louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04028102: Ultrasound Optimization of Initial Fluid Challenge in Sepsis
Official title: Optimization of Initial Fluid Challenge by Cardiac and Lung Ultrasound in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
treatment
fluid challenge
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 30
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 sepsis and hypotension in the Emergency Department

Brief summary: Initial sepsis treatment requires fluid challenge. While the Surviving Sepsis Campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. The aim of this study is to assess the difference between fluid volume determined par cardiac and lung Ultrasound versus the fixed 30 ml/kg.

Detailed description: Initial sepsis treatment requires fluid challenge (FC). While the Surviving Sepsis Campaign (SSC) indicates a fixed 30 ml/kg volume, there is concerns on the efficacy and safety of this volume.

Actually, the required volume is highly dependent of cardiac and pulmonary comorbidities, infection focus localization and intensity. The importance of the initial volume is crucial: if too low, it could not restore the hemodynamic status, if too high, it could induce a lung edema responsible for an increased morbidity and mortality.

Cardiac Ultrasound (US) has demonstrated its efficacy to approach cardiac output by measuring the velocity-time integral (VTI) in the aortic chamber and its variations induced by the FC. While the VTI induced variation by a 500-ml FC in 20 min is above 10%, the patient is still fluid responsiveness and FC has to be continued. Conversely, when the variation is below 10%, FC has to be stopped.

Lung Ultrasound can detect a sub-clinical pulmonary edema before oxygenation degradation by visualization of diffuses B lines. The combination of both techniques is thus able to individualize the actual needed FC volume.

In patients with sepsis as defined by SEPSIS-3 and with hypotension (MAP \< 65 mm Hg or lactate \> 2 mmol/l), the FC of saline serum is individualized by the US technique. The volume is compared with the fixed 30 ml/kg.

Eligibility criteria: Inclusion Criteria:

* patients \>18 years old with sepsis as defined by SEPSIS-3 and with hypotension (MAP \< 65 mm Hg or lactate \> 2 mmol/l)

Exclusion Criteria:

* documented end-of-life
* pregnancy
* B/B initial profile to the first Lung US

Primary outcomes:
measure: concordance of fluid volume
timeFrame: 3 hours after FC initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT03587402: Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
Official title: Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Radical Prostatectomy
Pelvic Floor
Lead sponsor: RAPbarcelona
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.

Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.

Detailed description: Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.

The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.

Eligibility criteria: Inclusion Criteria:

* Having undergone a radical prostatectomy surgical procedure.
* Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
* Do not exceed the year since the surgical intervention.
* Accept to participate in the study and grant signed informed consent.

Exclusion Criteria:

* Follow a pharmacological treatment for the UI.
* Presenting anatomical malformations of the pelvic floor musculature.
* Carry pacemaker.
* Present anal fistulas.
* suffer from serious psychic disorders.
* Presenting lower urinary tract infections.

Primary outcomes:
measure: Effects of transcutaneous perineal stimulation compared to anal stimulation
timeFrame: Baseline, 6 and 10 weeks
Secondary outcomes:
measure: Asses quality of life
timeFrame: Baseline and 10 weeks
measure: Assess adverse effects
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Regina Pané Alemany
Study officials:
affiliation: RAPbarcelona
name: Regina Pané
role: PRINCIPAL_INVESTIGATOR
affiliation: RAPbarcelona
name: Inés Ramírez
role: STUDY_DIRECTOR
References:
citation: Pane-Alemany R, Ramirez-Garcia I, Carralero-Martinez A, Blanco-Ratto L, Kauffmann S, Sanchez E. Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: randomized controlled trial study protocol. BMC Urol. 2021 Jan 28;21(1):12. doi: 10.1186/s12894-020-00718-y.
Clinical trial NCT04435002: The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome
Official title: The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupressure
Fatigue Syndrome, Chronic
Complementary Therapies
Quality of Life
Depression
Keywords: Acupressure
Fatigue Syndrome, Chronic,
Complementary Therapies
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized Controlled Clinical Trial
Primary purpose: TREATMENT

Brief summary: Chronic fatigue syndrome is a common problem in society. The treatment of this problem is limited. Acupressure is a treatment method that has become widespread and promising in recent years. For this purpose, the effect of acupressure treatment on chronic fatigue syndrome was investigated.

Detailed description: This study aimed to determine the effectiveness of acupressure technique in individuals with chronic symptoms. In our study, individuals participating in the study will be randomized by the physiotherapist who has received the training of acupressure therapy. The study will be done for a total of 10 sessions for 4 weeks. Individuals' fatigue levels will be measured by Fatigue Severity Scale, their quality of life will be measured by Short Form-36 and depression levels by Beck Depression Inventory. Evaluations will be made at the beginning and at the end of the treatment.

Eligibility criteria: Inclusion Criteria:

* 20-45 year old
* Not using any medical treatment,
* Not being included in any physiotherapy program in the last 3 months,
* Does not have any systemic disease,
* Spending at least 4 hours at the computer or desk during the work

Exclusion Criteria:

* Fibromyalgia
* Rheumatoid arthritis
* Open Wound
* Skin Failure

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 5 min
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 15 min
measure: Short Form-36 questionnaire
timeFrame: 15 min
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT01560702: Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
Official title: Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood, Injection, Injury Type Phobia
Gastrointestinal Ulcer Haemorrhage
Adverse Reaction to Epinephrine
Keywords: autologous blood
epinephrine
endoscopy
ulcer
hemostasis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2012-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.

Detailed description: To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.

Eligibility criteria: Inclusion Criteria:

* all adult patients with gastroduodenal ulcer

Exclusion Criteria:

* Patients with non ulcer bleeding.
* Patients with malignancy.
* Patients with bleeding disorders or under coagulation therapy.
* Patients with known allergy to epinephrine.

Primary outcomes:
measure: hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.
timeFrame: 12 months
Secondary outcomes:
measure: development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).
timeFrame: 12 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Sharkia
Study officials:
affiliation: Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt
name: Mohamed H Emara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02057302: A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia
Official title: A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Xuezhikang Dyslipidemia chinese medicine RCT
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 2400
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: Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS), which plays a dominant role in leading to CHD.

Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus). It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in a guideline for China adult dyslipidemia prevention.

This study aims to evaluate the benefit and side effect of Xuezhikang, a potential alternative drug of statins, for patients with dyslipidemia, and thus provide further evidence for clinical application.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years to 75 years
2. Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria
3. TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria
4. Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study
5. Patients agree to participate in this study and signed the informed consent form

Exclusion Criteria:

1. Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.
2. Patients with Homozygous Familial Hypercholesterolemia
3. Patients with known allergy to Chinese medicine or any other drug
4. Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year.
5. AST or ALT level increases at least twice the upper limits of normal in patients
6. Patients who are taking part in other clinical trials that will influence the results of this study

Primary outcomes:
measure: Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C
timeFrame: the detect the change from baseline to the 8th week
Secondary outcomes:
measure: Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom
timeFrame: to detect the change at baseline, 2nd week, 4th week, 6th week, and 8th week
Other outcomes:
measure: safety outcomes including vital signs and laboratory tests
timeFrame: to detect the change from baseline to 8th week
Locations:
Study officials:
References:
Clinical trial NCT01719302: Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma
Official title: Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage III Adult Soft Tissue Sarcoma
Keywords: Soft tissue sarcoma
gemcitabine
docetaxel
pazopanib
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2012-11-01
Enrollment: 6
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: Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.

The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
* tumor greater than 5 cm in longest dimension
* life expectancy of at least 6 months
* Zubrod performance status of 0-2
* signed informed consent
* adequate bone marrow function defined by:

  1. absolute peripheral granulocyte count of \>1500 cells/mm\^3
  2. hemoglobin \>8.0 g/dl
  3. platelet count \>100,000/mm\^3
  4. absence of a regular red blood cell transfusion requirement
* adequate hepatic function defined by:

  1. total bilirubin \<1.5 x upper limit of normal (ULN)
  2. AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
* adequate renal function defined by:

  1. serum creatinine \<1.5 x ULN
* negative pregnancy test for women of child bearing potential
* willingness to use effective contraception while on treatment and for 3 months thereafter

Exclusion Criteria:

* Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
* Pregnant women or nursing mothers
* concurrent chemotherapy or radiation therapy
* severe medical problems (at the discretion of the investigator)
* history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* symptomatic brain metastases
* cirrhosis
* dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft part sarcoma (ASPS)

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 1 cycle (28 days)
Secondary outcomes:
measure: Overall response rate
timeFrame: 4 cycles (112 days)
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
References:
Clinical trial NCT04604002: Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Official title: Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vascular
Normal Eyes
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 86
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology

Brief summary: Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

Detailed description: The objectives of this study are:

1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.

2. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.

3. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.

Eligibility criteria: Inclusion Criteria:

* All Populations:

  1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
  2. Age ≥ 22
* Normal Population:

  3. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
* Pathology Population:

  3. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye

Exclusion Criteria:

* All Populations:

  1. Subjects unable to read or write
  2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
  3. Subjects who cannot tolerate the imaging procedures
  4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image

Primary outcomes:
measure: Image quality score
timeFrame: through study completion, an average of 1 day
measure: Visibility of OCTA key anatomical vascular structures quality score
timeFrame: through study completion, an average of 1 day
measure: Identification of vascular abnormalities on OCTA
timeFrame: through study completion, an average of 1 day
measure: Adverse Events
timeFrame: through study completion, an average of 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
Study officials:
affiliation: Southeast Retina Center
name: Dennis Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03305302: Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL
Official title: Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Tongue
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing surgery

Brief summary: In terms of incidence, cancer of the tongue is one of the leading cancers in France. Moreover, this cancer is associated with physiological complications ranging from swallowing disorders to loss of taste. Following surgery, impaired perception of food taste may lead to cachexia. It is therefore necessary to carry out research in the field of impaired taste, notably with regard to the regeneration of taste buds. However, there is currently no available functional model of taste bud cells.

It is therefore necessary to obtain a cell line of human taste cells. These immortalised human cells will allow us to better orient our investigations for applications in humans: search for and characterisation of "taste modifiers" synthesised using organic chemistry, able to trigger the perception of food in cases of taste loss or taste impairment.

Moreover, given recent studies conducted by the investigating team proposing the existence of a fatty taste and its implication in obesity, the work of the team could be oriented towards the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of sugar. The availability of these chemical molecules would lead to a reduction in lipid intake as these agents contain no (or very few) calories. They will act as an organoleptic decoy.


Eligibility criteria: Inclusion Criteria:

* between 18 and 70 years old,
* with cancer of the mobile tongue
* requiring surgery

Exclusion Criteria:

- chronic smokers

Primary outcomes:
measure: Immortalised human taste bud cells, isolated from the fungiform tastebuds of patients with cancer of the mobile tongue.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: