louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06805669: This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)
Official title: Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma
Keywords: Sarcoma
Palliative Care
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.

Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Signed written and voluntary informed consent.
* Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
* Age ≥ 18 years.
* Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
* Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
* Life expectancy \> 6 months.
* Willing/able to complete questionnaires.

Exclusion Criteria:

* Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.
* Patient in need of urgent home support services or symptom management through a palliative care team.
* Patient is being actively followed by a palliative care physician.
* Active psychiatric disorder or drug abuse.
* Insufficient English literacy to complete questionnaires.

Primary outcomes:
measure: To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
timeFrame: From enrollment/baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Albiruni R. Abdul Razak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351546: A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Official title: A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Vildagliptin
Type 2 diabetes
Insulin sensitivity
Insulin action
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes at least 3 months prior to screening
* Blood glucose criteria must be met
* On stable dose of metformin therapy
* BMI less than or equal to 39

Exclusion Criteria:

* Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
* Treatment with thiazolidinediones or use of insulin within the previous 3 months
* Significant illness within 2 weeks prior to dosing
* High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Effect on insulin sensitivity at 6 weeks
Secondary outcomes:
measure: Lipolysis rate after 6 weeks of treatment
measure: Plasma free fatty acid concentration after 6 weeks of treatment
measure: Hepatic glucose production after 6 weeks of treatment
measure: Glucose disposal after 6 weeks of treatment
measure: Gluconeogenesis rate after 6 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: David Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00943046: Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads
Official title: Master Study of the SIELLO Pacemaker Leads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacemaker Syndrome
Keywords: leads
pacemaker
efficacy
safety
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-07-21
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Detailed description: The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker

Primary outcomes:
measure: Complication free rate of all SIELLO leads
timeFrame: 3 month follow-up visits
measure: Ventricular threshold of SIELLO T (passive fixation)
timeFrame: 3 month follow-up visits
measure: Atrial threshold of SIELLO S (active fixation)
timeFrame: 3 month follow-up visits
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Hamburg Altona
Study officials:
affiliation: n.k.
name: Anselm Schaumann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347369: A Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
Official title: a Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Disease
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of COVID-19 disease

Brief summary: The research aim to collect large samples of COVID-19 disease patients with clinical symptoms, laboratory and imaging examination data. Screening the biological indicators which are related to the occurrence of severe diseases. Then, investigators using artificial intelligence (AI) technology deep learning method to find a prediction model that can dynamically quantify COVID-19 disease severity.


Eligibility criteria: Inclusion Criteria:

* Patients of COVID-19 disease confirmed by virus nucleic acid RT-PCR and CT

Exclusion Criteria:

* unconfirmed suspected cases
* Patients during pregnancy and lactation
* incomplete clinical data
* inestigators considered patients ineligible for the trial

Primary outcomes:
measure: discrimination
timeFrame: up to 3 months
measure: Calibration
timeFrame: up to 3 months
measure: Net benefit
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
Study officials:
References:
Clinical trial NCT05808569: Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study
Official title: Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 537
Sex: FEMALE
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 undergoing adjuvant radiotherapy for breast cancer

Brief summary: Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one.

Furthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.


Eligibility criteria: Inclusion criteria

* Patients undergoing adjuvant radiotherapy for breast cancer
* Able to understand and sign informed consent

Exclusion criteria

* Patients with inadequate linguistic abilities and inability to express informed consent
* Patients denying informed consent
* Patients receiving palliative treatments
* Patients affected by major psychiatric disorders

Primary outcomes:
measure: Primary aim of this study is to identify patients perception of modesty during RT for breast cancer through the use of a dedicated 16 items questionnaire validated in a Delphi consensus for the purposes of this study
timeFrame: 1-5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario "A.Gemelli" IRCCS
state: RM
Study officials:
References:
Clinical trial NCT03900169: Familial Hypercolerstremia as Risk Factor in Stemi Patient Who Underwent Ppci
Official title: Familial Hypercoleresremia as Risk Factor in Stemi Patient Underwent Ppci
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Hypercholesterolemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stemi patient

Brief summary: Famulial hypercolerstremia as risk factor

Detailed description: Familial hypercolerestremia ad risk factor in stemi patient who underwent Ppci

Eligibility criteria: Inclusion Criteria:

-all patient that underwent Ppci

Exclusion Criteria:

* Previous ischemic patient
* Patient with raised renal chemistry
* Patient for CABG

Primary outcomes:
measure: Correlation between familial hypercolerstremia and prognosis of patients in PPCI
timeFrame: One year
measure: Correlation between non familial hypercolerstremia and prognosis of patients in PPCI
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Amira harby
Study officials:
References:
Clinical trial NCT05035069: Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
Official title: A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, General
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).

Detailed description: This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for TAVR through femoral artery access
* 1h ≤ Expected duration of surgery ≤ 3h
* Planned for general anesthesia without intubation
* 18 ≤ BMI ≤ 30
* ASA category Ⅱ～Ⅳ

Exclusion Criteria:

* Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
* Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
* Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
* Hemoglobin (HB) \< 10.0 g / dl (100 g / L)
* Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.

Primary outcomes:
measure: Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
timeFrame: Day 1
Secondary outcomes:
measure: Time from the start of drug infusion to the first BIS reduction to 60
timeFrame: Day 1
measure: Time from the end of drug infusion to the recovery of BIS to 90
timeFrame: Day 1
measure: Percentage of subjects received rescue treatment
timeFrame: Day 1
measure: Incidence of hypotension
timeFrame: Day 1
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Min Yan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05363969: Treatment of Self Harm Scars With Fraxel Laser
Official title: Treatment of Self Harm Scars With Fraxel Laser
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Harm
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of self harm scars with fractionated laser.

Detailed description: Fractionated resurfacing lasers have been shown to be useful for scars including acne scars, burns scars and striae. We will treat self harm scars with 3 to 4 treatments using a "Fraxel" fractionated laser. Patients will be screened to ensure they are not actively engaged in self harm behaviors.

Eligibility criteria: Inclusion Criteria:

* Self harm scars

Exclusion Criteria:

* Active self harm behaviors

Primary outcomes:
measure: Clinical improvement of scars
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03757169: Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)
Official title: Effect of Isometric Hand Grip Training on Blood Pressure of Hypertensive Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Hypertension
Keywords: training
hand grip
exercise
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two randomized groups.
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. A Meta analysis study have shown that isometric hand grip training promotes blood pressure reduction. It is going to be conducted a clinical trail to determine the effects of hand grip training in OSA patients to change the arterial hypertension.

Detailed description: Background: obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. Meta analysis study have shown that isometric hand grip strength promotes blood pressure reduction, and its reduction is higher than that observed after aerobic training. Objective: to analyze the effects of the isometric hand grip on blood pressure changes of patients with uncontrolled arterial hypertension with OSA. Methods: a randomized controlled trial involving 18 adults with OSA and uncontrolled arterial hypertension of both sexes, randomized between control group (receive general guidelines) and hand grip group. 12 weeks of training with load equivalent to 30% of maximum voluntary capacity was performed. All participants will be submitted for evaluation of blood pressure (BP) central and brachial, pulse wave velocity, full polysomnography,before and after the study protocol (the change from the baseline at 12 weeks). Expected results: the authors believe that hand grip training can change (reduce) blood pressure in patient with OSA.

Eligibility criteria: Inclusion Criteria:

* OSA diagnose based on polysomnography,
* Apnea-Hypopnea Index (AHI) \> 5,
* arterial hypertension (systolic arterial pressure \> 140 mmHg or diastolic arterial pressure \> 90 mmHg)

Exclusion Criteria:

* other heart disease

Primary outcomes:
measure: Change at ambulatory blood pressure monitoring
timeFrame: Change from the baseline ambulatory blood pressure monitoring at 12 weeks
Secondary outcomes:
measure: Change at blood pressure
timeFrame: Change from the baseline brachial blood pressure at 12 weeks
measure: Chance at Apnea-Hypopnea Index (AHI)
timeFrame: Change from the baseline AHI at 12 weeks
measure: Change at Pulse wave velocity
timeFrame: Change from the baseline pulse wave velocity at 12 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Pronto Socorro Cardiológico de Pernambuco - Procape
state: PE
Study officials:
References:
Clinical trial NCT01959269: Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy
Official title: RECORA- Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasm
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 483
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: Female and male patients ≥ 18 years of age with a diagnosis of metastatic colorectal carcinoma (mCRC) will be enrolled in the sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation.

Brief summary: The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.


Eligibility criteria: Inclusion Criteria:´

* Male or female patients ≥ 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga.
* Patients must have signed an informed consent form

Exclusion Criteria:

Primary outcomes:
measure: Overall survival
timeFrame: after 40 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: after 40 months
measure: Time to progression
timeFrame: after 40 months
measure: Disease control rate (DCR)
timeFrame: after 40 months
measure: Duration of Stivarga treatment
timeFrame: after 40 months
measure: Tumor status at different visits
timeFrame: after 40 months
measure: Incidence of treatment emergent adverse events (TEAE)
timeFrame: after 18 and 40 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: