cyrilzakka/clinical-trials huggingface dataset:
OS NMB Depth Measured by Central and Peripheral Monitor.

Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.

NMT (neuromuscular transmission) depth can be measured at the same arm with two different methods during clinical practice.

the first (TOF Watch) measures the musculus adductor pollicis acceleration while the second method (TOF Cuff Monitor) uses a blood pressure cuff to measure the pressure changes induced by the upper arm muscles.

During general anesthesia when NMB (neuromuscular block) is required both methods are used. Every 5 minutes, if clinical required, the NMB is monitored by TOF-PTC. If the measurement of TOF is zero the monitor continues by measuring PTC ( the system will measure TOF followed by PTC if TOF is zero) TOF-PTC is recorded and later compared for identity or systematic difference in one or the other direction.

The measured answer can be TOF 4 (4 answers) with a ratio between answer 1 and 4 expressed and a percentage, TOF 3 (3 answers), TOF 2, TOF 1, TOF 0 + PTC 20, TOF 0 + PTC 19, up to TOF 0 + PTC 0

Eligibility Criteria:
Inclusion Criteria: all patients scheduled for an elective surgery requiring neuromuscular block during anesthesia

* laparoscopic surgery of upper abdomen including all types of bariatric surgery.

Exclusion Criteria: not possible to measure NMT (neuromuscular transmission) by cuff or thumb monitor

* upper arm obesity excluding the use of an upper arm blood pressure cuff
* allergy to NMB (neuromuscular blockers)
* contra indication for a deep NMB
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose.

Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study.

No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians.

Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.
2. Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.

Exclusion Criteria:

1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia

Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.

1. The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
2. Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.

The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.


Eligibility Criteria:
Inclusion Criteria:

* Consent for participation
* Affiliation to the french social security system
* Patients benefit general anesthesia with oral intubation

Exclusion Criteria:

* Pregnant or breastfeeding patients;
* Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma);
* Patients under the protection of justice
* Patients with drained or undrained pneumothorax;
* Patients with a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room;
* Patients with coronary heart disease, heart failure or respiratory failure;
* Patients with intracranial pathology; patients with arterial oxygen saturation \<95% in the open air;
* Patients for whom the surgical procedure requires the installation of a double-lumen tube;
* Patients requiring rapid sequence induction; patients for whom the induction can not be carried out by the sequence sufentanil, propofol, rocuronium;
* Patients with sugammadex allergy;
* Patients placed under judicial protection
* Patients who have already been included in the study
Young Breast Cancer Cohort Study

This study is prospective cohort study to investigate and identify comprehensively the clinicopathological features and long-term outcome of young breast cancer (YBC).

We have enrolled Breast cancer patients under 40 year-old and collected their baseline characteristics including tumor character, familiar history and other background information. Moreover, we have collected breast cancer tissue/blood sample for analyzing genetic characteristics, if patient agree to genetic analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with breast cancer
2. Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery
3. Obtained informed consent form

Exclusion Criteria:

1) Cannot understand or disagree to informed consent form
Kinematics of Movements Provoked by an Augmented Reality App

Introduction: Home-based rehabilitation has the potential to reduce healthcare costs. However, due to less supervision in the home situation, it is possible that movements are made incorrectly. Therefore it is important to gain insight in which movements are made with a home-based rehabilitation system and what effects instructions could have on these movements. The current study investigated these movements made by the Rehabilitation Gaming System (RGS) app, this app uses augmented reality to provoke upper limb movements.

Methods: 16 healthy elderly and 16 stroke survivors participate in this study. Each participant was invited to the rehabilitation clinic for a one time measurement of 1.5 hours. During this measurement, four therapy exercises and four games on the RGS-app are performed. Each game should provoke a similar movement as one of the therapy exercises. Participants start with performing the therapy exercises for two minutes each. Thereafter they receive a video instruction on how to perform one of the games of the RGS-app, and they will play this game for 2 minutes. Thereafter the group is randomized into two conditions. The first group receives the same video instruction, while the second group receives a personalized live instruction based on the first two minutes of playing. After the new instruction, participants will play the game for two minutes again. This is repeated for all four games. Both the order of the therapy exercises and RGS-app games are randomized. During the study, participants wear Inertial Measurement Units (IMU's).


Eligibility Criteria:
Inclusion Criteria stroke survivors:

* People who suffered from a stroke at least 2 months ago.
* Smartphone users
* Mild to moderate upper limb impairment (Medical Research Council Scale for Muscle Strength (MRC) ≥ 2)

Exclusion Criteria stroke survivors:

* Severe cognitive impairment (Montreal Cognitive Assessment \< 19)
* Visual impairments (which cannot be corrected with glasses)
* Upper limb impairments not caused by the stroke

Inclusion Criteria healthy elderly:

* 60 years or older
* Smartphone users

Exclusion Criteria healthy elderly:

* Visual impairments (which cannot be corrected with glasses)
* Upper limb impairments which can affect smartphone use
Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion

Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.


Eligibility Criteria:
Inclusion Criteria:

* Single lesion in a Single vessel
* Reference vessel diameter 2.5 - 3.5 mm
* Lesion length ≤ 34 mm and ≤ 34 mm stent length
* Stable angina requiring revascularization, patients with unstable angina
* The patient has no difficulty to enforce the follow-up angiography
* Patient is ≥ 20 years old

Exclusion Criteria:

* Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
* Reference vessel diameter \< 2.5 mm or \> 4.0mm
* Contraindication to anti-platelet agents
* Treated with any DES within 3 months at other vessel
* Creatinine level ≥ 2.0 mg/dL or ESRD
* Severe hepatic dysfunction (3 times normal reference values)
* Patients with LVEF \< 30%
* Life expectancy 1 year
* Lesions with CTO or left main
* Target vessel of ST-elevation MI
* Lesions requiring overlapped stenting or more than 2 DES in each vessel
* Heavy calcified lesions (definite calcified lesions on angiogram)
* Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
* Pregnant women or women with potential childbearing
Testing the Effect of Mindfulness for Prostatectomy Outcomes

This research project has 2 parts: The first part of the research is to develop a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. The second part is the trial registered here, which will pilot the researchers' mindfulness intervention, developed in part 1, and observe any reduction of distress for men undergoing prostatectomy and their partners.

In part 1 of this research, researchers developed a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. Three patients who had previously undergone prostatectomy, and had expressed interest in participating in future research endeavors, and their partners were recruited to inform the design of the intervention. This group of six stakeholders identified the types of distress experienced by newly diagnosed prostate cancer patients and their partners, as well as their favored intervention approaches. These stakeholders do participate in the intervention or control groups in part 2 of this study.

Researchers used thematic analysis to assess the type of distress identified by stakeholders as well as approaches favored by them. They mapped these themes on the available mindfulness approaches, identified in their review, to develop an intervention that best captures the concerns of prostate cancer survivors and partners.

Part 2 is the pilot study. Researchers will enroll 20 more couples (men who are planning to undergo radical prostatectomy and their partners) to participate in a pilot study of the intervention. The pilot study will have 2 cohorts (groups). Half of the couples will be randomly assigned to the mindfulness intervention (intervention group) and the other half will receive the usual care (control group). All participants in the intervention and control groups in part 2 of the study will be analyzed to determine the effects and feasibility of the intervention.

Eligibility Criteria:
Part 2--Pilot study:

Inclusion Criteria

* Patients aged 35 - 90 who are planning to undergo radical prostatectomy at University of Michigan Hospital
* Partners of these men, aged 18 and older

Exclusion Criteria:

* Participants cannot be less than 18 years of age
Type 1 Diabetes and Obstructive Sleep Apnea

The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.

Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent collapse of upper airway during sleep, resulting in intermittent hypoxia, sleep fragmentation by transient arousals, and poor sleep quality. Continuous positive airway pressure (CPAP), applied at night, is considered the treatment of choice for persons who are diagnosed with OSA. Current evidence suggests that OSA is highly prevalent in adults with T1D and particularly those with moderate-to-severe OSA have poorer glycemic control. Our overall goal is to investigate the role OSA in glycemic dysregulation in adults with T1D.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 50 years old
* Type 1 Diabetes (duration 3-20 years) on insulin pump therapy and using a CGM device with an GMI (glucose management indicator) between 5.5 and 8.5% with hemoglobin in the normal range at screening
* Moderate to severe OSA by home sleep apnea test

Exclusion Criteria:

* Regular and adherent CPAP use per clinical guidelines
* Requiring oxygen or advanced positive airway pressure modalities during sleep
* Having a 'fall-asleep' or 'near miss' accident in the past 6-months
* Shift work
* Severe hypoglycemia (≥1 episode in the past 3 months or diagnosis of hypoglycemic unawareness)
* ≥1 trip to emergency room for poor glucose management in the past 6 months
* Proliferative retinopathy
* Fasting triglycerides \>400mg/dL,
* Liver transaminases \>2 times upper limit of normal,
* Renal transplantation or serum creatinine \>1.5 mg/dL
* Anemia (hemoglobin \<13.0g/dL in men or \<11.6g/dL in women)
* Acute coronary syndrome or stroke past 6 months
* Severe hypertension (blood pressure\>180/105 mmHg)
* Any other significant health condition: unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class\>2, pulmonary disease with dependence on oxygen or daily use of bronchodilators, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly)
* Recent major surgery
* Major psychiatric disorder
* Subjects will also be excluded if taking medications that can confound metabolic assessments including systemic glucocorticoids, antipsychotics, thiazide diuretics, beta-blockers, daily use of aminophylline or theophylline, or use of any immunosuppressant.
* Currently pregnant or trying to get pregnant or nursing
* Smoking, alcohol or illegal drug abuse
Retention of Metal Reinforced Polyamide Denture Base and Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture

The trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
4. Free from any tempro-mandibular disease.
5. Good oral hygiene.

Exclusion Criteria:

1. Neuromuscular disorder and orofacial disease.
2. Tempromandibular joint and muscle pain
3. xerostomia or excessive salivation.
4. Limited mouth opening
Effect of Mediterranean Diet in Dyslipidemic Patients

The purpose of this randomized cross-over clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation, metabolic risk and microbiome in patients with dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* One or more of this criteria (total cholesterol ≥ 200mg/dl, LDL- cholesterol ≥130 mg/dL, triglyceride ≥ 200mg/dl)
* If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
* Able to speak and read Korean
* Able to comply with all required study procedures and schedule
* Willing and able to give written informed consent
* Participants who are not participating in other clinical trials.

Exclusion Criteria:

* Participants with cancer treatment
* Participants with uncontrolled hypertension (systolic blood pressure (SBP) \>180 mmHg, or diastolic blood pressure (DBP) \>120 mmHg)
* Participants with uncontrolled diabetes or fasting glucose ≥ 200mg/dl)
* Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3 x institutional upper limit of normal) or renal disease (serum creatinine \>2.0 mg/dL)
* Participants with significant cardiovascular disease (ischemic heart disease or stroke)
* Participants who are taking lipid-lowering medications.
* Participants who are taking other clinical trial medications.
* Participants with acute infectious disease such as pneumonia, acute gastroenteritis, and urinary tract infection.
* Vegetarian (does not eat red meat, poultry or fish)
* Participants with food allergy (sea food, fish, nuts, egg, meat, tomato, wheat, or soybean)
* Participants who are not able to eat more than 10 mediterranean meal in a row.
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.

The purpose of this study was to study the effect of different combinations of fenofibrate and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to determine the dose combination allowing normalization of MetS patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged from 18 to 75 years old (at inclusion V1).
* With 3 of the following 5 criteria, including at least 2 biochemical abnormalities (glucose and one lipid abnormality)
* And having signed a written informed consent (at inclusion V1).

Exclusion Criteria:

* known Type 1 diabetes, or treated type 2 diabetes \[25\], \[26\];
* wth HbA1c \> 8 % \[27\] at the first blood sample;
* body mass index (BMI) \> 45 kg/m2;
* females who were not surgically sterilized or not using adequate contraceptive or not using adequate contraceptive precautions or not postmenopausal
* pregnant or lactating women;
* known hypersensitivity to fibrates;
* known hypersensitivity to metformin chlorhydrate; known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level;
* having received an investigational drug in the last 30 days before the date of randomization;
* unable or unwilling to comply with the protocol;
* likely to withdraw from the study before its completion;
* treated with some concomitant medications:
* reporting a change within the last 6 weeks before randomization and during the study in the medications that could interfere with the lipid profile (i.e., anti-hypertensive drugs, oral corticosteroids, thyroid hormones, retinoids, thiazidic derivatives, hormone replacement therapies);
* presenting with the following disease or conditions:

  * chronic respiratory insufficiency, patient with medical device for sleep apnea;
  * current chronic pancreatitis, or identified risk or known history of acute pancreatitis;
  * hepatic insufficiency, acute alcohol intoxication, alcoholism;
  * known cholelithiasis without cholecystectomy;
  * aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 times the upper limit normal (ULN);
  * musculoskeletal disease or increased creatine phosphokinase (CPK) \> 3 times the ULN;
  * renal failure or renal dysfunction defined by serum creatinine levels \> 135 μmol/L in males and \> 110 μmol/L in females \[28\];
  * acute conditions with the potential to alter renal function such as dehydration, severe infection, shock or intravascular administration of iodinated contrast agents;
  * acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction (within 3 months prior to randomization), shock;
  * known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomization capable of modifying the intestinal absorption of the drugs;
  * any other severe pathology such as cancer, mental illness, etc., which in the opinion of the investigator might pose a risk to the patient or confound the results of the study
Comparison Between Pure Laparoscopic Donor Right Hepatectomy and Convensional Donor Right Hepatectomy

Perioperative clincal outcome between PLDRH and conventional open donor right hepatectomy (ODRH) will be compared retrospectively.

the superiority of laparoscopic liver resection was well known in terms of reduced blood loss and minimized hospital stay compared with open liver resection. However, pure laparoscopic donor hepatectomy is a challenging procedure for beginner liver surgeons because of the major vessel preservation required during liver parenchymal transection. this study was designed to identify the superiority of laparoscopic donor hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients received right or right extended hepatectomy for liver donation at gangnam severance hospital

Exclusion Criteria:

* none