louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00813579: Study of Prospective Assessment of Living Kidney Donors: Pre and Post Donation
Official title: Study of Prospective Assessment of Living Kidney Donors:Pre and Post Donation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Donation
Keywords: assess the safety of living kidney donation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prspective one arm study of 80 live kidney donors . Pre and post donation evaluation(clinical evaluation BLOOD PRESURE BMI, Laboratory evaluaion of renal hepatic functions ,lipid profil, blood sugar, complet blood count,urinanalysis for protein creatinine ratio ,psychological assesment and renal ultrasound for kidney size and any abnormality at 3,6,12,24 months post donation.

Brief summary: This is a prospective assessment of 80 living kidney donors.


Eligibility criteria: Inclusion Criteria:

* Donors are suitable candidate for living donation
* Male or female donors minimum 21 years maximum 65 years of age
* Donors has been fully informed and has given written informed consent

Exclusion Criteria:

* Donors has diabetes mellitus or hypertension.
* Donors is pregnant or breastfeeding.
* Donors is known to be HCV,HBV,HIV positive or has significant liver disease.
* Donors with malignancy or history of malignancy.
* Donors has systemic or localized major infection.
* Donors is participating or has participated in another clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nagib AM, Refaie AF, Hendy YA, Elfawal MA, Shokeir AA, Bakr MA, Neamattala AH, Hamdy AF, Mahmoud KM, Ismail AM, Ghoneim MA. Long term prospective assessment of living kidney donors: single center experience. ISRN Nephrol. 2014 Jan 23;2014:502414. doi: 10.1155/2014/502414. eCollection 2014.
Clinical trial NCT05084664: Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
Official title: Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years.

Detailed description: hey were recruited in the study from October 2020 to September 2021 and allocated randomly into two groups. Group A received premodulated current in addition to exercises, and group B received diadynamic current with the same exercises. Each patient signed the informed consent form approved by the faculty of physical therapy, October 6 university, Egypt and prospectively registered (Clinical Trials.gov, Identifier NCT03338283). Patients was selected according to the following criteria.

Inclusive criteria

* Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
* lasting of the symptoms for 3 months
* no previous physiotherapy interventions.

Exclusive criteria

Internal or external fixation

* arthritis of elbow
* contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.

Eligibility criteria: Inclusion Criteria:

* Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
* lasting of the symptoms for 3 months
* previous physiotherapy interventions.

Exclusion Criteria:

* Internal or external fixation
* arthritis of elbow
* contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.

Primary outcomes:
measure: baseline hydraulic hand dynamometer
timeFrame: 6 weeks
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 6 weeks
measure: baseline hydraulic pinch gauge
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qaliubia
country: Egypt
facility: Bassam
Study officials:
References:
Clinical trial NCT01962064: Social Cognition in Ageing and in Frontotemporal Lobar Degeneration
Official title: Social Cognition in Ageing and in Frontotemporal Lobar Degeneration (Frontotemporal Dementia and Semantic Dementia): a Cognitive and Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frontotemporal Lobar Degeneration
Aging
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2013-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the age and the neurodegenerative disease effects on social cognition. Secondary goals are to better understand the relationships between different component of social cognition, executive functioning, and behavior and describing the neuronal substrates associated to the alteration of the social cognition in ageing and dementia.


Eligibility criteria: Inclusion Criteria:

* All the participants

  * Age between 40 and 80 years
  * Minimum of 7 years of education
  * French native speaker
* Healthy subjects

  * Non pathological Dementia rating scale score
* Patients

  * Clinical diagnosis of frontotemporal lobar degeneration

Exclusion Criteria:

* Chronic neurological disease
* Encephalitis
* Endocrinal disease
* Hepatic disease
* Case history of head injury with loss of consciousness of more than one hour
* Case history of stroke
* Case history of cancer during the five last years except squamous cell carcinomas
* Alcoholism or drug addiction
* Major psychiatric disorders according the Diagnostic and Statistical Manual of Mental Disorders

Primary outcomes:
measure: Social cognition scores
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Inserm - EPHE - University of Caen U1077
Study officials:
affiliation: University Hospital, Caen
name: Vincent de La Sayette, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730964: A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
Official title: A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Echocardiography
Keywords: Surveillance
Optison
Perflutren
Echocardiography
Subjects receive Optison during enhanced echocardiography
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 1039
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.


Eligibility criteria: Inclusion Criteria:

* The subject is over 18 years old.
* The subject has been scheduled for an Optison-enhanced echocardiography exam.
* The subject has provided signed and dated informed consent.

Exclusion Criteria:

* Known hypersensitivity to perflutren, blood, blood products or albumin.

Primary outcomes:
measure: The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.
timeFrame: Within 24 hours post contrast administration
Secondary outcomes:
measure: The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.
timeFrame: Within 24 hours post contrast administration
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Rubin Sheng, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01304264: Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma Patients
Official title: Comparison of Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations During the Addition of Dorzolamid vs Timolol in Glaucoma Subjects Treated With Prostaglandin Analogue Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Keywords: glaucoma, ocular, blood flow, fluctuations
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: Merck Sharp & Dohme LLC
First posted: 2011-02-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Regular visitors of Eye Clinic of Lithuania University of Health Science hospital

Brief summary: To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

Detailed description: Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation

Eligibility criteria: Inclusion Criteria:

* Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes

Exclusion Criteria:

* younger than 18 years old
* women of child bearing potential

Primary outcomes:
measure: Ocular Color Doppler Imaging
timeFrame: 8 AM; 8 PM
Secondary outcomes:
measure: IOP, BP, OPP (mean, fluctuations, amplitude)
timeFrame: 8 AM-12AM-4PM-8PM
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Eye Clinic Lithuania Health Science Hospital Kaunas Clinics
Study officials:
affiliation: Lithuania University of Health Science
name: Ingrida Januleviciene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04906564: RNF213 Variants and Collateral Vessels in Moyamoya Disease
Official title: RNF213 Variants and Collateral Vessels in Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moyamoya Disease
Keywords: Moyamoya Disease
RNF213 Variants
Collateral Vessels
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moyamoya disease patients

Brief summary: The purpose of this study is to detect the association between RNF213 variants and collateral vessels in patients with moyamoya disease.

Detailed description: Moyamoya disease (MMD) is a chronic cerebrovascular disorder characterized by the presence of occlusion which occurs at the internal carotid arteries and their main branches during the development of a basal collateral network. The ring finger 213 (RNF213) was identified as a strong susceptibility gene in patients with MMD in East Asia. The role of RNF213 variants in pathogenesis of MMD is still unclear. Specific "moyamoya vessels" correlate with the onset of stroke. The purpose of this study is to investigate the relationship between RNF213 variants and collateral vessels in patients with moyamoya disease, and provide potential pathogenesis of moyamoya disease.

Eligibility criteria: Inclusion Criteria:

* Written informed consent is obtained
* Patients with age between 4-60 years
* Cerebral digital subtraction contrast angiography (DSA) reveal severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate 'moyamoya collaterals'

Exclusion Criteria:

* There are other vascular diseases, including systemic vasculitis, neurofibroma, meningitis, sickle cell disease, down's syndrome, and previous basilar radiotherapy
* Patients with cardiogenic embolism, including a history of atrial fibrillation, valvular disease or cardiac valve replacement
* Physical or subjective failure to cooperate with the examination or serious comorbid diseases

Primary outcomes:
measure: Identification of RNF213 variants and different types of collateral vessels
timeFrame: Baseline
Secondary outcomes:
measure: Identification of serum biomarkers and different types of collateral vessels
timeFrame: Baseline
measure: Identification of clinical characteristics and different types of collateral vessels
timeFrame: Baseline
measure: Identification of RNF213 variants, serum biomarkers, clinical characteristics and different types of postoperative collateral vessels
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT04120064: Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol
Official title: Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Vitamin D Deficiency
Lead sponsor: Parkview Medical Center
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 60
Sex: ALL
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: Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency.

Detailed description: Study is looking at patients with diagnosed vitamin D deficiency (\<20ng/mL). Participants are healthy adults between 18 and 75. No diagnosis of cancer, pregnancy, hypercalcemia, hyperparathyroidism, gastrointestinal absorption disorder, or chronic kidney disease and not taking medications for seizures or osteoporosis. Participants are randomized into two treatment groups: (1) 5,000IU cholecalciferol daily or (2) one-time 300,000 international units (IU) cholecalciferol. Vitamin D level, calcium level, and renal function are measure one week after initiating treatment and then at 3 months, 6 months, 9 months, and 12 months.

Eligibility criteria: Inclusion Criteria:

* age 18-75yrs old
* serum 25(OH)-vitamin D level \<20ng/mL
* patient of Parkview Adult Medicine clinic
* not currently on cholecalciferol \>2,000IU daily
* no ergocalciferol administration within last week

Exclusion Criteria:

* history of hypercalcemia or hyperparathyroidism
* history of chronic kidney disease with baseline creatinine \>1.1
* history of gastric absorption abnormalities
* history of Paget's disease or osteomalacia
* history of thyrotoxicosis
* known malignancy
* currently pregnant
* taking medications for osteoporosis or seizures
* taking more than 1200mg/day of calcium
* inpatient hospitalization at the initiation of study meds

Primary outcomes:
measure: Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL
timeFrame: 12months
Secondary outcomes:
measure: Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year
timeFrame: 1 week, 3 months, 6 months, 9 months, 12 months
measure: Compliance with therapy as measured by the reported number of missed doses at one week on therapy and then every three months for a year
timeFrame: 1 week, 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Pueblo
country: United States
facility: Parkview Medical Center
state: Colorado
Study officials:
affiliation: Parkview Medical Center
name: Stephanie Murphy, DO
role: STUDY_CHAIR
References:
Clinical trial NCT05091164: Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center
Official title: Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Induce Sleep Endoscopy
Hypnosis
Obstructive Sleep Apnea Syndrome
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Polyclinique Poitiers
First posted: 2021-10-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: It is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (VAS) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. The collapsibility type obtained, classified according to Kezirian, will allow specific management by OAM in the event of predominant anteroposterior stenosis. There are no risks fort the patient. The Drug Induce Sleep endoscopy (DISE) is a fibroscopy of upper aerodigestive tract.


Eligibility criteria: Inclusion Criteria:

* Patient, women or men over 18 years old
* Moderate obstructive sleep apnea syndrome (Hypopnea apnea index between 15 and 30) without any serious sign
* Simple Ronchopathy
* Indication of video-fibroscopy of upper airways
* Affiliated subject or beneficiary of a social security scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Psychiatric disorders that can be decompensated by hypnosis (bipolarity, schizophrenia, ...)
* Smoking less than 10 cigarettes per day
* Alcoholism, chronic or serious disabling pathology
* Medical history of cancer of upper airways, radiotherapy
* Pregnancy
* Recent supper airway infection, rhinosinusitis
* Active allergy
* Non-obstructive sleep apnea syndrome
* severe non-obstructive sleep apnea syndrome (Hypopnea apnea index\> 30)
* Dental contraindication to mandibular advancement device
* Intolerance or allergy to local anesthesia with Xylocaine spray 5% known
* Refusal to participate in the study
* Protected patients: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Hospitalized without consent

Primary outcomes:
measure: proportion of patients for whom the DISE could be performed in good conditions of comfort
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Potiers
country: France
facility: Centre du Sommeil de la Polyclinique de Poitiers
Study officials:
References:
Clinical trial NCT02708264: Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?
Official title: Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Twin pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

* Singleton or higher order than twins multiple gestation
* Monoamniotic twins
* Twin twin transfusion syndrome
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Cerclage in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina
* Painful regular uterine contractions
* Labor
* Placenta previa

Primary outcomes:
measure: Spontaneous Preterm delivery <34 weeks
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: Gestational age
timeFrame: Time of delivery
measure: Birth weight
timeFrame: Time of delivery
measure: Spontaneous preterm birth rates <37, <28 and <24 weeks
timeFrame: Less than 24, 28, 34 and 37 weeks gestation
measure: Spontaneous rupture of membranes
timeFrame: Less than 34 weeks gestation
measure: Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)
timeFrame: Time of delivery
measure: Neonatal death
timeFrame: Between birth and 28 days of age
measure: Composite perinatal outcome
timeFrame: Between birth and 28 days of age
measure: Maternal side effects
timeFrame: Maternal side effects
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References: