louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06056271: Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Official title: Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Volta Medical
Sponsor class: INDUSTRY
Collaborators: name: Heart Rhythm Clinical and Research Solutions, LLC
First posted: 2023-09-28
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients indicated for ablation for atrial fibrillation

Brief summary: Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Explorer systems during AF ablation procedures.


Eligibility criteria: Inclusion Criteria:

1. Patients 21 years of age or older who is:

   * indicated for AF ablation or
   * Who has received an AF-ablation with the past 24 months where VX1 was used or
2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
3. Patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

1. Patients not indicated or were not indicated for catheter ablation according to current guidelines
2. Patients with AF secondary to an obvious reversible cause
3. Patients who are or may potentially be pregnant
4. Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug

Primary outcomes:
measure: Primary Clinical Efficacy Outcome
timeFrame: 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research LLC
state: Kansas
city: New York
country: United States
facility: Northwell Health
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT03636971: Gait Analysis Following Knee Viscosupplementation
Official title: Gait Analysis Following Single-shot Hyaluronic Acid Supplementation: a Pilot Randomised Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gait
Knee Osteoarthritis
Injection
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a pilot, double-blind, randomised trial that investigates which gait parameters are more sensitive following a single bolus injection of hyaluronic acid with mannitol, hyaluronic acid with sorbitol, or saline placebo for knee osteoarthritis. Outcome measures are gait analysis through a inertial sensors (Physilog), Knee Society Score (KSS), University of California Los Angeles (UCLA) activity-scale and EuroQol 5Dimensions. Follow-up will be of 4 weeks.


Eligibility criteria: Inclusion Criteria:

* diagnosis of primary knee OA Ahlbäck II-III and signed consent forms.

Exclusion Criteria:

* recent history of infection, diabetes, neurological impairment, chronic venous or lymphatic stasis, pain medication of level 2 or 3, psychiatric conditions, contraindications for HA joint injection and previous HA or steroid injections in the last six months.

Primary outcomes:
measure: Gait Speed
timeFrame: 4 weeks following injection
Secondary outcomes:
measure: KSS specific knee mobility scale
timeFrame: 4 weeks following injection
measure: EuroQool -5 dimensions self-reported scale of quality of life
timeFrame: 4 weeks following injection
measure: UCLA- activity scale
timeFrame: 4 weeks following injection
measure: Visual Analogue Scale (VAS) pain
timeFrame: 4 weeks following injection
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV - Hopital Orthopedique
state: Vaud
Study officials:
affiliation: CHUV
name: Brigitte Brigitte
role: STUDY_CHAIR
References:
citation: Pereira LC, Schweizer C, Moufarrij S, Krahenbuhl SM, Favre J, Gremion G, Applegate LA, Jolles BM. Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial. Pilot Feasibility Stud. 2019 Apr 22;5:56. doi: 10.1186/s40814-019-0443-4. eCollection 2019.
Clinical trial NCT05390671: CAR-T Cell Therapy in Patients With Hematological Malignancies
Official title: Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CART Therapy
Lead sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients \>18, with hematologic malignancies (lymphoma, leukemia, myeloma) in which the use of CAR-T therapy is approved, undergoing CAR-T therapy in Spain.

Brief summary: The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.

Detailed description: Information on baseline patient characteristics, haematological disease, comorbidities and CAR-T therapy procedure (lymphodepletion schedule, infused product) will be collected. Early post-infusion toxicity and recurrence data will be collected. The grading of adverse effects will follow the EBMT and ASTCT guidelines. Finally, data will be collected to analyse survival and, in case of death, cause of death).

Eligibility criteria: Inclusion Criteria:

* Adult patients \>18 y/o
* Patients receiving CAR-T cell therapy in Spain, since 2018.

Exclusion Criteria: T

* Patients receiving CART therapy as part of a clinical trial.

Primary outcomes:
measure: Progression free survival
timeFrame: 6 month
measure: Progression free survival
timeFrame: 12 month
measure: Progression free survival
timeFrame: 24 month
Secondary outcomes:
measure: Overall survival
timeFrame: 6 month,12 month and 24 month
measure: High relevance toxicity rates
timeFrame: During the firs month
measure: Progression free survival
timeFrame: 6 month,12 month and 24 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Angel Cedillo
Study officials:
References:
Clinical trial NCT00934271: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly
Official title: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Keywords: acromegaly
irradiation
remission
pituitary function
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 34
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: 34 patients with active acromegaly despite medical therapy

Brief summary: Hypothesis: Fractionated stereotactic radiotherapy is a safe therapy for treatment of patients with acromegaly in terms of both tumour control and biochemical remission

Detailed description: An audit was done on 34 patients with acromegaly (consecutive cohorte) treated with fractionated stereotactic radiotherapy in Rigshospitalet/National University Hospital, Copenhagen, Denmark. All patients had MR control regularly to monitor tunour control, and biochemical control assessed by growth hormone measurements during an oral glucose tolerance test. Furthermore all other pituitary axes were tested for sufficiency and concomitant medication likewise registered. The 7 year interim analysis demonstrated an acceptable tumour control and biochemical remission profile, and most patient had subsequent withdrawal of somatostatin analogue- and growth hormone receptor antagonis therapy. The observational study will continue with a new update in approx 2 years

Eligibility criteria: Inclusion Criteria:

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria:

pregnancy no visible tumour on MRI

-

Primary outcomes:
measure: Tumour control by pituitary MRI
timeFrame: 7 years
Secondary outcomes:
measure: biochemical remission
timeFrame: 10 years
measure: Affection of other pituitary axes
timeFrame: 10 years
measure: withdrawal of somatostatin analogue and growth hormone receptor antagomist
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National University Hospital, Department of Medical Endocrinology
Study officials:
References:
Clinical trial NCT05194371: Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China
Official title: Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2022-01-18
Enrollment: 3000
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 with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016 in 14 institutions in China

Brief summary: In this study, data of esophageal cancer patients undergoing definitive radiotherapy in 14 institutions from various provinces in China were evaluated to help strengthen confidence in anti-cancer, including rehabilitation, economic burden, and quality of life.


Eligibility criteria: Inclusion Criteria:

1. Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016
2. Age ≥ 18
3. The radiation field included primary esophageal tumor with or without lymph node metastasis

Exclusion Criteria:

1. Radiotherapy dose \< 50Gy
2. Palliative radiotherapy
3. The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc

Primary outcomes:
measure: Overall survival
timeFrame: 5 year
Secondary outcomes:
measure: the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess quality of life (QOL)
timeFrame: 5 year
measure: Costs of treatment
timeFrame: 5 year
measure: Proportion of using chemotherapy or target therapy concurrently with radiotherapy
timeFrame: 2 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
affiliation: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medic
name: Lvhua Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Kuaile Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01351571: An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
Official title: An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced and/or metastatic renal cell carcinoma treated with Avastin and interferon alpha-2a

Brief summary: This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Advanced and/or metastatic renal cell carcinoma
* Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label
* At least one measurable and non-measurable lesion according to RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow, renal and liver function

Exclusion Criteria:

* Contraindications to Avastin and/or interferon alpha-2a as per local label

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
Secondary outcomes:
measure: Progression-free survival: time from first drug administration to documented disease progression or death of any cause
timeFrame: approximately 4 years
measure: Overall response rate: complete response or partial response according to RECIST criteria
timeFrame: approximately 4 years
measure: Overall survival
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Aurangabad
country: India
city: Delhi
country: India
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03821571: Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Official title: Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Keywords: Hypertension,primary aldosteronism
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypertension is known to be the major risk factor for stroke. The most common cause of secondary hypertension, primary aldosteronism (PA), is characterized by the excessive secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10 % of hypertensive patients, and a higher incidence of vascular complications compared to patients with essential hypertension was observed in several studies. The vascular injury from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing endothelial dysfunction and fibrosis in the vasculature.

The association between cerebral small vessel disease (cSVD) and hypertension has been well studies in the past decades. However, not much study has focused on the cSVD burden in patient with PA. The goal of this study is to understand the features of cSVD in patients with PA and for the purpose of understanding the underlying pathophysiology of cerebrovascular injury in this particular patient group.


Eligibility criteria: Inclusion Criteria:

* age between 20-90 years-old
* patient with primary aldosteronism or healthy control
* consciousness clear
* willing to receive brain MRI

Exclusion Criteria:

* renal failure or Creatinine \> 2mg/dl
* coagulopathy or hepatic insufficiency
* unstable vital sign under inotropic agents
* pregnancy
* metal implant or cardiac pacemaker
* major brain surgery

Primary outcomes:
measure: Cerebrovascular reactivity
timeFrame: During the brain MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Bei-Hu Branch, National Taiwan University Hospital
Study officials:
affiliation: Bei-Hu branch, National Taiwan University Hospital
name: Hsin-Hsi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04647071: Allium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers
Official title: Study of the Effect of the Consumption of a Combination of Allium Extracts on the Incidence of Symptoms of Respiratory Infections in Healthy Elderly Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity
Keywords: Garlic
Onion
Immunity
Lead sponsor: DOMCA S.A.
Sponsor class: INDUSTRY
First posted: 2020-11-30
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To analyze the efficacy of daily consumption of a combination of garlic and onion extracts on the incidence of respiratory infection symptoms in healthy elderly volunteers living in a residence.

The duration of symptoms and related medication will also be studied.

Detailed description: It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.

66 healthy elderly volunteers living in a nursing home will be randomly distributed into 2 equal groups: control group and intervention group.

For 36 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.

Every 4 weeks, the medical team of the residence will review the cases of respiratory diseases of infectious origin of the volunteers.

Eligibility criteria: Inclusion Criteria:

* Live in a nursing home with medical services.
* Accept being vaccinated for the flu.
* Freely accepted to participate in the study and sign the informed consent document.
* Have the consent of the family.

Exclusion Criteria:

* Having any disease that affects the development and results of the study.
* Be unable to understand the study and sign voluntarily and freely the informed consent.
* Have a low expectation of compliance with the study protocol.

Primary outcomes:
measure: Incidence of respiratory symptoms associated with infections.
timeFrame: 36 weeks.
Secondary outcomes:
measure: Duration of symptoms.
timeFrame: 36 weeks
measure: Consumption of medicines.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Residencia de Mayores Claret
Study officials:
affiliation: Claret Residence for the Elderly (Granada, Spain).
name: Carlos Gracián, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00266071: Study of the Cutaneous Microcirculation in Elderly People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly People
Keywords: skin
pressure
age
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-12-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Pressure ulcers are a common and frustrating problem and their treatment is critical in elderly people. The interaction between external pressure and the skin vascular is central to the prevention of pressure ulcers. It is only through understanding of the physiology of cutaneous perfusion and its relation to external pressure or different stimuli that effective preventive measures to reduce skin beakdown can be adapted in clinical practice.


Eligibility criteria: Inclusion Criteria:

* volunteers

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Laboratoire de Physiologie - CHU
Study officials:
affiliation: University Hospital, Angers
name: Jean Louis SAUMET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583271: A Prospective Study of EUS Guided Celiac Block
Official title: A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Pancreatic Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 127
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: Patients with abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block.

Brief summary: The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
* Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
* Patient must provide signed written informed consent

Exclusion Criteria:

* Patients that have had a previous celiac plexus block are eligible for this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian Health: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Julia LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: