louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00523887: Fentanyl for Treatment Pain Caused by Radiotherapy
Official title: Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Radiation pain
Duragesic
Fentanyl
Pain
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 163
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.

Detailed description: The study is a phase IV, open label, single arm study. The purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. The patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. The study medication will be used for 4 weeks. VAS (visual analog scale), BPI Q9 (quality of life) and global assessment have been used to assess the effectiveness. VAS will be assessed every week. BPI Q9 will be assessed at week 1 and week 4. Global assessment will be assessed at week 4. The safety of the study drug will be evaluated using adverse event (AE) report.

The investigator will assess the pain intensity of patients and increase or even decrease Fentanyl dosage every week. Fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. Fentanyl will be administered for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients have the history of head and neck tumor
* Patients who are proceeding radiotherapy
* Patients who are administered weak opioids and pain score (Visual analog scale) of 4

Exclusion Criteria:

* Patients who have been administered Fentanyl for pain treatment within 2 weeks before the study
* Patients who will have surgery within 1 month
* Known presence of distant metastasis

Primary outcomes:
measure: To evaluate the clinical utility of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy. VAS (at week 1~4), BPI Q9 (week 1 and 4) and global assessment (week 4) have been used to assess the clinical utility.
Secondary outcomes:
measure: To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02896387: Ability of a Molecule (Prima) to Restore Physiological Differentiation in Epithelium Expressing Gene p63
Official title: Ex Vivo and in Vitro Assessment of the Pharmacological Properties of Molecule Prima in the Restoration of Physiological Differentiation of Gene p63 Dependant Epithelium
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ectodermal Dysplasia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-09-12
Enrollment: 5
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with genetic pathology of the ocular surface

Brief summary: Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. The most common forms are called Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic treatment, no cure is available. To understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients.

P63 gene belongs to the family of p53 gene. The functions of the two proteins are very similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.


Eligibility criteria: Inclusion Criteria:

* Patient with genetic pathology of the ocular surface
* Age ≥ 7 years

Exclusion Criteria:

* Agonal glaucoma
* low vision mostly related to retinal pathology
* Pregnant or breast-feeding patient

Primary outcomes:
measure: the differentiation of corneal epithelium by histological observation
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
city: Paris
country: France
facility: Hopital Necker
Study officials:
affiliation: Fondation ophtalmologique de Rothschild
name: Eric GABISON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02000687: Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
Official title: Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages 18-75 years old that received at least one IT. Participants will be obtained from the pool of islet transplant recipients transplanted at the Diabetes Research Institute at the University of Miami, Miller School of Medicine.

Brief summary: This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

Detailed description: After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide \<0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.

Eligibility criteria: Inclusion Criteria:

1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).

Exclusion Criteria:

1. Inability to provide written informed consent.
2. Mentally unstable and/or unable to comply with the procedures of the study protocol.
3. History of any solid organ transplant.

Primary outcomes:
measure: determine the rate of allosensitization in patients after failed islet transplantation
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Diabetes Research Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Rodolfo Alejandro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635.
Clinical trial NCT05111587: Epidemiology of Injuries Caused by the Practice of Artificial Structure Climbing
Official title: Epidemiology of Injuries Caused by the Practice of Artificial Structure Climbing: Prospective Cohort Study in Réunion Island
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sport Injury
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult who practices climbing in artificial structure must be included in Reunion Island

Brief summary: This study aims to precisely describe epidemiology of injuries than occur during practice of climbing in artificial structure.

Each participant will complete questionnaires in order to identify injuries. The first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.


Eligibility criteria: Inclusion Criteria:

- person who practices artificial structure climbing

Exclusion Criteria:

* person who refuses to participate
* person under tutorship or curatorship
* person who cannot read and write
* person who wants to leave Reunion Island within 12 months

Primary outcomes:
measure: location of injury
timeFrame: at month 3
measure: laterality of injury
timeFrame: at month 3
measure: mechanism of injury
timeFrame: at month 3
measure: circumstance of injury occurence
timeFrame: at month 3
measure: injury relapse or not
timeFrame: at month 3
measure: diagnosis of injury
timeFrame: at month 3
measure: record of exposure to injury
timeFrame: at month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: Climbing structure
Study officials:
References:
Clinical trial NCT03109587: Pilot Study of Probiotics in Pre-diabetic Adolescents
Official title: Pilot Study of Probiotics in Pre-diabetic Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2017-04-12
Enrollment: 16
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.

Detailed description: Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children.

The probiotic strains are known to improve glycemic control.

Eligibility criteria: Inclusion Criteria:

* Male or female, 13-19 y. of age at Visit 1.
* BMI: 99th percentile or greater
* Acanthosis nigricans
* Pubertal Tanner stage ≥3

Exclusion Criteria:

* Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies.
* Known severe immunodeficiency, or immune compromised.
* Current or previous history for insulin or metformin therapy (within last 3 months).
* Antibiotic or probiotic therapy 3 months prior to enrollment.
* Start of new dietary intervention within 1 month prior to enrollment.
* Diagnosed food hypersensitivity or active gastrointestinal disease

Primary outcomes:
measure: Change in microbiota composition
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in insulin resistance
timeFrame: baseline and 12 weeks
measure: Change in inflammation in blood
timeFrame: baseline and 12 weeks
measure: Change in inflammation in the gut
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hosptital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Christian L Roth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Christiane S Hampe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verma A, Nelson MT, DePaolo WR, Hampe C, Roth CL. A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity. J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec.
Clinical trial NCT02395887: Postural Balance and Stability Among Patients With Cervical and Back Pain
Official title: Postural Balance and Stability Among Patients With Cervical and Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Stenosis
Back Pain
Keywords: Spinal stenosis
Spinal decompression
Postural balance
Neurogenic claudication
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 patients, men and women above 18, which suffer from back or neck pain and are candidates for an operational intervention.

Brief summary: High percentage of chronic back pain is due to spinal stenosis. The clinical picture is of 'neurogenic claudication' which effects postural balance and stability. If conservative treatment fail to improve symptoms, an invasive treatment which includes spinal decompression can be done.

The research is an observational prospective one, pre and post operational intervention. The aim is to examine whether an operational intervention improves quality of life, pain, postural balance an stability among patients.

It's important to clarify, that although there is operational intervention, the research is observational. The decision weather to operate or not, is not a part of the research. The investigators assume that since there is a population that independently going through an operation, the investigators can observe this population and evaluate different aspects of the operation outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from back or neck pain
* Patients that are candidates for operational intervention

Exclusion Criteria:

* Pregnant women
* Patients who had a spinal operation in the past.

Primary outcomes:
measure: Dynamic postural balance tests
timeFrame: 6 months
measure: Static postural balance tests
timeFrame: 6 months
Secondary outcomes:
measure: Pain and quality of life questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Shay Shabat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06329687: A Study Evaluating the Safety of the Nasal Pump
Official title: A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dry Eye
Kerato Conjunctivitis Sicca
Lead sponsor: Oyster Point Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safety of the Tyrvaya nasal pump.

Detailed description: The study is testing the hypothesis that the use of the Tyrvaya nasal pump with silicone lubricant does not introduce any additional safety concerns as compared to the safety of the Tyrvaya nasal pump without the additional silicone lubricant.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Have provided verbal and written informed consent
* Willing to comply with all study related visits and procedures

Exclusion Criteria:

* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: United States, California
state: California
Study officials:
References:
Clinical trial NCT05432687: Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)
Official title: Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.


Eligibility criteria: Inclusion Criteria:

* male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....)
* urinary incontinence before surgery
* surgery for abdominal wallhernia

Primary outcomes:
measure: amount of incontinence after surgery (1 year)
timeFrame: 1 year
Secondary outcomes:
measure: amount of incontinence after 3 month
timeFrame: 3 month
measure: amount of incontinence after 6 month
timeFrame: 6 month
measure: quality of life after 3 month
timeFrame: 3 month
measure: quality of life after6 month
timeFrame: 6 month
measure: quality of life after 12 month
timeFrame: 12 month
measure: quality of incontinence after 12 month
timeFrame: 12 month
Other outcomes:
Locations:
city: Besançon
country: France
facility: University hospital of Besançon
Study officials:
affiliation: University hospital of Besançon
name: Emilie CERUTTI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512187: Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
Official title: Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Plaque Psoriasis
Obesity
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2007-08-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.


Eligibility criteria: Inclusion Criteria:

* 18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score ≥10 and a body mass index ≥30.

Exclusion Criteria:

* Other type of psoriasis (guttate, erythrodermic and pustular psoriasis)
* Uncontrolled hypertension
* Severe congestive heart failure
* Renal and liver impairment
* Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis
* Previous or active malignancies
* Pregnancy and lactations
* Previous treatment with cyclosporine
* Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.

Primary outcomes:
measure: Primary end point PASI 75 response
timeFrame: week 24
Secondary outcomes:
measure: secondary end point was % of body weight reduction
timeFrame: week 24
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona
Study officials:
affiliation: University of Verona, Section of Dermatology and Venereology
name: Giampiero Girolomoni
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gisondi P, Del Giglio M, Di Francesco V, Zamboni M, Girolomoni G. Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial. Am J Clin Nutr. 2008 Nov;88(5):1242-7. doi: 10.3945/ajcn.2008.26427.
Clinical trial NCT06280287: PET Imaging of Fibroblast Activation in Atherosclerosis
Official title: PET Imaging of Fibroblast Activation in Carotid and Coronary Atherosclerotic Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with carotid stenosis or CAD.

Brief summary: Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.

Detailed description: Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis. Abundant FAP-expressing cells in atherosclerotic plaques co-express endothelial biomarkers involved in endothelial-to-mesenchymal transition. FAP upregulation is also associated with a rupture-prone plaque phenotype with a thin fibrous cap. Positron emission tomography (PET) with 68Ga-FAPI-04 has been demonstrated as a feasible method to image fibroblastic activation in the arterial wall. The current study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.

Eligibility criteria: Inclusion Criteria:

* For the carotid stenosis group: patients with symptomatic carotid stenosis with \>50% stenosis on carotid CTA; OR patients with unsymptomatic carotid stenosis with \>70% stenosis on carotid CTA
* For CAD group: patients with stable ischemic heart disease OR acute coronary syndrome, including ST-elevation MId, non-ST elevation MI, and unstable angina
* signed informed consent

Exclusion Criteria:

* Pregnancy, lactation, or intention to become pregnant during the study
* Contradiction to MRI or CTA

Primary outcomes:
measure: SUVmax of atherosclerotic plaque in carotid or coronary arteries
timeFrame: through study completion, an average of 2 years
measure: TBR of atherosclerotic plaque in carotid or coronary arteries
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: