cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Animal Intervention Used as Therapy

The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in geriatrics. Many studies have shown a link between the presence of the animal and the psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or irritability that affects their quality of life and improved cognitive abilities. However, many methodological flaws in these researches exist.

The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short and medium term (before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session) compared to a group receiving the same stimulation without the dog's response.

Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: AAT group versus control group. The only difference between these two groups is the intervention of the dog at each workshop in the AAT group.

Each workshop will consist of three identical times. It will begin with a 15 minute introductory activity, the first goal will be to establish a relationship with patients (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the session This study should highlight a positive effect of animal assisted therapy on the well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of these positive effects.


Eligibility Criteria:
Inclusion Criteria:

Enrolled patients should have been informed and should not oppose the research, by themselves or through a trusted person, failing this, by the family, or, by a close person maintain stable ties; Subject aged over 65 years fulfilling the criteria of Alzheimer's disease the major NCD stage with or without vascular disorders; Ambulatory patient in Charpennes Day Hospital ; Being affiliated to health insurance.

Exclusion Criteria:

Patients with signs and symptoms suggestive of dementia related to other diseases than AD or mixed forms ; Patients with progressive and unstable pathologies which could interfere with the variables under consideration ; Deafness or blindness which could compromise the evaluation of the patient or his involvement during the sessions ; Patient being under guardianship ; Patient refusing the work with a animal ; Patient allergic to dogs ; Patient ending his care prior to the 13 weeks required for the study. Exclusion criteria will be sought during the questioning of the patient and his relatives as well as the review of his medical file (organic and neuroradiological explorations).
Swiss Atrial Fibrillation Cohort Study

Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall, 2600 patients with documented atrial fibrillation aged \>65 years will be included and followed on a yearly basis.

Yearly clinical examinations include a detailed questionnaire on personal characteristics, a resting electrocardiogram, neurocognitive function tests and questionnaires on disability and quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at baseline and after 2 years of follow-up.

The main study aims of this long term prospective study are to increase our knowledge on structural brain damage and its changes over time in patients with atrial fibrillation, to gain additional insights on the incidence and underlying mechanisms of cognitive decline in patients with atrial fibrillation and to evaluate the interrelationships of structural and functional brain damage in this population.


Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation documented within the last 24 months
* age \>=45 years

Exclusion Criteria:

* acute illness
* inability to provide informed consent
* Only short episodes of reversible forms of atrial fibrillation
Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is among the most common chronic respiratory diseases (CKD). Millions of people of all ages suffer from these diseases. COPD is between the fifth and sixth of the leading causes of death in Brazil. It generates an inflammatory pulmonary response that is softened by non-curative treatments and that present serious side effects. Low intensity laser (LBI) or laser therapy has been used for about 50 years to help the healing process, revealing efficient anti-inflammatory and analgesic responses, as well as experimental models of acute and chronic inflammation. However, little is known about its response in inflammatory lung diseases, especially COPD. Some reports indicate that laser therapy may interfere positively by relieving clinical signs, the onset, and the final symptoms of pulmonary inflammation. The present project aims to study the effects of LBI on Chronic Obstructive Pulmonary Disease in patients with pulmonary processes, determine their mechanisms of action and evaluate its effect on patients' functional capacity.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes;
* Over 18 years of age;
* With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days;
* Performing routine outpatient treatment with a pulmonologist;
* Agreement to participate.

Exclusion Criteria:

* Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery.
* Patients with cystic fibrosis and Kartagner's syndrome.
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).

Eligibility Criteria:
Inclusion Criteria:

* Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Must be able to provide an archived tumor sample
* Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor

  * Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated
* Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
* Must have at least 1 measurable lesion per RECIST v1.1
* Must have adequate organ functions
* Must be able to swallow and retain orally administered medication

Exclusion Criteria:

* Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
* Active infection requiring systemic treatment within 7 days
* Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
* Any severe and/or uncontrolled medical conditions
* left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
* QT interval using Fridericia's formula (QTcF) interval \>470 msec
* Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities
* Clinically significant eye disorders
Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy

Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.

Eligibility Criteria:
Inclusion Criteria:late second trimester

* IUFD
* Previous Multiple Cesarean Sections

Exclusion Criteria:Low lying placenta

* asthma
* allergy to misoprostol
* patient refuse to participate
Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged birth to 3 years who, as part of the standard of care in the clinical practice of medicine, are referred to and will undergo a radiographic diagnostic imaging procedure that uses intravascularly administered iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the ICM for contrast enhancement.
* Written informed consent has been given for the patient by one or more parents or other legally acceptable representatives, as required by local regulations and laws.
* When applicable (neonates), the patient's biological mother consents to providing information about her medical history and medication usage.
* The patient has normal pre-procedure (screening) serum TFTs (TSH, TT4, FT4, TT3), TSI, and urine (UI/UCr).
* The patient's pre-procedure (screening) serum chemistry is either normal or not clinically significantly abnormal.
* The patient has normal pre-procedure (screening) eGFR for age by the revised Schwartz formula \[Schwartz et al 2009\].
* The patient's parent(s) or other legally acceptable representative(s) is/are able and willing to comply with the study schedule and procedures.

Exclusion Criteria:

* The planned radiographic procedure is part of a clinical research study rather than clinical practice.
* The patient has known or suspected thyroid disease, Down syndrome (trisomy 21), or Type 1 diabetes.
* The patient currently receives thyroid hormone replacement therapy, or such therapy is planned or being considered.
* The patient has been exposed to thyroid protection for imaging procedures, within the last 6 months or such procedure is planned or being considered.
* The patient currently receives one or more anti-thyroid medications, or such therapy is planned or being considered.
* The patient has known or suspected past or present exposure to thyroid suppressants, including but not limited to drugs (e.g., amiodarone), inorganic iodide (potassium iodide, sodium iodide, etc.), perchlorate, thiocyanate, nitrate, lithium, and topical iodine disinfectant (e.g., povidone-iodine).
* The patient has undergone (or is expected to undergo during the study) radiation treatments to the head or neck.
* There is a high likelihood that the patient will undergo surgery or more than one ICM-enhanced procedure in the following 10 weeks.
* The patient has a history of hypersensitivity to ICM or any components, or a history of a severe cutaneous adverse reaction to ICM.
Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, Platelets\>=100 x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with sunitinib
Eplerenone in Hemodialysis Trial

Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Eplerenone is a drug that is very effective at improving heart failure and reducing blood pressure in patients that do not require dialysis. There is currently no evidence to tell physicians whether eplerenone would have similar benefits in patients that require dialysis. This evidence can only be reliably generated by performing a large scale study. Before such a study is undertaken, the investigators must determine whether eplerenone will be well tolerated and safe in patients that require dialysis. The investigators will perform an initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe medication to use in a very large, global study that will show whether or not eplerenone reduces important outcomes for patients like death from heart causes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* On hemodialysis \>90 days
* Prescribed target body weight within 1 kg of current for all dialysis sessions within 4 weeks prior to randomization
* Able to provide written informed consent to participate

Exclusion Criteria:

* Occurrence of documented clinically important hypotension (systolic blood pressure \<90 that required treatment) within 4 weeks of randomization
* Change in blood pressure medications within 4 weeks prior to randomization
* Occurrence of pre-dialysis serum potassium \>6.0 mmol/L in 4 weeks prior to randomization
* Currently treated with and cannot withdraw spironolactone or eplerenone due to medical necessity
* Known allergy or sensitivity to eplerenone
* Pregnancy
* Scheduled living related donor renal transplant within the next 6 months
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic NSCLC with EGFR mutations
* Measurable disease according to RECIST criteria
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Previous chemotherapy or therapy against EGFR for metastatic disease
* Symptomatic cerebral metastases
* Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
* History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
* Concomitant use of coumarins
Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation

The purpose of this study is to evaluate the effect of propofol, etomidate and propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal intubation and assess the adverse effect related to this drugs.


Eligibility Criteria:
Inclusion Criteria:

* between 18 - 65 age
* ASA I - II status
* elective surgery

Exclusion Criteria:

* emergency surgery
* pregnancy
* alcohol and drug abuse
* HT and cardiovascular disease
* BMI \> 25 kg/m2
* hypersensitivity against study drug
* sedative drug use in last month
* difficult intubation
Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM)

The assessment of post-procedural bleeding risk in cirrhosis remains a clinical challenge due to the lack of precise predictive tools and its high associated mortality. Although guidelines recommend a restrictive transfusion policy, adherence remains low, with a high rate of prophylactic transfusions despite unclear benefits. This multicenter, prospective, and observational study will evaluate the utility of ROTEM in bleeding risk stratification for cirrhotic patients with significant abnormalities in conventional hemostasis tests undergoing high-risk invasive procedures. The primary objective is to establish cut-off values with a high negative predictive value, optimizing transfusion decisions and reducing unnecessary blood product use. Additionally, the study will analyze the relationship between ROTEM, inflammation biomarkers, and coagulation factors, along with a cost-effectiveness analysis comparing different transfusion strategies. This will be the largest study to date assessing ROTEM in this setting, overcoming the limitations of previous studies, which have been mostly retrospective with heterogeneous populations and procedures. Its findings could contribute to the standardization of transfusion management in cirrhosis and improve healthcare resource efficiency. The widespread availability of ROTEM in other disciplines within the National Health System will facilitate its implementation in this clinical setting without requiring additional investment in equipment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years.
* Clinical, analytical, elastographic, histological, and/or imaging criteria consistent with the diagnosis of hepatic cirrhosis.
* Undergoing a high-risk invasive procedure, either in an outpatient setting or during hospitalization.
* Platelet count below 50,000/μL or INR greater than 1.5 with a platelet count below 100,000/μL.
* Signature of informed consent.

Exclusion Criteria:

* Cirrhotic patients with acute-on-chronic liver failure (ACLF) as defined by EASL criteria, and patients admitted to Intensive Care Units. These patients are excluded because hemostatic alterations in ACLF and critically ill patients are different and more pronounced compared to those in outpatient or general medical ward settings.
* Chronic kidney disease stage ≥3.
* Presence and/or history of thromboembolic complications.
* Presence of non-hepatic tumors.
* Presence of any primary hematologic disease (including inherited coagulopathies or thrombophilia).
* Recent surgery (\<8 weeks).
* History of organ transplantation, including liver transplantation.
* Pregnancy.
* Use of anticoagulants, antiplatelet agents other than acetylsalicylic acid, and/or antifibrinolytic therapy.
* Active disseminated intravascular coagulation.
The Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Disability Insurance

Starting in 2001, the Look AHEAD study randomized patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education"). The ILI successfully reduced weight, improved diabetes control, and functional status, among other outcomes. In this study, the investigators will compare participation in federal disability insurance programs between the ILI and the control group during and after the intervention period (2001-2017).

Starting in 2001, the Look AHEAD study randomized 5145 patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education ("Diabetes Support and Education").The Look AHEAD study tested whether participants with type 2 diabetes assigned to an intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular morbidity and mortality, relative to a control group receiving usual care and diabetes support and education. During the 12-year intervention period, the ILI led to persistent reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical fitness, among other clinical benefits. After the conclusion of the intervention in 2012, participants were consented to be linked with administrative data. The investigators attempted to link 3188 consenting participants with Social Security Administration databases. Of these, the investigators were able to successfully link 3093 participants. In this study, the investigators will compare participation in federal disability insurance programs including Social Security Disability Insurance (SSDI) and disability-related Supplemental Security Income (SSI) between the linked ILI and the control group during and after the intervention period (2001-2017). The investigators will investigate ILI-versus-control differences in whether participants ever applied or received benefits from SSDI and SSI. The investigators will also investigate ILI-versus-control differences in applications and benefit receipt in each year after randomization, relative to a pre-randomization assessment period. The investigators will use both multivariate regression controlling for baseline participant characteristics and clinic site and also survival analyses that estimate whether the time until SSDI or SSI application or benefit receipt differs between the ILI and control groups.

Eligibility Criteria:
(Note: age limits above are at time of randomization, which occurred between 2001-2004)

Inclusion Criteria:

* Look AHEAD participation: met age requirements and other criteria at time of study enrollment which occurred between 2001-2004 (as noted in Look AHEAD Research Group (2013))
* Consented to administrative data linkages
* Provided individual identifiers that could be linked with SSA databases
* Were successfully linked to SSA data

Exclusion Criteria:

-