cyrilzakka/clinical-trials huggingface dataset:
Treating Behavioral Disturbances in Individuals With Dementia

This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).

Dementia-related behavioral disturbances have been associated with excess disability, increased caregiver burden, and premature institutionalization. Pharmacotherapy is often necessary to treat these disturbances. This study will use citalopram and risperidone to treat people with dementia-related behavior problems.

Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start. Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks. Limited doses of the sedative lorazepam may be administered as needed throughout the study. During the first 2 weeks of the study, participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized. Following hospital discharge, participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks. Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter. Experimental laboratory measures will be collected at study start, Week 1, Week 2, and every 2 weeks thereafter until Week 12. Upon study completion, patients may continue to receive citalopram or risperidone under the supervision of their current physicians. Three months after study completion, participants may be contacted for a follow-up report of their psychiatric and medical status.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's type dementia and/or meet criteria for probable or possible Alzheimer's disease
* Inpatient admittance to Western Psychiatric Institute and Clinic
* Written informed consent from participant's legally authorized representative with the participant's assent
* Psychosis or behavioral problems severe enough to be a danger to the participant's health, well-being, or safety
* Score of 3 to 6 (moderate to severe) on at least one of the Neurobehavioral Rating Scale (NBRS) agitation or psychosis items
* Ability to participate in study evaluation and ingest oral medication

Exclusion Criteria:

* Diagnosis of an unstable medical illness within the last 12 months
* Kidney or liver dysfunction
* Diagnosis of delirium, substance-induced persisting dementia, or vascular dementia
* Score of 12 or higher on the Cornell Scale for Depression in Dementia, and a score greater than 3 on the depression item of the NBRS
* Diagnosis of Parkinson's disease or any neurological illness which may affect cognitive function
* History of schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, or bipolar affective disorder
* Alcohol or substance abuse or dependence
* Receiving monoamine oxidase inhibitors within 15 days of study
* Display behaviors which could endanger the participant's life or the lives of others
* Received fluoxetine within 4 weeks of screening
Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients

This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.

This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.

Eligibility Criteria:
Inclusion Criteria:

1. Who are able and willing to give signed informed consent
2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
3. Who have less than 20% of body surface area (BSA) afflicted with plaques
4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

1. Who have a history of allergy to vitamin D3 derivative preparations.
2. Who have a history of relevant drug hypersensitivity.
3. Who have a history of contact dermatitis induced by a topical medicine.
4. Who are pregnant or lactating.
5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
7. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
8. Whose serum calcium levels exceed the upper limit of reference range
9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
12. Who have been treated with topical therapy during the wash-out period.
A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).

The purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus who are taking stable doses of metformin only. Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-IV inhibitor (DPP-IVi) in combination with metformin may be eligible if washed off the SU or DPP-IVi to metformin only for a minimum of 4 weeks before dosing.
* Male and/or female subjects (females will be women of non childbearing potential) between the ages of 18 and 65 years, inclusive, with a body mass index (BMI) of 18.5 to 45.0 kg/m2 and C-peptide \>0.8 ng/mL.
* Screening and Day -2 troponin I concentration \</=0.05 ng/mL as measured by the Bayer Centaur Ultra assay.
* HbA1c \>/=7% and \</=11%. If the patient requires to be washed off an SU or DPP-IVi, the HbA1c limits will be \>/=7% and \</=9.5%.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance \</=60 mL/min based on the Cockcroft-Gault equation, diabetic neuropathy complicated by neuropathic ulcers.
* History of stroke, transient ischemic attack, or myocardial infarction within the past 6 months. Additionally, history of coronary artery bypass graft or stent implantation, clinically significant peripheral vascular disease, or congestive heart failure (NYHA Classes II-IV). Furthermore, a current history of angina/unstable angina. Also, 12 lead electrocardiogram (ECG) demonstrating QTc \>450 msec at screening, ECG findings suggestive of asymptomatic myocardial ischemia, or supine blood pressure \>/=160 mm Hg (systolic) or \</=100 mm Hg (diastolic).
* One or more self reported episodes of hypoglycemia within the last 3 months, or two or more self reported episodes of hypoglycemia within the last 6 months.
* Screening or Day -2 fasting (\>/=8 hours) blood glucose, \</=70 or \>/=270 mg/dL, confirmed by a single repeat if deemed necessary.
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
* Cohort B: post-liver transplant, with or without cirrhosis;
* Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
* Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Chronic genotype 1 or 4 HCV infection
* Normal ECG
* Negative serum pregnancy test for female subjects
* Male subjects and female subjects of childbearing potential must agree to use contraception
* Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion Criteria:

* Serious or active medical or psychiatric illness
* HIV or hepatitis B viral (HBV) infection
* Stomach disorder that could interfere with the absorption of the study drug
* Treated with an anti-HCV medication in the last 30 days
* Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
* Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
* History of clinically significant medical condition associated with other chronic liver disease
* Active spontaneous bacterial peritonitis at screening
* Females who are breastfeeding
* Infection requiring systemic antibiotics
* Participated in a clinical study with an investigational drug or biologic within the last 30 days
* Active or history (last 6 months) of drug or alcohol abuse
* History of organ transplant other than liver or kidney
Physical Activity Across the Curriculum (PAAC 3):Teacher vs. Remotely Delivered Classroom Physical Activity Breaks

The study is designed to compare two methods of delivering short (\~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote instructor through a video in the classroom. Both delivery methods will promote a variety of whole body movements using large muscle groups. The schools will not be able to choose which group (regular teacher or remote instructor) they will be part of.


Eligibility Criteria:
Inclusion Criteria:

* 2nd and 3rd grade students

Exclusion Criteria:

* Students who are confined to a wheel chair, blind, or intellectually disadvantaged may be unable perform tests for cardiovascular fitness or MVPA using accelerometers
Dermacyd Silver Floral (Lactic Acid) - Compatibility.

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Use of Antihistamines 30 days before selection
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reaction
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Benefits of Continued Use of Ovarian Function Suppression After 5 Years

To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.

This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with early primary breast cancer
* Female aged 18-60 years (including 18 year and 60 year)
* Hormone receptor (HR) positive HER2 negative
* Receive 5 years of OFS treatment
* ECOG score 0-1
* Voluntarily join this study and sign the informed consent form;
* The researcher believes that it can benefit.

Exclusion Criteria:

* The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years
* Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision
* Invasive metastases with known obvious symptoms
* Invasive metastases with known obvious symptoms
* Doctors think it is not suitable for inclusion
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)

Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed.

The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project.
* Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
* Informed consent

Exclusion Criteria:

* Not receiving OAC (warfarin/DOAC)
* Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism)
* Renal impairment (estimated glomerular filtration rate \< 30)
* Allergy to contrast media
* Pregnancy or breastfeeding
Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.

Purpose To evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics.

Methods and analysis This is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from PUMCH and other 3 hospitals in Beijing. After signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. The blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. The infants' fecal samples will be collected at 0\~3, 14, 42 days and 3, 6, 9, 12 months after born. Questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. Bio-specimen will be tested by 16S rRNA gene sequencing. Logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Ensure a regular prenatal check in the clinical centers.
* 20-45 years old.
* 8-13 gestational weeks.
* Singleton.
* Fully understand and voluntarily sign the informed consent.

Exclusion Criteria:

* IUI or IVF-ET pregnancy.
* Smoking or drinking.
* Antibiotics exposure within a month.
* With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
* With digestive disease, uncontrolled thyroid disease.
Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo

Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients

70 patients divided in to 2groups Group A controlled ovarian stimulation with H FSH and HHMg Group B controlled ovarian stimulation with HMG alone Results will be discussed later

Eligibility Criteria:
Inclusion Criteria:

1. Infertil women aged from 20_35yr
2. Normal utreus
3. Normal ovaries
4. unexplained infertility
5. no endometriosis

Exclusion Criteria:

1 - poor responders to gonadotropin 2-Prior history of more than 3unsucceful ICSI 3-Any malformation of sexual organs
Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches

The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, we hope to:

1. show that intravenous lidocaine infusion causes a clinically significant reduction in pain scores in patients with moderate/severe headache pain following non-traumatic subarachnoid hemorrhage;
2. show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage;
3. and report vasospasm prevalence in the cohort.

Participants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours they are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of their regular medical care.


Eligibility Criteria:
Inclusion Criteria: For study recruitment, patients must be 18 years or older, have a favorable neurological status defined as Hunt and Hess score ≤ 3 (as it accounts for patient awareness), can communicate numeric pain scores, and are diagnosed with non-traumatic subarachnoid hemorrhage.

Exclusion Criteria: Patients will be excluded from study consideration if they are diagnosed with traumatic subarachnoid hemorrhage, if they are \< 18 years of age, if numeric pain scores could not be captured for \> 3 days of hospitalization, if they had a prior aneurysm, chronic pain not associated with non-traumatic subarachnoid hemorrhage diagnosis, a disability before the stroke (\> 2 on modified Rankin Scale score), a Hunt and Hess score \> 3, or contraindications to lidocaine (significant cardiac disease, arrhythmia, seizures, previous allergic reaction to lidocaine.
Retrospective Analysis of Lymphomas and Cancers Synchronous Occurrence in Picardy From 2007 to 2012

Cancer is the leading cause of death in man and the second leading cause in women with 85,000 and 63,000 deaths, respectively, in 2012. A working group led by Holly L. Howe, PhD, in 2002 defined primary neoplasia Such as the occurrence and diagnosis of two or more independent neoplasms of different histology in the same patient. The occurrence of a new cancer has become more frequent in recent years: the prevalence of multiple primary neoplasia (NPM) is estimated between 0.73% and 11.7%. According to the French data, the risk of second cancer in people who have already had a first cancer is increased by 36% compared to the general population. Several studies have reported an increase in the risk of cancer after treatment of lymphoma but there are currently no studies on the occurrence of lymphoma and cancer of synchronous occurrence.

In our department, 19 patients presented cancer and lymphoma synchronously, that is to say 6 months between 2007 and 2012.

The main objective is to show that there is an increase in the incidence of cancers in patients diagnosed for lymphoma synchronously. Secondary objectives are to describe the clinical and biological characteristics of the patients concerned and to formulate hypotheses on the physiopathological mechanisms involved: peri-tumoral B-cell lymphoproliferation, alteration of the immune system or rearrangement of the BCR.

In a second step, the investigator could propose a multicenter epidemiological study using data from the different Cancer Registries. If results are confirmed in a larger cohort, recommendations could be made.


Eligibility Criteria:
Inclusion Criteria:

* Being older than 18
* Have been diagnosed for Hodgkin's or non-Hodgkin's lymphoma from 1 January 2007 to 31 December 2012
* Diagnostic confirmation either in anatomopathology or in cytology
* Delay of 6 months maximum between the two neoplasms (Synchronic / metachronous distinction)

Exclusion Criteria:

* Hemopathy other than lymphoma (CLL and lymphocytic lymphoma excluded)
* Diagnosis of lymphoma outside the inclusion period Metastases and recurrences were not considered as secondary cancers, but as relapses of the first neoplasia
* Cutaneous squamous cell carcinomas were not considered secondary cancer because of the absence of available incidence data (FRANCIM network)
Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma

The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.

This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18
2. histologically or cytologically confirmed adenocarcinoma of biliary tract
3. unresectable or metastatic
4. ECOG performance status of 0\~2
5. measurable or evaluable lesion per RECIST criteria
6. adequate marrow, hepatic, renal and cardiac functions
7. no prior chemotherapy or molecularly targeted therapy for the advanced biliary carcinoma (prior adjuvant chemotherapy will be allowed if administered ≥ 6 months from the study entry)
8. provision of a signed written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. known history of hypersensitivity to study drugs
5. prior exposure to EGFR tyrosine kinase inhibitor