louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00501358: Sleep Apnea and Tromboembolic Disease
Official title: Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndromes
Venous Thromboembolism
Keywords: SLEEP APNEA
venous thromboembolism
COAGULABILITY
COAGULATION FACTORS
HYPOXIA
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Fundacion Caubet-Cimera Islas Baleares
First posted: 2007-07-16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE).

OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.

Detailed description: DESIGN: Case-control study.

METHODS: 133 SAHS patients and 133 controls will be studied. The study includes:

a) medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.

Eligibility criteria: Inclusion Criteria:

* Case group:
* Pulmonary embolism diagnosed by CT Pulmonary Angiography.
* Control group:
* randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease

Exclusion Criteria:

* Refusal to sign informed consent.
* Expected survival less than 12 months
* Long-term oxygen therapy
* Hospital admission in the previous two months.
* Familiar thrombophilia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
state: Baleares
Study officials:
affiliation: Sociedad Española de Neumología y Cirugía Torácica
name: Alberto Alonso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05375058: Complicated Appendicitis During the COVID-19 Pandemic in Jordan
Official title: Impact of the COVID-19 Pandemic on the Incidence of Complicated Appendicitis in a Tertiary Medical Center, Amman, Jordan: A Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Complicated Appendicitis
Lead sponsor: Jordan University Hospital
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 257
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient that has a medical record for appendicitis and underwent appendectomy at University of Jordan hospital

Brief summary: Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.

Detailed description: The investigators have retrospectively investigated data on acute appendicitis cases. Two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the COVID-19 pandemic in Jordan University Hospital

Eligibility criteria: Inclusion Criteria:

* Any patient that presented with appendicitis and underwent an appendectomy at the university of Jordan hospital during the specified time periods (March 2019-December 2020)

Exclusion Criteria:

* Incomplete data record.

Primary outcomes:
measure: Occurrence of postoperative complications
timeFrame: Up to 2 years
Secondary outcomes:
measure: Length of in-hospital stay
timeFrame: Up to 2 years
measure: Imaging method used for diagnosis (CT or US)
timeFrame: Up to 2 years
measure: Type of operation (open or laparoscopic)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: Department of General Surgery, the University of Jordan, Amman, 11942, Jordan
name: Marzouq Amarin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02160158: Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers
Official title: Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fesoterodine
SR3
SR4
bioavailability
pharmacokinetics
sprinkle
applesauce
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
* Evidence or history of clinically significant urologic disease \[urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 48 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 48 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 48 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 48 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03098758: Molecular Analysis in Peritoneal Washing Citology for Locally Advanced Gastric Cancer
Official title: Pilot Study of Comparative Molecular Analysis CK20, CEA and BER-EP4 in Peritoneal Washing Citology for Locally Advanced Gastric Cancer and Their Ability to Predict Peritoneal Dissemination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Polymerase Chain Reaction
Keywords: Polymerase Chain Reaction
gastric cancer
citology
peritoneal washing
CK20
CEA
BER-EP4
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced gastric cancer without macroscopic peritoneal carcinomatosis

Brief summary: Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a recognized prognostic utility. However sensibility of this study is not appropriate. Studies with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging information.

Objective: To analyze the sensibility and specificity of the expression of CK20, CEA and Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without clinical evidence of peritoneal carcinomatosis.

Methodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of peritoneal recurrence.


Eligibility criteria: Inclusion Criteria:

* Patients with resectable advanced gastric cancer
* Informed consent

Exclusion Criteria:

* Macroscopic peritoneal carcinomatosis
* Non operable patients

Primary outcomes:
measure: specific markers in peritoneal cells
timeFrame: during surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli Hospital Universitari
state: Barcelona
Study officials:
affiliation: Corporación Parc Taulí
name: Alexis Luna, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04439058: Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery
Official title: Preoperative Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2020-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland) was used
Primary purpose: OTHER

Brief summary: The effects of SGB on the cardiovascular system remain controversial since the cardiac sympathetic nerves pass through the stellate ganglion. SGB is expected to have an ameliorative effect on impaired coronary circulation and cardiac function and thus to be well suited to the treatment of angina pectoris and myocardial infarction

Detailed description: investigators chose left SGB being safer with regards conductivity changes when compared to right SGB, in the present study investigators are trying to examine and compare whether coronary reperfusion in patients undergoing coronary artery bypass grafting who were subject to ultrasound guided left Stellate ganglion block (SGB ) performed in the induction of anesthesia could decrease post cardiopulmonary bypass ischemic changes, pulmonary hypertension and right ventricular dysfunction leading to enhanced recovery.

Place of work: Ain shams university hospitals cardiovascular surgery academy, Cairo, Egypt.

Number and selection of participants:

40 participants, 20 in each group (2 groups).

Eligibility criteria: Inclusion Criteria:

Ischemic heart disease patients age above 18 years

Exclusion Criteria:

allergy to LA, severe COPD

Primary outcomes:
measure: change in heart rate
timeFrame: change in heart rate from base line
measure: change in Ejection Fraction
timeFrame: change in Ejection Fraction from base line
measure: change in blood pressure
timeFrame: change in blood pressure from base line
measure: change in cardiac rhythm
timeFrame: change in cardiac rhythm from base line
Secondary outcomes:
measure: effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery
timeFrame: change of troponin level from base line
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Wail Abdelaal
Study officials:
affiliation: professor
name: diaa marzouk, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00874458: MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
Official title: Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

Detailed description: OBJECTIVES:

Primary

* Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).

Secondary

* Evaluate the sensitivity of MRI in detecting DCIS.
* Evaluate the contribution of mammography in accurately determining tumor size.
* Compare the contribution of MRI vs mammography in assessing tumor extension.
* Compare the contribution of MRI vs mammography in assessing dense breasts.
* Evaluate the morphology of DCIS by MRI.
* Evaluate the curve of dynamic MRI in assessing DCIS.
* Evaluate the impact of nuclear grade of DCIS by MRI.
* Evaluate the rate of revision surgery.

OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of ductal breast carcinoma in situ

  * Any grade disease allowed
* Unifocal disease by mammography
* No history of breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* WHO performance status 0-2
* Glomerular filtration rate ≥ 30 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy or contraindication to contrast MRI
* No pacemaker or vascular clip

PRIOR CONCURRENT THERAPY:

* No prior or concurrent liver transplantation

Primary outcomes:
measure: Correlation of tumor extension by MRI with surgical histology
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Claire Chapellier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05707858: The Naples Pediatric Food Allergy (NAPFA) Score
Official title: The Naples Pediatric Food Allergy (NAPFA) Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy in Children
Keywords: Food allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged 0-14 years with suggestive history of food allergy

Brief summary: Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem. The Oral Food Challenge (OFC) is the gold standard for FA diagnosis, but it is time-consuming, expensive, and potentially dangerous, as it can determine severe anaphylaxis. In addition, causing long-lasting impact on patient anxiety and mental health due to the physical duress and health risks involved with its application, OFC strategy is little applied in clinical practice with consequent diagnostic errors and delays. The goal of the Naples Pediatric Food Allergy (NAPFA) score is to develop a new clinical score including the main anamnestic, and clinical features for the easy identification of pediatric FA in primary care setting.


Eligibility criteria: Inclusion Criteria:

* subjects aged between 0-14 years with suggestive history of food allergy

Exclusion Criteria:

* Exclusion criteria: age \>14 years
* chronic systemic diseases,
* malignancy,
* immunodeficiency,
* infectious diseases,
* autoimmune diseases,
* inflammatory bowel diseases,
* celiac disease,
* metabolic and genetic diseases,
* cystic fibrosis,
* chronic pulmonary diseases,
* gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
* neurologic and/or neuropsychiatric disorders,
* gastrointestinal tract eosinophilic disorders,
* use of immunomodulating drugs in the previous 4 months
* use of steroids and antihistamines in the previous 2 weeks

Primary outcomes:
measure: Development of a new clinical score for the identification of pediatric FA in primary care setting
timeFrame: at the enrollment
Secondary outcomes:
measure: Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting
timeFrame: at the enrollment
measure: Validation of the new clinical NAPFA score for the identification of pediatric FA
timeFrame: at the enrollment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
affiliation: Department of Translational Medical Science, University of Naples Federico II
name: Roberto Berni Canani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398458: Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
Official title: Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocele
Varicose Veins
Keywords: Lymphocele, Varicose Vein, Gracilis Muscle, Sclerotherapy.
Lead sponsor: Bahria International Hospital
Sponsor class: UNKNOWN
First posted: 2022-06-01
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: post varicose vein surgery ,patient developed lymphocele in right thigh

Brief summary: A 48-year-old female presented to the plastic surgery outpatient department (OPD) with a history of painful, progressive swelling of the right groin and medial aspect of the right thigh for 4 months. After investigation, it was diagnosed as a giant lymphocele. A pedicled gracilis muscle flap was used to reconstruct and obliterate the cavity. There was no recurrence of the swelling. : Lymphocele is a common complication after extensive vascular surgeries. In the unfortunately case of its development, prompt intervention must be done to prevent its growth and ensuing complications.


Eligibility criteria: Inclusion Criteria: diagnosed case of lymphocele -

Exclusion Criteria: none

-

Primary outcomes:
measure: Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Bahria iInternational Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01972958: Effects of Community Health Programs by Nurses for Older Adults
Official title: Effects of Community Health Programs by Nurses for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2013-10-31
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As the aging population increases, preventing and decreasing disabilities become a critical issue for the health care system. Previous researches have shown that preventive community-based nursing services for older adults could achieve important health benefits at a relatively low cost. However, many frail and pre-frail older adults living in communities cannot get enough attention from current health care system. The role and function of nurses should be expanded to provide more comprehensive family-oriented care to improve health outcomes of older adults in Taiwan. The objectives of this study are:

1. Understand the difficulties and solutions for nurses providing community-based services in order to expand their better role and function.
2. Develop a cultural sensitive community advanced nurse service model for Taiwan in health care system.
3. Explore the effectiveness of community health programs by nurses for frail or pre-frail older adults in community.

Focus groups and literature review will be used to achieve the first and second study objectives. A single centre randomized controlled trial will be used in this study to achieve the third study objective. Two hundred and twenty people aged 65 and over who meet the Fried definition of frailty and pre-frailty will be recruited from the clinic of a hospital. Participants will be followed for a 6-month period. Frailty, quality of life, satisfaction to the services, hospitalizations and admissions to nursing care facilities will be measured and compared between experimental group and control group. This research is an important step in the examination of a new approach to the community older people by nurses. The study results will provide the evidence data to recommendation for related policy making in the future.


Eligibility criteria: Inclusion Criteria:

* 65 years and above, frail and pre-frail older adults, living in communities

Exclusion Criteria:

* Cognitive impairment.

Primary outcomes:
measure: To assess quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School of Nursing, National Taiwan University
Study officials:
affiliation: National Taiwan University Hospital
name: Lian-Hua Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: