louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03959670: Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System for Thoracoabdominal and Para-renal Aortic Aneurysms.(E-nside Study)
Official title: Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) for Thoracoabdominal and Para-renal Aortic Aneurysms. (E-nside Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Thoracoabdominal
Para-renal Aortic Aneurysms
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with thoracoabdominal or para-renal aortic aneurysm

Brief summary: The study was created to evaluate the theoretical anatomical feasibility of the new E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated with other techniques for this pathology in the vascular Unit of San Raffaele Hospital, in the past ten years. With this study, investigators want to analyze in how many cases the new prosthesis would be usable.

E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) is in the pre-CE marking stage. At present, the certifying organism is evaluating the documentation for the release the CE mark certification and Declaration of Conformity.


Eligibility criteria: Inclusion Criteria:

- patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital between January 2007 and January 2017.

Exclusion Criteria:

- incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness \>1-mm.

Primary outcomes:
measure: Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA)
timeFrame: between January 2007 and January 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
citation: Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.
citation: Sobocinski J, d'Utra G, O'Brien N, Midulla M, Maurel B, Guillou M, Azzaoui R, Roeder B, Resch TA, Haulon S. Off-the-shelf fenestrated endografts: a realistic option for more than 70% of patients with juxtarenal aneurysms. J Endovasc Ther. 2012 Apr;19(2):165-72. doi: 10.1583/11-3772.1.
citation: Bilman V, Cambiaghi T, Grandi A, Carta N, Melissano G, Chiesa R, Bertoglio L. Anatomical feasibility of a new off-the-shelf inner branch stent graft (E-nside) for endovascular treatment of thoraco-abdominal aneurysms. Eur J Cardiothorac Surg. 2020 Dec 1;58(6):1296-1303. doi: 10.1093/ejcts/ezaa276.
Clinical trial NCT01068470: Determining the Lymphokine Activated Killer (LAK) Cytotoxicity Present in Patients Undergoing Interleukin-2 Therapy
Official title: Lymphokine Activated Killer (LAK) Cell Activity Against Cell Lines In-vitro of LAK Generated in Vivo by Pulse Interleukin-2 Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Kidney Cancer
Keywords: Interleukin-2
Melanoma
Kidney Cancer
Lymphokine Activated Killer cells
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center

Brief summary: Therapy with Interleukin-2 stimulates lymphocytes in humans to become Lymphokine-activated Killer cells (LAK). This study will determine if these killer cells are able to kill certain standard cell-lines in the laboratory.

Detailed description: Blood samples will be taken from patients undergoing outpatient Interleukin-2 therapy to measure the LAK cytotoxicity at baseline, after 1 cycle of therapy and 2 months later. The LAK cytotoxicity assay will be a standard colorimetric assay that measures lactic dehydrogenase release from lysed cells.

Eligibility criteria: Inclusion Criteria:

* Patients must be undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center
* Patients must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

* Patients not undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center

Primary outcomes:
measure: LAK cytotoxicity
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beaumont
country: United States
facility: Loma Linda University Cancer Center
state: California
Study officials:
affiliation: Loma Linda University
name: Walter Quan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02641470: The Effect of DA9301 on Tablet Computer-Induced Asthenopia
Official title: Clinical Trial to Investigate the Effect of DA9301 on Tablet Computer-induced Asthenopia in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenopia
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant is native to cool temperature regions of the Northern Hemisphere. Considering its antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a significant role in treating various ocular pathologies. The investigators performed a randomized, case-controlled study in healthy subjects and investigated the protective effect of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.


Eligibility criteria: Inclusion Criteria:

1. Healthy subject aged 20 to 65 years with more than 2 hours of daily use of a smart phone or computer including a tablet and television

Exclusion Criteria:

1. Ocular disease in either eye

   * Ocular surface disease
   * Best corrected visual acuity \< 20/30
   * Intraocular pressure \> 21 mmHg
   * Optical coherence tomography proven retinal nerve fiber defect
   * Significant cataract (lens opacities classification system III)
   * Significant entropion or ectropion
   * Significant tear drainage problem proved with fluorescein dye dilution test
2. Soft or Hard contact lens use 3 or more days a week
3. History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study
4. Pregnant woman
5. Systemic disease

   * Uncontrolled hypertension (systolic /diastolic blood pressure \> 140/90mmHg)
   * Uncontrolled diabetes mellitus (fasting blood glucose level \> 180mg/dL)
   * Rheumatoid arthritis
   * Malignant disease
   * Active hepatitis (type B and C)
   * Acute or chronic infectious disease
   * Renal disease

Primary outcomes:
measure: Change of the modified questionnaire scores proposed by Ames et al.
timeFrame: before and immediately after tablet computer use on Day 0 and Day 29 (deviation window: Day 21-31)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: oph0112@gmail.com
name: Choul Yong Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park CY, Gu N, Lim CY, Oh JH, Chang M, Kim M, Rhee MY. The effect of Vaccinium uliginosum extract on tablet computer-induced asthenopia: randomized placebo-controlled study. BMC Complement Altern Med. 2016 Aug 18;16:296. doi: 10.1186/s12906-016-1283-x.
Clinical trial NCT00748670: Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
Official title: An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Jaw, Edentulous
Poor Bone Quality
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.


Eligibility criteria: Inclusion Criteria:

* 18 - 75 years of age
* Bone quality class III or IV, (according to Lekholm \& Zarb16)
* Willing to give signed informed consent

Exclusion Criteria:

* Need for bone augmentation of the maxilla
* Tobacco smoking more than 5 cigarettes/day
* Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Unable or unwilling to return for follow-up visits
* Bruxism or other parafunctional activity

Primary outcomes:
measure: Implant survival
timeFrame: Continuously during 5,5 years after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa, College of Dentistry, Dow's Institute for Dental Research
state: Iowa
city: Gävle
country: Sweden
facility: Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken
city: Halmstad
country: Sweden
facility: Odontologiska kliniken, Länssjukhuset
Study officials:
affiliation: University of Iowa, College of Dentistry, Dow's Institute for Dental Research
name: Clark Stanford, D.D.S., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05402670: Gastric Mucosal Changes in Patients With Dermatomyositis
Official title: Gastric Mucosal Changes in Patients With Dermatomyositis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Mucosal Manifestations in Patients With Dermatomyositis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dermatomyositis patients in the Department of Rheumatology, the Second Affiliated Hospital of Zhejiang University School of Medicine。 Healthy people undergoing physical examination at the Physical Examination Center of the Second Affiliated Hospital of Zhejiang University School of Medicine。

Brief summary: There are a large number of reports in the literature that patients with dermatomyositis often have various malignant tumors, and reports of gastric cancer are not rare. At present, the widely recognized gastric cancer occurrence patterns are: normal gastric mucosa-chronic superficial gastritis-chronic atrophic gastritis-intestinal metaplasia-dysplasia-gastric cancer, so the research about the gastric mucosal performance of patients with dermatomyositis is clinically meaningful


Eligibility criteria: Inclusion Criteria:

* 1、18-70years old，no gender limit. 2、Clinical diagnosis of dermatomyositis. 3、dermatomyositis group conform to 1 and 2，control group conform to 1 .

Exclusion Criteria:

* Contraindications for gastroscopy.

  * Past history of malignant tumors of the esophagus and stomach and or history of surgery.

    * Pregnant or lactating women. ④ Participated in other clinical studies within 3 months. ⑤Patients cannot express their main complaints correctly and cannot cooperate with the research.

Primary outcomes:
measure: Gastric mucosal manifestations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT02087670: Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program
Official title: Natriuretic Brain Pro-peptid (Pro-BNP)Changes in Patients With Chronic Heart Failure Enroled in a Controlled, Supervised Exercise Protocol Within a Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
cardiac rehabilitation
exercise
Natriuretic Brain Pro-peptid
Lead sponsor: Grupo Rehabilitacion en Salud
Sponsor class: NETWORK
Collaborators: name: Clinica Las Americas
First posted: 2014-03-14
Enrollment: 42
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: Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.

Detailed description: Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months

Exclusion Criteria:

* patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity

Primary outcomes:
measure: Natriuretic Brain Pro-peptid
timeFrame: 8 weeks
Secondary outcomes:
measure: Oxygen Consumption
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Rehabilitation in health research group. Universidad de Antioquia
name: Jesus Alberto Plata Contreras, physiatrist
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia,Rehabilitation in health research group
name: Ana Milena García Montoya, Resident
role: STUDY_CHAIR
affiliation: Hospital Universitario San Vicente Fundación
name: Sigifredo Ospina, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia, Rehabilitation in health research group
name: Luz Helena Lugo Agudelo, physiatrist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04445870: Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study
Official title: Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient entering an oncology care pathway

Brief summary: In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and caused a pandemic. It led decision makers to prioritize emergency and intensive care dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and treatment, may have been delayed during the containment period. Consequences of this "distraction effect" are being.

Detailed description: Quantitative monthly data were analyzed from January 1, 2019 to May 31, 2020 in two French tertiary care center (University Hospital and Godinot Cancer Institute in Reims) and in a third center in the French epicenter (Colmar hospital). Oncologic activity indicators were extracted using oncologic electronic file, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) and nation-wide procedure codes (CCAM). The monthly number of different steps of oncology care pathway (screening, diagnosis and treatment) were collected: faecal immunochemical testing (FIT), mammography, histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including first presentations, given personalized care program, medical announcement and reformulation nursing consultations, inserted central venous catheters, chemotherapy prepared and administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses.

Eligibility criteria: Inclusion Criteria:

* Every adult patient entering an oncology care pathway between 01/01/2019 and 31/12/2020

Exclusion Criteria:

* \<18 yo

Primary outcomes:
measure: data record
timeFrame: from 01/01/2019 to 31/12/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT05450770: Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination
Official title: The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Yellow Fever
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Saint-Louis Hospital, Paris, France
name: Bichat Hospital
name: Hôpital Cochin
First posted: 2022-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Category 2, multi-centric intervention research comparing 2 parallel groups of 40 HIV + subjects and 20 HIV- subjects included in the ANRS EP46 NOVAA trial.
Primary purpose: PREVENTION

Brief summary: ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination

Detailed description: The vaccine responses will be determined with the measurement of the neutralizing antibody titers using the neutralization tests PRNT and Pseudo type ACN 400 to M120 (ten years) in the participants of the ANRS EP 46 NOVAA trial, VIH+ and controls naïve to previous vaccination ten years after a primary anti-yellow fever vaccination.

Eligibility criteria: Inclusion Criteria:

* Subjects included in the ANRS EP 46 NOVAA trial:

  * 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 \> 350/mm3 and a viral load \<50 copies / mL for at least 6 months).
  * 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals.
  * Subjects agreeing to be monitored according to the terms of the protocol.
  * Subjects affiliated to a Social Security scheme or beneficiaries of such a scheme.
  * Signature of informed consent.

Exclusion Criteria:

* Non-volunteers for the 10-year follow-up
* Subject under curatorship, guardianship or safeguard of justice.

Primary outcomes:
measure: Immuno-virologic criterion
timeFrame: At Months 120 (10years)
Secondary outcomes:
measure: Predicting a sustained vaccine response 10 years later.
timeFrame: At Months 120 (10years)
Other outcomes:
Locations:
Study officials:
affiliation: Maladies Infectieuses St Louis Paris
name: Nathalie COLIN de VERDIERE
role: STUDY_DIRECTOR
affiliation: CIC Cochin Paris
name: Odile LAUNAY
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat Paris
name: Jade GHOSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845299: Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official title: An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to the Latanoprost Punctal Plug Delivery System (L PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma
ocular hypertension
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 40
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 determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.


Eligibility criteria: Inclusion Criteria:

* Over 18 years with ocular hypertension or open-angle glaucoma
* Subjects who have a best-corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Subjects who wear contact lenses
* Uncontrolled medical conditions
* Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

Primary outcomes:
measure: IOP change from baseline
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
state: California
Study officials:
affiliation: QLT Inc.
name: Oscar Cuzzani, MD
role: STUDY_DIRECTOR
References: