louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02389296: The Forensic Psychiatric Nurse - Warden or Empathic Caregiver
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Nursing
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-17
Enrollment: 212
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatric nurses working in either general hospitals or in mental health centers in 10 medical centers in Israel.

Brief summary: The aim of this study is to determine whether the work environment influences the role perception of nurses in psychiatric wards. This will be a comparative study. Questionnaires will be distributed to nurses working in psychiatric wards in 10 medical centers in Israel.


Eligibility criteria: Inclusion Criteria:

* RN Accredited Nurses
* Hebrew Speaking

Exclusion Criteria:

* Incomplete questionnaire

Primary outcomes:
measure: Empathetic Caregiver
timeFrame: One year
measure: Warden
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03725696: The Effect of Bariatric Surgery on Spermatogenesis
Official title: The Effect of Bariatric Surgery on Spermatogenesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bariatric Surgery Candidate
Sexual Function and Fertility Disorders
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men between the ages of 18 and 50 scheduled for bariatric surgery who meet the above enrollment criteria will be offered enrollment in the study at the time of their preoperative clinic visit.

Brief summary: Little is known about the effects of weight loss surgery on male reproductive health. This study will investigate the effect of bariatric surgery on male infertility by evaluating sexual health, blood hormone levels, and semen parameters before and after roux-en-y bariatric surgery.

Detailed description: Obesity is a worldwide epidemic that has numerous health consequences including male infertility. Prior studies have shown a variety of health benefits with bariatric surgery, including an improvement/resolution in diabetes and a significant improvement in serum testosterone levels. Based upon preliminary data from the literature, the investigators hypothesize that bariatric surgery is associated with a transient decrease followed by a robust long-term improvement in semen parameters including DNA fragmentation and oxidative stress. To test this hypothesis, the investigators propose a prospective observational study examining changes in hormone and semen parameters over the 12 months following Roux-en-Y gastric bypass surgery. The investigators will correlate these changes to weight loss, changes in subjective sexual function, and advanced semen parameters including DNA fragmentation. If successful, this study will conclusively identify a new modifiable cause for male infertility and suggest an additional medical indication for bariatric surgery in obese infertile men.

Eligibility criteria: Inclusion Criteria:

* Men aged 18-55
* Undergoing Roux-en-Y bariatric surgery

Exclusion Criteria:

* History of undescended testes
* Prior scrotal surgery
* Known karyotypic abnormalities

Primary outcomes:
measure: Changes in sperm concentration
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Weight loss
timeFrame: Baseline to 12 months
measure: Changes in sexual health
timeFrame: Baseline to 12 months
measure: Changes in reproductive hormones
timeFrame: Baseline to 12 months
measure: Changes in seminal oxidative stress
timeFrame: Baseline to 12 months
measure: Changes in sperm morphology
timeFrame: Baseline to 12 months
measure: Changes in seminal DNA fragmentation
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Scott Lundy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01656096: Renal Sympathetic Denervation in Mild Refractory Hypertension
Official title: Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Refractory Hypertension
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension


Eligibility criteria: Inclusion Criteria:

* Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization
* Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values)
* No change in blood pressure medication within 6 months after randomization
* Age 18 to 75 years
* Informed consent

Exclusion Criteria:

* Blood pressure outside range mentioned above
* Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
* Estimated glomerular filtration rate \<45 mL/min/1.73 m² (modification of diet in renal disease formula)
* Unstable angina pectoris
* Myocardial infarction within 6 months prior to randomization
* Planned surgery or cardiovascular intervention within 6 months after randomization
* Severe heart valve disease
* Severe comorbidities with limited life expectancy
* Pregnancy
* Participation in another trial

Primary outcomes:
measure: Change in systolic blood pressure (ABPM mean value)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Steffen Desch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desch S, Okon T, Heinemann D, Kulle K, Rohnert K, Sonnabend M, Petzold M, Muller U, Schuler G, Eitel I, Thiele H, Lurz P. Randomized sham-controlled trial of renal sympathetic denervation in mild resistant hypertension. Hypertension. 2015 Jun;65(6):1202-8. doi: 10.1161/HYPERTENSIONAHA.115.05283. Epub 2015 Mar 30.
Clinical trial NCT00274196: Ultrasound as a Diagnostic Tool for Occult Hip Fractures
Official title: A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Occult Fractures
Keywords: fractures, occult
hip
ultrasound examination
MRI
sensitivity
specificity
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.

Detailed description: Introduction: Most hip fractures are diagnosed by history, physical examination and confirmed by plain radiographs. When initial X-rays are negative or equivocal, and there is a clinical suspicion of occult hip fracture, additional diagnostic tests are necessary such as MRI which is expensive and in many hospitals less available, or bone scan which needs to be delayed 48-72 hours from injury to be indicative. Ultrasound examination has been shown to be an accurate measurement to diagnose occult fractures in the ankle and is a relatively easy, available, non-expansive examination. We propose the use of bedside ultrasound examination of the hip as a screening tool for occult hip fractures.

Objective: To measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing or ruling out occult hip fractures.

Materials and methods: We will include all patients 40 years and older with a painful hip after an injury, and with "normal" hip X-rays. Each patient will undergo two hip ultrasounds by two different examiners. Afterwards, the patients will undergo MRI of the hip. The MRI will serve as the gold standard for treatment decisions. The results of the ultrasound will be compared to the MRI to evaluate its sensitivity and specificity.

Eligibility criteria: Inclusion Criteria:

* Patients aged 40 years or older, with suspected hip fracture but normal plain X-rays

Exclusion Criteria:

* Patients younger than 40 years and with contra-indications for MRI scan

Primary outcomes:
measure: Comparison between ultrasound exam and MRI (sensitivity and specificity)
timeFrame: 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ori Safran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Charles Milgrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lubovsky O, Liebergall M, Mattan Y, Weil Y, Mosheiff R. Early diagnosis of occult hip fractures MRI versus CT scan. Injury. 2005 Jun;36(6):788-92. doi: 10.1016/j.injury.2005.01.024. Epub 2005 Apr 7.
Clinical trial NCT00484796: Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery
Official title: Comparison of Trigeminus-evoked Somatosensory Potentials (TRI-SEP) and Medianus-evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Surgery
Keywords: Carotid Surgery
Cerebral Ischemia
Cognitive Deficits
Somatosensory-evoked Potentials
Neuromonitoring
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 120
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: Patients undergoing carotid surgery

Brief summary: Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients undergoing elective carotid surgery.

Detailed description: For CNS-monitoring somatosensory-evoked responses ba electrical stimulation of the contralateral median nerve are established: A reduction of amplitude and a delay in latency may represent a sensible marker of imminent cerebral ischemia. This study will evaluate a new concept by using trigeminal nerve evoked somatosensory evoked potentials in comparison to the established MED-SEP. Beside the comparison of two methods of neuromonitoring, this study will investigate the neurological long-term outcome (90-day evaluation) with different neuropsychological tests for the detection of cognitive deficits.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Agreement with study procedure
* Elective carotid surgery

Exclusion Criteria:

* Inability to take somatosensory potentials
* Inability to respond to neuropsychological tests
* Severe preoperative neurological deficit

Primary outcomes:
measure: detection of episodes of cerebral ischemia during carotid surgery
timeFrame: intraoperative, 28 days, and 60 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy
state: Sachsen
Study officials:
affiliation: Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy
name: Armin R Sablotzki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00228696: National Wilm's Tumor Study Late Effects
Official title: National Wilm's Tumor Study Late Effects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wilm's Tumor
Keywords: late effects
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.

Detailed description: The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Although most people in this study enjoy good health, some may be at risk for certain health conditions. We are collecting information from as many participants as possible in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, we plan to work with geneticists to try to estimate heritability and recurrence risks.

Eligibility criteria: Inclusion Criteria:

Previously enrolled in NWTS 5.

Primary outcomes:
measure: To determine if survivors from Wilms tumors or their offspring are at risk for adverse medical conditions.
timeFrame: 1 year after closure of study
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Howard Katzenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05597696: Sitting Balance in Lower Limb Amputees
Official title: Evaluation of Sitting Balance in Lower Limb Amputees: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Traumatic Amputation of Lower Extremity
Keywords: Limits of stability
Sitting balance
Standing balance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.

Brief summary: The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

Detailed description: Postural stability is important for amputees to perform daily life activities and participate in social activities. The aim of this study is to compare the sitting and standing stability of transfemoral individuals with healthy individuals with similar demographic characteristics. A force platform was used to measure the postural stability of individuals. The sitting limits of stability of the participants were recorded in cm. Amputees between the ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with similar demographic characteristics were included in the study. Congenital amputees, individuals with bilateral lower extremity amputations, and individuals with central or peripheral vestibular disorders were excluded. Our study will reveal the importance of sitting stability limits in the evaluation and treatment of amputees.

Eligibility criteria: Inclusion Criteria for amputee:

* Unilateral transfemoral amputation
* Using their prosthesis for at least 6 months

Exclusion Criteria:

* congenital amputee
* Bilateral lower extremity amputation
* Central or peripheral vestibular disorders

Primary outcomes:
measure: Limits of stability
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation
state: Samanpazarı
Study officials:
References:
Clinical trial NCT06230796: Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke
Official title: Effects of FES-cycling in Patients With Hemiparesis After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Keywords: cycling
exercises
functional electrical stimulation
Lead sponsor: UGECAM Rhône-Alpes
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.
Primary purpose: PREVENTION

Brief summary: To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

Detailed description: Design: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.

Setting: Neurologic Rehabilitation Unit Interventions: 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).

In addition to the assigned group treatment, subjects will perform their own standard rehabilitation program.

Participants will be evaluated before training, after training, and at 3 month follow-up visit

Eligibility criteria: Inclusion Criteria:

* Adults with Hemiparesis after an unilateral first ever stroke
* Able to walk in security
* Time since stroke within 3 months to 1 year
* Sufficient cognitive function to understand and perform corresponding tasks

Exclusion Criteria:

* Any history of neurological disorders or cardiovascular instability
* High spasticity on ankle, knee, hip muscles
* Inability to exercise on a cyclo-ergometer
* Pacemaker and other contraindications of the use of electrical stimulation

Primary outcomes:
measure: VO2 peak at 2 months (L/min)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Maximum power
timeFrame: 2 months
measure: Walking ability
timeFrame: 4 months
measure: quadriceps muscular thickness
timeFrame: 2 months
measure: Middle Cerebral Artery Blood Flow Velocity During Exercise
timeFrame: 2 months
measure: Cognitive function
timeFrame: 2 months
Other outcomes:
Locations:
city: Saint didier au mont d'or
country: France
facility: SMR Val Rosay
Study officials:
References:
Clinical trial NCT06324396: IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Official title: IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Fontan Circulation
Keywords: Fontan
FALD
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Indiana Clinical and Translational Sciences Institute
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-03-22
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single center, open-label, prospective, investigation to quantify the effects of liver congestion and fibrosis has on hepatic statin transport (SA1) and response (SA2) in children, adolescents, and young adults with Fontan circulation.
Primary purpose: TREATMENT

Brief summary: This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.


Eligibility criteria: Inclusion Criteria:

* \> 8 years
* Status Post Fontan Completion
* Ability to provide informed permission-assent (\<18 years) or consent (≥18 years)
* Fasting overnight (\~8 hours)

Exclusion Criteria:

* Pregnancy
* Non-fasting
* Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
* Sildenafil and/or Pravastatin therapy within last 2 months
* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
* Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
* Inability to swallow a tablet
* \>5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
* Diarrhea in the last 24 hours \*History of solid organ transplantation

Primary outcomes:
measure: Sildenafil concentration as measured by area under the curve (AUC)
timeFrame: 2 years
measure: Pravastatin concentration as measured by area under the curve (AUC)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy
name: Jonathan Wagner, DO
role: PRINCIPAL_INVESTIGATOR
References: