bioihbjkbjnl/mcl2 huggingface dataset:
Carnitine Levels and Carnitine Supplementation in Type I Diabetes
Condition: Diabetes Mellitus, Type I; Hypoglycemia
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to determine whether type I diabetics with carnitine deficiency
      exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized
      hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to
      have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those
      subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour
      glucose monitoring.
    

Detailed description: 
      Hypoglycemia is a clinical marker of carnitine deficiency. Thus carnitine may compound the
      risk of hypoglycemia for children on insulin therapy. Currently, one of the limitations in
      the management of diabetes is hypoglycemia. The problem of hypoglycemia is of even greater
      significance in the pediatric population because children have smaller glycogen stores.

      In this study, we will determine if there is a group of children with increased frequency of
      hypoglycemia and carnitine deficiency. If there is a correlation from the initial 200
      children, we will compare two groups of type I diabetic children between the ages of 7 to 21
      years. We will take 20 children with the highest carnitine levels (found in a previous study)
      and 20 children with the lowest carnitine levels and perform continuous glucose monitoring
      for a 72-hour period. Those who have at least one episode of hypoglycemia will be asked to
      undergo repeat testing, after a 2-week period of oral carnitine supplementation.
      Supplementation will start at 50 mg/kg body weight for the first week and then increase to
      100 mg/kg body weight the second week. Laboratory studies obtained at baseline include
      Hemoglobin A1c, carnitine panel, and lipid panel. These will be repeated prior to the second
      continuous glucose monitoring. Insulin doses will not be changed between glucose monitoring
      sessions. A comparison will be made between individuals with hypoglycemia, to see if the
      number of hypoglycemic events has decreased.
    

Intervention name(s): Carnitine (drug)
Intervention type(s): Drug
Intervention description(s): Oral L-carnitine will be obtained from Sigma Tau Pharmaceuticals. Supplementation will be initiated at 50mg/kg body weight and increased to 100mg/kg body weight after one week.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        1. Children (male or female), between the ages of 7 and 21,

          2. who have had a diagnosis of Type 1 diabetes mellitus for at least two years and

          3. are currently on insulin replacement therapy.
      
Keywords: Diabetes Mellitus Type I,; Hypoglycemia,; Carnitine
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline
Condition: Age-related Memory Disorders; Mood Disorders
MeSH terms: Memory Disorders; Cognitive Dysfunction; Mood Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine the efficacy of 6 months' dietary supplementation with
      omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older
      adults. The effects of each of these interventions alone will also be assessed in order to
      determine whether the combined treatment confers synergistic or additive benefit relative to
      the effect of each therapy.
    

Detailed description: 
      After meeting inclusion criteria, one hundred-forty men and women, aged 62 to 80 years old,
      will be enrolled and randomly assigned to one of four groups: 1) omega-3 fatty acid and
      blueberry powder supplement, 2) omega-3 fatty acid and placebo powder, 3) placebo oil and
      blueberry powder supplement, or 4) placebo oil and placebo powder. They will participate in a
      24-week intervention with major assessments including neuropsychological and functional
      evaluation at pre-treatment baseline and during the final week of the intervention. In
      addition, an interim evaluation of neurocognitive function will be conducted at 12 weeks.
      Subjects will be asked to maintain diet diaries for three periods during the study. Mood will
      be assessed as a potential covariate of the neurobehavioral outcome measures and data on red
      blood cell fatty acid content, metabolic parameters, inflammation, and anthropometric factors
      will be gathered to assess compliance and explore individual differences in response to the
      intervention and to evaluate potential mechanisms of action.
    

Intervention name(s): Omega-3 fatty acid; Blueberry powder; Placebo oil; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).; Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.; Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.; Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.
Other intervention name(s): OmegaRx capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Working memory; Long-term memory; Neurocognition; Dietary supplementation; dementia
A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
Condition: Gallbladder Stone; Gallbladder Polyp
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account
      to this new method, the three incisions are all located on the lower abdominal, theoretically
      it could get more beautiful outlook and less stress response than traditional laparoscopic
      cholecystectomy(two of the three incisions located on upper abdomen) or single port
      laparoscopic cholecystectomy(one large incision located on umbilicus).

      We plan to conduct a randomized controlled trial to compare those there methods of
      laparoscopic cholecystectomy, in order to find out if there will be some advantages of this
      new method,such as in lowering the stress response,reducing impact on respiration, relieving
      post-operation pain and improving appearance.
    


Intervention name(s): laparoscopic cholecystectomy
Intervention type(s): Procedure
Other intervention name(s): lower abdominal three-port laparoscopic cholecystectomy; single port laparoscopic cholecystectomy; upper abdominal three-port laparoscopic cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F]SPA-RQ
Condition: Panic Disorder; Healthy
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to observe the effects of a panic attack in patients with panic
      disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby,
      further our understanding of its role in this illness. We will measure levels of Substance P
      in the brain by obtaining pictures of the brain using PET and MRI....
    

Detailed description: 
      The involvement of Substance P (SP) in depression and anxiety has been credibly demonstrated
      in a recent clinical trial. Although the precise physiological activation mechanism of the SP
      system is not yet known, the likelihood of exaggerated SP pathway activity in the
      pathogenesis of anxiety is supported in numerous animal studies that illustrate the
      anxiogenic, and anxiolytic effects of SP and SP antagonists (SPAs), respectively. Studies
      have further shown that SP release occurs in response to noxious, or aversive stimulation. SP
      stimulates NK1 receptors that then undergo endocytosis (i.e., internalization) resulting in a
      decrease in number of NK1 receptors on the cell surface. NK1 receptor quantification before,
      and after an aversive event, provides a dynamic measurement of SP neurotransmission.

      In this protocol, we will use a new PET ligand that has demonstrated ability to serve as an
      NK1 receptor antagonist, [18F]SPA-RQ ( [18F]-labeled Substance P Antagonist Receptor
      Quantifier). Using this tracer, we will: 1.) quantify NK1 binding parameters and determine
      the reliability and reproducibility of these measures in 10 healthy controls, 2.) we will
      look for regional differences in NK1 receptor binding in 10 patients with panic disorder (PD)
      versus 10 normal controls, and 3.) We will perform a single-blind, placebo-controlled study
      to evaluate NK1 receptor binding in PD patients and controls following either saline or
      doxapram infusion, which is a respiratory stimulant, in 20 patients with panic disorder (PD)
      versus 20 normal controls. Doxapram acts on both peripheral and medullary chemoreceptors to
      increase the rate and depth of breathing. It appears to be a potent and specific panicogenic
      agent, triggering panic attacks. The majority of PD patients, but not controls, are expected
      to experience a panic attack (aversive event) following the doxapram infusion. Comparison of
      pre-panic and post-panic NK1 receptor binding in PD patients will provide an estimate of SP
      release. The goal of the present study is to demonstrate the involvement of SP in panic
      disorder, and thereby, further our understanding of its role in the psychopathology of this
      illness.
    

Intervention name(s): [18F] SPA-RQ
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Tachykinin; Anxiety; Neuroreceptor; Internalization; Carbon Dioxide; Healthy Volunteer; HV; Panic Disorder
A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the amount of selpercatinib that gets into the
      blood stream and how long it takes the body to get rid of it, when given as different
      formulations. The information about any adverse effects experienced will be collected and the
      tolerability of selpercatinib will also be evaluated. The study may last up to 56 days
      including the 28 days of screening period.
    


Intervention name(s): Selpercatinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY3527723; LOXO-292
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy
Condition: Nephrectomy
Study type: Interventional

Summary: 
      To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy
      versus suture renorrhaphy
    

Detailed description: 
      Partial nephrectomy is the standard of care for T1 renal masses (local tumour) it preserves
      as much normal renal tissue as possible to avoid post-operative acute renal failure, chronic
      kidney disease and associated metabolic and cardiovascular morbidities . The main challenges
      that affect partial nephrectomy outcome is the need for renal ischemia to achieve good
      hemostasis, and the long-term oncological consequences associated with positive surgical
      margin. Laparoscopic partial nephrectomy has been widely used lately as it is associated with
      less blood loss, short hospital stay and early recovery in comparison to open partial
      nephrectomy . Hemostasis of the tumor bed after laparoscopic partial nephrectomy can be
      achieved by various techniques including Suture renorrhaphy which can be used whatever the
      bleeding area, the size of bleeding vessel, or the amount of bleeding. However, it consumes
      more ischemia time, involves functional parenchyma, and requires high laparoscopic skills .
      There for in our study we tried to find a way to improve the functional and oncological
      outcome of laparoscopic partial nephrectomy by comparing the bipolar coagulation versus
      conventional suture renorrhaphy in performing stable hemostasis of tumor bed
    

Intervention name(s): laparoscopic partial nephrectomy
Intervention type(s): Procedure
Intervention description(s): Operations were done under general anesthesia. Patients were positioned in modified lateral kidney position for trans-peritoneal procedures. Pneumoperitoneum using the Veress needle technique and trocar placement . Dissection to the renal hilum for good and sufficient exposure of the renal vessels. Good exposure of the tumor and marking the excision site with electro cautery. Clamping of renal vessels using laparoscopic Bulldog appliers. Excision of the renal mass using visual assessment to determine the suitable depth of normal parenchyma to be excised in order to achieve a negative surgical margin. Unclamping was done and re-assessment of the hemostasis to secure residual bleeding points. Approximation of the edges of renal parenchyma using suturing in both groups. The specimen was placed in an EndoCatch bag and removed through pfannenstiel incisionsurgical drain was placed in the paracolic gutter
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided into two groups by close envelope method in this prospective study. group (A) included 30 cases in which we used bipolar coagulation for hemostasis ,group (B) included 30 cases in which we used suture renorrhaphy.
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks
      lysozyme administration in patients with COPD.
    


Intervention name(s): Lysozyme hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LYL 90mg capsule: Three times daily for 52 weeks.; Matching Placebo capsule: Three times daily for 52 weeks.
Intervention MeSH terms: Muramidase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lysozyme hydrochloride; COPD
Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aim to Evaluate the combination of ididilimumab and docetaxel alone in the
      treatment of previous platinum-containing double-drug chemotherapy according to RECIST
      1.1Objective remission rate of advanced or metastatic non-small cell lung cancer with
      negative, driving gene negative (EGFR, ALK, ROS1); (ORR).
    

Detailed description: 
      This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative
      late-stage or metastatic non-small cell lung cancer (NSCLC) failed platinum-containing
      dual-drug chemotherapy. Center, single arm phase II study. In this study, 30 patients with
      advanced or metastatic non-small cell lung cancer who had failed platinum-containing
      dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease
      progression and intolerance. Toxicity, withdrawal of informed consent, death or other
      cessation of treatment as prescribed by the program, whichever occurs first. The primary end
      point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review
      Board (IRRC). The longest treatment time for ididibizumab is 24 months. An interim analysis
      will be conducted during the course of the study. The results and reports will be provided to
      the Independent Data Audit Committee (IDMC), which determines whether the trial is valid
      based on the valid cut-off value of the trial and whether the study data can be submitted in
      advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter
      will be finalized and approved by IDMC and the sponsor. The responsibilities and related
      procedures of IDMC members will be defined in the IDMC charter.
    

Intervention name(s): Sintilimab Combined With Docetaxel
Intervention type(s): Drug
Intervention description(s): Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w
Other intervention name(s): SCD
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small Cell Lung Cancer; Sintilimab; Docetaxel
The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial
Condition: Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized controlled trial was conducted from November 2015 and May 2016 with 112
      participants of people diagnosed with schizophrenia. Participants aged 18 years or older with
      Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from
      outpatient mental health clinics in Jordan, were randomly assigned participants either to
      receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment
      as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed
      at baseline, immediately post-intervention (post-treatment1) and at three months follow-up.
      The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS
      were psychiatric symptoms, recovery rate and quality of life.
    

Detailed description: 
      A randomized controlled trial was conducted from November 2015 and May 2016 with 112
      participants of people diagnosed with schizophrenia. Participants aged 18 years or older with
      DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in
      Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of
      intervention with face to face discussion, and treatment as usual [TAU] (intervention, n =
      56), or TAU (control, n = 56). Participants were assessed at baseline, immediately
      post-intervention (post-treatment1) and at three months follow-up. The primary outcome
      measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric
      symptoms, recovery rate and quality of life.
    

Intervention name(s): Empowerment
Intervention type(s): Behavioral
Intervention description(s): 6 weeks of empowerment program and supported face to face discussion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is aimed to evaluate the safety and efficiency of autologous bone marrow
      mononuclear cell transplantation in treating selective patients with type 2 Diabetes
      Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote
      β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate
      local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin
      and improve β-cells function.
    

Detailed description: 
      To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2
      diabetics. According to the intervention and baseline characteristics, patients are divided
      into 4 arms.
    

Intervention name(s): BMMCT
Intervention type(s): Other
Intervention description(s): Bone marrow mononuclear cell transplantation via selective catheterization
Other intervention name(s): Bone marrow mononuclear cell transplantation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2; diabetes mellitus; stem cell; safety; efficacy
Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study looking at the effect of lapatinib on concentrations of digoxin in
      the blood when both drugs are dosed together in Part 1; and looking at the safety and
      antitumor effect of lapatinib when used together with possible additional anticancer therapy
      as chosen at the doctor's discretion.
    


Intervention name(s): lapatinib; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): 1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10.; 0.5mg on Days 1 and 9
Other intervention name(s): lapatinib
Intervention MeSH terms: Lapatinib; Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lapatinib; Metastatic ErbB2 positive breast cancer; digoxin
Study Safety and Effectiveness of CURVE Laser Therapy for Circumference Reduction of the Waistline.
Condition: Injury to Subcutaneous Tissue
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level
      Laser Therapy for circumference reduction of the waistline.
    

Detailed description: 
      This study involves research to obtain information on the CURVE. In recent years Low Level
      Laser therapy devices have grown in popularity due to increased scientific understanding of
      their mechanism of action, published research, and patients demand for more non-invasive
      procedures in body contour and fat reduction. LLL are widely used in health clinics, medical
      spas and in aesthetic medicine in the treatment of cellulite and for inflammatory conditions
      such as carpal tunnel syndrome. This study will further evaluate the effectiveness of
      low-level laser treatments without the extraction of adipose tissue using liposuction or in
      combination with other treatment modalities.
    

Intervention name(s): Curve Low Level Laser Therapy
Intervention type(s): Device
Intervention description(s): Subjects assigned to the treatment group will be treated with 4 multi-paddle low-level diode laser consisting of 8 independent diode laser heads per treatment paddle, each emitting 630-680nm (red) laser light with each diode generating 40mW output ("CURVE" Laser - manufactured by YOLO Medical Inc.).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment