louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01714960: Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
Official title: Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers and Glaucoma Patients
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2).
* To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.


Eligibility criteria: Inclusion Criteria:

For stage 1:

- Healthy volunteers

For stage 2:

- Glaucoma patients

Exclusion Criteria:

For stage 2:

- Any relevant eye disease other than glaucoma

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Day 1 up to day 23
Secondary outcomes:
measure: Area under the curve (AUC)
timeFrame: Day 1 to day 17
measure: Maximal plasma concentration (Cmax)
timeFrame: Day 1 to day 17
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH, Early Phase Clinical Unit
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Medical Expert
role: STUDY_DIRECTOR
References:
Clinical trial NCT05930860: Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
Official title: Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Keywords: Endoscopic Submucosal Dissection
Endoscopic Resection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with gastric superficial neoplasms that can be treated by ESD according to ESGE guidelines or with gastric neoplasm outside of latest ESD guidelines criteria that are unfit for surgery.

Brief summary: Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.
* Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery

Exclusion Criteria:

* Final diagnosis of non neoplastic lesion.
* Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
* Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.

Primary outcomes:
measure: En bloc resection rate
timeFrame: 10 years
measure: R0 resection rate
timeFrame: 10 years
measure: Curative resection rate
timeFrame: 10 years
measure: Complication rate
timeFrame: 10 years
measure: Recurrence rate
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Federico Barbaro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02936960: Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Pancreatic Masses
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients undergoing EUS for the diagnosis and staging of a pancreatic mass will be recruited in this study at Qilu Hospital, Shandong University.

Brief summary: The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria for the characterization of pancreatic masses, with histopathological correlation, and to perform the validation of these criteria.


Eligibility criteria: Inclusion Criteria:

* patients with any pancreatic mass

Exclusion Criteria:

* Patients aged \<18 years or \>80 years
* Known allergy to fluorescein dye
* Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
* Pregnancy or breastfeeding
* Inability to provide informed consent

Primary outcomes:
measure: The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02821260: Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children
Official title: Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-07-01
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric epilepsy requiring surgical treatment

Brief summary: The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children.

Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication.

On average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. Beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist .

Therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients.

The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.


Eligibility criteria: Inclusion Criteria:

* Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France)

Exclusion Criteria:

* Parental opposition to the participation of their child to the study

Primary outcomes:
measure: Number of seizures
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT03906760: Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall
Official title: Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Bladder Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the gynecological surgery departments of the University Hospital Center of the Civil Hospitals of Lyon: Lyon Sud.

Brief summary: Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

Detailed description: PURPOSE: to retrospectively evaluate on MRI the local staging with assessment of ureteral orifices extension in bladder endometriosis./ MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 39 patients operated for bladder endometriosis over a 6 years period in 3 university Lyon hospitals were reviewed. Two experienced readers reported the vesical repletion volume, the largest lesion size, the location and extension of the lesion within the bladder wall, the distance between the ureteral orifices and the lesion when the vesicovaginal wall was involved, the presence of muco-sub mucosal complex edema and the association with external adenomyosis. MR images were compared with surgical and pathological findings. Efficacy parameters were calculated with 95% confidence interval (CI).

Eligibility criteria: Inclusion Criteria:

* Patient operated for pelvic endometriosis with bladder resection.
* Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes

Exclusion Criteria:

* Refusal to use clinical data and exploration acquired
* Absence of interpretable preoperative pelvic MRI

Primary outcomes:
measure: Comparison of MRI data with intraoperative data and anatomopathology.
timeFrame: Through bladder endometriosis surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie
Study officials:
References:
Clinical trial NCT00984360: Study of Naltrexone for Methamphetamine Addiction
Official title: A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Keywords: Meth
Methamphetamine Addiction
Methamphetamine Treatment
Naltrexone
Vivitrol
A118G
OPRM1
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form

Primary outcomes:
measure: MA (-) Urine Samples
timeFrame: Twice weekly for 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Addiction & Pharmacology Research Laboratory
state: California
Study officials:
affiliation: California Pacific Medical Center
name: John Mendelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03308760: Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
Official title: Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Unilateral Rupture of the Achilles Tendon
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU

Brief summary: Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.


Eligibility criteria: Inclusion Criteria:

* persons informed about the research
* sportsmen and women (competition or leisure, practiced \> 3h/week)
* Between 18 and 45 years old
* First episode of acute traumatic unilateral rupture of the Achilles tendon
* Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital
* Identical post-operative immobilisation programme for 6 weeks
* Absence of major post-operative complications delaying the rehabilitation

Exclusion Criteria:

* persons without national health insurance cover
* concomitant joint disease that could be aggravated by the tests
* heart disease/contra-indication to effort required during the isokinetic test
* management other than open surgery (orthopaedic, functional, percutaneous surgery, ...)
* Rupture of the contralateral tendon
* Contra-indication for the use of the Biodex S4 pro

Primary outcomes:
measure: Muscle strength
timeFrame: 6 months
measure: Postural parameters measured using a stabilometry platform
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05725460: Ultrasound Guided Median Nerve Hydrodissection Using Dextrose
Official title: Efficacy of Dextrose 5% in Comparison With Steroid in Median Nerve Ultrasound Guided Hydrodissection in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Iraqi Board of medical specialties
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection
Primary purpose: TREATMENT

Brief summary: to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome

Detailed description: in some cases there is prohibition to use steroid with example the patient rejection to use steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of dextrose 5%, unleash the median nerve for the surrounding structure and short follow up planned to be 2 weeks

Eligibility criteria: Inclusion Criteria:

severe carpal tunnel syndrome failed medical management -

Exclusion Criteria:

previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus

-

Primary outcomes:
measure: pain relief in 2 weeks follow up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad Medical City
Study officials:
References:
Clinical trial NCT04768660: Effects of Chewing Gum Against Postoperative Ileus
Official title: The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Neoplasm
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy

Detailed description: Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.

This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Eligibility criteria: Inclusion Criteria:

1. Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

Exclusion Criteria:

* 2. Ongoing treatment for mental disease 3. Diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function 4. Ongoing abuse of alcohol or other drugs 5. Previously known allergies to the content of chewing gum 6. Additional surgery after primary surgery.

Primary outcomes:
measure: First flatus after surgery
timeFrame: (with in the first 21 days)
measure: Length of hospital stay
timeFrame: (with in the first 21 days) ]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04832360: Testing Financial Incentive Interventions in Dyadic-Smoker Couples
Official title: Testing Financial Incentive Interventions in Dyadic-Smoker Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples \[DSCs\]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control \[CTL\], dyadic target \[DT\] FIT or single target \[ST\] FIT) and tracked across 3 months. The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up.

Detailed description: The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples \[DSCs\]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control \[CTL\], dyadic target \[DT\] FIT or single target \[ST\] FIT) and tracked across 3 months. During this time, participants will complete a baseline session and a follow-up. Between these visits, all participants will have access to a voluntary brief cessation program (i.e., online psychoeducation created for this study using Beat the Pack materials and resources from NCI, NIH + Nicotine Replacement Therapy \[NRT\]). The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up. In the ST condition, one member of each couple (i.e., the target) will receive monetary incentives; in the DT condition, both members of the couple will receive monetary incentives. This design allows for preliminary consideration of FITs in DSCs and tests whether FITs for both members of the dyad synergistically enhances outcomes.

Eligibility criteria: Inclusion Criteria:

both members:

* age of 18+
* smoke 5+ combustible cigarettes/day
* may not have participated in pilot study

Exclusion Criteria:

* \< 8th grade capacity to read/write in English
* hospitalization in recent 6 months
* current drug or alcohol use disorder
* psychotic symptoms
* medical exclusion for use of NRT

Primary outcomes:
measure: Smoking Abstinence
timeFrame: Follow-up study session 3 months post-baseline session
measure: Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples
timeFrame: Through study recruitment and study completion, an average of five months
measure: Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples
timeFrame: Through study recruitment and study completion, an average of five months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Michelle R vanDellen, PhD
role: PRINCIPAL_INVESTIGATOR
References: