louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00295087: X-Chromosome Inactivation Status and Premature Ovarian Failure
Official title: X-Chromosome Inactivation Status and Premature Ovarian Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Ovarian Failure
Keywords: Premature Ovarian Failure
X-Chromosome Inactivation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 13
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include women diagnosed with POF through clinics. Women diagnosed with POF may also inquire about this study through the Clinical Trials website.

Brief summary: Women who are affected with premature ovarian failure will exhibit skewed X-chromosome inactivation patterns compared to women with normal menstrual function (as defined by being pregnant), indicating a possible X-chromosome defect.

Detailed description: Premature ovarian failure (POF) affects approximately 1% of women. For most women a cause is not found, but structural abnormalities of the X-chromosome commonly lead to POF, suggesting genes on the X-chromosome are necessary for normal ovarian function. It is known that certain gene mutations on the X-chromosome can lead to changes in the normal random pattern of X-chromosome inactivation in females.

We propose to study X-inactivation patterns in a cohort of women with idiopathic POF, and compare their pattern to a mean age-matched cohort of women with normal menstrual function.

We hypothesize that some women with POF will show skewed X-inactivation, suggesting a mutation on the X-chromosome as the etiology of their POF.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with POF.
* A chromosomal analysis must have been performed to evaluate X-chromosomal abnormalities, and the results are known to be normal.

Exclusion Criteria:

* Patients who have a known etiology for their POF and/or an inability to obtain karyotype results for these patients or unknown X-chromosome abnormalities.

Primary outcomes:
measure: Skewed X-Inactivation appears increased in women with Premature Ovarian Failure
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh and Magee-Womens Hospital
name: W. Allen Hogge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01895387: Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes
Official title: Replacing With Whole Grains and Legumes Reduces Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activities in Plasma and Peripheral Blood Mononuclear Cells in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Fasting Glucose
Newly Diagnosed Type 2 Diabetes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 39
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.

Detailed description: Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

Eligibility criteria: Inclusion Criteria:

* Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL)
* or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)

Exclusion Criteria:

* current and/or past history of cardiovascular disease including angina
* liver or kidney dysfunction
* thyroid or pituitary disease
* unstable weight loss/gain (≥2 kg) over the previous 12 months
* pregnancy or lactation
* taking medications or supplements

Primary outcomes:
measure: Plasma Lp-PLA2 activity
timeFrame: Change from baseline in Lp-PLA2 at 12 weeks
Secondary outcomes:
measure: PBMC Lp-PLA2 activity
timeFrame: Change from baseline in PBMC Lp-PLA2 at 12 weeks
Other outcomes:
measure: LDL particle size
timeFrame: Change from baseline in LDL particle size at 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01056887: Copeptin in Differentiation of Polyuria and Polydipsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyuria
Polydipsia
Keywords: diabetes insipidus
primary polydipsia
copeptin
Utility of plasma copeptin in differential diagnosis of polyuria/ polydipsia while performing a traditional deprivation test
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Dr. Carson Liu Med Corp.
First posted: 2010-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with diabetes insipidus renalis Patients with primary polydipsia

Brief summary: The differential diagnosis of patients with polyuria/ polydipsia is often complex, but important for the therapeutic strategy.

Challenging is in particular the clinical differentiation between patients with a partial Diabetes insipidus centralis and patients with primary polydipsia as underlying disease, because both groups are associated with similar urinary osmolalities.

The determination of plasma arginine vasopressin is unusual in this context, since measurement of AVP is not reliably.

C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the neurohypophysis, but has a longer half life in the circulation, and is thus easier to measure.

Therefore, the investigators will analyze in that study the diagnostic utility of plasma copeptin in the differential diagnosis of polyuria and polydipsia.


Eligibility criteria: Inclusion Criteria:

* Patients with polydipsia/ polyuria, with indication for performing a deprivation test
* \> 18 years

Exclusion Criteria:

* dDAVP during the last 14d
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Univ Hospital Wuerzburg
state: Bavaria
Study officials:
References:
citation: Fenske W, Quinkler M, Lorenz D, Zopf K, Haagen U, Papassotiriou J, Pfeiffer AF, Fassnacht M, Stork S, Allolio B. Copeptin in the differential diagnosis of the polydipsia-polyuria syndrome--revisiting the direct and indirect water deprivation tests. J Clin Endocrinol Metab. 2011 May;96(5):1506-15. doi: 10.1210/jc.2010-2345. Epub 2011 Mar 2.
Clinical trial NCT03489187: Visualase Visualization Database (VIVID-1)
Official title: Visualase Visualization Database (VIVID-1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Tumor
Other
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2018-04-05
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have previously received treatment with VTTS when used as intended.

Brief summary: The purpose of the VIVID-1 data collection study is to establish a database of clinical images and associated technical files from commercial cases using the Visualase Thermal Therapy System (VTTS). All data collected will be de-identified. No safety or effectiveness assessments will be completed.


Eligibility criteria: Inclusion Criteria:

1. Patient correlating with the de-identified data set to be collected received standard of care treatment using the Visualase System prior to the date of site activation.

Exclusion Criteria:

1. Patient correlating with the de-identified data set to be collected is a minor (less than 18 years old, or as defined by local policy) that is not allowed to participate in this type of research project (eg, IRB approval with waiver of consent) per IRB policy
2. Patient correlating with the de-identified data set to be collected is enrolled in the Medtronic SLATE trial

Primary outcomes:
measure: Image assessment
timeFrame: During the Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Brunswick
country: United States
facility: Rutgers
state: New Jersey
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
city: Seattle
country: United States
facility: University of Washington Harborview
state: Washington
Study officials:
References:
Clinical trial NCT01618487: Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
Official title: Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lateral Epicondylitis
Tennis Elbow
Keywords: tennis elbow
lateral epicondylitis
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair.


Eligibility criteria: Inclusion Criteria:

* 18-65 yrs old
* pain over the lateral epicondyle (via palpitation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for a duration of greater than 6 months prior to enrollment
* conservative treatment has failed and surgical intervention is recommend as standard of care
* ability to give informed consent

Exclusion Criteria:

* had surgery by a physician or specialist within the last 2 years as treatment for lateral epicondylitis
* congenital deformities, tendon ruptures or elbow fractures within the past year
* co-existing elbow diagnosis (i.e. osteoarthritis or instability)
* pregnant women, women trying to get pregnant, or breastfeeding mothers
* under the age of 18 or over 65
* incapable of giving informed consent

Primary outcomes:
measure: symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine M. Kleinert Institute of Hand and Microsurgery
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute of Hand and Microsurgery
name: Tuna Ozyurekoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706887: Genetic Determinant of Blood Pressure Sensitivity to Salt Intake
Official title: Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Nedd4-2
blood pressure
polymorphism
salt intake
between 18 and 35 years old
BMI between 18 and 28 Kg per m2
no active disease
no alcool or drug abuse or smoke
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 219
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt retention by the kidney. The study address the consequence of a frequent genetic variation leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute a genetic predisposition to (or protection against) salt-sensitive hypertension.

Detailed description: Subjects were submitted one week to a low sodium-high potassium diet, and then switch to a high sodium,-low potassium diet for two weeks. the last week, subject were taken a 20 MG daily dose of amiloride, a potassium sparing diuretic.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* between 18 and 35 years odl
* BMI between 18 and 28 Kg per m2
* non smokers
* no active disease
* no alcool or drug abuse

Primary outcomes:
measure: Difference in Blood Pressure among genotypes
timeFrame: 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
Secondary outcomes:
measure: Ambulatory Blood Pressure (AMBP)
timeFrame: three weeks
Other outcomes:
Locations:
Study officials:
affiliation: genetic department
name: Xavier Jeunemaître, PD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554787: Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fatigue
Stroke
Keywords: After stroke with fatigue
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The high levels of fatigue in stroke patients without neurological impairment suggest it has a central origin rather than being the result of increased physical effort required after stroke（Winward et al., 2009）. Fatigue is different from post-stroke depression and the more serious stroke patients are more prone to fatigue（Windward et al., 2009）.

Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most effective of all traditional Chinese medicine and can tonifying middle and tonify the original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus membranaceus on post-stroke fatigue.


Eligibility criteria: Inclusion Criteria:

1. Gender: Male or female.
2. Age: between 40 and 80 years old.
3. Three months after stroke.
4. Hemorrhagic stroke or ischemic stroke.
5. Fatigue score from screen process ≧4.
6. Subject with comprehension or communication.
7. Volunteer signs the agreement to participate the study after whole study purpose and procedures description in detail.

Exclusion Criteria:

1. People from mental illness can not to participate the evaluation.
2. Major diseases such as cancer、Chronic pulmonary obstructive disease(COPD)、 Heart failure、Myocardial Infraction、Chronic renal failure or Liver cirrhosis.
3. Pregnant woman.
4. Breast-feeding woman.

Primary outcomes:
measure: EORTC QLQ-C30
timeFrame: 2 year(all patients)
measure: BFI-T score
timeFrame: 2 years(all patients)
Secondary outcomes:
measure: SF-36 score
timeFrame: 2 years(all patients)
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Chung Hsiang Liu, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807087: Comparison of Conventional Techniques & Piezosurgery in the Management of the Nasal Bony Pyramid
Official title: Prospective Randomized Study Between Conventional Techniques & Piezosurgery in the Management of Nasal Bony Pyramid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Injury
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is well-known and universally acknowledged that rhinoplasty is the most demanding procedure in facial aesthetic surgery. Postoperatively nasal osteotomies result in variable degrees of edema and ecchymosis and surgeons have tried various techniques, instruments, and postoperative methods to diminish these uncomfortable morbidities. Piezosurgery is used nowadays to decrease the incidence of injured soft tissues and vital structures passing near the osteotomy line. Its use in rhinoplasty was advocated to prevent unwanted back fractures as well as to decrease bleeding while keeping the nasal mucosa intact thus minimizing postoperative sequelae.


Eligibility criteria: Inclusion Criteria:

* Patients requesting aesthetic rhinoplasty, post-traumatic rhinoplasty, and post-cleft nose rhinoplasty.

Exclusion Criteria:

* Patients with severe systemic disease (American Society of Anesthesiologists physical status classification system III \& IV).
* Psychological disorders.
* Female patients younger than 16 years of age and male patients younger than 18 years of age.
* Patients with autoimmune and skin diseases.

Primary outcomes:
measure: Operative time
timeFrame: During procedure
measure: Visual analogue score
timeFrame: immediately after procedure
measure: Change in periorbital edema
timeFrame: Baseline and 1 week
measure: Change in eccyhmosis
timeFrame: Baseline and 1 week
Secondary outcomes:
measure: Functional - aesthetic outcome
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT05379387: Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study
Official title: Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Late Effect
Survivorship
Lifestyle
Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All AYA cancer patients, diagnosed at age 18-39 years and treated in one of the participating hospitals

Brief summary: Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk factors, developmental challenges and treatment regimens are different in AYAs compared to children. Therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically address unique AYA age-specific issues. Globally, so far, the identification of AYA patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed. The role of sociodemographic and treatment-associated risks, external exposures (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired (age-specific) health outcomes, remains largely unknown. Understanding who is at risk and why, will support the development of evidence-based AYA prevention, treatment and supportive care programs and guidelines.

Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (health-related quality of life and late effects) among a population-based sample of AYA cancer survivors. Study design: Retrospective, population-based, observational cohort study.

Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015, identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis Main study parameters/endpoints: Health-related quality of life; late effects


Eligibility criteria: Inclusion Criteria:

* Pathological confirmed cancer diagnosis;
* Age 18 - 39 years at time of first cancer diagnosis;
* Provide written informed consent.
* Treated in an Academic hospital or Netherlands Cancer Institute

Primary outcomes:
measure: Health related quality of life
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekziekenhuis
Study officials:
affiliation: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AvL)
name: Winette van der Graaf, Prof
role: STUDY_DIRECTOR
References: