bioihbjkbjnl/mcl2 huggingface dataset:
Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position
Condition: Stroke
Study type: Interventional

Summary: 
      The seated or "beach chair" position during surgery and general anesthesia decreases brain
      oxygen levels and can result in stroke. As such, poor neurological outcome following beach
      chair positioning is a growing concern. In the proposed study the investigators test the
      hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral
      oxygenation in anesthetized patients in the beach chair position.
    

Detailed description: 
      This is a prospective cohort study with randomized nested design. Patients presenting for
      shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia
      with propofol. Regional cerebral oxygenation will be measured using the INVOS 5100C monitor
      (Covidien, Boulder, CO). Depth of anesthesia will be maintained within a Bispectral Index
      range of 40-60. Following positioning, inspired oxygen fraction and minute ventilation will
      be sequentially adjusted. At each set point, regional cerebral oxygenation will be recorded
      and venous blood gas analysis performed. Statistical analysis will be repeated measures
      analysis of variance in which ventilation strategy is the within-subjects factor and
      anesthetic technique is the between-subjects factor; post hoc Tukey's correction will be used
      for multiple comparisons. If simple maneuvers of ventilation and anesthetic technique can
      prevent low brain oxygen levels, patient outcome may be improved.
    

Intervention name(s): Inspired oxygen fraction / end tidal carbon dioxide
Intervention type(s): Other
Intervention description(s): Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
FIO2 100%, PETCO2 30mmHg - beach chair position.
FIO2 100%, PETCO2 45mmHg - beach chair position.
FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cerebral oxygenation; Beach chair position; General anesthetic technique; Inspired oxygen fraction; End tidal carbon dioxide
Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
Condition: Laparoscopic Gynecologic, Abdominal, Other Surgery; General Anesthesia
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the treatment efficacy and safety of palonosetron for the
      patients who undergo laparoscopic gynecologic, abdominal or other surgery under general
      anesthesia.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can
      produce subject discomfort with medical and economic consequences. This study was designed to
      evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo
      gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated
      only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based
      guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate
      the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic
      gynecologic, abdominal or other surgery under general anesthesia.
    

Intervention name(s): Palonosetron; placebo control group
Intervention type(s): Drug; Drug
Intervention description(s): palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.; placebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
Other intervention name(s): Aloxi (palonosetron); placebo
Intervention MeSH terms: Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: palonosetron; postoperative nausea and vomiting
Brain Reaction to Treatment of Nicotine Dependence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to determine how the treatments for cigarette craving work.

      Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater
      reductions in regional brain activation from before to after both forms of active treatments
      than from before to after placebo.
    

Detailed description: 
      PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers
      in response to cigarette-related cues.
    

Intervention name(s): Zyban
Intervention type(s): Drug
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Position Emission Tomography (PET); Nicotine dependence; functional magnetic resonance imaging; cigarette cues
Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea,
      adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as
      EZ-start, is an extended duration ramp, where the patient receives pressure below their
      prescription during an acclimation phase. The algorithm gradually increases pressure to
      therapy level based on usage. The aim of this study was to determine the effectiveness of the
      AGPAP acclimation period and its impact on short term adherence.
    

Detailed description: 
      Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy
      remains the largest single obstacle to the successful resolution of sleep-disordered
      breathing in OSA patients. It has been estimated that up to 50% of patients who have been
      prescribed CPAP for Obstructive Sleep Apnea (OSA) are not using the treatment one year later.
      A myriad of possible causes for low compliance rates have been proposed and examined in
      previous studies. These include race, gender, education level, income, bed-partner's sleep
      quality, mask discomfort, continuity of care, nasal irritation, discomfort due to elevated
      expiratory pressure, and level of daytime sleepiness.

      Therefore, many investigators have proposed new methods and approaches to help deal with
      these problems. Interventions have ranged from people-centric approaches using intensive CPAP
      education and follow-up programs, to device modifications using features such as a ramp,
      C-FLEX®, BiLevel therapy, and heated humidification.

      In this study. The aim of this study was to determine the effectiveness of the Automated
      Graduated CPAP (AGPAP), also know as EZ-start acclimation period, and its impact on short
      term adherence
    

Intervention name(s): REMstar Auto A-Flex; modified REMstar Auto A-Flex with AGPAP
Intervention type(s): Device; Device
Intervention description(s): Standard CPAP; Modified device -Software upgrade to GP 12
Other intervention name(s): Philips Respironics System One; Philips Respironics System One
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Condition: Dyskinesia; Levodopa-Induced Dyskinesia (LID); Parkinson's Disease (PD)
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group
      study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an
      investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of
      levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel
      pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the
      early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in
      the evening, potentially reducing the negative impact of amantadine on sleep. This
      pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER
      formulation than can be tolerated with an immediate-release formulation. The once-nightly
      dosing regimen may also provide enhanced convenience and compliance.

      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly
      reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
    


Intervention name(s): ADS-5102; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral capsules to be administered once nightly at bedtime, for 13 weeks.; Oral capsules to be administered once nightly at bedtime, for 13 weeks.
Other intervention name(s): amantadine HCl extended release
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levodopa-Induced Dyskinesia; LID; Parkinsonism; Parkinson's Disease
Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the effects of high and low level sodium (salt) diets on blood
      pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High blood pressure, hypertension, aliskiren, low sodium diet
Oral Mucosal Absorption of ICI176,334-1
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the presence or absence of oral mucosal
      absorption of ICI176,334-1
    

Detailed description: 
      Oral mucosal absorption of ICI176,334-1 in Japanese healthy male subjects
    

Intervention name(s): ICI176,334-1
Intervention type(s): Drug
Intervention description(s): Subject will receive single dose of ICI176,334-1
Intervention MeSH terms: Bicalutamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral mucosal absorption; pharmacokinetics; safety; bicalutamide; Japanese; healthy subject
SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this clinical trial is to study the ability of SAR407899 to increase
      the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.

      The secondary objectives of this clinical trial are to study the ability of SAR407899 to
      shorten increase the time to erection duration of penile erection in male patients with
      mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of
      SAR407899 in these patients.
    


Intervention name(s): SAR407899; Placebo; Sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration; Oral administration; Oral administration
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rho-kinase inhibitor; male impotence
Vestibular Socket Therapy With and Without Bone Grafting
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best
      technique to manage this gap for optimal esthetic result.
    

Detailed description: 
      22 patients were randomly assigned to Group 1: Had received implants with the vestibular
      socket technique accompanied with bone grafting the jumping gap between the implant and the
      labial membrane.

      Group 2: Had received implants with the vestibular socket technique, but without bone
      grafting the jumping gap.

      Facial bone thickness and height were evaluated using CBCT scans at baseline before tooth
      extraction and after 6 and 13 months
    

Intervention name(s): vestibular socket technique with bone grafting; vestibular socket technique without bone grafting
Intervention type(s): Procedure; Procedure
Intervention description(s): a vestibular horizontal incision was made then a subperiosteal tunnel was created and a facial bone membrane was placed. The facial gap was filled with a mixture of autogenous bone and deproteinized bovine bone mineral; the vestibular incision was done horizontally about 3 to 4 mm apical to the mucogingival junction and extending 5 to 10 mm horizontally. A submucoperiosteal tunnel was created labially from the socket orifice till the vestibular access incision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage
      in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long-
      term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in
      surgical T4A stage.
    

Detailed description: 
      Gastric cancer is one of the most common cancers in Vietnam . Despite recent advances in
      multimodality treatment and targeted therapy, surgery remains the first option of treament
      for this disease. For resectable gastric cancer, complete removal of macroscopic and
      microscopic lesions and/or combined resections and also regional or extended lymphadenectomy
      should represent worldwide now.

      Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used for
      treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop
      for treament of (AGC) is still controversial in term of technical feasibility, safety and
      oncologic aspect for T4a stage.

      Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is
      difficult to radically perform. Peritoneal seeding of malignant cells, intra- and
      postoperative complications, trocarts metastasis may risk during procedures. Despite, some
      studies have demonstrated the safety and the short-term benefits of LG for T4a gastric
      cancer, the number of these studies and sample sizes have been still inadequate to give good
      evidence for applying it. and long-term oncologic outcomes There are more than 75% of
      patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in
      T4a. The purpose of this study was to compare short- and long- term outcomes of open and
      laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
    

Intervention name(s): Laparoscopic distal gastrectomy
Intervention type(s): Procedure
Intervention description(s): Distal gastrectomy and standard D2 lymphadenectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        all patients with surgical T4a (sT4a) gastric adenocarcinoma at the lower or middle third
        of the stomach who underwent ODG or LDG plus lymphadenectomy between January 2013 and
        December 2020 at the Gastro-intestinal Surgical Department of the University Medical Center
        at Ho Chi Minh City, Vietnam
Eat Well Live Well Nutrition Program
Condition: Diabetes or Diabetes Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to develop and evaluate a dietary change program specifically for
      low-income, African-American women who are at risk for developing diabetes due to obesity.
      The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and
      skills training through active learning exercises related to healthy eating. The program is
      delivered by peer educators in the community and addresses economic and cultural factors that
      are very important to program participants.
    


Intervention name(s): Eat Well Live Well Nutrition Program
Intervention type(s): Behavioral
Intervention description(s): 12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information.
The group sessions included are:
Rate Your Plate: determining high fat foods
Label Reading: reading food labels
Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income
Recipe Modification: preparing old recipes in new ways to reduce fat
Eating Out: order healthier fast foods
Coping with High Risk Situations: coping with situations in which these new habits may be threatened
Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including:
Substituting fat-modified foods for high fat foods
Avoiding fat as a seasoning or flavoring
Avoiding fried foods
Modifying meat
Replacing high fat foods with fruits, vegetables, grains and breads
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Aneuploidy Rates of in Vitro Matured Oocytes
Condition: Aneuploidy
MeSH terms: Aneuploidy
Study type: Observational

Summary: 
      In general, nearly 85% of retrieved oocytes are mature and reproductively useful after the
      retrieval, whereas the remaining percentage are still at metaphase I or germinal vesicle
      stage (MI: 4% and GV: 11 %, respectively).

      The objective of our study is to assess if immature oocytes co-cultured with autologous
      cumulus cells is a safer strategy than just leaving the oocytes in standard culture.
    

Detailed description: 
      Under controlled ovarian stimulation, patients with normal functional ovarian reserves
      produce a good number of oocytes at retrieval. However, in addition to quantity, oocyte
      maturity is an important variable for the success of reproductive technologies. In general,
      nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining
      percentage are still at metaphase I or germinal vesicle stage (MI: 4% and GV: 11 %,
      respectively). Due to the limited expectations held for in vitro maturation in said
      stimulated cycles, the rescue of immature oocytes is not widely used in current clinical
      practice and these oocytes are usually discarded due to the possibility of abnormal embryonic
      development or an increased rate of abortion.

      The objective of our study is to assess if immature oocytes co-cultured with autologous
      cumulus cells is a safer strategy than just leaving the oocytes in standard culture.
    

Intervention name(s): Non intervention
Intervention type(s): Other
Intervention description(s): Non
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Mature ooocytes from the same donors, will be used as control group.
Type 1 Diabetes Mellitus Effect on Bone Mineral Density
Condition: Diabetes Mellitus; Osteoporosis
MeSH terms: Osteoporosis; Diabetes Mellitus
Study type: Observational

Summary: 
      Because the diabetics are fracturing at a younger age than the general population (12), this
      leads us to believe there are significant factors that lead to fracture in Type 1 diabetes
      mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on
      BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data
      exists on pQCT in adults with Type 1 DM.

      Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral
      density (BMD) as measured by DXA compared to age and sex matched healthy controls.
    

Detailed description: 
      Because the diabetics are fracturing at a younger age than the general population(12), this
      leads us to believe there are significant factors that lead to fracture in Type 1 DM other
      than BMD. Very little longitudinal data exists on BMD in adults with Type 1 DM and the
      effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1
      DM.

      Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral
      density (BMD) as measured by DXA compared to age and sex matched healthy controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have Type 1 DM and their age and sex matched control and have been enrolled in
        a study of Type 1 DM and bone and had a baseline DXA and pQCT during the last 4 years.
        Persons that completed visit 1 for the previous study and had a DXA and pQCT done will be
        invited back for repeat DXA and pQCT measurement. If a diabetic patient does not have an
        age and sex matched control or their control does not want to be in the longitudinal study
        a new age and sex matched control will be recruited.
      
Biospecimen description: 
      We will be storing serum samples. No genetic tests will be performed on these.
    
Keywords: diabetes mellitus; bone