louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02186678: Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
Official title: Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paragangliomas
Pheochromocytomas
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.

In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.


Eligibility criteria: Inclusion Criteria:

Age ≥ 18

* PHEO or PGL: initial staging or restaging
* Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization

Exclusion Criteria:

Pregnant or breast-feeding woman

Primary outcomes:
measure: interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
timeFrame: 7 months
Secondary outcomes:
measure: assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
timeFrame: 7 months
Other outcomes:
measure: assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
timeFrame: 7 months
measure: assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
timeFrame: 7 months
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: David TAIEB, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03551678: Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
Official title: Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2018-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.


Eligibility criteria: Inclusion Criteria:

* age 18-40 years
* history of primary ACLR with or without meniscal repair
* full weight-bearing status
* neutral to varus knee alignment
* plans to remain in the area for at least 8 months.

Exclusion Criteria:

* Kellgren-Lawrence (KL) radiographic grade \> 2
* additional injury or surgery to the involved knee
* BMI \>30 kg/m2
* use of walking, orthopedic, or prosthetic assistive device
* pregnancy
* inability to have MRI

Primary outcomes:
measure: Knee Adduction Moment
timeFrame: Change from baseline to immediately after 8 weeks of retraining
Secondary outcomes:
measure: Medial knee compartment qMRI
timeFrame: Change from baseline to 6 months after retraining
measure: Knee Adduction Moment
timeFrame: Change from baseline to 3 months after retraining
measure: Knee Adduction Moment
timeFrame: Change from baseline to 6 months after retraining
measure: Serum inflammatory markers
timeFrame: Change from baseline to immediately after 8 weeks of retraining
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
Study officials:
affiliation: VAPAHCS and Stanford University
name: Constance Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00425178: FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
Official title: A Phase 1, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Patients With Diabetic or Venous Stasis Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Wounds
Diabetes
Venous Stasis Ulcers
Keywords: Chronic wounds
Diabetes
Ulcers
Arterial bypass
Angioplasty
Diabetic ulcers
Lead sponsor: CardioVascular BioTherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Warren General Hospital
First posted: 2007-01-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers. Procedure includes topical administration of FGF-1 or placebo and evaluation of safety, pharmacokinetics, and wound improvement.

Detailed description: Patients meeting eligibility criteria will be randomized to receive topical administration of either FGF-1 or placebo. Patients will be evaluated at days 1 and 7, post-treatment for safety, pharmacokinetics, and wound healing.

Eligibility criteria: Eligibility Criteria:

* Informed consent
* Female patients post-menopausal, sterilized, or on adequate birth control
* Full-thickness lower extremity diabetic or venous statis ulcers of specific target size and of at least 8 weeks but no more than 1 year duration
* Target ulcer freshly debrided at screening or within two weeks prior to screening
* Adequate blood supply defined by transcutaneous oxygen pressure \> 20 mmHG and ABI greater than or equal to 0.4
* Compliance with non-weight bearing regimen in diabetic patients
* Compliance with wound care regimen

Primary outcomes:
measure: Safety
measure: Pharmacokinetics
Secondary outcomes:
measure: Wound improvement
Other outcomes:
Locations:
city: Warren
country: United States
facility: Warren General Hospital
state: Pennsylvania
Study officials:
affiliation: Warren General Hospital
name: Thomas E Serena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217578: Neonatal Spinal Muscular Atrophy (SMA) Screening
Official title: Study on the Neonatal Screening of Spinal Muscular Atrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Muscular Atrophy
Keywords: Spinal Muscular Atrophy
Newborn Screening
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: The Chinese Foundation of Health
name: Taipei Institute of Pathology
First posted: 2017-07-14
Enrollment: 250000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates whose parents agree to be tested.

Brief summary: Parents or legal guardian of neonates who signed agreement will receive SMA screening test if their neonates are affected with SMA. The dried blood spots of routine newborn screening samples will be used to test if neonates have lost 2 copies of SMN1 gene. If neonates have positive SMA screening test, further confirmation with multiplex ligation-dependent probe amplification (MLPA) test and prospective motor function monitoring including physical and neurological examinations will be proved to make SMA confirmation. For any confirmed SMA patient, genetic counseling and standard of care will be proved.


Eligibility criteria: Inclusion Criteria:

1. Neonates born in Taiwan who receive regular newborn screening suggested by Ministry of Heath and Welfare.
2. Parents or legal guardian agree to perform SMA newborn screening.

Exclusion Criteria:

Parents or legal guardian do not agree to perform SMA newborn screening.

Primary outcomes:
measure: Number of neonates with confirmed the deletion of 2 copies of SMN1 gene
timeFrame: 3 years
Secondary outcomes:
measure: Number of neonates with confirmed SMA
timeFrame: 3 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT05050578: Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
Official title: Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Detailed description: Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Eligibility criteria: Key Inclusion Criteria:

* Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Manifest cylinder less than or equal to 0.75 diopter in each eye.
* Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Monovision or multifocal lens wearer.
* Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
* Routinely sleeps in habitual contact lenses.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
timeFrame: Day 30, each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Dr. Elsa Pao, OD
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Boiling Springs
country: United States
facility: North Spartanburg Eye Center
state: South Carolina
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research, LLC
state: Tennessee
city: Plano
country: United States
facility: Dr Christina R Chang & Associates, OD, PA
state: Texas
city: San Antonio
country: United States
facility: Dawn M. Rakich, OD
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02408978: Pilot Study of OXP005 to Assess Gastroduodenal Irritation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroduodenal Erosions
Lead sponsor: Oxford Pharmascience Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at the relative impact of both products on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subject
* Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum)
* H. pylori negative

Exclusion Criteria:

* Clinically significant abnormal laboratory parameters
* Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, centralcnervous, immunological, dermatological, GI or any other body system

Primary outcomes:
measure: Severity of GD irritation in the stomach and duodenum as measured by the Lanza score
timeFrame: Day 8
measure: Total number of GD erosions overall
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Ltd
Study officials:
affiliation: Quotient Clinical Ltd
name: Stuart Mair, MBChB, DRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01300078: A Clinical Trial Assessing Safety of MF101 for Hot Flushes
Official title: A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hot Flashes
Keywords: Hot Flashes
Hot Flushes
Vasomotor Symptoms
Menopausal Symptoms
Lead sponsor: Bionovo
Sponsor class: INDUSTRY
First posted: 2011-02-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.

Detailed description: MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.

Eligibility criteria: Inclusion Criteria (partial list):

* Postmenopausal women aged 40-65 years.
* Provide informed consent.
* Currently receive medical care from a health care provider. Other inclusions apply.

Exclusion Criteria (partial list):

* History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening.
* Unexplained uterine bleeding within 6 months prior to Screening.
* History of deep vein thrombosis or pulmonary embolism.
* Active liver disease or a history of impaired.
* Active gallbladder disease. Other exclusions apply.

Primary outcomes:
measure: Evaluate the safety of MF101, 10 g/day and 15 g/day
timeFrame: Randomization to 4 weeks
Secondary outcomes:
measure: Compare the safety of MF101 10g/day and 15 g/day
timeFrame: Randomization to 4 Weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates, Jordan Research and Education Institute (REDI)
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
Study officials:
name: Wulf Utian, PhD, DSc(Med), FRCOG, FACOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03533478: Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema
Official title: Efficacy of Nutritional Supplements Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema. Clinical Trial Phase II.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Nutritional supplement
Diabetic Macular Edema
Diabetes
Alzer
Oxidative Stress
Diamel
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 64
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: PREVENTION

Brief summary: Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.


Eligibility criteria: Inclusion Criteria:

* Diabetics type 2 insulin treated.
* Age between 18 and 65 years.
* Glycosylated hemoglobin (HB A1c) \<8% at the beginning of the investigation.
* Patients who express written voluntariness to enter the study with their signature of the informed consent document.
* If woman of childbearing age, negative pregnancy test and use of barrier contraceptives.

Exclusion Criteria:

* Pregnancy and lactation.
* Age over 65 years.
* Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical).
* Opacity of the refractive media that hinders the ophthalmological examination.
* History of hypersensitivity to another similar product or one of its components.
* Patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
* Subjects who are participating in another clinical trial Patients with cognitive disorders or a mental disorder that hinders their follow-up.

Primary outcomes:
measure: Macular retinal thickness
timeFrame: 1 year
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 year
Other outcomes:
Locations:
city: Vedado
country: Cuba
facility: National Institute of Endocrinology
state: Havana
Study officials:
affiliation: National Institute of Endocrinology, Cuba
name: Juana Elvira Maciques Rodríguez, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538278: Prospective Database for Acute Myeloblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myeloblastic, Acute
Keywords: AML
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prospective Database for Acute Myeloblastic Leukemia


Eligibility criteria: Inclusion Criteria:

* Patients with AML

Primary outcomes:
measure: safety and efficacy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Naeem Chaudhri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05162378: Amotosalen and Platelet Transfusion in Adult Heart Surgery
Official title: Impact of Treatment With Amotosalen on the Practice of Platelet Transfusion in Adult Heart Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Surgery
Keywords: Amotosalen
Platelet transfusion
Bleeding
heart surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subjects having had cardiac surgery or ascending aorta and platelet transfusion for any reason

Brief summary: Blood safety is ensured by the rigorous selection of donors and biological tests. However, infectious agents can escape this detection and be transmitted to recipients during transfusion. Amotosalen is a derivative of psoralens that intercalates with nucleic acids and inactivates them after UV exposure; it therefore makes it possible to inhibit any replication of an infectious agent present. Preliminary studies have shown its safety and efficacy in preventing the transmission of infectious agents during the administration of labile blood products (fresh frozen plasma and platelet concentrates) as well as the absence of loss of efficacy (absence of loss of pro-aggregating and procoagulant properties) of the transfused products. In addition, there is a significant reduction in side effects for platelet concentrates, especially compared to irradiated concentrates.

Treatment of platelet concentrates with Amotosalen may be responsible for a reduction in the platelet concentration in each concentrate with an overall decrease in efficiency and transfusion yield compared to untreated concentrates.


Eligibility criteria: Inclusion criteria:

* Major subjects ≥18 years old
* Cardiac surgery or ascending aorta
* Platelet transfusion for any reason
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria

* Subject having expressed opposition to participating in the study
* Presence or - installation of transient circulatory assistance (outside of the CEC) or definitive
* Heart or cardiopulmonary transplantation
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective study of the impact of the treatment with Amotosalen on the platelet transfusion practice in adult cardiac surgery unit
timeFrame: Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
name: Xavier DELABRANCHE, MD
role: PRINCIPAL_INVESTIGATOR
References: