louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03677960: Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Official title: Open-Label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: HSIL, High-Grade Squamous Intraepithelial Lesions
Human Papilloma Virus Infection
HIV Infection
Anal Cancer
Anus Neoplasm
Lead sponsor: Antiva Biosciences
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 27
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection


Eligibility criteria: Inclusion Criteria

1. Female or male subjects, at least 27 years old.
2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (\<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
3. History of cancer involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years
4. History of genital herpes with \> 3 outbreaks per year.
5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
timeFrame: MAD portion is 84 days
Secondary outcomes:
measure: Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
timeFrame: MAD portion is 84 days
Other outcomes:
measure: Histopathology of areas with biopsy-proven disease following multiple doses of ABI-1968 Topical Cream.
timeFrame: MAD portion is 84 days
Locations:
city: Chicago
country: United States
facility: Research Center
state: Illinois
city: Darlinghurst
country: Australia
facility: Research Center
state: Sydney
Study officials:
References:
Clinical trial NCT05319860: Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)
Official title: Effects of Aromatherapy on Chemotherapy-Induced Nausea and Vomiting: A Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting, and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic chemotherapy regimens.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Able to read and speak English or Spanish
3. Able to and willing to give informed consent
4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant)
5. Receiving three or more remaining cycles of chemotherapy
6. Symptoms of nausea or vomiting after the first chemotherapy infusion

Exclusion Criteria:

1. Unable or unwilling to give informed consent
2. Sensitivity to essential oils\*
3. Olfactory disorders
4. Receiving chemotherapy for the first time
5. Undergoing low emetogenic chemotherapy regimens
6. Patients with hormone-sensitive cancers
7. Timely request of treating provider

Primary outcomes:
measure: Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
timeFrame: 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
measure: Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
timeFrame: 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
Secondary outcomes:
measure: Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
timeFrame: Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Debbie Anglade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202460: The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study
Official title: The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Other Immunological States or Disorders
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schizophrenia , Bipolar Disorder , Major Depression

Brief summary: Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI.

Detailed description: Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.

Eligibility criteria: Inclusion Criteria:

* Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5

Exclusion Criteria:

* Unstable physical conditions

Primary outcomes:
measure: Oxidative Stress-related Immunological Factors
timeFrame: 18 month
Secondary outcomes:
measure: BDNF
timeFrame: 18 month
Other outcomes:
measure: Brain MRI
timeFrame: 18 month
Locations:
city: Changsha
country: China
facility: Mental Health Institute of 2nd Xiangya Hospital,CSU
state: Hunan
Study officials:
References:
Clinical trial NCT04118660: Thoracic Specimen Registry
Official title: Thoracic Specimen Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Diseases
Lung Cancer
Lung Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic Rochester patients with thoracic disease

Brief summary: The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors, lung transplants and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases.

Detailed description: The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors, lung transplants and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. Collected specimens will include peripheral blood, bronchoalveolar lavage (BAL) fluid, pleural fluid, tissue (surgical resections \& biopsies) and touch prep samples. The specimens will be stored in a central location at Mayo Clinic and managed by the Mayo Clinic Thoracic Specimen Registry Steering Committee. The registry will be a foundation for the development and implementation of research protocols and clinical trials that will enhance current knowledge of etiology and detection, discovery of new molecular and biochemical markers for screening, early diagnosis, and develop state-of-the-art therapeutic and preventive interventions for managing patients with, or at risk for, thoracic cancers or other thoracic diseases.

Eligibility criteria: Inclusion Criteria:

* Subject must be \> 18 years of age
* Presumed or known or screening of Thoracic Diseases (which includes but not limited to the following: thoracic neoplasms (masses/nodules) malignant or benign, interstitial lung diseases (ILD), chronic obstructive pulmonary disease (COPD), thoracic infections, thoracic malignancies metastatic to other organs, other cancers metastatic to the thoracic cavity.

Primary outcomes:
measure: Thoracic Specimen Repository
timeFrame: Through study completion, approximately 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric Edell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964860: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Official title: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.


Eligibility criteria: Inclusion Criteria:

In order to be included in the study, each subject must:

* be at least 18 years of age;
* be physically able to floss their teeth;
* have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
* have refrained from performing oral hygiene the morning of the Baseline visit;
* be in good general health;
* have interproximal MGI (Modified Gingival Index) score of \>2.8.

Exclusion Criteria:

Subjects are excluded from study participation where there is evidence of:

* severe periodontal disease;
* discoloration or pigmentation in the gingival tissue;
* meaningful misalignment of front teeth;
* fixed facial orthodontic appliances;
* use of antibiotics within two weeks of the Baseline Visit and at any time during the study;
* any diseases or conditions that could be expected to interfere with the subject safely completing the study.

Primary outcomes:
measure: Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
timeFrame: 30 days
Secondary outcomes:
measure: Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
timeFrame: 30 days
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Radiologio Oral Y Maxilofacial
Study officials:
affiliation: Procter and Gamble
name: Jon Witt, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05865860: Application and Safety Evaluation of 3D Visualization System in Microsurgical Training
Official title: Application and Safety Evaluation of 3D Visualization System in Microsurgical Training
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microsurgery
Binocular Visual Function
Nervous System
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ophthalmologists

Brief summary: Based on the relative shortage of ophthalmic surgeons in China, the long micromanipulation cycle and the existing micromanipulation training methods have their own limitations, such as traditional operating in porcine eyes limited to synchronous guidance and evaluation, while surgical simulators are very different for the simulation of real tissues, and the price is expensive and easy to lose. Based on these, the development of a digital training system, that is, based on traditional micromanipulation platforms such as animal tissue, physical microscopic instruments supplemented by synchronous surgical guidance and evaluation, can combine the advantages of traditional training and simulator, so as to improve the efficiency of ophthalmic surgeon training, and also provide digital ideas for other disciplines based on traditionally surgical teaching.

Detailed description: The digital vision technology are required for the daily training of microsurgeons enrolled in our study. We only observed biological indicators of surgeons before and immediately after the operation using the digital technology, according with the prospective observational study design.

Eligibility criteria: Inclusion Criteria:

* Age:20-45 years
* Refractive diopters: spherical: - 6.00 to + 1.00 D, cylindrical: - 1.50 to - 0 D, and binocular difference less than 1.5 D
* Monocular best-corrected visual acuity (BCVA) ≥ 20/20
* Normal stereoacuity (60 s of arc or better)

Exclusion Criteria:

* history of strabismus
* history of systemic diseases
* history of eye surgery

Primary outcomes:
measure: change of accommodative lag between pre- and post- microsurgery under digital visualization system.
timeFrame: 5 minutes before the microsurgery and after the microsurgery within 3minutes
Secondary outcomes:
measure: heart rate variability
timeFrame: 1 minutes before the microsurgery and after the microsurgery within 1minutes
measure: surgical performance
timeFrame: Intraoperative (When participant performs the operation, the surgical videos is simultaneously recorded.)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01539460: A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
Official title: A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sweat Gland Diseases
Keywords: Axillary osmidrosis
liposuction
minimally invasive surgery
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined.

Detailed description: Patients with excessive malodor are recruited. They are surgically treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* unpleasant odor from the axillae
* Willing and able to appear for all scheduled, post-operative visits

Exclusion Criteria:

* under the age of 18
* have undergone a prior surgical intervention
* inappropriate candidates for surgery due to medical or mental health reasons
* elect not to participate in the study

Primary outcomes:
measure: To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Yuejun Li
state: Shaanxi
Study officials:
affiliation: Department of Plastics and Burns, Tangdu Hospital
name: XUEYONG LI, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00264160: Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
Official title: Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Leukemia, Myeloid, Chronic
Keywords: AMN107
CML
Bcr Abl
cytogenetic response
Chronic Myelogenous Leukemia (CML)
imatinib mesylate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.


Eligibility criteria: Inclusion Criteria:

* Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
* Males or females ≥ 18 years of age

Exclusion Criteria:

* Impaired cardiac function
* Acute or chronic liver or renal disease
* Use of therapeutic coumadin
* Central nervous system (CNS) infiltration

Additional protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Cytogenetic response within 12 months
timeFrame: Every 6 months for 12 months
Secondary outcomes:
measure: To determine the rate of hematologic response at 12 months
timeFrame: Every Visit for 12 months
measure: To determine the rate of molecular response at 12 months
timeFrame: Every 3 months for 12 months
measure: To evaluate the time to cytogenetic and molecular response
timeFrame: At 12 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Tel Hashomer
country: Israel
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kantarjian HM, Giles F, Gattermann N, Bhalla K, Alimena G, Palandri F, Ossenkoppele GJ, Nicolini FE, O'Brien SG, Litzow M, Bhatia R, Cervantes F, Haque A, Shou Y, Resta DJ, Weitzman A, Hochhaus A, le Coutre P. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007 Nov 15;110(10):3540-6. doi: 10.1182/blood-2007-03-080689. Epub 2007 Aug 22.
Clinical trial NCT01010360: Identification of Celiac Ganglia
Official title: Identification of Celiac Ganglia for Endoscopic Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Ganglia
Keywords: celiac ganglia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EUS patients

Brief summary: Computer-aided image recognition will improve the technique of endoscopic ultrasound-celiac plexus block/celiac plexus neurolysis (EUS-CPB/CPN) and improved pain relief.

Detailed description: All subjects who are undergoing EUS will be eligible. Consecutive patients undergoing EUS will be invited to participate in this study. Subjects must be 18 years old or above at the time of the procedure.

Eligibility criteria: Inclusion Criteria:

* all EUS patients

Exclusion Criteria:

* under 18 yrs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Julia LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04699760: The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer
Official title: Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer Cachexia
Side Effects
Quality of Life
Keywords: cancer
nutrition
fish oil
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.

Detailed description: Primary outcomes:

* Weight
* Physical function
* Hand-grip strength

Secondary outcomes:

* Quality of life
* Mid-upperarm circumference
* Incorporation of n-3 PUFAs into cell membranes

Eligibility criteria: Inclusion Criteria:

* ≥18 years
* Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen

Exclusion Criteria:

* \< 18 years
* Patients in palliative care
* patients with haemophilia
* Patiens in treatment of anti-coagulation
* Patients with genetic hyperkolesterolemia
* Pre-dialytic patients (GFR\<15ml/min/1,73m2 eller kreatinin ≥500 mmol/L)

Primary outcomes:
measure: Weight loss
timeFrame: 8 weeks
Secondary outcomes:
measure: quality of Life score
timeFrame: 8 weeks
measure: Performance status - common daily abilities
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Departmen of Oncology, Rigshospital
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen
role: PRINCIPAL_INVESTIGATOR
References: