cyrilzakka/clinical-trials huggingface dataset:
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.


Eligibility Criteria:
Major Inclusion Criteria:

* male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
* experiencing a current major depressive episode
* able to provide written informed consent

Major Exclusion Criteria:

* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer

With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem.

The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012).

Most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). The first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. There are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. It is conventionally evaluated by scanner every 2 to 3 months. The response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it.

A KRAS mutation is present in approximately 70-90% of pancreatic adenocarcinomas. Its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of KRAS mutations has been demonstrated. New high-throughput DNA sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor DNA (ctDNA), including KRAS mutations.

Very few studies have investigated the change in cDNA levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma.

The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS cDNA in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

Eligibility Criteria:
Inclusion Criteria:

* Proven pancreatic adenocarcinoma (histology or cytology)
* Metastatic or locally advanced unresectable
* With thoraco-abdomino-pelvic scanner less than a month old
* Chemotherapy treatment regardless of the protocol
* Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
* Informed consent signed by the patient after clear and fair information about the study

Exclusion Criteria:

* Linguistic or psychological refusal or inability to understand and / or sign the informed consent
* History of cancer in the 5 years preceding inclusion
* Patient who has already received chemotherapy or radiotherapy for pancreatic cancer.
* Immediately resectable tumor
Optimizing Application And Support Of Immunization Information Systems (OASIS)

The overall purpose of this study is to evaluate the use of features of the New York State Immunization Information System (NYSIIS) by various types of primary care practices and determine how best to promote the use of IIS features and functionality. The primary goal is to promote the use of NYSIIS for immunization quality improvement (QI) in the practice setting. Customized training sessions will be conducted by study staff to educate practices on NYSIIS' enhanced features.


Eligibility Criteria:
Inclusion Criteria:

* NYSIIS administrator at a participating practice

Exclusion Criteria:

* Practices already utilizing/running reports used in the intervention
Treatment of Lateral Epicondylalgia With Shock Waves

Lateral epicondylalgia (LET) is characterized by pain, decreased muscle strength of the wrist extensor muscles, and disability. Among the treatments proposed in the literature, both focal shockwave therapy and radial shockwave therapy have been considered effective in the management of this musculoskeletal disorder. The objective of this study is to compare the safety and effectiveness of these two shockwave applications on the signs and symptoms of subjects with lateral epicondylalgia. In this clinical trial, subjects will be evaluated for elbow pain using a Visual Analog Scale (VAS), grip strength using a handheld dynamometer, and degree of disability using the Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE). A six-month follow-up will be performed.

Patients will be randomly divided into three groups. The first group will receive radial shock waves (rESWT), the second group will receive focal shock waves (fESWT), and the third group, which will act as a control, will receive a placebo treatment with very low energy parameters according to the literature.

Subjects will receive three sessions, one session per week.


Eligibility Criteria:
Inclusion Criteria:

* Pain in the lateral epicondyle \>3 months
* Pain when performing resisted grip
* Positive Cozen test
* Positive Maudsley test

Exclusion Criteria:

* Pregnancy
* Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
* Local infection or Cancer
* Recent treatments (Physiotherapy, Corticosteroids)-
AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
* Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
* Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.

Exclusion Criteria:

* Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
* Have a known hypersensitivity to thiazolidinediones or biguanides.
* Currently using insulin or any oral anti-diabetic agent other than metformin.
* History of metabolic acidosis.
* History of substance abuse.
* Have active cancer other than localized squamous or basal cell carcinoma.
* Chronic disease requiring treatment with corticosteroids.
* Other criteria will be evaluated at the screening visit.
Detection of Balance in the Elderly Under the Influence of Stress

The aging process involves physiological changes in organs and tissues that can evolve towards fragility and increased risk of falls. Falls, which can be one of the adverse results of frailty in older people, are the second leading cause of death worldwide. When an elderly person falls, it entails not only hospitalization, immobilization, and the consequent deterioration, but also usually causes fear of falling again, which can also lead to the onset of disability. The inherent aging process can be linked to the deterioration of postural control and balance, posing serious health problems. In falls in the elderly, both sensorimotor and cognitive functions are affected, the functioning of which is degraded to a greater extent by anxiety and stress. Nowadays, more extensive, and more precise research is needed in the study of the interactions between cognition, stress, and postural control in the context of postural instability and falls in older adults.

The purpose of the DEPIE Project is to detect whether neuromuscular changes that occur when exposed to stressful situations can affect the postural and motor control of the elderly. To this end, all participants will undergo the same baseline assessment and be subjected to a stressful (experimental) situation. Both young and older adults will be tested. The primary outcome measures will be heart rate variability, surface electromyography, pressures on the floor, and activity on manipulation.


Eligibility Criteria:
Inclusion Criteria:

* Young adults (ages 18-39).
* Older adults (≥65).
* Voluntarily participate in the study.
* Not meeting the exclusion criteria

Exclusion Criteria:

* Any disease, injury, or previous trauma that contraindicates muscular exertion, balance exercises, and/or walking.
* Any physical or mental illness that contraindicates exposure to stimuli generating emotional stress, such as severe depression or severe psychosis
* Difficulties in understanding study information and providing informed consent
Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors

The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* 18 years of age
* Advanced solid malignant tumors
* Tumor can be measured and evaluated
* Blood tests are within standard limits
* Normal blood coagulation
* ECOG Performance Status equal to 0 or 1
* Hemoglobin \> or = to 9.0 g/dL
* Absolute Neutrophil Count \> or = to 1,500
* Platelets \> or = to 100,000
* Calculated or measured creatinine clearance \< 50 mL/min
* Serum creatinine \< or = 1.5 times the upper limit of normal (ULN)
* AST, ALT, Alkaline Phosphatase \< 3 times ULN except if there is hepatic involvement then AST, ALT, and Alkaline Phosphatase \< or = to 5 times ULN
* Total Bilirubin \< or = to 2 mg/dL

Exclusion Criteria:

* Prior exposure to SNS-595
* Pregnant or breastfeeding.
* Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
* Requires kidney dialysis (hemodialysis or peritoneal).
* Known bleeding disorder (i.e., hemophilia, von Willebrand Disease, coagulopathy, etc.).
* Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
* Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
* Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
* Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.
Tissue Repair Gel in Venous Leg Ulcers in AU/US

The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.

This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).

The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.

Secondary endpoints include:

* Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
* Change from baseline in participant's perception of pain level at 12 weeks.
* Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
* Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
* Proportion of participants with any significant reduction in pain at or before 12 weeks.

There are also some supplementary and safety endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older
* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
* Target ulcer age must be ≥ 4 weeks at Screening.
* Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler.
* Body mass index (BMI) ≤ 50 kg/m2.
* HbA1C ≤12%.

Exclusion Criteria:

* Target ulcer has been treated with prohibited medications or therapies.
* History of radiation at the target ulcer site.
* Target ulcer decreases in area by 30% or more during screening period.
* History of osteomyelitis at the target ulcer within 6 months of screening.
* History of cancer in the preceding 5 years (except as noted in the protocol).
* Participants considered nutritionally deficient.
Pleural Effusions After Cardiac Surgery

Pleural effusions occur commonly in patients recovering from cardiac surgery, however, the impact on outcomes is not well characterized. The purpose of this study is to characterize the outcomes of cardiac surgery patients with pleural effusions.

All patients undergoing cardiac surgery between 2006 and 2019 were included in this observational, cross-sectional analysis using propensity matching.

Pleural effusions are common in patients recovering from cardiac surgery. Symptomatic patients with pleural effusions complain of shortness of breath, cough, chest pain and are more hypoxic and tachypneic. Clinically significant effusions can slow recovery in the hospital and beyond, and are a critical source of hospital readmissions after discharge. It is not well characterized how this impacts hospital outcomes. Further it is unknown if the effusions themselves are associated with impaired outcomes, or if pleural effusions simply arise in more complicated, older patients, thus suggesting the impaired outcomes are the result of coexisting morbidities. To better understand the impact of this complication and to address the question mentioned before, this study was carried out to determine the clinical and economic outcomes of pleural effusions in propensity-matched patients during early recovery from cardiac surgery. To compare patient groups with and without pleural effusion, the following baseline characteristics were used: e.g. age, sex, body-mass-index, priority of surgery, type of surgery, duration of surgery, APACHE II Score of patients on admission in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* In-patients of the Charité Universitätsmedizin Berlin
* at least 18 years old
* female or male sex
* cardiosurgical intervention (OPS 5.35 and 5.36) between 01/06 and 12/19
* post-operative monitoring in the intensive care unit

Exclusion Criteria:

* previous cardiosurgical interventions during the same hospital stay
* incomplete documentation.
Improving the Accuracy of Referrals of Patients With Chest Pain

This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel.

Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly. However, referring all patients with chest pain is not feasible, as recent studies showed that up to 80% of the patients with acute chest pain do not have ACS.

Bedside point-of-care (POC) high sensitive troponin testing (in fingerprick blood/capillary blood) and the modified HEART score have become available and might play a substantial role in the triage and diagnosis of chest pain patients in a pre-hospital setting by general practitioners (GPs) and EMT personnel in the future. We hypothesize that patients with chest pain can be referred more accurately by using the modified HEART score.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Chest pain or other complaints suspect of ACS for at least 2 hours where the GP or emergency medical personnel are in need of further diagnostics or risk stratification to come to a decision of referral.
* Patients, who have been informed of the nature of the study, agree to its provisions and have provided written informed consent.

Exclusion Criteria:

* Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
* Suspicion of an acute non-coronary diagnosis e.g. pulmonary embolism, thoracic aortic dissection or other life-threatening disease.
* Patients presenting cardiogenic shock, defined as: systolic blood pressure \<90mmHg and heart rate \>100 and peripheral oxygen saturation \<90% (without oxygen administration)
* Patients presenting with sudden onset heart rhythm disorders and second or third degree atrioventricular block.
* Patients with confirmed ACS, PCI or CABG \<30 days prior to inclusion.
* Impaired consciousness defined as an EMV \<8.
* Severe shortness of breath.
* Patients with known end-stage renal disease (dialysis and/or MDRD \< 30 ml/min).
* Patients with known cognitive impairment.
* Communication issues with patient/language barrier.
* Patients already participating in an interventional cardiology or cardiovascular trial.
Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt

Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites.

One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).

The indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites.

TIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life.

Very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales.

The main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients referred to the TIPS service between January 2012 and October 2020 at the University Hospitals of Strasbourg, with a follow-up period of at least 1 month
* Subjects who have not expressed any opposition to the use of their medical data for research purposes
* For subjects invited to fill in the questionnaires: subject having expressed his/her agreement with the use of his/her medical data in the framework of the current study

Exclusion Criteria:

* Diseased patient
* Liver transplant patient following TIPS
* Pregnancy
* Patient in a vulnerable situation
* Patient under court protection, guardianship or trusteeship
* Difficulties in understanding the questionnaire
* Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under legal protection
To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis

Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. In this study the investigators try to compare the efficacy of the classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin \& Dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Toxoplasmic chorioretinitis
* Location of the lesion within zone I of the retina or a lesion greater than 2DD with 3+-4+ vitreous inflammation in zone II or III
* No allergic history to the used drugs
* No any other diseases

Exclusion Criteria:

* Any allergic reaction to the used medications
* One eyed patients
* Partially treated patients
Decreasing Narcotics in Advanced Pelvic Surgery

In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.


Eligibility Criteria:
Inclusion Criteria:

* women \>/= 18 years old
* undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department

Exclusion Criteria:

* males
* \<18 years old
* women unwilling or unable to consent
* same-day-discharge surgery
* history of chronic pain for which they use medications
* current or active history of narcotic abuse
* sleep apnea
* liver or kidney dysfunction
* sulfa allergy