bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders
      (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive
      Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism
      Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April
      2016. The individuals enrolled in the program will be administered a standardized assessment
      battery during each visit with the care coordinator or study coordinator. The proposed study
      will analyze data gathered during each of the assessment periods in order to check the
      efficacy and viability of the protocol.
    

Detailed description: 
      Current collaboration between individuals, families, and providers through in-person meetings
      are extremely infrequent, costly, and occur most often when providers are intimately involved
      as part of a multidisciplinary team in a single setting such as at a school. Often, little
      information is transmitted between providers and/or school personnel in determining treatment
      goals and interventions. Furthermore, the transmission of information is often provider to
      provider or school personnel to provider, which excludes direct patient-input and lessens
      transparency in decision making. In an effort to improve current care and therefore improve
      successful adult transitions for adolescents with ASD, t-CARE is designed to mimic
      multidisciplinary team meetings. These meetings are incredibly impactful as they include
      direct individual and family involvement through facilitated information-sharing, while also
      maintaining patient-centered care across multiple providers and complex systems of care.
    

Intervention name(s): Care Coordination Visit
Intervention type(s): Behavioral
Intervention description(s): This is a longitudinal study. Adolescents or young adults with autism will participate in this study. Participants will be required to complete a baseline of assessment measures at enrollment and then monthly assessments (described in the study procedures below) during the first (approximately) 10-15 minutes of each visit with the t-CARE coordinator. The remainder of the visit will focus on care coordination and clinical treatment goals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
IGF-1 and Bone Loss in Women With Anorexia Nervosa
Condition: Anorexia Nervosa; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in
      bone density). A significant decrease in bone density is called osteopenia or osteoporosis.
      Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the
      bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this
      condition often have thin or weak bones that are more likely to break. They also have very
      low levels of a chemical called IGF-1 in their body. This chemical is very important for
      increasing bone growth in puberty and for maintaining healthy adult bones. The investigators
      would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can
      lead to an increase in bone formation, bone density, and bone strength in women with anorexia
      nervosa.
    


Intervention name(s): rhIGF-1; Risedronate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.; Risedronate 35mg PO one time weekly; Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly
Other intervention name(s): Increlex; Actonel
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Osteopenia; Osteoporosis; Bone density
Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess drug drug interaction through pharmacokinetics investigation at steady state of
      Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations
      in healthy Japanese male subjects
    


Intervention name(s): Telmisartan/Amlodipine; Telmisartan/Amlodipine/HCTZ; Telmisartan/HCTZ
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan/Amlodipine fixed-dose combination; Telmisartan/Amlodipine/HCTZ fixed-dose combination; Telmisartan/HCTZ fixed-dose combination
Intervention MeSH terms: Amlodipine; Telmisartan; Hydrochlorothiazide; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Neprilysin on Glucagon-like Peptide-1
Condition: Diabetes; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      In the current study we wish to investigate the effects on glucagon-like peptide-1 (GLP-1) of
      a neprilysin inhibitor
    

Detailed description: 
      Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced
      insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within
      minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A
      few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the
      degradation of GLP-1 but if this is the case in humans is unknown. We therefore administered
      a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and
      100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and
      measured plasma concentrations of GLP-1
    

Intervention name(s): Entresto; Sitagliptin 100mg; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose administration of Entrestro 194 mg sacubitril / 206 mg valstartan; 2 x 100mg sitagliptin as single dose.; No treatment
Other intervention name(s): ARNI; Neprilysin inhibibitor; DPP-4 inhibitor; placebo
Intervention MeSH terms: Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants are on 4 study days with wash out period of minimum 2 weeks randomized to 4 intervention arms
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GLP-1; Neprilysin; DPP-4
Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by
      making cancer cells more sensitive to the drug.

      PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C
      in treating patients who have recurrent or refractory multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of arsenic trioxide when administered with ascorbic
           acid in patients with recurrent or refractory multiple myeloma.

        -  Determine the therapeutic efficacy of this treatment combination in these patients.

        -  Determine the expression of MDR and Bcl-xL genes and the intracellular levels of GSH in
           these patients before and after this treatment regimen and assess whether these measures
           have prognostic value.

      OUTLINE: This is a multicenter, dose-escalation study of arsenic trioxide.

        -  Phase I: Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over
           5-10 minutes on days 1-5 weekly for 5 weeks. Treatment continues every 7 weeks for up to
           6 courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum
      tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of
      3 or 2 of 6 patients experience dose-limiting toxicity.

        -  Phase II: Patients receive the MTD of arsenic trioxide with ascorbic acid as outlined
           above.

      Patients are followed monthly for up to 5 years.

      PROJECTED ACCRUAL: A total of 31-43 patients (6-18 for phase I and 16-25 for phase II) will
      be accrued for this study within 2.5 years.
    

Intervention name(s): ascorbic acid; arsenic trioxide
Intervention type(s): Dietary Supplement; Drug
Intervention MeSH terms: Ascorbic Acid; Arsenic Trioxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Effect of LLLT and Ozone to Reduce Complications After Extraction of Impacted Lower Molar
Condition: Complications of Extraction of Impacted Teeth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Many factors cause third molars to stay impacted in the jaws, hence the extraction of
      impacted wisdom teeth occurs often in dental clinics. Pain, trismus, and edema are typical
      postoperative complications following third molar surgery. Various strategies have been
      developed to prevent or reduce these postoperative complications, Among these is the use of
      Low-Level Laser Therapy (LLLT), which demonstrates numerous benefits in lowering pain,
      trismus, and edema by managing inflammation. The precise biological mechanism of action
      remains unknown. There seems to be evidence that it may have neuro-pharmacological impacts on
      the production, metabolism, and release of a number of biological compounds, the other option
      is use of ozone which has antimicrobial effectiveness (viricidal, bactericidal, and
      fungicidal). Additional well-known advantages include immunological modulatory and
      stimulating actions, including anti-inflammatory, biosynthetic, anti-hypoxic, and
      bioenergetic characteristics. Ozone can interact with blood components in the right amounts
      to positively impact oxygen metabolism and cell energy while also triggering antioxidant
      defense mechanisms
    


Intervention name(s): low level laser therapy; ozone gel
Intervention type(s): Radiation; Drug
Intervention description(s): LLLT induces cellular biostimulation, speeds up tissue regeneration, enhances wound healing, and reduces pain and swelling through an anti-inflammatory effect. This is because the LLLT increases phagocytic activity, and the number and diameter of lymphatic vessels, decreases the permeability of blood vessels and restores microcapillary function; ozone is effective antimicrobial (viricidal, bactericidal, and fungicidal). Other well-known benefits include immunological modulatory and stimulating effects and anti-inflammatory, biosynthetic, anti-hypoxic, and bioenergeticseffects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study aims to evaluate the safety and clinical feasibility of epicardially delivered
      autologous atrial appendage micrografts in the treatment of heart failure. The micrografts
      consisting atrial-derived cells and their extracellular matrix, are placed on an infarction
      scar during CABG surgery.
    

Detailed description: 
      The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells.
      During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be
      excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims
      to address the surgical feasibility and patient safety of epicardially delivered atrial
      appendage micrografts during CABG surgery.

      Autologous cardiac cells are harvested from right atrial appendage during CABG of six
      patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their
      extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are
      placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered
      epicardially on top of a infarction scar. Parameters including echocardiography reflecting
      cardiac insufficiency are studied pre- and post-operatively as well as at three and six
      months of the follow-up. Cardiac functional magnetic resonance imaging is performed
      preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a
      control group. They are scheduled for elective CABG and are treated according to the normal
      hospital protocol, without the ECM sheet.
    

Intervention name(s): CABG surgery; AADC therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Elective CABG surgery; Atrial appendage derived cells are placed on the site of a infarct scar with matrix sheet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous micrografts; heart failure; coronary artery bypass surgery; cell therapy; atrial appendage; epicardial cell delivery
Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation
Condition: Analgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar
      spine fixation
    

Detailed description: 
      The erector spinae plane block (ESPB) its an interfacial plane block for an effective
      treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB
      has fewer side effects and is safe for patients of all ages having abdominal and thoracic
      operations .
    

Intervention name(s): Bupivacaine 0.25% Injectable Solution
Intervention type(s): Drug
Intervention description(s): Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
Condition: Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and side effects of the
      study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will
      also evaluate how much of the study drug gets into the blood stream and how long it takes the
      body to remove it.
    


Intervention name(s): LY3090106; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Caudal Block vs Local Wound Infiltration for Hernia Repair in Children
Condition: Anesthesia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To our knowledge there is still no study comparing the local wound infiltration by itself
      without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this
      study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal
      hernia repair with caudal block (CB) or local wound infiltration (LWI).
    

Detailed description: 
      Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing
      unilateral hernia repair will be enroled in the study. One group will receive caudal block
      (CB) and the other group will receive local wound infiltration (LWI).

      Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25%
      bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be
      assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the
      Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after
      operation. The time to first supplemental oral acetaminophen demand (first acetaminophen
      time) was defined as the time from the end of surgery to the first registration of more than
      4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of
      delayed side-effects and demands for rescue acetaminophen from the child will be gathered.
      The investigator, who will be blind to the treatment group, will document these data with the
      medical records.
    

Intervention name(s): Bupivacain- Caudal; Bupivacaine- Local
Intervention type(s): Procedure; Procedure
Intervention description(s): Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).; Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).
Other intervention name(s): Caudal block; Local Wound Infiltration
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: caudal block; local wound infiltration; hernia repair
A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977
      (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1
      hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or
      are HCV treatment-naive (patients who never received treatment for HCV infection).
    

Detailed description: 
      This is a Phase IIa, randomized (the study medications are assigned by chance), open label
      (all people know the identity of the intervention) study of TMC435 plus PSI-7977 (GS7977)
      with or without ribavirin. The study consists of a screening phase (6 weeks); a treatment
      phase (12 or 24 week period); and a posttreatment phase (follow-up period up to Week 48).
      Approximately 180 patients will be enrolled in this study. Patients will be sequentially
      enrolled into two cohorts in this study. Cohort 1 (90 patients) will include patients without
      advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy and Cohort
      2 (90 patients) will include only patients with advanced hepatic fibrosis who did not respond
      to previous PegIFN/ribavirin therapy or are HCV treatment-naive. Safety will be evaluated
      throughout the study and will include evaluations of adverse events, clinical laboratory
      tests, electrocardiogram, vital signs, and physical examination. The entire study duration
      for each participant will be approximately 48 weeks.
    

Intervention name(s): TMC435; PSI-7977 (GS7977); Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TMC435 will be administered as one oral capsule of 150 mg once a day.; PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.; Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).
Other intervention name(s): GS7977
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC435; PSI-7977; GS7977; Ribavirin; HCV; Hep C; Genotype 1
Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in China. The purpose of this study is to evaluate the
      pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy
      male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with
      different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with
      different manufacturing process
    


Intervention name(s): tafolecimab (a modified manufacturing process); tafolecimab (a original manufacturing process)
Intervention type(s): Drug; Drug
Intervention description(s): 450mg，SC，single dose; 450mg，SC，single dose
Other intervention name(s): IBI306 (a modified manufacturing process); IBI306 (a original manufacturing process)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®
Condition: Relapsing Remitting Multiple Sclerosis RRMS
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a 3-year, prospective, multi-center, open-label study to describe the long term
      changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment
      with Fingolimod. It was designed to longitudinally study the degeneration of retinal axons by
      measuring change in RNFL thickness by latest OCT-technology.
    


Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): All subjects received an oral dose of 0.5 mg fingolimod (FTY720) per capsule (hard gelatin capsules) once daily according to local label for the treatment of their MS.
Other intervention name(s): FTY720
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Multiple sclerosis (MS); MS