louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03254121: Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response
Official title: Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Hepatitis C
Keywords: Sustained virological response
Whole genome sequencing
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-08-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Please see eligibility criteria

Brief summary: In this international collaboration study, the research group will analyze somatic mutations of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in patients treated with hepatitis C (HCV) therapy

Detailed description: Method Paired liver tissue samples will be collected from the tumour sections and also from the adjacent non-tumour tissues, for comparison in each individual. The tissues have been collected as part of routine clinical work/other studies, by liver biopsies or at liver resection/liver transplantation. Data regarding the patient characteristic will be collected. Whole genome sequencing analyses are planned to be performed.

Eligibility criteria: Inclusion Criteria:

* Patients with sustained virological response (SVR) after interferon (IFN)-containing or IFN-free treatment, and developed hepatocellular carcinoma (HCC)
* Available liver biopsies from hepatocellular carcinoma and non-HCC tissue

Exclusion Criteria:

* Co-infection with chronic hepatitis B (HBsAg positive) or HIV infection.
* Liver transplantation prior to treatment-start, leading to SVR.
* Patients with diagnosed HCC prior to treatment-start, leading to SVR.

Primary outcomes:
measure: Characterisation of genomic mutations of HCC, developed in HCV patients with SVR
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Jan Bolinder, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05020821: Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty
Official title: Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthroplasty
Postoperative Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 92
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Shoulder arthroplasty is associated with significant postoperative pain. Appropriate pain control after shoulder arthroplasty is crucial for postoperative rehabilitation and patient satisfaction. Superior trunk block is a commonly employed regional anesthetic technique for shouler arthroplasty, and a continuous catheter is often placed to extend the analgesic benefit of the block. However, continuous peripheral nervel block (PNB) is more costly and time-consuming than sigle-shot PNB. Recent evidence suggests that intravenous (IV) dexmedetomidine (DEX) prolong the analgesic duration after sigle-shot PNB. The investigators will compare continuous superior trunk block with single-shot superior trunk block with IV DEX in patients undergoing shoulder arthroplasty.


Eligibility criteria: Inclusion Criteria:

1 Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective shoulder arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Heart failure
3. Hepatic or renal insufficiency
4. Opioid dependency
5. Coagulopathy
6. Pre-existing neurologic or anatomic deficits in the upper extremities
7. Severe psychiatric illness

Primary outcomes:
measure: Numeric rating scale pain score
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01698021: Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome
Official title: Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina
Keywords: Creatine Kinase, MB form
Troponin
Acute coronary syndrome
myocardial infarction
Unstable angina
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients presenting to the emergency department or being hospitalized for any reason in which we suspect an acute coronary syndrome.

Brief summary: The new assay of troponins T (highly sensitive troponins) detects concentrations much lower than before. Few data are currently available on their kinetics during acute coronary syndrome, especially in regard to the correlation with CK MB. The aim of the present study is to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value with respect to infarct size .

Detailed description: Patients who meet the inclusion criteria will have a highly sensitive troponins and CKMB assays q 8hr for the first day, and q 12h for the next 2 days. If clinically not indicated, the blood sample can be cancelled at any time, as in the case of a patient with an initial suspicion of acute coronary syndrome in which the final diagnosis is something else. Only patients with a definitive myocardial infarction will be analyzed.

Subgroup analyses includes ST-elevation MI, Non ST-elevation MI, revascularization vs no revascularization, procedural myocardial infarction.

Another analysis conducted is the correlation between the values of troponin and infarct size by echocardiography (in patients who have an echocardiography 2-7 days post AND 2-6 months post myocardial infarction)

Eligibility criteria: Inclusion Criteria:

* \>= 18 years-old
* Clinical suspicion of an acute coronary syndrome; (will be analyzed only patients with aposteriori definitive diagnosis of unstable angina or myocardial infarction)

Exclusion Criteria:

* none

Primary outcomes:
measure: Evaluation of troponins kinetic in acute coronary syndromes.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Paul Farand, Md MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561921: Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.
Official title: Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Success of Inferior Alveolar Nerve Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars


Eligibility criteria: Inclusion Criteria:

1. Age between 18-55 years old.
2. Systemically healthy patient (ASA I or II).
3. Mandibular molar teeth with:

   * Preoperative sharp pain.
   * No widening in the periodontal ligament (PDL).
   * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1.
   * Fully formed roots.
4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Drug abusers and subjects who were on antidepressant medication.
5. Re-treatment cases.
6. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.

Primary outcomes:
measure: success of inferior alveolar nerve block measured using a numerical rating scale (NRS)
timeFrame: 15 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06741384: Breathing Exercises on Depression in Postmenopausal Women
Official title: Effect of Breathing Exercises on Depression and Sexual Function in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postmenopausal
Depressive Symptom
Breathing Exercises
Lead sponsor: Middle East University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women

Detailed description: Sixty postmenopausal women will be sourced from the Obstetrics \& Gynecology outpatient clinic at El Mahalla El Kobra general hospital in Egypt, with referrals from gynecologists. Patients will be randomly assigned into two groups.

Study group: It will include 30 women participating in diaphragmatic breathing plus aerobic training.

Control group: It will include 30 women participating in aerobic training.

At baseline and poststudy, the following outcomes will be assessed:

1. Depression (Beck Depression Inventory II scale).
2. Sexual function (female sexual function index questionnaire).

Eligibility criteria: Inclusion Criteria:

* Minimum of 3 years after menopause.
* Mild to moderate depression.
* Mild to moderate sexual dysfunction.
* Their ages will be ranged from 45 to 60 years old.
* Their BMI will be less than 30 kg/m2.

Exclusion Criteria:

* Prolapse of the pelvic organs.
* Pelvic tumors.
* Vaginal infections.
* Musculoskeletal/ neurological limitations to exercise.
* Psychiatric disorders.
* Unstable cardiovascular conditions.
* Diabetes.

Primary outcomes:
measure: Depression
timeFrame: At baseline and after 8 weeks
Secondary outcomes:
measure: Sexual function
timeFrame: At baseline and after 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National institute for Gerontology
name: Mohammed Sayed Saif, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01688284: The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage
Official title: The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Recurrent Pregnancy Losses
Keywords: uterine natural killer cells
recurrent miscarriages
alloimmunity
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with Recurrent Pregnancy Losses (RPL).

Detailed description: Office hysteroscopy examination of the patients at the luteal phase of the natural cycle (day17 to day 20),with endometrial biopsy using pipple curette from the region of the fundus, the biopsy sent to flow cytometry laboratory in South Egypt Cancer Institute to be examined for:

1.1. Phenotypic analysis of uterine natural killer cells:

1.2. Induction and detection of intracellular cytokines by flow Cytometry:

Eligibility criteria: Inclusion Criteria:

1. Women with unexplained recurrent miscarriages (2 or more consecutive).
2. All patients have normal uterine cavity diagnosed by HSG and /or hysteroscopy, normal semen analysis, normal thrombophilic profiles, no history of malformed
3. normal fetus in the previous miscarriages

Exclusion Criteria:

1. Age above forty years old .
2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
4. Fibroids distorting uterine cavity .
5. Abnormal parental karyotype .
6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Primary outcomes:
measure: the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with RPL.
timeFrame: two years
Secondary outcomes:
measure: to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure
timeFrame: two years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital
Study officials:
affiliation: women health hospital,assiut university,egypt
name: Alaa M Ismail, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017184: Non-invasive Sensor for Core Temperature Measurement
Official title: Non-invasive Sensor for Core Temperature Measurement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Temperature Regulation
Keywords: Body Temperature Regulation Sensor Noninvasive
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.

Detailed description: During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the "gold standard" and to the new noninvasive sensor which is attached to the skin surface.

Eligibility criteria: Inclusion Criteria:

* age 18-25 - healthy
* after medical checkup
* after signing concent form
* with no heat stroke medical history

Exclusion Criteria:

* heat stroke medical history
* heart disease
* diabetes
* obesity

Primary outcomes:
measure: Rectal temperature
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer, Ramat- Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Heller institute, Sheba medical center
name: Yoram Epstein, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02171884: Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
Official title: Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assisted Reproductive Technology
Freezing/Thawing Procedure
Prolonged Culture Procedure
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 4 groups of infants:

* conceived naturally
* born following ART with IVF/ICSI (short culture)
* born following ART with IVF/ICSI and freezing/thawing of the embryo
* born following ART with IVF/ICSI (prolonged culture)

Brief summary: For this project, 4 groups of 38 infants have been created so as to evaluate the impact of Assisted-Reproduction Technology (ART) and more particularly the two procedures classically used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of culture in appropriate in vitro conditions to allow development of the embryo) in contrast with shorter culture of only two days.

Participation consists in accepting samples to be taken at the birth of the infant:

1. from the umbilical cord.
2. from the placenta.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written informed consent,
* Patients with national health insurance cover,
* Maternal age at conception between 20 and 43 years,
* Paternal age at conception between 18 and 50 years,
* Singleton pregnancy

Exclusion Criteria:

---Maternal disease:

* pulmonary, cardiac
* renal and metabolic diseases (including type 1 and 2 diabetes prior to the pregnancy)
* systemic inflammatory diseases
* hypertension
* neurological diseases
* chronic hepatitis B or C
* HIV infection

Primary outcomes:
measure: Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)
timeFrame: Baselines
measure: Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)
timeFrame: Baselines
measure: Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)
timeFrame: Baselines
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de BESANCON
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT00750984: A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Official title: A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Avascular Necrosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Aarhus University Hospital
First posted: 2008-09-11
Enrollment: 49
Sex: ALL
Minimum age (years): 29
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Detailed description: Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy:

* Less bone resection, less complicated revision surgery.
* Reduced stress shielding of the femur.
* Lower incidence of hip dislocations.
* Walking function improved by change in mobilisation regime and operative technique.
* Risk of femoral neck fracture is reduced by preoperative measurement of bone density.
* Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.

Eligibility criteria: Inclusion Criteria:

* Primary hip OA
* Secondary hip OA due to mild and moderate acetabular dysplasia
* Sufficient bone quality for cementless acetabular component
* Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
* \>29 years
* \<61 years

Exclusion Criteria:

* Neuromuscular or vascular diseases in affected leg
* Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
* Need of NSAID post-operatively
* Fracture sequelae
* Females at risk of pregnancy (no safe contraceptives)
* Severe hip dysplasia
* Sequelae from hip disease in childhood
* Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
* Alcoholism (females \> 14 units per week, males \> 21 units per week) AVN
* Osteoporosis

Primary outcomes:
measure: RSA
timeFrame: 1 week, 3 months, 1 year, 2 years, 5 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
measure: Microdialysis
timeFrame: 1 week
measure: Conventional X-ray
timeFrame: 1 week
measure: Gait Analysis
timeFrame: 1 week, 3 months, 1 year
measure: DEXA scan
timeFrame: Pre-operatively, 1 week, 1 year, 2 years
Other outcomes:
Locations:
city: Arhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Thomas Pryno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Kjeld Soeballe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: