louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04845217: Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
Official title: Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Interstitial Cystitis
Keywords: interstitial cystitis
bladder pain syndrome
peppermint
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Integrative Therapeutics, Inc.
First posted: 2021-04-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1 ratio to the intervention or placebo arm. Allocation concealment will be in place to ensure the individual enrolling the subject into the study has no a priori knowledge of group assignment. Block randomization will occur with randomly mixed block sizes of 4, 6, and 8 using the randomization list generator at www.sealedenvelope.com. Randomization information will be kept confidential and only available to study personnel.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

Detailed description: After being informed about the study and potential risks, all participants will complete validated IC/BPS symptom questionnaires for baseline screening. Once participants meet eligibility requirements and give written informed consent they will be randomized in a 1:1 ratio to peppermint oil (200mg TID) or placebo (also TID). Participants will complete validated IC/BPS questionnaires and follow up surveys over 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Women ages 18-65 years old
* Diagnosed with IC/BPS for at least one month prior to study enrollment

Exclusion Criteria:

* Culture proven urinary tract infection within 1 month of randomization
* Gross hematuria
* Currently pregnant or breastfeeding
* Unable to speak and read English
* History of allergic reaction to peppermint, coconut or enteric coating
* History of malabsorption syndrome
* History of gastroparesis
* History of gastric bypass surgery
* History of gastrointestinal, genitourinary or pelvic cancer in the last 5 years
* History of insulin dependent diabetes
* History of active urinary stone disease

Primary outcomes:
measure: O'Leary/Sant questionnaire scores
timeFrame: 8 weeks
measure: Pelvic Pain and Urgency/Frequency questionnaire scores
timeFrame: 8 weeks
Secondary outcomes:
measure: Urine pH
timeFrame: 8 weeks
measure: Incidence of urinary tract infections (UTIs)
timeFrame: 8 weeks
measure: Additional IC/BPS Treatments received
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Springs Medical Center
state: Kentucky
Study officials:
affiliation: Department Chair
name: Sean Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04227717: Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine
Official title: Assessment of a Custom-Built MRI Coil for Spine Radiotherapy Treatment Planning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thoracic Cancer
Spine Cancer
Thoracic Diseases
Spine Disease
Thoracic Neoplasms
Spine Metastases
Keywords: Thoracic lesions
Lumbar lesions
Sacral spine lesions
MRI Coil
spine radiotherapy
Memorial Sloan Kettering Cancer Center
19-476
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 9
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: Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.


Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age at the time of treatment
* Able to give informed consent
* Consented for spine stereotactic radiation therapy
* No contraindications for CT myelograms which include:

  * Allergy to CT contrast
  * Use of phenothiazines
  * Platelet count \< 60,000 K/mcl
  * INR \> 1.5
  * VEGF inhibitor use in the past 2 weeks prior to myelogram
  * NSAID use in the past 5 days prior to myelogram
  * Renal disease
  * Creatinine \> 1.2 mg/dL
* No contraindications for MRI scans which include:

  * Newly placed glucose monitors
  * Tattoos (Tattoos for radiation therapy are allowed)
  * Presence of a cardiac pacemaker
  * Presence of an implanted cardioverter defibrillator
  * Breast tissue expander
  * Aneurysm clip
  * Any other implanted metallic (BB, bullet, shrapnel, IUD, metallic stent or filter, spinal cord simulator etc.) or electronic device which is considered MR unsafe
  * Severe claustrophobia or inability to lie flat for the duration of the study, etc.

Exclusion Criteria:

* Presence of surgical spine hardware at the region of interest
* Presence of cervical spine lesions
* History of claustrophobia

Primary outcomes:
measure: Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yoshiya Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05412017: EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
Official title: EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: hepatitis C
Pharmacy
Testing
Lead sponsor: Cool Aid Community Health Centre
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The research project aims to understand how pharmacies can be involved in the identification and treatment of hepatitis C (hep C). The study will look at the effectiveness of hep C testing and treatment through pharmacies with support from the Cool Aid Community Health Centre (CACHC). The study will also evaluate the readiness of pharmacies to take on these extra tasks at the pharmacy. This information will be used to develop future strategies to better detect, treat and prevent hep C.

Detailed description: The primary objective of this project is to decrease barriers to care for hepatitis C (HCV) treatment for people who use drugs through the use of rapid diagnostic testing technologies, and task shifting HCV testing and treatment follow up to include trained pharmacy staff. Secondary objectives are to evaluate interest, readiness, and effectiveness of community-based pharmacies as a location for the screening and treatment of HCV.

A prospective, longitudinal interventional cohort design will be used to enrol people who access community-based pharmacies and have tested for HCV RNA. Persons with untreated chronic HCV infection will receive direct acting antiviral treatment. This is a trial of pharmacist-led HCV testing and treatment versus conventional care in HCV positive patients.

Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent
2. Age \> 18 years old
3. Documented HCV RNA test, interested in being tested for HCV antibody or at risk for HCV (ie. "Baby boomers": anyone born between 1945-1965, anyone known to currently (past 6 months) or have a history of injecting drugs, including anyone receiving Opiate Agonist Therapy (OAT), any gay or bisexual men who have sex with men (gbMSM))

Exclusion Criteria:

1) Declined to provide informed consent

Primary outcomes:
measure: HCV access to care for HCV testing and treatment
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Cool Aid Community Health Centre
state: British Columbia
Study officials:
affiliation: Medical Director
name: Chris Fraser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05678517: Seven-year Outcomes Following Intensive Anti-VEGF Therapy in Wet AMD
Official title: Seven-year Outcomes Following Intensive Anti-vascular Endothelial Growth Factor Therapy in Patients With Exudative Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Same as the original VIEW2 study (NCT00637377)
* Patients who finished the VIEW 2 study

Brief summary: The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD.

Detailed description: This study was conducted at two clinical sites in Budapest, Hungary after the "Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2)" phase-3 multicenter, prospective, randomized, double blind clinical trial (ClinicalTrials.gov ID: NCT00637377).

Patients were treated with intravitreal anti-VEGF injections between 2008 and 2017. During the first 2 years in the framework of the VIEW 2 study, participants were randomized per protocol to intravitreal aflibercept or ranibizumab treatment arms and received injections according to the VIEW 2 study protocol.

This study focused on long-term outcomes that happened after the VIEW 2 study. After finishing the VIEW 2 study, patients returned to daily routine medical care and were followed under regular clinical care in real-life conditions and were treated with predominantly ranibizumab anti-VEGF injections (participants received interventions as part of routine medical care). Treatment was administered as needed according to the judgement of the physician. Retreatment criteria were based on visual acuity, signs of activity on optical coherence tomography (OCT) or indirect slit lamp biomicroscopy. Results at the end of the follow-up (year 7) were retrospectively analyzed.

Eligibility criteria: * Same as the original VIEW2 study (NCT00637377)
* Finished VIEW 2 study

Primary outcomes:
measure: BCVA
timeFrame: At the end of follow-up (year 7)
measure: Geographic atrophy
timeFrame: At the end of follow-up (year 7)
measure: Retinal fluid
timeFrame: At the end of follow-up (year 7)
Secondary outcomes:
measure: Number of injections
timeFrame: Over the course of the follow-up (7 years)
measure: Adverse events
timeFrame: Over the course of the follow-up (7 years)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Ophthalmology, Semmelweis University
city: Budapest
country: Hungary
facility: Department of Ophthalmology, Bajcsy-Zsilinszky Hospital
Study officials:
affiliation: Semmelweis University
name: Andras Papp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379817: Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Official title: Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.


Eligibility criteria: Inclusion Criteria:

* Age above or equal to 18 years
* Written informed consent in accordance with institutional guidelines and obtained prior to any study procedures
* Confirmed diagnosis of multiple myeloma according to the Salmon and Durie criteria
* Has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab)
* Life expectancy above 3 months
* Active (relapsing or refractory) and measurable disease (on 18F-FDG PET/CT (performed within 4 weeks prior SSTR PET/CT) and biologically)
* Adequate renal function with GFR above or equal to 30mL/min/1.73m²
* Bone marrow aspiration and biopsy sample available within 30 days prior study enrolment with positive SSTR2 IHC

Exclusion Criteria:

* Pregnant or lactating patients
* Other active neoplastic disease
* Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT
* Eastern Cooperative Oncology Group Performance Status above or equal to 3
* Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment

Primary outcomes:
measure: Somatostatin receptor expression
timeFrame: through study completion, an average of 1,5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Institute
Study officials:
References:
Clinical trial NCT03764917: NGS Combined With RNAseq on Tumor Immune Escape in NSCLC
Official title: Study on the Effect of NGS Combined With RNAseq on Tumor Immune Escape in Advanced Non-small Cell Lung Cancer EGFR and ALK Mutant Negative Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: NGS
RNAseq
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 100
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: PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy Without EGFR and Alk mutation

Brief summary: Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq

Detailed description: Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.

Eligibility criteria: Inclusion Criteria:

Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy

Exclusion Criteria:

EGFR mutant positive Alk mutant positive

Primary outcomes:
measure: numbers of immune cells
timeFrame: 24 months
Secondary outcomes:
measure: numbers of tumor mutations
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Tongji University
name: Yayi He, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He Y, Chen L, Zhao L, Dang S, Liu G, Sasada S, Ma PC, van Zandwijk N, Rosell R, Popper HH, Wang H, Jiang M, Guo H, Liu X, Chen S, Zhang X, Xu M, Zhu B, Liu M, Zhou C. Genomic and transcriptional alterations in first-line chemotherapy exert a potentially unfavorable influence on subsequent immunotherapy in NSCLC. Theranostics. 2021 May 13;11(14):7092-7109. doi: 10.7150/thno.58039. eCollection 2021.
Clinical trial NCT02804217: Acquired Resistant Mechanism of the First-generation EGFR TKIs
Official title: Identification of Genomic Mutation Profile Using Next Generation Sequencing for Non-small-cell Lung Cancer Patients With Activating EGFR Mutations Harboring Acquired Resistance to the First-generation EGFR TKIs.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Aquired Resistance
EGFR TKIs
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with NSCLC harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance

Brief summary: Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).


Eligibility criteria: Inclusion Criteria:

* Histologically proven stage IIIB or IV non-small cell lung cancer
* patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
* patients who can provide pre-treatment (EGFR TKIs) tumor tissues
* patients with tumor lesions to be re-biopsy after drug resistance
* patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

* History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
* patients with other systemic diseases

Primary outcomes:
measure: mutation profile
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03277417: Does Amniotic Fluid Index Affect the Fetal Cardiac Performance?
Official title: Does the Amniotic Fluid Index Affect the Fetal Cardiac Performance?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oligohydramnios
Polyhydramnios
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-09-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women attending the Hillel Yaffe Medical Center's OB/GYN clinic

Brief summary: To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and polyhydramnios.


Eligibility criteria: Inclusion Criteria:

* Gestational age 24-42 weeks
* Singleton pregnancies

Exclusion Criteria:

* Fetal anatomical or chromosomal abnormality
* Known fetal cardiac defect
* Suspected fetal infection
* Suspected IUGR

Primary outcomes:
measure: Fetal cardiac ventricles
timeFrame: One month
Secondary outcomes:
measure: Gestational age
timeFrame: One month
measure: Mode of delivery
timeFrame: One month
measure: Birth weight
timeFrame: One month
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rinat Gabbay-Benziv, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01964417: The Comparative Study Between Bowel Preparation Method
Official title: The Comparative Study Between Bowel Preparation Method: 4L-split Dose of PEG Solution, Low-volume PEG Plus Ascorbic Acid Focusing on the Bowel Cleansing Efficacy, Patients' Affinity to Preparation Solution and Mucosal Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: BOWEL PREPARATION
PEG
Low-volume PEG Plus Ascorbic Acid
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 319
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the efficacy, acceptability and preparation-induced mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.

Detailed description: This was a prospective randomized single-blinded clinical trial of ambulatory patients to assess the efficacy of bowel preparation and preparation-induced mucosal inflammation.

Endoscopists who were blinded to the preparation taken, assessed both bowel cleansing by using the Ottawa bowel preparation assessment tool and preparation-induced mucosal inflammation. Acceptability was assessed by questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients who want colonoscopy purposing screening among adults between the age of 20\~65

Exclusion Criteria:

* Under the age of 20, older than 65, pregnant or lactating women, intestinal obstruction, structural intestinal disease, hypothyroidism, gastrointestinal motility, renal failure, congestive heart failure, liver failure, electrolyte abnormalities, who refused research informed consent, inflammatory bowel disease, the obvious symptoms of the disease in patients with lower gastrointestinal (bloody stools, diarrhea, etc.)

Primary outcomes:
measure: Comparison of colon cleansing between the two solutions using Ottawa scale
timeFrame: 3month
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital
Study officials:
affiliation: Inje University
name: Jongha Park, MD
role: PRINCIPAL_INVESTIGATOR
References: