cyrilzakka/clinical-trials huggingface dataset:
Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened CI users. The study will evaluate the potential benefit of training on speech recognition performance, psychosocial and cognitive function.

Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users with Auditory-Brain Training is evaluating the performance of older cochlear implant users completing a customized auditory-cognitive brain training program. The goal is to determine the effectiveness of training based on speech recognition, neural responses, cognitive, and psychosocial function. Successful training could result in improved outcomes for communication and cognition, new client-centered care models, and better consumer access to effective training.

Specifically, investigators will assess two training programs to determine whether participants can improve speech understanding and speed, attention and memory, and communication in daily life. Thirty participants will be randomly assigned to one of two treatment groups: auditory-brain training or non-auditory brain training. Participants will complete two hours of training online at home or office. Participants will meet virtually with a clinician weekly to discuss progress.The study will help determine the best training methods for older adult cochlear implant users.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age and over;
* Between 3 months and 3 years post cochlear implant activation;
* Passing score an cognitive screener (Callahan et al, 2002);
* Speech recognition scores on AZBio between 10% and 85%.

Exclusion Criteria:

* Single-sided deafness
* Non-fluent English
Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients

Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU) however their treatment remains unclear. This prospective pharmacodynamic study relates to the analgesia of procedural pains. The primary objective was to determine the 90% effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated patients.

Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation, reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were included.

During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new LD until BPS was at 3 or 4.


Eligibility Criteria:
Inclusion Criteria:

* 48th hour of mechanical ventilation
* mechanical invasive ventilation
* 48th hour midazolam sedation
* Behavioral Pain Scale (BPS) at 3 or 4
* mechanical ventilation of 5 days duration

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Impossibility of evaluation of the BPS tetraplegia, curare-link , post anoxic coma encephalic death
* Indication of deep conscious-sedation, malignant cranial trauma, toxic shock, acute respiratory distress syndrome
* Extra renal clearance OU people in hemodialysis
* Severe renal failure (creatinine clearance \<15ml/min)
* Severe hepatic failure
* State of consciousness with impossibility to use self-assessment scale
* Body mass index \>35 ou \<18
* Sufentanil midazolam paracetamol allergy or contraindication
* Guardianship or confirmed criminal Subject who give his informed consent
* Morphinic other than sufentanil (morphine, alfentanil fentanyl, remifentanil, nalbuphine, codeine, buprenorphine)
* Antalgic other than sufentanil and paracetamol ( tramadol nefopam, ketamine, dextropropoxyphene, non steroidal anti-inflammatory drug )
* MAO inhibitors
Characterization of a Prospective Cohort of Women With PCOS

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Women with PCOS are reported to have increased levels of stress hormones, which may be associated with decreased quality of life. Increased testosterone levels in women may decrease the risk of osteoporosis. The aim of the present study is to measure levels of stress hormones in urine and describe quality of life using questionnaires. In addition we aim to characterize body composition and bone architecture using DXA and ExtremeCT.

As part of the project, a Biobank with fasting blood samples from participants is established.


Eligibility Criteria:
Inclusion Criteria:

* PCOS

Exclusion Criteria:

* pregnancy
Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.

The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal.

One (1) Investigational Site in Paraguay will participate with up to 16 subjects enrolled in the study. Subjects indicated for a closed-chest cardiac invasive procedure will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-1013 StealthTrac Lead inserted and evaluated over the follow-up period (up to 7 days post procedure). Study participation requires 2 to 7 days with the Study Lead inserted. Following Study Lead removal, a final follow-up will be performed 27-33 days after lead insertion to assess for any latent Adverse Events. Subjects remain enrolled until completion of the 30-Day Follow Up.

The maximum duration for study participation is 33 days. The Study is expected to last up to 3 months after first enrollment: Enrollment and follow-up (1 month) and final report (2 months).

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Indicated for closed-chest cardiac invasive procedure (e.g., transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)

Exclusion Criteria:

1. BMI ≥ 35 kg/m2
2. Septic shock
3. Severe anemia
4. Acute coronary syndrome within past 90 days
5. NYHA IV Functional Classification of heart failure within past 90 days
6. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
7. Participation in any concurrent clinical study without prior written approval from the Sponsor
8. Inability or unwillingness to provide informed consent to participate in the Study

   Known prior history for any of the following:
9. Median or partial sternotomy
10. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
11. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
12. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
13. Pericardial disease, pericarditis and mediastinitis
14. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
15. FEV1 \< 1 liter
16. Surgically corrected congenital heart disease (not including catheter-based procedures)
17. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate, and silicone
Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories with fat. KD is of increasing interest among athletes because it may increase their maximal oxygen uptake (VO2max), the principal performance limitation at high altitudes. The investigators examined the tolerance of a 4-week isocaloric KD (ICKD) under simulated hypoxia and the possibility of evaluating ICKD performance benefits with a maximal graded exercise bike test under hypoxia and collected data on the effect of the diet on performance markers and arterial blood gases.

In a randomised single-blind cross-over model, 6 recreational mountaineers (age 24 to 44 years) will complete a 4-week ICKD followed or preceded by a 4-week habitual mixed western diet (HD). Performance parameters (VO2max, lactate threshold \[LT\], peak power \[Ppeak\]) and arterial blood gases (PaO2, PaCO2, pH, HCO3-) will be measured at baseline under two conditions (normoxia and hypoxia) as well as after a 4-week HD and 4-week ICKD under the hypoxic condition.

Eligibility Criteria:
Inclusion Criteria:

* Recreational mountaineers
* Familiarity with altitude (\>2500 m above sea level) and males/females 20 to 45 years old.

Exclusion Criteria:

* high training load (such as professional athletes) or new planned training
* dietary restrictions.
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial

The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in lower risk of capsular contracture after postmastectomy radiation therapy(PMRT) compared with acellular dermal matrix(ADM)-assisted implant-based breast reconstruction with subpectoral implant placement.

OUTLINE: This is a single center randomized clinical trial. Participant recruitment and enrollment will occur at Gangnam Severance Hospital Breast Cancer Center for 4 years, followed by one year of follow up data collection and analysis.

Arm I (Prepectoral): immediate ADM-assisted implant-based breast reconstruction with prepectoral implant placement.

Arm II (Subpectoral): immediate ADM-assisted implant-based breast reconstruction with subpectoral implant placement.

This clinical study is aimed at patients who have been diagnosed with breast cancer and who have undergone a total mastectomy for the therapeutic indication, and who are planning to undergo implant based reconstruction and postmastectomy radiotherapy.

It will be carried out prospectively in a single institution, and the study will be divided into two groups, subpectoral implant and prepectoral implant, according to the reconstruction method.

A total of 96 patients or 48 patients per arm will be recruited. Randomization will be accomplished using randomly permuted blocks, and randomization will be stratified on the basis of reconstruction method. (tissue expander insertion or direct-to-implant)

After completion of study treatment, patients are followed for 1 year for observation of capsular contracture and patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 19 years old
2. Histologically confirmed diagnosis of unilateral breast cancer
3. Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication
4. Patient undergoing immediate implant based breast reconstruction

Exclusion Criteria:

1. Underlying medical condition: for example, (AST or ALT \>100U/L, inadequate renal function; eGFR \< 30ml/min, congestive heart failure; New York Heart Association III-IV)
2. Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy
3. History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.
4. Not able to provide informed consent (Illiterate, foreigners, etc.)
Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis

This study compare the results of 2 methods in surgical treatment of Lumbar spine stenosis.These are microdecompresssion and open decompression with posterior stabilization. 100 patients are involved in this study who divided in 2 groups.Each group was treated with one method and follow up done which showed both method are effective with better results in those patients treated with microdecomppression.

This randomized controlled study was conducted between January 2016 and October 2018. One hundred patients were involved in this study. All these patients were suffered from radicular leg pain with MRI features of multilevel lumbar spinal stenosis and were treated by conservative treatment of medical treatment and physiotherapy without benefit for (6) months. Those patients were divided into two groups; Group A, (50) Microdecompression, and Group B, (50) patients who were treated by open wide laminectomy and posterior stabilization. Both groups of patients were followed up with ODI (Oswestry disability index) and VAS (Visual analogue score) for the back and leg pain for one year.

Results: The results showed that both groups got significant improvement regarding Oswestry disability index. Regarding back pain, there was a significant improvement in both groups with better results in-group A due minimal tissues injury as the advantage of minimal invasive technique. In both groups, there were marked improvement of radicular leg pain postoperatively.

Conclusions: Both Microdecompression and wide open laminectomy with posterior stabilization were effective in treatment of multilevel lumbar spinal stenosis with superior results of Microdecompression regarding less back pain postoperatively with less blood loss and soft tissue dissection.

Eligibility Criteria:
Inclusion Criteria:

* patients were suffered from back pain of different degrees with spinal claudication

Exclusion Criteria:

* Smoking
* Diabetic patients,
* Previous spinal surgery,
* any neuromuscular disorder like poliomyelitis, and
* vertebral instability proved by Dynamic plain radiographs
Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)

Bladder cancer is the fourth and eighth most common malignancy among men and women, respectively. About 75% of bladder cancers are diagnosed as non muscle-invasive and according to specific tumor-stage and grade characteristics, intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) is used to prevent recurrence and/or progression. However, BCG immunotherapy is associated with significant adverse events and treatment failure may occur in 30-40% of cases, hence the necessity for alternative therapies. In an orthotopic MB49 mouse bladder cancer model, another bacterial vaccine (Ty21a/Vivotif) turned out to be more effective than BCG for inducing tumor regression and mice survival upon intravesical instillation; and potentially safer because Ty21a bacteria did not infect/persist in any mice tissues nor in human bladder explants or cell lines, in contrast to BCG. Ty21a/Vivotif has been used in the last 30 years in millions of individuals as an oral typhoid vaccine with a high safety record. In this phase I trial we will be testing the safety of intravesical administration of Ty21a and its effect on bladder immunity in non-muscle invasive bladder cancer (NMIBC) patients, for whom recommendation of BCG therapy is not mandatory.

Escalating doses of Ty21a/Vivotif® will be administered by the intravesical route to evaluate whether Ty21 may replace the standard BCG immunotherapy in NMIBC patients.

The minimal starting dose will be instilled intravesically once a week for 4 weeks in 3 patients. If well tolerated, a 5-fold higher dose will be instilled 4-times in 3 other patients, and so on for a maximum of 4 doses to be tested.

The maximal tolerated dose will then be administered to 3 new patients 6-times once a week. If 6 instillations are well tolerated, 7 additional patients will be included to receive 6 instillations with this maximal tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an intermediary or low risk of progression of bladder cancer (according to an EORTC score and clinical considerations) and thus not requiring BCG immunotherapy will be included after a transurethral resection of the bladder tumor (TURBT). Male and Female patients aged \> 18yrs, with a Karnofsky performance status of 60% or more, sero-negative for HIV, HBV and HCV and with laboratory parameters for vital function in the normal range or with abnormalities without clinical significance may be included.

Exclusion Criteria:

* Patients with NMIBC that require BCG treatments or with muscle-invasive bladder cancer, sero-positive for HIV, HBV and HCV or with other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders, autoimmune disease), will be excluded.
Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort

The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.

Numerous meta-analyses and systematic reviews have delved into the treatment of DA, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in China. To bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.

Eligibility Criteria:
Inclusion criteria:

(1) histologically confirmed non-ampulla DA;

Exclusion criteria:

1. had other gastrointestinal cancer;
2. had incomplete medical records, or lost follow-up shortly after diagnosis;
3. refused clinical data collection.
Educational Model for Cardiac Patients

The purpose of this study was to compare the effect of an educational model, which included cardiac rehabilitation with emphasis on physical activity and telephone follow up, with the usual management of individuals undergoing to first percutaneous coronary intervention, in relation to physical activity five until seven months after discharge.

Randomized controlled trial (RCT) at a public teaching hospital, which has specialized care for CAD in Ribeirão Preto, state of São Paulo, Brazil. The intervention group received usual care and an educational programme and the control group received only usual care.

A researcher (who didn't had contact with the patients) generated the random allocation in SPSS software, concealing it from the investigators in sequentially numbered, sealed and opaque envelopes.

Another researcher performed the individual interview with each participant (baseline) and aplied the instruments of socialdemographic data, physical activity, ansiety and depression, perceived health status and selfefficacy to practice of physical activity. At the end of the interviewThe same researcher opened the envelope to allocate the participants to either intervention or control group. The participants of intervention group remained with the researcher to receive the intervention.

The educational programme consisted of four booklets entitled 1. Percutaneous Transluminal Coronary Angioplasty, 2. Going home after your coronary angioplasty, 3. How to take care of your heart and your health, and 4. How to practice physical activities. The educational programme included the telephone follow-up that contained three calls to motivate the participants to change their lifestyle and clarify doubts. The contents of the booklets were explained step by step to the participants by the researcher who conducted the interviews.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or more) of both genders
* Patients undergoing the first percutaneous coronary intervention
* Patients who had a properly functioning home phone line

Exclusion Criteria:

* No cognitive conditions to participate (assessed by the ability to inform the name, current date, day of the week, place, age and place of birth confirmed by the participant's identification document)
* Who did not have clinical or physical conditions to answer the questionnaires (individuals with dyspnea and / or mental confusion)
* Who reported difficulties to speak on the phone (hearing loss)
* Who had sequelae that could influence activities of daily living (limb amputation or paralysis)
* Who had a contraindication to physical exercise, prescribed by the doctor, and who already participated in a supervised cardiac rehabilitation program
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate


Eligibility Criteria:
Inclusion criteria:

1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
3. Measurable disease according to RECIST
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
2. Any other than one previous platinum based systemic regimen given for R/M disease
3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
4. Pregnancy or breast feeding
Effects of Position and a Test Meal on Esophago-gastric Junction Morphology and Function Assessed by High-resolution Impedance Manometry (HRM)

Retrospective analysis for HRM measurements using liquid swallows and a test meal for the presence of hiatal hernia. The investigators will correlate hernia descriptions with presence of acidic reflux and clinical complaints.

We will retrospectively analyze all patients referred to hour unit for high-resolution esophageal manometry. These patients have been tested using liquid swallows and a test meal. We will analyze the HRM measurements for presence of manometric signs of hiatal hernia and determine predictive factors for hernia presence. We will correlate hernia description versus presence of acid reflux, clinical complaints and HRM measurements.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to our functional lab for esophageal high-resolution manometry from January 2013 - December 20165
* Lack of documentation of patient preferences against usage of medical data for biomedical research
* Male and female patients ≥18 years of age

Exclusion Criteria:

* Age under 18 years
* Patient's wishes against scientific use of their clinical data