bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Condition: Paranoid Delusions
MeSH terms: Schizophrenia; Delusions; Paranoid Disorders
Study type: Interventional

Summary: 
      The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused
      Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of
      persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.
    

Detailed description: 
      Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that
      combines group and individual modalities to reduce paranoia-biased information-processing and
      social avoidance, and to increase insight and reality testing capacity.

      This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the
      primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory
      delusions will be recruited from outpatient clinics in New York City Metropolitan area.
      Participants will be randomly assigned to either experimental or control group. The
      experimental group will receive PFCBT in addition to standard care and the control group will
      receive standard care alone. PFCBT will include participation in one group session and one
      individual therapy session weekly over the 15 weeks. The preliminary efficacy of the
      intervention will be evaluated using standardized measures by blind evaluators conducted at
      baseline, post-treatment, and at 6-months post-termination follow-up.
    

Intervention name(s): Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
Intervention type(s): Behavioral
Intervention description(s): The PFCBT is a 15-week Program that includes weekly group and individual sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychosis; Paranoia; Cognitive Behavioral Therapy; Delusions; Group Therapy
Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
Condition: Cirrhosis, Liver
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the safety and effectiveness of GI262570 compared to
      placebo (a pill that looks exactly like GI262570 but contains no active medicine) in
      improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who
      are enrolled in the study must have had prior treatment with interferon (either pegylated or
      standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but
      either failed to clear the virus or didn't tolerate the treatment.
    


Intervention name(s): GI262570 0.5 mg; GI262570 1.0 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GI262570 0.5 mg; GI262570 1.0 mg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Hepatitis C liver fibrosis
NAC in CC Resistant PCOS After LOD
Condition: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This prospective randomized placebo-controlled double blind clinical trial will conducted in
      Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate
      resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be
      randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200
      mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or
      clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical
      pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live
      birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation,
      mid- luteal sub-endometrial blood flow indices, and incidence of side effects.
    


Intervention name(s): N-acetyl-cysteine; Clomiphene citrate
Intervention type(s): Drug; Drug
Intervention description(s): N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling; Clomiphene citrate + Laparoscopic ovarian drilling
Intervention MeSH terms: Acetylcysteine; Clomiphene; Enclomiphene; Zuclomiphene; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; N-acetyl-cysteine; Clomiphene citrate; Clomiphene citrate resistant; Laparoscopic ovarian drilling; therapy
Bridge Occlusion Balloon in Lead Extraction Procedure
Condition: C.Surgical Procedure; Cardiac; Cardiac Dysrhythmia; Disorder of Pacing Function
MeSH terms: Arrhythmias, Cardiac; Cardiac Conduction System Disease
Study type: Interventional

Summary: 
      To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within
      the Superior Vena Cava in lead extraction patients.
    

Detailed description: 
      This study will evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon,
      Spectranetics) within the Superior Vena Cava in lead extraction patients. This will be
      performed in a non-emergent setting to allow for evaluation of how best to integrate this new
      technology into the investigators clinical practice. The study will focus on the effect of
      the Bridge balloon on the patient preparation clinical workflow, ease of
      insertion/positioning/deployment, and the ability to recognize proper inflation and vein
      sealing under fluoroscopy. Understanding these factors will help build a more robust clinical
      workflow with the goal of better patient outcomes in the case of an Superior Vena Cava
      injury. The images and data generated during this study can help in dissemination of the
      practical use knowledge to fellow lead extractors.

      At the time of the protocol registration, the timeframe 12 months was entered, this was
      actually the anticipated length of the study at registration. The timeframe was corrected to
      33 minutes (average time) at the time of results entry.
    

Intervention name(s): Bridge Balloon
Intervention type(s): Device
Intervention description(s): The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy.
Other intervention name(s): Bridge Occlusion Balloon, Spectranetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Lead extraction; Superior Vena Cava Tear; Pacemaker/Defibrillator lead extraction
PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients
Condition: General Anesthetic Drug Adverse Reaction
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      The aim of the study is to assess the pharmacokinetic and pharmacodynamic properties of
      rocuronium and sugammadex and their clinical effect in the terms of both the relaxation of
      paralysed muscles (rocuronium) and the reversal of neuromuscular blockade (sugammadex) in
      children over 2 years of age undergoing general anesthesia for surgical procedures needing
      muscle relaxation for more than 30 minutes.
    

Detailed description: 
      The study group was divided into three subgroups depending on the different doses of
      sugammadex. Group I received dose of 0.5 Mg/kg, Group II - 1.0 Mg/kg and Group III received
      dose of 2 Mg/kg of sugammadex. General anesthesia was performed among all included patients
      at the same way. During general anesthesia monitoring of TOF - Train-of-four, was used to
      assess the muscle relaxation force of rocuronium as well as the reversal of neuromuscular
      blockade by sugammadex. For this purpose, 1.5 ml of blood samples taken 8 times, were
      collected to determine the PKPD of the tested drugs, according to own protocol.
    

Intervention name(s): Sugammadex Injection
Intervention type(s): Drug
Intervention description(s): Sugammadex was administered in the dose of 0.5 Mg/kg or 1.0 Mg/kg or 2.0 Mg/kg to reverse neuromuscular blockade.
Other intervention name(s): Sugammadex 100Mg/ml Intravenous Solution
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children, aged 2-18 yrs, assessed according to American Society of Anesthesiologists (ASA)
        scale as I or II, qualified to surgical procedures requiring muscle relaxation for more
        than 30 minutes, and undergoing general anesthesia
      
Keywords: General anesthesia; Children
Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department
Condition: Fever
MeSH terms: Emergencies; Fever
Study type: Observational

Summary: 
      This study primarily aims to describe factors associated with hospitalisation of children
      aged 3 months to 5 years presenting with fever to an urban paediatric A&E departments by
      describing and analysing characteristics both of those patients admitted to hospital and
      those managed in the community. To complement this, information on the short-term healthcare
      utilization by families attending the emergency department because of feverish illness will
      be collected. The study will be carried out in one participating centre in Switzerland and
      the United Kingdom, respectively, to enable a head to head comparison of the assessment and
      admission practices in two European countries. The resulting data will be used as the basis
      for further research in this area and will provide information on how to optimally structure
      service provision in acute febrile childhood illness.
    

Detailed description: 
      A significant number of children 0 to 5 years of age are seen in paediatric Accident &
      Emergency departments (A&E) with feverish illness. Most of these patients could safely be
      managed in a primary care setting, particularly with guidelines in place on how to optimally
      assess these children. Some patients, however, will require admission, either because of a
      potentially serious underlying disease or because of other factors, for example parental
      concern or difficulties in communication because of language barriers. An increase in the
      number of children attending A&E departments with feverish illness as well as a rise in the
      volume of admissions has been noted over time. To enable an appropriate adaptation of acute
      medical services for children an in depth understanding of the assessment and admission
      processes is crucial.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 3 months to 5 years presenting to an urban paediatric emergency department
        with fever
      
Keywords: Feverish illness in children
Pattern Recognition Prosthetic Control
Condition: Prosthesis User; Congenital Amputation of Upper Limb; Amputation; Traumatic, Limb
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      Many different factors can degrade the performance of an upper limb prosthesis users control
      with electromyographic (EMG)-based pattern recognition control. Conventional control systems
      require frequent recalibration in order to achieve consistent performance which can lead to
      prosthetic users choosing to wear their device less. This study investigates a new adaptive
      pattern recognition control algorithm that retrains, rather than overwrite, the existing
      control system each instance users recalibrate. The study hypothesis is that such adaptive
      control system will lead to more satisfactory prosthesis control thus reducing the need for
      recalibration and increasing how often users wear their device. Participants will wear their
      prosthesis as they would normally at-home using each control system (adaptive and
      non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks
      total). Prosthetic usage will be monitored during each period in order to compare user wear
      time and recalibration frequency when using adaptive or non-adaptive control. Participants
      will also play a set of virtual games on a computer at the start (0-months), mid-point
      (1-months) and end (2-months) of each period that will test their ability to control
      prosthesis movement using each control system. Changes in user performance will be evaluated
      during each period and compared between the two control systems. This study will not only
      evaluate the effectiveness of adaptive pattern recognition control, but it will be done
      at-home under typical and realistic prosthetic use conditions.
    


Intervention name(s): EMG-Pattern Recognition Controller
Intervention type(s): Device
Intervention description(s): Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device in a home trial.
Other intervention name(s): Coapt Complete Control Gen2
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a randomized crossover home trial consisting of two 8-week periods with an intermittent 1-week washout period (17 weeks total). Participants will use either adaptive control or non-adaptive control during the first 8-week period then switch to using the opposite control style during the second 8-week period.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pattern recognition; home trial; randomized cross-over trial; prosthesis; electromyography
High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain
Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Hip Osteoarthritis; Perioperative/Postoperative Complications; Surgery; Opioid Use; Catastrophizing Pain; Chronic Pain
MeSH terms: Osteoarthritis, Hip; Chronic Pain; Pain, Postoperative; Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior
      to surgery in the setting of Fast-Track Hip-surgery with Arthroplasty in a group of expected
      High Pain Responders and the effect on postoperative pain and postoperative inflammation.
    

Detailed description: 
      This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain
      after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.

      The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid
      given as an intravenous bolus after the spinal anaesthesia has been given, but before the
      surgery starts.

      The hypothesis is that by attenuating the inflammatory response to the surgery itself by the
      steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon
      ambulation 24 hours after unilateral Hip Arthroplasty.

      Patients referred to Unilateral Total Hip Arthroplasty because of Hip-osteoarthritis at
      Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are
      screened and offered inclusion in the study.

      The two groups will be randomized and double blinded. One group will be treated, as the
      current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the
      medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

      The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg
      bodyweight).

      The patients will be monitored the first 7 days after surgery, during the admission to the
      hospital, and by a Pain-diary in the patients own home.

      Blood tests will be taken preoperatively and postoperatively to determine the effect of the
      highdose steroid on the inflammatory response.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): An intravenous bolus dose of dexamethasone given prior to surgery.
Other intervention name(s): Dexa-ratiopharm
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized double blinded controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip Arthroplasty; Hip Replacement; Perioperative Medicine
Acupuncture and Dry Needling in Peripheral Acute Fatigue Reduction
Condition: Sedentary Lifestyle; Males
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Introduction: Neuromuscular fatigue is defined when the muscle becomes incapable of
      generating muscle power or strength after exercise or long repetitive activities. As well as,
      the inability to maintain optimum performance and generate maximum voluntary contractions
      during a physical exercise. When performing physical activity, the body's metabolic response
      increases proportionally to exercise to satisfy the demands of the human physiological. Part
      of the energy accumulated during exercise is lost to the environment in the form of heat and
      another part is maintained internally through the physiological control for thermoregulation.
      In addition, the muscle generates an electric signal important to determine its status
      regarding power and fatigue.

      Objective: To investigate the reduction of acute peripheral fatigue induced by isometric
      contractions from acupuncture and dry needling techniques, compared to absolute rest.

      Methods: This is a cross-sectional study and experimental study, with descriptive, analytical
      and quantitative approach. It follows the Consolidated Standards of Reporting Trials
      (CONSORT) guidelines. The volunteers will be gathered according to the eligibility criteria,
      and randomly divided in 3 groups: the control group (G1), the volunteers who will remain in
      prolonged rest; the acupuncture group (G2), in which volunteers will receive six needles in
      six acupoints in the non-dominant upper limb and the dry needling group (G3), in which the
      volunteers will receive application of six needles arranged in the non-dominant biceps
      brachialis.
    


Intervention name(s): Acupuncture; Dry needling
Intervention type(s): Procedure; Procedure
Intervention description(s): Six needled will be inserted in six already defined acupoints along the non-dominant upper limb for a period of 30 minutes.; Six needles will be inserted in six predefined points along the volunteers non-dominant biceps brachialis for 30 minutes.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Muscle fatigue; Thermography; Acupuncture; Dry needling
Potato Research for Enhancing Metabolic Outcomes
Condition: Insulin Resistance; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The potato is a nutritious food that comprises approximately 30% of total vegetable intake in
      the United States (US). Consumption of pulses in the US is low but its contribution to health
      is frequently promoted. However, in the US diet, potatoes contribute as much dietary fiber,
      far more potassium, and a host of similar nutrients as pulses. When prepared to enhance its
      slowly digested starch content, potatoes produce a moderate glycemic response. In encouraging
      a shift towards plant-based foods and sustainable diets, the potato can partially replace
      meat in meat dishes to enhance the overall quality of the diet and reduce meat intake to
      recommended levels.
    

Detailed description: 
      Approximately 11% of individuals with untreated prediabetes progress to diabetes every year.
      Reversion to normal blood glucose concentrations reduces the incidence of diabetes by 56%.
      Healthy eating patterns such as the DASH and the Mediterranean Diet have shown that high
      intakes of fruits, vegetables, whole grains, legumes or pulses, and potatoes are associated
      with cardiometabolic health. In contrast, dietary patterns rich in meat and sugar-rich foods
      are associated with increased risk of mortality, type 2 diabetes, and coronary heart disease.
      These findings suggest that it may be prudent to replace certain foods with fruits and
      vegetables rather than simply embrace plant-based diets. Small changes that bestow health
      benefits are likely to be sustainable in the long-term. The objective of the present
      application is to develop a diet intervention to reverse insulin resistance in an overweight
      or obese population. The central hypothesis is that in the context of an overall healthy
      eating pattern, potatoes and pulses will not differ in the glycemic and insulinemic
      responses, lipid profile, and hsCRP concentration they elicit.
    

Intervention name(s): Reduced Meat High Potato Diet; Reduced Meat High Pulses Diet
Intervention type(s): Other; Other
Intervention description(s): The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.; The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized parallel design
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder
Condition: Insomnia; Depressive Disorder, Major
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia
      related to major depressive disorder.
    

Detailed description: 
      This study is a double-blind, randomized, placebo-controlled, parallel group study. The study
      consists of two groups of subjects with major depression treated for ten weeks with a common
      antidepressant regimen, 20-40 mg of fluoxetine hydrochloride per day; and randomized to
      receive (in addition) either eszopiclone 3 mg or placebo for eight weeks. This study was
      previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon
      Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
      Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Eszopiclone 3 mg QD; Placebo tablet
Other intervention name(s): Lunesta, (S)-Zopliclone
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia related to major depressive disorder.