bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
Condition: Cerebral Palsy; Child, Preschool
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Self-produced locomotion often is limited in children with cerebral palsy and other
      conditions that cause severe motor impairments. As a result, these children may be at risk
      for secondary impairments in spatial cognition, communication, social development, and other
      domains influenced by independent mobility. To compensate, power mobility has increasingly
      been advocated for young children with severe motor impairments. The study hypotheses were:

        1. Children with severe disabilities that prevent independent locomotion who learn to use
           power mobility devices when they are 14- to 30-months-of-age will have greater
           communication, social, and cognitive development over a 12-month period, and will
           demonstrate more competent coping skills than children with the same characteristics who
           do not use power mobility.

        2. Parents of children who use power mobility will view it as a positive influence on their
           children's lives, and will perceive their children's development to be more mature than
           the parents of children who do not use power mobility will perceive their children's
           development.
    

Detailed description: 
      More extensive description is not desired.
    

Intervention name(s): Power wheelchair; No power wheelchairs
Intervention type(s): Other; Other
Intervention description(s): Children used power wheelchairs for one year. They continued to receive their usual early intervention services.; Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
Other intervention name(s): Invacare Power Tiger wheelchairs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; wheelchair; disabled children
Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test a new treatment of pancreatic cancer that cannot be
      removed by surgery. This treatment is a Phase I dose escalation research study which will
      combine one drug at increasing doses with a fixed dose of a second drug and radiation
      therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil
      will remain the same for all patients.
    

Detailed description: 
      -  Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine,
           5-fluorouracil and radiation therapy. We also hope to assess the number of people who
           respond to this therapy and to assess the feasibility of giving intraoperative radiation
           therapy following gemcitabine, 5-fluorouracil, and external beam radiation therapy.

        -  A surgical procedure, either laparotomy or laparoscopy, will be required to check the
           amount of disease before treatment is started.

        -  All patients will receive the same two chemotherapy drugs and radiation therapy. Both
           gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy.
           5-fluorouracil will be given continuously by intravenous infusion and will continue
           until the external beam radiation therapy is completed. The gemcitabine will be given
           (at different doses for each cohort of patients) once per week for seven weeks.
           Radiation therapy will be given daily for five days for seven weeks. On those days when
           gemcitabine is given, radiation therapy will be given approximately four hours after the
           gemcitabine dose.

        -  Four weeks after completing the radiation therapy and chemotherapy, patients will
           undergo a scan to check the extent of disease. Following the scan, patients will be
           considered for a repeat surgical procedure to remove the tumor, if possible. If removal
           of the tumor is not possible, patients will receive intraoperative radiation therapy.

        -  After completing the therapy, patients will be seen at least every 3 months for one
           year. A complete physical exam and CT scan will be done regularly.
    

Intervention name(s): Gemcitabine; 5-Fluorouracil; Radiation Therapy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.; 5-FU via continuous IV infusion.; External Beam Radiotherapy (weeks 1-6), Monday through Friday.
Intervention MeSH terms: Gemcitabine; Fluorouracil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gemcitabine; 5-fluorouracil; 5-FU; unresectable pancreatic cancer; non-metastatic pancreatic cancer
Essential Fatty Acids in Adult ADHD
Condition: Adult Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this project is to investigate the effect of a dietary supplementation with
      essential fatty acids in adults on cognitive functions related to attention and impulse
      control in the general population and in individuals with a diagnosis of attention deficit
      hyperactivity disorder (ADHD).
    


Intervention name(s): Essential fatty acids
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of the study is to elucidate the effects of lupin protein (Lupinus
      angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify
      the role of arginine, one of the most abundant amino acids in lupin protein.
    

Detailed description: 
      The study is based on a previous finding that a daily dosage of 25 g lupin protein isolate,
      administered as protein drinks, is capable to influence the plasma lipids positively.

      Consequently, the physiological effects of a mixed diet containing 25 g lupin protein isolate
      per day will be investigated compared to 1) a diet containing 25 g of milk protein as well as
      to 2) a diet with 25 g milk protein and additionally the amino acid arginine supplemented
      daily.

      A double-blinded, controlled, randomized cross-over trial will be performed. Altogether 75
      volunteers with hypercholesterolemia will be divided into three groups of 25 subjects each.
      After a run-in period (baseline), the first group will consume foods with lupin protein
      isolate (group A), the second group will receive the same foods with milk protein isolate
      (group B) and the third group will consume the foods with milk protein and 1,6 g arginine per
      day over a period of four weeks. After a wash-out period of six weeks, the diet will be
      crossed within the three groups for a second intervention period of four weeks. After another
      wash-out period, diet will be crossed within the three groups once again.

      Arginine will be provided as capsule (1,6 g per day = four capsules per day) in one of the
      two groups receiving foods with milk protein. In the other groups (receiving foods with lupin
      protein or milk protein only) four placebo capsules will be served, containing mannitol.
    

Intervention name(s): Fabricated foods with lupin protein; Mannitol; Arginine; Fabricated foods with milk protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): - Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread); - Placebo capsules containing mannitol (four capsules per day); - Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g); Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
Intervention MeSH terms: Mannitol; Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dietary protein; Lupin protein; Cholesterol metabolism; Protein metabolism; Hypercholesterolemia; Protein-enriched foods
A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this randomized, stratified, single-blinded study is to compare two home based
      strength-training protocols (High Intensity Interval Training and Progressive Resistance
      Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in
      children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy is a common neuro-developmental disorder. Among other signs of upper motor
      neuron syndrome, walking pathologies and muscle weakness are leading signs of disability in
      children with cerebral palsy. Moreover, the gradual decline in muscle strength is part of the
      aging process and can be particularly devastating for people with motor disabilities.
      Therefore muscle-strengthening programs are indicated for children with cerebral palsy. There
      is evidence that lower extremity muscle strength can be increased by Progressive Resistance
      Training (PRT) in children with cerebral palsy. However, PRT is time consuming and therefore
      not always feasible for children with neurologic disorders. Moreover, it does not influence
      the anaerobic capacity needed for everyday activities in children. High Intensity Interval
      Training (HIIT) is a time efficient method, which increases both aerobic and anaerobic
      capacities. The aim of this randomized, stratified, single-blinded study is to compare two
      home based strength-training protocols (HIIT and PRT) and their effects on muscle strength,
      gait and aerobic and anaerobic capacity in children with cerebral palsy.
    

Intervention name(s): High Intensity Interval Training; Progressive Resistance Training
Intervention type(s): Other; Other
Intervention description(s): See arm description; See arm description
Other intervention name(s): HIIT; PRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Muscle structure; Strength training
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)
      in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
    


Intervention name(s): Inotuzumab Ozogamicin (CMC-544)
Intervention type(s): Drug
Intervention description(s): Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles
Intervention MeSH terms: Inotuzumab Ozogamicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell Non-Hodgkin's Lymphoma; NHL
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3
      study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10
      mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg)
      compared to placebo administered daily for 8 consecutive weeks in subjects with primary
      hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus
      placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily
      Vytorin versus placebo with respect to change in the concentrations of total cholesterol,
      triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be
      assessed.
    


Intervention name(s): ezetimibe with simvastatin; Ezetimibe with Simvastatin; Ezetimibe with Simvastatin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks; Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks; Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks; Placebo once daily for a total of eight weeks
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin
Condition: Elevated Lipoprotein(a); Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label, single sequence, two-treatment, two-period drug-drug
      interaction study to evaluate the effect of multiple doses of ISIS 681257 on the
      pharmacokinetics of a single dose of warfarin.
    


Intervention name(s): ISIS 681257; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Xmg dose administered as a subcutaneous injection; 25mg tablet administered orally
Intervention MeSH terms: Warfarin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic
      25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.
    


Intervention name(s): Humalog Mix25; Insulin Lispro Biphasic 25
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses; Subcutaneus injections Insulin Lispro Biphasic 25 ("Geropharm") twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Lispro Biphasic; Insulin
CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D
      duration >12 months, HbA1c 7.5-<11.0%, using an insulin pump or MDI)) will be randomly
      assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will
      be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group
      will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial
      will be followed by a 6-month extension study during which the RCT control group will
      initiate CGM and the RCT CGM group will continue CGM.
    


Intervention name(s): Continuous Glucose Monitor (CGM)
Intervention type(s): Device
Intervention description(s): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation
Condition: Circulation; Drug Dose; Calculated SAP
Study type: Interventional

Summary: 
      Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation
      and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.
    

Detailed description: 
      Pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical
      ventilation have been shown to be effective parameters to predict preload responsiveness.
      Although induced hypertension decreases PPV and SVV, the influences of phenylephrine,
      dopamine and ephedrine on PPV and SVV are unknown.
    

Intervention name(s): Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation
Intervention type(s): Other
Intervention description(s): This research mainly study the effect of clinical commonly used vasoconstrictor drugs on blood pressure of pressure
Intervention MeSH terms: Phenylephrine; Dopamine; Oxymetazoline; Ephedrine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia
Condition: Tachycardia, Ventricular
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 4

Summary: 
      Determine effects of remifentanil conscious sedation in patients undergoing
      Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia
      and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin
    

Detailed description: 
      The purpose of the study is to determine the effects of remifentanil conscious sedation in
      patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic
      ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

      Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly
      broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect
      is practically eliminated within 5 minutes after the intravenous sedation is stopped.

      You are being asked to participate in this study because you are already scheduled to undergo
      EP studies under the care of your cardiologist for the ablation of idiopathic ventricular
      tachycardia and/or persistent frequent PVCs of non-ischemic origin.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: idiopathic ventricular tachycardia
Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer
Condition: Pancreatic Ductal Adenocarcinoma
Study type: Observational

Summary: 
      The primary objective of the study will be to estimate the prevalence of germline mutations
      in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic
      ductal adenocarcinoma.
    

Detailed description: 
      The proposed research is a multi-site prospective and observational plan to investigate the
      prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two
      genes will be analyzed, all of which have been associated with an increased risk for cancer.
      The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH
      test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A,
      CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE,
      PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .
    

Intervention name(s): Multi-gene Next Generation Sequencing Panel
Intervention type(s): Genetic
Intervention description(s): Participants will have genetic testing
Other intervention name(s): CancerNext
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be patients who are diagnosed within 12 weeks of enrollment with
        Pancreatic Ductal Adenocarcinoma.
      
Biospecimen description: 
      Blood, saliva or DNA
    
Keywords: Germline; Pancreatic; Genetic Testing
Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity
Condition: In Vitro Fertilization
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a prospective randomized clinical trial to compare the efficacy of the urinary
      and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.
    

Detailed description: 
      The study population comprised of all infertile patients aged 20-37 years which underwent of
      in-vitro fertilization in royan institute, Tehran Iran.

      In this study all patients were treated with a long stimulation protocol in which
      GnRH-analogue (Buserelin subcutaneous, 0.5cc daily) was given as a pre-treatment and
      recombinant FSH (rFSH) administration was started when pituitary desensitization was
      confirmed. From the 7th day of stimulation in both groups, daily monitoring of follicle size
      by ultrasound was performed and the dose of rFSH was adjusted according to the response of
      each patient. When at least two follicles > 18 mm diameter were seen, ovulation was triggered
      with hCG and patients allocated into three different study groups as per the following:

        1. Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle)

        2. Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle)

        3. Group C consisted of 60 patients received 10,000 IU urinary hCG Oocyte retrieval
           performed about 34-36 hours after hCG administration and then oocytes were assessed for
           nuclear maturity. Embryos transferred 2-3 days thereafter.

      Data collection will be performed by using questionnaire to be filled as per the available
      records and laboratory results. Data analysis will be done through descriptive and perceptive
      statistical methods by using SPSS software version 16 for windows.
    

Intervention name(s): recombinant hCG; recombinant hCG; urinary hCG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): recombinant hCG(250 µg Ovitrell); recombinant hCG(500 µg Ovitrell); 10,000 IU urinary hCG
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovulation induction; urinary; hCG; recombinant hCG