louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02588417: Intrathecal Dexamethasone and Labor Analgesia
Official title: Intrathecal Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Combined Spinal Epidural for Vaginal Delivery Analgesia: A Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Effects of; Anesthesia, in Labor and Delivery
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.

Detailed description: This prospective double-blind trial included 80 primigravidas during vaginal delivery with a cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups; Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The primary outcome measure was the duration of spinal analgesia. Secondary outcome measures include time from spinal analgesia to delivery, total amount of epidurally administered levobupivicaine, adverse effects of neuraxial block and neonatal outcome.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I,II patients schedueled for normal vaginal deliveries
* age between 18-35 years old

Exclusion Criteria:

* Patients who refused to participate
* complicated pregnancies

Primary outcomes:
measure: duration of spinal analgesia
timeFrame: 1 day
Secondary outcomes:
measure: time from spinal analgesia to delivery
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: professor of anaesthesia cairo university
name: nadia yo helmy, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06363617: Implementation of the Fatty Liver Index in Primary Care
Official title: Implementation of the Fatty Liver Index in Primary Care for Patients at Risk of Hepatic Steatosis to Optimize Clinical Control: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Steatosis
Overweight and Obesity
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 434
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 14 years and older.
* Attended at the Basic Care Units (BCU) participating in the Primary Care Center Baix a Mar study.
* Intention to undergo medical follow-up at the study center.
* Body mass index ≥ 25.

Exclusion Criteria:

* Pregnant women
* Alcohol consumption habit (Standard Drink Unit (SDU); one SDU equals 10 grams of alcohol. Risky consumption is considered from 4 SDUs in men and 2 SDUs in women).
* Displaced patients not assigned to the study center.
* Patients classified as Advanced Chronic Care Model or Complex Chronic Patient.
* Participants diagnosed with any of the following pathologies: Chronic liver diseases, including hepatic steatosis; Dementia; Active oncological diseases
* Cognitive or affective pathology that limits the ability to collaborate with lifestyle interventions carried out at the center.
* Patients under the care of endocrinology specialists.
* Participation in another clinical trial involving an experimental intervention during the period of this trial.

Primary outcomes:
measure: Lifestyle Intervention
timeFrame: Month 6
Secondary outcomes:
measure: Low-density lipoprotein cholesterol
timeFrame: Month 12
measure: Triglycerides
timeFrame: Month 12
measure: Gamma-glutamyl transpeptidase
timeFrame: Month 12
measure: Medical and nursing visits
timeFrame: Month 12
measure: Analytical checks in the first year
timeFrame: Month 12
measure: Lipid-lowering drugs
timeFrame: Month 12
measure: Healthcare spending
timeFrame: Month 12
measure: FLI administration
timeFrame: Month 12
Other outcomes:
Locations:
city: Vilanova I La Geltrú
country: Spain
facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
state: Barcelona
Study officials:
affiliation: CSAPG
name: M Carmen Rosas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01358617: Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma
Official title: Observational - Expression of Ubiquitin Carboxyl-Terminal Hydrolase 1 (UCHL1) in Neuroblastoma Cancer Stem Cells and Its Relationship to Patient Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disseminated Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Stage 4S Neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-23
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Neuroblastoma

Brief summary: This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer

Detailed description: PRIMARY OBJECTIVES:

I. Determine whether ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression is an indirect cancer stem cell marker in pediatric patients with neuroblastoma. Correlate UCHL1 expression with staging information and patient's outcome.

Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: None Retained Biospecimen Description: Tissue Study Population Description: Tissue microarray samples from patients with Neuroblastoma supplied by the COG Biopathology Center Sampling Method: Probability

OUTLINE:

Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Results are then compared with patients' clinical data, including age at diagnosis, race, date of diagnosis, histology, stage and location at diagnosis, presence of cancer predisposition, date of completion of treatment, surgery performed, type of chemotherapy received, history of recurrence, and status (alive with disease, alive without disease, dead), if available.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with neuroblastoma
* Tissue microarrays containing normal and neuroblastoma samples provided by the Children's Oncology Group (COG) Biopathology Center

Primary outcomes:
measure: Association between test result (percent cells with positive UCHL1 staining dichotomized into high and low categories) and International Neuroblastoma Staging System (INSS) stage
timeFrame: Baseline
Secondary outcomes:
measure: Relationship between UCHL1 expression and tumor histology, and MYCN amplification
timeFrame: Baseline
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Aaron Sugalski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06374017: Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response
Official title: Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: To Measure Systolic Blood Pressure Postintubation
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 120
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: PREVENTION

Brief summary: Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,

Detailed description: This study will be conducted in the operating theatres of Cairo university hospitals.

Patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups:

Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Group L: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Group D: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.

Eligibility criteria: Inclusion Criteria:

* • ASA I,II

  * Age 18-60y
  * Patients scheduled for any operations under general anesthesia and needs endotracheal intubation using direct laryngoscopy in the operating theatre.

Exclusion Criteria:

* • Uncontrolled high blood pressure \> 160/100 heart disease in the form of ischemic heart disease and severe valvular disease.

  * Patients with the history of allergy to lidocaine or dexmedetomidine.
  * ASA III \& IV.
  * Patients refuse to share in this study
  * Suspected difficult intubation that needs more than 2 trials.

Primary outcomes:
measure: To measure systolic blood pressure immediately after intubation.
timeFrame: Immediately after endotracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University hospitals
Study officials:
References:
Clinical trial NCT03498417: Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy
Official title: Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Ophthalmopathy
Graves Disease
Autoimmune Thyroiditis
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with Graves' disease, with or without GO. The presence of GO will be established in any patient who had at least one of the following eye features: a) exophthalmometry ≥17 mm in women and ≥19 mm in men, based on measurements conducted for the normal population; b) eyelid aperture ≥9 mm; c) clinical activity score ≥1/7; iv) presence of diplopia; v) presence of corneal alterations; vi) presence of GO-related alterations of the fundi; and vii) reduction in visual acuity that could be attributed to GO.
2. Patients with autoimmune thyroiditis
3. healthy subjects

Brief summary: The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.


Eligibility criteria: Inclusion Criteria:

1. for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R;
2. for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination.
3. for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases.

For all subjects: Informed consent

Exclusion Criteria:

1) lack of informed consent

Primary outcomes:
measure: Frequency of serum IGF-1R-Abs above the upper normal levels
timeFrame: Baseline
Secondary outcomes:
measure: Serum concentrations of IGF-1R-Abs
timeFrame: Baseline
measure: Relationship between serum IGF-1R-Abs and the activity of GO
timeFrame: Baseline
measure: Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies
timeFrame: Baseline
measure: Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies
timeFrame: Baseline
measure: Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies
timeFrame: Baseline
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Endocrinology Unit I, University of Pisa
Study officials:
affiliation: University of Pisa
name: Michele Marinò, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03959917: TURP; Complications and Outpatient Care
Official title: Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Prostatic Hyperplasia
Keywords: prostate
resection
incontinence
erectile dysfunction
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a feasibility cohort study. All patients planned for TUR P are eligible. Patients in the ambulatory group have prostate size less than 50 cc and ASA score less less than 4 and ser under 80 years of age. This is clinical routine at the study site.

Brief summary: This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.

Detailed description: Transuretral prostate resection (TUR P) is a common procedure to relieve voiding problems in men. After the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated.

The post surgical care is generally a couple of days inhospital care. The reson for this, is the risk of clot formation and in rare cases post surgical infection.

However, in selected cases, outpatient surgery has been performed with encouraging results. However, the technique has not been spread widely. The use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability.

Also, complications in contemporary TUR P in the modern era (outside of the selected patients of clinical trials) is lacking. The information of complications that can be expected is therefore an important for patient counseling. In some studies, the use of incontinence pads after TUR P is more than 15%, which is important to reliably ascertain if this is holds true.

Eligibility criteria: Inclusion Criteria:

* Planned for transurethral resection of the prostate (TUR P)

Exclusion Criteria:

* No consent to participate

Primary outcomes:
measure: Proportion of patients able to be discharged the day of surgery
timeFrame: One day
measure: Proportion of patients readmitted to hospital the first day of surgery
timeFrame: One day
Secondary outcomes:
measure: Change in IPSS score
timeFrame: 6 months
measure: Number of patients with cancer in surgical specimen
timeFrame: 6 months
measure: Readmission rates within 30 days of surgery
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
measure: Proportion catheter free
timeFrame: 6 months
Other outcomes:
Locations:
city: Östersund
country: Sweden
facility: Östersunds hospital
state: Jämtland
Study officials:
References:
Clinical trial NCT05956717: The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children
Official title: The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents aged 8-18 years with normal eye health

Brief summary: The study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the EQ-5D-Y, CHU9D, and CHROME-G scales with the use of a self-assessment method.


Eligibility criteria: Inclusion Criteria:

* Spherical equivalent ranged -1.00D from-5.00D
* Optimal corrected visual acuity ≥1.0 in both eyes
* No apparent strabismus or other eye disease
* Able to read Chinese and communicate in Mandarin, able to understand the questions in the questionnaire

Exclusion Criteria:

* A history of corneal surgery within 1 year
* Eyelid abnormalities or infection
* An inability to wear orthokeratology
* Use medications that affect the wear of eye and corneal contact lenses
* Those who have participated in a clinical trial of a drug within 90 days
* Allergic patients who have used contact lenses and/or care products
* The researchers consider it inappropriate to participate in this program

Primary outcomes:
measure: Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score
timeFrame: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
measure: Changes in the Child Health Utility 9D (CHU9D) score
timeFrame: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
Clinical trial NCT00894517: A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 61
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).


Eligibility criteria: Inclusion Criteria:

* Symptoms due to an enlarged prostate
* Able to provide semen samples at required visits.

Exclusion Criteria:

* Previous use of any botulinum toxin for the treatment of any urological condition
* History of vasectomy
* History of undescended testicles or testicular trauma
* Subject who has not ejaculated for greater than 1 year
* History of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months
* History of bladder stones
* History of cancer in the prostate, testicles, or bladder
* Previous use of chemotherapy for cancer treatment
* History of urinary incontinence
* Previous prostate surgery

Primary outcomes:
measure: Percent Change in Total Sperm Count Per Ejaculate
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Log Transformed Sperm Concentration
timeFrame: Baseline, Week 12
measure: Change From Baseline in Ejaculatory Volume
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total Sperm Motility
timeFrame: Baseline, Week 12
measure: Change From Baseline in Normal Sperm Morphology
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01328717: Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial
Official title: Clinical Trial Protocol for Contour Link System With Contour Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Subjects with diabetes and study staff used an investigational blood glucose monitoring system.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and above
* Diagnosed as having type 1 or type 2 diabetes
* Currently self-testing blood glucose at home for at least three months
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Gestational Diabetes
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company

Primary outcomes:
measure: Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References: