cyrilzakka/clinical-trials huggingface dataset:
Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

The purpose of this study is to determine whether intraoperative brain oxygenation monitoring in cardiac surgery patients is effective in reducing postoperative neurologic and neurocognitive dysfunction.

This study represents a prospective, randomized assessment of the potential clinical and economic benefit to be derived from the continuous non-invasive monitoring of regional cerebral oxygen saturation (rSO2) during cardiac surgery employing cardiopulmonary bypass (CPB). Previous studies have shown that low rSO2 values obtained during surgery are highly associated with postoperative frontal lobe dysfunction, cognitive declines, disorientation, and other clinical indices of prolonged recovery. Low rSO2 values are thought to reflect the development of tissue hypoxia within susceptible regions of the cerebral cortex during the non-pulsatile perfusion of CPB. Rapid detection and correction of such episodes should help avoid regional hypoxia and its attendant postoperative sequelae. This study will assess neurologic, psychometric, and quality of life markers of brain dysfunction which could result from CPB. Each study patient will be assessed both pre- and postoperatively (pre-hospital discharge and at three months) for neurologic and neurocognitive dysfunction.

Comparison(s): Intervention versus control group. Patients assigned to the intervention rSO2-monitored group will be managed with conservative measures designed to maintain the rSO2 value at, or above, its preoperative value. Such measures include increases in pump flow, blood pressure, anesthetic dose, arterial oxygen tension, carbon dioxide tension, and hematocrit. Those patients in the control group will be managed according to current established practice. Although rSO2 is also recorded in this group, the monitor's readings are blinded.

Eligibility Criteria:
Inclusion Criteria:

* Primary coronary artery bypass surgery
* Ages 18-90
* Voluntary participation with signed informed consent

Exclusion Criteria:

* An unwillingness to participate in the study
* Inability to obtain informed consent
* Expressive or receptive aphasia
* Inability to correctly perform the neurocognitive tests preoperatively
* Inability to correctly perform the saccadic and anti-saccadic eye movement tests preoperatively
* Non-English speaking candidates
* Patients for whom it is known that follow-up will be improbable
* Previous cardiac surgery
* Concomitant procedures
* Pre-existing psychotic disorders
* Patients with active alcohol (ETOH) abuse requiring emergent surgery
* Patients scoring 2 or higher on the CAGE evaluation
* Mini-Mental State Exam preoperative score of 23 or less
* Severe visual or auditory disorders
* Parkinson's disease
Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge

In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. After education, patient completes a survey, estimated to take 5 minutes to complete.

The purpose of this study is to compare different methods of teaching patients about their prescription medicines. It is possible that certain teaching methods are better than others at educating patients.

Patients who receive Lortab medication or prescription during their ED visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. After the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. This takes approximately five minutes and asks the patient to rate the quality of the information received.

Eligibility Criteria:
Inclusion Criteria:

* non-critical emergency room patients being prescribed Lortab
* age 18 year or older

Exclusion Criteria:

* emergency room patients not receiving Lortab as their first prescribed medication
* age less than 18 years
Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease

The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT


Eligibility Criteria:
Inclusion Criteria:

* One pocket on each side of the mouth (split design)
* Single rooted tooth
* Pocket depths measured greater than 4mm with bleeding on probing
* Horizontal bone loss
* No furcation involvement

Exclusion Criteria:

* current heavy smokers (\>10 cigarettes/day)
* have uncontrolled diabetes (HbA1c ≥ 6.5%)
* other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia
* taking antibiotics within 3 months before the procedure
* vertical bone defects that requires surgical regenerative treatment.
* Pregnancy
Study of Febrile Syndromes After Tick Bite

Febrile syndromes after tick bites can be caused by different microorganisms: bacteria (B. miyamotoi, A. phagocytophilum, R. helvetica...), parasites (Babesia spp) and viruses (TBE virus). The clinical picture is not specific but complications may appear depending on the microorganism identified (thrombosis with N. mikurensis, meningoencephalitis with B. miyamotoi and the TBE virus). Thus, in order to provide appropriate treatment and monitoring, the infection should be documented.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject whose sample was sent to the bacteriology laboratory for research on Anaplasma phagocytophilum between 2009 and August 2020

Exclusion criteria:

* Subject having expressed his opposition to his medical data and biological resources not being reused for scientific research.
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.


Eligibility Criteria:
Inclusion Criteria:

1. Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom
2. Control Group: Patients with reproductive age without any ovarian cysts

Exclusion Criteria:

* suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses and Safety and Pharmacokinetics of BIRT 2584 XX Administered With and Without Food as Single Dose to Healthy Male Volunteers

The study comprised two parts. The objective of the first study period was to assess the safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without food in male healthy volunteers and to determine the relative bioavailability of the BIRT 2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG 400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT 2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days, or 750 mg qd for 28 days) in healthy male subjects (part 2)


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of the screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age ≥ 18 and ≤ 63 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (greater than 24 hours) (less than 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
* Participation in another trial with an investigational drug (less than 2 months prior to administration or expected during trial)
* Smoker (more than 10 cigarettes/day or more than 3 cigars/day or more than 3 pipes/day)
* Alcohol abuse (more than 60 g of ethanol per day)
* Drug abuse
* Blood donation or loss greater than 400 mL (less than 1 month prior to administration or expected during the trial)
* Clinically relevant laboratory abnormalities
Superobese Patients

Super obesity (SO) is defined as a Body Mass Index (BMI) \> 50 kg/m2, and represents the extreme severity of the disease, resulting in an increase in morbidity, mortality, and in poorer quality of life compared with morbid obesity (BMI \> 35 and \<50 kg/m2).


Eligibility Criteria:
Inclusion Criteria:

* Morbid and superobese patients

Exclusion Criteria:

* Follow up not completed
Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1).

To assess the behavior of immune cells in peripheral blood and tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients who enable to have standard operation
* Patients who refuse standard preoperative chemotherapy and are diagnosed with following cancers; gastric adenocarcinoma, esophageal squamous cell carcinoma, non-small-cell lung carcinoma, renal cell carcinoma or oral squamous cell carcinoma
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney)
* Patients with written informed consent
* Patients who have measurable target lesion
* Patients who are enable to undergo biopsy for sampling tumor tissue

Exclusion Criteria:

* Known or previous autoimmune disease
* Known or suspected interstitial lung disease (ILD)
* Patients with history of serious anaphylaxis induced by antibody preparation
* Uncontrollable hypertension
* Uncontrollable endocrine disease
* Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea
* Uncontrollable diabetes
* Prior therapy with sustained anticancer agents, radiotherapy or surgery for primary disease
* Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study
* Known or suspected infection or inflammatory disease
* Prior therapy with hematopoietic stem cell transplantation
* Known or suspected central nervous system (CNS) involvement
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea

The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug Safety (MFDS).


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals aged 12 years and older who are living in Korea
* Individuals with chronic HCV infection eligible for treatment with Sovaldi as indicated in the approved prescribing information for Sovaldi
* Individuals who have been informed of all pertinent aspects of the study and have voluntarily signed Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have their legally authorized representatives sign the PIPA consent form

Key Exclusion Criteria:

* Individuals treated with Sovaldi outside of the approved prescribing information for Sovaldi in Korea
* Individuals who have a contra-indication (refer to the Korea prescribing information)
* Individuals who have a contra-indication to ribavirin or peginterferon alfa or daclatasvir
* Pregnant or breast feeding women
* Individuals who have previously been administered Sovaldi
* Individuals participating in a concurrent HCV clinical trial
* Individuals planning on leaving the country during the study period

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation

The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the clinical study;
2. Aged ≥ 18 years;
3. Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;
4. At least one measurable lesion as per PERCIST v1.0;
5. Expected survival time ≥ 3 months;
6. ECOG score 0-2;

Exclusion Criteria:

1. Previous treatment with BRAF inhibitors or MEK inhibitors;
2. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery;
3. Severe active infections requiring systemic anti-infective therapy;
4. Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Monitoring Strategies for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke

Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).

Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.

Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
* Age ≥ 18 years

Exclusion criteria

* History of atrial fibrillation (or atrial flutter) documented.
* Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
* Evidence of lacunar infarction.
* Hemorrhagic stroke
* Patient for palliative care
Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma

This study will evaluate the efficacy and safety of GSK256066 in the treatment of subjects with mild bronchial asthma, using a number of clinical and biological markers of efficacy.


Eligibility Criteria:
Inclusion criteria

* Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
* Pre-bronchodilator FEV1 \>75% of predicted at screening.
* Non-smoker
* Demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
* Have Asthmatic response
* Able and willing to give written informed consent to take part in the study.
* Available to complete all study measurements.

Exclusion criteria:

* History of cardiovascular disease
* Clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
* History of hayfever
* The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
* The subject has tested positive for HIV antibodies.
* The subject has positive drugs of abuse test.
* Subjects weighing less than 50kg are to be excluded from participating in the study.
* The subject has participated in a study with a new molecular entity during the previous 3 months.
* History of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
* There is a risk of non-compliance with study medication or study procedures.
* History of blood donation (450 mL) within 2 months of starting the clinical study.
* The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))

This study is a prospective cohort study to evaluate the long-term effects of early activity and mobilisation compared to standard care on disability, function and health status for patients at 1, 2 and 5 years after recruitment of patients randomised into the TEAM Phase III RCT (ClinicalTrials.gov NCT03133377). The primary outcome of the study will be the level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 12 level (WHODAS) at 2 years after recruitment.

Incomplete recovery following critical illness is a major public health problem in Australia.

Each year around 150,000 Australians are admitted to intensive care (ICU). These critically ill patients require substantial resources and invasive, expensive interventions. Approximately 10% die and many of the remaining patients who survive have delayed and compromised functional recovery. As many as 25% of the ICU survivors who were living at home prior to ICU are unable to return home due to impaired physical function. Globally, the quality of survival following an ICU admission has been identified as one of the largest health challenges for these patients. This study will address the quality of survival and long-term functional recovery for patients who require life support in ICU. These patients account for 62% of the total bed-days in Australian ICUs, with direct care costs of $2 billion per year. The long-term outcomes for these patients are very poor. In my Australian cohort study, 50% of patients who survived hospital had disability

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the TEAM Phase III RCT Protocol.

Exclusion Criteria:

* There are no exclusion criteria.
Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE

The objective of this registry is the characterization of patients with atrial fibrillation (AF) and/ or atrial flutter (AFL) with confirmed VHD who are prescribed edoxaban in a real life clinical setting.

This is an observational, prospective, multicenter, edoxaban Canadian registry of adults (≥18) diagnosed or confirmed with AF and/or AFL with VHD, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with NOAC is clinically indicated and who are prescribed edoxaban. A total of about 300 patients will be enrolled from approximately 10 sites in Quebec. Patients will be treated according to standard local practices. There is no formal interventions. Treatment decisions are left to the physician's discretion.

Registry data will be collected by the investigator or delegate at baseline, 6, 12 and 24 months and recorded in the electronic Case Report Form (eCRF).

Data available in the patient's file will be collected. The only procedure to be performed in the context of this registry is the completion of questionnaires: the Montreal Cognitive Assessment (MoCA©) test and the Anti-Clot-Treatment Scale (ACTS-Q) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥ 18 years at baseline (signing of consent);
2. Willing and able to provide written informed consent;
3. Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form;
4. Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months;
5. Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban.

Exclusion Criteria:

1. Patients with AF and/or AFL secondary to reversible cause;
2. Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis;
3. Patients planned to have an intervention for valvular heart disease in the next 12 months;
4. Pregnant or breastfeeding women.
5. Short term anticoagulation post cardioversion or ablation.