louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00200122: Restore Claims Characterization Study
Official title: Restore Claims Characterization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.


Eligibility criteria: Inclusion Criteria:

* Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
* Primary pain in the lower half of the body.

Exclusion Criteria:

* Requires, or will in the future, diathermy treatments.
* Had implanted spinal cord stimulation system within the last six months.

Primary outcomes:
measure: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Secondary outcomes:
measure: Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Contact Medtronic for Exact Location
state: Illinois
city: Indianapolis
country: United States
facility: Contact Medtronic for Exact Location
state: Indiana
city: Kansas City
country: United States
facility: Contact Medtronic for Exact Location
state: Missouri
city: Syosset
country: United States
facility: Contact Medtronic for Exact Location
state: New York
city: Eugene
country: United States
facility: Contact Medtronic for Exact Location
state: Oregon
city: Dallas
country: United States
facility: Contact Medtronic for Exact Location
state: Texas
city: San Antonio
country: United States
facility: Contact Medtronic for Exact Location
state: Texas
city: Huntington
country: United States
facility: Contact Medtronic for Exact Location
state: West Virginia
Study officials:
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Clinical trial NCT03899922: Monitoring Drug-induced Uveitis
Official title: Monitoring Drug-induced Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Uveitis Drug-Induced
Eye Diseases
Uvea--Diseases
Keywords: Uvea toxicity
chemotherapies
drugs
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

Brief summary: Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed description: Several drugs and chemotherapies seem to have an impact on the eyes and are responsible of uveitis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by uveitis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility criteria: Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 01/04/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs
timeFrame: to 01/04/2019
Secondary outcomes:
measure: Causality assessment of reported uveitis according to the WHO system
timeFrame: to 01/04/2019
measure: All relevants statisticals associations between type of uveitis and the category of drug
timeFrame: to 01/04/2019
measure: All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs
timeFrame: to 01/04/2019
measure: Duration of treatment when uveitis happen (role of cumulative dose)
timeFrame: to 01/04/2019
measure: All relevants statisticals associations between drug-drug interactions and adverse events
timeFrame: to 01/04/2019
measure: All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis
timeFrame: to 01/04/2019
measure: All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event
timeFrame: to 01/04/2019
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Study officials:
References:
Clinical trial NCT02510222: Magnesium Therapy in Children With Cerebral Palsy
Official title: Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: child
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial.

The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.

Detailed description: Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy.

Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family.

The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy.

Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.

Eligibility criteria: Inclusion Criteria:

* Age below12 years.
* Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch.
* Acceptance of caregivers to participate in the study and signing the written consent.
* Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).

Exclusion Criteria:

* Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy).
* Gastrostomy tube feeding.
* Joint contractures.
* Congenital malformations.
* Suspected inborn error of metabolism.
* Suspected inherited neurologic disease.
* Care giver's refusal to participate in the study.
* Occurrence of side effects of oral magnesium sulfate.
* Patients with cardiac, renal, GIT problem or chronic diarrhea.

Primary outcomes:
measure: Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria
timeFrame: 1 month
Secondary outcomes:
measure: Improvement in H/M ratio in H-reflex by electrophysiologic assessment
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Hospital, Faculty of Medicine, Ain Shams University
Study officials:
affiliation: Pediatric department, Faculty of Medicine , Ain Shams University
name: Sahar MA Hassanein, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00945022: Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Official title: Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Dryness
General Surgery
Keywords: General Surgery
Lead sponsor: IMD Tech Ltd
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. The current management involves the wetting of patient's lips using wet bandage. This action is dependent on the presence of a family member or a nurse, which is not always possible. Many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery.

The investigated Lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.


Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for surgery under general anesthesia.
* Male/female age 18 and up.
* Subject able to comprehend and give informed consent for participation in this study
* Subject must sign the Informed Consent Form.

Exclusion Criteria:

* Subjects who have any form of suspicious lesion in treatment target area.
* Pregnant or lactating Subjects
* Subjects with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in treatment target area.
* Eczema or dermatitis in treatment target area
* Subjects on drugs or psychologically determined unsuitable for the study.
* Subject is suffering extreme general weakness.
* Subject objects to the study protocol.
* Concurrent participation in any other clinical study
* Physician objection

Primary outcomes:
measure: The safety of using the Lipsus device for oral wetting will be established by physician's assessment/observation of adverse events (signs of pain, allergies, infection or any adverse effect).
timeFrame: 2 days
Secondary outcomes:
measure: The efficacy of using the Lipsus device for oral wetting will be established by Level of oral dryness improvement measured by VAS oral dryness questionnaire.
timeFrame: 2 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaari Zedek Medical Center
Study officials:
affiliation: Shaari Zedek Medical Center, Jerusalem
name: Alexander Yuskavitch, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815022: Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia
Official title: Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery
Keywords: Temperature
Spinal anesthesia
Cesarean section
Cephalad sensory blockade
Regional anesthesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 400
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.


Eligibility criteria: Inclusion Criteria:

1. Nulliparous women
2. \> 18 years and \< 45 years

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years or older than 45 years
3. Those who were not willing to or could not finish the whole study at any time
4. Alcohol addictive or narcotic dependent patients
5. Subjects with a nonvertex presentation
6. Diagnosed diabetes mellitus and pregnancy-induced hypertension
7. Twin gestation and breech presentation
8. Pregnant fever

Primary outcomes:
measure: Maximum cephalad sensory blockade to pinprick, cold and touch
timeFrame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
Secondary outcomes:
measure: Velocity of the sensory blockade at identical body position
timeFrame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
measure: The total dose of phenylephrine required to maintain baseline arterial blood pressure
timeFrame: From the delivery of anesthetic mixture to 25 min after spinal anesthesia
measure: Time interval of the occurrence of the hypotension
timeFrame: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01460225: Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Official title: Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Idiopathic Constipation
Keywords: constipation
chronic idiopathic constipation
no prior history of surgery to the colon
not on any type of medication that could alter gastrointestinal motility or transit
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2011-10-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.


Eligibility criteria: Inclusion Criteria:

* chronic idiopathic constipation

Exclusion Criteria:

* medications that slow gastrointestinal (GI) motility
* prior surgery to the GI tract

Primary outcomes:
measure: Gastric Emptying
timeFrame: Day 1 and Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT05127525: EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)
Official title: Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Branch Retinal Vein Occlusion
Glaucoma/Closed Angle Glaucoma
Lead sponsor: iRenix Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 centers in the United States (US).

Detailed description: Intravitreal injection therapy (IVT) of anti-vascular endothelial growth factor (VEGF) agents has transformed the treatment landscape of several retinal diseases, including exudative (wet) macular degeneration, retinal vein occlusion, diabetic macular edema, and choroidal neovascularization. The most common adverse effects of IVT occur due to the side effects of Povidone-Iodine 5% (PI; brand name: Betadine® 5%; Alcon, Fort Worth, TX), the antiseptic placed on the ocular surface prior to each injection. PI is nearly universally used to prevent ocular infection (endophthalmitis). PI leads to marked corneal epithelial toxicity in humans,6, 7 resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT. Post-IVT pain is severe enough to require oral analgesics in up to 30% of patients and is a frequent cause of treatment discontinuation. Therefore, there is an unmet need in ophthalmology for a potent ocular antiseptic with a superior safety profile.

Eligibility criteria: Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
4. Currently receiving intravitreal steroid injections
5. Concurrent participation in another clinical trial

Primary outcomes:
measure: Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT
timeFrame: 2 hours post-injection
Secondary outcomes:
measure: Telephone questionnaire regarding patient-reported post-injection pain
timeFrame: 2 hours post-injection
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida
state: Florida
Study officials:
affiliation: iRenix Medical
name: Stephen Smith, MD, MS
role: STUDY_CHAIR
References:
Clinical trial NCT05036525: Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.
Official title: Evaluation of the Efficacy and Safety of a High Molecular Weight Native Hyaluronic Acid Gel (HANBIO BarriGel) in Adhesion Prevention After Open Thyroidectomy: a Prospective, Randomized Controlled, Single Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesion
Thyroid Diseases
Lead sponsor: HAN Biomedical Inc
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions

Detailed description: The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.

Eligibility criteria: Inclusion Criteria:

* Male and female between 20 and 70 years of age.
* Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
* Naïve patients to thyroid surgery.
* Subjects are willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

* Pregnant or lactating female patients.
* Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse.
* Patients with previous neck radiotherapy within 1 year.
* Concurrent diseases/conditions which will be unable to evaluate the outcomes.
* Patients receiving any adhesion prevention adjuvant.
* Previous history of Keloid or hypertrophic scar.
* Anticoagulant used within a week from surgery.
* Subjects are hypersensitive to sodium hyaluronate.
* Participate in another clinical trial within 1 month.
* Patients presence of surgical site infection.
* Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.

Primary outcomes:
measure: Dysphagia Handicap Index (DHI)
timeFrame: Preoperative 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: