louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06112470: Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs
Official title: Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs (ALLMED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy Penicillin
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Military personnel reporting a drug allergy to antibiotics

Brief summary: This study focuses on the experience of the military patient reporting a suspected drug allergy, with its own specificities. Suspicions of drug allergies during a mission expose the doctor to difficulties.

This study will improve understanding of the allergy patient's point of view. The end result could be a set of ideas for measures to raise awareness among these patients, and motivate them to undergo an allergological assessment.


Eligibility criteria: Inclusion Criteria:

* Military personnel (active or reservist)
* Reporting a drug allergy during a periodic medical check-up or during a consultation in a medical unit
* Not opposed to participating in the study.

Exclusion Criteria:

* Candidate on admission visit
* Opposition to study
* Minor (under 18 years of age)
* Pregnant, parturient or breast-feeding woman
* Person deprived of liberty by a judicial or administrative decision, person under psychiatric care
* Non-French nationals
* Person of full age subject to a legal protection measure
* Person unable to express non-opposition

Primary outcomes:
measure: Patients' experiences of drug allergies
timeFrame: Through study completion (12 months)
Secondary outcomes:
measure: Patients' obstacles
timeFrame: Through study completion (12 months)
Other outcomes:
Locations:
city: Versailles
country: France
facility: 15ème antenne médicale - Camp des Matelots
Study officials:
References:
Clinical trial NCT02637570: Effect of Hibiscus Tea and Green Tea Supplements on Athletic Performance, Blood Pressure, Muscle Damage Indices and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy male athletes
18-35 years old
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluated effect of Hibiscus tea and green tea supplements on athletic performance, blood pressure, muscle damage indices and oxidative stress in male athletes 18-35 years old and cardiovascular disease prevention approach.


Eligibility criteria: Inclusion Criteria:

* age between 18 to 35 y/o
* no history of smoking or alcohol consumption
* no taking nutritional sport supplements during the last 2 months

Exclusion Criteria:

* any injury during intervention
* any inflammatory disease during the intervention

Primary outcomes:
measure: athletic performance assess by heart rate in step test (Harvard test).
timeFrame: 6 weeks
measure: blood pressure
timeFrame: 6 weeks
measure: serum's malondialdehyde
timeFrame: 6 weeks
measure: serum's lactate dehydrogenase
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: male sports club members of Isfahan university of medical sciences
Study officials:
References:
Clinical trial NCT01055470: Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
Official title: Open, Randomized, Controlled Clinical Trial of Lornoxicam as Compared to Diclofenac in Osteoarthritis of Knee Joint in Patients of Tertiary Care Hospital of Gujarat.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee Joint
Lead sponsor: Government Medical College, Bhavnagar
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patient aged between 25 to 65 yrs of either gender suffering from osteoarthritis of knee according to criteria given by American College of Rheumatology
* Informed consent obtained from the patient.

Exclusion Criteria:

* Patients with any other systemic llness,
* Patients with pregnancy and lactation,
* Patients taking other drugs like lithium\[4\], digoxin, methotrexate, anticoagulants, antidiabetics, diuretics,
* Patients with H/O hypersensitivity to NSAIDs,
* Patients who had consumed any analgesics in last 1 month

Primary outcomes:
measure: Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test
timeFrame: 3 months
Secondary outcomes:
measure: To monitor side effects of study drugs.
timeFrame: 3 months
Other outcomes:
Locations:
city: Bhavnagar
country: India
facility: Sir Takthasinhji General Hospital
state: Gujarat
Study officials:
affiliation: Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
name: Dr.Vishalkumar Kishorbhai Vadgama, M.B;B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Proffessor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
name: Dr. Chandrabhanu Rajkishore Tripathi, M.D. (Pharmacology)
role: STUDY_CHAIR
References:
Clinical trial NCT00670670: A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1
Official title: A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Caries Lesions
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: GC Europe
First posted: 2008-05-02
Enrollment: 325
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in orthodontic patients after removal of the fixed appliances.


Eligibility criteria: Inclusion Criteria:

* one or more white spot lesion at the time of removal of fixed appliances

Exclusion Criteria:

* white spots already present before start orthodontic treatment

Primary outcomes:
measure: Amelioration of the opacity of white spots into a more natural tooth-like translucency
timeFrame: After 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy De Pauw, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05929170: Comparison of Extremely Obese Patients Undergoing Gastric Sleeve Surgery
Official title: Comparison of Different Tipe Extremely Obese Patients Undergoing Gastric Sleeve Surgery in Terms of Perioperative Risk (Cardiopulmonary Parameters and Other Perioperative Risk Factors) and Effectiveness of the Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Morbid
Hypertension
Diabetes Mellitus, Type 2
Keywords: gastric sleeve operation
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 160
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: Obese patients (BMI Higher than 30 kg/m2)

Brief summary: By the comparison of the preoperative and postoperative data of approximately 160 patients undergoing gastric sleeve surgery, we try to draw conclusions about the effectiveness of gastric sleeve surgery, expected complication rate.

Detailed description: We plan to compare the preoperative and postoperative data of approximately 160 patients undergoing gastric sleeve surgery (android-gynoid, male-female, comparison of patients with different degree of obesity, age comparison, etc.) Many preoperative and postoperative data are known about the patients (weight, height, BMI, preoperative comorbidities, heart ultrasound values, respiratory function values, laboratory parameters, smoking habits, rate of weight loss in half a year and one year, etc.). By statistical analysis of these data, we try to draw conclusions about the effectiveness of gastric sleeve surgery, expected complication rate, etc.,

Eligibility criteria: Inclusion Criteria:

Obesity (BMI higher than 30 kg/m2)

Exclusion Criteria:

Lack of patient consent to the study, Pregnancy

Primary outcomes:
measure: Assessing the results of gastric sleeve surgery, by weight loss
timeFrame: up to one year
Secondary outcomes:
measure: Assessing the half and one-year results of gastric sleeve surgery, by change in comorbidities
timeFrame: half year, one year
measure: Assessing the half and one-year results of gastric sleeve surgery, comparing different groups (male-female, android-gynoid tipe of obesity, ect.)
timeFrame: half year, one year
measure: Assessing the half and one-year results of gastric sleeve surgery, weight loss. (We try to find a confluence between the perioperative parameters and the expected outcome)
timeFrame: half year, one year
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Siptár Miklós
Study officials:
References:
Clinical trial NCT05572970: Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)
Official title: Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cancer
Keywords: Balstilimab
AGEN2034
Zalifrelimab
AGEN1884
Monotherapy
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access study for cancer treatment with balstilimab alone or in combination with zalifrelimab for an intermediate-size participant population. This study addresses the treatment needs of participants who have been previously and specifically treated with balstilimab alone or in combination with zalifrelimab in a clinical study, who have experienced a benefit from this treatment and/or wish to continue treatment, and who are eligible for treatment under this expanded access study.

Detailed description: This study will not exceed 100 participants. Participants will be reevaluated annually to assess the treatment benefit of zalifrelimab and/or balstilimab and thereby, continued eligibility for treatment. Under this program, treatment will be continued with balstilimab, as either monotherapy or as used in combination therapy with zalifrelimab, for participants that have previously received one or both of these investigational medicinal products in a clinical study.

Eligibility criteria: Inclusion Criteria:

* Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Gynecologic Oncology
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Flower Mound
country: United States
facility: Texas Oncology
state: Texas
Study officials:
affiliation: Agenus Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04893070: Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population
Official title: Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Covid19
Keywords: Quality of life
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of military staff followed at the 1st Centre Médical des Armées (Paris, France) who have suffered from COVID-19 and were managed in ambulatory care (COVID+ group) and who have not been infected by SARS-CoV-2 (COVID- group).

Brief summary: In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.


Eligibility criteria: Inclusion Criteria:

* Military personnel
* COVID+: diagnosed with COVID-19 and managed in ambulatory care since March 14th, 2020
* COVID-: not having been infected with SARS-CoV-2

Exclusion Criteria:

* Hospitalized for COVID-19
* Having received a treatment against COVID-19 (other than paracetamol)

Primary outcomes:
measure: Long-term quality of life (mental component)
timeFrame: 18 months after COVID-19 first symptoms
Secondary outcomes:
measure: Long-term quality of life (physical component)
timeFrame: 18 months after COVID-19 first symptoms
Other outcomes:
Locations:
city: Paris
country: France
facility: 1er Centre Médical des Armées
Study officials:
References:
Clinical trial NCT04144270: The Importance of Muscle Function in Patients With Disseminated Bladder Cancer
Official title: The Importance of Muscle Function in Patients With Disseminated Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Bladder Neoplasm
Keywords: Urinary Bladder Neoplasm
Urothelium Neoplasm
Oncology
Muscle function
Sarcopenia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Merck Sharp & Dohme LLC
name: Beckett Foundation
name: Onkologisk Forskningsfond
First posted: 2019-10-30
Enrollment: 30
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: Patients with localized cancer in the urinary tract undergoing neoadjuvant chemotherapy prior to radical cystektomy or patients with disseminated disease undergoing chemotherapy or immunotherapy. Patients are identified and included from Department of Oncology, Rigshospitalet, Copenhagen, Denmark.

Brief summary: This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age ≥ 18 år
* Histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology
* ECOG performance status 0 - 3
* Meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease).

Exclusion Criteria:

* Age \< 18

Primary outcomes:
measure: Muscle mass
timeFrame: Up to 36 months
Secondary outcomes:
measure: Muscle strength
timeFrame: Up to 36 months
measure: Muscle mass changes during systemic oncological treatment
timeFrame: Up to 36 months
measure: Muscle strength changes during systemic oncological treatment
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lise Hoej Omland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01552070: Recruitment on Extravascular Lung Water in Acute Respiratory Distress Syndrome (ARDS)
Official title: Impact of Alveolar Recruitment Maneuver on Extravascular Lung Water of Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Acute Lung Injury
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
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 investigate the change of extravascular lung water (EVLW), cytokine and oxygenation parameters in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) after alveolar recruitment maneuver.

Detailed description: This investigation is a prospective randomized control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of alveolar recruitment maneuver and PiCCO monitoring system.

Patients and methods:

From September 2010 to September 2012, consecutive patients with ALI/ARDS undergo alveolar recruitment maneuver will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLW will be measured by PiCCO monitoring system, alveolar recruitment maneuver will be setting by protocol under supervision of chest physicians and respiratory therapists. Serum cytokine such as endothelin-1, TNF-, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.

Eligibility criteria: Inclusion Criteria:

* acute hypoxemic respiratory failure requiring intubation; and hypoxemia, defined as a partial pressure of arterial oxygen (PaO2) less than 100 mmHg under a high fraction of inspired oxygen (FiO2)
* PaO2/FiO2 ratio \< 200.

Exclusion Criteria:

* encephalopathy or coma,
* a need for cardiac resuscitation,
* hyperkalemia of more than 5.5 mEq/L (contraindication to the succinylcholine use),
* acute brain injury,
* pregnancy,
* age less 20 years old or recent thoracic surgery.

Primary outcomes:
measure: Extravascular lung water change with/without recruitment maneuver.
timeFrame: 7 days
Secondary outcomes:
measure: cytokines change with/without recruitment maneuver.
timeFrame: 28 days
measure: ventilator use duration
timeFrame: 28days
measure: weaning rate
timeFrame: 28days
measure: ICU stay
timeFrame: 28days
measure: ICU survival
timeFrame: 28days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Thoracic Medicine, Shuang Ho Hospital, Taipei Medical University
city: Taoyuan
country: Taiwan
facility: Sant Paul Hospital
Study officials:
affiliation: Change Gung Memorial Hospital
name: Horng-Chyuan Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Fu-Tsai Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06424470: Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.

Detailed description: Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.

Eligibility criteria: Inclusion Criteria:

* Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
* 18 ≤ Age ≤ 75 years old.
* Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.

Exclusion Criteria:

* With drug-induced prurigo nodularis.
* With clinically significant diseases.
* With severe liver and kidney function damage at the screening.
* With malignant tumors within the first 5 years before the screening.
* Plan to undergo major surgical procedures during this study.

Primary outcomes:
measure: Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.
timeFrame: Up to week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Xinghua Gao
role: PRINCIPAL_INVESTIGATOR
References: