cyrilzakka/clinical-trials huggingface dataset:
Recovery Napping Protocol for Anesthesiologist Performance

Sleep deprivation impacts performance of shift workers in health care. Anesthesiologists are a population at risk that endures stressful situations and changing working hours. The decreased performance could be the cause for undesirable events. Power-napping is known to be an efficient technique to mitigate the detrimental effects of sleep deprivation and is a feasible measure to implement in critical care units. Still there are few insights that measure the clinical relevance in the field. With the high-fidelity simulations this study is able to measure clinical performance and test for those effects. Therefore we propose a prospective, monocentric study to evaluate a power-napping protocol (less than 30min)

Residents in anesthesiology will be recruited on voluntary basis. They will pass the high fidelity simulation twice, once as a baseline measure under normal conditions after a typical night at home and once sleep deprived after a night shift.

BASELINE Participants will wear actigraphy bracelets to define their sleep pattern for 2 weeks, Then they will spent a normal night at home before coming to the performance center in the afternoon (13h to18h). There they will respond to questions about stress and sleep, will be equipped with smart shirts (HEXOSKIN) to measure their level of stress during the performance, and then undertake a crisis simulation. Afterwards they pass some standardized cognitive tests.

TRAINING The whole year group of residents will be trained to understand sleep management and learn power napping. After the workshop they will individually be trained during 2 weeks including some follow up calls.

INTERVENTION The participants carry again actigraphy bracelets. Then they work a night shift in their service where they usually sleep less than four hours. The morning after the shift participants are free to spend how the like while sleep is being controlled with actigraphy bracelets. In the afternoon (13 to 18h) they return for the second time to the performance center. They are randomly assigned to a napping or non napping group and equipped with ambulatory ECG (Hexoskin) as well es ambulatory EEG (Somfit). After the intervention period (nap or leisure time) they proceed with the same performance measures as at baseline including a simulation crisis and computerized cognitive tests.

Eligibility Criteria:
Inclusion Criteria:

* Second to Fifth year of residency
* Completing night shifts at anesthesia/reanimation unit

Exclusion Criteria:

* No Consent
Radiation Therapy in Treating Women With Invasive Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.

OBJECTIVES:

Primary

* Compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 (TGF-β) in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy.

Secondary

* Establish longitudinal serum and plasma biorepository for retrospective evaluation of TGF-β and other biomarkers with special relevance to radiation response.
* Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (hypofractionated radiotherapy): Patients undergo external-beam radiotherapy once daily 5 days a week for up to 3.5 weeks (16 fractions total).
* Arm II (standard fractionated radiotherapy): Patients undergo radiotherapy as in arm I at a lower dose for up to 5 weeks (25 fractions total).

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer
* Underwent lumpectomy (breast-preserving surgery) with or without adjuvant chemotherapy within the past 12 weeks

  * Histologically negative surgical margins (i.e., no tumor on ink)
* Candidates for postoperative breast radiotherapy

  * Determined not to need radiotherapy to regional nodes (e.g., third supraclavicular field)
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of scleroderma or systemic lupus erythematosis
* No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior breast radiotherapy
Concussion in Motor Vehicle Accidents: The Concussion Identification Index

The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment for concussion.

This Phase 2 study, Concussion in Motor Vehicle Accidents - The Concussion Identification Index (CIDI), focuses on the psychometric properties of the relationship between acute injury events, i.e. head impact, loss of consciousness (LOC), and post-traumatic amnesia (PTA), commonly reported post-crash signs and symptoms, and neurocognitive outcomes.

Cohort 1 is the validation group and will be used to confirm the optimal cut-off score of the Concussion Identification Index (CIDI) with the score on the ImPACT.

Cohort 2 is the cross-validation group.

Eligibility Criteria:
Inclusion Criteria:

* Patients injured in a motor-vehicle related accident

Exclusion Criteria:

* Age younger than 10 years old or older than 60 years of age
* Patients who presented for initial evaluation of injuries greater than 90 days after MVA occurred
* Patients who declined to take a computerized neurocognitive test battery
* Patients who were not fluent in either English or Spanish
Cessation of Thumb/ Finger Sucking Habit

The aim of this study is to assess the use of electronic habit reminder and palatal crib in the cessation of thumb/finger sucking habit.

Treatment of thumb/finger sucking by extraoral approaches are well accepted by school-age children (Adair, 1999). It was reported in a case study by Krishnappa et al that the use of an extraoral electronic habit reminder is a new method used for cessation of thumb/finger sucking habit in short time and it is more comfortable and acceptable to the child (Krishnappa et al, 2016).

This study will be conducted in, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. Diagnosis and patient selection will be at outpatient clinic in the specific days of diagnosis. Impression taking, delivery of appliances and follow up will be at post graduate clinic under supervision of the main and assistant supervisor.

Eligible patients will be randomized to form two groups, Intervention group: Treatment by using electronic habit reminder which will be constructed by taking impression for the thumb/finger using silicon impression material (putty consistency) and pouring it with dental stone. The replica of the finger is used to formulate a custom made cover for it, which consists of stainless steel wires with specific design and acrylic resin this is the first part of the reminder. The second part is in the shape of wrist watch which is connected to the first part by a wire. When the child puts his finger in his mouth the stainless steel wires touch each other and the watch produces alarming sound and counts how many times the alarm goes off. The child should wear the appliance most of the time except during eating and activities.

Control group: Treatment by using palatal crib which will be constructed by taking impression for upper arch with alginate impression material, and then will be sent to the lab for fabrication. Cementation of the appliance and then follow up.

Follow up will be at two weeks and 1, 3, 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Children with thumb/finger sucking habit.
* After eruption of upper first permanent molar
* open bite

Exclusion Criteria:

* Patients with special health care need
* Uncooperative child
* Parents refuse the participation of their child
Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels

The line of "5-hour Energy"® products are available over-the-counter as energy supplements. The appeal of these products involves ease of use, low caloric value, and the absence of sugar to prevent a "crash" later in the day. The definitive efficacy and potency of the products is unknown due to the lack of evidence-based clinical reports. It is suspected that the efficacy related to these products is due to the caffeine content, which was reported as 138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this randomized, double-blind, placebo controlled, four way crossover study is to evaluate the efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, caffeine, and placebo for perceived energy and wakefulness.

Please see brief summary contained above.

Eligibility Criteria:
Inclusion Criteria: Subjects must be age 18 years or older who consume no more than five caffeinated beverages and products per day. One caffeinated beverage is defined as any of the following: six ounces of cold or hot coffee or tea, twelve ounces of soda with caffeine, or one energy drink.

Exclusion Criteria:

* Age less than 18 years
* Subjects who are pregnant or breast-feeding
* Diagnosis of any of the following disease states:

  * Attention Deficit Hyperactive Disorder
  * Anxiety
  * Coronary Artery Disease
  * Cardiac arrhythmias
  * Cerebral vascular accident
  * Narcolepsy
  * Seizure disorders
  * Uncontrolled hypertension
* Active therapy with stimulant medications - any medications containing amphetamine, atomoxetine, dextroamphetamine, diethylpropion, lisdexamfetamine, methylphenidate, phentermine, or modafinil
* Use of decongestants or other products containing phenylephrine or pseudoephedrine for more than 15 days within the past 30 days
* Subjects who work third shift or rotate to two or more different shifts for their job, not allowing them to have a regular sleep schedule
Sitagliptin and Glucagon Counterregulation

To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM

The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.

Eligibility Criteria:
Inclusion Criteria:

1. Written consent has been given.
2. Patients with metformin treated T2DM (metformin dose \>0,5 g/day and stable during the preceding 3 months)
3. Age \>65 years.
4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
5. Ability to complete the study

Exclusion Criteria:

1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
2. Type 2 diabetes, positive GAD antibodies
3. eGFR \<60 ml/min
4. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
5. Any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes.
6. Liver disease such as cirrhosis or chronic active hepatitis
7. History of coronary heart disease or heart failure class III or IV
8. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
10. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise

To examine the influence of compression garments manufactured with Far-Infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors.

Participants: Eighty recreationally active (1-5 hrs per week) healthy participants between the ages of 18 - 35 will visit the Neuromuscular Research Laboratory on 6 separate occasions, with 4 of those occasions also requiring a visit to Health services for a blood draw.

Procedures (methods): During pre-screening, each participant will complete an informed consent document, a health history questionnaire, and have their stature and body mass assessed. A familiarization session will then be conducted on a separate day where all participants will practice the strength assessment, eccentric isokinetic protocol, and ultrasound assessments. Participants will be assigned to 1 of the 4 treatment groups based on their initial maximal isometric strength values using a matched-participants design. The first experimental session will then begin 2-10 days later, where the participants will perform the repeated eccentric exercise protocol (10 sets of 15 eccentric contractions 210 deg/sec with 3 min of rest between sets) with the non-dominant leg following a 60 min rest period where they will wear the apparel and perform a 5 min warm-up on a cycle ergometer. Follow-up blood draws and strength and ultrasound assessments will be obtained at 24 and 48 hours post-exercise. Each participant will also complete a visual analog scale at baseline, 24, 48, and 72 hours post-exercise to examine perceived muscle soreness.

Eligibility Criteria:
Inclusion Criteria:

* Cohort of Adult Males \& Females
* Participant is between the ages of 18-35
* Healthy, Recreationally Active (1-5 hours per week)
* Participant has provided written and dated informed consent to participate in the study
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire
* Participant agrees to abstain from smoking, caffeine (4hrs prior), tobacco (24hrs prior), and alcohol (24 hrs) before testing days
* Participant agrees to abstain from exercise 24 hours prior to each testing visit and after 72 hours of the induced exercise damage
* Participant will refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) and protein supplementation 24 hours before the exercise testing protocol, as well as for the 72 hour period following the exercise testing protocol.

Exclusion Criteria:

* Participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: beta-alanine, creatine, taurine, or any supplemental antioxidants (Acai, pomegranate, beet juice).
* Participant is in, or has participated in another clinical trial within 6 weeks prior to enrollment
* Participant has a known allergy or sensitivity to test product (determined from health history questionnaire and consent form)
Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers

The primary objective of the PGL.EXPO-2 study is to test the hypothesis that exposure (occupational, environmental and/or domestic) to succinate dehydrogenase inhibitors (SDHi) could contribute to tumor emergence in subjects carrying a germline mutation in one of the SDHx genes.The primary endpoint will be the proportion of subjects (cases or controls) exposed to SDHi and the association with paraganglioma risk.

In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study

Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases will have developed a tumor, while the controls will be tumor-free. Controls will be matched to the cases according to age and type of gene affected. Past exposures will be sought through a telephone questionnaire.

In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study

Eligibility Criteria:
Inclusion Criteria:

* Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
* Controls: SDHx mutation carriers with no SDHx-related tumor

Exclusion Criteria:

* Incapacity to exercise free and informed consent for the study
* Patient under tutorship or guardianship or legal safeguard
P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma.

Treatment P-Gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at three different sites. The regimen was repeated every 2 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy. Stage IIIE/IVE patients patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Primary tumor radiotherapy was recommended after they achieved CR.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ENKTL
* age:18-80years
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Eastern CooperativeOncology Group performance status of 0 to 2.
* Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery

After being informed about the study and potential risks, all participants giving written informed consent who meet the eligibility requirements will take Drospirenone-only pills (4 mg, once daily). Cervical mucus by modified Insler score will be evaluated on Day 4-7 of Drospirenone taking. Pre-bariatric surgery results will be compared with post-bariatric surgery results.

Eligibility Criteria:
Inclusion Criteria:

* Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital
* Need contraception
* Able to use non-hormonal contraception during the study
* Giving consent

Exclusion Criteria:

* Pregnancy or history of giving birth within 3 months
* Breastfeeding within the 6 months
* History of using DMPA within 12 months
* History of using other types of hormonal birth control pills within 4 weeks
* History of bilateral oophorectomy or hysterectomy
* Suspected ovarian tumor or pathological ovarian cyst
* Regular cigarette smoking
* Contraindications to Drospirenone
Multicenter Cross Sectional Study of Primary Intestine Lymphoma

The purpose of this study is to determine whether whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (QOL) in patients with primary intestinal lymphoma.

Intestine is the one of commonly involved extranodal sites of non-Hodgkin's lymphoma (NHL). Thus, small and large Intestine account for approximately 30-40% of primary gastrointestinal tract lymphoma. More than 70% of intestinal lymphoma presents as localized disease, and surgery such as bowel resection is performed in many patients with intestinal lymphoma for diagnosis and treatment. However, it is still unclear whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (QOL). Thus, we analyze the clinical features and treatment outcome of patients with NHL of intestine, and at the same time perform a multicenter cross-sectional study about the QOL in survivors of intestine NHL. We evaluates the treatment outcomes of patients with intestine NHL from hospitals affiliated with the Consortium for Improving Survival of Lymphoma (CISL) in Korea. We assess the QOL of survivors who completed their treatment using the EORTC QLQ-C30 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Primary intestine lymphoma.

Definition of primary intestine lymphoma:

1. Dominant site should be small and large intestine with or without regional lymph node involvement
2. Distant lymph node involvement can be allowed if the intestine lesion is the presenting site
3. Contiguous involvement of other organs such as liver, spleen can be allowed

Exclusion Criteria:

* Intestine involvement as a dissemination process in stage IV nodal lymphoma
Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)

The goal of this prospective observational cohort study is to learn about treatment strategies for unruptured intracranial aneurysms in the Chinese population. The main questions it aims to answer are:

* To establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy.
* To establish clinical management path for patients with unruptured intracranial aneurysm.

According to the treatment of all patients with unruptured intracranial aneurysm, they were divided into the following groups: 1. Conservative treatment group; 2. Intracranial aneurysm clipping group; 3. Coil embolization or stent-assisted coil embolization group; 4. Flow diversion group.


Eligibility Criteria:
Inclusion Criteria:

A. age \> 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.

C. patients' consent were obtained.

Exclusion Criteria:

1. Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;
2. Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;
3. Combined with cerebrovascular malformations;
4. Combined with brain tumors or malignant tumors in other parts ;
5. Combined with systemic connective tissue disease and systemic rheumatic disease ;
6. Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;
7. During pregnancy and perinatal period.