louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02283008: Inhaler Technique Training
Official title: Evaluating the Efficacy of 2 Different Educational Strategies for Improving and Maintaining Inhaler Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma Chronic
Obstructive Pulmonary Disease
Lead sponsor: Northampton General Hospital NHS Trust
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The evidence for poor inhaler technique is both well established and observed worldwide. What is unclear from the evidence is why individuals demonstrate poor technique, despite the majority admitting to having previously had instruction on inhaler technique. The primary research question is 'Will there be a difference between post education inhaler technique scores when comparing structured education against informal education?'

To try and establish why individuals use inhalers incorrectly a semi structured interview is proposed


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria will be anybody whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition.

Exclusion Criteria:

* The only exclusion criteria will be if a willing participant is not on an inhaler of any type.

Primary outcomes:
measure: Inhaler technique scores will be compared at 6 weeks post inhaler technique education. The proportion achieving proficiency will be compared between those recieving usual care and those recieving structured care.
timeFrame: 6 weeks per cohort
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03739008: Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia
Official title: Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia : a Serie of 3 Cases Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Global Amnesia
Reversible Vasoconstriction Syndrome
Keywords: Thunderclap headache
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a proven or probable RCVS concomittant with certain transient global amnesia in the Neurology department of Gui de Chauliac and Lariboisière hospitals

Brief summary: Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks.

This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.


Eligibility criteria: Inclusion Criteria:

* Patients with a proven or probable RCVS concomitant with certain transient global amnesia

Exclusion Criteria:

* Not proven transient global amnesia, not proven or possible RCVS

Primary outcomes:
measure: Occurrence of concomitant TGA and proven RCVS
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas Gaillard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00613808: Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
Official title: An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Venous Ulcers
Keywords: venous
leg
ulcer
Lead sponsor: Nitric BioTherapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 6
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: The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

Detailed description: SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.

Eligibility criteria: Inclusion Criteria:

* Must have given written informed consent and HIPAA authorization
* Must be ≥ 18 years of age
* Must have a venous ulcer for 60 days or greater
* ABPI \> 0.8 and ≤ 1.2
* Must have ulcer between 3cm2 and 25cm2 in size

Exclusion Criteria:

* Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
* BMI ≥ 35
* Has evidence of clinical infection
* Suffers from diabetes mellitus with HbA1c ≥ 8%
* Suffers from clinically significant arterial disease
* Has a known allergy to any of the compounds / drugs that are part of this protocol
* Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
* Has used any investigational drug(s) within 30 days preceding randomization
* Is unable to manage self-treatment
* Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
* Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
* Is using any of the prohibited concomitant medications or treatments
* Has previously participated in this study

Primary outcomes:
measure: Effect of daily application of Nitric Oxide on rate of closure in venous ulcers
timeFrame: 24 weeks or wound closure
Secondary outcomes:
measure: Change in quality of life
timeFrame: 24 weeks or wound closure
measure: Incidence of adverse events
timeFrame: 24 weeks or wound closure
Other outcomes:
Locations:
city: Denver
country: United States
facility: Diabetic Foot & Wound Center
state: Colorado
city: San Antonio
country: United States
facility: Alamo Podiatry Associates
state: Texas
Study officials:
affiliation: Private Practice, Denver, CO
name: Jeffrey Jensen, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03844308: Wellness Tool in Anesthesia Providers
Official title: Guided Meditation as a Wellness Tool in Anesthesia Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Occupational Stress
Affective Symptoms
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It is a waitlisted controlled study where the control group will receive the intervention after the intervention arm completes the study.
Primary purpose: PREVENTION

Brief summary: This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers.

Detailed description: In this study, investigators will evaluate the effect of Isha Kriya meditation on stress and burnout among perioperative healthcare providers. To do this, investigators will randomize healthy participants to one of two groups: one who will meditate twice daily for six weeks (group 1), and the other who will not meditate for first six weeks and then meditate for another six weeks (group 2). Investigators will then evaluate stress and burnout using validated electronic instruments at baseline and at six weeks for group 1 and at baseline, six weeks, and 12 weeks for group 2.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Perioperative healthcare provider

Exclusion Criteria:

* Low English proficiency
* Currently enrolled in another interventional study that could impact the primary outcome, as determined by the Principal Investigator
* Not currently residing in the United States

Primary outcomes:
measure: Changes in burnout levels among perioperative healthcare providers
timeFrame: From baseline to six weeks for group1 and baseline to 12 weeks for group 2
measure: Changes in stress levels among perioperative healthcare providers
timeFrame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
measure: Changes in mood disturbances among perioperative healthcare providers
timeFrame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Secondary outcomes:
measure: Adherence to implementing a meditation program among healthcare providers.
timeFrame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03895008: Comparing the Prognosis of Patients With Cardia and Non-cardia Gastric Cancer.
Official title: Comparing the Stage-for-Stage Prognosis of Patients With Cardia and Non-cardia Gastric Cancer After Operation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Cardia gastric cancer
Non-cardia gastric cancer
Resection
Prognosis
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
Collaborators: name: Qinghai People's Hospital
name: LanZhou University
First posted: 2019-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: gastric cancer

Brief summary: To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.

Detailed description: The aim of this study is to compare the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.In this study, patients with cardiac and non-cardiac gastric cancer who undergo radical resection from January 2019 to December 2024 will be included. We will follow up the patient's progression, recurrence time and survival time.

