bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Stress Ball in Angiography
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The target of this study was to determine the influence of stress ball application on pain
      and anxiety levels experienced by patients during angiography procedures.
    

Detailed description: 
      The purpose of this research was to investigate the effect of stress ball application, which
      is a non-pharmacologic method, on the pain and anxiety levels of patients during the
      angiography procedure. The present randomized controlled trial was conducted on all adult
      patients undergoing angiography between January 2023 and June 2023 in the Cardiovascular
      Surgery Clinic of a state hospital in eastern Turkey. The sample population was composed of
      120 randomized patients who underwent stress ball application and received routine care.
      Numerical Rating Scale (NRS), Patient Information Form, and State-Trait Anxiety Inventory
      (STAI) were employed for data collection. The mean NRS posttest score of the experimental
      group patients increased significantly less than the control group (p<0.001), while the mean
      STAI posttest score decreased significantly (p= 0.019). A positive significant correlation
      was determined between the mean NRS and STAI post-test scores of the patients in the
      experimental group (p<0.05). It was found that the level of state-trait anxiety decreased as
      the pain decreased. The stress ball applied during angiography decreased the anxiety and pain
      levels of the patients. Stress ball application may be recommended as a complementary method
      to support pharmacologic treatment.
    

Intervention name(s): experimental group
Intervention type(s): Behavioral
Intervention description(s): Patients in the experimental group were told how to use the stress ball before the procedure. The patient was then taken to the angiography unit. The stress ball was placed on the palms of the patients according to the procedure position. During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes. After the procedure, the NRS and STAI were filled out as a post-test 10 minutes after the patient was taken to the ward. The answers given by the patients were recorded by the researcher by marking them on the forms.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This controlled randomized study
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pain; Angiography; Anxiety; Nursing; Stress ball
The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral
      supplementation will improve systemic inflammation, vascular function, and symptomatic status
      of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA
      affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of
      inflammation.
    

Detailed description: 
      The OMEGA-PAD II trial will be a 1:1 randomized, double-blinded trial comparing oral
      supplementation of n-3 PUFA (4.4g/day) to placebo in claudicants (Rutherford stage 1-3) for 3
      months. Eligible patients will be screened according to specified inclusion and exclusion
      criteria. All patients will be treated per our current practice as reflected in the American
      Heart Association Practice guidelines on PAD. Blood draws, vascular function testing and
      6-minute walking tests will be performed at baseline and after 3 months. n-3 PUFA
      supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals,
      Watsonville, California, USA), corresponding to a total of 4.4g/day. Each ProOmega capsule
      contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of
      capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same
      color and shape as the treatment capsules.
    

Intervention name(s): Pro-Omega; ProOmega Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months; Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dopamine Release in the Human Brain Following Alcohol Administration
Condition: Heavy Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine whether there is an increase in dopamine levels in
      the human striatum following an oral administration of alcohol, as has been evidenced in
      animal models. This will be a Positron Emission Tomography (PET) study using the radiotracer,
      [11C]-(+)-PHNO (11C]-( + )-4-propyl-
      3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol).
    

Detailed description: 
      This will be a within subjects study in 8 heavy drinkers ages 21-45. The within factors will
      be PET scans following an alcoholic beverage and following a non-alcoholic beverage.
      Participants will also have a baseline session prior to the scans where they will complete
      various cognitive tasks and questionnaires. During each PET scan, subjective drug effects as
      well as heart rate, blood pressure, blood alcohol content and cortisol levels will be
      collected. The change in PHNO binding potential between the two scan conditions will be the
      primary outcome measure.
    

Intervention name(s): alcoholic beverage; non-alcoholic beverage
Intervention type(s): Drug; Drug
Intervention description(s): An appropriate amount of 95% USP ethyl alcohol will be mixed in orange juice and tonic water to obtain a drink equivalent to 3-5 standard drinks. The beverage will be consumed over a period of 15 minutes.; This beverage will be a mixture of orange juice and tonic water. The beverage will be consumed over a period of 15 minutes.
Other intervention name(s): Ethyl alcohol 95%; Tropicana orange juice and Schweppes tonic water.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
HM vs Fibreglass Casts in Treating Pediatric Supracondylar Humeral Fractures
Condition: Pediatric Supracondylar Humeral Fracture
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      Supracondylar humeral fractures are the most common elbow fractures in children and cast
      immobilization continues to remain as the recommended treatment for modified Gartland's
      classification Type I and Type IIa injuries. Apart from plaster of Paris and fibreglass
      casts, the use of waterproof, tubular hybrid mesh (HM) casts have been gaining traction for
      cast immobilization. Although the use of HM cast has been reported to have similar clinical
      outcomes and overall patient satisfaction scores to the fibreglass cast, the results of the
      recent studies are only limited and generalizable only to paediatric distal radius fractures.

      As the application method of HM and fibreglass casts are fundamentally different, it has not
      been reported if the difference in application duration between the cast materials is
      significant and its potential implications in outpatient clinic operation.

      Hence, through a randomized controlled trial, this study primarily aims to investigate if the
      clinical outcomes, patient satisfaction and duration of cast application with the HM casts
      would be comparable with fibreglass casts in children with supracondylar humeral fractures.

      Through this study, the investigators hope to evaluate the advantages and disadvantages of
      the respective casting material which may better aid physicians in deciding a more
      appropriate cast material for treating paediatric supracondylar humeral fractures with cast
      immobilization and the implications of casting duration on clinic operations.
    


Intervention name(s): HM Cast; Fibreglass Cast
Intervention type(s): Device; Device
Intervention description(s): Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.; Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.
Intervention MeSH terms: Calpastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Supracondylar humeral fracture; Pediatric fracture; Hybrid mesh cast; Fibreglass cast
The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Condition: Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and
      iron overload in patients with thalassemia were compared to patients who didn't receive
      n-acetylcysteine after 3 months of study duration
    

Detailed description: 
      N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its
      efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative
      stress due to excess of b-globin chains and iron overload. In this study the investigators
      compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron
      overload in thalassemia patients before and after treatment with NAC for 3 months and with
      that of patients who served as controls.
    

Intervention name(s): N-acetyl cysteine
Intervention type(s): Drug
Intervention description(s): Mucolytic and antioxidant drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF
Condition: Hepatic Encephalopathy; Acute-On-Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Hepatic Encephalopathy; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Brain Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE
      in patients with ACLF. The investigators plan to study the efficacy of combining intravenous
      BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients
      with ACLF and its impact on overall survival and improvement in grade of HE.
    

Detailed description: 
      Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of
      chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE)
      is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable
      disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data
      available from cirrhotic patients. No studies have compared different treatment options for
      HE in patients with ACLF.
    

Intervention name(s): Branched chain amino acid; Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm; Oral lactulose will be given to patients in both arms
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective interventional cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: branched chain amino acids; hepatic encephalopathy; lactulose; acute on chronic liver failure; bispectral index
The Effect of Clove Oil on Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The study has two groups. one of them is experimental group that is given massage with clove
      oil. The other one is control group that is given standard midwifery care. Each group
      consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale
      before and after massage application.
    

Detailed description: 
      Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce
      labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor
      pain. In the literature, there are a lot of study examining effectiveness of massage
      techniques. However there is no study about massage application with clove oil on labor pain.
      The investigators would like to give a massage with clove oil to pregnants to reduce their
      labor pain. Hereby the investigators will evaluate effectiveness of clove oil.
    

Intervention name(s): Massage Application with clove oil; Massage Application without any oil
Intervention type(s): Other; Other
Intervention description(s): The experimental group is given a massage with clove oil,; The control group is given a massage without any oil as a standard midwifery care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups as experimental and control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: labor pain; midwifery; pregnant women; massage
Enteral Formula Tolerance in Pediatric Patients
Condition: Enteral Nutrition
Study type: Interventional

Summary: 
      The purpose of this prospective study seeks to assess ability to achieve enteral feeding
      goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.
    

Detailed description: 
      In this prospective study, a population of stable, tube-fed children will consume a standard
      polymetric tube feeding formula to assess ability to achieve enteral feeding goals and
      tolerance outcomes.
    

Intervention name(s): Enteral Formula
Intervention type(s): Other
Intervention description(s): pediatric subjects will be fed a standard pediatric enteral formula tube feeding
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: tube-fed; Formula Tolerance; Pediatric Patients
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD)
      of single subcutaneous (SC) injection of GW003 in healthy subjects.
    


Intervention name(s): GW003
Intervention type(s): Biological
Intervention description(s): single SC injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
R(+)XK469 in Treating Patients With Advanced Neuroblastoma
Condition: Disseminated Neuroblastoma; Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of R(+)XK469 in treating
      patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to
      stop cancer cells from dividing so they stop growing or die.
    

Detailed description: 
      OBJECTIVES:

      I. Determine the maximum tolerated dose, recommended phase II dose, and dose-limiting
      toxicity of R(+)XK469 in two different dosing schedules in patients with advanced
      neuroblastoma.

      II. Determine the safety of this drug in these patients. III. Determine the tolerance to this
      drug in these patients. IV. Determine the pharmacokinetics and pharmacodynamics of this drug
      and its metabolites in these patients.

      V. Determine, preliminarily, any antineoplastic activity of this drug in these patients.

      OUTLINE: This is a dose-escalation study.

      SCHEDULE A: Patients receive R(+)XK469 intravenously (IV) over 30 minutes on days 1, 3, and
      5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
      toxicity. Cohorts of 3-6 patients receive escalating doses of R(+)XK469 until the recommended
      phase II dose or maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
      determined, additional patients are accrued and treated at the recommended phase II dose (for
      a maximum of 20 patients treated at that dose).

      SCHEDULE B: Once the recommended phase II dose is determined on schedule A, additional
      patients are accrued and receive escalating doses of R(+)XK469 IV over 30-60 minutes on day
      1, beginning at a reduced dose. Courses repeat every 3 weeks in the absence of disease
      progression or unacceptable toxicity. Dose escalation continues as in Schedule A.
    

Intervention name(s): R(+)XK469
Intervention type(s): Drug
Intervention description(s): Given IV
Other intervention name(s): XK469
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness, safety and tolerability of three
      different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
    

Detailed description: 
      Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the
      world population. Hallucinations and delusions are the most striking characteristic positive
      symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and
      lack of emotion, energy, and motivation) may also be present. The first antipsychotics
      developed for the treatment of schizophrenia were effective against positive symptoms, but
      showed little efficacy for negative symptoms and were also associated with a high incidence
      of side effects. Second generation antipsychotics, represent a significant advancement in the
      treatment of psychotic disorders because they are effective and at the same time exhibit
      fewer side effects than first generation antipsychotics. Although generally safer than first
      generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable
      side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these
      drugs vary considerably.
    

Intervention name(s): OPC-34712 [Brexpiprazole] High Dose; Experimental: OPC-34712 [Brexpiprazole] Middle Dose; Experimental: OPC-34712 [Brexpiprazole] Low Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Higher dose, tablet, once daily, for six weeks; Middle dose, tablet, once daily, for six weeks; Lower dose, tablet, once daily, for six weeks; Placebo, once daily, for six weeks
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Condition: Hypoparathyroidism; Hypocalcemia
MeSH terms: Hypocalcemia; Hypoparathyroidism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate the safety, biological activity, and pharmacokinetics of PTH
      delivered by subcutaneous injection compared with an infusion pump. We anticipate pump
      delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion
      of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium,
      phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump
      therapy will require lower PTH doses and should normalize markers of bone turnover. We expect
      the improved metabolic control during pump therapy will be especially evident in patients
      with more severe forms of hypoparathyrodism where there is an unmet need for improved
      therapy.
    

Detailed description: 
      Prior studies (92-CH-0011) have been important in establishing synthetic human parathyroid
      hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional
      therapy with calcium and calcitriol. We are conducting a randomized crossover study comparing
      twice-daily subcutaneous injections vs. PTH pump therapy. We hypothesize that pump delivery
      of PTH 1-34, compared to twice-daily administration, will provide smoother metabolic control
      of serum mineral levels and normalization of urine mineral excretion. The two arms will be
      divided into an inpatient and an outpatient phase. There will be three inpatient admissions,
      baseline, 3 months, and 6 months. Subjects will be randomized to either pump therapy or to
      twice daily injections at the beginning of the study and will cross over to the alternate PTH
      delivery system (injections vs. pump) at the conclusion of the initial 3-month treatment
      period.

      Patients between 10 and 70 years of age who have had chronic hypoparathyroidism for at least
      1 year may be eligible for this study. Participants have two 10- 12-day hospital admissions
      and one 5-day admission. The first two inpatient admissions are separated by 3-month
      outpatient periods. Outpatient monitoring will require weekly blood tests and monthly urine
      tests to monitor mineral levels. After third hospital admission, patients will be placed on
      conventional therapy.
    

Intervention name(s): Synthetic Human Parathyroid Hormone 1-34
Intervention type(s): Drug
Intervention MeSH terms: Hormones; Parathyroid Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoparathyroidism; Parathyroid Hormone 1-34