervention name(s): GuessWhat Mobile Application
Intervention type(s): Other
Intervention description(s): The GuessWhat app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.
Masking: None (Open Label)
Primary purpose: Other
Keywords: digital; mobile health; game; autism; technology; therapy
A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the
      effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous
      system's (SNS) activity in subjects with essential hypertension.
    


Intervention name(s): Bisoprolol; Atenolol
Intervention type(s): Drug; Drug
Intervention description(s): Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.; Atenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.
Other intervention name(s): Concor®
Intervention MeSH terms: Atenolol; Bisoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Bisoprolol; Atenolol
Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging
Condition: Stomach Neoplasm
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      " Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic
      artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation
      should consider the oncologic safety and liver-related complication. Theoretically, the ALHA
      preservation is the most ideal in the aspect of liver function protection. However, it is
      technically difficult which consumes much time. Not only that, oncologic safety could be
      threatened as some soft tissues, including lymph nodes, could be remained while in preserving
      the ALHA.

      There has been no standardized method to evaluate the ALHA, and to decide whether preserve or
      ligate it.

      This prospective study has been designed to develop the decision algorithm to define the ALHA
      preservation/ligation, using near-infrared fluorescence imaging during surgery. "
    


Intervention name(s): Group1; Group2; Group3
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery; Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery; No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural
      African American (AA) adults in South Carolina (SC) for assessing the usefulness of
      tablet-based resources in good diabetes self-management behaviors, and (2) to test a
      tablet-aided intervention for improving diabetes self-management behaviors
    

Detailed description: 
      The proposed study will assess the feasibility of recruitment of African American adults
      residing in rural South Carolina who will assist with improving the usability of tablet
      computers. In addition, we will implement a pilot trial of the TABLETS (Tablet-Aided
      BehavioraL intervention Effect on Self-management skills) intervention for diabetes, using
      motivational strategies, among rural African Americans. The proposed project is designed to
      address 3 important issues: recruitment for a hard-to-reach population, utility of
      technology-enabled intervention, and development of a tablet-aided intervention tailored to
      understand best practices for diabetes self-management
    

Intervention name(s): Tablets Intervention
Intervention type(s): Behavioral
Intervention description(s): The TABLET intervention adds a novel tablet-based delivery mechanism to provide real-time videoconferencing education about diabetes self-management behaviors to high-risk, low-income African American (AA) adults with diabetes. Cardiovascular disease (CVD) knowledge/ information modules consist of materials developed from a CVD patient education booklet adapted from Maine Heart Center of Maine Health and supplemented by clinical guidelines to specifically address behavioral risk factors. Motivation/behavioral skills training modules consist of patient activation (asking questions to providers), patient empowerment (CVD responsibility contracts, flow charts for lab results), and behavioral skills training (self-monitoring, goal-setting).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type II; African Americans; Blacks; Non-Hispanic Blacks; Randomized Control Trial; Controlled Clinical Trial; Behavioral Research; Behavioral Medicine
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in
      patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise
      therapy and metformin as monotherapy
    


Intervention name(s): Placebo; Sitagliptin phosphate
Intervention type(s): Drug; Drug
Intervention description(s): Double-blind period (12 wk); Placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD; Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MK-0431; ONO-5435; Type 2 diabetes mellitus
Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the link between insulin resistance and alterations
      in skeletal muscle mitochondrial redox homeostasis
    


Intervention name(s): Intralipid, 20% Intravenous Emulsion; MitoQ; Salbutamol
Intervention type(s): Drug; Dietary Supplement; Drug
Intervention description(s): Lipid infusion; Oral administration of MitoQ capsules; Beta2-agonist infusion
Other intervention name(s): Mitoquinone mesylate; Mitoquinone; MitoQ10
Intervention MeSH terms: Ubiquinone; Soybean oil, phospholipid emulsion; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Measured Energy Value of Walnuts in the Human Diet
Condition: Metabolizable Energy of Walnuts
Study type: Interventional

Summary: 
      The objective of this study is to measure the energy value of walnuts in the human diet and
      study molecular mechanisms that may help explain the beneficial health effects of walnuts.
      The hypothesis is that there will be less metabolizable energy in walnuts due to decreased
      fat digestibility.
    

Detailed description: 
      Previous studies have demonstrated that nut consumption imparts a variety of health benefits,
      including reduction of cardiovascular disease and improved satiety. The aim of this study is
      to determine the energy value of walnuts in the human diet and to probe mechanisms by which
      walnuts impart health benefits. The metabolizable energy value of walnuts will be calculated
      based on the chemical composition and energy content of the consumed diet and excreta. This
      will provide a better estimate of the energy value of walnuts than simply calculating energy
      value based on Atwater factors. In addition to determining the energy value of walnuts, we
      will evaluate the effects of walnut-rich diets on plasma phytonutrient levels and on gene
      expression changes to determine what protective mechanisms are activated by walnut
      consumption.
    

Intervention name(s): Walnut Diet; Control Diet
Intervention type(s): Other; Other
Intervention description(s): Controlled diet with 1.5 oz/d of walnuts.; Controlled diet without walnuts.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: metabolizable energy; walnuts; Atwater factors; energy value
Analysis of Metabonomics for Pleural Effusion
Condition: Pleural Diseases
MeSH terms: Pleural Effusion; Pleural Diseases
Study type: Observational

Summary: 
      This is a multicenter retrospective study that collected diagnostic information of patients
      with pleural effusion. The overall survival (OS) time of malignant patients was followed up,
      defined as the time from diagnosis to death. Clinical data and residual pleural effusion
      specimens were collected from patients. Metabonomics was utilized to differentiate between
      benign and malignant pleural effusion and to evaluate the prognosis of lung cancer patients
      with malignant pleural effusion.
    

Detailed description: 
      Pleural effusion (PE) is a common yet challenging problem in clinical settings. PE is a
      symptom caused by over 50 diseases and is typically classified as either malignant pleural
      effusion (MPE) or benign pleural effusion (BPE). MPE affects a significant number of
      individuals, with an estimated annual incidence of 500-700 cases per million population.
      Metastatic cancer is the leading cause of MPE, and lung cancer accounts for approximately
      37.5% of cases. The management of MPE is a major clinical challenge due to its association
      with a typically poor prognosis, with a median survival of only 3 to 12 months. However,
      predicting survival in MPE patients can be difficult due to significant heterogeneity in
      underlying malignancy and patient performance status. Therefore, accurate prognostication
      remains a significant challenge in the management of MPE.

      Metabonomics is an analytical technique for detecting metabolites in biological samples and
      has been widely used in disease diagnosis and prognosis evaluation in recent years. The aim
      of this study is to use Metabonomics technology to compare and analyze the differences in
      metabolites between benign and malignant pleural effusion, and to explore its application in
      the prognosis evaluation of lung cancer patients with malignant pleural effusion.
    

Intervention name(s): Detection of pleural effusion
Intervention type(s): Other
Intervention description(s): Detection of pleural effusion
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with pleural effusion
      
Biospecimen description: 
      pleural effusion
"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia
Condition: Combined Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      "Phospholipovit" vs placebo in patients with combined hyperlipidemia
    

Detailed description: 
      It is well known that atherosclerosis and its complications are the leading cause of
      morbidity and mortality in the world, and the high blood cholesterol is one of the leading
      risk factors for atherosclerosis.

      Among cholesterol-lowering agents, the most common are inhibitors of HMG-CoA reductase,
      so-called statins. Nevertheless, low attention is paid to the process responsible for
      cholesterol removing from the cells - the so-called "reverse cholesterol transport" (RCT).
      The major lipoproteins, involved in RCT, are high-density lipoproteins (HDL). The
      effectiveness of RCT is determined not only by the level of cholesterol in HDL, but also by
      the composition of HDL, in particular, by the content of phosphatidylcholine (PC) in HDL.

      Based on the original phospholipid composition, the Institute of Biomedical Chemistry
      developed the "Phospholipovit" - the aqueous medium of nanoemulsion of phospholipids with a
      particle size of 20-25 nm. The intestinal absorption of phospholipids nanoemulsion should
      contribute to the HDL enrichment by phospholipids, and, consequently, to the enhancement of
      RCT. A study of the safety and tolerability of the "Phospholipovit" in healthy patients has
      been completed. The "Phospholipovit" has demonstrated safety and tolerability.

      The main objective of this study is to evaluate the effectiveness and safety of
      "Phospholipovit", a powder for preparation of an oral solution, 500 mg compared with placebo
      in patients with combined hyperlipidemia.
    

Intervention name(s): "Phospholipovit"; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg orally 2 times a day, for 12 weeks; 500 mg orally 2 times a day, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At clinical centers, patients will be equally randomized by the "envelope method" into two groups to receive "Phospholipovit" or placebo.
The drugs will be administered after the signed informed consent. "Phospholipovit" will be administered 500 mg orally 2 times a day, for 12 weeks. Placebo will be administered orally 2 times a day, for 12 weeks. All patients will be examined after 12 weeks.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Phospholipid nanoparticles; non-HDL-C level; TG level
Study of the Effect of the Supine Position at Brain Velocities in Noncerebro - Injured Patient
Condition: Anesthesia General
Study type: Observational

Summary: 
      To evaluate the pulsatility index changes after setting supine position in non brain- injured
      patient under general anesthesia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient who need a surgery in supine position and who don't have brain injured or pulmonary
        desease.

        Forty patients over 24 month period were included in the study, after informed consent.

        Pulsatility index is mesured with doppler ultrasound:

          1. before general anesthesia

          2. after general anesthesia in dorsal position

          3. in supine position

          4. in supine position with 15° proclive Evaluation to the pulsatility index changes in
             theese position