louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00189280: Aldara for the Treatment of Large and/or Multiple sBCC
Official title: Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Basal Cell
Keywords: Aldara, sBCC
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.


Eligibility criteria: Inclusion Criteria:

* One or more sBCC on torso, neck or face
* Total surface area \<= 40 sq cm

Exclusion Criteria:

* Pregnancy or women who are breastfeeding
* Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors
* Metatypical, adnexal, or sclerodermiform carcinomas
* Current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion
* Known HIV positive serology
* Skin tumor that is already or highly likely to become metastatic
* Presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous)
* Previous organ transplant history

Primary outcomes:
measure: Clinical clearance of sBCC
timeFrame: 12 or 16 weeks after treatment
Secondary outcomes:
measure: Reduction in size of tumour
timeFrame: 12 or 16 weeks after treatment
measure: Rate of clearance, Cosmetic outcome
timeFrame: 12 or 16 weeks after treatment
measure: Sustained clearance rate over 3 year follow-up
timeFrame: 3 years after treatment
measure: Tolerability & QoL
timeFrame: 12 or 16 weeks after treatment
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de DermatologieHôpital Dupuytren
Study officials:
affiliation: Service de DermatologieHôpital Dupuytren, LIMOGES
name: Professeur Bedane
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01026480: Ileal Pouch-Anal Anastomosis Registry
Official title: Ileal Pouch-Anal Anastomosis (IPAA) Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ileal Pouch-Anal Anastomosis
Keywords: Ileal Pouch Anal Anastomosis
IPAA
Pull through
IBD
Ulcerative colitis
Familial adenomatous polyposis
FAP
Hereditary nonpolyposis colorectal cancer
HNPCC
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 936
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for, or who have undergone, ileal pouch-anal anastomosis (IPAA) procedure and have been treated by a Center for Digestive Disorders physician at Boston Medical Center

Brief summary: Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.

Detailed description: In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
* Treated by a Center for Digestive Disorders physician
* Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure

Exclusion Criteria:

* Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
* Patients who are currently incarcerated

Primary outcomes:
measure: Pouch status: functional pouch or non-functional pouch (diverted or excised)
timeFrame: Once per year for duration of the study
Secondary outcomes:
measure: Quality of life
timeFrame: Once per year for duration of the study
measure: Health status
timeFrame: Once per year for duration of the study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: James M Becker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Francis A Farraye, MD
role: STUDY_DIRECTOR
affiliation: Boston University
name: Arthur F Stucchi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02799680: Allogeneic CART-33 for Relapsed/Refractory CD33+ AML
Official title: Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed and/or Refractory CD33+ AML
Keywords: CART
AML
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2016-06-15
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

Detailed description: The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* CD33 negative leukemia
* Any uncontrolled active medical disorder that would preclude participation as outlined
* Pregnant or lactating women

Primary outcomes:
measure: Occurrence of study related adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate of allogeneic CART-33
timeFrame: up to 24 weeks
measure: Disease-free survival
timeFrame: up to 24 weeks
measure: Overall survival
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: Huisheng Ai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03327480: The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis
Official title: The Effects of Hand Orthosis in Thumb Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis Thumb
Keywords: osteoarthritis thumb
orthosis
functioning
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled prospective trial
Primary purpose: TREATMENT

Brief summary: The investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis

Detailed description: The investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. The investigators will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2. The investigators will recommend these orthosis for six weeks. They will assess pain and disability before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* Being aged between 18 and 70
* Grade 1 or 2 thumb osteoarthritis

Exclusion Criteria:

* The other hand disorders such as fracture and carpal tunnel syndrome
* Previous hand surgery

Primary outcomes:
measure: AUSCAN (Australian Canadian Oateoarthritis Hand Index)
timeFrame: before the treatment, end of the sixth week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02781480: Clinical Trial of Gene Therapy for the Treatment of Leber Congenital Amaurosis (LCA)
Official title: An Open-label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno Associated Virus Vector for Gene Therapy of Adults And Children With Retinal Dystrophy Associated With Defects in RPE65 (LCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leber Congenital Amaurosis
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
First posted: 2016-05-24
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: AAV2/5-OPTIRPE65
Primary purpose: TREATMENT

Brief summary: A clinical trial of AAV2/5 vector for patients with Defects in RPE65

Detailed description: A dose escalation and dose expansion (Phase I/II) trial of adults and children with retinal dystrophy associated with defects in RPE65. ATIMP will be administered to one eye only in a single sub-retinal procedure

Eligibility criteria: Key Inclusion Criteria:

* Aged 3 years or older
* Early-onset severe retinal dystrophy consistent with RPE65 deficiency

Key Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Have participated in another research study involving an investigational therapy for ocular disease within the last 6 months.

Primary outcomes:
measure: Overall Safety of Adeno-Associated Virus Vector (AAV-OPTIRPE65) - Number of Participants With a Safety Event
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Centre, University of Michigan
state: Michigan
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT04243980: Anatomical Femoral Stem in Total Hip Arthroplasty
Official title: Short Term Results of Short Anatomical Femoral Stem in Total Hip Arthroplasty - Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Compliance
Patient Satisfaction
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 50
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 aged 18 - 90 who had THR as an elective surgery

Brief summary: A study that detect the femoral anteversion after total hip arthroplasty using short anatomical femoral stem compared to the contrast side


Eligibility criteria: Inclusion Criteria:

* age 18-90
* patients who had THR as an elective surgery
* patients who had THR with short femoral anatomical stem

Exclusion Criteria:

* severe osteoporosis with Dorr C classification
* s/p bilateral hip arthroplasty
* non-complaint patients
* revision surgery

Primary outcomes:
measure: Femoral anteversion
timeFrame: Post-Operatively, through study completion, an average of 2 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 6 weeks, 3 month, 6 month post-operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01727180: Pruritus in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Pruritus
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD stage 3 to 5D, followed-up in the Far Eastern Memorial Hospital

Brief summary: We believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. We therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus.


Eligibility criteria: Inclusion Criteria:

* Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus.

Exclusion Criteria:

* Patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Once at the entry of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Hon-Yen Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220580: Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache
Official title: Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Headache Disorders
Healthy
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case-control study
Primary purpose: OTHER

Brief summary: Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.

The aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators will measure multiomic changes (transcriptomics and metabolomics) after pain induction by Cold Pressor Test. 3 blood samples, two for RNA and one for metabolites are taken 5 minutes before a Cold Pressor Test and again 1 hour after the Cold Pressor Test.

The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.


Eligibility criteria: Inclusion Criteria:

* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
* Weight: 45 kg to 95 kg

Exclusion Criteria:

* Daily consumption of any medication.
* Consumption of any medication less than 12 hours prior to the study day.
* Headache on the study day or 48 hours prior to the study day.
* Amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).
* Any severe cardiovascular disease, including cerebrovascular illness.
* Amnestic or clinical signs of current mental illness.
* Amnestic or clinical signs of current substance or drug abuse.
* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.

Primary outcomes:
measure: Transcriptomic changes
timeFrame: 1 hour
measure: Metabolomic changes
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Region H
Study officials:
affiliation: Danish Headache Center
name: Jes Olesen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00493480: Danish Carvedilol Study in Portal Hypertension
Official title: Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cirrhosis
Portal Hypertension
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with large esophageal varices who have not yet experienced bleeding, are normally treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or have to discontinue the treatment because of side effects. The aim of this study is to evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than propranolol in lowering the portal pressure in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis
* HVPG \> 12 mmHg

Exclusion Criteria:

* Respiratory disease that contradict endoscopy
* Hepatic encephalopathy
* Hepatorenal syndrome
* COPD or Asthma
* Treatment with vasoactive drugs within 1 week of inclusion
* Heart disease that contradict treatment with beta-blocking agents
* IDDM
* Pregnancy

Primary outcomes:
measure: If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
timeFrame: 3 months
Secondary outcomes:
measure: If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
timeFrame: 3 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
name: Erik F Hansen, MD,Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonefeld K, Hobolth L, Juul A, Moller S. The insulin like growth factor system in cirrhosis. Relation to changes in body composition following adrenoreceptor blockade. Growth Horm IGF Res. 2012 Dec;22(6):212-8. doi: 10.1016/j.ghir.2012.09.001. Epub 2012 Sep 30.
citation: Hobolth L, Moller S, Gronbaek H, Roelsgaard K, Bendtsen F, Feldager Hansen E. Carvedilol or propranolol in portal hypertension? A randomized comparison. Scand J Gastroenterol. 2012 Apr;47(4):467-74. doi: 10.3109/00365521.2012.666673. Epub 2012 Mar 9.
Clinical trial NCT04115280: Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia
Official title: Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Aldosteronism
Atrial Fibrillation
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Atrial arrhythmia is the most frequent cardiac arrhythmia. It is a source of significant morbidity.

Hypertension is a major risk factor for atrial arrhythmias. Primary hyperaldosteronism (PA) is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias with a specific, sometimes curative, treatment. The purpose of the study is to show that the prevalence of PA among hypertensive patients under 65 years old with atrial arrhythmia is high, justifying systematic screening.

Detailed description: Atrial arrhythmia is the most frequent cardiac arrhythmia, affecting one million patients in France. It is a source of significant morbidity, a major deterioration in the quality of life and considerable health expenditure.

Hypertension is a major and modifiable risk factor for atrial arrhythmias. Primary hyperaldosteronism is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias, but also stroke, coronary artery disease, heart and kidney failure. This form has a specific treatment, sometimes curative.

The objective of this study is to show that the prevalence of primary hyperaldosteronism among patients under 65 with atrial arrhythmias is high, justifying systematic screening in this population.

The investigators will consecutively include 65-year-old hypertensive patients hospitalized in the department with atrialarrhythmia. They will benefit from an aldosterone to renin ratio assay under standardized conditions at 3 months.

Patients whose aldosterone (pmol/l) to renin (mUI/l) ratio is greater than 64 will benefit from saline infusion test if necessary and adrenal scan. Patients with a definite diagnosis who would prefer surgical treatment will benefit from adrenal venous catheterization.

Eligibility criteria: Inclusion Criteria:

* Hypertensive patients aged of 18 to 65 years with atrial arrhythmia.

Exclusion Criteria:

* BMI above 30
* Any situation where the discontinuation of treatments (including betablockers and diuretics) presents a risk according to the investigator

Primary outcomes:
measure: Evaluation of the prevalence of primary hyperaldosteronism
timeFrame: Data collected after the saline infusion test (6-month visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: PAU
country: France
facility: CH de Pau
Study officials:
References: