louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06557291: Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
Official title: Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy After Relapse on Adjuvant Checkpoint Inhibitor Therapy and Subsequent Surgical Resection in Patients With BRAF V600-mutated Stage III/IV Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRAF V600 Mutated-Stage III/IV Melanoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.


Eligibility criteria: Inclusion Criteria:

* Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma.
* Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis.
* Documented local or central assay-positive for tumor BRAF V600E/K mutation.
* Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy.
* Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection.
* Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED.

Exclusion Criteria:

* Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies.
* More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy.
* Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.

Primary outcomes:
measure: Relapse-free Survival-2 (RFS-2)
timeFrame: Up to 63 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 63 months
measure: Distant Metastases-free Survival (DMFS)
timeFrame: Up to 63 months
measure: Number of Patients with an Adverse Event (AE) Related to Dabrafenib and Trametinib Combination Therapy
timeFrame: Up to 63 months
measure: Mean Number of Times an AE Related to Dabrafenib and Trametinib Combination Therapy was Experienced
timeFrame: Up to 63 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02784691: Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (Diclofenac).


Eligibility criteria: Inclusion Criteria:

* Patients with age above 70 years,
* Having a knee Arthritis (unilateral or bilateral) for at least 6 months,
* Pain intensity ≥ 40 mm on a visual analog scale (VAS)
* Lack of analgesic treatment or analgesic,

Exclusion Criteria:

* Cognitive disorders : moderate to severe stage or not allowing an understanding of the VAS (as determined by the clinician)
* A history of chronic inflammatory rheumatic disease,
* Diagnosis of osteoarthritis of secondary origin,
* Non-steroidal anti-inflammatory medication within 7 days prior to inclusion,
* Diagnosis of severe hepatic and renal insufficiency, gastrointestinal bleeding, severe heart failure,
* Allergy to diclofenac or similar activity substances such as other NSAIDs, aspirin, excipients,
* Damaged skin

Primary outcomes:
measure: Intensity reduction of pain
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT00202891: Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)
Official title: Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pyoderma
Keywords: pyoderma
sisomicin
nadifloxacin
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Fulford India Limited
First posted: 2005-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, randomized, parallel-group clinical study is designed to compare the efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary pyodermas.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings.
* \>=6 years of age.
* Written informed consent.

Exclusion Criteria:

* Patients must not take any other antibiotics.
* Patients should not be hypersensitive to any of the test drugs.
* Patients are not to have any other investigational drug within one month of starting this study.
* Patients cannot be enrolled more than once in the study.
* Patients must not have any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment.
* Pregnant women and nursing mothers are to be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00655291: Efficacy of XP20B Following Bunionectomy Surgery
Official title: Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Keywords: pain
Lead sponsor: Xanodyne Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 190
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: The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.


Eligibility criteria: Inclusion Criteria:

* having undergone bunionectomy surgery
* having achieved the requisite level of pain

Exclusion Criteria:

* pregnant or lactating
* history of substance abuse
* clinically significant condition or lab abnormality
* taken any prohibited medications
* gastrointestinal bleeding or history of

Primary outcomes:
measure: Average pain over a fixed dosing period
timeFrame: Multiple-day
Secondary outcomes:
measure: multiple pain assessments over a fixed dosing period
timeFrame: Multiple-day
measure: Rescue medication use
timeFrame: Multiple-day
measure: Safety evaluations
timeFrame: Multiple-day
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Investigatve Site
state: California
city: Owings Mills
country: United States
facility: Investigative Site
state: Maryland
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: San Marcos
country: United States
facility: Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
Study officials:
affiliation: Xanodyne Pharmaceuticals
name: Keith Moore, PharmD
References:
Clinical trial NCT02544191: GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia
Official title: GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Azoospermia
Keywords: azoospermia nonobstructive
male infertility
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA. It was generally believed that gonadotrophin treatment would be ineffective in the presence of high plasma levels of endogenous gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal gonadotropin) are effective in the treatment of non-obstructive azoospermia.


Eligibility criteria: Inclusion Criteria:

* Male subjects aged 18-45 with clinical diagnosis of non-obstructive azoospermia.
* At least testicular volume more than 8.0ml on one side .
* FSH more than 5.5 IU/L.

Exclusion Criteria:

* Subjects with anatomical abnormalities of the genital tract.
* allergy to the drugs used for treatment.
* Y chromosome deletions or abnormal karyotypes.
* Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease

Primary outcomes:
measure: Sperm retrieval rate (SRR)
timeFrame: 4 months
Secondary outcomes:
measure: Hormonal profile
timeFrame: 9 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Center for Reproductive Medicine, Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University
name: Bing Yao, MD
role: STUDY_DIRECTOR
References:
citation: Hu X, Ding Z, Hong Z, Zou Z, Feng Y, Zhu R, Ma J, Ge X, Li C, Yao B. Spermatogenesis improved by suppressing the high level of endogenous gonadotropins in idiopathic non-obstructive azoospermia: a case control pilot study. Reprod Biol Endocrinol. 2018 Sep 22;16(1):91. doi: 10.1186/s12958-018-0401-7.
Clinical trial NCT04897191: Healthy Age-dependent Reference Values for Microvascular Structure and Function
Official title: Assessing Age-dependent Reference Values for Microvascular Structure and Function in Healthy Participant Together With Macrovascular Function With Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Endothelium
Microvascular Circulation
Arterial Stiffness
Healthy Ageing
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aiming at n=10 of each decade

Brief summary: The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. How healthy ageing affects the smallest blood vessels (microcirculation) and is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation. We have developed an automated software (OCTAVA) to determine metrics to characterise the microcirculation on the layers of density, diameter and tortuosity.

In the current study we aim at providing reference values of these metrics in hands and feet of healthy people according to age together with macrovascular function in arms and legs.


Eligibility criteria: Inclusion criteria:

Healthy, 20-70 years, BMI 20-30 kg/m\^2

Exclusion criteria:

Diabetes mellitus, symptoms of acute infection, cardiac arrhythmias, active malignancy, clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication, active vasoactive medication.

Primary outcomes:
measure: Microvascular density
timeFrame: 1 day (One timepoint during single visit)
measure: Microvascular diameter
timeFrame: 1 day (One timepoint during single visit)
measure: Microvascular turtuosity
timeFrame: 1 day (One timepoint during single visit)
Secondary outcomes:
measure: Blood pressure
timeFrame: 1 day (One timepoint during single visit)
measure: Endothelial function
timeFrame: 1 day (One timepoint during single visit)
measure: Arterial stiffness
timeFrame: 1 day (One timepoint during single visit)
measure: Arterial stiffness
timeFrame: 1 day (One timepoint during single visit)
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
Study officials:
affiliation: University of Surrey
name: Christian Heiss, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05703191: A Real-world Study of Nitric Oxide Generator and Delivery System
Official title: The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension of Newborn
Lead sponsor: Novlead Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 10
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: Newborns

Brief summary: The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.


Eligibility criteria: Inclusion Criteria:

1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
2. Admitted to the Department of Neonatology at the hospital, gender unlimited
3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
4. Documented Oxygenation index (OI) ≥8 prior to the treatment
5. Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study

Exclusion Criteria:

1. Proven risks of nitric oxide contraindication
2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation
3. Other circumstances that investigators believe unsuitable for enrollment

Primary outcomes:
measure: Change From Baseline in Oxygenation Index (OI)
timeFrame: Baseline, Minutes 45
Secondary outcomes:
measure: Change From Baseline in Oxygenation Index (OI)
timeFrame: Baseline, Hour 24, 2 hours after iNO is discontinued
measure: Change From Baseline in Oxygen Saturation
timeFrame: Baseline, Hour 24, 2 hours after iNO is discontinued
measure: Change From Baseline in Pulmonary Artery Pressure (PAP)
timeFrame: Baseline, Hour 24, 2 hours after iNO is discontinued
measure: Percentage of subjects responding to iNO
timeFrame: Hour 24, 2 hours after iNO is discontinued
measure: Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment
timeFrame: Minutes 45, Hour 24, 2 hours after iNO is discontinued
measure: Adverse events
timeFrame: Baseline up to 24 hours after iNO is discontinued
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangzhou
Study officials:
affiliation: Southern Medical University, China
name: Bin Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04162691: Single Cell Sequencing Analysis of Thymoma
Official title: Single Cell Sequencing Analysis of Thymoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thymoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the clinic for investigation of a suspected thymoma condition

Brief summary: The purpose of this study is to understand how genetics play a role in thymoma. Intratumoral heterogeneity is among the greatest challenges in precision cancer therapy. However, developments in high-throughput single-cell RNA sequencing (scRNA-seq) may now provide the statistical power to dissect the diverse cellular populations of tumors. This study aims to find out how it affects genetic and protein expression in patients with malignant thymoma, compared to Benign thymoma, at a single-cell level using a flow cytometry and RNA-sequencing protocol.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with thymoma
* Ability to provide written consent and comply with the protocol
* At least 18 years of age

Exclusion Criteria:

* Patients undergoing thymoma treatment
* Patients with previous malignancy
* Known HIV positive status.
* Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.

Primary outcomes:
measure: Determination of cell population from thymoma
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: An Zhao
Study officials:
References:
Clinical trial NCT00354991: Hyzaar Asia HEAALTH (0954A-950)
Official title: An Open Label Study to Assess the Efficacy of Losartan/HCTZ Combination Therapy in Patients With Essential Hypertension Who Were Inadequately Controlled on Current Antihypertensive Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female and = 18 years of age
* Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal

Exclusion Criteria:

* History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate
* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
* Previous history of severe essential hypertension
* History of stroke or myocardial infarction (heart attack)
* Evidence of renal or liver disease
* Uncontrolled diabetes mellitus
* Any known bleeding disorder
* Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide)
* Other antihypertensive medications or medications that may affect blood pressure

Primary outcomes:
measure: Percentage of patients reaching a blood pressure goal (diastolic <90mm Hg for non-diabetics; <80mm Hg for diabetics) after 8 weeks of treatment
timeFrame: 8 Weeks
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 13 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kim KS, Fan WH, Kim YD, Zhu W, Ngau YY, Tong P, Kim BS, Santos M, Lin WH, Buranakitjaroen P, Massaad R, Smith RD; Asia HEAALTH Study Investigators. Effectiveness of open-label losartan/hydrochlorothiazide combination therapy in Asian patients with hypertension not controlled with ACE inhibitor or ARB monotherapy. Hypertens Res. 2009 Jun;32(6):520-6. doi: 10.1038/hr.2009.42. Epub 2009 Apr 24.
Clinical trial NCT04430491: To Evaluate the Use of Radiomics to Classify Between Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease
Official title: Multi-center Validation of a Radiomics Based Model for the Diagnosis of Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Usual Interstitial Pneumonia
Keywords: Lung
CT
UIP
IPF
ILDs
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
First posted: 2020-06-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the hospital for lung disease. Two cohorts were included. One from Belgium, and a second one from the US.

Brief summary: To investigate the ability of machine learning models based on radiomic features extracted from thin-section CT images to differentiate IPF patients from non-IPF interstitial lung diseases.


Eligibility criteria: Inclusion Criteria:

* UIP with final diagnosis in biopsy
* ILDs with final diagnosis in biopsy

Exclusion Criteria:

* patients with no biopsy confirmation

Primary outcomes:
measure: IPF classifier
timeFrame: Up to 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: