louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00656656: Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
Official title: Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pemphigus
Keywords: pemphigus
rituximab
immunoadsorption
dexamethasone
treatment
management
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.
* Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.

Exclusion Criteria:

* General condition too poor to tolerate immunoadsorption treatment.
* Severe dementia or psychiatric disease.

Primary outcomes:
measure: Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
timeFrame: up to 43 months
Secondary outcomes:
measure: Number of Patients Who Experienced Side-effects of Treatment
timeFrame: up to 43 months
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Department of Dermatology, University of Luebeck
state: Schleswig-Holstein
Study officials:
affiliation: Department of Dermatology, University of Luebeck
name: Detlef Zillikens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03867656: Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Official title: Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Bone resorption
Bone formation
CTX
P1NP
GLP-2
GIP
Bone turnover
Bone remodeling
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2019-03-08
Enrollment: 10
Sex: MALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Primary purpose: BASIC_SCIENCE

Brief summary: Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male
* Age 25 to 70 years old.
* Type 2 diabetes.
* In Metformin or sulfonylureas

Exclusion Criteria:

* Treatment with other antidiabetics
* Osteopososis or gastrointestinal disease
* Smoking
* Long term steroid treatment
* Weight change more than 3 kg within the last 3 months.
* Overweight or intestinal surgery

Primary outcomes:
measure: CTX
timeFrame: -10 minutes to 240 minutes
measure: P1NP
timeFrame: -10 minutes to 240 minutes
Secondary outcomes:
measure: PTH
timeFrame: -10 minutes to 240 minutes
measure: Sclerostin
timeFrame: -10 min to 240 min.
measure: Glucose
timeFrame: -10 minutes to 240 minutes
measure: Insulin
timeFrame: -10 minutes to 240 minutes
measure: C-peptide
timeFrame: -10 minutes to 240 minutes
measure: GIP
timeFrame: -10 minutes to 240 minutes
measure: GLP-2
timeFrame: -10 minutes to 240 minutes
measure: Glucagon
timeFrame: -10 minutes to 240 minutes
measure: Blood pressure
timeFrame: -10 minutes to 240 minutes
measure: Heart rate
timeFrame: -10 minutes to 240 minutes
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: University of Copenhagen
name: Mette Rosenkilde, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00784056: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN Tangerine Mix (Lactic Acid).


Eligibility criteria: Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin II and III;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History of photodermatosis active;
* Family or personal antecedent of cutaneous photo induced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study;

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
measure: The sensibility will be evaluated according to the skin type.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT03514056: Frequency of Fibromyalgia in Behcet Disease
Official title: Frequency of Fibromyalgia in Behcet Disease in Province Bursa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Behcet Syndrome
Keywords: Fibromyalgia
Behcet Disease
Trigger points
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-05-02
Enrollment: 146
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: Study population consists of participants who are between age 18-75, not pregnant and who were not diagnosed previously with diabetes mellitus or chronic renal failure

Brief summary: In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed. It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in province Bursa.

Detailed description: There are few studies in the literature investigating the frequency of fibromyalgia in Behçet's disease. In various studies, the incidence of fibromyalgia in Behçet's disease was 5.7% -37.1%, which is widely distributed. There are no studies in literature comparing disease severity and pain thresholds at trigger points in fibromyalgia with and without Behcet's disease. In this study, it was aimed to investigate the frequency of fibromyalgia in Behcet's disease according to the criteria defined by the American Colloge of Rheuatology in 2010 and updated in 2013. It was also aimed to compare the severity of disease in fibromyalgia with and without Behcet's disease.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Behcet disease according to international study group criteria
* Patients diagnosed with fibromyalgia according to classification criteria that were defined by the American Collage of Rheumatology in 2010 and updated in 2013
* Patients older than 18
* Patients younger than 75

Exclusion Criteria:

* Participants which were previously diagnosed with diabetes mellitus
* Participants which were previously diagnosed with chronic renal failure
* Pregnant women

Primary outcomes:
measure: fibromyalgia 2013 criteria
timeFrame: Six months
Secondary outcomes:
measure: Fibromyalgia impact questionnaire
timeFrame: Six days
measure: Pain thresholds
timeFrame: Six months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Education and Research Hospital
Study officials:
References:
Clinical trial NCT06644456: CAT Score and Airway Limitation in Adult Smokers
Official title: Relationship Between CAT Score and Airway Limitation in Adult Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smokers
Keywords: smoker
CAT
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who applied to MSKU Chest Diseases Polyclinic with respiratory complaints and had a history of smoking were subjected to respiratory function tests.

Brief summary: This study aimed to show the relationship between CAT Score and airway limitation in smokers who applied to MSKU Chest Diseases Polyclinic with respiratory complaints (shortness of breath, cough, sputum, etc.) and underwent respiratory function tests. CAT Score is a measurement used to evaluate the quality of life of Chronic Obstructive Pulmonary Disease (COPD) patients. CAT Score is a scale used to assess patients' symptoms (such as shortness of breath, cough, and sputum) and problems affecting their daily activities. CAT Score usually takes a value between 0 and 40, and a high score may indicate that the patient's quality of life is low. There are studies on the usability of CAT Score in Bronchiectasis, Tuberculosis, and Asthma Diseases other than COPD. We hypothesize that there is a positive correlation between CAT Score and airway limitation in smokers before COPD develops. The study was planned as cross-sectional. Between July 2024 and December 2024, patients who apply to MSKU Chest Diseases Polyclinic with respiratory complaints and have a history of smoking will have their CAT scores, 6-minute walking test, and height and weight measurements performed and recorded. In our study, the comparison of CAT Scores of individuals who smoke and have normal respiratory function test parameters with those who are not normal but excluded from COPD is planned as the primary endpoint, and comparisons of CAT Scores with exercise capacities and body mass indexes are planned as the secondary endpoint.


Eligibility criteria: Inclusion Criteria:

* Smoking history Being over 18 years old Being symptomatic

Exclusion Criteria:

* Having a diagnosis of chronic respiratory disease (COPD, Asthma, IPF)

Primary outcomes:
measure: CAT
timeFrame: day 1
Secondary outcomes:
measure: 6MWT-BMI
timeFrame: day 1
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla EAH
Study officials:
References:
Clinical trial NCT04086056: CraNIRS Clinical Study
Official title: A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniosynostoses
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with craniosynostosis.

Brief summary: Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems.

In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses.

In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull.

Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.


Eligibility criteria: Inclusion Criteria:

* Boys and girls.
* Aged 3 to 18 months old.
* Subjects with a craniosynostosis diagnosis confirmed by imaging.
* Craniosynostosis requiring a corrective surgery in ventral position.
* Parents/ legal guardian must provide non opposition prior to participation in the study.

Exclusion Criteria:

- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.

Primary outcomes:
measure: Regional cerebral oxygen saturation measure
timeFrame: Day 0 before anesthesia
measure: Regional cerebral oxygen saturation measure
timeFrame: Day 0 during surgery
measure: Regional cerebral oxygen saturation measure
timeFrame: Day 0 after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon service neurochirurgie pédiatrique
Study officials:
affiliation: Hospices Civils de Lyon service neurochirurgie pédiatrique
name: Federico DI ROCCO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219556: Xirtam H Combination In the Treatment of Hypertension Evaluation Study.
Official title: Prospective, Multicentric, Large Scale Observational Study to Evaluate the Effectiveness & Safety of Xirtam H in Indian Patients Suffering From Hypertension.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Antihypertensive Agents
Drug Therapy, Combination
Olmesartan Medoxomil
Hydrochlorothiazide
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 8704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertension

Brief summary: This is post-marketing observational study in which data on safety and effectiveness of Xirtam H will be collected from routine clinical practice. The study objectives are to investigate the effect of Xirtam-H on blood pressure and achievement of target blood pressure as well as safety and satisfaction of treatment. All hypertensive patients (Blood pressure \> 140/90 mmHg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study. The routine investigation suggested by the attending physician will be done in patients of hypertension. No additional investigation will be done for the study purpose. The patient not controlled on existing treatment and prescribed Xirtam H will be included in study after taking the informed consent. The patient will be followed up for 2-follow up visit each after 6 weeks. The physical examination, routine investigation, blood pressure measures will be done and the data will be entered in the CRF as mentioned in CRF in each visit. The study is planned to be carried out in 9604 patients from around 300 - 350 trial sites in India.


Eligibility criteria: Inclusion Criteria:

* All Indian hypertensive patients (Blood pressure \> 140/90 mm Hg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with corresponding product prescribing information

Primary outcomes:
measure: Changes in seated diastolic pressure
timeFrame: 12 weeks
measure: Changes in seated systolic pressure
timeFrame: 12 weeks
measure: Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of patients with adverse events as measure of safety
timeFrame: 12 weeks
measure: Percentage of patients with satisfaction to treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Many Locations
country: India
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03498456: Triple Therapy With Tegoprazan in H. Pylori Positive Patients
Official title: A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 284
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.

Detailed description: This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Eligibility criteria: Inclusion Criteria:

* H. pylori positive based on the screening test
* Peptic ulcer disease

Exclusion Criteria:

* Prior treatment for H. pylori eradication
* Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hwoon Yong Jung, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946356: Psychological Wellbeing, Physical Activity, and Disability in Fibromyalgia
Official title: The Relationship Between Psychological Wellbeing, Physical Activity, and Disability in Patients With Fibromyalgia: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with fibromyalgia

Brief summary: This study aims to investigate the association between psychological wellbeing, physical activity, and disability in patients with fibromyalgia. Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. The study will use descriptive statistics, correlation analysis, and multiple regression analysis to analyze the data.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia
* Age between 18 and 70 years old

Exclusion Criteria:

* Unable to complete self-reported questionnaires
* Presence of other chronic pain conditions

Primary outcomes:
measure: Depression, Anxiety, and Stress Scale (DASS)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT00387556: Ondansetron Reduce Vomiting Associated With Ketamine PSA
Official title: Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conscious Sedation
Keywords: ketamine
children
emesis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2006-10-13
Enrollment: 268
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.


Eligibility criteria: Inclusion Criteria:

* age 1-21 years, ASA I or II, fracture of dislocation reduction

Exclusion Criteria:

* age \< 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.

Primary outcomes:
measure: incidence of vomiting
timeFrame: Duration of ED stay and after discharge
Secondary outcomes:
measure: Length of ED stay
timeFrame: Duration of ED stay
measure: Satisfaction with Sedation
timeFrame: Length of ED stay.
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Childrens Hospital
state: Colorado
Study officials:
affiliation: University of Colorado Health Science Center
name: Joe E Wathen, MD
role: PRINCIPAL_INVESTIGATOR
References: