louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03896633: Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Official title: A BIOEQUIVALENCE STUDY OF THE GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION COMPARED TO REFERENCE LISTED DRUG AZOPT® (BRINZOLAMIDE) OPHTHALMIC SUSPENSION 1% IN SUBJECTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Open Angle or Ocular Hypertension
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 637
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 main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

Detailed description: The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Eligibility criteria: Inclusion Criteria:

* Male and females 18 years of age or older,
* diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

* Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
* ocular hypertension.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: Change in Intraocular Pressure (IOP)
timeFrame: 6 weeks
Locations:
city: Bridgewater
country: United States
facility: Various
state: New Jersey
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References:
Clinical trial NCT02561533: Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
Official title: Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillary Thyroid Carcinoma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 53
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: Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.

Detailed description: The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.

FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.

Eligibility criteria: Inclusion Criteria:

* Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (\>1cm)
* Undergoing thyroid surgery (histology of index nodule)

Exclusion Criteria:

* Not undergoing thyroid surgery

Primary outcomes:
measure: Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT06885333: Whole-Brain Tumor Burden Metrics with Inflammatory and Molecular Markers to Predict Postoperative Neurocognitive Decline in Glioma
Official title: Integrating Whole-Brain Tumor Burden Metrics with Inflammatory and Molecular Markers to Predict Postoperative Neurocognitive Decline in Glioma Patients -a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Glioma : Oligodendroglioma or Astrocytoma
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 192 glioma patients

Brief summary: Although surgical resection improves overall survival in patients with diffuse Low-grade gliomas (DLGG), it can also result in deterioration of neurocognitive function, which are poorly understood and lack effective predictive models. This study aims to develop a model using whole-brain tumor burden metrics, inflammatory and molecular markers for predicting high risk of neurocognitive decline (ND) postoperatively. The study involved 192 patients with left frontal DLGG. MRI data were analyzed to derive whole-brain tumor burden metrics, including tumor radiomics, whole-brain cortical thickness, myelin content, and network characteristics. postoperative inflammatory and molecular markers were collected. Postoperative follow-up neurocognitive function was assessed using the Montreal Cognitive Assessment at 3 months and 1 year. Machine learning models were constructed using Pycaret.


Eligibility criteria: Inclusion Criteria:

1. Histopathologically proven DLGG based on 2021 WHO criteria
2. Age ≥ 18 years,
3. Karnofsky Performance Status ≥ 70%,
4. Tumor involved unilateral left frontal lobe and did not reach the central sulcus.

Exclusion Criteria:

1. With previous treatment before image acquisition,
2. Presenting cognitive impairment pre-operatively based on The Montreal Cognitive Assessment (MoCA)
3. Survival of less than 3 months post-surgery
4. Lack of compliance with neurocognitive assessments in 3-month and 1-year after surgery

Primary outcomes:
measure: neurocognitive function was assessed using the Montreal Cognitive Assessment
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00503633: Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study)
Official title: Biomarkers of Insomnia and Fatigue in HIV/AIDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: sleep disorders
genetics
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 350
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: Adults with HIV

Brief summary: The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.

Detailed description: This study will characterize insomnia subtypes and identify genetic markers and metabolic parameters associated with these subtypes. The results will be useful in later developing interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of HIV-infected persons.

A cross-sectional sample of 350 subjects will be recruited to describe relationships between biomarkers and insomnia subtypes. The initial assessment will include:

* wearing a wrist actigraph for 72 hours
* providing a fasting blood sample
* measuring blood pressure, height, weight, neck, waist, hip, and thigh
* completing questionnaires
* urine screening

Depending on the results of the initial assessment, approximately 200 subjects will be followed every month by telephone to assess symptoms and every 3 to 6 months with study visits similar to the initial assessment. Findings from this longitudinal part of the study will characterize the development of insomnia, fatigue, and daytime sleepiness over time in patients living with HIV.

Eligibility criteria: Inclusion Criteria:

* HIV infection
* Access to a telephone
* Able to read and write English

Exclusion Criteria:

* Current use of illicit drugs
* Currently pregnant or within the previous 3 months
* Working nightshift
* Diagnosis of sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movements, dementia, or psychotic illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kathryn A Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06975033: The Impact of an Educational Discharge Video on Post-Operative Health Care Utilization After Holmium Laser Enucleation of the Prostate (HoLEP) Procedures
Official title: The Impact of Discharge Educational Discharge Videos on Post-Operative Care Utilization After Holmium Laser Enucleation of the Prostate (HoLEP) Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HoLEP
Patient Satisfaction
Educational Video Intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: State University of New York - Upstate Medical University
name: University of Rochester
First posted: 2025-05-16
Enrollment: 114
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This will be a randomized interventional study. Patients scheduled to undergo a HoLEP at UCSF will be randomized into two groups after the procedure: one group will watch a scripted educational HoLEP video and the other group will not receive a video. We will monitor the post-operative care utilization after discharge. Secondary outcomes will include patient satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18+
2. Patients scheduled for a HoLEP procedure
3. Patients willing to complete both baseline and follow up surveys
4. Patients able to provide informed consent
5. Patients are English-speaking and understand English

Exclusion Criteria:

1. Patients under 18+
2. Patients unable to consent
3. Patients unable to complete surveys
4. Patients without a prostate.
5. Patients are non-English speakers

Primary outcomes:
measure: Healthcare Utilization
timeFrame: up to 60 days (estimated time frame between initial surgery and first follow up visit)
measure: Participant Satisfaction
timeFrame: up to 60 days (estimated time frame between initial surgery and first follow up visit)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Scott SUNY Upstate Medical University
state: New York
Study officials:
affiliation: University of California, San Francisco
name: David Bayne, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264133: A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
Official title: An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years and older.
2. Patient is documented to be HBsAg positive for \> 6 months.
3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
4. Patient has ALT levels \>=80 IU/L
5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis \<= 6)
6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
7. Patient with previous liver transplantation
8. Patient is pregnant or breast-feeding.
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
measure: Proportion of patients with HBV DNA levels < 60 IU/mL
timeFrame: 48 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01719133: Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen
Official title: Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: allergy
birch
Lead sponsor: Anergis
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.

Detailed description: The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter \> 4 mm with erythema)

Eligibility criteria: Inclusion Criteria:

* history of allergy symptoms during previous birch pollen season
* positive skin prick test to birch pollen extract

Exclusion Criteria:

* pregnancy
* uncontrolled asthma
* other significant clinical conditions or immune disorders
* subjects taking antihistamines or drugs with antihistamine activity

Primary outcomes:
measure: skin prick test reactivity
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Francois Spertini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pellaton C, Perrin Y, Boudousquie C, Barbier N, Wassenberg J, Corradin G, Thierry AC, Audran R, Reymond C, Spertini F. Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides. Clin Transl Allergy. 2013 Jun 1;3(1):17. doi: 10.1186/2045-7022-3-17.
Clinical trial NCT05381233: Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy
Official title: Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy in Relation to Care Burden and Fatigue of Their Mothers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluations
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Caregiver Burden (CB) is expressed as a multidimensional response related to caregiving, including physical, psychological, emotional, social, and economic problems and has been identified as a public health concern. All these factors negatively affect caregiver health and indirectly affect the care of the disabled child .To provide better support for parents of children with CP, we must understand the difficulties faced those parents and identify the key and common areas where assistance can be rendered.

Detailed description: The symptoms of CP vary from person to person. A person with severe CP might need to use special equipment to be able to walk, or might not be able to walk at all and might need lifelong care. A person with mild CP, on the other hand, might walk a little awkwardly, but might not need any special help. CP does not get worse over time, though the exact symptoms can change over a person's lifetime.

Eligibility criteria: Inclusion Criteria:

* Age older then 18 years.
* there BMI will be ranged from 18.5 too 24.9 kg/m2 (Misra et al., 2009) .
* They are the main caregiver for there children.
* They are of low or middle socioeconomic status according too socioeconomic status scale (El-Gilany et al., 2012).
* Having at least 7months of experience in taking care of the child.
* They have no congenital spinal anomalies or lower limb deformities.

Exclusion Criteria:

* Children wif congenital anomalies and chromosomal disease.
* Children wif recent musculoskeletal surgery.
* Any associated problems.

Primary outcomes:
measure: Gross motor function classification System (GMFCS)
timeFrame: 3 months
measure: Arabic Version of Zarit burden Inventory measure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Emad
Study officials:
affiliation: physical therapy
name: emad ismaiel, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00867633: Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan
Official title: Observational Study of Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urothelial Carcinoma
Keywords: urothelial carinoma
aristolochic acid
DNA
adduct
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who received nephrectomies

Brief summary: To study the association between aristolochic acid and urothelial carcinoma in Taiwan


Eligibility criteria: Inclusion Criteria:

* the resected kidney tissue in the tissue bank

Exclusion Criteria:

* the patients who had been ever exposed to arsenics, rubber, chemicals, irradiation for pelvis, or received chemotherapy.

Primary outcomes:
measure: the incidence of aristolochic-acid DNA adduct in the samples
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05546333: Comparing Electrical Impedance Tomography to Computed Tomographic Angiography
Official title: Assessing the Effectiveness of Electrical Impedance Tomography Images to Detect Pulmonary Emboli Compared to Computed Tomographic Angiography
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: UC Health Medical Center of the Rockies
First posted: 2022-09-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR) for a suspected pulmonary embolism

Brief summary: The study aim is to determine whether electrical impedance tomography (EIT) is equivalent in the detection of pulmomary emboli compared to Computed Tomographic Angiography (CTA). EIT is a non-invasive, non-ionizing functional imaging technique that can be performed at bedside. Electrical impedance tomography data will be collected on individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR). The primary outcome measure is to assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli. The study will include up to 63 participants. EIT data will be collected for up to 20 minutes during tidal breathing and for approximately five to ten seconds during breath-holding.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Undergoing a CTA of the chest at MCR

Exclusion Criteria:

* Under 18 years of age
* Body mass index (BMI) \> 30
* Individuals with known thoracic metal implants or devices, such as pacemakers (internal and external), staples, or spinal and rib hardware
* Individuals deemed by the research team as too unstable to safely apply the EIT belt, such as hemodynamic or respiratory instability (e.g., intubated patients), and individuals with unstable spinal injuries
* Open wounds at the site of electrode belt application

Primary outcomes:
measure: Correspondence to CTA
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: UCHealth Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Colorado State University
name: Jennifer L Mueller, PhD
role: PRINCIPAL_INVESTIGATOR
References: