bioihbjkbjnl/mcl2 huggingface dataset:
Epidural Calcitonin in Lower Limb Amputation
Condition: Amputation Stumps
Study type: Interventional

Summary: 
      A prospective randomized double-blind clinical trial design will be used in a cohort of sixty
      patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and
      II who will undergo lower limb amputation, will be enrolled into the present study. Patients
      will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC)
      Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.
    

Detailed description: 
      a cohort of sixty patients of both genders, physical status American Society of
      Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled
      into the present study. Patients will divided randomly into two equal groups: Epidural
      Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising
      of 30 patients each.
    

Intervention name(s): Calcitonin; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.; Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Other intervention name(s): maicalciac; fentavera
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Fentanyl; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: epidural calcitonin; amputation; postoperative pain; Later Complication
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if treatment with BG00012 can decrease the number of MS relapses during a
      certain time period. Other goals of the study are to determine if, over time, BG00012
      treatment can decrease the number of certain types of brain lesions commonly seen in MS
      patients and slow down the time it takes for MS to get worse.

      Other objectives of the study are to determine the safety and tolerability of BG00012, as
      well as the effect it may have on tests and evaluations used to assess MS. Additionally,
      glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
    

Detailed description: 
      Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects
      approximately 400,000 persons in North America and 365,000 persons in Europe. It is
      predominantly a disease of young adults, primarily women, with disease onset typically
      occurring between the ages of 20 and 40.
    

Intervention name(s): BG00012; Placebo; Glatiramer Acetate
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): dimethyl fumarate; Tecfidera®
Intervention MeSH terms: Glatiramer Acetate; Dimethyl Fumarate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: relapsing; multiple sclerosis; oral; remitting
Muscle Vibration and Joint Position Sense
Condition: Vibration; Exposure
Study type: Interventional

Summary: 
      The present study aimed to investigate and compare the acute effect of local vibration (63 Hz
      vs 42 Hz frequencies) on the biceps brachii muscles on the elbow joint position sense (JPS)
      in healthy young men. Forty-five healthy young men aged 19 to 30 years were enrolled in the
      study. The participants were randomly assigned to receive either 63 Hz (n=15) or 42 Hz (n=15)
      or sham vibration (control group) (n=15). Participants in the experimental group received
      five bouts of 1-minute of each vibration exposure localized to the biceps brachii muscle,
      with a 1-minute rest between the bouts. Active elbow joint position error (in degrees) was
      selected as an outcome measure to assess elbow JPS. To measure active elbow joint position
      error, the subject was made to sit on the chair with eyes closed and shoulders in 0 degree of
      abduction and elbows fully extended. The examiner passively moved the elbow to 90 degrees of
      flexion (target position) and maintained it for 10 seconds. The subject was requested to
      memorize the target position. The subject was asked to actively flex the elbow to the target
      position from the initial starting position (elbow fully extended) and hold it for 5 seconds.
      Three trials were conducted, with a 30-second rest given between each trial. The target and
      reproduced angles in each trial were measured using a standard plastic goniometer. The
      difference between the target and reproduced angles in each trial was calculated to determine
      active elbow joint position error. Measurements were taken at baseline and immediately after
      the vibration protocol.
    


Intervention name(s): 63 Hz Vibration; 42 Hz Vibration; Sham vibration
Intervention type(s): Other; Other; Other
Intervention description(s): Vibrations of 63 Hz were applied with handheld vibration device.; Vibrations of 42 Hz were applied with handheld vibration device.; Handheld device was applied to the participants without any vibrations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Muscle vibration; joint position sense; proprioception; elbow; rehabilitation
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of
      intravenous (iv) Lacosamide (LCM) in pediatric subjects >= 1 month to < 17 years of age with
      epilepsy.
    


Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution for infusion
Concentration: 10 mg/ml
Route of Administration: intravenous
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; pediatric; intravenous; children; Lacosamide; VIMPAT®; seizure
The Effect of Eucaloric High-Protein Fiber Diet in Healthy Adults: A Repeated Single-Arm Clinical Trial
Condition: Dietary Exposure
Study type: Interventional

Summary: 
      The aims of this study is to investigate the effect of eucaloric high protein and fiber diet
      on healthy subjects.
    

Detailed description: 
      Several studies have shown that high protein diet can reduce body fat, increase muscle mass,
      and improve some metabolic parameters of subjects. Also, several studies have shown that high
      intake of fiber could reduce body weight and improve cardiometabolic parameters. Therefore,
      combining high-protein diet and high-fiber diet should have a positive synergistic effect on
      several of anthropometric and metabolic parameters. The aims of this study is to investigate
      the effect of eucaloric high protein and fiber diet on healthy subjects. Thirteen healthy
      subjects, age 29,85 ± 4,06 years old, with body mass index (BMI) 29,55 ± 4,12 kg/m2 were
      prescribed eucaloric high protein diet for two weeks, followed by washing period for two
      week. Then, they were prescribed with eucaloric high protein and high fiber diet for two more
      weeks. Twenty grams of dietary fiber were in the form of isomaltooligosaccharides (IMO) based
      creamer formulae. Their body composition, waist circumference, fasting blood glucose, blood
      uric acid and total cholesterol concentration were measured after every dietary intervention.
    

