louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01346553: Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)
Official title: Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Insufficiency
Keywords: Chronic Venous Insufficiency (CVI)
Lead sponsor: GB-Veintech
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 15
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 External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. The external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. Alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. The device is synchronized with the calf muscles pump to function as a one-way venous valve. This study was design in order to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic venous insufficiency.


Eligibility criteria: Inclusion Criteria:

* Males and females age 18 and up.
* Patient is diagnosed to have deep chronic venous insufficiency (CVI) proved by recent duplex examination.
* Patient able to comprehend and give informed consent for participation in this study.
* Patient must commit to both screening and treatment visits.
* Patient must sign the Informed Consent Form.

Exclusion Criteria:

* Acute deep vein thrombosis.
* Chronic deep vein obstruction.
* Peripheral arterial occlusive disease.
* Ankle edema that is not caused by chronic venous insufficiency
* Partial or complete immobility.
* Pregnancy.
* Known cognitive disorder.
* Drug abuse.
* Patient objects to the study protocol.
* Concurrent participation in any other clinical study.

Primary outcomes:
measure: The safety of using the ESVV for CVI treatment
timeFrame: 6 hours
Secondary outcomes:
measure: Assessing the efficacy of using the ESVV for treatment of consequences of CVI.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe Medical Center, Zrifin, Israel
name: Arie Bass, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05282953: A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients with Retinitis Pigmentosa and Choroideremia (ABACUS)
Official title: A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients with Retinitis Pigmentosa and Choroideremia (ABACUS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa
Choroideremia
Lead sponsor: Kiora Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I/II dose-escalating study of the safety, tolerability and efficacy of KIO-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (ABACUS). Open label.


Eligibility criteria: Inclusion Criteria:

1. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).
2. Have a visual acuity of:

   1. no light perception for Cohort 3 or
   2. no light perception or bare light perception for Cohort 1 confirmed with a LogMar \>2.9 using the Berkeley Rudimentary Vision Test (BRVT), or
   3. count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and \> 1.6 using the BRVT.
3. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of \< 0.05 using the BRVT.

Exclusion Criteria:

1. Have evidence of material/substantial optic nerve disease.
2. Have a history of retinal detachments.
3. Have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media.
4. Have high intraocular pressure (IOP) \>22 mm Hg.
5. Have had a previous intraocular surgery (excluding phakocataract surgery).
6. Have aphakia.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by overall changes in retinal thickness and appearance, clinical chemistry and hematology, and other eye assessments.
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adeliade Hospital
state: South Australia
city: North Adelaide
country: Australia
facility: Harley Eye Clinic
state: South Australia
Study officials:
affiliation: Royal Adelaide Hospital
name: Robert Casson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00933751: Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome
Official title: Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Surgery
Keywords: central venous oxygen saturation
oxygen transport
physiologic monitoring
tissue oxygenation
Patients before high risk abdominal surgery
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients before emergent high risk abdominal surgery

Brief summary: Tissue hypoxia is one of the most important factors leading to the development of multiorgan failure. Patients presenting for emergent major abdominal surgery might suffer from organ hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may improve the outcome. The investigators believe that hypoperfusion of the abdominal organs will cause a decrease of the saturation in the hepatic vein and in the IVC.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients presenting for emergency surgery due to acute abdomen pain
* Older than 18 years old
* Not pregnant

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Major coagulopathy
* Permanent pacemaker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Yaakov
country: Israel
facility: Assaf-Harofeh MC
Study officials:
References:
Clinical trial NCT00004851: Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Official title: Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: HCV Antibody Library
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Detailed description: To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Eligibility criteria: Persistent infection with mild hepatitis that is non-progressive.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren G. Magnuson Clinical Center (CC)
state: Maryland
Study officials:
References:
citation: Feinstone SM, Alter HJ, Dienes HP, Shimizu Y, Popper H, Blackmore D, Sly D, London WT, Purcell RH. Non-A, non-B hepatitis in chimpanzees and marmosets. J Infect Dis. 1981 Dec;144(6):588-98. doi: 10.1093/infdis/144.6.588.
citation: Hijikata M, Shimizu YK, Kato H, Iwamoto A, Shih JW, Alter HJ, Purcell RH, Yoshikura H. Equilibrium centrifugation studies of hepatitis C virus: evidence for circulating immune complexes. J Virol. 1993 Apr;67(4):1953-8. doi: 10.1128/JVI.67.4.1953-1958.1993.
citation: Shimizu YK, Hijikata M, Iwamoto A, Alter HJ, Purcell RH, Yoshikura H. Neutralizing antibodies against hepatitis C virus and the emergence of neutralization escape mutant viruses. J Virol. 1994 Mar;68(3):1494-500. doi: 10.1128/JVI.68.3.1494-1500.1994.
Clinical trial NCT03320551: Can A Nutrition Education Immersion Program Foster Sustainable Improvements in Clinical Parameters Over Time?
Official title: Can A Nutrition Education Immersion Program Foster Sustainable Improvements in Clinical Parameters Over Time?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: Education
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Whole Foods, Inc.
First posted: 2017-10-25
Enrollment: 73
Sex: ALL
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: OTHER

Brief summary: Nutrition and Education Immersion program sponsored by WholeFoods, Inc. for their employees.

Detailed description: An ongoing Nutrition and Education Immersion program is currently ongoing that is supported by Whole Foods, Inc. for their employees. Eighty employees have previously agreed to attend a one week nutrition education and immersion program October 14-21, 2017. This program will involve nutrition education seminars, exercise and support classes that they are scheduled to attend. All meals are provided. They will all be 100% plant based with low oil. All employees will complete a dietary survey at the beginning of the study. Clinical parameters will be tested at start and end of the program. The majority of the lectures are CME certified by Rush University.

All participants will be approached for participation on day one to allow for the collection of the data being obtained as part of the existing project. In addition to the data from the program, this project will include a lab draw for nutritional markers at baseline and at the end of the immersion program, a dietary survey, SF-36, and DASI at baseline. Participants will be contacted by phone at months 3 and 6 and will be asked to complete the dietary survey, SF-36, and DASI. In addition, self-reported weight will be collected, and occurrence of health events (hospitalizations, new diagnoses). This will end their participation.

Eligibility criteria: Inclusion Criteria:

* 18yrs or older
* all comers with and without cardiovascular disease risk factors
* are attending the one week lifestyle immersion program sponsored by Whole Foods

Exclusion Criteria:

-unwilling to provide consent

Primary outcomes:
measure: Weight
timeFrame: Up to 6 months
Secondary outcomes:
measure: Mediterranean Diet Survey
timeFrame: Up to 6 months
measure: 36 Item Short Form Survey
timeFrame: Up to 6 months
measure: Duke Activity Status Index
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
city: Naples
country: United States
facility: Naples Beach Hotel and Golf Club
state: Florida
Study officials:
affiliation: University of Florida
name: Monica Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02089451: A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects
Official title: A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-64 years both inclusive at the time of signing informed consent
* Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
* Body mass index 20.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Primary outcomes:
measure: Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)
timeFrame: From 0 to 12 hours
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)
timeFrame: From 0 to 12 hours
measure: Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)
timeFrame: From 0 to 12 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Hovelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KMD, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 May;37(5):503-509. doi: 10.1007/s40261-017-0499-y.
Clinical trial NCT03284151: Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma
Official title: Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate cancer
good prognosis
focused treatment
Cyberknife
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 26
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostatic adenocarcinoma Capra≤2

Brief summary: Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Detailed description: Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).

Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.

Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.

Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35\<2cc. Bladder neck and urethra: V35\<1cc.

Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.

Eligibility criteria: Inclusion Criteria:

* Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions\>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.

Exclusion Criteria:

* systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.

Primary outcomes:
measure: Delay between the initial diagnosis and date of salvage treatment
timeFrame: through study completion, up to 36 months
Secondary outcomes:
measure: PSA evaluation
timeFrame: 3, 6, 12, 18, 24, 30, 36 months
measure: Birads score evaluation
timeFrame: 12, 24, 36 months
measure: Acute and late toxicity
timeFrame: 3, 6, 12, 18, 24, 30, 36 months
measure: IPSS evaluation
timeFrame: 12, 24, 36 months
measure: IIEF5 evaluation
timeFrame: 12, 24, 36 months
Other outcomes:
Locations:
city: Esch Sur Alzette
country: Luxembourg
facility: Centre Francois Baclesse
Study officials:
affiliation: Centre Francois Baclesse
name: Philippe Nickers, MD, PhD
role: STUDY_CHAIR
affiliation: Centre Francois Baclesse
name: Michel Untereiner, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01349751: Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
Official title: Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Observation of Neuromuscular Block
Disease (or Disorder); Gynecological
Keywords: abdominal incision
hyperbaric
isobaric
levobupivacaine
spinal anaesthesia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.

Detailed description: The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.

Eligibility criteria: Inclusion Criteria:

* ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy

Exclusion Criteria:

* contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm

Primary outcomes:
measure: time to T4-dermatome sensory blockade
timeFrame: 30 minutes
Secondary outcomes:
measure: side effects
timeFrame: 1 to 4 hours intraoperation plus within 2 hours in the recovery room
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital
name: Vimolluck - Sanansilp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01829451: Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
Official title: Autocrosslinked Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Bipolar Radiofrequency Endometrial Ablation: a Randomised, Controlled and Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 32
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.


Eligibility criteria: Inclusion Criteria:

* menorrhagia

Exclusion Criteria:

* abnormal uterine cavity,
* abnormal endometrial biopsy

Primary outcomes:
measure: prevention of intrauterine adhesion formation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: