louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04782960: Subconjunctival Bupivacaine in Strabismus Surgery
Official title: The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Keywords: Subconjunctival bupivacaine.
Strabismus surgery.
Postoperative analgesia.
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.

Detailed description: 40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

* All patients aged 14 _30 years old with body mass index 18_28kg/m.
* American Anaesthesiologist Association physical states I,II.
* singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.

Exclusion Criteria:

* were patients with chronic pain.
* ocular hypertension.
* inability to communicate.
* history of hematological disease.
* allergy to local anesthetic drugs.

Primary outcomes:
measure: Visual analog scale (VAS) pain score
timeFrame: 5 minutes after extubation
Secondary outcomes:
measure: Nausea and vomiting
timeFrame: 24 hours postoperatively
Other outcomes:
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
measure: Visual analog scale (VAS) pain score
timeFrame: 30 minutes after extubation
measure: Visual analog scale (VAS) pain score
timeFrame: 60 minutes after extubation
measure: Visual analog scale (VAS) pain score
timeFrame: 2 hours after extubation
measure: Visual analog scale (VAS) pain score
timeFrame: 4 hours after extubation
measure: Visual analog scale (VAS) pain score
timeFrame: 6 hours after extubation
measure: Visual analog scale (VAS) pain score
timeFrame: 12 hours after extubation
measure: Visual analog scale (VAS) pain score
timeFrame: 24 hours after extubation
Locations:
Study officials:
affiliation: Fayoum University Hospital
name: Mohammad A Hamed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02254460: Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk
Official title: A Double Blind, Randomized, Two-way Cross-over Study to Investigate the Uptake of Iron From Micronutrient Fortified Powder vs. From Tailored Control in Milk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.


Eligibility criteria: Inclusion Criteria:

* Demonstrates understanding of the study and willingness to participate as evidenced by participants' parents and/or legal guardian's voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
* Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
* Good general and mental health with, in the opinion of the investigator or medically qualified designee
* Child residing in the peri-urban areas of Bangalore city
* Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.

Exclusion Criteria:

* Children in Care (CiC)
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
* Participants with severe anaemia (Haemoglobin \< 8g %) as determined by laboratory results
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
* Recent history (3 months) of serious infections, injuries and/ or surgeries
* Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week) in last 6 months prior to screening visit
* Use of any prescription medications within 15 days prior to screening and throughout the entire duration of the study
* Recent history (within the last 1 year) of alcohol or other substance abuse.

Primary outcomes:
measure: Fractional Iron Absorption
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00390260: Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative Arthroscopy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.


Eligibility criteria: Inclusion Criteria:

* Elective outpatient arthroscopic knee surgery expected to last \<= 90 minutes using general anesthesia
* Patients must experience moderate to severe pain following surgery
* Patient must be in general good health as judged by the primary investigator

Exclusion Criteria:

* Osteoarthritis; rheumatoid arthritis
* Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
* Asthma associated with nasal polyps
* Any arthroscopic knee surgery in the past 6 months

Primary outcomes:
measure: Total Pain Relief over 6 hours following a single oral dose compared to placebo.
timeFrame: 6 hours
Secondary outcomes:
measure: Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206. doi: 10.1185/030079907X162647.
Clinical trial NCT00203060: Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 404
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.


Eligibility criteria: Inclusion Criteria:

Men and women with Parkinson's disease (PD) whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without other known or suspected cause of parkinsonism.

Subjects must be age 35 years or older.

Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.

Exclusion Criteria:

Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease

Primary outcomes:
measure: The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks.
timeFrame: 58 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Pharmaceutical Industries, Ltd.
name: Sheila Oren, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05842460: Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers
Official title: Testing the Impact of an "Ultraprocessed" Front-of-package Warning Label Among Brazilian Consumers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: The Bloomberg Family Foundation, Inc.
First posted: 2023-05-06
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are:

* Do "ultraprocessed" warnings affect Brazilian consumers' intention to purchase products?
* Do "ultraprocessed" warnings affect Brazilian consumers' product perceptions?

Participants will see images of four products carrying either nutrient warning labels (which are currently mandatory in Brazil) or nutrient warning labels alongside an experimental warning label informing that the product is ultraprocessed. Participants will then answer survey questions about each product. Researchers will compare responses between both arms to determine if the "ultraprocessed" warning significantly changes the effect of nutrient warnings.


Eligibility criteria: Inclusion criteria:

* 18 years or older,
* residing in Brazil,
* responsible for at least 50% of the household's grocery purchases.

Exclusion criteria:

* involvement in any pre-testing.

Primary outcomes:
measure: Purchase intentions
timeFrame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Secondary outcomes:
measure: Product healthfulness perceptions
timeFrame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
measure: Product processing status perceptions
timeFrame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
measure: Message effectiveness perceptions
timeFrame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lindsey Taillie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cotter T, Kotov A, Wang S, Murukutla N. 'Warning: ultra-processed' - A call for warnings on foods that aren't really foods. BMJ Glob Health. 2021 Dec;6(12):e007240. doi: 10.1136/bmjgh-2021-007240. No abstract available.
citation: Romero Ferreiro C, Lora Pablos D, Gomez de la Camara A. Two Dimensions of Nutritional Value: Nutri-Score and NOVA. Nutrients. 2021 Aug 13;13(8):2783. doi: 10.3390/nu13082783.
Clinical trial NCT06608160: 68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
Official title: 68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PET / CT
Lung Carcinoma
Immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.

Brief summary: Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.


Eligibility criteria: Inclusion Criteria:

1. Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
2. Pseudoprogression cannot be ruled out in clinical practice;
3. Lung cancer confirmed by pathology or cytology, regardless of pathological type;
4. Fully-informed written consent obtained from patients;
5. Patient ability to comply with protocol requirements;
6. Age 18-75 years;
7. Life expectancy of at least 6 months.

Exclusion Criteria:

1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
2. Intestinal perforation, complete intestinal obstruction;
3. Active phase of hepatitis B；
4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
5. Patients with poor compliance.

Primary outcomes:
measure: Diagnostic performance 1
timeFrame: Follow-up for 4-8 weeks, not exceeding 12 weeks.
Secondary outcomes:
measure: Diagnostic performance 2
timeFrame: Follow-up for 4-8 weeks, not exceeding 12 weeks.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT03545360: Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
Official title: Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-04
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 22 years
* Voluntarily signed informed consent form

Exclusion Criteria:

* Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
* Diabetics dependent on insulin or oral hypoglycemic medications
* Known cardiovascular disease such as arrhythmias, congestive heart failure
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
* Medical, physical or other contraindications for body sculpting/ weight loss
* Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
* Any medical condition known to affect weight levels and/or to cause bloating or swelling
* Active infection, wound or other external trauma to the area to be treated
* Pregnant, breast feeding, or planning pregnant before the end of the study
* Serious mental health illness
* Active or recurrent cancer or current chemotherapy and/or radiation treatment
* Negative affection to heat

Primary outcomes:
measure: Waist circumference reduction
timeFrame: 5 months
Secondary outcomes:
measure: Serious adverse events following the treatment
timeFrame: 5 months
measure: Photo evaluation
timeFrame: 5 months
measure: Subject Satisfaction
timeFrame: 5 months
measure: Therapy discomfort
timeFrame: 2 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Aesthe Clinic
Study officials:
References:
Clinical trial NCT01584960: The Effect of Endurance Training in Patients With Prostate Cancer
Official title: The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Insulin Sensitivity
Body Composition, Beneficial
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2012-04-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer patients with an increase in PSA following radical prostatectomy

Exclusion Criteria:

* severe cardiovascular disease
* severe arthritis
* severe neuropathy
* severe hypertension
* therapy with antidiabetic agents
* other treatment for prostate cancer than radical prostatectomy

Primary outcomes:
measure: PSA doubling time
timeFrame: 2 years
Secondary outcomes:
measure: Insulin sensitivity, body composition and inflammation status
timeFrame: 0 months, 6 months and 24 months of training
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre of Inflammation and Metabolism, Rigshospitalet
Study officials:
affiliation: Centre of Inflammation and Metabolism, Rigshospitalet
name: Bente K Pedersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT02862860: Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function
Official title: Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-1 Diabetes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.

The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:

* LDL oxidation
* HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written consent
* Patients with national health insurance cover

Patients with T1D

* T1D Patients treated with insulin via a pump or multiple injections
* HbA1c \< 9.5 %

Control patients

* Normal fasting glycaemia (\< 6.1 mmol/L)
* Age \> 18 years, matched for sex and age with T1D patients

All patients

* Normal serum HDL cholesterol (\> 1.04 mmol/L in men, \> 1.30 mmol:L in women)
* Serum LDL cholesterol \< 5 mmol/L
* triglyceridemia \< 1.7 mmol/L
* Waist circumference \< 102 cm in men, \< 88 cm in women

Exclusion Criteria:

* Smoking
* Kidney failure (Creatinine clearance\< 60 ml/min/1.73 m2)
* Liver failure
* Dysthyroidism
* Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month
* Antioxidant (vitamin E, dietary supplements, DHA)
* Pregnancy of more than 15d

Primary outcomes:
measure: Average blood glucose
timeFrame: through study completion, an average of 7 days
measure: Time hypoglycemia
timeFrame: through study completion, an average of 7 days
measure: Time hyperglycemia
timeFrame: through study completion, an average of 7 days
measure: Amplitude of glycemic variations
timeFrame: through study completion, an average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: