louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03604627: Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation
Official title: Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older,
2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m\^²),
4. In complete remission of their pediatric cancer for at least 10 years,
5. Patient affiliated to a social security scheme or beneficiary of such a scheme,
6. Patient Information and Signed Informed Consent.

Exclusion Criteria:

1. Perspective less than 10 years,
2. Persons deprived of liberty or guardianship (including trusteeship),
3. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
4. Pregnant women.

Inclusion criteria for extension cohort:

1. Patients 30 years of age or older,
2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),
4. In complete remission of their pediatric cancer for at least 10 years,
5. Patient affiliated to a social security scheme or beneficiary of such a scheme,
6. Patient Information and Signed Informed Consent.

Exclusion criteria for extension cohort:

1. Persons deprived of liberty or guardianship (including trusteeship),
2. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
3. Pregnant women.

Primary outcomes:
measure: Incidence of a calcium score
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Trousseau
Study officials:
References:
Clinical trial NCT00436527: Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Official title: MetroGel 1% Hydration Study: A Kinetic Regression Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application.

Detailed description: This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the Corneometer CM 825.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least moderate erythema with telangiectasia and a minimum of two inflammatory lesions

Exclusion Criteria:

* Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis

Primary outcomes:
measure: Six replicate Corneometer CM 825 measurements
timeFrame: 8 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 1 day
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado Springs Research Center
state: Colorado
Study officials:
affiliation: Galderma Laboratories, LP
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02257827: Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule
Official title: Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Hypofractionated schedule
Intensity Modulated Radiotherapy
Conformal radiotherapy
Lead sponsor: Marilia Medicine School
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 220
Sex: MALE
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: There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of prostate cancer
* With age between 18-75 years classified in low
* Intermediate and high-risk group according to their Gleason score
* T stage and initial PSA (iPSA).
* Low risk group included patients with Gleason score \<7 / stage T1-T2a, and iPSA \<10 ng/mL.
* Intermediate risk included Gleason score \< 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
* High-risk patients with Gleason score \>7, or Stage \> T2b, or iPSA \>20 ng/mL.
* All patients classified as high risk was submitted to the bone scans.

Exclusion Criteria:

* Patients with metastases
* Prior history of prostatectomy
* Pelvic radiotherapy treatment
* Chemotherapy treatment were excluded of this trial.

Primary outcomes:
measure: Gastrointestinal and geniturinary acute toxicity
timeFrame: 6 months
measure: Gastrointestinal and geniturinary late toxicity
timeFrame: 24 months
Secondary outcomes:
measure: Biochemical control
timeFrame: 3 years
Other outcomes:
Locations:
city: Marilia
country: Brazil
facility: Faculty of Medicine of Marilia
state: Sao Paulo
Study officials:
affiliation: FAMEMA
name: Gustavo Viani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04367727: Effect of Light Emitting Diode Therapy on Muscle Fatigue
Official title: Effect of Different Pre Application Time Intervals of Light Emitting Diode Therapy on Muscle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Fatigue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training.

Detailed description: 1. To determine the effect of light emitting diode applied 5 minutes before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
2. To determine the effect of light emitting diode applied 1 hour before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
3. To determine the effect of light emitting diode applied 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
4. To determine the difference between light emitting diode applied 5 minutes,1 hour or 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.

Eligibility criteria: Inclusion Criteria:

* Healthy non athletics subjects.
* Age ranges from 20-40 years.
* Body mass index is less than 25 kg/m 2

Exclusion Criteria:

* Neurological deficit and recent injury to either upper extremity
* non diagnosed pain .
* Contraindications to LED irradiation (such as light hypersensitivity, fluctuating blood pressure, insufficient blood circulation, fever and inflammation of the skin)
* Conditions in which physical exertion is contraindicated (such as cardiovascular deficits, hypertension and respiratory problems)
* Restriction in shoulder or elbow range of motion;
* Neoplasm,
* Rheumatoid,
* Strength training in the past 6 months;
* Previous surgery in the spine or upper extremity;
* Complaints of pain in the shoulder, elbow,wrist, and trunk musculature system;
* Use of dietary supplements; and not in any other exercise program for at least the past 3 months.

Primary outcomes:
measure: Isometric peak torque of elbow flexors
timeFrame: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours
measure: Isometric peak torque of elbow flexors
timeFrame: change from before light emitting diode application at1 minute
measure: Isokinetic peak torque of elbow flexors
timeFrame: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours
measure: Isokinetic peak torque of elbow flexors
timeFrame: change from before light emitting diode application at 1 minute after light emitting diode application
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT02764827: Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts and Specific IgE
Official title: Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts (Bermuda ,Johnson Grasses and Careless Weed) With Specific IgE Levels.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immediate Type Hypersensitivity
Keywords: skin prick test
grass and weed pollens
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People 18-60 years of age who recently have positive skin prick test to grass pollen or careless weed are pricked with local and imported Bermuda grass, Johnson grass and careless weed allergen extracts. Specific IgE levels are also measured at the same day.

Brief summary: Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE.

Detailed description: Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen sensitization. Local allergen extracts are cheaper and more available but need standardization. Pollen allergen extracts: Bermuda, Johnson and careless weed are locally prepared and compared mean wheal diameter of skin prick test to imported allergens and also to specific IgE.

Eligibility criteria: Inclusion Criteria:

* Positive skin prick test to Bermuda or Johnson or careless weed

Exclusion Criteria:

* Chronic diseases such as heart disease, liver, renal and severe sepsis
* Severe allergic symptoms such as anaphylaxis
* Extensive skin rashes
* Pregnancy

Primary outcomes:
measure: Mean wheal diameter of local and imported grass and weed pollens
timeFrame: 18 months
measure: sIgE levels of Bermuda grass,Johnson grass and careless weed
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04521127: Dry Needling and Kinesio Taping in the Treatment of Myofascial Pain Syndrome
Official title: Comparison of Dry Needling and Kinesio Taping Methods in the Treatment of Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome of Neck
Keywords: Taping
Pain
Trigger Point
Dry needling
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with a conventional therapy control group.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness of kinesio tape and dry needling in the treatment of myofascial pain syndrome of the trapezius muscle.

Detailed description: Myofascial pain syndrome (MPS) is a common problem with manifesting itself such as trigger points, taut bands, range of motion limitations and pain. One of the most common place for MPS is neck region and trapezius muscle is the common cause of these symptoms and 9 different trigger point location has been identified on trapezius muscle. Myofascial trigger points, characterized by hypersensitive nodules, can be palpated in stretched bands in the affected muscles. In order to eliminate trigger points fascial releasing, dry needling, kinesio taping and other physical therapy applications can be used.

Although there are several studies investigating the effectiveness of Kinesio taping (KT) and Dry needling(DN) methods in MPS, it is controversial which one is superior to others.

The aim of this study is to compare the effects of exercise, KT, and DN methods on pain and disability in the treatment of upper trapezoidal muscle MPS.

Eligibility criteria: Inclusion Criteria:

* Being diagnosis with MPS and having active myofascial trigger points on trapezius muscle

Exclusion Criteria:

* Fibromyalgia
* a history of myofascial trigger point injection
* acute trauma
* inflammatory joint or muscle disease
* infection or malignancy on cervical region
* neurological disorders
* cervical radiculopathy or myelopathy
* inadequate cooperation for the treatment
* a history of neck surgery or spinal degeneration

Primary outcomes:
measure: Pressure Pain Threshold (PPT) Measurement
timeFrame: two weeks
Secondary outcomes:
measure: Visual analog scale
timeFrame: two weeks
measure: Neck Disability Index
timeFrame: two weeks
measure: Global Perceived Effect Scale
timeFrame: two weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Bolu Abant Izzet Baylsa University
name: Mustafa Fatih Yaşar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00480727: Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Official title: Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unstable Cervical Injury
Keywords: Halo Thoracic Orthosis
Re-tension
Pin loosening
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2007-05-31
Enrollment: 44
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: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.

Detailed description: Halo Thoracic Orthoses (Halos) are used to immobilise unstable cervical fractures. The halo grips the skull via 4 pins. Pin loosening is a major complication of halo wear. Pin loosening is painful and can result in loss of control of the fractures. Treatment is required urgently and involves re-siting the pin.

Comparisons: This study will compare two pin management practises with the aim to determine which is optimal to reduce the incidence of complications including pin loosening. Patients will be randomly allocated into 2 groups. The control group will receive treatment in accordance with current practise at The Alfred, the pins will not be re-tensioned throughout the treatment period. The alternative treatment group will have their pins re-tensioned fortnightly.

Eligibility criteria: Inclusion Criteria:

* Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital

Exclusion Criteria:

* Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.

Primary outcomes:
measure: Pin Complications
timeFrame: Treatment duration (approx 12 weeks)
Secondary outcomes:
measure: Anxiety Text
timeFrame: Fortnightly
measure: Pain
timeFrame: Fortnightly
measure: Pin Tension Measurements
timeFrame: Fornightly
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred Hospital, Bayside Health
name: Karly N Wheeler, Bach Prosthetics & Orthotics
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuester WM, Stamper RE, Ordway NR. Analysis of pin force distributions of halo orthoses. Biomed Sci Instrum. 2002;38:221-6.
citation: Garfin SR, Botte MJ, Waters RL, Nickel VL. Complications in the use of the halo fixation device. J Bone Joint Surg Am. 1986 Mar;68(3):320-5.
citation: Vertullo CJ, Duke PF, Askin GN. Pin-site complications of the halo thoracic brace with routine pin re-tightening. Spine (Phila Pa 1976). 1997 Nov 1;22(21):2514-6. doi: 10.1097/00007632-199711010-00010.
Clinical trial NCT02679027: Difficult Intubation and Tongue Protrusion
Official title: New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation, Tongue Mobility
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.

Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.

To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.


Eligibility criteria: Inclusion Criteria:

* Undergoing abdominal surgery with general anesthesia
* Able to sit

Exclusion Criteria:

* Enable to sit,
* Patients had head or neck surgery,
* Patients with unstable cardiological and respiratory hemodynamic symptoms,
* Dental prosthesis

Primary outcomes:
measure: Intubation difficulty scale
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06285227: Study of CM313 in Healthy Subjects
Official title: A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects age ≥ 18 years \& ≤50 years.
* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria:

* With history of malignant tumors;
* Plan to undergo major surgery during the research period
* Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
* With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
* The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
* Positive results in baseline alcohol breath test or urine drug abuse screening.

Primary outcomes:
measure: Adverse event
timeFrame: Up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
Study officials:
affiliation: Huashan Hospital
name: Qing Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Yu Xue
role: PRINCIPAL_INVESTIGATOR
References: