bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Condition: Injury as a Result of Positioning
Study type: Interventional

Summary: 
      The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on
      participants undergoing shoulder surgery in the beach chair position (BCP) to determine
      cerebral desaturation events (CDE) and to further determine cognitive changes pre and post
      surgery using the Mini Mental State Exam.
    

Detailed description: 
      In this prospective, randomized, controlled study, investigators used a standardized
      anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the
      Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near
      Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia
      management and would not affect the post-operative cognitive outcomes of participants
      undergoing surgery in the beach chair position. Investigators secondarily wanted to document
      the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in
      participants placed in the BCP if the MAP was strictly maintained.
    

Intervention name(s): NIRS; NIRS monitored not treated
Intervention type(s): Device; Device
Intervention description(s): Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline; Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.
Other intervention name(s): Near infrared spectroscopy; Near infrared spectroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: orthopedic procedures
Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs
      insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of
      insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two
      treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body
      weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other
      adverse events.
    


Intervention name(s): insulin glargine
Intervention type(s): Drug
Intervention description(s): once daily
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety
      and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).
      Approximately 63 subjects will be enrolled across two cohorts.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled study designed to evaluate the
      efficacy, safety, tolerability, and pharmacokinetics of different doses of MEDI0382
      administered as multiple SC doses to subjects with T2DM. Approximately 63 subjects will be
      enrolled across two cohorts.

      For cohort 1, sufficient subjects will be invited to participate in the study such that a
      maximum of 39 subjects will complete dosing. Subjects in cohort 1 will be randomised using a
      ratio of 2:1 to one of 2 treatment arms to receive either MEDI0382 or placebo. A maximum of
      26 will complete dosing in the active arm and 13 will complete dosing in the placebo arm.

      For cohort 2, sufficient subjects will be invited to participate in the study such that a
      maximum of 24 subjects will complete dosing. Subjects in cohort 2 will be randomised using a
      ratio of 3:1 to receive either MEDI0382 or placebo. A maximum of 18 will complete dosing in
      the active arm and 6 will complete dosing in the placebo arm.
    

Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI0382 will be administered subcutaneously once daily for 49 days.; Placebo will be administered subcutaneously once daily for 49 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: 0382, T2DM
Activating Collaborative CIS Support Via Targeted Provider Mailing
Condition: Precancerous Condition
MeSH terms: Precancerous Conditions
Study type: Interventional

Summary: 
      RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer
      Information Service may be more effective than a standard reminder letter in helping patients
      who have had an abnormal Pap test keep their follow-up colposcopy appointment.

      PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer
      Information Service support to see how well it works compared with a standard reminder letter
      in women scheduled for colposcopy after an abnormal Pap test.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effect of a usual care mailing intervention vs a Cancer Information Service
           (CIS) support mailing intervention on the likelihood that women with an abnormal Pap
           test will keep their medical follow-up appointments and be satisfied with how they talk
           to their provider.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 intervention arms.

        -  Arm I (Usual-care mailing intervention): Patients receive a generic letter reminding
           them of their follow-up colposcopy appointment.

        -  Arm II (Cancer Information Service [CIS] support mailing intervention): Patients receive
           a targeted letter reminding them of their follow-up colposcopy appointment, asking them
           or someone they designate to call the CIS, and suggesting some questions to ask the CIS
           about colposcopies and Pap tests.

      At their follow-up appointments, all patients undergo an exit interview to compare patient
      satisfaction between the 2 interventions. Patients in arm II also answer questions about
      their CIS experience, and if the intervention made their follow-up visit less difficult.
    

Intervention name(s): Usual care mailing intervention; CIS support mailing intervention
Intervention type(s): Other; Other
Intervention description(s): routine colposcopy reminder letter; Mailed reminder plus provider recommendation to call CIS and sample questions to ask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: cervical intraepithelial neoplasia; atypical squamous cells of undetermined significance; high-grade squamous intraepithelial lesion; low-grade squamous intraepithelial lesion
Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation
Condition: Atrial Fibrillation; Hypertension
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators have conducted a prospective, double-blind, randomized study to assess the
      comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD)
      versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed
      after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).
    


Intervention name(s): PVI+renal denervation; PVI + GP ablation; Optimal medial therapy (OMT)
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.; To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).; Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Canadian Aesthetic Experience With Sculptra Therapy
Condition: Skin Aging
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective To evaluate the degree of correction achievable with Sculptra for
      nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial
      ageing.

      To document the types and incidence of device-related adverse events with Sculptra.
    


Intervention name(s): Poly-L-Lactic Acid
Intervention type(s): Drug
Intervention description(s): Deep dermal injection
Other intervention name(s): Sculptra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aesthetic facial volume enhancement
Improving Person Centered Care for Post Abortion Patients in Kenya
Condition: Reproductive Health
Study type: Interventional

Summary: 
      The purpose of this study is to understand the effect of a phone based post-abortion
      intervention on the experience of post-abortion care.
    

Detailed description: 
      This study evaluates whether personalized text messages and phone calls to post abortion
      women can improve post abortion person-centered care, perceived social support, post-abortion
      family planning, and reduce perceptions of social stigma and stress. Women were randomized to
      one of three study arms: personalized communication with a peer counselor or nurse who
      received person-centered care (PCC) training, or a control arm where participants received
      the standard of care.
    

Intervention name(s): Person Centered Care - Post Abortion Support
Intervention type(s): Behavioral
Intervention description(s): Post abortion phone based support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post abortion; person-centered care
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
Condition: Colorectal Cancer Screening
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for
      screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual
      screening rates by use of time-to-event analyses (also known as survival analysis). The
      outcome variable of interest is the first time since randomization to have CRCS, either based
      on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons
      between groups, but also over time.

      Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study
      aims. First, we will enroll patients age 50-74 years using the same criteria as for the
      primary SOS study, which includes neither history of colorectal cancer nor evidence of
      life-limiting disease. Participants who return the questionnaire, consent and considered
      eligible will be randomized to receive one of three different at-home fecal test kits. The
      kits will be returned to the GH centralized laboratory, and participants will be informed
      about lab results using standard GH pathways. Participants who have a test-positive will
      receive a series of two follow-up surveys (first at 1-2 weeks post result and second at
      4-months post result). A comparison group of test-negative results will be matched based on
      selected criteria, and this group will also receive the follow-up surveys. Participants at
      both time intervals who do not return the survey via mail will be called and if available,
      administered the questionnaire via phone.
    


Intervention name(s): 3 sample g-SENSA; 2 sample InSure; 1 sample OC-Micron
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.; Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.; Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colorectal Neoplasms; Mass Screening; Population Surveillance; Randomized controlled trial; Occult Blood; Colonoscopy; Sigmoidoscopy; Health Behavior
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
Condition: Epilepsy; Partial Seizure Disorder; Epilepsies, Partial; Complex Partial Seizure Disorder
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial; Epilepsy, Complex Partial
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with
      partial seizures.
    


Intervention name(s): Pregabalin; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): 150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects; 300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
Intervention MeSH terms: Pregabalin; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation
Condition: Nipple Infection
Study type: Interventional

Summary: 
      The aim of the study was to determine the effect of tea tree oil and coconut oil applied to
      the nipples during the early postpartum period on nipple crack formation.
    

Detailed description: 
      This randomized controlled experimental research included a total of 90 women in the research
      sample abiding by the research criteria, with 30 each in the intervention groups (coconut oil
      or tea tree oil application) and 30 in the control group. Women in the intervention groups
      applied coconut oil or tea tree oil to the nipples on the 3rd, 7th and 10th days postpartum,
      while the control group did not have any intervention
    

Intervention name(s): İntervention 1; İntervention 2
Intervention type(s): Other; Other
Intervention description(s): Group 1 applied coconut oil to the nipple; Group 2 applied tea tree oil to the nipple
Other intervention name(s): application of coconut oil and tea tree oil to the nipple.
Intervention MeSH terms: Tea Tree Oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in
      clinical practice. This study was conducted to have a prospective, randomised, controlled
      study compare the safety and efficacy of the autologous skin cell with skin graft (experiment
      group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot
      ulcers.
    

Detailed description: 
      The primary objective of this study is to assess the effectiveness and safety of autologous
      skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment
      of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group
      is better than the control group.
    

Intervention name(s): autologous skin cell; skin graft
Intervention type(s): Device; Procedure
Intervention description(s): autologous skin cell and skin graft; split-thickness skin graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer; Autologous skin cell
Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device
Condition: Localized Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Focal treatment of localized prostate cancer aims to destroy the cancerous foci without
      damaging surrounding tissues to avoid the side effects of radical treatments. This is why
      focal treatment is positioned as an alternative to radical surgery as well as an alternative
      to active surveillance.

      This study is a feasibility study. It aims at treating the index tumor (the most aggressive
      one) which determines the vital prognosis of patient, while preserving the maximum
      surrounding prostatic tissue to preserve quality of life. The expected result is the total
      destruction of aggressive tumor areas by focal or multifocal treatment strategy using the
      Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by
      the negative biopsy rate between 6 and 12 months post-treatment.
    


Intervention name(s): Focal High Intensity Focused Ultrasound (HIFU) treatment
Intervention type(s): Device
Intervention description(s): Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIFU; Prostate Cancer; Focal; Quality of life; Index study
Effects of Different Bread Types in NCWS
Condition: Non-Coeliac Wheat Sensitivity (NCWS)
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Although wheat and gluten containing food products are generally considered to be healthy, a
      large number of individuals in the general population reduces or limits their intake and/or
      replaces wheat by other grains because of possible symptoms. This non-coeliac wheat
      sensitivity (NCWS) is accompanied by a range of (extra-)intestinal complaints soon after
      consuming wheat, which improve after wheat withdrawal. Evidence for a biological mechanism
      and for the exact contributing compound is limited. Furthermore, the impact of grain type,
      bread processing and the resulting compositional changes in bread on gastrointestinal
      tolerability in NCWS is unclear, especially as consumed part of a typical daily human diet.

      The objective of this study is to investigate the effects of well-characterised breads on
      (extra-)intestinal symptoms in individuals with NWGS using two double-blind randomized
      cross-over design (study A and B). Subjects are required to avoid any products that cause GI
      symptoms (e.g. wheat products) during the trial. The investigators hypothesize that grain
      type and processing will have a different effect on the primary outcomes.

      In addition, we want to explore the in vitro effect of each bread type on gut microbiota
      composition and activity.
    


Intervention name(s): Different types of bread
Intervention type(s): Dietary Supplement
Intervention description(s): Two studies comprising a double-blind randomized cross-over study. All subjects start with a run-in period of 3 days, thereafter they will receive three different types of bread in a randomized order for 1 day each, with a wash-out period of at least 7 days in between. Before test days 2 and 3, there is also a run-in period of three days.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind randomized cross-over study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Non-Coeliac Wheat Sensitivity; Wheat Sensitivity; Bread; Wheat; Gastrointestinal symptoms
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)
Condition: Vaccination With MenbVac
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in
      children aged 4-8 years.
    


Intervention name(s): MenbVac
Intervention type(s): Biological
Intervention description(s): Blood test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Neisseria meningitidis B:14, P1-7, 16; Serum bactericidal activity; Menbvac
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes
Condition: Postprandial Lipemia; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias
Study type: Interventional

Summary: 
      Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular
      risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates
      profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little
      information exists about the effect of proteins.

      The purpose of this study is to compare the effects of the milk proteins casein, Whey
      Isolate, Whey Hydrolysate, and Alphalact-Albumin on postprandial lipid and incretin responses
      to a high-fat meal in type 2 diabetes.
    


Intervention name(s): Casein; Whey Isolate; Whey Hydrolysate; Alphalact-Albumin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Casein; Whey; postprandial; Triglyceride; Free fatty acids; Retinyl palmitate; Incretins; Type 2 Diabetes