Intervention name(s): Isomalto Oligosaccharide
Intervention type(s): Dietary Supplement
Intervention description(s): all of the subjects were given eucaloric prepared meal which contain high protein and DF (contain 25-30 gram DF and protein content between 30-40% of total macronutrient distribution range)
Intervention model: Single Group Assignment
Intervention model description: A Repeated Single-Arm Clinical Trial The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects. Thirteen healthy subjects, age 29,85 ± 4,06 years old, with body mass index (BMI) 29,55 ± 4,12 kg/m2 were prescribed eucaloric high protein diet for two weeks, followed by washing period for two week. Then, they were prescribed with eucaloric high protein and high fiber diet for two more weeks. Twenty grams of dietary fiber were in the form of isomaltooligosaccharides (IMO) based creamer formulae. Their body composition, waist circumference, fasting blood glucose, blood uric acid and total cholesterol concentration were measured after every dietary intervention.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: isomalto-oligosaccharide; blood glucose; cholesterol; fibre diet
Contingency Management of Alcohol Abuse in the Severely Mentally ILL
Condition: Alcohol Abuse; Schizophrenia; Bipolar Disorder; Major Depressive Disorder
MeSH terms: Alcoholism; Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      The investigators will evaluate the efficacy of a comprehensive 12-week contingency
      management intervention for treating alcohol dependence for persons with severe mental
      illness who are seen within the context of a community mental health center setting. The
      primary contingency will be submission of alcohol-free urines. Additional reinforcers will be
      provided for intensive outpatient addiction treatment attendance. Reinforcers will be
      vouchers or actual items useful for day-to-day living. Participants will be 120 adults
      diagnosed with alcohol dependance and severe mental illness.
    

Detailed description: 
      The contingency management (CM) paradigm that will be used is the variable magnitude of
      reinforcement procedure. In order to encourage engagement in study procedures and reduce
      dropout in the randomized sample, all participants will undergo a 4-week pre-randomization
      induction period. During the induction period, participants will be reinforced for providing
      urine-tests three times a week. Those who demonstrate study participation and need for
      treatment during the induction period will be randomized to receive treatment as usual and
      either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay
      urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance;
      or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement.
      Randomization will be used to assign participants to treatment conditions.

      The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay
      urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary
      outcome will be changes in intensive outpatient group attendance assessed by intensive
      outpatient clinician-report, as well as administrative data sources, and self-report. Other
      outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms,
      other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be
      assessed [for 4-weeks prior to study enrollment (self-report, clinician ratings etc)] and
      throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.
    

Intervention name(s): Contingency Management
Intervention type(s): Behavioral
Intervention description(s): Behavioral reinforcement for alcohol abstinence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol abuse; drug abuse; schizophrenia; bipolar disorder; major depressive disorder; contingency management; psychosocial treatment
Non-invasive Hemoglobin Monitoring in Cesarean Section
Condition: Placenta Previa
MeSH terms: Placenta Previa
Study type: Interventional

Summary: 
      Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean
      section with placenta previa and this will be compared with actual laboratory findings.

      The investigators will investigate whether noninvasive hemoglobin monitoring can adequately
      reflect the massive bleeding that occurs within a short period of time and find out if it
      matches the actual laboratory findings.
    


Intervention name(s): Masimo SpHb™ monitor
Intervention type(s): Device
Intervention description(s): Attach the Masimo Rainbow SET® Radical-7 ™ pulse oximeter probe to the third or fourth finger and perform a Masimo SpHb ™ monitor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of UV-C Enriched Foods on Vitamin D Deficiency
Condition: Vitamin d Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This study is an experimental design study in which demographic characteristics, food
      consumption, biochemical parameters and anthropometric measurements of individuals with low
      vitamin D levels before and after consuming UV-enriched foods will be examined.
    

Detailed description: 
      It was designed to be applied to individuals with low vitamin D levels working in Fatih
      Sultan Mehmet Training and Research Hospital who meet the research conditions.

      n the first phase of the study, demographic information will be recorded by asking
      demographic information from the people who volunteered to participate in the study and who
      meet the study criteria by using a questionnaire form and 3-day food consumption record
      information by face-to-face interview technique; anthropometric measurements of the
      participants will be taken and baseline blood values will be recorded. At the beginning of
      the experimental study, individuals will be randomized by computer-assisted randomization
      into four different groups. Biochemical analyses will be analyzed every two weeks, analyses
      will be repeated 1 month after the study and the effects of vitamin D enrichment on
      biochemical parameters will be determined.
    

Intervention name(s): Vitamin D status
Intervention type(s): Other
Intervention description(s): Four different groups will be compared with each other in terms of vitamin D effect.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty-eight people aged 18-65 years with serum 25(OH)vitamin D levels below 30 μg/L and who meet the study criteria will be selected for the study. Four groups, 12 per group, will be randomly selected by computer-assisted randomization.
Group 1 (UV-C mushroom+normal bread group):
Group 2 (UV-C mushroom + UV-C bread group) Group 3 (normal mushroom + normal bread group) Group 4 (normal mushroom + normal bread + supplement group)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Screening
Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy
Condition: Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      Outcome of psychodynamic psychotherapy measured by [123I] nor-B-CIT SPET imaging

      Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the
      treatment of depression. There is evidence that serotonin transporter (SERT) densities are
      altered in depression. Preliminary observations have suggested that SERT function may recover
      in connection with dynamic psychotherapy.

      The objective was to determine whether SERT densities change in relation to clinical recovery
      during psychodynamic psychotherapy.
    

Detailed description: 
      N=26

      Method Twenty six drug-naïve currently depressed (moderate/severe) patients with no previous
      treatment were recruited for the study. The baseline study included a group of 18 healthy
      controls. The patients were randomised into psychotherapy and waiting-list control groups.
      For controls, psychotherapy was started after a 6-month waiting period. [123I] nor-B-CIT SPET
      imaging was performed at baseline and after 12 months of psychotherapy. For the controls,
      additional imaging was performed after the 6-month waiting period.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patiens of clinic
      
Biospecimen description: 
      DNA, creatine, B-vitamin,BP from blood samples.
    
Keywords: Psychotherapy; depression
Safety of an Oral Probiotic in Healthy Adults
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety of an oral probiotic in healthy
      individuals.
    

Detailed description: 
      The oral cavity houses one of the most diverse microbiota in the human body. There are nearly
      800 unique oral bacterial species identified with more species expected to be added with
      further sampling and identification. As with microbiota of other sites in the human body, a
      balanced oral microbiota is essential to maintaining the health of the human host.
      Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from
      birth, and remains a predominant member of the commensal microbiota throughout life. This
      randomized, double-blind, placebo-controlled study is conducted to investigate the safety and
      tolerability of a Streptococcus salivarius DB-B5 strain.
    

Intervention name(s): Streptococcus salivarius DB-B5; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.; Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Condition: Microvascular Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the pharmacodynamic effects of SAR247799 on macrovascular endothelial function of
      the brachial artery using flow-mediated dilation (FMD) in patients with type 2 diabetes
      mellitus (T2DM).

      Secondary Objective:

        -  To assess the pharmacodynamic effects of SAR247799 on microvascular endothelial function
           using laser Doppler perfusion monitoring in patients with T2DM.

        -  To assess the safety profile of SAR247799 in patients with T2DM.

        -  To assess the plasma pharmacokinetic profile of SAR247799 in patients with T2DM.
    

Detailed description: 
      Study duration per patient is approximately 10 weeks including a 4-week treatment period.
    

Intervention name(s): SAR247799; Placebo; Sildenafil; Acetylcholine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Capsule Route of administration: Oral; Pharmaceutical form:Capsule Route of administration: Oral; Pharmaceutical form:Encapsulated tablet Route of administration: Oral; Pharmaceutical form:Solution Route of administration: Transdermal
Intervention MeSH terms: Sildenafil Citrate; Acetylcholine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Air Pollution and Cardiovascular Disease
Condition: Metabolic Disorder
MeSH terms: Cardiovascular Diseases; Metabolic Diseases
Study type: Observational

Summary: 
      To determine the effects of ambient airpollution exposures on cardiovascular responses among
      healthy adults without cardiovascular disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will maintain enrollment criteria of the in-progress study being healthy adults without
        CV disease or risk factors
      
Biospecimen description: 
      plasma and urine
Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating
      patients who have recurrent or metastatic cancer of the cervix.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response, time to progression, disease free survival, and overall survival
           of patients with recurrent and/or metastatic cancer of the cervix treated with a
           combination of topotecan and paclitaxel.

        -  Determine the feasibility and toxicity of this regimen in these patients.

      OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30
      minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every
      21 days for a minimum of 2 courses in the absence of disease progression or unacceptable
      toxicity.

      Patients are followed every 3 weeks.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
    

Intervention name(s): filgrastim; paclitaxel; topotecan hydrochloride
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Paclitaxel; Topotecan
Primary purpose: Treatment
Keywords: recurrent cervical cancer; stage IVB cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma