bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition
Condition: Parenteral Nutrition; Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      The present protocol describes a randomized, patient-blinded study in which either
      SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total
      Parenteral Nutrition (TPN) regimen will be given to adult surgical patients for 5 consecutive
      days.

      As serum prealbumin is a well-established surrogate efficacy parameter reflecting the
      patient´s nutritional status, the change of the serum prealbumin level at the day of the
      final study visit compared to baseline will represent the primary efficacy parameter in the
      present study.
    

Detailed description: 
      In addition, other variables will be assessed in this study, i.e., postsurgical new onset of
      nosocomial infection, CRP, free fatty acids, immunology parameters, the results of physical
      examination, vital signs, relevant nutrition- and safety-related laboratory parameters in
      venous blood and urine, the results of an Electrocardiography (ECG), and the number,
      severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs).
      The aim of the planned study is to demonstrate that SmofKabiven emulsion for infusion is not
      inferior to the comparative drug (hospital compounded "All in one" emulsion for parenteral
      nutrition).
    

Intervention name(s): SmofKabiven emulsion for infusion; Hospital compounded "All in one" emulsion
Intervention type(s): Drug; Drug
Intervention description(s): Total Parenteral Nutrition; Total Parenteral Nutrition
Other intervention name(s): Study intervention; Investigational Product; Control; Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SmofKabiven; Abdominal surgery; Parenteral; Nutrition
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      In this study the investigators will recruit patients with the diagnosis of schizophrenia
      that are taking atypical neuroleptics and that are willing to participate in an exercise and
      diet program. The investigators will measure weight and abdomen circumference.
    


Intervention name(s): Exercise program; Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Homogenous exercise program in local fitness centers; Weigh loss diet program prescribed by a professional nutritionist
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Schizophrenia; weight gain; atypical neuroleptics
Walking Aids in the Management of Hip Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not the use of a nonpharmacologic
      intervention (single point cane) is effective in the treatment of knee osteoarthritis.
    

Detailed description: 
      Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain
      and disability. Non-pharmacological treatments for hip OA include education, exercise,
      appliances (walking sticks or insoles), and weight reduction if obese or overweight. Canes
      are often recommended to reduce adverse forces across joints although there is currently no
      research evidence regarding the efficacy of walking sticks for hip OA. Little information is
      available regarding the impact of walking aids on psychosocial function and quality of life
      in individuals with hip OA. This study will evaluate the effects of walking aids in hip OA by
      examining gait biomechanics, quality of life, pain, and opinions regarding using a cane.

      Comparisons: Compare gait biomechanics in people with symptomatic unilateral hip OA while
      walking with and without a cane at baseline and after 4 weeks of cane use. Compare gait
      biomechanics in people with symptomatic unilateral hip OA with and without a cane to those of
      healthy, age-matched controls. Compare pain and health-related quality of life in people with
      symptomatic unilateral hip OA following 4 weeks of cane use. Determine the association
      between changes in gait biomechanics, pain, and health-related quality of life in people with
      symptomatic unilateral hip OA following 4 weeks of cane use.
    

Intervention name(s): single point cane
Intervention type(s): Device
Intervention description(s): Adjustable single point cane with SureGrip handle
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Walking Sticks; Canes
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the study volunteer breathes. The accuracy of a
      noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation
      measurements from a laboratory blood gas analyzer.
    


Intervention name(s): LNCS ADTX Sensor
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Three Protocols for Phenylephrine Administration in Cesarean Delivery
Condition: Cesarean Section Complications; Spinal Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75
      mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension
      occurred) and single shot (1.5 mcg/Kg) phenylephrine.
    

Detailed description: 
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal
      hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is
      still unknown. The most common PE protocols used for prophylaxis against PSH are: single
      shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5
      mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled
      trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min
      doses were the best doses for fixed infusion with accepted incidence of both PSH as well as
      reactive hypertension. Using variable infusion rate of PE had been recently introduced in
      another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very
      good results regarding PSH. In this study, the investigators will compare variable infusion
      of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will
      stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).
    

Intervention name(s): Single shot phenylephrine; Fixed infusion phenylephrine.; Variable infusion phenylephrine.; Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.; Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min; Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.; Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.
Other intervention name(s): Phenylephrine; Phenylephrine; Phenylephrine; Marcaine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and
      pharmacodynamic (PD) properties of multiple oral doses of DBPR108 in healthy male subjects.
    

Detailed description: 
      This study represents the administration of dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108
      to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic
      (PD) properties following multiple oral doses in healthy subjects.

      DPP4 is a validated drug target for the treatment of human type 2 diabetes. Objectives of the
      study will be to assess the safety and tolerability, PKs and PDs of DBPR108 at steady state
      after administration of multiple oral doses to healthy male subjects.
    

Intervention name(s): DBPR108; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.; Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DBPR108; DPP4; Diabetes; Glucagon-like peptide-1 (GLP-1); Incretins
Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy
Condition: Work Stress; Work Ability; Work Performance
MeSH terms: Occupational Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress,
      Work Ability and Work Performance in subjects with Hepatic Encephalopathy.
    


Intervention name(s): Acetyl-L-carnitine; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Acetylcarnitine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine if dietary fat alters insulin requirements in type
      1 diabetes.
    

Detailed description: 
      This cross-over prospective study will require a two day admission to the clinical research
      center. Subjects will undergo closed loop glucose control and will received a diet with
      controlled macronutrient content.
    

Intervention name(s): High fat meal
Intervention type(s): Other
Intervention description(s): 40 grams saturated fat
Other intervention name(s): Macronutrient
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia
Condition: Schizophrenia
MeSH terms: Seizures; Schizophrenia
Study type: Interventional

Summary: 
      This trial attempts to investigate whether the dosage (frequency) has an effect on the
      treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among
      schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST,
      while the other half will be recruited to 50 Hz MST.
    

Detailed description: 
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive
      therapy (ECT).Widespread stimulation of cortical and subcortical regions is inevitable for
      ECT since the substantial impedance of the scalp and skull shuts most of the electrical
      stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus
      to a specific area of the brain because they can pass the scalp and skull without resistance.
      In Addition, electric current will penetrate into deeper structures, while magnetic stimulus
      are only capable to reach a depth of a few centimeters. As a consequence, MST are able to
      generate focus stimuli on superficial regions of the cortex while ECT can't, which may give
      MST the capability to produce comparable therapeutic benefits with the absence of apparent
      cognitive side effects. Though high dose (frequency) MST is gaining popularity, there is no
      evidences supporting its superiority over low dose (frequency) MST either on efficacy,
      safety, or seizure quality.
    

Intervention name(s): 25 Hz magnetic seizure therapy; 50 Hz magnetic seizure therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 25 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.; In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 50 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnetic seizure therapy; schizophrenia; controlled trial; cognition
Evaluation of an Investigational Multifocal Lens
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to test the performance of an investigational multifocal test
      soft contact lens.
    


Intervention name(s): lotrafilcon B; etafilcon A
Intervention type(s): Device; Device
Intervention description(s): Soft contact lens to be worn as daily wear, monthly replacement modality.; Soft contact lens to be worn as daily wear, daily disposable modality.
Other intervention name(s): AirOptix Aqua Multifocal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of
      ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast
      cancer.
    


Intervention name(s): Gefitinib; Docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer
Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
Condition: Female Patients With High Tone Pelvic Floor Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether vaginal diazepam suppositories are an
      effective treatment of high tone pelvic floor dysfunction.
    

Detailed description: 
      High tone pelvic floor dysfunction is a common cause of pelvic pain in females. It is thought
      to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. Currently,
      treatment options include warm baths, stretching, physical therapy with myofascial therapy or
      biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. Physical therapy
      can be effective. However, it usually involves frequent visits to a specialized physical
      therapist to undergo intravaginal treatments consisting of myofascial release, massage, or
      biofeedback. We would like to find a treatment option for patients that would be effective
      without the invasive and time consuming nature of physical therapy. It is known that diazepam
      is a valid treatment option for disorders involving spasticity including spastic cerebral
      palsy5 and tetanus. A literature search on diazepam and high tone pelvic floor dysfunction
      revealed one paper. This study has an intrinsic flaw as it is a retrospective chart review,
      and the results are confounded by concurrent physical therapy. They were, however, able to
      find that patients treated with diazepam suppositories showed a significant improvement in
      pelvic floor tone. They also assessed pain and sexual function, but these did not reach
      statistical significance.
    

Intervention name(s): Vaginal Diazepam Suppository; Placebo Suppository
Intervention type(s): Drug; Drug
Intervention description(s): 10mg compounded vaginal suppository; Patients will be asked to use one vaginal suppository every night for 28 days
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: high tone pelvic floor dysfunction; levator pain; dyspareunia
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate
      the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to
      the ANA/DCD/065 trial
    


Intervention name(s): insulin aspart; insulin NPH
Intervention type(s): Drug; Drug
Intervention description(s): Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day; Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as
      first-line treatment could be considered a promising approach to improve the outcome of BRAF
      mutant metastatic colorectal cancer patients
    


Intervention name(s): FOLFOXIRI plus bevacizumab
Intervention type(s): Drug
Intervention description(s): BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by
IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by
OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with
l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by
5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks
Intervention MeSH terms: Bevacizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        BRAF mutant mCRC
Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to study the effect of megestrol acetate in the gain of body
      weight in patients with severe Chronic obstructive pulmonary disease in order to improve the
      survival of the patients.
    

Detailed description: 
      It has been demonstrated that the body weight measured as a Body mass index (BMI)is an
      independent risk factor of mortality in the severe COPD.It seems to be one influence of
      inflammatory factors in the development of denutrition in these patients.

      The use of especial diets has no so good results in the aim to improve the weight, being
      necessary to complement with muscular rehabilitation or anabolic products. The megestrol
      acetate has demonstrated good results in a short period of time, nevertheless the studies are
      scarce.

      The beneficial effects of the megestrol acetate seems to be mediated by cytokines.
    

Intervention name(s): Megestrol acetate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.; sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
Intervention MeSH terms: Megestrol; Megestrol Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; body weight; megestrol acetate; cytokines