louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02136667: Preeclampsia and Circulating Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum CVD Risk in Women With Previous Preeclampsia.
Keywords: Preeclampsia
Cardiovascular disease (CVD) risk
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
name: Karen Elise Jensen Foundation
name: Central Denmark Region
First posted: 2014-05-13
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from a well-characterised cohort, previously assembled at the Department of Obstetrics at Randers Regional Hospital in 2001-2005.

Brief summary: In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year follow-up study comparing 32 exposed (women with a history of pregnancy complicated by preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).

Participants will be recruited from a well-characterised cohort, previously assembled during their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in 2001-2004.

Blood and urine samples, collected during their pregnancies, are stored in a biobank, thus rendering the possibility of longitudinal assessment.


Eligibility criteria: Inclusion Criteria:

* Participation in previous study 2001-2005.

Exclusion Criteria:

* Current pregnancy or breastfeeding

Primary outcomes:
measure: Circulating biomarkers of cardiovascular disease 10 years postpartum.
timeFrame: 10 years postpartum
Secondary outcomes:
measure: Markers of arteriosclerosis and atherosclerosis
timeFrame: 10 years postpartum
measure: Circulating biomarkers of cardiovascular disease at baseline pregnancy.
timeFrame: During pregnancy
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Randers NØ
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Aarhus University Hospital
name: Ulla B Knudsen, Professor
role: STUDY_CHAIR
affiliation: Clinical Research Unit, Randers Regional Hospital
name: Martin Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, Aarhus University Hospital
name: Camilla S Kronborg, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00204867: Virtual Colonoscopy (VC) for Primary Colorectal Screening
Official title: CT Virtual Colonoscopy for Primary Colorectal Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyps
Keywords: colorectal
polyps
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Naval Medical Center
First posted: 2005-09-20
Enrollment: 272
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Screening population for colorectal cancer

Brief summary: This study involves a primary VC screening for colorectal polyps. The research hypothesis is that VC screening, including surveillance of sub-cm polyps, is a safe and effective approach.

Detailed description: The purpose of this study is to use virtual colonoscopy screening to learn more about what happens to small colon polyps (less than 10 mm) over time. From this, we can find out whether it's safer to remove all colon polyps right away or leave the small ones in place and remove only those that grow to 10 mm or more.

Eligibility criteria: Inclusion Criteria:

* Medium-sized colorectal polyps (6-9 mm)

Exclusion Criteria:

* No medium-sized colorectal polyps (6-9 mm)

Primary outcomes:
measure: The growth rate (natural history) of small colorectal polyps
timeFrame: The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Perry J. Pickhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickhardt PJ, Kim DH, Pooler BD, Hinshaw JL, Barlow D, Jensen D, Reichelderfer M, Cash BD. Assessment of volumetric growth rates of small colorectal polyps with CT colonography: a longitudinal study of natural history. Lancet Oncol. 2013 Jul;14(8):711-20. doi: 10.1016/S1470-2045(13)70216-X. Epub 2013 Jun 7.
Clinical trial NCT00134667: Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)
Official title: A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Keywords: AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
Photodynamic Therapy
PDT
Visudyne
pegaptanib sodium
verteporfin
Predominantly Classic
Age-Related Macular Degeneration (AMD)
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-08-25
Enrollment: 360
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.


Eligibility criteria: Inclusion Criteria:

* Subjects of either gender; aged 50 years or greater.
* Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition
* Best corrected visual acuity in the study eye between 20/40 and 20/200

Exclusion Criteria:

* Any prior PDT with Visudyne to the study eye
* Any previous AMD thermal laser therapy to the study eye

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Centers, P.C., Northwest Location
state: Arizona
Study officials:
References:
Clinical trial NCT00527267: Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects
Official title: A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperparathyroidism
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.


Eligibility criteria: Inclusion Criteria:

* Men and Women greater than or equal to 18 years of age
* Using effective contraceptive measures
* Mean iPTH during screening of greater than or equal to 300 pg/mL
* Mean calcium during screening of greater than or equal to 8.4 mg/dL
* Stable on hemodialysis

Exclusion Criteria:

* Unstable medical conditions
* Parathyroidectomy within 3 months
* Change in Vitamin D therapy
* Receiving antidepressants
* Experienced an MI within 3 months
* Inability to swallow tablets
* Previously received AMG 073

Primary outcomes:
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.
timeFrame: Efficacy Assessment Phase - last 14 weeks of study
Secondary outcomes:
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase
timeFrame: Efficacy Assessment Phase - last 14 weeks of study
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase
timeFrame: Efficacy Assessment Phase - last 14 weeks of study
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase
timeFrame: Efficacy Assessment Phase - last 14 weeks of study
measure: To evaluate the safety of AMG 073 compared with placebo.
timeFrame: Entire study - 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05901467: Recall by Genotype: Neuropeptide Stimulation
Official title: Recall by Genotype: Neuropeptide Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Reproductive Disorder
Keywords: reproductive disorders
kisspeptin
infertility
GnRH
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.

Detailed description: Assignment: All study subjects will undergo the same interventions. Individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility).

Delivery of Interventions:

* Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
* On the day of the study, the subjects will have an intravenous (IV) line placed and

  * Undergo up to q10 min blood sampling x 12 hours
  * Receive a single kisspeptin IV bolus at hour 8
  * Receive a single GnRH IV bolus at hour 11

Eligibility criteria: Inclusion Criteria:

* No prescription medications that could interfere with hypothalamic reproductive function
* No illicit drug use
* No excessive alcohol consumption (more than 10 drinks/week)
* No history of an allergic medication reaction requiring emergency medical care
* Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg)
* White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range
* Normal hemoglobin
* Blood urea nitrogen (BUN), creatinine not elevated
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal
* Enrolled in the Partners HealthCare Biobank and genotypically characterized
* For women

  * No oral contraceptives for at least 1 month
  * No contraceptive implants for at least 3 months
  * Not breastfeeding and not pregnant
  * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)

Primary outcomes:
measure: Endogenous LH pulse amplitude
timeFrame: Hours 0-8
measure: Kisspeptin-induced LH pulse amplitude
timeFrame: Hours 8-11
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie B Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770067: Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Official title: Prospective Evaluation of the Efficacy and Safety of Continuous In-situ Ultra High-dose Antibiotics (CITA) and Minimally Invasive Surgery (MIS) Utilizing Regulated Negative Pressure-assisted Wound Therapy (RNPT) in the Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection
Keywords: Cardiac Resynchronization Therapy Devices
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.


Eligibility criteria: Inclusion Criteria:

* High-risk patients for CIED infections
* CIED infections

Exclusion Criteria:

* Systematic infection

Primary outcomes:
measure: Lack of CIED Infection
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Moris Topaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06981767: Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus
Official title: Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Oral Lichen Planus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to provide clinical evidence on the efficacy of bromelain for managing OLP, potentially offering a safer and more effective treatment option.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from symptomatic OLP
* Patients free from any visible oral lesions other than OLP.
* Patients who agreed to take the supplied interventions.
* Patient who will agree to participate in the study.
* Patients who will accept to sign the informed consent.

Exclusion Criteria:

* Patients suffering from any systemic disease.
* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
* Treatment with any oral topical medications for at least four weeks prior to the study.
* Pregnant and lactating mothers.

Primary outcomes:
measure: Clinical improvement
timeFrame: Recorded at baseline, and weekly for 4 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: baseline, daily for the first week, then weekly for the remaining 3 weeks.
measure: Oral health-related quality of life
timeFrame: at baseline, and weekly for the 4 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01446367: Corneal Changes After Retinal Surgery
Official title: Corneal Topographic Changes After 20-gauge Pars Plana Vitrectomy Associated With Scleral Buckling for the Treatment of Rhegmatogenous Retinal Detachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhegmatogenous Retinal Detachment
Lead sponsor: Universidade Federal do Paraná
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rhegmatogenous retinal detachments

Brief summary: The purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment.

Detailed description: Patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses corneal curvature changes.

Eligibility criteria: Inclusion Criteria:

* Patients with rhegmatogenous retinal detachments

Exclusion Criteria:

* Previous eye surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Weinberger D, Lichter H, Loya N, Axer-Siegel R, Muzmacher L, Gabbay U, Yassur Y. Corneal topographic changes after retinal and vitreous surgery. Ophthalmology. 1999 Aug;106(8):1521-4. doi: 10.1016/S0161-6420(99)90447-5.
Clinical trial NCT01654367: Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer
Official title: The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Detailed description: The investigators select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Eligibility criteria: Inclusion Criteria:

1. Karnofsky≥70
2. Provision of informed consent
3. Pathological confirmation of breast cancer
4. Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy
5. Not previously received treatment with bisphosphonate
6. Laboratory criteria:

   PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl GOT,GPT,ALP≤2\*ULN TBIL,DBIL,CCr≤1.5\*ULN
7. Surgery , radiotherapy and chemotherapy has finished

Exclusion Criteria:

1. Pregnant of lactation woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy

Primary outcomes:
measure: therapeutic assessment
timeFrame: 6 months
Secondary outcomes:
measure: Adverse reactions and disease-free survival
timeFrame: 2 years
Other outcomes:
measure: Recurrence or death
timeFrame: 5 years
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Cancer Hospital
name: Jin Zhang, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01120067: Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
Official title: Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Psychology
Pain
Veterans
Stress Disorders, Post-Traumatic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-05-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.

Detailed description: Objectives:

The primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). A secondary objective is to examine potential mechanisms of action that might account for improvements in pain or PTSD. Third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. It is hypothesized that 1) participants receiving the intensive treatment (PT) will report significantly greater decreases in symptoms of pain and PTSD from pre-treatment to post-treatment when compared to participants randomized to a standard care (SC) condition, and 2) participants receiving PT will show greater maintenance of change on measures of pain and PTSD at 3 months following the completion of treatment when compared to participants randomized to the SC condition.

Eligibility criteria: Inclusion Criteria:

* Patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology.
* Patients must also meet diagnostic criteria for PTSD.

Exclusion Criteria:

* Patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.

Primary outcomes:
measure: McGill Pain Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: John Otis, BS BA PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai J, Whealin JM, Scott JC, Harpaz-Rotem I, Pietrzak RH. Examining the relation between combat-related concussion, a novel 5-factor model of posttraumatic stress symptoms, and health-related quality of life in Iraq and Afghanistan veterans. J Clin Psychiatry. 2012 Aug;73(8):1110-8. doi: 10.4088/JCP.11m07587. Epub 2012 Jun 26.