louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06671717: Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory/Relapsed Peripheral T-cell Lymphoma
Official title: Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Relapsed Peripheral T-Cell Lymphoma
Refractory Peripheral T-Cell Lymphoma
Keywords: Allogeneic hematopoietic stem cell transplantation
Pralatrexate
Remission status before transplantation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Wuhan TongJi Hospital
name: West China Hospital
First posted: 2024-11-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma


Eligibility criteria: Inclusion Criteria:

* Patients fully understand the study, voluntarily participate in and sign on the informed consent;
* Diagnosed by histopathology Peripheral T-cell lymphoma;
* ECOG PS score 0 or 1;
* Relapsed or Refractory Peripheral T Cell Lymphoma；
* According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter\>1.5cm; measurable extranodal lesion diameter\>1.0cm)；
* Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory;
* Expected survival at least 12 weeks；
* Agreed to receive treatment with Pralatrexate

Exclusion Criteria:

* NK/T-cell lymphoma;
* Achieving CR or PR after induction chemotherapies without relapse;
* Dysfunction of vital organs;
* Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
* Unwilling to accept allogeneic hematopoietic stem cell transplantation;
* Undergoing other clinical studies within a month;
* Without donor for transplantation;
* Allergies to similar drugs and excipients of the research drug

Primary outcomes:
measure: Progression-free survival (PFS) at 1 year after transplantation
timeFrame: Participants will be followed for an expected average of 1 years after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University, Institute of Hematolgoy, Beijing,
Study officials:
affiliation: Peking University People's Hospital
name: Xiaodong Mo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496041: Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
Official title: Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: Stenosis (> 75%) or occlusion of the superficial femoral artery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 205
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: This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.


Eligibility criteria: Inclusion Criteria:

* Stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
* New TASC (2007) A, B, or C lesions
* Vessel diameter between 4.5 and 6.5 cm
* Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
* At least 1 outflow vessel down to the ankle
* Signed informed consent
* \> Age 50, life expectancy \> 1 year
* Capable of concluding the necessary follow-up visits

Exclusion Criteria:

* Refusal to participate in the study
* Acute ischemia
* Inflow lesions \> 50%, not successfully corrected before the procedure
* Combination with other treatment with the exception of treatment to improve the inflow

Primary outcomes:
measure: Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control.
timeFrame: 1 year
Secondary outcomes:
measure: Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate)
timeFrame: 1 year
measure: Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion
timeFrame: 1 year
measure: Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA.
timeFrame: 1 year
measure: Limbs-salvage rate
timeFrame: 1 year
measure: Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class.
timeFrame: 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frank Vermassen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01517841: Barriers to Peritoneal Dialysis Selection
Official title: Barriers to Selection and Initiation of Peritoneal Dialysis in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: peritoneal dialysis
modality choice
kidney disease
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with late stage CKD and ESRD patients who are cared for by nephrologists at MetroHealth Medical Center.

Brief summary: The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study.

Hypotheses:

1. 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change
2. 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.


Eligibility criteria: Inclusion Criteria:

* All patients of age greater than or equal to 18 years at MHMC who are late stage CKD

Exclusion Criteria:

* Patients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years
* Patients who are not candidates for peritoneal dialysis
* Pregnant women

Primary outcomes:
measure: Barriers to making a dialysis modality decision
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center- Center for Reducing Health Disparities
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Suma Prakash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348941: Efficacy and Safety of D-chiro-inositol in Obese Patients
Official title: Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Detailed description: Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.

However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.

It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.

Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.

Eligibility criteria: Inclusion Criteria:

* Women between 25 and 40 years old
* Diagnosis of insulin resistance (HOMA ≥2.5)
* 26≤ BMI ≤32

Exclusion Criteria:

* Subjects with no indication for treatment
* Pregnancy and breastfeeding
* Treatment with drugs or supplements that interfere with the mechanism of action of insulin

Primary outcomes:
measure: HOMA index
timeFrame: Three time points: change in HOMA index from the baseline to 2 and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome
state: RM
Study officials:
References:
Clinical trial NCT05579834: Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity
Official title: Perioperative Management in Terms of Hemothorax Caused by Posterior Correction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Deformity
Hemothorax Postoperative
Keywords: spinal deformity
posterior correction surgery
hemothorax
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)

Brief summary: Owing to the development of instruments and surgical techniques, the number of spinal deformity correction surgeries has increased significantly. The incidence of hemothorax due to posterior correction surgery for spinal deformity is reported to be as low as 0.1%, and the vast majority of these cases were treated through observation without additional intervention. However, if hemothorax that occurs is missed, it can result in increased mortality and morbidity. Furthermore, there is a paucity of data on management of hemothorax caused by posterior correction surgery. The aim of this retrospective study is to evaluate our cases of hemothorax after posterior correction surgery for spinal deformity.

Detailed description: We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.

Eligibility criteria: Inclusion Criteria:

* Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)

Exclusion Criteria:

-

Primary outcomes:
measure: hemothorax
timeFrame: 2016-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi Üniversitesi
state: None Selected
Study officials:
References:
Clinical trial NCT01343134: Anatomical and Functional Macular Changes in Retinal Detachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhegmatogenous Retinal Detachment
Keywords: Retina
Rhegmatogenous retinal detachment
Macular detachment
Spectral domain OCT
Microperimetry
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with successful repair of rhegmatogenous retinal detachment after macula off and minimum 6 month follow-up after surgery

Brief summary: The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.


Eligibility criteria: Inclusion Criteria:

* Rhegmatogenous retinal detachment

Exclusion Criteria:

* Epiretinal membrane

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Department CHU Dijon
state: Burgundy
Study officials:
affiliation: Ophthalmology department CHU Dijon
name: Catherine Creuzot-Garcher, MD;PhD
role: STUDY_DIRECTOR
affiliation: Ophthalmology Department CHU Dijon
name: Marie Pierre Delolme, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05574634: The Role of the Locus Coeruleus in Age-related Distractibility
Official title: Losing Specificity: the Role of the Locus Coeruleus in Age-related Distractibility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Alzheimer Disease
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural disconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.


Eligibility criteria: Inclusion:

* Healthy adult participants
* No younger than 18 and no older than 75 yrs of age
* Ability to provide written informed consent

Exclusion:

* History of surgery involving metal implants
* Possible metal fragments in the eyes
* Pacemaker
* A history of claustrophobia
* Braces
* Weighing over 250 pounds
* Pregnant or possibility of being pregnant.
* Severe medical or psychiatric conditions (e.g., blind or deaf, head trauma)
* Learning disabilities or developmental disabilities

Primary outcomes:
measure: Change in accuracy on the place-face selective attention task after two weeks
timeFrame: Scan before and after attentional practice (2 weeks between scans)
measure: Change in fMRI LC-SN connectivity after two weeks
timeFrame: Scan before and after attentional practice (2 weeks between scans)
Secondary outcomes:
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Polytechnic Institute and State University
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Tae-Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707534: Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19
Official title: Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Keywords: COVID 19
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 110
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: This open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using World Health Organization ordinal scale at day 28 in hospitalized patients with COVID-19.

Detailed description: The coronavirus disease 2019 (COVID-19) pandemic is a serious global health threat. Multiple antiviral or immunomodulatory therapies have failed to show any mortality benefit for patients with COVID-19. Dexamethasone was shown in prior studies to improve mortality and ventilator free days. However, it is unclear what dose of dexamethasone is most beneficial in hospitalized patients with COVID-19. This randomized single center open label clinical trial is to evaluate two different doses of dexamethasone (20mg vs. 6mg) on the health outcome for hospitalized patients with COVID-19. The intervention arm is dexamethasone 20mg daily for 5 days, followed by dexamethasone 10mg daily for 5 days. The comparator is dexamethasone 6mg daily for 10 days. Three hundred participants will be enrolled. The primary outcome is clinical improvement using World Health Organization ordinal scale at day 28.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* RT-PCR confirmed COVID-19 infection
* Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) or need supplemental oxygen with oxygen mask or nasal cannula

Exclusion Criteria:

* Underlying disease requiring chronic corticosteroids
* Severe adverse events before admission, i.e. cardiac arrest;
* Contraindication for corticosteroids;
* Death is deemed to be imminent and inevitable during the next 24 hours
* Recruited in other clinical intervention trial
* Pregnancy
* Patient on judicial protection

Primary outcomes:
measure: Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28
timeFrame: 28 days from study enrollment
Secondary outcomes:
measure: 28-day Mortality
timeFrame: 28 days from study enrollment
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Huimin Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu H, Daouk S, Kebbe J, Chaudry F, Harper J, Brown B. Low-dose versus high-dose dexamethasone for hospitalized patients with COVID-19 pneumonia: A randomized clinical trial. PLoS One. 2022 Oct 3;17(10):e0275217. doi: 10.1371/journal.pone.0275217. eCollection 2022.
Clinical trial NCT06748534: Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility
Official title: Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Accommodative Insufficiency
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.

Detailed description: The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Participants aged 15 to 35 years.
* Diagnosed with accommodative infacility.
* Capable of adhering to the full study duration of 6 weeks.
* Measurable accommodative dysfunction confirmed through baseline eye examinations.
* Written informed consent from participants or guardians.

Exclusion Criteria:

* Presence of other significant ocular or neurological conditions.
* Inability or unwillingness to adhere to the prescribed treatment.
* Prior treatment for accommodative infacility within the past 6 months.
* Significant uncorrected refractive errors.
* Medical contraindications for using plus lenses or vision therapy.

Primary outcomes:
measure: Monocular and Binocular Accommodative Facility (MAF/BAF)
timeFrame: 12 Months
measure: subjective measures of visual comfort
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital
state: Punjab
Study officials:
References: