louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06646770: SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)
Official title: Segmentectomy Versus Lobectomy in Clinical T1c Non-Small Cell Lung Cancer: A Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
T1c
Segmentectomy
Lobectomy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are:

1. Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival?
2. What are the mortality and morbidity rates of segmentectomy compared to lobectomy?

Researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival.

Participants will:

* Undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection
* Be followed up with a chest CT in every 3 months in first year, every 6 months in second year and every year for following 3 years


Eligibility criteria: Inclusion Criteria:

* Clinical T1c NSCLC
* Parenchymal nodule \>2 cm in diameter
* Parenchymal nodule ≤3 cm in diameter
* Consolidation / Tumor Rate (CTR) ≥ 0.50
* Definitive pathological diagnosis of NSCLC preoperative or intraoperatively
* No evidence of distant metastasis
* No evidence of N2 disease
* Adequate pulmonary functions for lobectomy or segmentectomy

Exclusion Criteria:

* Pure GGO lesions
* Pathologic diagnosis other than NSCLC
* Technically not suitable for simple or complex segmentectomy, or lobectomy
* Evidence of distant metastasis
* Pathologically confirmed N2 or N3 disease
* Major comorbidity that precludes surgery
* Intraoperative mediastinal nodal dissection of less than 3 lymph node stations
* Prior malignancy in five years

Primary outcomes:
measure: Survival Survival
timeFrame: 5 years
Secondary outcomes:
measure: Complication rate associated with surgery
timeFrame: 90 days
measure: Mortality rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
name: Akif Turna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02822170: A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU
Official title: A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 4
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: The purpose of this small pilot study is to refine a combined intervention of IV amino acids and cycle ergometry in critically ill patients, and to gather preliminary data, before proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined intervention.


Eligibility criteria: Inclusion Criteria:

1. \>=18 years old
2. Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC \>48 hours
3. Expected ICU stay \>4 days after enrollment (to permit adequate exposure to the proposed intervention)

Exclusion Criteria:

1. \>120 continuous hours of mechanical ventilation or HFNC before enrollment
2. Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
3. No expectation for any nutritional intake within the subsequent 72 hours
4. Severe chronic liver disease (MELD score \>20) or acute fulminant hepatitis.
5. Documented allergy to the amino acid intervention
6. Not ambulating independently prior to ICU admission (use of gait aid permitted)
7. Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)
8. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
9. Pre-existing intracranial or spinal process affecting motor function
10. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
11. Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
12. Weight \>150kg
13. Pregnant
14. Incarcerated

Primary outcomes:
measure: 6-minute walk distance (6MWD)
timeFrame: 6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
References:
Clinical trial NCT03505970: Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation
Official title: Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sports Nutritional Physiological Phenomena
Keywords: Physiological Phenomena
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind crossover
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to attend the laboratory on five separate visits to a randomized, double-blind, placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters (MCT1, MCT4, NHE).


Eligibility criteria: Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Smokers
* Chronic disease
* Prior or current use of steroids
* Use of creatine in the last 6 months
* Use of beta-alanine in the last 6 months

Primary outcomes:
measure: H+ transporter activity
timeFrame: 5 minutes Post-exercise
Secondary outcomes:
measure: Exercise performance
timeFrame: 1 hour Post-supplementation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06436170: The Role of Radial Peripapillary Vessel Density in Irvine-gass Syndrome
Official title: Radial Peripapillary Vessel Density as a New Biomarker in Irvine-Gass Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Macular Edema
Keywords: OCTA;RPC; IGS;PCME
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 58
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of PCME following phacoemulsification, addressed to our Unit, were enrolled in the study. The diagnostic criteria for PCME were: 1) vision loss in the operated eye within 3 months after surgery in patients with acute PCME and after 3 months for patients with chronic PCME; 2) changes on B-scan structural OCT with intraretinal cystoid spaces and central macular thickness (CMT) of at least 300 micron; 3) leakage and pooling of dye in macular cystoid spaces and late hyperfluorescence of the optic nerve head on FA. Clinical suspicion of PCME was confirmed using FA and structural OCT.

Brief summary: Pseudophakic cystoid macular edema (PCME), also known as Irvine-Gass syndrome (IGS), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) . It is the most common cause of decreased vision after uneventful phacoemulsification, with a rare incidence of 0.1-2.35% for clinically significant PCME .

Macular edema in IGS can be diagnosed and classified by optical coherence tomography (OCT), which enables its morphologic assessment. Fluorescein angiography (FA) is the gold standard to perform differential diagnosis for macular edema.

To date, OCT angiography (OCTA) has been proposed to study various retinal vascular diseases. In contrast to FA, OCTA is able to visualize Radial peripapillary vessel density (RCP).

The aim of this study was to investigate abnormalities in the vascular network of the optic nerve head in patients with IGS compared to healthy eyes, using OCT-A


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of PCME Cataract surgery

Exclusion Criteria:

diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy

-

Primary outcomes:
measure: the role of OCTA in diagnosis of IGS
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University Federico II of Naples
Study officials:
References:
Clinical trial NCT03297775: Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
Official title: Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Interstitial Lung Disease
Keywords: Rheumatoid Arthritis
RA
Interstitial Lung Disease
ILD
lung disease
connective tissue disease
CTD
idiopathic pulmonary fibrosis
IPF
airways disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 750
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk for the development of lung disease.

Brief summary: The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.


Eligibility criteria: Inclusion Criteria:

1. ≥ 45years old
2. Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

1. Inability to give informed consent
2. Pregnant women
3. History of interstitial lung disease
4. Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
5. Subjects over the age of 90 years old or less than 45 years old

Primary outcomes:
measure: Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging
timeFrame: 3-5 years
Secondary outcomes:
measure: Progression of lung disease over time
timeFrame: 3-5 Years
measure: Impact of subclinical RA-ILD on health-related quality of life in RA
timeFrame: 3-5 Years
measure: Outcome of airways disease
timeFrame: 3-5 Years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Joyce S Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03314675: Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
Official title: Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: CRT-D, LV Latency
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 16
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: The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data


Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
* Patient successfully implanted with a left ventricular lead
* High likelihood of LV latency ≥ 40 ms
* LV lead in lateral or postero-lateral position in the coronary venous system
* Patient is able to understand the nature of the clinical investigation
* Patient is willing to undergo the required measurements at the investigation site
* Patient provides written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Patients with irregular ventricular rhythm due to atrial tachycardia
* Pregnant or breast-feeding women
* Participation in an interventional clinical investigation

Primary outcomes:
measure: Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
timeFrame: 1 day
Secondary outcomes:
measure: Device-base measured LV latency in the LV IEGM channel and Far Field channel
timeFrame: 1 day
measure: 12-lead ECG-measured LV latency in the channel with earliest QRS onset
timeFrame: 1 day
measure: Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel
timeFrame: 1 day
measure: 12-lead ECG-measured latency intervals
timeFrame: 1 day
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: České Budějovice
country: Czechia
facility: Ceske Budejovice hospital
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabetiszentrum NRW
city: Gera
country: Germany
facility: SRH Waldklinikum Gera GmbH
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Rotterdam
country: Netherlands
facility: The Erasmus University Medical Center
Study officials:
affiliation: Wuerzburg University Hospital
name: Peter Nordbeck, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06539975: Effectiveness of Evening Primrose Oil for Induction of Labor
Official title: Effectiveness of Evening Primrose Oil for Induction of Labor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Induction of Labor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a douple-centered, serially-numbered closed opaque envelope, randomised clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effectivness of primrose oil in induction of labour .

Detailed description: Using primrose oil in addition to misoprostol for induction of labor in one group of pregnant women and compare the result with those of another group in which we are using misoprstol only.

Eligibility criteria: Inclusion Criteria:

* pregenent of 38 weeks and longer
* singleton pregenency
* vertex presentation
* indication of labor induction
* bishop score \<6 and cervical dilation\<2 cm

Exclusion Criteria:

* women who delivered by classical cs or had a history of myomectomy , hysterscopic uterine surgery , or cervical surgery like conisation
* women with multiple gestation
* women with evidence of low implanted placenta by ultrasound
* women with contraindication to misoprostol or vaginal delivery

Primary outcomes:
measure: The interval between induction of labor and delivery
timeFrame: induction of labor may take more than 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hemmatzadeh S, Mohammad Alizadeh Charandabi S, Veisy A, Mirghafourvand M. Evening primrose oil for cervical ripening in term pregnancies: a systematic review and meta-analysis. J Complement Integr Med. 2021 Jul 14;20(2):328-337. doi: 10.1515/jcim-2020-0314. eCollection 2023 Jun 1.
citation: Moradi M, Niazi A, Heydarian Miri H, Lopez V. The effect of evening primrose oil on labor induction and cervical ripening: A systematic review and meta-analysis. Phytother Res. 2021 Oct;35(10):5374-5383. doi: 10.1002/ptr.7147. Epub 2021 Apr 29.
Clinical trial NCT06303375: Effect of Kinesio Taping on Pain, Posture and Function in Lower Cross Syndrome
Official title: Effect of Kinesio Taping on Pain, Posture and Function in Patient With Lower Cross Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Cross Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 44
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine the impact of Kinesio taping on pain, postural alignment and functional outcomes in individuals with lower cross syndrome.

Detailed description: Participants with lower cross syndrome who present to physical therapy department will be screened for eligibility on basis of inclusion and exclusion criteria. Group A will receive the treatment with moist hot pack along with stretching of tight erector spinae, hip flexors and strengthening of weak abdominals and gluteal muscles along with Kinesiotaping using inhibition and facilitation technique for LCS and Group B will receive the treatment with moist hot pack along with stretching of tight erector spinae, hip flexors and strengthening of weak abdominals and gluteal muscles. The patients will receive the treatment sessions 3 days per week for almost 04 weeks. They will be evaluated after the treatment for PAIN, POSTURAL ASSESSMENT, FUNCTIONAL DISABILITY in order to check for the effect of the treatment.

Eligibility criteria: Inclusion Criteria:

* Age- 30 to 50 years.
* Female patients.
* Anterior pelvic tilting \> 7-10 degrees.
* Postural imbalance characterized by anterior pelvic tilt, lumbar hyper lordosis, and associated muscle imbalances.
* Discomfort, pain, or limitations related to the lower back, pelvis, and hips attributed to LCS.
* Willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Musculoskeletal pathologies affecting the lower back, pelvis, hips, or lower extremities (e.g., herniated disc, lumbar radiculopathy, lumbar stenosis, hip labral tear).
* Kinesiotaping interventions for LCS in the past 3 months.
* Allergies to tape materials or skin sensitivities that might prevent safe tape application.
* Pregnant individuals due to potential discomfort.
* Open wounds, infections, or skin conditions at the taping application site.
* Severe cardiovascular, pulmonary, renal, or neurological diseases.
* In other clinical trials involving interventions for LCS.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 4th week
measure: Anterior pelvic tilting
timeFrame: 4th week
measure: Oswestry Disability Index (ODI)
timeFrame: 4th week
measure: Muscle Length
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway hospital Rawalpindi
state: Punjab
Study officials:
affiliation: Riphah International University
name: Asmar Fatima, MS OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404675: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
Official title: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: NSCLC
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
* Positive EGFR 21 exon mutation or 19 exon deletion
* Age 18-75 years old with performance status of 0 to 2
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria
* Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
* Evidence of interstitial lung diseases
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 20 months
measure: Objective response rates
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
Study officials:
References: