louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02146846: Population Pharmacokinetics of Imatinib in CML Patients in Iran
Official title: Population Pharmacokinetics of Imatinib in CML Patients in Iran
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Myelogenous Leukemia
Keywords: cml
Lead sponsor: Kerman University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with approved diagnosis of chronic myeloid leukemia taking Imatinib as treatment

Brief summary: The purpose of this study is to determine population Pharmacokinetics and differences and variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in Iranian population.

Detailed description: patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.

Eligibility criteria: Inclusion Criteria:

* patient in chronic phase of myeloid leukemia
* no liver and renal failure

Exclusion Criteria:

* multiple dug treatment
* previous treatment of interferon
* patients in blast or accelerated phase

Primary outcomes:
measure: Percent of changes of AUC, trough Concentration from predicted values
timeFrame: Blood sampling are collected on atleast the 30th day of treatment at the following time: 1 hour before the dose and 1 hour after the dose
Secondary outcomes:
Other outcomes:
Locations:
city: Kerman
country: Iran, Islamic Republic of
facility: Shahid-Bahonar hospital
Study officials:
affiliation: Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences
name: ehsan mohajeri, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01378546: Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP
Official title: Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lambert Eaton Myasthenic Syndrome (LEMS)
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-06-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells.

3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.


Eligibility criteria: Inclusion Criteria:

* Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.
* If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study.
* Tested and found by ECG not to have a prolonged QTc syndrome.
* Agrees to have a second ECG at the time of peak drug effect. Has understood and signed the Informed Consent.

Exclusion Criteria:

* Is known to have a sensitivity to 3, 4-DAP.
* Has a history of past or current seizures or of severe asthma, or has an epileptiform EEG.
* Is believed by the investigator to be unable to comply with the protocol.
* Is unable to give informed consent.
* No patient will be excluded based on race, ethnicity, gender, or HIV status

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Louis H Weimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06986746: Awareness Program on Knowledge Regarding Prevention of Hypertensive Crisis
Official title: Effects of Planned Awareness Program on Knowledge Regarding Prevention of Hypertensive Crisis in Hypertensive Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Knowledge
Hypertension crisis
Planned awareness program
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine the effect of planned awareness program on knowledge regarding prevention of hypertensive crisis in hypertensive patients. Current literature is mainly on hypertension (HTN) control limited accessible studies on hypertension crises but these studies lack the detailed awareness program regarding prevention of hypertension crisis in diagnosed hypertension patients.

Detailed description: Hypertension crisis(elevation of BP to 180/110mmHg or greater) is the very extreme form of poorly controlled hypertension that can develop in individuals with known pre-existing HTN and in patients who are not aware that they have hypertension.

Eligibility criteria: Inclusion Criteria:

- Diagnosed hypertensive patients

Exclusion Criteria:

* Language barrier
* Not willing to participate
* Unable to understand teaching program

Primary outcomes:
measure: Hypertension Crisis Knowledge
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tarbela
country: Pakistan
facility: Combined Military Hospitals
state: KPK
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MS-CPPT PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02178046: Non-Invasive Oral Biofilm Characterization
Official title: Non-Invasive Oral Biofilm Characterization
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gingivitis
Keywords: Gingivitis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2014-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from UCI Medical Center a referral base for dentists in the greater Orange County area for diagnosis of patients with suspected intra-oral lesions. The UCI student dental health clinic caters to UCI students, staff and faculty.

Brief summary: There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth

Detailed description: The researcher can use imaging techniques to map changes in gingival blood flow during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard

The researcher can use imaging techniques to map inflammatory microstructural changes in the oral mucosa including swelling, vasodilation and edema during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard

Eligibility criteria: Inclusion Criteria:

* Adult male or female 18-25 years of age
* Volunteers with gingivitis but no periodontitis

Exclusion Criteria:

* Subjects who must receive dental treatment during the study dates.
* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
* Individuals who have taken antibiotics in the previous 3 months
* Individuals who are pregnant or nursing

Primary outcomes:
measure: Changes in gingival perfusion
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Petra Wilder-Smith, DDS. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04020146: PPAR, RXR, and VDR Expressions in Peri-implantitis
Official title: PPAR-γ, RXR, and VDR Expressions in Gingival Tissue Samples of Healthy Individuals, Periodontitis and Peri-implantitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Periimplantitis
Keywords: periodontitis
periimplantitis
RXR
VDR
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study consisted of three groups as group 1; healthy controls (C, n=15), group 2; periodontitis patients with stage 3 grade B (P, n=15), and group 3; peri-implantitis patients (PI, n=15).

Brief summary: ABSTRACT Objective: Periodontitis and peri-implantitis are the irreversible destructive diseases of the periodontal and peri-implant tissues. The present study aimed to determine the receptor expressions of Peroxisome proliferative-activated receptor (PPAR)-γ, Retinoid X receptor (RXR)-α, and Vitamin D receptor (VDR) in the diseased tissues around teeth and dental implants.

Methods: The study consisted of three groups as group 1; healthy controls (C, n=15), group 2; periodontitis patients with stage 3 grade B (P, n=15), and group 3; peri-implantitis patients (PI, n=15). Periodontal clinical parameters as the plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were recorded. Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing. Hematoxylin-eosin (H\&E) and immunohistochemistry staining were performed. Total inflammatory cell counts and fibroblast cell density were evaluated on H\&E-stained slides while PPAR-γ, RXR-α, and VDR were evaluated via immunohistochemistry.


Eligibility criteria: Inclusion Criteria:

* healthy individuals
* periodontitis patients
* periimplantitis patients

Exclusion Criteria:

* smokers,
* systemically compromised patients

Primary outcomes:
measure: Inflammatory cells counts
timeFrame: 6 months
measure: Fibroblast counts
timeFrame: 6 months
measure: Peroxisome proliferative-activated receptor (PPAR)-γ
timeFrame: During histological processing
measure: Retinoid X receptor (RXR)-α
timeFrame: 6 months
measure: Vitamin D receptor (VDR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT06536946: B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers
Official title: Expression of B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma
Keywords: B-catenin
Cutaneous squamous cell carcinoma
Immunohistochemistry
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: archived formalin fixed parrafin embedded tissue pieces of patients of cutanous squamous cell carcinoma and its mimickers admitted to sohag University hospital from period juniory 2023 to June 2024

Brief summary: Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it

Detailed description: Skin cancer is one of the most common form of cancer worldwide. Cutaneous squamous cell carcinoma is one of most common skin tumers that caused by many factors as ultra violet ,ionizing radiation and others . It was an advanced spectrum ranging from actinic keratosis to invasive and metastatic squmous cell carcinoma. Correct identification of cutaneous squamous cell carcinoma is a challenge as it has both clinically and histopathologically mimickers.

So the aim of this study is to identify the expression of B-catenin in cutaneous Squamous cell carcinoma and its mimickers.

Eligibility criteria: Inclusion Criteria:

* tissue blocks with sufficient materials Cases with sufficient data

Exclusion Criteria:

* tissue blocks with insufficient and necrotic materials. Casas with insufficient data

Primary outcomes:
measure: Detection of B-catenin expression in cutanous squamous cell carcinoma and its mimickers
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospital
Study officials:
References:
Clinical trial NCT06054646: Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Official title: Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Wrinkles - Rough Texture - Hyperpigmentation
Lead sponsor: Egyptian Atomic Energy Authority
Sponsor class: OTHER_GOV
Collaborators: name: Waleed Nemr,Egyptian Atomic Energy Authority
First posted: 2023-09-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work was to assess the efficacy of irradiated amniotic collagen matrix in comparison with platelet rich plasma in facial rejuvenation.The present study included 20 patients with facial wrinkles divided into 2 groups using split face technique: Group (A) subjected to microneedling with amnion gel on the right side of the face . Group (B) subjected to microneedling with PRP on the other side of the face.According to a skin analysis camera (antera camera), there was statistically significant improvement after treatment and between both groups as regard to the roughness(texture) and melanin appeared by Antera camera in which group (A) showed better improvement than group (B). Also, skin biopsies showed improvement in both sides after treatment in which the epidermis was thicker, collagen bundles were broader and thicker than before treatment also elastic fibers were longer, evenly arranged and thicker than before treatment. The patients were followed up over a period of 3 months after the last session with no complications or changes were occurred and the results of sessions were maintained.


Eligibility criteria: Inclusion Criteria:

* Patients who did not receive any treatment for aging within the last 6 months.
* Patients who accepted to participate in this study.

Exclusion Criteria:

* Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.

Primary outcomes:
measure: Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)
timeFrame: 2 weeks
measure: Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)
timeFrame: 2 weeks
measure: skin pigmentation assessed by skin hyper-pigmentation index
timeFrame: 2 weeks
measure: Histopathology improvement of skin biopsy
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Egyptain Atomic Energy Authority
Study officials:
References:
Clinical trial NCT04021446: A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer
Official title: A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of Adolescent and Young Adult Cancer: The ACSEND Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiometabolic Dysregulation
Young Adult Cancer
Adolescent Cancer
Body Composition
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main goal of this clinical trial is to use a novel exercise intervention to improve cardiometabolic and biopsychosocial health outcomes in overweight/obese sedentary survivors of AYA cancers at risk for chronic comorbid conditions. The investigator's hypothesis is that an exercise intervention will improve: cardiometabolic health; body composition; physical fitness and biopsychosocial outcomes when compared to the attention control group.


Eligibility criteria: Inclusion Criteria:

* AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease

Exclusion Criteria:

* Metastatic disease Pregnancy

Primary outcomes:
measure: Cardiometabolic health - Insulin Resistance
timeFrame: change from baseline to 4 months, to 8 months to 1 year
measure: Cardiometabolic health - metabolic syndrome waist circumference
timeFrame: change from baseline to 4 months, to 8 months to 1 year
measure: Cardiometabolic health - metabolic syndrome blood pressure
timeFrame: change from baseline to 4 months, to 8 months to 1 year
Secondary outcomes:
measure: Body Composition
timeFrame: change from baseline to 4 months, to 8 months to 1 year
measure: Cardiorespiratory fitness (Physical Fitness)
timeFrame: change from baseline to 4 months, to 8 months to 1 year
measure: Muscular Strength (Physical Fitness)
timeFrame: change from baseline to 4 months, to 8 months to 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00562146: Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients
Official title: Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Brain Injury
Keywords: nutrition
enteral access
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute brain injured patients admitted to Neuro-ICU will be consecutively enrolled.

Brief summary: The success rate of unguided nasojejunal feeding tube insertion will be determined in acute brain injured patients. Factors influencing tube self-progression will be evaluated.

Detailed description: Nutrition support is important in brain injured patients. Several studies have shown that small bowel feeding compared with gastric feeding may be associated with a reduction in pneumonia in critically ill patients. The Canadian Clinical Practice Guidelines recommended that small bowel feedings should be considered for patients at high risk for intolerance to enteral nutrition.

There are several methods to place postpyloric tube, but there is a high success rate with endoscopic or radiological assistance. However, they are time consuming procedures, which is of limited availability at bedside and requires trained staff.

Nasojejunal tube with spiral end (Flocare Bengmark NJ tube) has been used for bedside placement for 10 years. But only limited data are available for success rate, especially in brain injured patients. The aim of this study is to access the success rate and influencing factors of spiral end nasojejunal tube in such a population.

Eligibility criteria: Inclusion Criteria:

* Acute brain injured patients admitted to Neuro-ICU

Exclusion Criteria:

* Patients' stay in ICU shorter than 3 days
* Patients with contraindication to naso-feeding tube placement

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: ICU, Beijing Tiantan Hospital, Capital Medical University
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03962946: Distal Radius Fracture: Clinical Outcome After Conservative Treatment in the Elder Patient
Official title: Distal Radius Fracture: Clinical Outcome After Conservative Treatment in the Elder Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Keywords: Adolfsson-score
Suhm Score
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a distal radius fracture who had undergone a conservative treatment at the University Hospital in Basel

Brief summary: This study is performed to evaluate the outcome of conservative treatment after distal radius fractures in patients of 65 years or older at the time of the injury, primarily with respect to the prognostic value of the Adolfsson-score for the functional demands of the patient on his hand.


Eligibility criteria: Inclusion Criteria:

* Distal radius fracture with conservative treatment
* Treated in 2014 or 2015
* X-ray of injury
* Informed consent by the patient to participate in the study

Exclusion Criteria:

* No X-ray
* No signed informed consent
* Demented patients

Primary outcomes:
measure: Adolfsson score
timeFrame: single time point assessment at baseline
Secondary outcomes:
measure: Suhm Score
timeFrame: single time point assessment at baseline
measure: Quick Disabilities of the Arm, Shoulder and Hand (DASH) score
timeFrame: single time point assessment at baseline
measure: Range of wrist joint motion (degree)
timeFrame: single time point assessment at baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedic Surgery and Traumatology, University Hospital Basel
name: Daniel Rikli, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: