louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00738985: Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Mixed Hyperlipidemia and Two or More Risk Factors
Official title: Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Patients With Mixed Hyperlipidemia and Two or More Risk Factors to Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cardiovascular Diseases
Hyperlipidemia
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To measure the percentage of patients who achieve all the treatment lipid goals being treated with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).

Detailed description: Patients will receive placebo for 4 weeks, then Vytorin 10/20 mg for 6 weeks, if efficacy of treatment is achieved, they will continue with Vytorin 10/20 mg + placebo for 12 more weeks, if not achieved, will receive Vytorin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with Vytorin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive Vytorin 10/20 mg + MK0524A 2 gr for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patient Without Ischemic Cardiovascular Disease Who During The Treatment With Statin Have LDL-C \<130 Mg/Dl at Visit 1 Or Within The 6 Month Period Before Visit 1

Exclusion criteria:

* The use of any other lipid lowering agent
* Life expectancy lower than a year.
* Any condition that may interfere with the adherence to the study protocol

Primary outcomes:
measure: Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE)
timeFrame: 18 Week(s)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05400785: Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning
Official title: Efficacy of the Mobile Phone Application (Circadian Rhythms for Mood) for Prediction and Prevention of Mood Episode Recurrence in Mood Disorders Based on Machine Learning of Daily Digital Phenotype Variables : A Sham-controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Bipolar 1 Disorder
Bipolar II Disorder
Lead sponsor: Hucircadian
Sponsor class: INDUSTRY
Collaborators: name: Korea University Guro Hospital
name: Korea University Ansan Hospital
name: Pusan National University Hospital
name: Inje University Ilsan Paik Hospital
First posted: 2022-06-02
Enrollment: 93
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, 19-70 years old
* Diagnosis with Bipolar I disorder, Bipolar II disorder, Major depressive disorder based on DSM-5 criteria, in euthymic state for more than two weeks at the time of the recruitment
* Android smartphone users, capable of installing and executing the CRM application
* Consent to wear wearable device (Fitbit) continuously and synchronize and backup data regularly

Exclusion Criteria:

* Patients who have not experienced major depressive, manic, or hypomanic episode in the last two years
* Patients who are difficult to specify mood episode or evaluate symptoms of mood episode independently due to personality traits (borderline personality trait, cyclothymic temperament, etc.)
* Patients with degenerative neurological disorders (Parkinson's disease, dementia, Huntington's disease, etc.), neurodevelopmental disorders (intellectual disorder, autism spectrum disorder, down syndrome, etc.), epilepsy, severe traumatic brain damage, stroke, and other brain neurological disorders
* Inmates or patients who are forced into custody for the treatment of mental or physical illness (non-voluntary isolation or hospitalization)
* Patients with difficulties in understanding the objectives and process of the study and the potential benefits and risks of participating in the study

Primary outcomes:
measure: Comparison of total number of recurrent mood episodes between the active and sham groups
timeFrame: 12 months
measure: Comparison of duration of mood episodes between the active and sham groups
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT05954585: Family Navigator Intervention
Official title: The Development of a Family Navigator Intervention and Prevention Protocol to Reduce Risk of Suicide and Self-injurious Behavior for Youth Aged 8 to 14 Years
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Treatment as Usual
Family Navigator
Keywords: emergency department, suicide, youth, family navigator
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 54
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will develop and examine the feasibility and acceptability of a family navigator protocol while leveraging digital health communication. It will employ an ecological model within a socio-cultural theoretic framework of mental health service disparities and barriers to treatment.

Detailed description: The purpose of this study is to develop and pilot a Family Navigator intervention with technology-enhanced information sharing for families with youth (80 youth-caregiver dyads) who were discharged from the emergency after an admission for SSIB. This novel intervention aims to reduce suicidal and non-suicidal self-injurious behavior risk and prevalence rates by way of increasing attendance to community-based mental health services for youth aged 10 to 14.

Eligibility criteria: Inclusion Criteria:

* youth 10 to 14 years old living at home with legal guardian/caregiver

Exclusion Criteria:

* presentation including psychosis, sexual assault, or child abuse,
* are in police or child protective services' custody,
* are unable to assent due to severity of illness or developmental disabilities, \>cannot communicate in English or Spanish, or
* if no caregiver or legal guardian is able to provide consent.

Primary outcomes:
measure: Mental Health Services
timeFrame: 6 months
Secondary outcomes:
measure: Suicidal ideation
timeFrame: 6 months
measure: Suicidal behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Mary Kathryn Cancilliere, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06673485: The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla
Official title: The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: maxillary sinus augmentation
Sinus graft
Internal Sinus lifting
Allogenic bone graft
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of Vit D and Calcium administration on allogragt bone maturation radiographically and histomorphometercally in maxillary sinus augmentation in cases of D4 bone density.


Eligibility criteria: Inclusion Criteria:

* Patient with residual bone height from 5 : 8 .
* Patient with insufficient Vit D levels.
* Patient with D4 bone density.

Exclusion Criteria:

* Patients that have aproporiate amount of Ca and Vit D.
* Sinus pathology that precludes routine sinus augmentation.
* Heavy smookers patients.
* Systemic diseases that interfere with bone maturion.

Primary outcomes:
measure: The Implant Stability Quotient
timeFrame: Immediate post-operative, and 6 Months post-operative
Secondary outcomes:
measure: DXA Scan
timeFrame: pre-operative, and 6 Months post-operative
measure: Vitamin D serum levels
timeFrame: Pre-operative, and 6 Months post-operative
measure: Calcium Serum Level
timeFrame: Pre-operative, and 6 Months post-operative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alazhar University
Study officials:
References:
Clinical trial NCT05802485: PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT
Official title: PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT: PANDORE-PANC-IPC 2021-082
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer Non-resectable
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study consists of a 25 ml blood sample collection:

* Before the start of treatment
* Approximately 2 months after the start of induction chemotherapy
* At the end of induction chemotherapy
* Prior to local treatment (radiotherapy, surgery)
* At the time of tumor progression

Collection of tumor material:

* During the initial diagnostic biopsy
* On the operating room in case of surgery
* At tumor biopsy in case of recurrence or progression (optional) As well as the completion of a questionnaire at inclusion.


Eligibility criteria: Inclusion Criteria:

* Non-metastatic pancreatic adenocarcinoma that is not immediately resectable (borderline and locally advanced tumors according to the NCCN 2020 classification)
* No previous treatment with surgery or chemotherapy
* Age \> 18 years
* General condition WHO 0-2 (patient whose general condition can allow medical treatment or surgery)
* Therapeutic management at the Paoli-Calmettes Institute
* Signature of the informed consent specific to the PANDORE-PANC study
* Patient affiliated to a social security system or benefiting from such a system

Exclusion Criteria:

* Metastatic disease
* Pancreatic tumor of a histological type other than adenocarcinoma
* Other tumor under treatment or for which treatments have been completed for \< 1 year
* Pregnant or breastfeeding women
* Person in an emergency situation
* Person of legal age under legal protection (guardianship, curatorship or safeguard of justice) or unable to give consent.

Primary outcomes:
measure: Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma
timeFrame: up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01812785: Study to Investigate the Causes of Fever in Children Living in Urban Dar es Salaam and Rural Ifakara
Official title: Study to Investigate the Causes of Fever in Children Living in Urban Dar es Salaam and Rural Ifakara
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Children
Infectious Diseases
Keywords: Fever
Children
Non-malaria fevers
Diagnosis
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2013-03-18
Enrollment: 1010
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients aged 2 months to 10 years presenting at the outpatient clinic of Amana district hospital in Dar es Salaam, and at the outpatient clinic of St-Francis designated-district hospital in Ifakara, Kilombero District.

Brief summary: The goal is to improve the evidence-based management of fever cases seen in outpatient clinics in malaria endemic countries, through a better understanding of the value of accurate malaria diagnosis, and through an improved understanding of the other causes of fever in children. The objective is to describe systematically (as much as possible) the etiologies of fever in children in an urban and in a rural environment of sub-Saharan Africa.


Eligibility criteria: Inclusion Criteria:

* axillary temperature of 38°C or more
* first consultation for the present problem
* history of fever lasting for one week or less
* main complaint was not an injury or trauma
* no report of an antimalarial or antibiotic medicine taken during the previous week

Exclusion Criteria:

* severe malnutrition
* categorized as P1 (requiring immediate live saving procedures)

Primary outcomes:
measure: Proportion of each disease and proportion of fevers of unknown origin in febrile children aged 2 months to 10 years attending an Outpatient Department of a district hospital in Dar es Salaam and in Ifakara
timeFrame: December 2011
Secondary outcomes:
measure: Clinical and laboratory predictors of each disease
timeFrame: December 2011
Other outcomes:
Locations:
city: Ifakara
country: Tanzania
facility: St Francis hospital
state: Morogoro
city: Dar es Salaam
country: Tanzania
facility: Amana district hospital
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Blaise Genton, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994485: Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
Official title: Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Portal Hypertension
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.

Detailed description: Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.

Eligibility criteria: Inclusion Criteria:

* Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins)
* Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II)

Exclusion Criteria:

* Pregnancy
* Hepatic encephalopathy grade III-IV
* Hepatocellular carcinoma
* Treatment with statins in the previous 3 months
* Hypersensitivity to statins
* Previous surgical shunt or TIPS
* Treatment with calcium channel blockers

Primary outcomes:
measure: Number of Patients with Reduced Portal Pressure After Intervention
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta university hospital
name: NADIA ELWAN, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta university hospital
name: RAAFAT SALAH, PROFESSOR
role: STUDY_CHAIR
affiliation: Tanta university hospital
name: MANAL HAMISA, Ass Prof
role: STUDY_CHAIR
affiliation: Tanta University hospital
name: EBTESAM A SHADY, BACHELOR
role: STUDY_CHAIR
References:
citation: Elwan N, Salah R, Hamisa M, Shady E, Hawash N, Abd-Elsalam S. Evaluation of portal pressure by doppler ultrasound in patients with cirrhosis before and after simvastatin administration - a randomized controlled trial. F1000Res. 2018 Mar 1;7:256. doi: 10.12688/f1000research.13915.1. eCollection 2018.
Clinical trial NCT02046785: Hemodynamic Measurements at Different Inclinations of the Head
Official title: Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypovolemic Shock
Keywords: Fluid administration
Cardiac output
Right atrial pressure
Resuscitation
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

Detailed description: * Check if values of central venous pressure (CVP), pulse pressure variation (Δpp), heart rate (HR), mean arterial pressure ((PAM) vary in different angles headboards
* Compare values of CVP, Δpp, HR and MAP as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

Eligibility criteria: Inclusion Criteria:

* Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure \<90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h.
* Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O.
* Tue signing the informed consent by legal guardian.

Exclusion Criteria:

* Presence cardiac arrhythmias.
* Presence of abdominal or thoracic trauma.
* Contraindication for passive elevation of the members.
* Hypoxia significant PaO2/FiO2 \< or equal 100.

Primary outcomes:
measure: Different Backrest position's effect on CVP, CO and ∆PP measures
timeFrame: Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014.
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Rosangela O Felice, expert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750385: Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
Official title: Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Achalasia
Keywords: Esophageal Achalasia
antibiotic prophylaxis
blood culture
procalcitonin levels
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional Heller's myotomy. However, the issue of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

Detailed description: Objective: To elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM are randomized to either use antibiotic prophylactically or not.

Main outcome measurements: Blood culture positive incidence; secondary outcomes are procalcitonin levels, C-reactive protein levels, white blood cell counts and so on.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of esophageal achalasia
* Ready to have the treatment as POEM and no contraindication of POEM
* Ability to get informed consent

Exclusion Criteria:

* Patients who had indications for antibiotic prophylaxis as determined by the American Society for Gastrointestinal Endoscopy
* Patients who had received antibiotics for any reason within the previous 7days
* Patients who had possible signs of any infection at the time of the procedure
* Patients who had chronic inflammatory diseases need hormonotherapy : such as rheumatic arthritis or inflammatory bowel diseases.

Primary outcomes:
measure: Blood culture positive incidence
timeFrame: after 12 hours of POEM
Secondary outcomes:
measure: procalcitonin level
timeFrame: after 12 hours of POEM
Other outcomes:
measure: clinical manifestation
timeFrame: during hospital stay and up to 1 week
Locations:
Study officials:
affiliation: Fudan University
name: Ping-Hong Zhou, M.D,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03740685: Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis
Official title: Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis, Acute
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute pancreatitis

Brief summary: changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis


Eligibility criteria: Inclusion Criteria:

* Age\>=18 years
* Diagnosis of acute pancreatitis confirmed by at least 2 of the following:

  1. Typical epigastric abdominal pain
  2. Elevation amylase/lipase \>3 times upper limit normal and/or
  3. Confirmatory findings on cross-sectional imaging
  4. Enrollment within 8 hours of presentation

Exclusion Criteria:

* Class II or greater NYHA heart failure
* Oxygen dependent COPD
* Chronic kidney disease\>stage 2
* Existing necrosis on abdominal CT
* Organ dysfunction prior to enrollment
* Sepsis
* Acute respiratory distress syndrome
* Malignancy not in remission for at least 5 years
* Active drug use
* Known allergy to dexamethasone
* Altered mental status
* Insulin-requiring diabetes
* Abdominal surgery within 60days

Primary outcomes:
measure: High sesitive C reactive protien
timeFrame: 72hours
measure: Serum Amylase
timeFrame: 72hours
measure: Serum Lipase
timeFrame: 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assiut University
Study officials:
References: