louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02720133: Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors
Official title: Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk Factors
Fasting
Keywords: ramadan fasting
variation of biochemical parameters
variation of hematological parameters
verify now assay
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stable patients with cardiovascular risk factors who fast during Ramadan

Brief summary: Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.

Detailed description: This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.

Eligibility criteria: Inclusion Criteria:

* Patients with cardiovascular risk factors in stable conditions
* Ramadan fasting

Exclusion Criteria:

* Impossibility, contraindication or interruption of fasting

Primary outcomes:
measure: all cause clinical complications
timeFrame: 5 years
Secondary outcomes:
measure: evidence of acute coronary complications
timeFrame: 5 years
Other outcomes:
measure: clopidogrel and aspirin related complications
timeFrame: 5 years
Locations:
city: Monastir
country: Tunisia
facility: Emergency Departement
state: Non-US/Canada
Study officials:
affiliation: University Hospital Of Monastir Tunisia
name: Semir Nouira, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attarzadeh Hosseini SR, Hejazi K. The effects of ramadan fasting and physical activity on blood hematological-biochemical parameters. Iran J Basic Med Sci. 2013 Jul;16(7):845-9.
citation: Bouida W, Beltaief K, Baccouche H, Sassi M, Dridi Z, Trabelsi I, Laaouiti K, Chakroun T, Hellara I, Boukef R, Sakly N, Hassine M, Added F, Razgallah R, Najjar F, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on aspirin resistance in type 2 diabetic patients. PLoS One. 2018 Mar 12;13(3):e0192590. doi: 10.1371/journal.pone.0192590. eCollection 2018.
citation: Bouida W, Baccouche H, Sassi M, Dridi Z, Chakroun T, Hellara I, Boukef R, Hassine M, Added F, Razgallah R, Khochtali I, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on platelet reactivity in diabetic patients treated with clopidogrel. Thromb J. 2017 Jun 2;15:15. doi: 10.1186/s12959-017-0138-0. eCollection 2017.
Clinical trial NCT02902133: Acetazolamide to Prevent Post Operative CSF Leak
Official title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cerebrospinal Fluid Leak
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test the use of Acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).


Eligibility criteria: Inclusion Criteria:

* Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
* Elective transsphenoidal resection of a pituitary adenoma, with BMI \>25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
* Patients who voluntarily sign Informed Consent
* Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
* Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)
* Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
* It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy
* Sulfonamide allergy
* Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception

Primary outcomes:
measure: Incidence of CSF Leakage
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of suspected drug adverse events
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Ronald Benveniste, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05892133: Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
Official title: Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Knee Osteoarthritis
Lead sponsor: Molde University College
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. It is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. Leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. The investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.


Eligibility criteria: Inclusion Criteria:

* Knee artrosis, refered to surgery

Exclusion Criteria:

* Kognitive disability
* Inflamatory disease in muscles
* varus/ valgus and extension deficit \>15 degrees
* Neurological disorders

Primary outcomes:
measure: Change in Leg press strength
timeFrame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
measure: Group differences in Patient satisfaction
timeFrame: Change from 3 week post-surgery, 12 months post-surgery.
Secondary outcomes:
measure: Change in Voluntary activation
timeFrame: Baseline, 1 week pre-surgery, 3week post-surgery.
measure: Change in Self reported knee function
timeFrame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
measure: Change in Walking speed
timeFrame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
measure: Change in Chair rising ability
timeFrame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
measure: Change in Balance
timeFrame: Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Other outcomes:
Locations:
city: Molde
country: Norway
facility: Molde University College
state: Møre Og Romsdal
Study officials:
affiliation: Molde UC
name: Berg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00998933: Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
Official title: An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Keywords: Testosterone replacement therapy
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

Exclusion Criteria:

* Males: history, current or suspected prostate or breast cancer.
* Female: pregnant or lactating.

Primary outcomes:
measure: Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Gardens
country: United States
facility: Site 1
state: Florida
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.
Clinical trial NCT01188733: Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
Official title: Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cirrhosis
Portal Hypertension
Esophageal Varices
Keywords: portal hypertension
varices
cirrhosis
octreotide
somatostatin analog
Child Pugh Class A,B
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.

In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
2. presence of small esophageal varices, defined as varices \< 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
3. age ≥ 18 years

Exclusion Criteria:

* pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
* allergic to sandostatin
* high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
* Child Turcotte Pugh Class C cirrhosis
* hepatocellular carcinoma
* evidence of ongoing alcohol or illicit drug abuse within 6 months of the study
* serum creatinine greater than 2 mg/dL
* platelet count below 50,000 per microliter
* prothrombin time 4 seconds or more greater than control
* human immunodeficiency virus (HIV) positive
* symptomatic gallstones
* previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena
* previous history of variceal bleeding
* history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation
* use of any investigational drug within 1 month prior to screening and
* current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00434733: Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
Official title: A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza H5N1, pandemic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-02-13
Enrollment: 4400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

* Receipt of another investigational agent within 4 weeks
* Receipt of influenza vaccination for current season 2006/2007.
* any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
* fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
* Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
* Surgery planned during the study period
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
* Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
* History of (or current) drug or alcohol abuse
* Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Adverse event rate
Secondary outcomes:
measure: Seroconversion and seroprotection after two doses of H5N1 vaccine
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Centrum Badań Farmakologii Klinicznej monipol
Study officials:
affiliation: Novartis Vaccines and Diagnostics GmbH & Co KG., Germany
name: Novartis Vaccines and Diagnostics GmbH & Co KG Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT02876133: Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection
Official title: Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Colon Sessile Serrated Adenoma/Polyp
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 987
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.

Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective colonoscopies

Exclusion Criteria:

* known polyposis syndromes
* primary sclerosing cholangitis
* inflammatory bowel disease
* personal colorectal cancer history

Primary outcomes:
measure: average number of serrated lesions ≥10 mm detected per colonoscopy
timeFrame: immediate
Secondary outcomes:
measure: Serrated class lesions detection rate
timeFrame: immediate
measure: Serrated lesions <10 mm detected per colonoscopy
timeFrame: immediate
measure: SSL detection rate
timeFrame: immediate
measure: Adenoma detection rate
timeFrame: immediate
measure: Adenomas detected per colonoscopy
timeFrame: immediate
measure: Advanced (malignant) adenocarcinoma detection rate
timeFrame: immediate
measure: Incidence of procedure related adverse events
timeFrame: immediate
Other outcomes:
Locations:
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto
Study officials:
affiliation: Hospital Beatriz Ângelo
name: Alexandre O Ferreira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19.
Clinical trial NCT04338633: Post-operative Pain Reduction
Official title: Post-operative Pain Reduction After Application of Three Intracanal Medicament Within Necrotic Root Canals and Pulp
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of the Elements
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recruited patients with necrotic pulp after application of conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards.

Detailed description: The investigator will recruit patients who are found eligible to the criteria, conventional calcium hydroxide paste , Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle . After 48 hours, patients will be randomly assigned to removal of intracanal medication

After the visit, patients will be asked to record post operative pain by Numerical Rating Scale)in a given sheet

Eligibility criteria: Inclusion Criteria:

* • Medically free patients.

  * Patient's age between 25-50 years.
  * Sex includes both male and female.
  * Radiographic evidence of a periapical radiolucent lesion associated with tooth.
  * Necrotic pulp as indicated by thermal pulp testing.
  * No history of previous endodontic treatment of the tooth.

Exclusion Criteria:

* • Teeth with unfavorable conditions for rubber-dam application.

  * Teeth with acute periapical abscesses swelling.
  * Medically compromised patients.
  * Immature teeth with open apices.
  * Multi rooted teeth.
  * Pregnant women.

Primary outcomes:
measure: change in post operative pain (Visual Analogue Scale)
timeFrame: Intrappointment at 4,24,48,72 and 96 hours ]
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
affiliation: Dean of Faculty
name: Magdy Mohamed Aly, Professor
role: STUDY_DIRECTOR
References:
citation: Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
Clinical trial NCT01602133: Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter
Official title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Puncture
Keywords: venous puncture
seldinger technique
ultrasound guidance
Lead sponsor: Prodimed SAS
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with need of an intravenous therapy on peripheral line
* Unsuccessful attempts at establishing a peripheral intravenous line by nurse
* Age over 18 YO
* Written informed consent obtained

Exclusion Criteria:

* pregnant woman
* local contra-indication for venous puncture
* unconscious patient
* need of intravenous therapy requiring central line

Primary outcomes:
measure: length of use of the catheter measured in number of days
timeFrame: seven days
Secondary outcomes:
measure: adverse event during the period of use of the catheter
timeFrame: seven days
Other outcomes:
Locations:
city: Corbeil-essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien- Corbeil- France
name: Pascal Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: