louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02886377: The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset
Official title: The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optic Neuritis
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 250

Brief summary: To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.

Detailed description: Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to the results of the AQP4-Ab test. All patients with complete medical histories underwent routine neurological examinations, brain MRIs, and ophthalmological examinations, including best corrected visual acuity (BCVA), intraocular pressure, slit lamp and fundus examination, VF and VEP, laboratory testing, including blood routine, HIV HBV HCV Syphilis, mitochondrial DNA sequencing, and a profile of autoantibodies, including antinuclear antibody (ANA), extractable nuclear antigen antibodies (SSA/SSB), rheumatoid factor (RF), anticardiolipin antibodies (ACA), and antithyroglobulin antibody.

Eligibility criteria: Inclusion Criteria:

* Optic neuritis patients

Exclusion Criteria:

* The presence of significant refractive errors (3D of spherical equivalent refraction or 2D of astigmatism), intraocular pressure of 21 mmHg or higher, systemic conditions that could affect the visual system, and a history of ocular trauma or concomitant ocular diseases, including a history of media opacification, ocular pathologies affecting the cornea, lens, retinal disease, glaucoma, or laser therapy. All patients in the study groups had an episode of ON more than six months before the study inclusion time point.

Primary outcomes:
measure: retinal nerve fiber layer thickness
timeFrame: 2013.11-2016.12
Secondary outcomes:
measure: visual field
timeFrame: 2013.11-2016.12
measure: visual evoked potential
timeFrame: 2013.11-2016.12
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: World Health Organization
name: Hui Yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03808077: The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer
Official title: A Randomized Controlled Trial to Compare the Effectiveness of Deep vs. Moderate Neuromuscular Blockade in Reducing Postoperative Pain and Intra-Abdominal Insufflation Pressure During Minimally Invasive Robotic Prostatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
robotic surgery
muscle relaxants
neuromuscular blockade
18-408
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 139
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
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 if there is a difference in intra-abdominal pressure which surgeons use during surgery and post-surgery pain in men who undergo robotic prostate surgery with deep neuromuscular blockade (NMB), compared with moderate NMB.


Eligibility criteria: Inclusion Criteria:

* Adult patients under the age of 80
* American Society of Anesthesiologists Physical Status 1, 2, 3.
* Elective Robotic Prostatectomy
* Patient undergoing surgery at Josie Robertson Surgical Center

Exclusion Criteria:

* Age younger than 18
* Inability to provide informed consent
* Allergy to rocuronium, sugammadex, midazolam, propofol, fentanyl, lidocaine, mannitol (IV Acetaeminophen), IV Acetaminophen, Ketorolac, Morphine, Hydromorphone, Dexamethasone, Zofran, Benadryl, Compazine
* Neuromuscular disease
* Any patient with previous abdominal surgery less than or equal to 20 years prior to scheduled surgery date
* Patients with BMI\>35
* Severe renal impairment (Creatinine clearance \< 30 ml/min)
* Patient receiving Toremifene or any history of receiving Toremifene
* Chronic pain patients
* Patients receiving suboxone
* Patients receiving succinylcholine

Primary outcomes:
measure: Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique
timeFrame: 1 year
measure: Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Rieth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856477: Pharmacogenetic and Antidepressant Treatment in Elderly
Official title: Pharmacogenetic in the Therapeutic Strategy in Depressed Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 28
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.

Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects.


Eligibility criteria: Inclusion Criteria:

* current major depressive disorder
* antidepressant treatment

Exclusion Criteria:

* dextromethorphan contra-indication
* other psychiatric disorder
* kidney failure
* liver failure mini mental State Examination (MMSE)\<18

Primary outcomes:
measure: patient remission
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: pierre Vandel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289977: Immune Responses After Human Subject Challenge With Sand Fly Bites
Official title: Immune Responses After Human Subject Challenge With Sand Fly Bites: Exploratory Study for Selection of Potential Leishmania Vaccine Antigen Candidates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Sandfly
leishmaniasis
immune response
individuals age 18-50
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-02-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female military health care beneficiaries in good health, age 18-50

Brief summary: Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is to evaluate the human immune response to uninfected laboratory raised sand fly bites and select from the immune response to sand fly saliva, possible substances to use for a future vaccine to protect against the parasite leishmaniasis.

Detailed description: Based on travel history and possible exposure, subjects were entered into one of 2 arms, Ph. dubosqui or Lu. lutzomyia controlled sand fly repeated feedings. At baseline a pheresis was done to collect baseline cells. Subjects received sand fly bites on a q2 week schedule for 2 months followed by a q2 months schedule for one year. They had an option to extend for a late recall feeding at 18 months, when a skin biopsy was performed 48 hours after sand fly bites. Currently the study is fully enrolled and all human subject contact is complete. We (laboratory at NIAID) are studying the humoral, cellular immune responses using blood samples, and cytokine expression in the skin biopsy samples.

Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Plans to remain in DC area for at least one year
* willingness to participate in all study procedures
* general good health
* military health care beneficiary
* able to provide informed consent

Exclusion Criteria:

* Prior travel to geographic areas where leishmania transmitting sand flies are common
* positive antibody to sand fly saliva on screening blood test
* pregnancy
* elevated serum IgE
* history of chronic medical illness
* adult history of treatment requiring anemia
* large reactions to insect bites
* history of multiple vasovagal reactions to phlebotomy
* difficult venous access for phlebotomy
* Taking medications that could interfere with immune responses

Primary outcomes:
measure: Human Th1 immune response to specific sand fly salivary proteins
timeFrame: 6-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Naomi E Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529177: Metformin for the Treatment of Unexplained Oligozspermia
Official title: Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Metformin
Insulin resistance
male infertility
unexplained Oligozspermia
Clomiphene citrate
Unexplained azoospermia
Lead sponsor: The Egyptian IVF-ET Center
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 600
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.

Detailed description: Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.

Eligibility criteria: Inclusion Criteria:

* oligospermia ( \< 10 million per mil-litter )
* normal FSH
* high insulin

Exclusion Criteria:

* abnormal karyotype
* obstructive azoospermia

Primary outcomes:
measure: sperm count
timeFrame: 6 months
Secondary outcomes:
measure: abnormal forms of spermatozoa
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Egyptian IVF-ET center
Study officials:
affiliation: The Egyptian IVF-ET Center
name: Ragaa mansour, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836077: Pecha Kucha Method Effects on Posttraumatic Growth and Psychological Resilience
Official title: Education Given to Breast Cancer Patients Receiving Chemotherapy With Pecha Kucha Method Effects on Posttraumatic Growth and Psychological Resilience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Growth
Psychological Resilience
Breast Cancer Patients
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to investigate the effect of the training given to breast cancer patients receiving chemotherapy with pecha kucha method on posttraumatic growth and psychological resilience.

Detailed description: This study is a randomized controlled trial planned to investigate the effect of the training given to breast cancer patients receiving chemotherapy with the pecha kucha method on posttraumatic growth and psychological resilience.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* At least one course of adjuvant chemotherapy prior to treatment,
* Literacy
* Communicable patients
* Patients who agreed to participate in the study

Exclusion Criteria:

* With a psychiatric diagnosis,

Primary outcomes:
measure: Post Traumatic Growth Inventory
timeFrame: Before the training
measure: Post Traumatic Growth Inventory
timeFrame: 1 month after the training
measure: Post Traumatic Growth Inventory
timeFrame: 2 month after the training
measure: The Brief Resilience Scale
timeFrame: Before the training
measure: The Brief Resilience Scale
timeFrame: 1 month after the training
measure: The Brief Resilience Scale
timeFrame: 2 month after the training
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zülfünaz Özer
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Zülfünaz Özer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakir N, Gun Kakasci C, Demir C. The effect of training with the Pecha Kucha method on the attitudes of chronically ill women toward COVID-19 vaccination. Women Health. 2022 Oct-Dec;62(9-10):809-817. doi: 10.1080/03630242.2022.2146834. Epub 2022 Nov 14.
Clinical trial NCT05707247: Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication
Official title: Evaluation of the Feasibility of an Expert Decision Support System for Patients Regarding the Optimization of the Management of Drugs With Conditional Administration in the Surgical Department: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Situation
Keywords: prototype software
patient interface
experimental medical device
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 37
Sex: ALL
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 experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems.

The study hypothesis is that the clinical use of the experimental device is feasible.


Eligibility criteria: Inclusion criteria:

* Male or Female 18 years or older (no upper age limit)
* Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg
* Patient understanding and reading French
* Subject neurosensorially able of interacting with a tactile electronical interface
* Subject able to understand research objectives, risks and provide dated and signed informed consent
* Subject covered by a health insurance scheme

Exclusion criteria:

* Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface
* Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.)
* Pregnant or lactating woman (on declaration)
* Patient under safeguard of justice, under guardianship, under curatorship

Primary outcomes:
measure: To evaluate the feasibility of the INSAMED computer tool
timeFrame: Day 2 post operative
Secondary outcomes:
measure: Evaluate the time delay, in usual care setting, of rescue drug administrations after surgery, to confirm the interest of developing expert systems to improve the existing one.
timeFrame: 60 minutes after software activation
measure: Assess patient satisfaction with usual care
timeFrame: 60 minutes after software activation.
measure: Assess patient satisfaction with the ease of use of the experimental device
timeFrame: 60 minutes after software activation.
measure: assess the security of the device
timeFrame: Day 2 post operative
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Eric NOLL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02722447: Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
Official title: Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 1100
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 treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.


Eligibility criteria: Inclusion Criteria:

* Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses).

Exclusion Criteria:

* Age \< 18 years
* Any absolute contraindication to anticoagulant treatment
* Pregnancy or breast-feeding
* Presence of active cancer
* Concomitant presence of proximal deep vein thrombosis or pulmonary embolism
* Any concomitant indication for long-term anticoagulant treatment
* Creatinine clearance ≤30 ml/min, according to Cockcroft-Gault equation
* Cirrhosis Child-Pugh score B or C
* Liver disease associated with coagulopathy and high risk of bleeding
* Any other contraindication to rivaroxaban as per local SmPC
* Failure to provide written informed consent

Primary outcomes:
measure: Rate of recurrent venous thromboembolism
timeFrame: 24 months
Secondary outcomes:
measure: Rate of major bleeding events
timeFrame: Until 2 days from the last intake of the study drug
measure: Rate of clinically relevant non-major bleeding events
timeFrame: Until 2 days from the last intake of the study drug
measure: Percentage of patients with residual vein occlusion
timeFrame: 3 months and 24 months
measure: Rate of cardiovascular events
timeFrame: 24 months
Other outcomes:
Locations:
city: Faenza
country: Italy
facility: Ospedale di Faenza
city: Padua
country: Italy
facility: Ospedale di Padova
city: Pieve di Soligo
country: Italy
facility: Ospedale di Pieve di Soligo
city: Reggio Emilia
country: Italy
facility: Ospedale di Reggio Emilia
city: Siena
country: Italy
facility: University of Siena
city: Varese
country: Italy
facility: Ospedale di Circolo
city: Varese
country: Italy
facility: University Of Insubria
Study officials:
References:
Clinical trial NCT01114347: Prevention of Nosocomial E. Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: an Evaluation of Cranberry Gel Capsules
Official title: Prevention of Nosocomial Escherichia Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: a Randomized, Prospective, Double Blind Study for the Evaluation of Cranberry (Vaccinium Macrocarpon) Gel Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cross Infection
Bacteriuria
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.


Eligibility criteria: Inclusion Criteria:

* Patient is cared for by the department of the Gynecology at the Nîmes Unversity Hospital
* The patient is programmed for surgery with placement an indwelling catheter for 48 hours with a sterile urinary cytobacteriologic exam at inclusion

Exclusion Criteria:

* the urinary cytobacteriologic exam at inclusion is positive
* the patient is taking antivitamin K
* the patient is taking antibiotics
* history of urolithiasis
* the patient refuses to participate
* the patient is pregnant or nursing
* the patient is not associated with a social security system (no insurance)
* the patient is under guardianship

Primary outcomes:
measure: Presence/absence of Asymptomatic bacteriuria
timeFrame: 15 days post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References: