louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002136: A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days
Official title: A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
tecogalan
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Detailed description: Patients receive intravenous DS-4152 by infusion once every 21 days; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
* Life expectancy of at least 12 weeks.
* NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
* Recovered from toxicity of any prior anticancer therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Leukemia or lymphoma.
* Current gastrointestinal bleeding by stool guaiac.
* Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
* Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
* Acute intercurrent infection other than genital herpes.
* Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.

Concurrent Medication:

Excluded:

* Other anticancer therapy.
* Other investigational agents.

Patients with the following prior conditions are excluded:

* History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
* History of myocardial infarction within past 6 months.

Prior Medication:

Excluded:

* Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
* Investigational agents within the past 4 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cancer Therapy Research Ctr
state: Texas
Study officials:
References:
citation: Eckhardt SG, et al. Results of a phase I trial of the novel angiogenesis inhibitor, tecogalan sodium (meeting abstract). Proc Annu Meet Am Assoc Cancer Res. 1995; 36:A628
Clinical trial NCT02823236: Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
Official title: Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Keloid
Keywords: Keloid
Scar
Lead sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
Sponsor class: OTHER
Collaborators: name: Grupo Medifarma, S. A. de C. V.
First posted: 2016-07-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.

Detailed description: Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.

Eligibility criteria: Inclusion Criteria:

* Keloids size equal or major than 1 cm
* Keloids less than 5 years old
* Keloids in trunk

Exclusion Criteria:

* Keloid with a surgical indication
* Hypertrophic scars
* Scars after burn wounds
* Pregnancy
* Lactation
* Use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication
* Known hypersensitivity for triamcinolone or pirfenidone
* Severe comorbidity not controlled
* Inflammatory acne
* Diabetes Mellitus
* Hypertension
* Renal, hepatic or respiratory failure
* Topical treatment 4 weeks before recruitment
* Previous treatment with intralesional steroids

Primary outcomes:
measure: Change in Keloid Scar Assessment
timeFrame: 0 and 24 weeks
measure: Change in Keloid Scar Assessment by Patients
timeFrame: 0 and 24 weeks
Secondary outcomes:
measure: Occurrence of adverse effects
timeFrame: Every 4 weeks after the beginning of the intervention up to 52 weeks
measure: Quality of life of the patient
timeFrame: 24 weeks
measure: Recurrence defined as an increase size of the keloid scar at week 52
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Dermatológico "Dr. Ladislao de la Pascua"
Study officials:
affiliation: Centro Dermatológico Dr. Ladislao de la Pascua
name: Martha Alejandra Morales-Sánchez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05089513: Uterus Transplantation by Robotics - Gothenburg III
Official title: Uterus Transplantation by Robotics and in Donor and Recipient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Absolute Uterine Factor Infertility
Keywords: uterus, infertility, transplantation, robotics
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation

Detailed description: Inclusion; absolute uterine factor infertility, age between 18 and 38, BMI less than 28, non-smoker

Eligibility criteria: Inclusion Criteria:

Uterine factor infertility, age 18-38 years, psychological stable, in steady relationship.

Exclusion Criteria:

Smoking, systemic disease, psychological instability

Primary outcomes:
measure: Surgical success
timeFrame: 0-4 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 10-48 months
Other outcomes:
measure: Live birth rate per attempted and surgically succesful transplantation
timeFrame: 19-72 months
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska
state: None Selected
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT00982813: Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes
Official title: Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Periodontal Disease
Keywords: Periodontal disease
Per-term delivery
Sulcular bleeding index
Bacteriological gingival presence
Cytokines
Active periodontal disease with sulcular bleeding index
Bacteriological sampling in periodontal pocketing
Cytokines in the periodontal pocketing
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.


Eligibility criteria: Inclusion Criteria:

* Women older than 18
* Pre-term birth between 24 and 37 gestational weeks

Exclusion Criteria:

* Patient's opposition
* Delivery before 24 gestational weeks or after 37 gestational weeks

Primary outcomes:
measure: Sulcular bleeding index as active disease
timeFrame: one week after delivery
Secondary outcomes:
measure: Plaque index
timeFrame: one week after delivery
measure: Depth of periodontal pocketing
timeFrame: one week after delivery
measure: Clinical attachment level
timeFrame: one week after delivery
measure: Bacterial sampling of gingival crevicular fluid
timeFrame: One week after delivery
measure: Search for cytokines in the gingival crevicular fluid
timeFrame: one week after delivery
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Henri-Jean PHILIPPE, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202913: Building Resilience for Healthy Kids
Official title: Building Resilience for Healthy Kids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 867
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: School based, mental-health intervention focused on improving self-efficacy and coping skills in children aged 9-13 years. The overall premise of our intervention is that by teaching children these skills they will in-turn become more resilient when faced with life-stressors and/or adverse events.

Detailed description: Healthy Kids is a 1:1 health coaching intervention delivered in school-settings. Students meet weekly with their assigned health coach and together they identify both strengths and areas for improvement with respect to resilience, developing resilience skills, and setting resilience goals. Topics discussed include coping skills, self-efficacy, and interpersonal relationships. The program was developed using the social determination theory (SDT), goal theory, and elements from the social-ecological model. SDT was used within the intervention to promote and facilitate behavior change. Goal theory was also utilized to develop strategies to support youth short- and long-term goal setting. Finally, weekly discussions about resilience and goal setting activities accounted for elements of the social-ecological model which acknowledges that behaviors are not independent factors, but are influenced by multiple levels of one's personal and social environment.

Eligibility criteria: Inclusion Criteria:

* All children in participating school

Exclusion Criteria:

* None.

Primary outcomes:
measure: Child & Youth Resilience Measure - Revised (CYRM-R)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Eagleview Middle School
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Jill L Kaar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JA, Heberlein E, Pyle E, Caughlan T, Rahaman D, Sabin M, Kaar JL. Study protocol for a school-based single group pragmatic trial to promote resilience in youth: Building Resilience for Healthy Kids. Contemp Clin Trials Commun. 2021 Feb 6;21:100721. doi: 10.1016/j.conctc.2021.100721. eCollection 2021 Mar.
citation: Lee JA, Heberlein E, Pyle E, Caughlan T, Rahaman D, Sabin M, Kaar JL. Evaluation of a Resiliency Focused Health Coaching Intervention for Middle School Students: Building Resilience for Healthy Kids Program. Am J Health Promot. 2021 Mar;35(3):344-351. doi: 10.1177/0890117120959152. Epub 2020 Sep 22.
Clinical trial NCT01417013: Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
Official title: A Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye or lubricant eye drops
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.

Detailed description: The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.

Eligibility criteria: Inclusion Criteria:

* Corrected VA of 0.6 LogMar or better OU

Exclusion:

* Topical ocular medication use
* Presence of Ocular conditions (blepharitis, conjunctival infections, etc)

Primary outcomes:
measure: TBUT
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03521713: To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
Official title: A Randomized, Active Comparator-Controlled, Parallel-Group, Single-Blind, Multicenter, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex) in the Treatment of Anemia Associated With Chronic Renal Failure in Pre-dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 214
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.


Eligibility criteria: Inclusion Criteria:

* Glomerular Filtration Rate \<60 mL/min/1.73m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
* Hemoglobin (Hb) level in the range of ≥7 g/dL and \<10 g/dL at screening
* Erythropoiesis Stimulating Agent (ESA) naïve subjects or previously treated subjects with ESA-free period of \>3 months (in case of pre-treatment with long-acting ESA such as pegylated epoetin, the long-acting ESA-free period of \>6 months)

Exclusion Criteria:

* Subjects who have received steady dialysis or subjects who are currently on dialysis
* Subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a GFR decrease of \>20% within 12 weeks prior to screening)
* Subjects who have already undergone renal transplantation or who are scheduled for renal transplantation

Primary outcomes:
measure: Mean Absolute Change in Hb levels
timeFrame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Secondary outcomes:
measure: Hemoglobin Responder Rate
timeFrame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
measure: Mean EPO dosage (Week 1 to Week 24)
timeFrame: Week 1 ~ Week 24
measure: Mean EPO dosage (Week 21 to Week 24)
timeFrame: Week 21 ~ Week 24
Other outcomes:
measure: Safety: Any adverse events
timeFrame: Week 1 to Week 52
measure: Immunogenicity: Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose))
timeFrame: (Week -2~Week 1 (Prior to Dose)), Week 52
Locations:
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
Study officials:
affiliation: Gazi University Medical Faculty
name: Turgay Arinsoy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02907736: Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute stroke, admitted for endovascular therapy.

Brief summary: Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS.

The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* AIS secondary to a large vessel occlusion
* admitted for endovascular therapy.

Exclusion Criteria:

* Pregnant or breast feeding patient patient under legal protection
* Patient opposition to participate in this study

Primary outcomes:
measure: thrombus origin
timeFrame: baseline
measure: red cells counts
timeFrame: baseline
measure: white cells counts
timeFrame: baseline
measure: platlet counts
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A. de Rothschild
name: Jean-Philippe Désilles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation OPH A. de Rothschild
name: Mikael Mazighi, MD, PhD
role: STUDY_CHAIR
References:
citation: Ducroux C, Di Meglio L, Loyau S, Delbosc S, Boisseau W, Deschildre C, Ben Maacha M, Blanc R, Redjem H, Ciccio G, Smajda S, Fahed R, Michel JB, Piotin M, Salomon L, Mazighi M, Ho-Tin-Noe B, Desilles JP. Thrombus Neutrophil Extracellular Traps Content Impair tPA-Induced Thrombolysis in Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):754-757. doi: 10.1161/STROKEAHA.117.019896. Epub 2018 Feb 8.
Clinical trial NCT04405336: Tab Block and Patient Controlled Analgesia in CS
Official title: Effect of Tab Block and Patient Controlled Analgesia in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: cesarean section rate become increasing nowadays

Detailed description: indication of cesarean section are different from case to case and the use of pain controlling agents is very important to relieve post operative pain

Eligibility criteria: Inclusion Criteria:

* women coming for an elective CS

Exclusion Criteria:

* women who has a n emergency CS or complicated normal deivery needs urgent CS

Primary outcomes:
measure: The number of women who will feel less pain post CS
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera( Al Gazeera) hospital
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00171236: Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Official title: Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heterozygous Familial Hypercholesterolemia
Mixed Dyslipidemia
Keywords: Heterozygous familial hypercholesterolemia
mixed dyslipidemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 84
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* 10-16 years old Heterozygous familial hypercholesterolemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: