louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04354909: Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis
Official title: Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Infectious Active Uveitis
Keywords: Non infectious active uveitis
Soluble-CD95-Ligand
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non-infectious uveitis

Brief summary: The study aims at defining the role of soluble CD95 Ligand in the physiopathology of the non-infectious uveitis. Soluble CD95 Ligand might have a prognostic interest as well as potential for the discovery of new therapeutic strategies

Detailed description: Non-Infectious active uveitis is a severe inflammatory ocular disease which can expose to the blindness. Actually, the knowledge of the physiopathology of uveitis stay poorly. CD95 Ligand (CD95-L) belongs to a TNF (tumor necrosis factors) receptor family. It knows to play a preponderant role to maintain the eye immune privilege. In particular conditions depending on immunologic environment, CD95-L has pro-inflammatory properties and can interact with Th17 lymphocytes and neutrophils, two cells implicated in non-infectious uveitis. The hypothesis is that s-CD95-L levels might be a prognostic factor in non-infectious uveitis and the study of the molecular mechanisms involved could provide new therapeutic targets.

This study will recruit 100 patients with non-infectious uveitis followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected during to assess s-CD95-L. Fundamental research will be realized on patients' sample to evaluate underlying molecular mechanisms.

Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, accordingly to usual care.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-infectious uveitis according to the SUN (Standardization of the Uveitis Nomenclature) working Group;
* Age ≥ 18 years;
* being affiliated to health insurance,
* willing to participate.

Exclusion Criteria:

* Pregnant or breastfeeding women,
* patient under legal protection measure ,
* poor understanding of the French language

Primary outcomes:
measure: levels of s-CD95-L
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between levels of s-CD95-L and Disease activity score
timeFrame: Baseline, Month 3
measure: Th17 dosage
timeFrame: Baseline, Month 3
measure: polynuclear neutrophils levels
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
Clinical trial NCT02436109: Ultrasound Guidance for Epidural Analgesia and Anesthesia
Official title: Ultrasound Guidance for Epidural Analgesia and Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epidural Space Depth
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Normally, before the needle is placed in a patients' back, the anesthesiologist will feel between their back bones with his/her fingers to find the right spot for the needle. This study will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

Detailed description: The investigators will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

Eligibility criteria: Inclusion Criteria:

* term pregnancy
* elective cesarean

Exclusion Criteria:

* scoliosis
* high bmi

Primary outcomes:
measure: epidural space depth
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765309: A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders
Official title: A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Tissue expanders
Botulinum toxin
Botox
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.


Eligibility criteria: Inclusion Criteria:

* Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion Criteria:

* Unwilling to receive study injections

Primary outcomes:
measure: Difference between preoperative and postoperative pain scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Joyce K Aycock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250809: Scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective Controlled Randomized Study
Official title: CVC Pros and Cons of Scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Other Female Genital
Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 15
Sex: FEMALE
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: CVC Pros and Cons of scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective Controlled Randomized Study


Eligibility criteria: Inclusion Criteria:

1. Patients who require the placement of a central venous catheter for medical purposes and have an absence of infection.

Primary outcomes:
measure: Pros and Cons of scheduled Triple-lumen Central Venous Catheter Exchange
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Harriet Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04313309: Evaluating Chronic Pain Management Program
Official title: Evaluating Outcomes of a Integrative Yoga Therapy for People With Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 30
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: This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.


Eligibility criteria: Inclusion Criteria:

* Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology
* Self referred or referred willing to give informed consent

Exclusion Criteria:

* Autoimmune disorder
* Malignancies
* Cognitively impairment

Primary outcomes:
measure: Severity of pain and its impact on functioning: Brief Pain Inventory
timeFrame: From baseline to 6-week post intervention
Secondary outcomes:
measure: General Quality of Life: Nottingham Health Profile
timeFrame: From baseline to 6-week post intervention
measure: Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)
timeFrame: From baseline to 6-week post intervention
Other outcomes:
Locations:
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_CHAIR
References:
Clinical trial NCT04124809: Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage
Official title: Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blastocyst Disintegration
Keywords: blastocyst
Vitrification
artificial collapse
survival rate
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2019-10-11
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.
Primary purpose: BASIC_SCIENCE

Brief summary: : This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.

Detailed description: One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.

Eligibility criteria: Inclusion Criteria:

* Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4

Exclusion Criteria:

* bad quality blastocysts expansion rate less than 3

Primary outcomes:
measure: survival rate
timeFrame: immediately after thawing
measure: survival rate
timeFrame: 140 min after thawing
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Hawaa Fertility Center
state: Qalyubiya
Study officials:
affiliation: HFC
name: sahar A Eissa, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01184209: Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency
Official title: Prospective Cohort-study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: Charite University, Berlin, Germany
First posted: 2010-08-18
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with chronic secondary or primary adrenal failure

Brief summary: Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.

Detailed description: This is a prospective study following patients with chronic adrenal insufficiency by contacting them every 6 months via questionnaires and telephone. QUestionnaires assess incidence and causes of adrenal crisis, frequency of hospitalization.

Eligibility criteria: Inclusion Criteria:

* chronic primary or secondary adrenal insufficiency requiring glucocorticoid substitution therapy

Exclusion Criteria:

* adrenocortical carcinoma
* long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other reasons than adrenal insufficiency
* age \< 18 years

Primary outcomes:
measure: incidence of adrenal crisis
timeFrame: during study period
Secondary outcomes:
measure: mortality
timeFrame: during study period
Other outcomes:
measure: hospital admission
timeFrame: during study period
Locations:
city: Berlin
country: Germany
facility: University of Berlin
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
Study officials:
affiliation: University of Wuerzburg
name: Bruno Allolio, MD
role: STUDY_CHAIR
References:
citation: Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.
Clinical trial NCT00757809: Study Evaluating The Tolerability Of Multiple Doses Of HKI-272
Official title: A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female (non-child bearing potential) subjects
* Ages 18-50.

Primary outcomes:
measure: Occurence of diarrhea
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT03655509: Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm
Official title: Searching a Dysfunction of Corticotropic and Thyrotropin Axis During the Acute Phase ( ≤48h ) of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm: Impact on the Incidence of Complications and Recovery at 1 Month
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subarachnoid Hemorrhage
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. Impact on the incidence of complications and recovery are evaluated at 1 month.

Blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma ACTH at 8 am and thyroid hormones (T3, free T4 , and TSH). Dynamic test ACTH stimulation (test Synacthene) with renewal of serum cortisol to H + 1 (60min). Evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. GOS to 1 month.

Detailed description: Searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. Impact on the incidence of complications and recovery are evaluated at 1 month.

Blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma ACTH at 8 am and thyroid hormones (T3, free T4 , and TSH). Dynamic test ACTH stimulation (test Synacthene) with renewal of serum cortisol to H + 1 (60min). Evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. GOS to 1 month.

Eligibility criteria: Inclusion Criteria:

* Acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (Glasgow coma scale \>=9)

Exclusion Criteria:

* Pituitary failure
* Patient with corticosteroids drugs or antithyroid drugs

Primary outcomes:
measure: ACTH stimulation test
timeFrame: 2 days
Secondary outcomes:
measure: ATCH levels
timeFrame: 2 days
measure: plasma cortisol
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00666809: Vardenafil in Tinnitus
Official title: Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Keywords: Vardenafil,
Tinnitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is incidental evidence (casuistic findings) that the treatment with vardenafil of male patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement of their tinnitus.

Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic tinnitus.


Eligibility criteria: Inclusion Criteria:

* Chronic subjective cochlear tinnitus
* No treatment of tinnitus within 4 weeks prior to study entry
* Duration of tinnitus \> 3 months

Exclusion Criteria:

* Acute tinnitus
* Intermittent tinnitus
* History of M. Menieré
* History of conductive deafness
* History of psychogenic deafness
* History of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant)
* Patients diagnosed of multiple sclerosis
* History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
* Nitrates or nitric oxide donors
* Any other concurrent treatment of tinnitus during study
* pregnant and breast-feeding women
* women with child-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended)
* Other exclusion criteria apply according to the Summary of Product Characteristics

Primary outcomes:
measure: Total score of the Tinnitus
timeFrame: 4 times in 16 weeks
Secondary outcomes:
measure: Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
timeFrame: 16 weeks
measure: Quality of life (SF 36 Questionnaire)
timeFrame: 16 weeks
measure: Serum human chorionic Gonadotropin (hcG), pregnancy test
timeFrame: once at screening
measure: Safety and tolerability
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
state: Berlin / 285
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04081909: Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
Official title: Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intravenous Anesthesia
Keywords: Opioid
Ketamine
Dexmedetomidine
Sevoflurane
Perioperative complications
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Peri-operative opioid administration has long been one of the three pillars of 'balanced anaesthesia',over the span of just a few years,opioids were widely used in perioperative analgesia because of pain as the fifth vital sign.However, opioid administration is not without concern and is associated with many side-effects such as constipation, urinary retention, respiratory depression and postoperative nausea and vomiting .Cleft lip,palate,alveolus are common craniofacial abnormalities and usually require surgical repair.These patients have risks for various perioperative complications due to their young age and craniofacial abnormalities.

This study was designed to compare the effects of opioid based anesthesia（OBA） and opioid free anesthesia(OFA )on perioperative complications in patients with in cleft lip,palate,alveolus surgery, including respiratory depression, postoperative nausea and vomiting, hemodynamic effects, etc.


Eligibility criteria: Inclusion Criteria:

* American Society Anesthesia I, II；
* Age between 3 months and 12 years;

Exclusion Criteria:

* allergy to anesthetic and analgesic drugs;
* history of neuromuscular;
* renal, neurological, hepatic disease;
* cardiopulmonary diseases;
* bradycardia

Primary outcomes:
measure: Respiratory depression
timeFrame: 24 hours following surgery
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting in the recovery room
timeFrame: first 2 postoperative hours
measure: Incidence of postoperative nausea and vomiting on day 1
timeFrame: 1st postoperative day
measure: Severity of postoperative pain
timeFrame: 24 hours
measure: Severity of postoperative pain
timeFrame: 24 hours
measure: hemodynamic changes
timeFrame: Intraoperative
measure: hemodynamic changes
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References: