louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04377295: Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab
Official title: Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Ranibizumab in Radiation Maculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Maculopathy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 40 years with diagnosis of radiation maculopathy. They did not present other ophthalmological diseases.

Brief summary: This study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

Detailed description: The radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. The radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity.

Ranibizumab is a vascular endothelial growth factor antagonist and it represents an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after intravitreal injections of Ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.

Eligibility criteria: Inclusion Criteria:

* age older than 40 years
* diagnosis of radiation maculopathy
* treatment-naïve with Ranibizumab
* absence of other vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 40 years
* No diagnosis of radiation maculopathy
* previous treatments with Ranibizumab
* presence of vitreoretinal and vascular retinal diseases

Primary outcomes:
measure: Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab
timeFrame: one year
measure: Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001881: Signs and Symptoms of Genetic Abnormalities Linked to Inherited Heart Disease
Official title: Clinical Manifestations of Mutations in Genes Linked to Familial Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy, Hypertrophic, Familial
Keywords: Cardiac Hypertrophy
Genetics
Phenotypes
Hypertrophic Cardiomyopathy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 9999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the heart passed on to family members through abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses.

In this study researchers hope to determine the signs and symptoms (clinical correlation) associated with specific genetic abnormalities causing inherited heart diseases.

In order to do this, researchers plan to evaluate patients and family members of patients diagnosed with inherited heart disease. Patients participating in the study will undergo several tests including blood tests, electrocardiograms (EKG), and echocardiograms. Patients may also be asked to undergo an MRI of the heart to provide a clearer picture of it.

Patients participating in this study may not be directly benefited by it. However, information gathered from the study may contribute to the medical care, treatment, and prevention of problems for others in the future.

Detailed description: Familial cardiomyopathy (FC) often demonstrates both non-allelic and allelic genetic heterogeneity. We propose to determine the clinical correlates of specific genetic defects which cause FC by identifying and expanding a set of kindreds with identical and distinct molecular defects.

Eligibility criteria: Individuals with cardiomyopathy referred for evaluation to the NIH.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Fananapazir L, Epstein ND. Prevalence of hypertrophic cardiomyopathy and limitations of screening methods. Circulation. 1995 Aug 15;92(4):700-4. doi: 10.1161/01.cir.92.4.700. No abstract available.
citation: Wigle ED, Rakowski H, Kimball BP, Williams WG. Hypertrophic cardiomyopathy. Clinical spectrum and treatment. Circulation. 1995 Oct 1;92(7):1680-92. doi: 10.1161/01.cir.92.7.1680.
citation: Fananapazir L, McAreavey D. Hypertrophic cardiomyopathy: evaluation and treatment of patients at high risk for sudden death. Pacing Clin Electrophysiol. 1997 Feb;20(2 Pt 2):478-501. doi: 10.1111/j.1540-8159.1997.tb06206.x.
Clinical trial NCT05136781: DEXAMETHASONE for Non-urgent Thoracic Surgery
Official title: Assessment of DEXAMETHASONE to Prevent Respiratory Complications After Non Urgent Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Surgery
Anesthesiology
Corticosteroids
Respiratory Complication
Keywords: Thoracic surgery
Anesthesiology
Corticosteroids
Respiratory Complication
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent scheduled lung resection surgery

Brief summary: Thoracic surgery is at high risk of respiratory complications. Despite the improvement of surgical procedures such as video-thoracoscopy, respiratory complications appear in 15 to -20% of procedures. Thoracic surgery induces local pulmonary inflammation which is involved in the occurrence of post-operative respiratory failure. Similarly to the example of the acute respiratory distress syndrome, corticosteroids could reduce lung injury secondary to immunological stress. In addition, recent studies suggest that dexamethasone could lead to a reduction of respiratory complications after major non cardiothoracic surgery.

Since dexamethasone is recommended to prevent postoperative nausea and vomiting, around one in two patients receive dexamethasone during anesthetic induction. By retrospective analysis with compensation of bias by propensity score, the investigators aim to assess the effect of dexamethasone to prevent respiratory complications


Eligibility criteria: Inclusion Criteria:

* age : minimum 18 years old
* Patients who underwent scheduled lung resection surgery

Exclusion Criteria:

* absence of patient's consent
* age under 18 years
* pregnant women

Primary outcomes:
measure: incidence of respiratory failure rates between patients receiving or not DEXAMETHASONE
timeFrame: 7 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT05976295: Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
Official title: Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Jianpi Qushi Huatan Decoction) in women with PCOS.


Eligibility criteria: Inclusion Criteria:

1. The diagnosis of PCOS is based on the Rotterdam criteria.
2. Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness in TCM theory.
3. women aged 18-40 years without fertility requirements.
4. A willingness to undergo this treatment plan.

Exclusion Criteria:

1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
4. Suspected Cushing's syndrome.
5. Adrenal or ovarian tumors secreting androgen.
6. Poorly controlled type II diabetes.
7. Pregnancy or lactation.
8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
9. Those who had taken hormones or other drugs during the previous 3 months.
10. Acute heart, liver, kidney or blood diseases.

Primary outcomes:
measure: Ovulation rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nancang
country: China
facility: The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
state: Jiangxi
Study officials:
References:
Clinical trial NCT05719181: Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.
Official title: Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study of 6\12\2021 to20\4\2023
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Diabetes Mellitus
Blood Disease
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: two groups; first group with protein , second group without (control)
Primary purpose: SCREENING

Brief summary: Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

Detailed description: The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

Secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

Eligibility criteria: Inclusion Criteria:

* Patients have good oral hygiene.
* Systemic healthy individuals ,Age more than18 years.
* Healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol).
* Patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant.

Exclusion Criteria:

* Presence of systemic diseases preventing implantation.
* Previous implantation or augmentation of the same region.
* The need for additional bone augmentation procedures (such as maxillary sinus augmentation)
* Partial or total edentulous ridge associated with a severe knife-edge ridge .
* Acute infection or any pathological lesion a the implant site.
* Allergy to one of the materials to be used during operation.
* Pregnancy.
* Radiation therapy, bisphosphonate drugs , Osteoradionecrosis.

Primary outcomes:
measure: Effect of Recombinant Human Bone Morphogenetic The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.
timeFrame: At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
state: Alresafa
Study officials:
affiliation: University of Baghdad
name: Adbullah Al Abbas, B.D.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03457181: Effect of Music During Carotid Endarterectomy
Official title: Effect of Music on Patient's Anxiety, Satisfaction and Pain During Carotid Endarterectomy: Multicenter Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-07
Enrollment: 64
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: OTHER

Brief summary: The purpose of this study is to test the hypothesis that music listening during carotid endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and greater patient satisfaction.

Detailed description: Patients who decided to participate in the study were randomized by means of a computer-generated randomization order into 2 groups: Music Group (Group M) and Operating Room (OR) Noise Group (Group O). Randomization was independently carried out in both centers.

Preoperative and postoperative State Trait Anxiety Inventory (STAI) scores, intraoperative STAI responses, preoperative and postoperative numerical rating scale scores for anxiety, pain scores and hemodynamic parameters were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing carotid endarterectomy using cervical plexus block
* American Society of Anesthesiologists class 2 to 3
* Ability to consent

Exclusion Criteria:

* inability to communicate
* not understand the aim and objectives of the study
* not provide informed written consent
* contraindications for the block (local infection, coagulation disorders)
* hypersensitivity to the local anesthetics
* refusal of regional anesthesia

Primary outcomes:
measure: Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed )
timeFrame: 60 minutes
Secondary outcomes:
measure: Differences in intraoperative State-Trait Anxiety Inventory Response (calm)
timeFrame: 60 minutes
measure: Differences in postoperative anxiety numerical rating scale scores
timeFrame: 10 minutes
measure: Differences in preoperative State-Trait Anxiety Inventory scores
timeFrame: 20 minutes
measure: Differences in postoperative State-Trait Anxiety Inventory scores
timeFrame: 20 minutes
measure: Differences in pain scores
timeFrame: 10 minutes
measure: Changes in mean arterial pressure
timeFrame: 60 minutes
measure: Changes in heart rate
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04543981: Prevalence of the Signs and Symptoms of TMD in Adolescents
Official title: Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a Sample of Egyptian Adolescents According to Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD):A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TMJ Disorder
TMD
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 733
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DC/TMD shhts will be assessed and obtained from adolescents in Diagnostic center clinic at the faculty of Dentistry, Cairo University

Brief summary: the Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a sample of Egyptian adolescents

Detailed description: Our study is observational cross sectional study to evaluate the prevalence ofTempro-mandibular Joint Disorder( TMDs) in Egyptian adolescents based on Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD) .The following examinationwill be done for each patient and recorded in his/her chart:

Include maximal mandibular opening capacity, joint noises, deviation of mandible during opening and closing, tenderness of the TMJ and masticatory muscles, headache and pain in TMJ area.

All clinical examinations will be carried out by one investigator. Examination of TMJ disorders include the following aspects: I) Examination of TMJ sounds (clicking and crepitus) using a stethoscope over the TMJ area and by having the patient open and close the mouth.

II) Associated muscle disorders will be determined by:

1. palpation of TMJ area.
2. digital palpation and functional manipulation of the masticatory muscles according to Okeson.

Eligibility criteria: Inclusion Criteria:

* Adolescents(age range10-18 years old).
* A well-defined dentalCl I, Cl II/1, Cl II/2, and Cl III relationship (Angle Classification).
* Mixed and permanent dentition.
* Both sexes.
* Normal skeletal pattern

Exclusion Criteria:

* Adolescents with syndromes.
* Systemic diseases affecting bones.
* Adolescents with rheumatoid arthritis.
* Previous trauma in the face.
* Neurological disorders.
* Psychiatric disorders.
* Neoplasia.
* Adolescents who had received orthodontic treatment.

Primary outcomes:
measure: TMD
timeFrame: at the time of examination of each participant
Secondary outcomes:
measure: Myofacial pain
timeFrame: at the time of examination of each participant
measure: mouth opening
timeFrame: at the time of examination of each participant
measure: TMJ noises
timeFrame: at the time of examination of each participant
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Cairo/Giza
Study officials:
affiliation: Cairo University
name: Manal foda, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02638181: The Expression of Matrix Metalloproteinase 13, Tissue Inhibitor of Metalloproteinases 3, and Calcium-sensing Receptor in Human Trabecular Meshwork
Official title: The Expression of Matrix Metalloproteinase 13（MMP13）, Tissue Inhibitor of Metalloproteinases 3（TIMP13）, and Calcium-sensing Receptor（CaSR） in Human Trabecular Meshwork
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open-angle Glaucoma
Keywords: matrix metalloproteinase 13
tissue inhibitor of metalloproteinases 3
calcium-sensing receptor
trabecular meshwork
open-angle glaucoma
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining method and western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and Eosin staining.


Eligibility criteria: Inclusion Criteria:

* intraocular pressure greater than 22 mmHg with two or more medications
* wide anterior chamber angle
* glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect
* visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry

Exclusion Criteria:

* the presence of any secondary form of glaucoma including exfoliation syndrome or a history of ocular trauma, etc

Primary outcomes:
measure: the expressions of matrix metalloproteinase 13 and calcium-sensing receptor
timeFrame: one hour after operation
Secondary outcomes:
measure: histological changes of trabecular meshwork
timeFrame: one hour after operation
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: xiaorong li
role: STUDY_DIRECTOR
References: