bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy
Condition: Patients Undergoing Modified Radical Mastectomy
Study type: Interventional

Summary: 
      Modiﬁed radical mastectomy (MRM) is one of the most common surgeries performed, and one that
      may be associated with signiﬁcant acute postoperative pain in breast surgery. Acute
      postoperative pain is an independent risk factor in the development of chronic
      post-mastectomy pain .

      Various regional anesthetic procedures have been tried to provide better acute pain control
      and, consequently, less chronic pain. They can reduce perioperative opiates requirement and
      thereby decreasing their possible side effects. These regional procedures include local wound
      inﬁltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral
      block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound
      (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable
      alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia
      for patients about to undergo breast surgery.

      Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane
      blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus
      muscle in the mid-axillary line and spares the pectoral nerves.

      We assumed that SAPB could safely provide a better analgesic proﬁle with an opioid-sparing
      effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.
    


Intervention name(s): Serratus Anterior Plane Block; Lumbar Intrathecal Fentanyl Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): SAPB will be done preoperative before induction of anesthesia under songraphic guidance and aseptic conditions with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 5th rib is identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane. The ribs, pleura, overlying serratus muscle and latissimus dorsi muscle will be identified, and the needle will be advanced cephalic in-plane until the tip reaches the plane between the serratus anterior and latissimus dorsi. Afterward, 2 mL dextrose 5% will be injected; then, 30 mL of bupivacaine 0.25% will be injected in the plane between the serratus anterior and latissimus dorsi.; Patients will receive 25 microgram intracthecal fentanyl immediately preoperative.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of Relaxation Techniques on Earthquake Survivors
Condition: Earthquake; Mental Health Issue
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of relaxation and breathing exercises on
      individuals experiencing post-earthquake stress-related symptoms.
    

Detailed description: 
      Earthquakes negatively affect survivors both physically and psychologically. Early
      psychological symptoms after disasters are considered normal responses to an abnormal event.
      Therefore, it is not unexpected to feel very intense negative emotions after such traumas.
      However, the chronicity of these negative emotions puts the lives of individuals at risk.
      Mental problems such as stress, depression, posttraumatic stress disorder and anxiety are
      seen at high levels among earthquake survivors. In this study, it was aimed to investigate
      the effect of relaxation and breathing exercises applied to earthquake survivors who
      experienced post-earthquake stress-related symptoms.

      There are two gropus: relaxing exercise group and control group. Relaxing and breathing
      exercise protocol is only for relaxing exercise group. A protocol consisting of 40 minutes of
      progressive muscle relaxation exercise and breathing exercises, 3 times a week for 4 weeks,
      was planned. Control group participants were asked to continue their daily lives. Evaluations
      were made before and 4 weeks after the intervention and stress-related symptoms were
      measured.
    

Intervention name(s): Progresive Muscle Relaxation and Breathing Exercise
Intervention type(s): Other
Intervention description(s): Intervention protocol contains 40 minuntes sessions, which involved tensing and relaxing the body along with deep breathing.
Protocol consisted with; Warm-up (5 minutes breathing exercise) Progressive Muscle Relaxation Exercises (The participants performed PMR for each body part in a particular order, beginning with the face muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet. This muscle tensing and relaxing procedures were performed in accompaniment with deep breathing.) Cool-down (5 minutes breathing exercise)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with a control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: earthquake; physiotherapy; breathing exercise; relaxing exercise; stress; mental health
Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite
      the obvious thinness and extreme behaviors for weight loss. The result is a massive weight
      loss and / or pathological thinness. The care of anorexia is difficult and few treatments
      have proved to be effective in adults.

      Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an
      electrical current of low intensity. It allows to modulate the corticospinal excitability:
      two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull
      according to the region which is desired to influence the operation.

      Although tDCS was shown to no noticeable side effects, it is first necessary to assess the
      feasibility and safety of this technique in these physically frail patients. A recent pilot
      study suggests the acceptability, safety and efficacy of tDCS program in patients with
      anorexia nervosa.

      Given these preliminary data and the extreme seriousness and vulnerability of patients with
      resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of
      this technique in patients suffering from resistant anorexia nervosa. The current data are
      too preliminary to consider a randomized controlled trial, the investigators hope, initially,
      replicate the data from this pilot study in a second sample with a more rigorous and
      comprehensive assessment methodology .
    

Detailed description: 
      During stimulation, the anode will be placed over the left dorsolateral prefrontal cortex and
      the cathode on the right dorsolateral prefrontal cortex. Stimulation of 2 milli-Ampere is
      applied for 25 minutes each session.

      20 sessions will be conducted twice a day respecting a period of four hours between sessions.

      The tDCS sessions will start maximum 15 days after the inclusion visit.

      Two intermediate control visits will be conducted. One after the first week of tDCS, the
      other immediately after the last session of tDCS.

      The main assessment visit will be carried out one month (+/- 5 days) after the last session
      of tDCS. Finally a reminder visit will be performed 6 months (+/- 3 weeks) after the last
      session of tDCS to assess the stability over time of the potential effects observed.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sever anorexia nervosa
Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to measure effects of the combined treatment with GH and IGF-I on
      glucose sensitivity and body composition in patients with GHD and IGT or diabetes.
    

Detailed description: 
      The study was a 6 months randomised placebo controlled trial of adults with GHD and type 2
      diabetes. All receive GH (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and are
      randomised to IGF-I or placebo (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months).
      Glucose metabolism is evaluated with euglycemic hyperinsulinemic clamp and body composition
      by computed tomography (CT) and bio impedance;.
    

Intervention name(s): NutropinAq (GH) and Increlex (IGF-I); NutropinAq and placebo
Intervention type(s): Drug; Drug
Intervention description(s): NutropinAq (GH)(0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and Increlex (IGF-I) (15 µg/kg/d for 1 month, 30 µg/kg/d for 5 months); NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.
Other intervention name(s): NutropinAq (GH); Increlex (IGF-I); NutropinAq (GH); Placebo
Intervention MeSH terms: Mecasermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: GH and IGF-I; growth hormone deficiency and IGT or diabetes
Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30
      mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity
      Disorder (ADHD) in a 12-hour laboratory classroom setting.
    


Intervention name(s): Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg and/or 20 mg capsules; Placebo Comparator
Intervention MeSH terms: Methylphenidate; Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD, children, subjects, laboratory classroom
Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug
      and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients
    

Detailed description: 
      This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical
      trial design. During a screening epoch patient eligibility will be assessed. The screening
      epoch will be followed by a 21-day Run-in epoch during which patients will continue their
      inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting
      bronchodilator-rescue medication. After the Run-in period patients will be randomized to one
      of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment
      period one is followed by a 10 to 14 days washout period after which patients begin the
      second 7-day treatment period which is then followed by a second 10 to 14 days washout period
      followed by the third 7-day treatment period. At the end of each treatment period spirometry
      will be performed to assess the primary endpoint in terms of trough FEV1. The study
      population will consist of approximately 144 patients with asthma who have been treated in a
      stable regimen of ICS/LABA for at least 4 weeks prior to screening.
    

Intervention name(s): NVA237 (glycopyrronium bromide); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose; In each treatment arm, patient will receive placebo
Intervention MeSH terms: Glycopyrrolate; Bromides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma,; NVA237,; glycopyrronium bromide; allergic asthma,; allergy triggered asthma,; reactive asthma,; asthma attack,; difficulty breathing
Acute Glycemic Effects of Crackers Made by Different Flours
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the acute effects of cracker consumption made by different flours on
      glycemic responses.
    

Detailed description: 
      This study aimed to 1.determine the glycemic index and glycemic load of crackers made by
      different flours (wheat, rye and sunflower) and 2. investigate the effects of these types of
      crackers on postprandial glycemic responses in healthy humans.
    

Intervention name(s): Glucose as reference food; Cracker made by wheat flour; Cracker made by rye flour; Cracker made by sunflower flour
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by wheat flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by rye flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from sunflower flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; crackers; glycemic index; glycemic load
Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
Condition: Healthy Men and Women
Study type: Interventional

Summary: 
      Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols,
      procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG)
      consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were
      limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD
      or CVD risk factors and thus to our knowledge, it remains unknown as to whether the
      consumption of Concord Grape (poly)phenols can maintain vascular function in healthy
      individuals. The aim of this study is therefore to examine both acute and chronic effects of
      Concord Grape on cardiovascular health by investigating whether daily consumption of Concord
      Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial
      function, blood pressure and blood lipids, in young healthy men and women.
    


Intervention name(s): Placebo; Concord Grape extract 1; Concord Grape extract 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Identical formulation as the treatment consisting of colored maltodextrin using artificial colors; 1 g Concord Grape extract in 2 capsules; 500 mg Concord Grape extract in 2 capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vascular function; endothelial function; polyphenols; Concord Grape
Lifestyle Intervention for Diabetes and Weight Management in Psychosis
Condition: Type 2 Diabetes Mellitus; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Bipolar I Disorder; Substance-induced Psychosis; Psychotic Disorders; Major Depressive Disorder
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Psychoses, Substance-Induced; Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Psychotic Disorders; Mental Disorders; Shared Paranoid Disorder
Study type: Interventional

Summary: 
      The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with
      psychotic illnesses than in the general population. Life expectancy of individuals with
      psychosis is also 20-25 years less than the general population, primarily due to premature
      onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic
      illness has been an exclusion criterion in all large-scale studies of diabetes prevention and
      management. We propose a 3-year randomized controlled trial examining the effectiveness of a
      lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity
      in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM.
      Weight and glycemic control will be the primary outcome variables. It is hypothesized that a
      significant weight reduction and improvement in glycemic control will be found in those who
      receive the LI relative to those who do not.
    


Intervention name(s): Lifestyle Intervention; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity; Care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in
      patients with chronic low back pain compared to waiting list group, or placebo.
    

Detailed description: 
      Chronic low back pain is a significant health problem in industrialized countries. Use of
      complementary medicine is increasing in patients with low back pain. Until now there is no
      evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low
      back pain.
    

Intervention name(s): Disci/Rhus toxicodendron comp.®; placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks; s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: low back pain; complementary therapies
Efficacy of Two ONS in Patients at Nutritional Risk With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Malnutrition
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Malnutrition
Study type: Interventional

Summary: 
      Rationale: The aim of the study was to compare the glycemic and insulinemic response of
      malnourished patients with type 2 diabetes after oral feed between a diabetic oral
      nutritional supplements (ONS) and a standard one.

      Methods: Randomized, double-blind, crossover, multicenter clinical trial, conducted in
      patients with type 2 diabetes and a diagnosis of malnutrition (SGA). Patients were randomized
      to receive two ONS: diabetic (Bi1 diacare hp/hc) or control (standard, isocaloric and
      isoproteic), a week apart. A glycemia and insulinemia curve was made at times: 0', 30', 60',
      90', 120', and 180', after drank 200 ml of the ONS. The analyzed variables were the area
      under the curve (AUC 0-t) of glucosa and insulin, and the maximum concentration of glucose
      (Cmax).
    


Intervention name(s): Diabetic; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): It is a hypercaloric and hyperproteic dietary supplement formulated to contribute to control the glycemia with: a specific mix of carbohydrate with a low GI, fiber, EVOO and EPA&DHA; It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control
Other intervention name(s): Bi1 diacare hp-hc
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, crossover, double blind, multicenter, clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ONS; Type 2 diabetes; Malnutrition; EVOO; carbohydrates; glycemic index
Bacterial Microbiota In The Tonsils Of Children
Condition: Adenotonsillitis
Study type: Observational

Summary: 
      We, the investigators, propose to look at the bacteria on and in tonsils using gene
      microarrays. We expect to find previously reported bacteria but also the possibility of
      previously undetected organisms. We think that the bacterial pathogens present on the
      tonsillar surface are different from the tonsil core. And we also think that the bacteria of
      the tonsil surface will differ between patients undergoing adenotonsillectomy and normal
      controls with no adenotonsillar problems.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children undergoing adenotonsillectomies at the Comer Children's Hospital