louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01884870: Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy
Official title: The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Calculi
Keywords: Asymptomatic
ureteral
calculi
renal function
treatment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.

Detailed description: The prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in North America and 10.1% in Italy. The widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. Clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. Therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health.

The situation becomes even more distressing when managing asymptomatic stones. Studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. The guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. Conversely, the same is not true for silent ureterolithiasis. The purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.

Eligibility criteria: Inclusion Criteria:

* Silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi.
* Patient willing to participate in the study
* Complete pre/post-operative work-up

Exclusion Criteria:

* Treatment outside our institution
* No will to be a part of the study
* Incomplete pre/post-operative work-up

Primary outcomes:
measure: Ipsilateral Renal Function
timeFrame: 1 year
Secondary outcomes:
measure: Serum Creatinine level
timeFrame: 1 year
measure: Estimated Creatinine Clearance
timeFrame: 1 year
measure: Renal Anatomy assessed by Ultrasound
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Clinics Hospital - University of Sao Paulo Medical School
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Giovanni S Marchini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888870: ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
Official title: The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemophilia A With Inhibitor
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Sinocelltech Ltd.
First posted: 2023-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.

Detailed description: This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.

Eligibility criteria: Inclusion Criteria

1. Moderate or severe hemophilia A;
2. Aged 14-66 years old;
3. Inhibitor positive at 2 consecutive visits;
4. Inhibitor titer \> 10 BU at the screening visit.

Exclusion Criteria:

1. The patient has contraindications to drug ingredients or hamster protein allergy;
2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
3. Failed systemic ITI treatment in history;
4. Poor patients compliance;
5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.

Primary outcomes:
measure: success rate of ITI success rate of ITI success rate of ITI success rate of ITI
timeFrame: 12 months
measure: Success rate and partial success rate of ITI after 3-month treatment
timeFrame: 3 months
Secondary outcomes:
measure: ITI success time
timeFrame: 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Science and Blood Disease Hospital
name: Lei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Science and Blood Disease Hospital
name: Renchi Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01957670: Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
Official title: Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Keratoconjunctivitis Sicca
Dry Eye Syndromes
Lead sponsor: Lacrima Medical LTD
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients


Eligibility criteria: Main Inclusion Criteria:

1. Male or female, 18 years of age and over at screening
2. Diagnosis of mild to moderate Dry Eye, as defined by:

   1. Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND
   2. Schirmer Test score (with anesthesia, 5 minutes \< 5 mm either eye) ; AND
   3. OSDI score of ≥12 and OSDI score of \<33

Main Exclusion Criteria:

1. Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
2. Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection
3. Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
4. Receipt of any type of topical artificial eye drops within 3 days prior to screening
5. Receipt of topical cyclosporine eye drops within 3 months prior to screening

Primary outcomes:
measure: Lower Tear Meniscus Height using Optical Coherence Tomography
timeFrame: up to 8 hours
Secondary outcomes:
measure: Visual Analog Scale score
timeFrame: up to 8 hours
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Israel
Study officials:
References:
Clinical trial NCT05774470: Bradycardia Recognition and Detection in Young Infants Part-I
Official title: Bradycardia Recognition and Detection in Young Infants Using the Owlet OSS 3.0 Monitor (Brady-I Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Bradycardia
Hypoxemia of Newborn
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Owlet Baby Care, Inc.
First posted: 2023-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants admitted to the neonatal intensive care unit.

Brief summary: This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.

Detailed description: We will attach an Owlet monitor to infants for a 48-hour period. We will prospectively collect data from this device to determine the accuracy of bradycardia and hypoxemia detection compared with hospital monitors. In addition, we will collect simultaneous high-resolution real time cardiorespiratory data from Philips MP70 patient monitors at the University of Alabama at Birmingham.

Eligibility criteria: Inclusion Criteria:

* Off ventilatory support/NCPAP/HFNC and phototherapy for \> 48 hours
* Less than one-year corrected age
* Current weight \>1500 grams
* Parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

* a major malformation
* a neuromuscular condition that affects respiration or causes apnea
* active skin breakdown or skin infection
* terminal illness or decision to withhold or limit support
* We will exclude data from infants who develop shock/sepsis or require ventilatory support or phototherapy during the study period.

Primary outcomes:
measure: Bradycardia and/or hypoxemia
timeFrame: 48 hours
Secondary outcomes:
measure: Bradycardia episodes
timeFrame: 48 hours
measure: Hypoxemia episodes
timeFrame: 48 hours
measure: Diagnostic accuracy
timeFrame: 48 hours
measure: Limits of agreement
timeFrame: 48 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04297670: HPV Prevalence in 16-20 Year Old Males
Official title: Evaluation of the Impact of Quebec HPV Immunization Program: Prevalence of HPV Types in 16-20 Year Old Males
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Infection
Keywords: Prevalence
Boys
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 681
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sexually active 16-20 years old boys studying at a professional school or college.

Brief summary: In Quebec, 18 birth cohorts of girls were vaccinated against HPV (aged 9 to 29 years in 2020). With an observed vaccination coverage of \>80% an important herd effect might be expected. This study aim is to measure the HPV types prevalence in unvaccinated sexually active boys aged 16 to 20 years.

Detailed description: An HPV immunization program is in place in Quebec since 2008. By 2020 18 birth cohorts of girls were eligible for vaccination. Vaccine uptake with at least one dose of vaccine was \>80%. With such a high vaccine uptake an important herd immunity might be expected. The main objective of this study is to measure the prevalence of different HPV types in unvaccinated sexually active boys aged 16 to 20 years. This is a cross sectional study which includes one visit for all participants. Self sampling technic is used. During this phase of the study a total of 681 boys will be recruited. An additional phase of the study will be conducted at the condition that the prevalence of HPV6/11/16/18/31/33/45/52 and 58 in unvaccinated boys will be at least 8.65%. The second phase of the study if conducted will measure the prevalence of the same HPV types in 681 vaccinated boys of the same age.

Eligibility criteria: Inclusion Criteria:

* unvaccinated against HPV
* sexually active

Exclusion Criteria:

* received an HPV vaccine
* non sexually active

Primary outcomes:
measure: Prevalence of HPV 6/11/16/18/31/33/45/52 and 58
timeFrame: Up to 18 months
Secondary outcomes:
measure: Prevalence of 31 HPV types
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Laval University Research Hospital Center
Study officials:
References:
Clinical trial NCT04205370: Sleep Behaviors in Pregnancy
Official title: Sleep Behaviors in Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Pregnancy Complications
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The researchers would like to know how long pregnant women spend in different positions during the night - and how often women change positions - across pregnancy. The researchers also want to see if the sleep monitor is able to improve sleep behaviors


Eligibility criteria: Inclusion Criteria:

* At least 28 weeks pregnant
* Receiving pre-natal care at Michigan Medicine
* Have either and Android or iPhone smartphone

Exclusion Criteria:

* Less then 28 weeks pregnant
* Receiving pre-natal care external to Michigan Medicine
* Does not poses a smartphone

Primary outcomes:
measure: Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach
timeFrame: Until delivery, approximately 12 weeks
Secondary outcomes:
measure: Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach
timeFrame: Until delivery, approximately 12 weeks
measure: Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position
timeFrame: Until delivery, approximately 12 weeks
measure: Percentage of sleep position changes following alert from Pregnancy Coach
timeFrame: Until delivery, approximately 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Louise O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05167370: High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
Official title: High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumors
Brain Tumors
Keywords: Solid Tumors
Brain Tumors
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 2
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of amifostine to determine how effective it is in the reduction of infection in a high dose chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Detailed description: Autologous stem cell transplant (ASCT) permits chemotherapy dose-escalation to exploit the steep dose-response of solid tumors to alkylating agents. Although ASCT regimens have activity in some high risk pediatric solid tumors, non-hematological regimen-related morbidity and mortality are major barriers to additional dose escalation. We hypothesized that the chemoprotectant amifostine (Ethyol®) would reduce the toxicity of ASCT without compromising anti-tumor efficacy. This is a study of amifostine at 1125 mg/m2 to determine the efficacy of it's chemoprotection in the reduction of bacteremia in a high dose busulfan, melphalan and thiotepa chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Eligibility criteria: Inclusion Criteria:

* High risk Ewing's Sarcoma Family Tumors (ESFT) including Ewing's Sarcoma, Askin's tumor, peripheral PNET
* High risk desmoplastic small round cell tumors (DSRCT)
* Relapsed Wilm's tumor, diffuse anaplastic Wilm's tumor
* High risk brain tumors including PNET/Medulloblastomas/germinomas
* Relapsed germ cell tumors
* Metastatic or relapsed rhabdoid tumors
* Other relapsed/refractory pediatric embryonal tumors
* Less than 30 years of age
* Performance \>= 50%
* Cancer Diagnosis verification and staging
* Disease Response and Recovery
* Adequate Organ Function (Renal, Liver, Cardiac)

Exclusion Criteria:

* Uncontrolled Infection
* Pregnancy or Breastfeeding (For Females)
* Disease Progression
* Uncontrolled Intercurrent Illness
* HIV Positive
* Receiving other Investigational Agents
* Amifostine Allergy

Primary outcomes:
measure: Incidence of Bacteriemia in a High Dose Busulfan, Melphalan and Thiotepa Chemotherapy Regimen With Autologous Peripheral Blood Stem Cell Rescue in Patients With High Risk and Relapsed or Refractory Pediatric Solid Tumors
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: CCHMC
name: Sonata Jodele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04948970: Steroid Panel for One-step Diagnosis of Adrenal Diseases
Official title: Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects will consist of patients who were treated for adrenal diseases such as adrenal incidentaloma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma at Seoul National University Hospital, and who agreed to participate in this study at Seoul National University Hospital and Seoul National University Bundang Hospital.

Brief summary: The aim of this study is to develop a one-step diagnostic method for adrenal diseases, Patients with adrenal diseases including non-functioning adrenal adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Using mass spectrometry analysis based on a multisteroid panel, serum, urine, saliva, and hair samples of the patients will be analyzed. The diagnostic yield of each and combination of steroids will be evaluated.

Detailed description: Adrenal diseases consist of heterogenous diseases. To differentiate various adrenal diseases, multiple steps of diagnostic tests are needed. In this study, the investigators aimed to develop a one-step diagnostic method to differentiate various adrenal diseases using multisteroid panel.

About 400 patients with adrenal diseases including non-functioning adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Serum, hair, saliva, and urine samples of the patients will be analyzed using mass spectrometry. Each and combination of multisteroid will be evaluated for diagnosing adrenal diseases.

Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with adrenal diseases

Exclusion Criteria:

* Taking medications that can affect steroid metabolism
* Major depression, chronic alcoholism
* Suspected cancer metastasis to adrenal glands
* Other acute stress conditions

Primary outcomes:
measure: Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases
timeFrame: Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made
Secondary outcomes:
measure: Diagnostic accuracy of each steroid component for differentiating adrenal diseases
timeFrame: Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Jung Hee Kim, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06553170: Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery
Official title: Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery: Adherence to a New Protocol at Brest CHU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: diabetes
glycemic balance
anesthesia
perioperative medecine
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients diabetics in Brest CHU

Brief summary: It is recognized that a poor glycemic, pre- and intraoperative balance is the source of increase in morbimortality. There was no local protocol at the CHRU Brest regarding the perioperative management of the diabetic patient. This retrospective observational work aims to assess the application of the French recommendations for the perioperative management of diabetes, and compare management before and after the introduction of a protocol based on its recommendations published in 2017 by the SFAR.

The main endpoint is the percentage of patients for whom half of the patients recommendations from the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after protocol and staff training.

Detailed description: Half of the recommandations are implemented for each recommendation evaluated applicable in 29% of patients(n=25) in the before group versus 66.23% (n=52) in the after group (p\<0.05).

This corresponds to an improvement significant of 36.23% for our primary endpoint.

Eligibility criteria: Inclusion Criteria:

* patients diabetics
* urology or visceral surgery

Exclusion Criteria:

* ambulatory surgery

Primary outcomes:
measure: follow the recommendations
timeFrame: 1 year after
Secondary outcomes:
measure: complications and mortality
timeFrame: 1 year after
Other outcomes:
Locations:
city: Brest
country: France
facility: Cadic
state: Bretagne
Study officials:
affiliation: chru brest, france
name: anna cadic
role: PRINCIPAL_INVESTIGATOR
References: