louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04359862: Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Official title: Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Respiratory Distress Syndrome
COVID19 Infection
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
Primary purpose: TREATMENT

Brief summary: It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.

Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.

Patients will be randomized to one of the treatment groups:

* SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
* PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)


Eligibility criteria: Inclusion Criteria:

* Age 18 years or more.
* Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
* Signature of Patient's Consent or Verbal Consent of Legal Representative

Exclusion Criteria:

* Intracranial hypertension
* Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
* Current volume \< 250ml
* History of malignant hyperthermia
* Liver failure
* Neutropenia (\<0.5x109)
* Pregnant or lactating women
* Have received chemotherapy in the last month since their inclusion in the study

Primary outcomes:
measure: PaO2/FiO2
timeFrame: Day 2
Secondary outcomes:
measure: TNFα
timeFrame: Day 2
measure: IL-1b
timeFrame: Day 2
measure: IL-6
timeFrame: Day 2
measure: IL-8
timeFrame: Day 2
measure: Mortality
timeFrame: Day 30
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Bizkaia
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
References:
Clinical trial NCT02008162: Bronchoreversibility and Radiologic Morphology of Emphysema
Official title: Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emphysema
COPD
Keywords: Emphysema, COPD, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, LVRS
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery

Brief summary: To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.


Eligibility criteria: Inclusion Criteria:

* Radiologic evidence of severe heterogeneous emphysema
* GOLD COPD class III-IV
* No other significant pulmonary comorbidity
* Quit smoking since at least 4 months

Primary outcomes:
measure: post-bronchodilator FEV1 change
timeFrame: 1 h
measure: post-bronchodilator change in FVC
timeFrame: 1h
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Tor Vergata
Study officials:
affiliation: Tor Vergata University
name: Eugenio Pompeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06530862: Piriformis Syndrome; Extracorporeal Shock Wave Therapy and Dry Needling
Official title: Comparison of the Efficacy of ESWT and Dry Needling Treatments in the Management of Piriformis Syndrome; A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Piriformis Syndrome
Extracorporeal Shock Wave Therapy
Keywords: ESWT
Dry Needling
Piriformis Syndrome
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling
Primary purpose: TREATMENT

Brief summary: This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. The ESWT group received 3 sessions of radial ESWT, 1 session per week. The DN group received 3 sessions of ultrasound-guided needling, 1 session per week. Clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Complaint for more than 3 months

Exclusion Criteria:

* disc pathologies according to radiological imaging
* hip joint and soft tissue pathologies
* recent history of trauma, history of surgery in the lumbar and hip region
* history of rheumatologic disease
* history of polyneuropathy
* history of sciatic nerve injury
* history of malignancy
* opioid analgesia or corticosteroid intervention for pain in the last month
* patients receive another treatment during the study
* Having a contraindication for DN treatment or ESWT treatment

Primary outcomes:
measure: Visual analog scale (VAS) score
timeFrame: 7 months
measure: Lower extremity functiunal scale (LEFS)
timeFrame: 7 months
measure: Oswestry disability index (ODI)
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Burak Tayyip Dede
Study officials:
References:
Clinical trial NCT02450162: Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT) in Two Recession Surgeries
Official title: Comparison of the Changes of Lateral Rectus Muscle Insertion Measured With AS-OCT in Two Recession Surgeries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intermittent Exotropia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients

: 30 for conventional recession surgery 30 for hang-back recession surgery

Brief summary: * Background and study aims : The investigators conducted this study to compare the movement of extraocular muscle after two types of recession surgery with non-invasive tool called AS-OCT.
* Who can participate? patients who will undergo two types (conventional method and hang-back method) of typical bilateral lateral rectus recession surgery for correcting intermittent exotropia
* What does the study involve? Volunteers will attend a clinic for four visits over three months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT.
* What are the possible benefits and risks of participating? This is non-invasive test for your postoperative follow up. Therefore, there will be no risks about this test.
* Where is the study run from? Samsung Medical Center
* When is the study starting and how long is it expected to run for? From April 2015 to Dec 2015

Detailed description: This study is a following study of our prior study about AS-OCT in strabismus. The aim of this study is to compare the longitudinal changes of lateral rectus (LR) muscle insertion between two types of bilateral recession surgery. An AS-OCT scan of the LR muscle was performed every visits. Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 in each group.

Eligibility criteria: Inclusion Criteria:

* patients who will undergo bilateral lateral rectus recession surgery for correcting intermittent exotropia

Exclusion Criteria:

* previous ocular surgery
* other ocular diseases except intermittent exotropia
* amblyopia

Primary outcomes:
measure: The change of limbus-muscle insertion distance measured with AS-OCT
timeFrame: baseline and 1.3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04423562: PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices
Official title: Investigation of the Prognostic Value of pVO2 in Recipients of Left Ventricular Assist Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Assist Device
Prognosis
Advanced Heart Failure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 500
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: All patients implanted with a durable LVAD (post-2006) and available post implant VO2 (stable phase) can be included in this study.

Brief summary: Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.

The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.

Detailed description: Background and purpose:

Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients, though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2 predicts outcome in LVAD treated HF patients.

The investigators will pool data from all willing centers of the World to investigate the prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends on the treatment indication (BTT and DT).

Methods:

Data is collected in anonymized form from all centers willing to contribute data.

Hypothesis:

The hypothesis is that lower pVO2 is associated with higher rates of death or urgent transplantation (primary endpoint).

Eligibility criteria: Inclusion Criteria:

* Durable LVAD implantation
* VO2 in stable post implant phase

Exclusion Criteria:

* No VO2 data available
* Concomittant RVAD (temp/durable device)

Primary outcomes:
measure: Outcome after implantation
timeFrame: Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: DK
Study officials:
affiliation: Rigshospitalet, Denmark
name: Finn Gustafsson, MD,PhD,DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mirza KK, Szymanski MK, Schmidt T, de Jonge N, Brahmbhatt DH, Billia F, Hsu S, MacGowan GA, Jakovljevic DG, Agostoni P, Trombara F, Jorde U, Rochlani Y, Vandersmissen K, Reiss N, Russell SD, Meyns B, Gustafsson F; PRO-VAD Investigators. Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD). JACC Heart Fail. 2021 Oct;9(10):758-767. doi: 10.1016/j.jchf.2021.05.021. Epub 2021 Aug 11.
Clinical trial NCT02225262: A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
Official title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Cancer of the Prostate
Prostate Neoplasm
Keywords: Prostate cancer
CyberKnife
Stereotactic
Radiation
Lead sponsor: Community Cancer Center, Normal, Illinois
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer.

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.

Detailed description: The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Eligibility criteria: Inclusion Criteria:

* Male Age ≥ 21
* Histologically proven prostate adenocarcinoma
* Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
* PSA ≤ 20 ng/ml
* Prostate volume ≤ 100 cc

Patients belonging in one of the following risk groups:

* Low:

  * CS T1b-T2a and Gleason 2-6 and PSA ≤ 10
* Intermediate:

  * CS T2b and Gleason 2-6 and PSA ≤ 10, OR
  * CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml

Exclusion Criteria:

* Any histology other than adenocarcinoma
* Age \< 21
* KPS \<= 40 \<70
* ECOG Performance Status ≥ 2
* Patient weight \>350 lbs. (table limitation)
* Prior XRT to prostate or lower pelvis
* Prior surgery or cryotherapy to prostate
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
* Chemotherapy for a malignancy in the last 5 years
* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
* Hormone ablation for 2 months prior to enrollment, or during treatment

Primary outcomes:
measure: Local control rate
timeFrame: 5-10 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5-10 years
Other outcomes:
Locations:
city: Normal
country: United States
facility: Community Cancer Center
state: Illinois
Study officials:
affiliation: Community Cancer Center
name: Shermian Woodhouse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05854862: Analysis of Relevant Influencing Factors of Glycemic Control in Patients With Diabetes
Official title: Analysis of Relevant Influencing Factors of Glycemic Control in Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glycemic Control
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 10000
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 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from August 2013 to the present.

Brief summary: This study aims at the analysis of relevant influencing factors of glycemic control in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

Patients aged 18-90 years with diabetes and the diagnostic criteria of diabetes is according to the World Health Organization in 1999.

Exclusion Criteria:

Patients with stress hyperglycaemia. Patients with severe systemic disease. Patients treated with systemic glucocorticoids within the last three months. Patients without any records about HbA1c, CGM and SMBG.

Primary outcomes:
measure: HbA1c
timeFrame: day 1
measure: TIR
timeFrame: day 1-14
Secondary outcomes:
measure: MBG
timeFrame: day 1-14
measure: MAGE
timeFrame: day 1-14
measure: SD
timeFrame: day 1-14
measure: Incidence of hypoglycemia
timeFrame: day 1-14
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03832062: Value of Analysing Under-utilised Leftover Tissue (VauLT)
Official title: Value of Analysing Under-utilised Leftover Tissue (VauLT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Ventana Medical Systems
First posted: 2019-02-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Leftover formalin-fixed tissue from cancer surgery

Brief summary: Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to therapeutic resistance. It also limits the ability of small samples to represent the whole tumour, having implications for diagnosis, molecular analysis and understanding of the tumour immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of that required for diagnosistic purposes, one may create a more representative sample for analysis.

Detailed description: In order to establish the feasibility of homogenization as a potential companion diagnostic tool, our study aims to 1) evaluate how many surgical cases have left over tissue amenable to homogenization and 2) pilot homogenization across multiple tumour types. The molecular profile of the homogenate will be compared to that obtained from the diagnostic specimen using next generation sequencing techniques.

Eligibility criteria: Inclusion Criteria:

1. Leftover formalin-fixed tissue (ie that would be otherwise discarded by histopathology) from cancer surgery.
2. Tissues for Research consent has been provided.
3. Patient age \>18yo.
4. Minimum of 1 gram of residual tumour remaining in leftover surgical tissue
5. Minimum of 1 gram of normal tissue present.

Exclusion Criteria:

1. Advanced Practitioner in histological dissection deems tumour sample to be inadequate.
2. Leftover surgical tumour tissue greater than 20kg.

Primary outcomes:
measure: The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups
timeFrame: 24 Months
Secondary outcomes:
measure: Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue
timeFrame: 24 Months
measure: Median time (in minutes) required for the blending (actual homogenization) of each tissue type
timeFrame: 24 Months
measure: Difference in molecular profile between the diagnostic block and the homogenized sample. This will be measured by next generation sequencing techniques across the 8 primary tumour types
timeFrame: 24 Months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Samra Turajlic
role: STUDY_CHAIR
References:
Clinical trial NCT01303562: Clinical Assessment of Barley and Oat Phytochemicals
Official title: Clinical Assessment of Barley and Oat Phytochemicals: Acute Bioavailability, Pharmacokinetics, and Bioactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: oat
barley
whole grain
bioavailability
phytochemical
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Kellogg Company
First posted: 2011-02-24
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).


Eligibility criteria: Inclusion Criteria:

* Men and postmenopausal women
* BMI 27-35.9 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications or laxatives (including fiber supplements)
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
* Regular use of oral steroids
* Regular daily intake of ≥ 2 alcoholic drinks
* Infrequent or excessive number of regular bowel movements
* Illicit drug use
* Vegetarians
* No fish oil supplements (including cod liver oil) for one month prior to study admission
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission

Primary outcomes:
measure: Levels of phytochemicals and their in vivo metabolites in blood
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Clinical and Translational Research Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Jeffrey B Blumberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: