louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01273792: Investigation of Biomarkers in Susac Syndrome
Official title: Investigation of Relevant Biomarkers in Patients With Susac Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Susac Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 30
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: patients with Susac syndrome (male/female; healthy control subjects

Brief summary: Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult. The aim of this investigation is to identify relevant biomarkers and to elucidate the pathogenesis of Susac syndrome

Detailed description: Susac Syndrome is a rare disease characterized by encephalopathy, branch retinal artery occlusion and sensorineural deafness. The pathogenesis is not yet clear, an autoimmune endotheliopathy is discussed. Because of the variable and often incomplete clinical presentation, the establishment of the diagnosis is often delayed or even completely missed.

The aim of this study is to identify biomarkers that facilitate the reliable and prompt establishment of the diagnosis. Patients with a definite diagnosis of Susac syndrome and healthy subjects as controls are investigated.

Furthermore, the correlation of serological markers with structural retinal and cerebral changes will contribute to clarification of the pathogenesis of Susac syndrome.

Eligibility criteria: Inclusion Criteria:

* adult male and female patients with definite Susac syndrome or matching healthy control subjects
* ability to provide informed consent

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: disease specific patterns of pathology on cranial MRI
measure: disease specific patterns of pathology in optical coherence tomography
measure: serological biomarkers
timeFrame: not defined, cross-sectional analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Study officials:
affiliation: NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
name: Jan M Dörr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorr J, Radbruch H, Bock M, Wuerfel J, Bruggemann A, Wandinger KP, Zeise D, Pfueller CF, Zipp F, Paul F. Encephalopathy, visual disturbance and hearing loss-recognizing the symptoms of Susac syndrome. Nat Rev Neurol. 2009 Dec;5(12):683-8. doi: 10.1038/nrneurol.2009.176.
Clinical trial NCT05542992: Deep Learning Model for Pure Solid Nodules Classification
Official title: Deep Learning Model Supplementary PET-CT as a More Effectively Diagnostic Method for Pure Solid Nodules Classification: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: deep learning model
pure-solid nodules
PET-CT
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: Zunyi Medical College
name: The First Affiliated Hospital of Nanchang University
name: The First Hospital of Lanzhou University, Gansu, China
First posted: 2022-09-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary radiological pure-solid nodules with size less than 3cm

Brief summary: The purpose of this study is to compare the predictive performance of a CT-based deep learning model for pure-solid nodules classification and compared with the tumor maximum standardized uptake value on PET in a multicenter prospective cohort.


Eligibility criteria: Inclusion Criteria:

* Participants scheduled for surgery for radiological finding of pulmonary pure-solid lesions from the preoperative thin-section CT scans;
* The maximum short-axis diameter of lymph nodes less than 3 cm on CT scan;
* Age ranging from 18-75 years;
* definied pathological examination report available;
* Obtained written informed consent.

Exclusion Criteria:

* Multiple lung lesions;
* Poor quality of CT images;
* Participants with incomplete clinical information;
* Participants who have received neoadjuvant therapy before initial CT evaluation.

Primary outcomes:
measure: AUC
timeFrame: 2022.01-2023.12
Secondary outcomes:
measure: Accuracy
timeFrame: 2022.01-2023.12
measure: sensitivity
timeFrame: 2022.01-2023.12
measure: Specificity
timeFrame: 2022.01-2023.12
measure: PPV
timeFrame: 2022.01-2023.12
measure: NPV
timeFrame: 2022.01-2023.12
Other outcomes:
Locations:
city: Yangpu
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: China, Gansu
country: China
facility: Lanzhou
city: China, Guizhou
country: China
facility: Zunyi
city: China, Jiangxi
country: China
facility: Nanchang
city: China, Zhejiang
country: China
facility: Ningbo
Study officials:
References:
Clinical trial NCT01303692: Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
Official title: Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients
Keywords: bone mineral loss
prostate cancer
GnRH agonist alone vs. GnRH agonist plus anti-androgen combination
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 312
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent

Brief summary: Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent

Detailed description: MC MD

Eligibility criteria: Inclusion Criteria:

* Korean prostate cancer over 50 years old with pathological confirmation
* Patients receiving GnRH antagonist or GnRH agonist plus anti- androgen combination within 6 months since starting.
* Patients measured bone density level before starting to receive hormone therapies above.

Exclusion Criteria:

* Patients who are treated other anti-osteoporosis drugs and who are treated bisphosphate due to BMD T score below -3.0.
* Patients who are hard to be analysed by attach to other bone disease.
* Patients who are hard to be analysed by limitation of chart record according to investigators'discretion.

Primary outcomes:
measure: comparison of bone density before and after hormone therapy
timeFrame: 1 year
measure: comparison of bone density between GnRH agonist alone vs. CAB group
timeFrame: 1 year
Secondary outcomes:
measure: correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value
timeFrame: 1 year
measure: correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value before and after hormone therapy
timeFrame: 1 year
measure: 1year comparison of FRAX score before and after hormonal therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca Korea
name: Joon Woo Bahn
role: STUDY_DIRECTOR
References:
citation: Kim SH, Joung JY, Kim S, Rha KH, Kim HG, Kwak C, Lee JY, Jeon SS, Hong SK, Jeong H, Jo MK, You D, Jeong IG, Hong JH, Kim CS. Comparison of bone mineral loss by combined androgen block agonist versus GnRH in patients with prostate cancer: A 12 month-prospective observational study. Sci Rep. 2017 Mar 6;7:39562. doi: 10.1038/srep39562.
Clinical trial NCT02937792: Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section
Official title: Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the safety of high dose spinal in elective CS after prolonged sitting position.

Detailed description: This is a prospective double-blind randomized study, designed to include cases in two groups (using epical program for sample size calculation), one study groups and one control group (parallel). Each group should have at least 30 female patients scheduled for elective caesarean section with a total of 60 cases.

Eligibility criteria: Inclusion Criteria:

* Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance

Exclusion Criteria:

* Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal

Primary outcomes:
measure: vital signs
timeFrame: 45 minutes
Secondary outcomes:
measure: complications
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT00004492: Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Anemia
Keywords: genetic diseases and dysmorphic syndromes
hematologic disorders
rare disease
sickle cell anemia
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months.

Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis

Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day

--Prior/Concurrent Therapy--

Chemotherapy:

* No other concurrent antisickling agent

Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole

--Patient Characteristics--

Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL

Hepatic: AST/ALT no greater than 100 units/L

Renal: Creatinine no greater than 1.5 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior adverse reaction to hydroxyurea or clotrimazole
* No recent or progressive neurologic dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Eugene Paul Orringer
role: STUDY_CHAIR
References:
Clinical trial NCT06970392: Brief Sleep Intervention for Bedtime Resistance
Official title: Brief Sleep Intervention for Bedtime Resistance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Sleep
Keywords: Feasibility trial
Bedtime Resistance
Bedtime Pass
Primary Care
Integrated Care
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is non-controlled feasibility study testing the delivery of a brief sleep intervention for children aged 3-7 who struggle to fall asleep independently. The interventions is designed to be delivered by a behavioral health consultant during routine primary care visits. The treatment components consist of education about good sleep hygiene and the "Bedtime Pass." The hypotheses are that the intervention will be delivered with fidelity in the time allotted, and that parents will rate the intervention as feasible and acceptable.


Eligibility criteria: Inclusion Criteria:

* Caregiver of a child aged 3-7 years who receives primary care services who endorses their child demonstrating bedtime resistance; English-speaking; receiving primary care at the study locations.

Exclusion Criteria:

* Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.

Primary outcomes:
measure: Acceptability Survey
timeFrame: Immediately post-intervention and 30 days post-intervention
measure: Treatment Fidelity Checklist
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Pediatric Insomnia Severity Index
timeFrame: 30 days post-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01538992: Renal Denervation in Patients With Advanced Heart Failure
Official title: Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Heart Failure
Keywords: renal denervation
heart failure
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.

Detailed description: Primary Outcome Measures:

• Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events

Secondary Outcome Measures:

• Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR)

Eligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Eligibility criteria: Inclusion Criteria:

* Heart Failure patients NYHA Class III or IV
* Left Ventricular Ejection Function \< 35%
* GFR \> 45 mL/min/1.73m2
* Optimal stable medical therapy

Exclusion Criteria:

* Do not eligible renal artery anatomy for treatment as determined by Angiography, and
* History of prior renal artery intervention
* Single functioning kidney.
* Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
* Systolic BP \< 110mmHG Hospitalisation because of heart failure in last 3 weeks.

Primary outcomes:
measure: Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: • Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Bursa Postgraduate Hospital
name: HASAN ARI, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00700492: Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?
Official title: Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Subfertility
Keywords: subfertility
pregnancy rate
miscarriage
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Tubal patency demonstrated
* ovulation induction with human menopausal gonadotropin

Exclusion Criteria:

* ovulation induction with clomiphene citrate

Primary outcomes:
measure: clinical pregnancy rate per cycle
timeFrame: 12 weeks pregnancy
Secondary outcomes:
measure: rate of miscarriages per cycle
timeFrame: 12 weeks pregnancy
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
state: Vlaams Brabant
Study officials:
affiliation: University Hospital Gasthuisberg, Catholic University Leuven, Belgium
name: Thomad D'Hooghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01250392: The Effect of Active Choice on Nurse Visit Participation
Official title: The Effect of Time-Slot Scheduling and Active Choice on Biometric Screening and Nurse Visit Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Participation in Nurse Visits
Keywords: Active choice
Nurse visits
Behavioral economics
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-11-30
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to see if behavioral nudges will increase an individual's likelihood of participating in a nurse visit. The behavioral nudges under consideration are encouraging subjects to make an active choice and sending reminders.

Detailed description: The employees in our sample will schedule their nurse visit time slot via e-mail and a health service provider website. Much as is the case in the current system, the control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and given instructions for scheduling an appointment. The treatment group, the active choice only arm, will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening. The treatment group will also receive email reminders one week before their appointment.

Eligibility criteria: Inclusion Criteria:

* Harrah's employee
* Registered e-mail address with Harrah's
* Part of Harrah's Choosing Wellness Program

Exclusion Criteria:

* Under 18
* Already participated in a nurse visit

Primary outcomes:
measure: Nurse Visit Participation
timeFrame: This will be measured after all of the nurse visit windows have been closed, by 4/30/11
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Caesars Corporate Office
state: Nevada
Study officials:
affiliation: National Bureau of Economic Research
name: David I Laibson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04731792: Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.
Official title: Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Stress
Pain
Bronchial Fibroscopy
Pulmonary Transplantation
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.

The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.

Translated with www.DeepL.com/Translator (free version)


Eligibility criteria: Inclusion Criteria:

* Patient with a lung or cardio-pulmonary transplant
* Adults (age \> 18 years old)
* Patient who give their informed consent for the protocol
* Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality

Exclusion Criteria:

- children

Primary outcomes:
measure: Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)
timeFrame: 1 day
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
Study officials:
References: