bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of Intellivent-ASV Mode With Conventional Modes in Patients With BMI >35
Condition: Ventilation Therapy; Complications
Study type: Interventional

Summary: 
      compare effects of intellectual mode (in our case it will be Intellivent - ASV -) with
      conventional ventilation modes after uncomplicated cardiac surgery in patients with body mass
      index >35
    

Detailed description: 
      The study includes the comparison of two methods of invasive respiratory support ventilation(
      conventional ventilation modes and automatic IntelliventASV mode (a fully automated, or
      closed-loop, ventilation mode that consists of pressure-controlled ventilation or pressure
      support ventilation depending on a patient's respiratory activity. In fully automated
      ventilation mode, tidal volume, pressure levels (including PEEP), minute ventilation, and the
      oxygen fraction in inspired air are controlled solely by the ventilator) after uncomplicated
      cardiac surgery). It assumes 30 randomized patients:15 patients in two study groups male and
      female aged 30 to 70 years of age inclusive, with BMI > 35 kg/m2. The study will be
      randomized, single-center, prospective.
    

Intervention name(s): respiratory support
Intervention type(s): Procedure
Intervention description(s): respirators for invasive mechanical ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: postoperative care; closed-loop modes; safety
Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Does the routine clinical practice of follow up after primary treatment in lung cancer
      patients has any utility.
    

Detailed description: 
      Patients of cancer, after their primary treatment are subsequently called for follow up
      visits to assess the disease status. This has two important implications from the point of
      view of resource management. One, patients often have to travel long distances to report to
      the hospital and have to take care of other logistics such as their accommodation, local
      travel and food. Further often the patient travels with 1-2 attendants which adds to the
      logistic burden. Also, these patients of follow up also contribute to the load on existing
      hospital services. Many authors have speculated that follow-up visits generate anxiety about
      possible disease recurrence. On the other hand, many others have suggested that although
      there may be a transient increase in anxiety, patients are ultimately reassured by this
      practice. Hence, there is no firm evidence for the practice and the need for follow up in
      oncology care.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All curative lung cancer patients after there intial primary treatment who have already
        been given scheduled appointment shall be called telephonically every 3 months. A set of
        questions shall be asked to the patient in his /her vernacular during the telephonic
        interview.After the telephonic interview, the patients shall then report to the cancer care
        specialist at the Hospital for the due follow up visit.
      
Keywords: lung cancer; followup; physical follow up; telephonic followup
Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38
Condition: Spinocerebellar Ataxias
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional

Summary: 
      Spinocerebellar ataxia 38 (SCA 38) is a very rare autosomal dominant inherited disorder
      caused by a mutation in ELOV5 gene, specifically expressed in cerebellar Purkinje cells,
      encoding an enzyme involved in the synthesis of fatty acids. The present study aimed to
      assess the effect of cerebellar anodal transcranial direct current stimulation (tDCS)
      administered employing deltoid (CD-tDCS) and spinal (CS-tDCS) cathodal montage. Clinical
      evaluation was performed at baseline (T0), after 15 sessions of tDCS (T1) and after one month
      of follow-up (T2).
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Anodal stimulation was delivered by a battery-driven stimulator (Neuroelectrics, Barcellona, Spain) through a pair of saline-soaked surface sponge electrodes (7 x 5 cm2) producing a constant current of 2 mA for 20 min. The anode was placed 2 cm under the inion and the cathode was placed over the right deltoid muscle (CD-tDCS) or the spinal lumbar enlargement (2 cm under T11) as described by Benussi et al. (CS-tDCS). An electroconductive gel was applied to the electrodes to reduce contact impedance and the electrodes were held in place using elastic gauzes.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gait; ataxic symptoms; dysarthric symptoms
The Turkish Feeding/Swallowing Impact Survey
Condition: Deglutition Disorder; Dysphagia; Outcome Assessment; Quality of Life
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      The purpose of this study is to test the reliability and validity of the Turkish
      Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing
      disorders.
    

Detailed description: 
      The purpose of this study is to test the reliability and validity of the Turkish
      Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing
      disorders.The internal consistency, test-retest reliability, and criterion validity of
      T-EAT-10 will be investigated. The internal consistency will be assessed using Cronbach's
      alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be
      calculated for test-retest reliability. The criterion validity of the scale will be
      determined by assessing the correlation between the Turkish Feeding/Swallowing Impact Survey
      and Karaduman Chewing Performance Scale, Tongue Thrust Rating Scale, Pediatric version of the
      Eating Assessment Tool. The validity will also be determined by completion of the Turkish
      Feeding/Swallowing Impact Survey before and after swallowing rehabilitation of pediatric
      patients.
    

Intervention name(s): CAREGIVERS; CHILDREN OF CAREGIVERS
Intervention type(s): Other; Other
Intervention description(s): The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers; Chewing performance with Karaduman Chewing Performance Scale, tongue control with Tongue Thrust Rating Scale, dysphagia symptom severity with the Pediatric version of the Eating Assessment Tool will be evaluated. These assessments will be done before and after swallowing rehabilitation program.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Caregivers of pediatric patients with swallowing disorders
Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application
Condition: Enterocutaneous Fistulas
MeSH terms: Intestinal Fistula; Fistula
Study type: Observational

Summary: 
      For non-healing ulcers, abnormal periods of wound healing processes: inflammation,
      proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled"
      wound, investigators hypothesized that these glue-assisted closure (GAC)-failed
      enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by
      excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the
      chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Low-output enterocutaneous fistulas receiving glue application
      
Biospecimen description: 
      Plasmas and fistula tissues
Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
Condition: Sinusitis, Chronic
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS)
      before and after sinus surgery.
    

Detailed description: 
      Rhinosinusitis (RS) is a heterogenous disease, with variable etiologies, manifestations, and
      progression. Generally, RS can be divided into acute, subacute, and chronic RS, depending on
      the symptoms and duration of the disease. Most commonly, acute RS is caused by a viral
      infection (viral RS), which starts in the nasal passages and progresses to inflammation of
      the sinuses. When this inflammation of the paranasal sinuses does not resolve and lasts for
      at least 12 weeks, the disorder is broadly defined as chronic RS (CRS), which is usually
      accompanied by bacterial infections. This inflammatory disease pathophysiology is further
      subdivided into CRS with (CRSwNP) and without (CRSsNP) nasal polyps. Recently, several
      studies aimed at phenotyping the diverse pathophysiology among patients suffering from CRS
      characterized subgroups based on the presence of inflammatory clusters. CRSsNP is marked by
      pro-inflammatory neutrophilic inflammation of the nasal mucosa and a nasal cytokine profile
      that is characterized by increased levels of TGFβ1 and IFNγ and low or undetectable levels of
      IL-5. In contrast, patients with CRSwNP demonstrate eosinophilic inflammation of the nasal
      mucosa, low levels of TGFβ1, but high levels of Th2/Th17-type cytokines such as IL-17 and
      IL-5, higher levels of eosinophil cationic protein (ECP) and mast cell tryptase, and lower
      levels of IL-10.

      Currently biomarkers associated with physician diagnosed disease severity and
      patient-perceived quality of life impairments are lacking. Analysis of markers of
      inflammation in the nasal mucosa and peripheral blood leukocytes in combination with quality
      of life symptom scoring will enable us to identify biomarkers associated with CRS disease
      severity. This study will determine if biomarkers identified in the nasal mucosa and
      peripheral blood leukocytes correlate with physician diagnosed and patient-perceived disease
      severity.
    

Intervention name(s): Sinus surgery
Intervention type(s): Procedure
Intervention description(s): Standard Clinical Sinus Surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are patients at UNC Healthcare ENT clinics
      
Biospecimen description: 
      Whole blood, urine, nasal lavage fluid, nasal epithelial lining fluid
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared
      to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as
      positive control. In addition, the tolerability and safety of SR58611A in patients with MDD
      will be evaluated.
    


Intervention name(s): amibegron (SR58611A)
Intervention type(s): Drug
Intervention MeSH terms: Amibegron; Amibegron hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Clinical Trials; Major Depressive Disorder
n-3 Polyunsaturated Fatty Acids in Obesity
Condition: Adipose Tissue Inflammation; Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Inflammation in the adipose (fat) tissue is an important condition leading to metabolic
      derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids
      exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity.
      This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose
      tissue inflammation in morbidly obese patients.
    


Intervention name(s): reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA); control
Intervention type(s): Drug; Drug
Intervention description(s): 4g daily, 8 weeks; equivalent amount of fat as butter
Other intervention name(s): Omacor®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Effect of Interval Training on Arterial Stiffness in Women With Hypertension
Condition: Arterial Stiffness
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      this study is aiming to assess the chronic effect of the interval training program on
      arterial stiffness in women with hypertension
    


Intervention name(s): interval training exercise
Intervention type(s): Other
Intervention description(s): interval training exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips
Condition: Alveolar Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional
Phase: Phase 4

Summary: 
      The clinical cases in the present study described the khoury shell technique using an
      allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar
      ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are
      characterized by more aggressive surgery.
    


Intervention name(s): Horizontal alveolar bone augmentation
Intervention type(s): Procedure
Intervention description(s): Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site
Other intervention name(s): MAXGRAFT@Cortico - Botiss
Intervention model: Single Group Assignment
Intervention model description: Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allograft; Autogenous chips; Horizontal augmentation; Khoury shell technique
Chronic Resveratrol Supplementation in Healthy Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The effects of chronic resveratrol supplementation have yet to be investigated in healthy
      humans. It is hypothesised that the effects will be different to those seen in acute
      supplementation. This study will look specifically at cognitive performance, cerebral blood
      flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It
      is hypothesized that these measures will be affected differently by acute and chronic
      supplementation.
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.; Methyl Cellulose. 1 capsule taken once daily for 28 days.
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cognitive performance; Cerebral blood flow; Subjective sleep; Subjective mood; Subjective health
Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma
Condition: Gastric Cancer; Surgery
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to compare disease-free survival between adjuvant
      capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in
      curatively resected gastric cancer patients.
    

Detailed description: 
      Although gastrectomy is the only potentially curative treatment in gastric cancer patients,
      the overall survival results remain unsatisfactory. The main factor accounting for high
      mortality rate is the relapse after surgical resection. During the past few decades, the
      principle of combined modality treatment has been developed and applied in practice for
      various solid tumors and gastric cancer has not been an exception. In an attempt to prevent
      recurrence and increase the cure rate of gastric cancer patients after surgery, multiple
      studies using variable modalities have been undertaken. One of the landmark study in adjuvant
      trials was the Intergroup study INT-0116, which reported a significant improvement in
      survival with the use of chemoradiation therapy after gastric resection of stage Ib to IV
      gastric cancers. Thereafter, the chemoradiation therapy has gained popularity and has been
      increasingly recognized as a standard of care in U.S. Nevertheless, the result from INT-0116
      study has been challenged by the fact that the surgical treatment applied in the trial was
      gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is
      debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients
      with extensive lymph node dissection.

      It is still disputable if chemoradiotherapy after D2 can improve the results of D2 alone.
      Thus, the assessment of the effect of adjuvant chemoradiotherapy in D2 resected gastric
      cancer is essential.
    

Intervention name(s): Capecitabine, cisplatin, Radiotherapy (+/-)
Intervention type(s): Drug
Intervention description(s): Capecitabine, cisplatin + Radiotherapy (randomized)
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; radiotherapy; postoperative therapy; chemotherapy
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal
      (kidney) function can affect their elimination from the body via metabolism. This study will
      therefore compare the pharmacokinetics (time course of drug concentrations in the body),
      safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy
      control subjects.
    


Intervention name(s): CP-945,598; CP-945,598
Intervention type(s): Drug; Drug
Intervention description(s): Administration of CP-945,598 in subjects with normal renal function.; Administration of CP-945,598 in subjects with severe renal impairment.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omega-3 Fatty Acids and Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being done to understand the effects of dietary omega-3 fats on insulin
      sensitivity in adult men and women.
    

Detailed description: 
      Dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), which include eicosapentaenoic acid
      (EPA) and docosahexaenoic acid (DHA) from fish oil, prevent insulin resistance in rodents,
      but data in humans is ambiguous. No existing studies have systematically evaluated the
      influence of n-3 PUFAs on insulin sensitivity and beta cell function in insulin resistant,
      non-diabetic humans. The Investigators hypothesize that 6 months of oral supplementation of
      purified EPA/DHA (3.9g/day) will significantly improve hepatic and peripheral insulin
      sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals.
      Based on recent work in mice, the investigators also hypothesize that EPA/DHA will increase
      the content and function of mitochondria in skeletal muscle, measured using a combination of
      in vivo and in vitro methods. Overall, the investigators hypothesize that EPA+DHA
      supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant
      humans, and this improvement will be associated with mitochondrial biogenesis and attenuated
      lipid accumulation in skeletal muscle and liver.

      A sub-study was added in which participants receiving dietary omega-3 fatty acids or placebo
      supplements underwent abdominal subcutaneous adipose tissue biopsies to measure the content
      of total, pro- (M1) and anti- (M2) inflammatory macrophages (immunohistochemistry),
      crown-like structures (immunohistochemistry), and senescent cells (β-galactosidase staining),
      as well as a two-step euglycemic, pancreatic clamp with a stable-isotope labeled precursor
      ((U-13C)palmitate) infusion to determine the insulin concentration needed to suppress
      palmitate flux by 50% (IC50(palmitate)f).
    

Intervention name(s): Omega-3; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
Other intervention name(s): Essential fatty acids; Omega-3 fatty acids; Omega-3 polyunsaturated fatty acids; PUFAs; Lovaza
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Breathalyzer Validation Study
Condition: Alcohol Drinking; Alcohol Intoxication
MeSH terms: Alcoholic Intoxication; Alcohol Drinking
Study type: Interventional

Summary: 
      The proposed project will test three commercial cellphone breathalyzers against a police
      grade breathalyzer device.The study will test the accuracy of these smartphone breathalyzers
      at assessing Breath Alcohol Content (BrAC) against a standard police grade breathalyzer. This
      study aims to fill the knowledge gap by determining the validity of smartphone paired
      breathalyzer devices to accurately assess BrAC. Data collection includes collection of BrAC
      measurements, as well as survey data.
    


Intervention name(s): Alcohoot; BACtrack Mobile Pro; DRIVESAFE Evoc; BACtrack Vio; Drinkmate; Floome; Intoxilyzer 240
Intervention type(s): Device; Device; Device; Device; Device; Device; Device
Intervention description(s): Alcohoot branded smartphone-paired breathalyzer; BACtrack Mobile Pro branded smartphone-paired breathalyzer; DRIVESAFE Evoc branded smartphone-paired breathalyzer; BACtrack Vio branded smartphone-paired breathalyzer; Drinkmate branded smartphone-paired breathalyzer; Floome branded smartphone-paired breathalyzer; Intoxilyzer 240 police grade breathalyzer
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research