cyrilzakka/clinical-trials huggingface dataset:
Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints

The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints.

In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use disorder. They also perform a neuropsychological assessment. Questionnaires are given to the patient and his/her caregiver to be filled in at home.

Levels of anxiety/depression, sleep quality and alcohol consumption are related to neuropsychological performance, diagnosis and responses to the questionaires.


Eligibility Criteria:
Inclusion Criteria:

* To have cognitive complaints
* To have french as native language
* Not to be opposed to be included
* To be affiliated to the social security

Exclusion Criteria:

-To be under tutorship or curatorship
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients

This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.

This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF. A total of 195 pulmonary CF patients that meet all the inclusion and no exclusion criteria and provide written informed consent will be randomized to receive 50 mg CTX-4430, 100 mg CTX-4430, or placebo in a 1:1:1 ratio. Follow-up visits will be conducted approximately every 4 weeks from Week 4 to Week 52 (4 weeks after completion of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Forced expiratory volume at one second (FEV1) ≥50 percent predicted at Screening
* At least 1 pulmonary exacerbation in the 12 months before Screening

Exclusion Criteria:

* Pregnant or nursing women
* Medical condition that is unstable, could be adversely impacted by participation in the study, or could impact assessment of the study results
* History of organ transplantation
* History of alcoholism or drug abuse within 2 years before Screening
* Regular use of a high-dose NSAID within 60 days before Screening
Surveillance of Synagis in Korean Pediatric Patients

Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:

  * Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
  * Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
  * Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD).
* Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.

Exclusion Criteria:

* Contraindications according to the approved label.
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age as of date of data extraction,
2. Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
3. Diagnosis of Hypertension (HTN) defined by International Classification of Diseases, Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mm Hg) on their most recent clinic visit.
4. Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
5. Receives primary medical care at one of the participating health systems
6. Have a Maryland and D.C. home address

Exclusion Criteria:

1. Age \<18 years
2. Diagnosis of end-stage renal disease (ESRD) treated with dialysis
3. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
4. Cognitive impairment or other condition preventing participation in the intervention
5. Planning to leave the practice or move out of the geographic area in 24 months
6. No longer consider the practice site their location for primary care
7. Unwillingness to provide informed consent
Clinical Pharmacists in the Emergency Department

The purpose of this study is to investigate the effect of implementing clinical pharmacists in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists conduct medication history, make medical interaction screenings, -reconciliations and -reviews on unscheduled patients admitted to the Emergency Department during daytime.


Eligibility Criteria:
Inclusion Criteria:

* unscheduled patients admitted to the Emergency Department at Randers Regional Hospital at weekdays during daytime (9 am to 16.15 pm)
* 4 or more drugs prescribed

Exclusion Criteria:

* patients triage red
* patients who cannot give informed consent
* terminal patients
* patients admitted to detoxification
* patients refered to the acute outpatient department
* patients remaining in the Emergency Department overnight
The Parkinson's Disease NeuroGenebank at Scripps Clinic Registry

By creating a neurogenebank from Parkinson's disease patients' blood donations we will ultimately be able to define genes for Parkinson's disease and other neurological conditions.


Eligibility Criteria:
Inclusion Criteria:

* Is age 30 years or older at the time of onset of Parkinson's
* Has been diagnosed with idiopathic Parkinson's Disease by a Scripps Neurologist
* Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented or have legal representative/guardian willing to do so
* Able to understand and grant informed consent or have a legal representative/ guardian who is able to do so

Exclusion Criteria:

* Patient has been previously enrolled in The Parkinson's Disease NeuroGenebank at Scripps Clinic Registry
* If a blood draw would be contraindicated for any reason
* Has a significant chronic medical condition (i.e. CVA, hepatic encephalopathy) which, in the investigator's option, may interfere with the patient's optimal participation in the study
* Treatment with any investigational agents or devices within 30 days preceding enrollment in the study
* Has undergone ECT within 90 days preceding enrollment in the study
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group \[IMWG\] diagnostic criteria)
2. Transplant ineligibility
3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):

   * Serum M-protein ≥ 0.5 g/dL, or
   * Urine M-protein ≥ 200 mg/24 hours, or
   * In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio \< 0.26 or \> 1.65)
4. No prior treatment for multiple myeloma
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

1. Multiple myeloma of IgM (immunoglobulin M) subtype
2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
4. Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
5. Waldenström macroglobulinemia (WM)
6. Known amyloidosis
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 to 65 years of age
* Percent of predicted FEV1 ≥ 50% and ≤ 80%
* At least 12% reversibility over pre-bronchodilator FEV1
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
* Ongoing asthma symptoms with ACQ score ≥ 1.5 points

Exclusion Criteria:

* History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
* Any uncontrolled, clinically significant systemic disease
* Respiratory infection within 4 weeks of the screening visit
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)

Previous study showed that the proportions of hemorrhagic Infarction after intravenous thrombolysis were 24.2% and 32.5% in the control group and the alteplase group, and most of them were asymptomatic. Hemorrhagic Infarction was a part of the natural progression after acute ischemic stroke. Previous study have shown no significant relationship between hemorrhagic Infarction and poor outcome in acute ischemic stroke (AIS) patients. In this study, a randomized controlled trial will be conducted to explore the efficacy and safety of early antiplatelet therapy after hemorrhagic infarction in acute ischemic stroke treated with intravenous thrombolysis.


Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic patients receiving intravenous thrombolysis within 4.5 hours upon stroke onset
2. Be confirmed as Hemorrhagic Infarction at 24 to 36 hours after intravenous thrombolysis by computerized tomography
3. The patient or family member signed an informed consent

Exclusion Criteria:

1. Early use of anticoagulant drugs within 1 week after intravenous thrombolysis;
2. Tirofiban was used after receiving endovascular treatment;
3. Intraoperative stent placement after receiving endovascular treatment;
4. Subarachnoid hemorrhage or ventricular hemorrhage;
5. There are contraindications for aspirin use;
The Safety and Efficacy of Supraglottic Airway Use in Children

This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.

Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.

The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation \& ventilation

Exclusion Criteria:

* N/A
Family-school Partnership Intervention for Early Childhood Education

Strategies for creating and maintaining reciprocal partnerships between teachers and parents are considered essential elements of developmentally appropriate practice in early childhood education (ECE). Particularly for children who are high-risk for behavioral, developmental, or mental health problems, effective partnerships between family and preschool are essential for promoting optimal classroom participation and learning outcomes. The current study is an uncontrolled (pre-post) feasibility trial of Family-School Partnership Intervention (FPSI). FSPI was developed using stakeholder input, is delivered by existing preschool staff, and aims to promote development and reduce barriers to learning among children with pre-clinical social-communication delays. FSPI integrates evidence-based practices (EBPs) from education (7 EBPs; National Association for the Education of Young Children) with clinical interventions for toddlers with autism spectrum disorder (ASD) (12 EBPs at the educator-parent level and 8 EBPs at the parent-child level; Naturalistic Developmental Behavioral Interventions). Data will be collected across 10 ECE programs. At each participating ECE program, research procedures will be completed during a single school year. Selected ECE programs will include public school, Head Start, and private preschool programs. Participants include 20 non-teaching support staff (1-2 per program; e.g., director, principal, education-coordinator), 30 lead teachers (2-4 per program), and 60 children with social-communication deficits (two per teacher). Data collection will focus on feasibility data (enrollment, attendance, attrition, data completion), observational measures of implementation fidelity (at the educator-parent and parent-child level), and mixed methods to evaluate educator and parent acceptability and satisfaction and identify implementation drivers/barriers. This research will prepare a large, multi-site hybrid trial to evaluate the effectiveness of FSPI for promoting social-communication skills and kindergarten readiness, in addition to factors that mediate the relation between FSPI delivery and fidelity (implementation drivers/barriers).


Eligibility Criteria:
Inclusion Criteria:

* currently attending classroom of participating preschool teacher.
* nominated by teacher as child with elevated levels of social-communication challenges

Exclusion Criteria:

* n/a
Medical Management Survey : Organization of Perioperative Practices in Anesthesia and Ambulatory Surgery

In France, there are no precise data regarding perioperative organization of medical structure and care management of ambulatory surgical patients. Particularly, data on management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and treatment are needed, in several groups of patients.

This is a prospective epidemiological observationnal study involving a sample of 300 ambulatory surgical centers among 1000 french centers.

In a first step, a survey on the specific organization and care management of the structure will be carried out.

In a second step, data on the management of 3000 patients admitted in these structure will be performed. The will allow an analysis of practices in a selection of acts (which seem to be more frequent and more relevant). Data from three different questionnaires on pain management, PONV prevention and treatment and VTE prevention will be recorded for each patient.

Eligibility Criteria:
Inclusion Criteria:

* All patients managed for ambulatory surgery by medical structures during the two days of the survey.
* For the patient managed for specific ambulatory surgery by medical structures, a more detail survey will be conducted (if applicable). Specific surgery are :Oral surgery ( wisdom tooth extraction surgery), Knee arthroscopy, Abdominal wall surgery (including inguinal hernia surgery), Perianal surgery, Varicose veins surgery, Cholecystectomy/laparoscopy surgery, Lumpectomy, Uterine surgery, Hallux valgus, Hand surgery (except carpal tunnel surgery)

Exclusion Criteria: None
Gut Microbiota and New Hypertension

This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and above.
* Newly diagnosed with hypertension, defined as having a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, confirmed by medical records or a recent health examination.
* Willing to provide a fecal sample for microbiota analysis.
* Able to give informed consent.
* Have not undergone any pharmacological treatment.

Exclusion Criteria:

* Individuals with a history of chronic gastrointestinal diseases, such as inflammatory bowel disease or irritable bowel syndrome, which could independently affect gut microbiota.
* Use of antibiotics, probiotics, or prebiotics within the last three months, as these can alter the natural state of the gut microbiota.
* Presence of other significant chronic diseases like diabetes, severe renal or liver diseases, or heart failure.
* Pregnancy, as it can lead to physiological changes influencing gut microbiota.
* History of bariatric surgery or any other major gastrointestinal surgery.
* Currently on medications known to significantly affect blood pressure other than standard antihypertensive treatments.
Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum

The main goal of this study is to assess the role of Netrin 1, neogenin and ZEB1 in PAS-associated invasion

* To evaluate the immunohistochemical expression of these proteins in PAS specimens in comparison with the control placental tissues.
* To correlate their expression with the demographic parameters.
* To assess the correlation between their expression in PAS specimens.

Eligibility Criteria:
inclusion criteria

* PAS patients who underwent hysterectomy to allow proper pathologic grading of PAS

exclusion criteria

* patients with fundal and middle anterior or posterior placenta,
* pregnancy associated with morbid conditions such as hypertension, diabetes mellitus, autoimmune disease, cardiac disease, renal disease, history of anemia, blood transfusion, other blood diseases and endocrinal disease; fetal distress or intrauterine growth retardation.
* uterine scar pregnancies were excluded
Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic

Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and Group P administered pethidine and VAS was recorded for both groups.

Prospective, randomized, double blind clinical study including 120 patients with acute renal pain admitted in emergency department. They were randomly assigned to one of two groups using a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0, 15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events and functional status.

Eligibility Criteria:
Inclusion Criteria:

* Patients, who did not administer any analgesics at least within the last two hours. - -
* Patients aged between 20-60 years.

Exclusion Criteria:

* Patients with previous renal surgery
* liver and renal failure
* hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer,
* gastrointestinal bleeding and perforation,
* hypertensive and history of cardiac diseases
* pregnancy and lactation and
* urine examination showing more than 5 leukocytes suggestive of pyuria.
* patients with hyperthyroidism are excluded
Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma

The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.


Eligibility Criteria:
Lower GI endoscopy patients

Inclusion Criteria:

* Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
* Male or female, aged 18 years or above
* Referred to lower GI endoscopy. Referral reasons can be among others:

  * Positive FOBT (Fecal Occult Blood Test)
  * Follow up after polypectomy
  * Screening because of age
  * Bleeding
  * Abdominal pain
  * Familial or past history of colon cancer or adenoma
  * Abnormal imaging such as barium enema
  * Change in bowel habits
* Both self-referrals, referrals from external GP or specialists and internal referrals can be included.

Exclusion Criteria:

* Previous diagnosis of an inflammatory bowel disease
* Previous diagnosis of intestinal polyposis syndrome

CRC patients

Inclusion criteria:

* Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
* Male or female, aged 18 years or above
* Diagnosis of CRC for which resection is planned
* Both internal and external referrals from specialists can be included

Exclusion Criteria:

* Previous diagnosis of an inflammatory bowel disease
* Previous diagnosis of intestinal polyposis syndrome