Eligibility criteria: Inclusion Criteria:

1. Histopathology or cytopathology proven cardia or non-cardia gastric cancer;
2. Operable gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
3. Life expectancy of at least 6 months;
4. ECOG（Eastern Cooperative Oncology Group ） score 0-1;
5. Age: 18\~80 years old;
6. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).

   For example: WBC（White blood cell count ）\>4.0×109/L; NEU（Neutrophils）\>1.5×109/L; PLT（Platelet）\>100×109/L;
7. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
8. Not concomitant with other uncontrollable benign diseases before the recruitment;
9. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Advanced gastric cancer patients with distant metastasis and inoperable ;
2. Pregnant or lactating women;
3. Patients who have no desire to participate in the study.

Primary outcomes:
measure: Disease Free Survival（DFS）
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
state: Qinghai
city: Xining
country: China
facility: People's Hospital of Qinghai Province
state: Qinghai
Study officials:
References:
Clinical trial NCT01380808: Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
Official title: A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.

Detailed description: the efficacy of the combination is much better than monotherapy

Eligibility criteria: Inclusion Criteria:

1. Female between 18 and 70 years old
2. Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally.
3. Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative)
4. Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy
5. Patients previously treated by capecitabine containing regimen should response to the chemotherapy containing capecitabine and progressed at least 4 months after the last capecitabine treatment
6. Karnofsky score more than 70；ECOG 0\~2；
7. Normal functions with heart, liver,renal and bone marrow
8. WBC≥4×109/L；Hb≥90 g/L；plt≥100×109/L
9. Got ICF before enrollment

Exclusion Criteria:

1. Pregnant or breast-feeding women or positive serum pregnancy test
2. Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling
3. Participation in any investigational drug study within 4 weeks preceding treatment start.
4. Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer.
5. Serious uncontrolled intercurrent infections
6. Poor compliance

Primary outcomes:
measure: progression free survival
timeFrame: 1 year
Secondary outcomes:
measure: overall response rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lv F, Cao J, Liu Z, Wang Z, Zhang J, Zhang S, Wang L, Zhao X, Shao Z, Wang B, Hu X. Phase II study of Pseudomonas aeruginosa-Mannose-Sensitive hemagglutinin in combination with capecitabine for Her-2-negative metastatic breast cancer pretreated with anthracycline and taxane. PLoS One. 2015 Mar 13;10(3):e0118607. doi: 10.1371/journal.pone.0118607. eCollection 2015.
Clinical trial NCT04513808: Total Intravenous Anesthesia and Recurrence Free Survival
Official title: Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Cancer
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 1614
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: As usual with time-to-event outcomes, enrollment will be based on the number of outcome events, not the number of patients enrolled. We anticipate that about 1614 patients will be required to generate 579 recurrences and/or deaths, but this is only a rough estimate since follow-up duration is a function of when patients are enrolled, not just their number.
Primary purpose: TREATMENT

Brief summary: The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.

Detailed description: The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to volatile sevoflurane anesthesia.

The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.

Eligibility criteria: Inclusion Criteria:

* Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
* Scheduled for potentially curative esophageal cancer surgery.
* Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.

Exclusion Criteria:

* Previous surgery for esophageal cancer (except diagnostic biopsies) Age \<18 or \>85 years old.
* ASA Physical Status ≥4.
* Any contraindication to propofol or sevoflurane.
* Other cancer not believed by the attending surgeon to be in long-term remission.
* Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 4 years
Secondary outcomes:
measure: ICU duration
timeFrame: From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months
measure: Hospital duration
timeFrame: Up to 100 months
measure: QoR-15
timeFrame: 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanhai Chest Hospital
Study officials:
affiliation: Shahai Hospital
name: Yuwei Oui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426008: Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media
Official title: Growth Factors Supplementation to Single-Step Culture Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In Vitro Human Embryo Development
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banon IVF Center Assiut, Egypt
First posted: 2015-04-24
Enrollment: 426
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.

Detailed description: The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Eligibility criteria: Inclusion Criteria:

* all patients

Exclusion Criteria:

* over 40 years old

Primary outcomes:
measure: Clinical Pregnancy rate ( % )
timeFrame: 3 months
Secondary outcomes:
measure: ongoing Pregnancy rate ( % )
timeFrame: 6 months
measure: rates of blastocyst formation and quality
timeFrame: 6 days of culture
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ibnsina IVF center
Study officials:
References:
Clinical trial NCT00954408: Fatigue in Dystonia (a Single Session, Questionnaire-based Study of Fatigue in Dystonia)
Official title: Fatigue in Dystonia (IRB No. 108-2008)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystonia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 123
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current dystonia patients in our clinic between the ages of 21 and 100.

Brief summary: The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia.

Detailed description: The purpose of the study is to determine the prevalence of fatigue in patients with dystonia. There are many factors which may impact fatigue but perhaps the most important of these is sleep. It is therefore critical that we collect data on sleep habits and sleepiness to help interpret our data on fatigue. We will be using the Epworth Sleepiness Scale to assess daytime somnolence and the Parkinson's Disease Sleep Scale to assess the presence or absence of common sleep disorders affecting patients with movement disorders along with the Multidimensional Fatigue Inventory and the Fatigue Severity Scale.

Eligibility criteria: Inclusion Criteria: diagnosis of dystonia

* Informed consent to be contacted about research

Exclusion Criteria:

* None

Primary outcomes:
measure: To determine the prevalence of fatigue and sleepiness in patients with dystonia.
timeFrame: At the time of their visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Movement Disorders Center
state: Florida
Study officials:
affiliation: University of Florida
name: Michael S Okun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: