louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02952417: Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction
Official title: Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 180000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013

Brief summary: The aim of this study was to estimate the impact of sex on relative survival and excess mortality following acute myocardial infarction (AMI) using a population-based cohort within a relative survival framework. Patient-level data concerning demographics, co-morbidity, cardiovascular risk factors and treatments at discharge were extracted from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of December, 2013.

Detailed description: Details of SWEDEHEART and data validation have been described previously. Cases of acute myocardial infarction were defined as STEMI and NSTEMI according to the current European Society of Cardiology, American College of Cardiology and American Heart Association guidelines and determined at local level by the attending Consultant.

Eligibility criteria: Inclusion Criteria:

* Patients were included if they are aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013

Exclusion Criteria:

-

Primary outcomes:
measure: Excess mortality rate ratio
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Alabas OA, Gale CP, Hall M, Rutherford MJ, Szummer K, Lawesson SS, Alfredsson J, Lindahl B, Jernberg T. Sex Differences in Treatments, Relative Survival, and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry. J Am Heart Assoc. 2017 Dec 14;6(12):e007123. doi: 10.1161/JAHA.117.007123.
Clinical trial NCT04245917: Natural History Study of MNGIE
Official title: Natural History Study of Mitochondrial Neurogastrointestinal Encephalomyopathy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Mitochondrial Neurogastrointestinal Encephalomyopathy
Keywords: MNGIE
Lead sponsor: Entrada Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female MNGIE patients greater than 5 years of age

Brief summary: Non-interventional, prospective, multicenter, natural history study of patients with mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)


Eligibility criteria: Inclusion Criteria:

* Has MNGIE

Exclusion Criteria:

* Substance abuser

Primary outcomes:
measure: MNGIE Clinical Course
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: New York
country: United States
facility: Columbia University
state: New York
city: Houston
country: United States
facility: Baylor St Luke's Medical Center and Texas Children's Hospital at Baylor College of Medicine
state: Texas
city: Bornova
country: Turkey
facility: Ege University Medical Faculty; Department of Pediatrics
state: Izmir
city: Ankara
country: Turkey
facility: Gazi Üniversitesi Tıp Fakültesi
Study officials:
affiliation: Columbia University
name: Michio Hirano, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00490217: Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome
Official title: Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Bacterial Peritonitis
Primary Peritonitis
Ascites
Keywords: Spontaneous bacterial peritonitis
incidence
Finland
etiology
liver cirrhosis
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-06-22
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Spontaneous bacterial peritonitis (SBP) is a severe complication of ascites in cirrhotic patients. Under clinical experience, this condition seems to be more uncommon in Finland. The aim of this study was to measure the incidence of SBP in consecutive patients with ascites requiring hospitalization in a Finnish University Hospital.

Detailed description: Spontaneous bacterial peritonitis (SBP) is a complication of liver cirrhosis with high mortality and low survival rates. The incidence of SBP is reported to range from 11-35% in patients with ascites requiring hospitalization. Under clinical experience, the incidence of SBP in Finland seems to be lower than reported elsewhere. Alcohol is the dominant etiologic factor of liver cirrhosis in Finland (90%), which might be a factor affecting the incidence of SBP. The aim of this study is to measure the incidence of SBP in Finland. We included consecutive patients who underwent diagnostic paracentesis for ascites in Tampere University Hospital during 2/1994 - 12/1998 and 1/2005 - 3/2007. Spontaneous bacterial peritonitis was diagnosed when the ascitic fluid contained over 250 polymorphonuclear cells / mm\^3 regardless of culture and with no evidence of intra-abdominal source of infection e.g. an abscess or a perforation.

Eligibility criteria: Inclusion Criteria:

* Diagnostic paracentesis performed during the study period

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
name: Jahangir A Khan, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
name: Pekka Collin, MD
role: STUDY_DIRECTOR
affiliation: Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
name: Pekka Pikkarainen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01956617: The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
Official title: The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mininimum Effective Anaesthetic Volume of Local Anaesthetic
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is to determine the minimum effective volume of ropivacaine 0.5% required to produce an effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method study design, 30 patients scheduled for elective total hip and knee arthroplasty will be included in the study.


Eligibility criteria: Inclusion Criteria:

* orthopaedic patients scheduled for elective hip and knee arthoroplasty
* ASA 1 - 2 or stable ASA 3
* age between 18 and 70 years
* good ability to communicate and to cooperate

Exclusion Criteria:

* ASA \> 3 or unstable ASA 3
* BMI \> 32
* chronicle pain
* nephrological diseases or nephropathy
* known contraindications against the use of local anaesthetics
* pregnancy

Primary outcomes:
measure: minimum effective volume
timeFrame: from day 1 up to 20 weeks
Secondary outcomes:
measure: block success
timeFrame: Day 1
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
Clinical trial NCT01970917: Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Official title: Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndrome
Healthy
Keywords: tear film thickness
optical coherence tomography
topical lubricants
tear film thickness in healthy subjects
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterized and data about efficacy is sparse.

The aim of the present project is to investigate the effect of topically administered Olixia pure® eye drops on tear film thickness in healthy subjects.

Tear film thickness will be determined using ultra high-resolution optical coherence tomography (OCT). Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye drops, the fellow eye will receive physiologic saline solution as placebo control. The study eye will be chosen randomly.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 Dpt.
* Schirmer I test \> 10 mm and BUT \> 10 sec

Exclusion Criteria:

* Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Ametropia =/\> 6 Dpt
* Pregnancy
* Difference of more than 5 mm in Schirmer I test or difference of \> 3 sec in BUT between the two eyes
* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study

Primary outcomes:
measure: Tear film thickness
timeFrame: up to one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhoefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487617: Arteriopathy and Endothelial Function
Official title: Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Arteriopathy
endothelial function
fruit juice
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2007-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value


Eligibility criteria: Inclusion Criteria:

* Peripheral arteriopathy
* Stable cardio-respiratory status

Exclusion Criteria:

* Dialysis

Primary outcomes:
measure: Endothelial function 1 hour after taking the juice
timeFrame: 1 hour after taking the juice
Secondary outcomes:
measure: Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years
timeFrame: 3 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Vasculaire
city: Strasbourg
country: France
facility: Service de Physiologie et d'Explorations Fonctionnelles
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Olivier Rouyer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06182917: Prognostic Value of MRD Detection in CA125 Non-sensitive Ovarian Cancer Patients
Official title: A Study for Assessing the Value of Minimal Residual Disease Detection in Disease Monitoring of CA125 Non-sensitive Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 35
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study intends to include 35 patients with low CA125 level ovarian cancer at first diagnosis or recurrence between the ages of 18-75 years old.

Brief summary: Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.


Eligibility criteria: Inclusion Criteria:

* Age 18-75;
* Pathologically confirmed ovarian cancer;
* CA125 ≤200U/ml at first diagnosis or recurrence;
* Physical condition score PS ≤ 2 points;
* Enough tumor samples for WES detection;
* Patients and their families can understand and are willing to participate in this study and provide written informed consent.

Exclusion Criteria:

* Patients unable to provide sufficient tissue / blood samples for research detection;
* Pregnant or lactating women;
* Other diseases considered by the research doctor to affect the prognosis and survival;

Primary outcomes:
measure: The prognostic value of MRD
timeFrame: 12 months
Secondary outcomes:
measure: Progress Free Survival
timeFrame: From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: west china second University， SICHUAN University, China
state: Sichuan
Study officials:
affiliation: West China Second University Hospital
name: Mengpei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Second University Hospital
name: Rui Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05623917: Sleep Quality, Stress, Depression, Blood Pressure Responses to Diaphragmatic Respiratory Exercise in Systemic Sclerosis
Official title: Sleep Quality, Stress/Depression, Autonomic Responses to Breathing Exercise in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: systemic sclerosis women usually report problems such as stress/depression, fatigue, not deep sleep. complementary therapies may improve the reported problems in those patients

Detailed description: the assignment of females with systemic sclerosis (n= forty females) to two equal groups. the group will contain 20 females. the first group will receive tele-supervised Diaphragmatic Respiratory Exercise ( applied at the homes of the females two times per the day, at the morning and at the evening, twenty minutes for every time, the sessions will be applied daily for 3 months in all females). the females in the second group will be waiting-list control females.

Eligibility criteria: Inclusion Criteria:

* systemic sclerosis women (40 females)

Exclusion Criteria:

* obesity
* thoracic diseases
* heart disease
* females with mental diseases

Primary outcomes:
measure: cortisol
timeFrame: 12 weeks
Secondary outcomes:
measure: systolic blood pressure
timeFrame: 12 weeks
measure: diastolic blood pressure
timeFrame: 12 weeks
measure: pulse rate
timeFrame: 12 weeks
measure: respiratory rate
timeFrame: 12 weeks
measure: Patient Health Questionnaire
timeFrame: 12 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: 12 weeks
measure: fatigue using visual analogue scale
timeFrame: 12 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01853917: Evaluation of Barriers to Postpartum Care in HIV Infected Women
Official title: Evaluation of Barriers to Postpartum Care in HIV Infected Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Pregnancy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2013-05-15
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected pregnant women

Brief summary: The purpose of this study is to evaluate why the majority of HIV infected women in the Harris County Health District system who are pregnant do not come to clinic for their HIV disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. The study will ask subjects questions about HIV, drug use, depression and social problems.

Detailed description: This study is evaluating information pre and postpartum to assess what are barriers to patients coming into care for HIV after they have a baby. We will try to evaluate recurrent themes in questionaires and interviews to try and identify the barriers to care.

Eligibility criteria: Inclusion Criteria: HIV infected pregnant women who

* HIV-infected women who are pregnant by confirmatory tests or an HIV positive woman who has had a baby within the last 6 months and is coming to care postpartum.
* Women who intend to get care at Harris County Hospital District.
* Subjects must be \>18 years old.

Exclusion Criteria:

* Women unable to complete questionnaires.
* Women who are unable to speak, read, or understand English or Spanish.

Primary outcomes:
measure: evaluate results from qualitative interviews
timeFrame: women seen after they have their baby
Secondary outcomes:
measure: evaluate results from questionaires
timeFrame: before they have a baby and after they have a baby
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris County Hospital District Clinics-Thomas Street Clinic, Northwest Clinic
state: Texas
city: Houston
country: United States
facility: Harris County Hospital District Clinics-LBJ hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Tanvir Bell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540917: Measurement Skin Temperature During Pulsed Laser Exposure
Official title: Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Port-Wine Stain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
name: Candela Corporation
First posted: 2007-10-08
Enrollment: 118
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Detailed description: The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling.

This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.

Eligibility criteria: Inclusion Criteria:

* 7 years of age and older with diagnosis of port wine stain birthmark
* 18 years of age and older with no port wine stain
* non-pregnant women
* apparent good health

Exclusion Criteria:

* age less than 7 years old
* pregnant women
* history of photodermatoses or skin cancer
* current use of photosensitizing drugs

Primary outcomes:
measure: skin temperature during laser treatment
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical Clinic University of California Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John S. Nelson, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: