louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01930526: Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
Official title: Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Exercise
Cycling
Single leg
Pulmonary Rehabilitation
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 22
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: Pulmonary rehabilitation (PR) with supervised exercise training is a key part of care for patients with chronic lung disease (COPD). Patients can improve their shortness of breath, walking distance and quality of life. However, many patients do not improve their overall fitness. They are too breathless to train at a high enough intensity. In a laboratory training study, patients with COPD improved their overall fitness by using single leg cycling. Despite this knowledge, single leg cycling has not been used clinically. The objective of this project is to use and assess single leg cycling in a clinical setting. Single leg cycling can be incorporated into a clinical service (replacing traditional two legged cycling) as the predominant aerobic training strategy, resulting in improvements in cardio-respiratory fitness (peak oxygen uptake).


Eligibility criteria: Inclusion Criteria:

* Patients with COPD referred for Pulmonary Rehabilitation

Exclusion Criteria:

* Unstable cardiac disease
* any neurological or orthopaedic condition that would make cycling difficult

Primary outcomes:
measure: Change in peak oxygen uptake achieved by incremental cycle ergometry
timeFrame: Measured at the end of an average of eight weeks of pulmonary rehabilitation compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger S Goldstein, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans RA, Dolmage TE, Mangovski-Alzamora S, Romano J, O'Brien L, Brooks D, Goldstein RS. One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. Ann Am Thorac Soc. 2015 Oct;12(10):1490-7. doi: 10.1513/AnnalsATS.201504-231OC.
Clinical trial NCT02095626: Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation
Official title: Pilot Study to Investigate the Clinical Effect of Orally Inhaled AP301 on Treatment of Primary Graft Dysfunction (PGD) in Mechanically Ventilated Patients After Primary Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PGD Primary Graft Dysfunction
Keywords: Peptide
Lead sponsor: Apeptico Forschung und Entwicklung GmbH
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.


Eligibility criteria: Inclusion Criteria:

* Being a male or female recipient on the AKH's waiting list for primary single or double LuTX
* PGD score ≥ 1 within 72 hours after LuTX
* Informed consent is available

Exclusion Criteria:

* History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
* Postoperative ECMO support
* Paediatric /adolescent recipients (\< 18 years)
* Lobar transplantation
* Retransplantation
* Combined solid organ transplants
* Participation in other drug trials

Primary outcomes:
measure: P/F ratio
timeFrame: 7 days
Secondary outcomes:
measure: EVLW
timeFrame: 7 days or until extubation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Thoracic Surgery MedUni Vienna
Study officials:
affiliation: Medical University of Vienna
name: Walter Klepetko, Univ.Prof.Dr.med.univ.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02091726: Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
Official title: Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
Keywords: Circumcision
HIV prevention
Surgical device
Cyanoacrylate
Tissue Adhesive
voluntary
Lead sponsor: Simunye Primary Health Care
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.


Eligibility criteria: Inclusion Criteria:

* Men at least 18 years of age

Exclusion Criteria:

* Poor general health
* Anatomical abnormalities that would complicate circumcision
* Bleeding disorder
* Ongoing infection
* Cannot attend followup visits

Primary outcomes:
measure: Time for Procedure
timeFrame: 1 hour
Secondary outcomes:
measure: Completely Healed at 4 Weeks
timeFrame: 4 weeks
measure: Wound Separation
timeFrame: 4 weeks
measure: Cosmetic Result Excellent
timeFrame: 4 weeks
measure: Participant Fully Satisfied and Would Recommend to Friends and Family
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Simunye Primary Healthcare
state: Western Cape
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa
name: Norman Goldstuck, MD
role: STUDY_DIRECTOR
References:
citation: Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
Clinical trial NCT03931226: Impact of Spa Treatments on the Consumption of Care in Children
Official title: Impact of Spa Treatments on the Consumption of Care in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Otorhinolaryngologic Diseases
Dermatologic Disease
Keywords: drug consumption
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 8372
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This pharmacoepidemiology study of the "observational study" type, in real life, will concern children aged 1 to 15 living in France at the time of the study. It will be conducted at the departmental level of the Haute-Garonne through the use of the APPLE database (PrescriptiOns Medicines Mother Children) and at the national level through the use of the database. EGB (General Sample of Beneficiaries).

Brief summary: Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. The benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures.

Few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. Moreover, no real-life study of a large sample of children seems to have been conducted in this area. The present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.


Eligibility criteria: Inclusion Criteria:

* Children living in France at the time of the study
* 'POMME' cohort : children included at birth and 'EGB' cohort : children from birth to 15 years-old

Exclusion Criteria:

Primary outcomes:
measure: Drug consumption
timeFrame: until 7 years-old of children
Secondary outcomes:
measure: Description of spa treatment
timeFrame: until 7 years-old of children
measure: Population of children
timeFrame: until 7 years-old of children
measure: Compare 2 data sources
timeFrame: until 7 years-old of children
measure: impact of SPA treatment on the pathology
timeFrame: until 7 years-old of children
measure: Medical costs
timeFrame: until 7 years-old of children
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Agnès Sommet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05171426: Incidental Cancer in Familial Adenomatous Polyposis
Official title: Incidental Cancer in Colectomy Specimens From Patients With Familial Adenomatous Polyposis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: familial adenomatous polyposis
colectomy
rectum
cancer
adenoma
Lead sponsor: Dr. Ersin Arslan Education and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-12-28
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Familial Adenomatous Polyposis patients

Brief summary: Colectomy is life-saving in patients with familial adenomatous polyposis (FAP) because cancer development is inevitable in individuals with this disease. In this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for FAP. Prophylactic colectomy should be performed in patients with FAP, as colorectal cancer transformation is inevitable in these individuals. The possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.

Detailed description: Colectomy is life-saving in patients with familial adenomatous polyposis (FAP) because cancer development is inevitable in individuals with this disease. In this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for FAP. The files of patients diagnosed with FAP who underwent surgery in our clinic between 2010 and 2020 were retrospectively reviewed. Definitive surgery was performed in patients with histopathological malignancy identified in colonoscopic biopsies in the preoperative period, while prophylactic surgery was performed in patients without malignancy. The incidence of incidental malignancy in histopathological specimens from patients who underwent prophylactic colectomy was determined. Prophylactic colectomy should be performed in patients with FAP, as colorectal cancer transformation is inevitable in these individuals. The possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Familial Adenomatous Polyposis

Exclusion Criteria:

* did not receive surgical treatment
* data deficiencies

Primary outcomes:
measure: incidental cancer
timeFrame: 2 or 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Dr. Ersin Arslan Training and Resource Hospital
Study officials:
References:
Clinical trial NCT00678626: Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
Official title: A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
* Her-2negative breast cancer or unknown Her-2 status.
* at least 1 measurable lesion as defined by RECIST.
* ECOG status 0-1
* adequate bone marrow, hepatic and renal function.
* left ventricular ejection fraction of greater than or equal to 50%.
* willingness to discontinue hormonal therapy.

Exclusion Criteria:

* any previous chemotherapy for advanced disease.
* prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
* symptomatic brain metastases.
* prior anti-IGF-1R based investigational therapy.
* peripheral neuropathy greater than grade 2.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)
timeFrame: 3 years
measure: Overall Response
timeFrame: 3 years
measure: Overall Survival
timeFrame: 3 years
measure: Safety and tolerability
timeFrame: 3 years
measure: Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire
timeFrame: 3 years
measure: Pharmacokinetics of CP-751,871
timeFrame: 3 years
measure: Optional tissue markers of the IGF-1R pathway from tumor tissue obtained
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01548326: Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Official title: Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Vaccination Failure
Keywords: Vaccination Failure
Nonresponder
Hepatitis B virus
Atorvastatin
Immunization against viral Hepatitis
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.

Detailed description: 20 person of vaccinated individuals who have HBsAb\<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.

Eligibility criteria: Inclusion Criteria:

* Previous 3 dose hepatitis B vaccination
* Negative HBc Ab
* Negative HBs Ag
* HBs Ab less than 10 in ELIZA

Exclusion Criteria:

* positive serologic evidence of Hepatitis B infection
* Chronic use of Atorvastatin
* Immunosuppressive Disease

Primary outcomes:
measure: Change from baseline in serum HBsAb level
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: IL-4 level in WBC culture
timeFrame: 1 month after vaccination
measure: IL 17 level in WBC culture
timeFrame: 1 month after vaccination
measure: TGF-beta level in WBC culture
timeFrame: 1 month after vaccination
measure: IFN-gamma level in WBC culture
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Baqiyatallah University of Medical Sciences
Study officials:
affiliation: Baqiyatallah University of Medical Sciencesc
name: Nematollah Jonaidi Jafari, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04624126: External Device for Erectile Dysfunction (3D-Erect)
Official title: Non-invasive External Device for Erectile Dysfunction (3D-Erect): a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Impotentia Erigendi
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).

Detailed description: A clinical trial to test the safety and feasibility of our newly developed non-invasive 3D-printed external penile device for the treatment and recovery of erectile dysfunction.

Eligibility criteria: Inclusion Criteria:

* males \>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
* having a female partner willing to participate in the study.

Exclusion Criteria:

* not willing to attempt sexual vaginal intercourse with their partner
* inability to wear/operate the external penile device for any reason

Primary outcomes:
measure: Change in modified International Index of Erectile Dysfunction score
timeFrame: baseline and up to 1 month post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care, Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Michael Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002226: Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
Official title: A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Skin Neoplasms
Sarcoma, Kaposi
Antineoplastic Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.

Detailed description: Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have KS with at least 5 skin lesions.
* Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy.
* Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have had surgery within 4 weeks of study entry.
* Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry.
* Have pulmonary KS (KS in your lungs).
* Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers.
* Are allergic to Cremophor.
* Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy).
* Are pregnant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Norris Cancer Ctr / USC
state: California
city: Los Angeles
country: United States
facility: UCLA Care Ctr / Ctr for Hlth Sciences
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp / HIV Care Unit
state: California
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
Study officials:
References:
citation: Gill P, Arasteh K, Jacobs M, Friedman-Kiel A, Miles S, Gracey S, Hannah A, Langecker P. A multicenter, dose-escalating study in patients with AIDS-related Kaposi's Sarcoma 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29