louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02105181: Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
Official title: Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Stricture
Keywords: benign biliary stricture
anastomotic biliary stricture after liver transplantation
chronic pancreatitis
biliary surgical procedure
fully covered metal stent
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.

The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.

Detailed description: After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.

Eligibility criteria: Inclusion Criteria:

* a history of liver transplantation, chronic pancreatitis or biliary surgery
* impairment of liver function tests such as elevated liver enzymes and/or cholestasis
* a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .

Exclusion Criteria:

* an uncertainty about the benign nature of the stricture
* an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum

Primary outcomes:
measure: Initial success rate of temporary FCMS placement
timeFrame: 6 months
Secondary outcomes:
measure: Final success
timeFrame: 18 months
measure: Stricture recurrence
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Société Française d'Endoscopie Digestive
name: Frederic Prat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03429881: Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.
Official title: Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma: a Pilot, Prospective, Randomized Study Comparing Stripping With CO2 Laser Vaporization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microparticle
Endometriosis
Laparoscopy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE).

Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting: Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

Measurements and Main results: Blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian endometrioma surgery was performed.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.

Exclusion Criteria:

* previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, GnRH-agonists, progestins, or danazol in the preceding 3 months. We excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.

Primary outcomes:
measure: Microparticle levels after two laparoscopic treatments of ovarian endometriomas
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
Clinical trial NCT00967681: Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease
Official title: Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Fibrocystic Disease
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
* Patients older than 20 years.
* Female patients.
* Informed consent.

Exclusion Criteria:

* Presents of another disease not well controlled.
* Pregnant women or lactating.
* Patient which are receiving another products from other investigations trials.

Primary outcomes:
measure: The ultrasonographic improvement at 24 weeks (end of the treatment)
timeFrame: 24 weeks
measure: Adverse effects at 24 weeks (end of the treatment)
timeFrame: 24 weeks
Secondary outcomes:
measure: Lesion size according clinical measurement at 24 weeks (end of the treatment)
timeFrame: 24 weeks
measure: Pain according patient examination at 24 weeks (end of the treatment)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: "Ramón González Coro" Gynecologic and Obstetric Hospital
Study officials:
affiliation: Ramón González Coro Hospital
name: Daisy Hernández, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04391881: Oral Manifestation of COVID 19 Patient: A Cross Sectional Study on Egyptian Population
Official title: Oral Manifestation of COVID19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Health and COVID 19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian population tested COVID positive either hospitalized or not

Brief summary: The oral manifestation of COVID 19 that could help in the diagnosis of patient

Detailed description: Oral ulceration,oral lesion,sensitivity that has been reported by patient tested positive for COVID 19

Eligibility criteria: Inclusion Criteria:

* Tested COVID positive
* No other chronic disease that has oral manifestation
* Above 18

Exclusion Criteria:

* Children
* Patient with no COVID positive

Primary outcomes:
measure: Oral manifestation
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Lecturer at cairo ubiversity
name: Dina Mounir Elkady
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01115881: Relationship Between Macular Thickness Measurement and Signal Strength in Optical Coherence Tomography
Official title: Relationship Between Macular Thickness Measurement and Signal Strength Using Stratus Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optical Tomography
Keywords: To examine the relationship between signal strength and macular thickness measured by stratus OCT
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 40
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: healthy

Brief summary: Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT stratus, that combines SNR and uniformity of the signal within a scan The scale of signal strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing excellent image quality It has been showed that signal strength has a better image quality discriminating ability than SNR The operation manual recommends a minimum signal strength of 5 for macular thickness measurement There is no consensus on the level of signal strength above which should be considered to be good quality The inclusion Criteria for acceptable signal strength varies widely in the literature the purpose of our study is to examine the relationship between signal strength and macular thickness measured by stratus OCT


Eligibility criteria: Inclusion Criteria:

* healthy subjects in this study other than refractive error, all included eyes had no concurrent ocular pathologic features BCVA of at least 20/30, and had spherical refractive error within the range of
* 4.00 D to 4.00 D

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir medical center
Study officials:
affiliation: Sackler school of medicine Tel-Aviv university
name: Ori Segal, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03236181: Chronic Effects of Fats on Satiety & Energy Needs
Official title: Chronic Effects of Fats on Satiety and Energy Expenditure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Energy Expenditure
Appetite
Satiety
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2017-08-01
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of dietary fat on satiety (the experience of fullness between one meal and the next) and energy metabolism over an extended period of time (chronic effects). How dietary fat sources affect satiety, appetite and energy use is unclear. The investigators will use a controlled setting for the studies. They want to know if the source of dietary fat alters satiety, satiety hormones, and energy expenditure responses after consuming different diets.

Detailed description: This work will address the interaction of obesity and dietary fatty acids in regulating satiety and energy metabolism. The primary objective is to determine the effects of chronic intake of dietary fatty acids of varied saturation and chain length on satiety, thermogenesis and energy utilization in healthy individuals. The investigators hypothesize that unsaturated fatty acids will 1) increase satiety and 2) increase energy metabolism and that 3) the fatty acid binding protein polymorphisms are associated with reduced energy expenditure in response to dietary fat intake.

Eligibility criteria: Inclusion Criteria:

* body mass index between 25.0-34.9 kg/m2
* free of major diagnosed, untreated medical conditions
* non-smoking or use of other tobacco products, including e-cigarettes
* not taking steroid-based medications
* not planning to or currently attempting to gain or lose weight
* willing to comply with study demands
* low intake of long chain omega-3 fatty acids (\<0.10 g/d) or willing to reduce intake for 6 weeks prior to starting the study

Exclusion Criteria:

* diagnosed eating disorders
* diabetes (blood sugar ≥ 126 mg/dl)
* hypertension (systolic \> 160 mmHg or diastolic \> 100 mmHg)
* diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
* currently pregnant or planning to become pregnant, or lactating
* taking medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)

Primary outcomes:
measure: Acute effect of fat intake on energy expenditure as determined by metabolic rate
timeFrame: Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Susan Raatz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02838381: Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
Official title: Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 553
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.


Eligibility criteria: Inclusion Criteria:

For all patients:

* signed written informed consent

For cohort A:

* patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival \> or = at 20 months
* Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1

For cohort B:

* patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival \< 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)

For cohort C:

* patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy

For cohort D:

* patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts

Exclusion Criteria:

For all patients:

* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
* patient with a neurodegenerative disease
* patient under guardianship, curator or under the protection of justice

Primary outcomes:
measure: frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer
timeFrame: at inclusion
measure: progression-free survival
timeFrame: within 5 years after the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Montbéliard
country: France
facility: Hôpital Nord Franche Comté
Study officials:
References:
Clinical trial NCT03334981: Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome
Official title: Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Abstinence Syndrome
Keywords: meconium concentration
buprenorphine
methadone
pregnant
liquid chromatography-tandem mass spectrometry
opioid-dependant woman
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 92
Sex: FEMALE
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: Newborns and mothers under opioid replacement therapy during pregnancy

Brief summary: The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* pregnant women
* Having agreed to participate in the study after information
* Under opioid replacement therapy during pregnancy, in combination or not with other psychotropic drugs or legal or illegal substances.
* Delivery after more than 34 weeks of amenorrhea

Exclusion Criteria:

* Pregnant women not receiving substitution treatment (methadone or buprenorphine).
* Patient under substitution treatment delivering before 34 weeks of amenorrhea
* Patient aged under 18 yrs old
* Patient unable to understand the study (mental deficiency, impairment of consciousness, not French) or not accepting to answer the questionnaires.
* Severe malformation syndrome or chromosomal abnormality in newborn discovered during pregnancy.
* mother's death or newborn's death

Primary outcomes:
measure: meconium concentration of buprenorphine
timeFrame: variation over time at baseline and 24hrs to 48hrs after birth
measure: meconium concentration of methadone
timeFrame: variation over time at baseline and 24hrs to 48hrs after birth
Secondary outcomes:
measure: urine concentration of buprenorphine or methadone
timeFrame: baseline and 24hrs to 48hrs after birth
measure: by the score of Lipsitz,
timeFrame: 4 times a day when the newborn is awake from baseline to 48hrs
measure: screening of other drugs in mother's urine and meconium
timeFrame: baseline and 24hrs to 48hrs after birth
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT00205881: Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Official title: Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hearing Loss
Keywords: HiResolution Bionic Ear
severe to profound hearing loss
bilateral implantation
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.


Eligibility criteria: Inclusion Criteria:

1. No previous implant experience.
2. Age 18 years or older.
3. Postlingual onset of hearing loss.
4. Sensorineural hearing loss of a severe or greater degree in both ears.
5. Normal/patent cochlear anatomy in each ear.
6. English language proficiency.
7. Willingness and ability to participate in all scheduled procedures.

Exclusion Criteria:

No exclusion criteria specified, except for the opposite of inclusion criteria listed above.

Primary outcomes:
measure: Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
timeFrame: 8 months of bilateral cochlear implant use
Secondary outcomes:
measure: HINT Sentences in Noise
timeFrame: 8 months of bilateral cochlear implant use
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Clinic/House Ear Institute
state: California
city: Palo Alto
country: United States
facility: California Ear Institute (Let Them Hear Foundation)
state: California
city: Miami
country: United States
facility: University of Miami - Cochlear Implant Center
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Hearing and Balance Center
state: Florida
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: New York
country: United States
facility: New York University Cochlear Implant Center
state: New York
city: Dallas
country: United States
facility: Dallas Otolaryngology Associates
state: Texas
Study officials:
affiliation: Advanced Bionics
name: Mary Joe Osberger
role: STUDY_CHAIR
References: