louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02769325: Atropine in Laparoscopic Gynaecological Surgery
Official title: Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Laparoscopic Surgery
Gynecology
Keywords: atropine
pain, postoperative
Lead sponsor: Clinica Santa Maria
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery

Detailed description: Patients that meet eligibility criteria will receive a standardised general anesthesia based on sevoflurane and opioids and will be randomised in two groups, using computer generated randomisation system. Allocation concealment is established on opaque envelopes that contain random allocation.

Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will be administered.

At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study.

Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care unit (PACU) and 24 postoperative hours by an investigator blinded to study group

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI \<35

Exclusion Criteria:

* Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers

Primary outcomes:
measure: 24 hours morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Visual analog scale at 24 hours
timeFrame: 24 hours
measure: pain visual analog scale at postanesthesia care unit
timeFrame: 2 hours post
measure: number of patients with postoperative nausea and/or vomiting
timeFrame: 24 hours
measure: Patient satisfaction, on a qualitative scale
timeFrame: up to three days
measure: number of patients that refer palpitations
timeFrame: 24 hours
measure: number of patients that refer mouth dryness
timeFrame: 24 hours
measure: number of patients that refer blurred vision
timeFrame: 24 hours
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Santa Maria
Study officials:
References:
Clinical trial NCT06281925: Cryotherapy & Oxaliplatin
Official title: A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Peripheral Neuropathy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
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 primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.

Detailed description: Peripheral neuropathy often manifests as numbness and tingling in the hands and feet, which may be detrimental to the patients' overall safety and quality of life, thereby causing them to stop or delay treatment. Everyday tasks such as walking, buttoning a shirt, or tying shoes can become challenging. Select chemotherapy agents are known to cause significant peripheral neuropathy. Studies have been performed demonstrating efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the body, in relation to paclitaxel. These studies have shown drastic differences between those who receive cryotherapy during treatment and those who do not. There are few studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use of oxaliplatin, which will be undertaken in this study.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years
* Willingness to participate in research
* Diagnosed with stage III colon cancer
* Chemotherapy naïve
* Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.

Exclusion Criteria:

* Pre-existing peripheral neuropathy
* Pre-existing diabetes
* Raynaud's disease
* Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA \> 2)
* Upper extremity amputees
* Specific autoimmune diseases: Guillain-Barre; Lupus; Rheumatoid arthritis; and Sjogren's syndrome

Primary outcomes:
measure: Proportion of Participants with Peripheral Neuropathy at Visit 2
timeFrame: Visit 2 (Day 1)
measure: Proportion of Participants with Peripheral Neuropathy at Visit 3
timeFrame: Visit 3 (Day 21)
measure: Proportion of Participants with Peripheral Neuropathy at Visit 4
timeFrame: Visit 4 (Day 42)
measure: Proportion of Participants with Peripheral Neuropathy at Visit 5
timeFrame: Visit 5 (Day 63)
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sarah Mendez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02628925: Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
Official title: Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale (Nu-DESC DK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: mass screening
Nursing diagnosis
Psychiatric Status Rating Scale
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical staff on 2 different wards

Brief summary: Delirium is one of the most common complications among elderly hospitalized patients, postoperative patients and patients on intensive care units. The reported prevalence is between 11 and 80 %. Delirium is associated with a high morbidity and threefold higher 6-month mortality. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with a high sensitivity and specificity.

The purpose of this study is to translate the Nu-DESC to danish and evaluate afterwards its feasibility and understanding by different medical staff.

Material and methods:

The Nu-DESC will be translated after International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines to Danish by permission of the original author.

The evaluation will be performed, by filling out evaluation forms, where the feasibility and understanding will be rated on a 6 step Likert scale.

Detailed description: Translation of the original tool and evaluation of understanding and feasibility by medical staff.

Eligibility criteria: Inclusion Criteria:

* Medical staff working in the recovery room or orthopedic ward

Exclusion Criteria:

* Medical staff from other wards

Primary outcomes:
measure: Difference in understanding of the content of Nu-DESC DK by different medical staff groups
timeFrame: Within the first week after questionnaire is filled out
measure: Difference in feasibility of the content of Nu-DESC DK by different medical staff groups
timeFrame: Within the first week after questionnaire is filled out
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00451425: Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain
Official title: Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Gain
Keywords: pregnancy
weight gain
obesity
macrosomia
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Excessive weight gain during pregnancy is associated with complications during delivery primarily due to macrosomia (large babies) but also with high levels of weight retention post pregnancy and thereby increased risk of future weight related health problems. The primary aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent Motivational Interviewing (MI), prescription of physical activity and extended information on recommended weight gain during pregnancy in regards to preventing excessive gestational weight gain.


Eligibility criteria: Inclusion Criteria:

* \>18 years,
* Adequate language skills (swedish),
* BMI\>19.9,
* Pregnancy estimated \<16 weeks (LMP),
* Planned for basic pregnancy surveillance (healthy mother).

Exclusion Criteria:

* History of eating disorder,
* History of having a growth restricted child.

Primary outcomes:
measure: The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
timeFrame: 9 months
Secondary outcomes:
measure: Weight retention(kg) up until one year after delivery is compared between study groups.
timeFrame: one year after delivery
measure: Number of fetal and maternal complications in pregnancy is compared between study groups
timeFrame: 9 months
measure: Number of fetal and maternal complications during delivery is compared between study groups
timeFrame: during delivery
measure: Child birth weight and weight development of the child up to one year of age is compared between study groups.
timeFrame: one year
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Modrahalsovarden Orebro lan
Study officials:
affiliation: Region Örebro County
name: Kerstin Nilsson, MD. MD
role: STUDY_CHAIR
References:
citation: Ronnberg AK, Ostlund I, Fadl H, Gottvall T, Nilsson K. Intervention during pregnancy to reduce excessive gestational weight gain-a randomised controlled trial. BJOG. 2015 Mar;122(4):537-44. doi: 10.1111/1471-0528.13131. Epub 2014 Nov 4.
Clinical trial NCT05068622: Gastric Tube in Pyloric Stenosis
Official title: Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Pyloric Stenosis
Respiratory Complication
Keywords: Hypertrophic Pyloric Stenosis
gastric tube
Respiratory Complication
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021

Brief summary: Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.


Eligibility criteria: Inclusion Criteria:

* all patients with hypertrophic pyloric stenosis

Exclusion Criteria:

* refusal of data collection and use from patient's parent or family

Primary outcomes:
measure: occurrence of respiratory complications before surgery
timeFrame: baseline, pre-surgery
Secondary outcomes:
measure: number of : pre-operative vomiting
timeFrame: baseline, pre-surgery
measure: pre-operative comfort
timeFrame: baseline, pre-surgery
measure: pre-operative dehydration
timeFrame: baseline, pre-surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Nord
Study officials:
References:
Clinical trial NCT00002222: A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
Official title: An Open Label Study of the Safety and Tolerability of Valganciclovir, an Oral Prodrug of Ganciclovir, for the Treatment of Cytomegalovirus Retinitis in Subjects With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Ganciclovir
Antiviral Agents
Drug Administration Schedule
Cytomegalovirus Retinitis
Prodrugs
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past. This study also examines the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis.

Detailed description: Patients receive valganciclovir twice a day for 21 days as induction therapy then daily as maintenance therapy. Patients are encouraged to remain on study for at least 3 months and will remain until common study closure.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed with caution:

* Acyclovir.
* Famciclovir.
* Valaciclovir.
* Imipenem-cilastatin.
* Myelosuppressive agents.

Patients must have:

* HIV infection with CMV retinitis.
* Minimum of 4 weeks prior treatment with ganciclovir, foscarnet, or cidofovir.
* Intraocular implant in either or both eyes, as long as CMV retinitis is active in one eye, upon approval by Roche.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms of conditions are excluded:

* Active extraocular CMV disease.
* Severe uncontrolled diarrhea or evidence of malabsorption.

Concurrent Medication:

Excluded:

* Foscarnet.
* Cidofovir.
* CMV hyperimmune globulin.
* Probenecid.

Patients with the following prior conditions are excluded:

* Ocular media opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment.
* Simultaneous participation in another study (unless approved by Roche).

Required:

* A minimum of 4 weeks treatment with ganciclovir, foscarnet, or cidofovir.
* Approval required for prior use of investigational anti-CMV agents.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell AIDS Clinical Trials Unit
state: New York
Study officials:
References:
Clinical trial NCT05388422: Application of 3D Scanner to Measure Physical Size in Patients With Severe Cerebral Palsy
Official title: Physical Measurement in Patients With Severe Cerebral Palsy Using 3D Scanner and Improvement of Manufacturing Techniques for Hip Dislocation Prevention Assistive Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: 3D Scanner
Cerebral palsy
Hip dislocation
Orthotic devices
Protective devices
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner.

Detailed description: 1. Design : Prospective Study
2. Setting: Hospital rehabilitation department and Home
3. Intervention: Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
4. Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes: the hip and knee joint range of motion (ROM), pain intensity, satisfaction and discomfort score for the hip brace, quality of life (QOL) of the patients and their caregivers, and the wearability test.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of cerebral palsy
2. age 1-15 years
3. GMFCS Level IV, V
4. quadriplegia, or diplegia for more than 6 months
5. Patients who have written consent with permission from the child and caregiver.

Exclusion Criteria:

1. Patients who did not agree to participate in the study
2. Patients who refused the examination
3. Patients who had hip surgery experience
4. Patients who were scheduled to undergo surgery during the clinical study
5. Patients who could not be measured with a 3D scanner

Primary outcomes:
measure: Migration index
timeFrame: 1 weeks
Secondary outcomes:
measure: Visual analog scale (Pain index)
timeFrame: 1 weeks
measure: Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
timeFrame: 1 weeks
measure: Likert scale (score)
timeFrame: 1 weeks
measure: Range of motion of hip joint
timeFrame: 1 weeks
measure: wearability test
timeFrame: 1 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Juseok Ryu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01658722: Retrieval of Patient Information After Discontinuation
Official title: A Phase 3b Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN15727-301 and 302 But Did Not Enroll in Study ELN115727-351
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer's Disease
Lead sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2012-08-07
Enrollment: 169
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Alzheimer's disease who discontinued treatment in bapineuzumab Phase 3 clinical studies (ELN115727-301/302/351) or who completed studies ELN115727-301 or 302 but did not enroll in study ELN115727-351

Brief summary: A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.


Eligibility criteria: 1. Signed, dated, and written informed consent obtained from the subject and/or the subject's legally acceptable representative (LAR, if applicable) in accordance with local regulations.
2. Signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations.
3. Subject must have participated in the Study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo).
4. Subject must have been off treatment for at least 12 months prior to Visit 1.
5. Subjects must have a primary caregiver for the duration of the study.
6. Subject's caregiver must have the ability to assess the subject and answer questions over the phone.

Primary outcomes:
measure: Dependence Scale
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: