louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05814419: Familial Hyperlipidemia Family Registry
Official title: Familial Hyperlipidemia Family Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Familial Hyperlipidemia
Keywords: Cholesterol
School based
Biometric Screening
Genetic
Healthy Hearts
Children
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 11
Sex: ALL
Minimum age (years): 6
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: As above

Brief summary: The aim of the study is to identify children and families that are at risk for cardiovascular disease because of a condition known as familial hyperlipidemia. This condition may increase the risk of cardiac events such as hardening of the arteries anywhere in the body which can result in heart attacks, strokes, and death over ten fold.

Children have already been assessed in the Healthy Hearts screening program and identified as having elevated cholesterol. A buccal smear will identify whether the familial hyperlipidemia condition exist in your child.

If the child's test shows that they have the specific gene for familial hyperlipidemia and shows a genetic tendency towards premature heart disease, we would encourage genetic testing for as many blood family members as possible.

The study plan is to determine whether the Healthy Hearts screening program is a more effective way of identifying students at risk since it is estimated that less than 10% of those individuals with the problem have been identified. If it is effective, then it will be incorporated as part of the standard screening process in the Healthy Hearts program.

Aim 1: Is a school screening program a more effective method to identifying those at risk for familial hyperlipidemia? Aim 2: What percent of children with elevated cholesterol ≥ 200 mg/dl have familial hyperlipidemia?


Eligibility criteria: Inclusion Criteria:

\* Primary family member of child from school screening program with documented FH variant

Exclusion Criteria:

* none

Primary outcomes:
measure: FH Determination for Family members of School children with elevated Cholesterol and docmented FH variant
timeFrame: Evaluation of family members over a defined 5 year period
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
References:
Clinical trial NCT02858219: A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vestibulodynia
Keywords: Botulinum toxin
Pain improvement
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 60
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: The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.


Eligibility criteria: Inclusion Criteria:

* Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
* Negative screening test results
* Notified associated factors
* Menopause, surgically sterilized women or women using effective contraceptive method
* Good understanding and predictable adherence to the protocol
* beneficiary/affiliated to French social security/social healthcare
* signed Informed Consent Form

Exclusion Criteria:

* Predictable poor adherence
* Pregnant or breastfeeding women
* Myasthenia
* Treatment with aminoglycosides
* Major mental disorders
* Underlying etiology
* Vulnerable subjects (particularly adults under guardianship)
* Any reason deemed relevant by the investigator
* Current or former (in the last 3 months) participation to another clinical trial

Primary outcomes:
measure: Pain improvement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Paris
country: France
facility: Hôpital Tenon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Fabien Pelletier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298619: Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission
Official title: Impact on Survival of Early Detection of Recurrence in the Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Lymphoma
High Risk
Relapse
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Standard cohort: patients followed-up at the Santa Maria Loreto Mare Hospital Imaging cohort: patients followed-up at the University of Naples Federico II

Brief summary: Cohort study enrolled high-risk Hodgkin Lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (Imaging cohort) or with standard clinical-based surveillance (standard cohort).


Eligibility criteria: Inclusion Criteria:

* High risk Hodgkin Lymphoma
* achievement of complete response to first line therapy

Exclusion Criteria:

* comorbidities that could impair participation in follow-up procedures

Primary outcomes:
measure: Event Free Survival (EFS)
timeFrame: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years
Secondary outcomes:
measure: EFS for clinically silent relapses
timeFrame: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years
measure: Response rate
timeFrame: After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00893919: Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prophylaxis of Organ Rejection
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: baseline, 2-period, 14 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: William Allen Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02229019: The Southampton Mealtime Assistance Roll-out Trial
Official title: The Southampton Mealtime Assistance Roll-out Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volunteer Mealtime Assistants
Keywords: Volunteers
Mealtime assistance
Older adults
Nutrition
Nursing
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Medical Research Council
First posted: 2014-08-29
Enrollment: 258
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Southampton Mealtime Assistance Study aims to determine whether it is feasible and acceptable to introduce trained volunteers as mealtime assistants in five different departments of one large hospital.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 70 years admitted to one of the wards under study

Exclusion Criteria:

* Patients with active bowel pathology
* Patients in the terminal phase of their life
* Patients who are artificially fed (parenterally or enterally)

Primary outcomes:
measure: Feasibility and acceptability of volunteer mealtime assistants in different hospital departments
timeFrame: 16 months
Secondary outcomes:
measure: Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants
timeFrame: 16 months
measure: Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme
timeFrame: 16 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Fiona Rossiter, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howson FFA, Robinson SM, Lin SX, Orlando R, Cooper C, Sayer AAP, Roberts HC. Can trained volunteers improve the mealtime care of older hospital patients? An implementation study in one English hospital. BMJ Open. 2018 Aug 5;8(8):e022285. doi: 10.1136/bmjopen-2018-022285.
Clinical trial NCT02022319: The Observer Variation of Shear Wave Elastography
Official title: Intra- and Inter-observer Variation of Thyroid Shear Wave Elastography - a Variability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodular Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant from the large background of benign lesion. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary. Therefore there is a need to develope the available diagnostic tools for the pre-operative diagnostic work-up of thyroid nodules.

The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules.

Hypothesis:

1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and intra-observer reliability and day-to-day variation.

The study will be conducted as part of a larger PhD study, and an evaluation of the diagnostic value of thyroid SWE will be evaluated in a larger study.

Perspectives:

An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.


Eligibility criteria: Inclusion Criteria:

* patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter),
* Patients undergoing thyroid surgery.

Exclusion Criteria:

* Nodules located in the isthmus of the thyroid

Primary outcomes:
measure: Elasticity index
timeFrame: Repeat measures obtained on the same day (ten minutes to one hour between measurements), and measures obtained on a different day (one day to several weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Øre-Næse-Halsafdeling H, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT06779019: a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction
Official title: Breast Enhanced Strategies and Techniques(BEST) (Focus on Chinese Breast Reconstruction) Trial PART 1: Evaluation of Predictive Methods of Reconstruction Outcomes--Flap Perfusion Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Flap Necrosis
Keywords: LSCI
ICG
breast reconstruction
implant-based breast reconstruction
flap necrosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: China Medical Board (CMB)
First posted: 2025-01-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients who received mastectomy and immediate direct-to-implant reconstruction

Brief summary: This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.

Detailed description: This study prospectively evaluates and compares the effectiveness of Indocyanine Green (ICG) fluorescence imaging and Laser Speckle Contrast Imaging (LSCI) in predicting the risk of necrosis following direct-to-implant breast reconstruction. The investigation includes both intraoperative and postoperative assessments of flap perfusion, with a focus on identifying specific thresholds for necrosis prediction. By analyzing the sensitivity, specificity, and predictive accuracy of each technique, the study aims to establish their respective strengths and limitations. Additionally, the research aims to explore the feasibility of using these methods in different surgical stages, evaluating their consistency and reliability in monitoring the viability of the skin flap and nipple-areolar complex.

Eligibility criteria: Inclusion Criteria:

All patients presenting for implant-base reconstruction immediately after mastectomy

Exclusion Criteria:

delayed reconstruction, expander removal followed by prothesis implant, ICG allergy or intolerance, autologous reconstruction

Primary outcomes:
measure: necrosis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pumch
state: Beijing
Study officials:
References:
Clinical trial NCT01898819: The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
Keywords: DEXMEDETOMIDINE
intraocular pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 70
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy

Exclusion Criteria:

1. eye surgery prevoiusly
2. unstable angina or congestive heart failure
3. concomittant eye disease (glaucoma, diabetic retinophaty, cataract, retinal detachment)
4. high intraocular pressure over 30mmHg after screening test.
5. uncontrolled hypertension (diastolic bp\>110mmHg)
6. bradycardia under 60bpm
7. Ventricular conduction abnormality
8. hepatic failure
9. renal failure
10. drug hyperactivity
11. neurological or psychiatric illnesses
12. mental retardation
13. patients who can't read the consent form due to illiterate or foreigner

Primary outcomes:
measure: Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy.
timeFrame: change of intraocular pressure from T0 to T11 for 60mins
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00955019: Novel Method of Surveillance in Barrett's Esophagus
Official title: Novel Method of Surveillance in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Keywords: Barrett's
Esophagus
Reflux
dysplasia
adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-08-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with barretts esophagus

Brief summary: This study is being done to see how biomarkers (abnormalities in molecules of cells ) present in their Barrett's esophagus agree with results from surveillance biopsies; and to compare three different brush devices used to collect cells to see which of these 3 brush devices obtains a higher number of cells.

Detailed description: During an endoscopy done for clinical surveillance of your Barrett's Esophagus participants are randomized to one of three brush devices by random chance like a flip of a coin. This is being done to see if one collects more cells than the others. A soft brush will be used to collect cells from the lining of the esophagus, this is known as brush cytology. With the endoscope positioned in your esophagus, samples (biopsies) of lining of the esophagus will then be taken to determine the nature of the Barrett's mucosa in the same manner as for any patient undergoing routine surveillance endoscopy for Barrett's esophagus. A part of the specimen will be used to store tissue samples that can later be used.

Eligibility criteria: Inclusion Criteria:

* Patient age greater than 18 years of age
* Prior histological demonstration of Barretts Esophagus that is endoscopically visible with no dysplasia
* Low grade, high grade dysplasia or early esophageal cancer

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT06100419: SPSIP Block in Breast Surgeries for Postoperative Analgesia
Official title: Is Serratus Posterior Superior Intercostal Plane Block Effective in Modified Radical Mastectomy Surgeries?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmastectomy Pain
Keywords: serratus posterior superior intercostal plane block
regional anaesthesia
postmastectomy pain
interfascial plane blocks
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 7
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case series
Primary purpose: PREVENTION

Brief summary: The aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. The primary research question it seeks to address is as follows: • Can SPSIPB be applied to reduce pain following breast surgeries? Participants are expected to provide accurate responses to the researcher's questions for the assessment of postoperative pain.

Detailed description: Postoperative analgesia techniques for breast surgeries encompass options such as Paravertebral Block, Erector Spinae Plane Block, Serratus Anterior Plane Block, and Pectoral Nerve Blocks. Although the Paravertebral Block is considered the gold standard for postmastectomy pain relief, its limited usage is primarily attributed to complications. SPSIPB's potential in thoracic surgeries has been noted, offering a broad sensory block suitable for MRM and axillary lymph node dissection. In this study, the effectiveness of SPSIP block for post-mastectomy pain has been investigated.

Eligibility criteria: Inclusion Criteria:

* Female patients who will undergo breast surgery

Exclusion Criteria:

* unstable patients
* patients with bleeding disorders
* Patients allergic to local anesthetic drugs
* Patients who did not agree to participate in the study
* Patients with infection at the application site

Primary outcomes:
measure: numeric rate scores (NRS)
timeFrame: first 24 hours
Secondary outcomes:
measure: total tramadol consumption
timeFrame: first 24 hours
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
References: