louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04874675: An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery
Official title: A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Impacted Third Molar Tooth
PAIN
Lead sponsor: University of Zimbabwe
Sponsor class: OTHER
Collaborators: name: UZ-CHS-PERFECT
First posted: 2021-05-06
Enrollment: 78
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: Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .

Detailed description: Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.

Eligibility criteria: Inclusion Criteria:

* patients older than 18 years of age
* patients undergoing third molar extractions
* patients with or willing to get orthopantomogram for assessment of impacted third molars

Exclusion Criteria:

* patients younger than 18 years
* patients not willing to consent to the study
* patients with associated co-morbidities
* patients not willing to undergo radiological evaluation
* patients allergic to medications used in the study
* pregnant patients

Primary outcomes:
measure: post operative pain
timeFrame: within 7 days post extraction
Secondary outcomes:
measure: Time rescue medication is used
timeFrame: within 7 days post extraction
measure: cheek swelling
timeFrame: with in 7 days post extraction
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Dr Silas bere
Study officials:
References:
Clinical trial NCT06780475: Validation of in Vitro Method for Anti-MCPyV Immunotherapy on Patients With Cutaneous Merkel Cell Carcinoma
Official title: Validation of in Vitro Method for Anti-MCPyV Immunotherapy on Patients With Merkel Cell Carcinoma of Skin
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Merkel Cell Carcinoma of Skin
Keywords: Merkel Cell Carcinoma of Skin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2025-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or with an active follow-up beside dermatologist.

Brief summary: The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Detailed description: The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years old;
* Diagnosed with Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or an active follow-up;
* Informed for the study and no-opposed for participation;
* Affiliated with a social security scheme or in an equivalent situation.

Exclusion Criteria:

* Patients ongoing another interventional clinical trial;
* Patients under guardianship or trusteeship;
* Pregnancy or breastfeed;
* Patients refusal.

Primary outcomes:
measure: Anti-MCPyV functionality
timeFrame: Day 0 and Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Dermato-oncology Department, Ambroise Paré Hospital, APHP
Study officials:
affiliation: Dermato-oncology Department, Ambroise Paré Hospital, APHP
name: Astrid Blom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: U1186 INSERM, PAUL BROUSSE Hospital, APHP
name: Yassine Taoufik, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05949775: Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors
Official title: Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Malignant Solid Tumors
Lead sponsor: Stemirna Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2023-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: PD-1/PD-L1 drug therapy benefits patients with secondary drug-resistant malignant solid tumors, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H.
Primary purpose: TREATMENT

Brief summary: This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.


Eligibility criteria: Inclusion Criteria:

* Are ≥18 years old, without limitation of sex at time of consent.
* Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion.
* Fresh biopsy specimens can be provided for vaccine preparation.
* Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H

Exclusion Criteria:

* It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past;
* The predicted number of new antigens is less than 10;
* Those who are pregnant or breastfeeding;
* Those with an expected survival period of less than 3 months;

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: Time Frame: from enrolling to patients disease progression，assessed up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03825575: Sacral Neuromodulation as Treatment for Fecal Incontinence
Official title: Sacral Neuromodulation as Treatment for Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
Anorectal manometry
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate if low level laser therapy will do more good than harm for patients with severe refractory fecal incontinence. It is a proof of concept study without a placebo arm.

Detailed description: The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptoms and quality of life questionnaires and physiological assessments of pelvic floor function, at 4 weeks and 12 weeks after beginning of treatment.

Eligibility criteria: Inclusion Criteria:

Patients with fecal incontinence

Exclusion Criteria:

* Pregnant patients
* Known malignancies in the area of treatment
* Active bleeding in area of treatment
* Active deep vein thrombosis
* When tatoos are present at area of treatment
* Patients that are light sensitive
* Patients who take steroids.

Primary outcomes:
measure: Change in number of fecal incontinence episodes
timeFrame: 4 weeks and 12 weeks
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: 4 weeks and 12 weeks
measure: Change in symptoms score
timeFrame: 4 and 12 weeks
measure: Change in anal sphincter tone
timeFrame: 12 weeks
measure: Change in increase of anal sphincter pressure during squeezing
timeFrame: 12 weeks
measure: Change in squeezing duration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jihong Chen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Treatments for Fecal Incontinence [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK356097/
citation: Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
citation: Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
Clinical trial NCT00890175: Staccato Loxapine Pulmonary Safety in Patients With Asthma
Official title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma, Staccato loxapine
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.


Eligibility criteria: Inclusion Criteria:

* History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value.

Exclusion Criteria:

* History of COPD, or any other acute or chronic pulmonary disease

Primary outcomes:
measure: Change in FEV1 from baseline by spirometry
timeFrame: at each post-treatment time point (15 min to 34 hr)
Secondary outcomes:
measure: Change in FVC from baseline by spirometry
timeFrame: at each post-treatment time point (15 min to 34 hr)
measure: Treatment emergent adverse events
timeFrame: Post-treatment time points
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group & Research Center, A.P.C.
state: California
Study officials:
affiliation: Alexza Pharmaceuticals, Inc.
name: Mildred D. Gottwald, PharmD
role: STUDY_DIRECTOR
References:
citation: Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114.
Clinical trial NCT03378375: Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation
Official title: Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 315
Sex: ALL
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: ALS diagnosed patients according to Airlie House criteria

Brief summary: Introduction: Resting energy expenditure (REE) formulas for healthy people (HP) are used to calculate REE (cREE) in amyotrophic lateral sclerosis (ALS) patients. In ALS an increase of measured REE (mREE) in indirect calometry (IC) compared to cREE is found in 50-60%. The aims were (i) to assess accuracy of cREE assessed using eleven formulas as compared to mREE and (ii) to create if needed a specific cREE formula for ALS patients.

Method: ALS patients followed in the ALS expert center of Limoges between 1996 and 2014 and with a nutritional evaluation were included. mREE assessed with IC and cREE calculated with eleven predictive formulas (Harris Benedict (HB) 1919, HB 1984, WSchofield, De Lorenzo, Johnstone, Mifflin, WHO/FAO, Owen, Fleisch, Wang and Rosenbaum) were collected at time of diagnosis. Fat free mass (FFM) and fat mass (FM) were measured with impedancemetry. A Bland and Altman analysis was carried out. The percentage of accurate prediction ± 10%of mREE, and intraclass correlation coefficients (ICC) were calculated. Using a derivation sample, a new REE formula was created using multiple linear regression according to sex, age, FFM and FM. Accuracy of this formula was assessed in a validation sample.


Eligibility criteria: Inclusion Criteria:

* ALS diagnosed patients according to Airlie House criteria
* treated with riluzole
* respiratory quotient (RQ) of patients in indirect calorimetry (IC) should be in between 0.7 and 0.87

Exclusion Criteria:

-

Primary outcomes:
measure: Resting energy expenditure emeasures
timeFrame: nutritional assessement should have been be performed within a 1.5 months' time period. IC had to be performed no later than 12 months after diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU LImoges
Study officials:
References:
Clinical trial NCT00537875: Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens
Official title: Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Lead sponsor: National Research Institute of Tuberculosis and Lung Disease, Iran
Sponsor class: OTHER_GOV
First posted: 2007-10-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether powdered ginger root (encapsulated ginger) is effective for reducing the frequency, duration and severity of both acute and delayed nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Must be able to give written informed consent.
* Have a diagnosis of cancer and currently receiving chemotherapy containing cisplatin (any dose).
* Scheduled to receive antiemetics: granisetron (kytril), hydrocortisone.
* Must be able to complete study questionnaires.
* Must be able to swallow capsules.

Exclusion Criteria:

* Have no clinical evidence of current or impending bowel obstruction.
* Concurrent radiotherapy that is classified as high or intermediate risk of causing emesis.
* Pregnant or lactating.
* Patients taking therapeutic doses of coumadin (individuals on low-dose to maintain peripheral or central venous catheters are allowed), aspirin (individuals taking low-dose 80mg aspirin are allowed), or heparin.
* Patients with a history of a bleeding disorder(s) in past 6 months and those experiencing thrombocytopenia.

Primary outcomes:
measure: Nausea, Vomiting
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Research Institute of Tuberculosis and Lung Disease (NRITLD)
Study officials:
affiliation: National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences
name: Shadi Baniasadi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044875: Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy
Official title: A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Keywords: Diabetic retinopathy
Laser treatment
Complications
Laser wavelength
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 120
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 purpose of this study is to measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome.

The study also compares pain score of patients receiving laser treatment and side effects of laser treatment.

Detailed description: Diabetes mellitus (DM) is a major medical problem throughout the world. The most common and potentially most blinding of these complications is proliferative diabetic retinopathy (PDR).

Panretinal photocoagulation is established as the gold standard of treatment, supported by the data of the Diabetic Retinopathy Study (DRS).This study found that laser treatment reduced the rate of severe visual loss by 50%. Currently the green 532nm laser is the most common wavelength used. However, this conventional green laser has some complications such as pain, vitreous haemorrhage, choroidal effusion and visual field loss.

Due to the complication of conventional lasers, the yellow laser (577 nm)with peak absorption of oxyhemoglobin and good absorption of melanin is postulated to be more effective at producing retinal laser burns with a lower power and less pain compared to the green laser.

Eligibility criteria: Inclusion Criteria:

* Patient more than 18 year of age
* Eyes with proliferative diabetic retinopathy requiring laser PRP
* Newly diagnosed patient
* Patients with no other intervention/surgeries done before the study

Exclusion Criteria:

* Eyes with media opacity not allowing adequate laser photocoagulation
* Patients who have had previous laser photocoagulation
* Patients who have had previous vitreoretinal surgery

Primary outcomes:
measure: Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
timeFrame: 2 years
Secondary outcomes:
measure: Patient pain score during laser procedure
timeFrame: 2 years
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Eye Research Centre
Study officials:
affiliation: University of Malaya Eye Research Centre
name: Kenneth C Fong, FRCOphth
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya Eye Research Centre
name: Nurliza Khaliddin, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02535975: The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Graves' Ophthalmopathy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 80
Sex: ALL
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: This is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months after withdrawal of treatment.


Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years
2. Patients should not have diabetes (HbA1c level at screening should be lower than 6.5)
3. Mild Graves' ophthalmopathy according to EUGOGO statement.
4. Clinical activity score lower than 4
5. Being euthyroid for at least 2 month before the enrollment
6. No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops)

Exclusion Criteria:

1. Moderate-severe Graves' ophthalmopathy
2. Clinical activity score ≥ 4
3. Contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (AST and ALT levels should be within normal range), severe concomitant illness
4. Pregnant women
5. Current use of metformin or containing preparations
6. Metformin intolerance
7. Inability to comply with the study protocol

Primary outcomes:
measure: Change of Clinical Activity Score (CAS) score
timeFrame: At 0, 6 and 12 months
measure: Change of NOSPECS score
timeFrame: At 0, 6 and 12 months
Secondary outcomes:
measure: adverse events
timeFrame: At 0, 6 and 12 months
measure: Quality of life questionnaires (GO-QoL)
timeFrame: At 0, 6 and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Endocrinology, Internal Medicine, Yonsei University College of Medicine
Study officials:
References: