louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04416646: Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma
Official title: Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma: Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cell Carcinoma
Keywords: Cabozantinib
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from Italian oncology Centers

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the treatment of patients with renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Age 70 years
* Histological diagnosis of Renal Cell Carcinoma (any histology, with the exclusion of urothelial carcinomas)
* Locally advanced disease or metastatic disease (any site, measurable or non- measurable lesions), progressing after at least one line of VEGFR-targeted therapy (as per official registration of the drug at AIFA, in case of extension to first-line treatment, TKI-naïve patients will also be eligible), with or without previous exposure to check-point inhibitors.
* Life expectancy of at least 3 months
* Adequate hepatic, renal and bone marrow function as judged by the treating oncologist.
* Written informed consent

Exclusion Criteria:

* Inability to swallow cabozantinib tablets
* Serious comorbidities or cognitive impairment, which may interfere with cabozantinib administration and/or patient's follow up, as judged by the treating physician
* Absence of a reliable caregiver, as judged by the treating physician

Primary outcomes:
measure: Clinical tolerability of Cabozantinib
timeFrame: Average of 1 year
Secondary outcomes:
measure: Description of response rate of patients treated with Cabozantinib.
timeFrame: From date of randomization until the date of last documented, assessed up to 18 months"
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
References:
Clinical trial NCT02700646: Improving Motor Skill Development in Infants After Cardiac Surgery
Official title: Improving Motor Skill Development in Infants After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 65
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.

Detailed description: Congenital heart disease (CHD) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. Children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. Early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. To date, no interventions to improve the gross motor functioning of children born with CHD have been developed. The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Activities will be tailored based on the individual infant's motor ability and medical status.

Eligibility criteria: Inclusion Criteria:

* All hospitalized infants under age 4 months having cardiac surgery before age 3 months
* Intubation \>/= 24 hours \</= 14 days

Exclusion Criteria:

* Prematurity \</= 36 weeks gestation
* Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult

Primary outcomes:
measure: Gross Motor Scale score
timeFrame: 3 months after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Karen Uzark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305446: Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
Official title: Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Meningococcal, Serogroup B
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.


Eligibility criteria: Inclusion Criteria:

1. Individuals of 18 through 50 years of age on the day of informed consent;
2. Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
3. Individuals who could comply with study procedures including follow-up;
4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.

Exclusion Criteria:

1. Progressive, unstable or uncontrolled clinical conditions;
2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;
3. Abnormal function of the immune system;
4. Chronic clinical significant conditions;

4. Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.

Primary outcomes:
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs).
timeFrame: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)
Secondary outcomes:
Other outcomes:
measure: Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.
timeFrame: Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.
Locations:
city: Krakow
country: Poland
facility: 01, Novartis Investigational Site
Study officials:
References:
citation: Maritan M, Cozzi R, Lo Surdo P, Veggi D, Bottomley MJ, Malito E. Crystal structures of human Fabs targeting the Bexsero meningococcal vaccine antigen NHBA. Acta Crystallogr F Struct Biol Commun. 2017 Jun 1;73(Pt 6):305-314. doi: 10.1107/S2053230X17006021. Epub 2017 May 11.
Clinical trial NCT04919746: Change in Dielectric Constant, Elasticity and Temperature by Acupuncture
Official title: Change in Dielectric Constant, Elasticity and Temperature by Stimulation of Systemic Acupuncture Points
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Keywords: Acupuncture
Lower limb
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals.

Detailed description: Systemic acupuncture is a therapeutic resource in Chinese Medicine that uses needles at specific points in the body, consistent with a system called acupuncture meridians. The aim of the study is to evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals. Will be evaluated 360 volunteers aged between 18 and 38 years and both sexes divided into six homogeneous groups. Pregnant women or those with a delay in the menstrual cycle for more than 28 days will be excluded. The evaluation will consist of measuring the dielectric constant at different depths of the skin, elasticity and infrared thermography of systemic acupuncture points. The procedure will be performed in three moments: pre systemic acupuncture (prior to stimulation), immediate post-systemic acupuncture (20 minutes after the start of stimulation), and post systemic acupuncture (40 minutes after the start of stimulation). Systemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao), lasting 20 minutes. The multiple comparison ANOVA test will be performed, with statistical significance of 5% (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Volunteers aged between 18 and 38 years, both genders and without health complaints.

Exclusion Criteria:

* Pregnant female volunteers or those with a delay in the menstrual cycle for more than 28 days.

Primary outcomes:
measure: Dielectric constant
timeFrame: 10 minutes
measure: Elasticity
timeFrame: 10 minutes
measure: Infrared thermography
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05376046: Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA)
Official title: Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sickle Cell Disease
Vaso-occlusive Crisis
Keywords: sickle cell disease
vaso-occlusive crisis
reticulocyte count
thrombin generation assay
hypercoagulability
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients in the study were diagnosed and treated for SCD at Rouen University Hospital. Patients were included during annual visit in our tertiary centre. Patients with VOC were included less than 24hours after admission to emergency department. All patients treated with hydroxyurea have been treated for at least three years. All patients received a systematic annual visit to determine VOC development in the year. Patients were analyzed in four subgroups based on genotype and clinical status:

* homozygous SCD (S/S) or β0 thalassemia (S/β0) at steady state;
* homozygous SCD with α3.7 thalassemia (S/Sα3.7) at steady state;
* heterozygous SCD with C haemoglobin (S/C) or β+ thalassemia (S/β+)at steady state;
* patients hospitalized for VOC with any genotype.

Brief summary: Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.

The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.


Eligibility criteria: Inclusion Criteria:

* Sickle cell disease

Exclusion Criteria:

* \<18 years
* pregnancy
* Patient under protective guardianship or curatorship

Primary outcomes:
measure: Hospitalisation for Vaso-occlusive crisis within one years
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen university Hospital
Study officials:
References:
Clinical trial NCT02874846: Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
Official title: A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open Angle Glaucoma
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-08-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older.
2. Ocular hypertension or open-angle glaucoma in both eyes.
3. Unmedicated intraocular pressure \> 17 mmHg in one or both eyes and \< 30 mmHg in both eyes.
4. Corrected visual acuity in each eye equivalent to 20/200 or better.
5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
2. Intraocular pressure ≥ 30 mmHg.
3. Use of ocular medications within 30 days.
4. Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
5. Previous eye surgery (other than cataract).
6. Ocular trauma within 6 months.
7. Clinically significant ocular disease that might interfere with the study.
8. Central corneal thickness greater than 620 µm.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
timeFrame: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 7 days (day 1/2 to day 8/9)
Other outcomes:
Locations:
city: Bedminster
country: United States
facility: Nancy Ramirez
state: New Jersey
Study officials:
affiliation: Aerie Pharmaceuticals
name: Theresa Heah, MD
role: STUDY_DIRECTOR
References:
citation: Peace JH, McKee HJ, Kopczynski CC. A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma. Ophthalmol Ther. 2021 Mar;10(1):89-100. doi: 10.1007/s40123-020-00322-1. Epub 2020 Nov 26.
Clinical trial NCT03871946: Fibromyalgia in Patient With Impaired Fasting Glucose
Official title: Fibromyalgia in Patient With Impaired Fasting Glucose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Lead sponsor: Hitit University
Sponsor class: OTHER
Collaborators: name: Eskisehir Osmangazi University
First posted: 2019-03-12
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-65 years female patients

Brief summary: To assess the frequency of fibromyalgia among women with impaired fasting glucose.

Detailed description: Objective: To assess the frequency of fibromyalgia among women with impaired fasting glucose.

Materials and Methods: The sample was selected from the patients who applied to the Internal Medicine clinic and whose fasting blood glucose level were ≥100 and \<126 mg/dL in their routine examination \[Group1 \] and patients whose fasting blood glucose were less than 100 constituted the control group \[Group2 \]. Oral glucose tolerance test \[OGTT \] has been applied to patients with impaired fasting glucose and whose 2nd hour OGTT levels were under 140 has been included. Patients were evaluated in terms of fibromyalgia according to modified 2010 ACR Fibromiyalgia Criteria. Functional status was assessed by using the Fibromyalgia Impact Questionnaire \[FIQ \].

Eligibility criteria: Inclusion Criteria:

* the study group subjects: fasting blood glucose level was between 100 and 126 mg/dL;
* the control group subjects: fasting blood glucose level was \< 100 mg/dL.

Exclusion Criteria:

* Patients with a severe systemic disease (chronic kidney disease, liver disease etc. ),
* psychiatric disease,
* hypothyroidism or hyperthyroidism,
* any connective tissue disease
* patients who used medications that influenced the fibromyalgia symptoms, such as analgesics, antidepressants, and anticonvulsive medications

Primary outcomes:
measure: the frequency of fibromyalgia among women with impaired fasting glucose.
timeFrame: 16 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03574246: Effects of Two Packing Type in Maxillofacial Surgery
Official title: The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sore Throat
Nausea and Vomiting, Postoperative
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent leakage to stomach and trachea. The aim of this study is to compare the efficacy of two packing types in throat pain.


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent oral maxillofacial surgery (maxillary and mandibular cysts, orthognathic surgery, palate and alveolar clefts, mandibular and maxillary fractures and reconstruction surgeries) under general anesthesia between the ages of 18-60
2. ASA 1-2 groups of patients
3. Patients who have completed growth and development
4. Patients who are willing to comply with the requirements of the study
5. Patients with complete medical records
6. Operations expected to last at least 2 hours

Exclusion Criteria:

1. Patients with severe systemic disease other than ASA 1-2
2. Difficult entubation story
3. Patients with BMI\> 35 kg / m2
4. Contraindications for the use of NSAIDs
5. Patients with diclofenac sodium and metoclopramide allergy
6. Patients whose medical records are inadequate
7. Patients with major tranquilizer or opiate addiction
8. Patients with mental and physical anxiety that would interfere with cooperative operation

Primary outcomes:
measure: Postoperative Pain
timeFrame: Postoperatively 2nd hour
measure: Postoperative Pain
timeFrame: Postoperatively 4th hour
measure: Postoperative Pain
timeFrame: Postoperatively 6th hour
measure: Postoperative Pain
timeFrame: Postoperatively 12th hour
measure: Postoperative Pain
timeFrame: Postoperatively 24th hour
Secondary outcomes:
measure: Nausea and Vomiting
timeFrame: Postoperatively 5th minute
measure: Nausea and Vomiting
timeFrame: Postoperatively 10th minute
measure: Nausea and Vomiting
timeFrame: Postoperatively 15th minute
measure: Nausea and Vomiting
timeFrame: Postoperatively 30th minute
measure: Nausea and Vomiting
timeFrame: Postoperatively 60th minute
measure: Nausea and Vomiting
timeFrame: Postoperatively 120th minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Dentistry
state: Yenimahalle
Study officials:
References:
Clinical trial NCT01532167: Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis
Official title: Impact and Utility of Positron Emission Tomography (PET) for the Assessment of Inflammatory Activity Arteritis Versus Clinical Score and Laboratory Values in Takayasu Arteritis: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takayasu Arteritis
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for TA at our institution's immunology outpatient clinic were included between.

Brief summary: The purpose of this study is to demonstrate that \[18F\]FDG PET is a a better method than clinical and laboratory values for the identification and assessment of inflammatory activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise evaluation of response to therapy.

Detailed description: Inflammatory activity and fibrosis are the main causes of morbidity and mortality in patients with Takayasu arteritis. The investigators objective is to determine the utility of using 18F-FDG PET in the basal evaluation and follow-up of patients and compare the results with Dabague's clinical score.

Eligibility criteria: Inclusion Criteria:

* TA was diagnosed if the patient met 3 or more ACR criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia
state: DF
Study officials:
affiliation: Instituto Nacional de Cardiologia
name: Maria E Soto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiologia
name: Erick Alexanderson, MD
role: STUDY_DIRECTOR
References: