louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02624661: Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
Official title: Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Trigeminal Neuralgia
Headache Disorders
Keywords: Trigeminal ganglion
Glycerol
Nerve block
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-12-08
Enrollment: 1
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: Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.


Eligibility criteria: Inclusion Criteria:

* Informed and written consent
* Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
* Unsatisfactory effect of pharmacological treatment

Exclusion Criteria:

* Microvascular decompression is seen as a better alternative
* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Anomalies which hinder or impede the used method of injection
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin

Primary outcomes:
measure: Number of adverse events
timeFrame: For the follow-up period of 12 weeks
Secondary outcomes:
measure: Number of attacks with trigeminal neuralgia
timeFrame: 12 weeks
measure: Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale
timeFrame: 12 weeks
measure: Intensity of the trigeminal neuralgia attacks assessed by questionnaire
timeFrame: 12 weeks
measure: Number of doses of common analgesics
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Erling A Tronvik, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425861: A First in Human Trial Evaluating THB335 in Healthy Participants
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Third Harmonic Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2).

Detailed description: THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells.

The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants.

Eligibility criteria: Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
* Males or females, of any race, between 18 and 65 years of age, inclusive.
* Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures
* Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening

Exclusion Criteria:

* Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study
* A positive urine drug screen/alcohol breath test
* The participant currently smokes, vapes, or uses nicotine-containing products.

Primary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events
timeFrame: Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study)
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Part 1, and Part 2 on Day 1. Part 2 on Day 14
measure: Time to Cmax (Tmax)
timeFrame: Part 1, and Part 2 on Day 1. Part 2 on Day 14
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Part 1, and Part 2 on Day 1. Part 2 on Day 14
Other outcomes:
Locations:
city: Miami
country: United States
facility: QPS Miami
state: Florida
Study officials:
affiliation: QPS Holdings LLC
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02376361: Hemodialysis Access Surveillance Evaluation Study
Official title: Hemodialysis Access Surveillance Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Access
Thrombosis
Keywords: Surveillance
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: Transonic Systems Inc.
First posted: 2015-03-03
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).

Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.


Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.

Exclusion Criteria:

* Patients requiring surgical intervention on the arteriovenous access.
* History of access thrombosis (one or more access thrombosis of the current arteriovenous access).
* Patients with signs of access infection.
* Patients with a malignancy.
* Patients with life expectancy of less than six months.
* Unable to understand the study.
* Unable to sign the consent form.
* Patients with psychiatric disorder.
* Age less than 18 or greater than 80 years.
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Hemodialysis Access Thrombosis Rate
timeFrame: Up to 24 months
Secondary outcomes:
measure: Tunneled Hemodialysis Catheter Rate
timeFrame: Up to 24 months
measure: Number of Participants With a Tunneled Hemodialysis Catheter
timeFrame: Up to 24 months
measure: Number of Hemodialysis Access Thrombectomy Procedures
timeFrame: Up to 24 months
measure: Number of Hemodialysis Access Angiogram and Angioplasty Procedures
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
affiliation: University of Miami
name: Loay Salman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366261: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Official title: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pleural Diseases
Keywords: Flex-rigid pleuroscopy
pleural biopsy
pleural effusion
safety
thoracoscopy
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.


Eligibility criteria: Inclusion Criteria:

* 18 or more years old
* unilateral pleural effusion of unknown origin
* pleural irregularities suspicious for pleural malignancy
* referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

* uncontrolled bleeding tendency
* unstable cardiovascular status
* severe heart failure
* ECOG performance status 4
* persistent hypoxemia after evacuation of pleural fluid

Primary outcomes:
measure: diagnostic adequacy of semirigid thoracoscopy
timeFrame: 12 months
Secondary outcomes:
measure: safety
timeFrame: 1 month
Other outcomes:
Locations:
city: Golnik 36
country: Slovenia
facility: University Clinic Golnik
state: Golnik
Study officials:
References:
citation: Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.
Clinical trial NCT04973761: Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns
Official title: Evaliation of Oral Health Quality of Life for Children With Zirconium Crowns Versus Anteroir Strip Composite Crowns After 6 and 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 136
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months


Eligibility criteria: Inclusion Criteria:

* healthy children Cariuos primary anteroir teeth Cooperative children

Exclusion Criteria:

* children with systemic diseases Children with bad oral habits

Primary outcomes:
measure: Oral health related quality of life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT06056661: Within My Reach (WMR) Adaptation
Official title: Culturally Adapting Individually-oriented Relationship Education (Within My Reach) for Latino Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Violence
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Mental Research Institute
First posted: 2023-09-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to adapt a relationship education program. The research team is adapting so that it is helpful for Latino sexual minority men.


Eligibility criteria: Inclusion:

* Identify as Latino/e/x or Hispanic
* Age 18 years or older
* Currently reside in Miami-Dade County or Broward County
* Identify as gay, bisexual, or other non-heterosexual identity
* Identify as a man
* Comfortable speaking English

Exclusion:

* Unable to provide consent
* Deemed that participating would be potentially harmful to the participant or research staff

Primary outcomes:
measure: Acceptability, as measured by the Acceptability of Intervention Measure (AIM)
timeFrame: Up to 3 months
measure: Appropriateness, as measured by the Intervention Appropriateness Measure (IAM)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in Sexual Risk Composite, as measured by HIV risk assessment
timeFrame: Baseline compared to up to 3 months
measure: Change in Acceptance of Couple Violence
timeFrame: Baseline compared to up to 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Audrey Harkness, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03970161: Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Official title: Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Nerve Injury
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.

Detailed description: Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.

Eligibility criteria: Inclusion Criteria:

1. Patients with T2DM
2. Patients without microangioma

Exclusion Criteria:

1. Patients with any other ocular disease that might affect retinal nerve injury
2. Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
3. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
4. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.

Primary outcomes:
measure: Peripapillary RNFL thickness
timeFrame: 96 weeks
measure: GCL+ in the macular area obtained using the 3D wide mode
timeFrame: 96 weeks
measure: Retinal thickness in all macular regions
timeFrame: 96 weeks
measure: RNFL thickness in the macular area obtained using the 3D Macula (v) mode
timeFrame: 96 weeks
measure: GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
timeFrame: 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The third affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Xiang Zhu, Dorctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244761: Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface
Official title: Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy
Keywords: high flow tracheal oxygen
modified interface
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The tracheostomized patient

Brief summary: Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.

Detailed description: Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been shown that can improve oxygenation,but can not induce positive end-expiratory pressure and elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory resistance might induce PEEP and consequently elevate EELV.

Eligibility criteria: Inclusion Criteria:

* The tracheostomized patient requiring the convenient oxygen therapy.

Exclusion Criteria:

* Under 18 years;
* history of esophageal, gastric or lung surgery;
* The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).

Primary outcomes:
measure: The mean end expiratory pressure.
timeFrame: the last 1 minutes of steady breathing during the standard or modified HFT.
Secondary outcomes:
measure: Changes in global and regional EELV
timeFrame: the last 1 minutes of steady breathing during the standard or modified HFT.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jian-Xin Zhou
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jian-Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02677961: An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Official title: An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms, Connective and Soft Tissue
Bone Neoplasms
Keywords: sarcoma
registry
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 1500
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: Adult patients with a diagnosis of bone or soft-tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.)

Brief summary: Translational studies in cancer research can be impeded by the lack of high-quality clinical data that can be correlated with research questions. This is particularly true in the case of rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this study to create a prospective EHR-based clinical registry for individuals with bone and soft-tissue tumors.

Detailed description: PRIMARY OBJECTIVES:

I. To create a secure EHR-based registry to allow for the prospective collection of clinical and research data in a collection of rare diseases (bone and soft-tissue tumors).

II. To facilitate the identification and validation of clinical and molecular features that may be associated with prognosis and/or response to therapy in (subtypes) of bone and soft-tissue tumors.

III. To pilot a mechanism that will facilitate future collaboration between institutions for research and analysis of bone and soft-tissue tumors.

IV. To standardize biospecimen collection for correlative biomarker analysis for patients undergoing treatment and surveillance for bone and soft tissue tumors at Ohio State University.

OUTLINE: This is an observational study.

Patients complete quality of life questionnaires and their medical records are reviewed. Patients may also undergo collection of blood samples for up to 2 years, unless otherwise specified in the protocol.

Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis or presumed diagnosis of bone or soft tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.)
* Patient, or his/her designated power of attorney, must be able to understand and approve of the consent to participate.

Exclusion Criteria:

* Prisoners are excluded from participation in the Registry.

Primary outcomes:
measure: Overall Survival
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: David A Liebner, MD
role: PRINCIPAL_INVESTIGATOR
References: