louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00452322: Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Official title: Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Keywords: Testosterone
Hypogonadism
Safety
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2007-03-27
Enrollment: 60
Sex: MALE
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of male hypogonadism by testosterone substitution has be monitored in terms of safety. This study relates to safety of a new long-acting preparation.

Detailed description: A reliable form of androgen substitution therapy regarding kinetics, tolerance and restoration of androgenicity is paramount in hypogonadal men. Intramuscular injection of the long-acting ester testosterone undecanoate (TU) offers a new modality.

The objective is to assess safety of TU regarding metabolic and pharmacogenetic confounders in hypogonadal men treated with this new formulation.

This is a longitudinal prospective one-arm open intervention and observation trial. A minimum of 5 individual assessments is a prerequisite. Investigated modulators of safety parameters entering regression models are: nadir and/or delta total testosterone concentrations, body mass index (BMI), and age.

The setting Andrological outpatient department.

Eligibility criteria: Inclusion Criteria:

* Men presenting hypogonadism-related symptoms and desiring substitution therapy. Such symptoms are fatigue, loss of libido, depressiveness, change in body composition/weight, decreased physical performance, decrease in aggressive behaviour, disability to cope, decreased work performance, lack of androgenization. At least one of these symptoms has to be accompanied by low total testosterone levels (\< 12 nmol / L).
* All patients have to give written informed consent for the use of their data for scientific evaluation as approved by the Ethics Committee of the Medical Faculty, University of Muenster, Germany and the State Medical Board.

Exclusion Criteria:

* Prostate Cancer
* Breast Cancer
* Desired Paternity

Primary outcomes:
measure: Prostate (size, PSA-level)
measure: Erythropoeisis (Hemoglobin, Hematocrit)
measure: Lipoproteins (HDL, LDL, Triglycerides)
measure: Blood pressure
measure: Pulse
Secondary outcomes:
measure: Possible changes of body mass index
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Institute of Reproductive Medicine of the University Clinics
Study officials:
affiliation: University Clinics Muenster, Germany
name: Eberhard Nieschlag, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Zitzmann M, Nieschlag E. Androgen receptor gene CAG repeat length and body mass index modulate the safety of long-term intramuscular testosterone undecanoate therapy in hypogonadal men. J Clin Endocrinol Metab. 2007 Oct;92(10):3844-53. doi: 10.1210/jc.2007-0620. Epub 2007 Jul 17.
Clinical trial NCT06168422: A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
Official title: A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Heart Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 2100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with calcified coronary artery disease

Brief summary: The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years;
2. Meet the indications for coronary intervention;
3. IVUS examination suggests severe calcified lesions (calcification angle \>270°) or OCT examination suggests severe calcified lesions (calcification angle \>180° and/or length \>5mm and/or thickness \>0.5mm);
4. The diameter of the target lesion vessel is greater than 2.75mm;
5. The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2.

Exclusion Criteria:

1. inability to provide written informed consent;
2. inability to administer antiplatelet agents and anticoagulant therapy;
3. the subject is participating in other unfinished clinical trials;
4. life expectancy \<1 year;
5. non-in situ vascular lesions;
6. patients with haemodynamic instability;
7. Previous stroke within 6 months.
8. left main stem lesions.

Primary outcomes:
measure: MACEs
timeFrame: 12 months
Secondary outcomes:
measure: Cardiac Death
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 12 months
measure: Target Vessel Revascularization
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: BRCA 2,3-5
timeFrame: 12 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
Study officials:
affiliation: Fuwai central China cardiovascular hospotial
name: Muwei Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640322: Craniocervical Dysfunction Index in Turkish Patients With Non-specific Neck Pain
Official title: Turkish Validity and Reliability of the Craniocervical Dysfunction Index in Patients With Non-specific Neck Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neck Pain
Craniocervical Disfunction
Keywords: Neck Pain
Craniocervical Disfunction
Reliability
Validity
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aproximately 5o patients with non-specific neck pain between the ages of 20-60 years

Brief summary: The aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with non-specific neck pain, reliability and validity of the index Turkish speaking adults.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-60 years
* Clinical diagnosis of non-specific neck pain
* Being able to communicate in Turkish
* Volunteering to participate in the study

Exclusion Criteria:

* Over 60 years of age
* Those with impairments in cervical mobility that affected the postural assessment

Primary outcomes:
measure: Craniocervical Dysfunction Index
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaadin Keykubat University
Study officials:
References:
Clinical trial NCT02759822: Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias
Official title: Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Keywords: Haploidentical Hematopoietic Stem Cell Transplantation
Partially Matched Hematopoietic Stem Cell Transplantation
Post-transplant Cyclophosphamide
Hematopoietic Stem Cell Transplantation
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2016-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute leukemias referred for stem cell transplantation without HLA-matched related or unrelated donor

Brief summary: This is a prospective observational cohort study of haploidentical transplantation with post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic leukemia (ALL).

Detailed description: Hematopoietic stem cell transplantation (HSCT) is the most effective treatment for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), with the lowest rates of relapse.

Fertility rate in Brazil is falling, and only 25% of people born today will have a matched sibling donor. On the other hand, currently donor non-related to about 50% of patients enrolled in Brazilian Receptor Registry (REREME). Consequently, at least 35% of patients won't have a matched donor.

The haploidentical transplantation is defined as a partially matched hematopoietic cell transplantation, using a partially matched family donor (parent, sibling or child). Haploidentical transplantation activity is growing worldwide, with results comparable matched unrelated donors.

The objective of this study is to test the feasibility of haploidentical transplantation with post transplant cyclophosphamide for acute leukemias in a Brazil.

Eligibility criteria: Inclusion Criteria:

* Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion Criteria:

* Severe comorbidities
* Second transplant

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
Secondary outcomes:
measure: Cumulative incidence of leukemia relapse
timeFrame: 5 years
measure: Transplant Related Mortality
timeFrame: 6 months
measure: Cumulative Incidence of acute Graft Versus Host Disease
timeFrame: 5 years
measure: Cumulative Incidence of chronic Graft Versus Host Disease
timeFrame: 5 years
measure: Cumulative Incidence of Infectious Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
Study officials:
affiliation: Instituto Nacional de Cancer
name: Leonardo J Arcuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02086422: Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-03-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Patients with CHF benefit from heart rate lowering, and the investigators have previously demonstrated that this does not adversely affect exercise tolerance. In a pacemaker population we also have shown that preventing heart rate lowering is detrimental in terms of symptoms and prognosis.

The aim of the study is to therefore to establish whether heart rate limitation in patients with heart failure has a negative impact on exercise capacity. If the investigators establish that this is not the case, physicians will be able to confidently prescribe heart rate lowering agents, and programme pacemakers to allow bradycardia without the concern that there will be detrimental effects of symptom.


Eligibility criteria: Inclusion Criteria:

* Able to walk on a treadmill Able to provide consent Heart failure (or not) depending upon the arm. Patients with atrial fibrillation to have had an AV node ablation (or very slow response to AF)

Exclusion Criteria:

* Cognitive impairment, known reaction to ivabradine, musculoskeletal issues limiting walking on a treadmill.

Primary outcomes:
measure: Examining the effects of iatrogenic CI on exercise capacity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT05151822: Virtual Reality in Awake Surgery : Pilot Study VIRAS
Official title: Virtual Reality in Awake Surgery : Pilot Study VIRAS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Keywords: Awake surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The virtual reality mask is a tool likely to improve the conditions for performing awake surgery:

* by improving tolerance for the patient,
* by improving ergonomics in the operating room.

In order to control the risks as well as possible, the investigators propose to test the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest: the patients operated in orthopedics under local anesthesia are immobile during the procedure. This target population will allow an immersion of the equipment in the operating room, with an awake patient, during a short time (on average 1 hour of intervention) and for a technically light interventional procedure.


Eligibility criteria: Inclusion Criteria :

* Major subject
* Consent for the study
* Patients eligible for orthopedic surgery with local anesthetic block
* Estimated duration of the Orthopedic surgery of minimum 1 hour

Exclusion Criteria :

* Age \< 18 years, Age \> 75 years,
* Known central neurological pathology/cognitive impairment,
* Mini-Mental State examination (MMSe) \< 23 if no school certificate, \< 27 if school certificate,
* History of vertigo,
* Claustrophobia,
* Visual deficit not compatible with the use of the virtual reality mask,
* Contraindication to surgery,
* Outpatient treatment,
* Refusal or inability to consent.

Primary outcomes:
measure: Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)
timeFrame: 1 Day
Secondary outcomes:
measure: Device-related adverse event
timeFrame: 1 Day
measure: Withdrawal of the device
timeFrame: 1 Day
measure: Device tolerance for the patient
timeFrame: 1 Day
measure: Device tolerance for the medical staff
timeFrame: 1 Day
measure: Patient state of anxiety
timeFrame: 1 Day
Other outcomes:
Locations:
city: Brest
country: France
facility: Pr SEIZEUR Romuald
Study officials:
References:
Clinical trial NCT04130022: Premedication Gastric Ultrasound
Official title: Ultrasound Assessment of Gastric Volume After Drinking Premedication: A Prospective Descriptive Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

* Patients who are not adhere to institutional fasting guidelines.

Primary outcomes:
measure: Change of Qualitative and Quantitative Gastric Assessment After Premedication
timeFrame: Ultrasound scan performed at baseline (before surgery) to measure gastric volume and 3 minutes after taking premedication to assess change.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00883922: Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery
Official title: Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Defects
Cardiac Surgery
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 70
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac surgery

Brief summary: Children (ages 0-12) that have heart surgery are often at a high risk of developing complications and have to be continuously monitored. Part of the routine care at UCLA includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive care unit. However, there is not much data on the use and effectiveness of this monitor in comparison to other monitors used for children.

The purpose of this study is to further evaluate the effectiveness of the continuous central venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors during a heart surgery. This is an observational study and the patients will not undergo any research specific procedures in the operating room (OR). The investigators will observe and record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to evaluate the importance of the monitor. This study will also look at the demographics (age, gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart surgery to improve quality of care. The investigators will also observe the same parameters in the ICU. The investigators hypothesized that low central venous saturations are associated with worse clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (age 0-12 years) scheduled for cardiac surgery and requiring placement of a central venous catheter.

Exclusion Criteria:

* Patients with contraindications for placement of a central venous catheter will be excluded from this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
Clinical trial NCT01843322: Endoleak Repair Guided by Navigation Technology
Official title: Endoleak Repair Guided by Navigation Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Endoleak
Keywords: Image guided therapy
Endovascular procedures
Angiography
Vascular surgical procedures
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: SINTEF Health Research
name: St. Olavs Hospital
First posted: 2013-04-30
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation technology instead of computed tomography (CT) guidance of the needle puncture? Parameters logged during the procedure:

* was the needle placement successful?
* number of needle punctures?
* time used on guidance procedure
* X-ray exposure dose


Eligibility criteria: Inclusion Criteria:

* detected endoleak

Exclusion Criteria:

* n/a

Primary outcomes:
measure: detected leakage
timeFrame: within 1 hour after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Petter Aadahl, MD Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00145522: Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
Official title: A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Keywords: Menopause, IGF-1, HRT
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 135
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
* non hysterectomized women, complaining of at least 14 hot flushes per week

Exclusion Criteria:

* Known, suspected or history of breast cancer or hormone-dependent neoplasia,
* undiagnosed genital bleeding,
* venous or arterial history or presence of thromboembolism,
* cerebrovascular disease

Primary outcomes:
measure: IGF1 values after 12 cycles of 28 days
timeFrame: 1 year
Secondary outcomes:
measure: after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern
timeFrame: 1 year
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Site 8
city: Cagliari
country: Italy
facility: Site 15
city: Catania
country: Italy
facility: Site 4
city: Firenze
country: Italy
facility: Site 9
city: Milano
country: Italy
facility: Site 10
city: Milano
country: Italy
facility: Site 11
city: Modena
country: Italy
facility: Sit 14
city: Roma
country: Italy
facility: Site 6
city: Torino
country: Italy
facility: Site 1
city: Torino
country: Italy
facility: Site 2
city: Udine
country: Italy
facility: Site 7
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: