louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05810662: RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH
Official title: Randomized Study of Intraoperative Glucose Saline Versus Ringer Lactatein Cancer Pediatric Patients Doing Major Surgeries and Impact on Electrolytes ,Glucose and pH
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fluid and Electrolyte Imbalance
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare two electrolytes maintenance in perioperative period in children undergoing major surgeries on perioperative change in pH,lactate,sodium and glucose level

Detailed description: Patients were randomized into 2 groups ringer lactate versus 5%dextrose in 0.9% saline,using a computer generated random list in blocks of 4 after recruitment the enrolling investigators opened sealed opaque envelopes that concealed group allocation participants ,trial investigators,attending anesthetist providing general anesthesia for the cases and the outcomes were blinded to group allocation

Eligibility criteria: Inclusion Criteria:

* 1to 10 years Children undergoing major surgeries ie considered major if any invasive procedure in which extensive resection will be preformed e.g body cavity is opened,organs are removed and normal anatomy is altered abd duration not less than 2 hours or more than 5 hours.

Exclusion Criteria:

* patient guardian refusal

  _ Children with documented endocrine distrubances(DM,inborn error of metabolism,hyperthyroidism)
* age less than one year
* preexisting renal disease,hepatic disease and patien suffering from heart failure.
* preexisting electrolyte imbalance (normal sodium level 135-145)

Primary outcomes:
measure: PH and lactate level
timeFrame: In the introperative period
Secondary outcomes:
measure: Sodium and glucose level
timeFrame: The intraoperative period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer institute
Study officials:
References:
Clinical trial NCT02223962: Effects of Physical Activity Counseling After an Exacerbation in COPD
Official title: The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Keywords: physical activity
COPD
activity monitors
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.

Detailed description: After signing the informed consent, the patients will be randomized into a control group, receiving usual care, or the intervention group receiving real-time feedback and physical activity counseling.

Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts based on the step count from the Fitbit Ultra. In agreement with the patient and based on the step counts a patients provided, a new goal for the next week was set. The goal was to strive for the highest possible level of physical activity during one month.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Chronic Obstructive Lung Disease (Tiff\<70%)
* Hospitalized because of exacerbation
* Capable of working with electronic devices

Exclusion Criteria:

* Orthopedic/Neurologic problems making it difficult to be active
* Participation in a rehabilitation program

Primary outcomes:
measure: Improvement in physical activity
timeFrame: 1 month
Secondary outcomes:
measure: Improvement in functional exercise capacity
timeFrame: 1 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
References:
citation: Hornikx M, Demeyer H, Camillo CA, Janssens W, Troosters T. The effects of a physical activity counseling program after an exacerbation in patients with Chronic Obstructive Pulmonary Disease: a randomized controlled pilot study. BMC Pulm Med. 2015 Nov 4;15:136. doi: 10.1186/s12890-015-0126-8.
Clinical trial NCT00005529: Self-Scored Cardiovascular Disease Risk Appraisal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Heart Disease Risk Reduction
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop and test a self-scored cardiovascular disease health risk appraisal.

Detailed description: BACKGROUND:

Health risk appraisals (HRA) are being used increasingly by health centers and worksites to inform people of their personal mortality and morbidity risks. However, recent research suggests that many HRAs have limited reliability and validity with respect to coronary heart disease, the leading cause of death in this country. Self-scored HRAs appear to be considerably less accurate in predicting CHD risk than computerized instruments, chiefly because people do not always know the physiologic values required by these instruments and because they frequently make errors computing their scores.

DESIGN NARRATIVE:

During Phase I, a new appraisal named CardioRisk was developed. The Phase I prototype version contained eight major self-reported risk factors. CardioRisk predicted the risk of developing cardiovascular disease (CVD) in a 12-year period using an equation based on recent accelerated failure time models from the Framingham Heart Study. The purpose of Phase II was to thoroughly test and refine the prototype instrument. The Phase II analyses were designed to assess the psychometric properties of CardioRisk, to evaluate its utility as judged by patients, and to determine whether the instrument changed perceptions of personal CVD risk. These results were compared to data for other appraisals to determine whether CardioRisk outperformed comparable products.

In the proposed commercial application, CardioRisk would be distributed by health promotion organizations to increase awareness of the risk factors for cardiovascular disease. Estimates from the American Heart Association put the demand for these products at 180,000 HRAs per year. The potential market for this product includes worksites, community health centers, managed health care organizations, public health departments, and clinics.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00980629: Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
Official title: A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-09-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED

Brief summary: This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients (aged 18-65 years) with a diagnosis of AD.
2. Female patients of child bearing potential must be using a medically acceptable form of contraception.
3. Patients who are able and willing to give signed informed consent.
4. Patients who have pruritus exceed the reference range.

Exclusion Criteria:

1. Patients who have a history of allergy to hydrocortisone.
2. Patients who have a history of relevant drug hypersensitivity.
3. Patients who have a history of contact dermatitis induced by a topical steroid.
4. Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
5. Patients who have a history or presence of any cancer.
6. Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
7. Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
8. Patients who have pruritus associated with conditions other than AD.
9. Patients who have pruritus only on the face and head.
10. Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
11. Patients who have used M5161(active ingredient of M516102).
12. Patients who cannot communicate reliably with the investigator.
13. Patients who are pregnant or lactating.
14. Patients who have used any IMP and/or participated in any clinical trial within 3 months.

Primary outcomes:
measure: Pruritus score
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital Morvan
city: Munster
country: Germany
facility: Universitätsklinikum Münster
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Edinburgh
country: United Kingdom
facility: The Royal Infirmary of Edinburgh
Study officials:
References:
Clinical trial NCT02631629: Food-based Solutions for Optimal Vitamin D Nutrition and Health
Official title: Food-based Solutions for Optimal Vitamin D Nutrition and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Fortification
Lead sponsor: Technical University of Denmark
Sponsor class: OTHER
Collaborators: name: Seventh Framework Programme
First posted: 2015-12-16
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.

Detailed description: The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into two groups. One receiving vitamin D fortified foods and the other receiving the same kind of foods non-fortified. Foods given in the study period are free of charge for the participants and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp bread.

The study includes a baseline visit and a final visit, at both visits blood samples will be drawn, anthropometrics, muscle strengths, dietary and background questionnaires.

Eligibility criteria: Inclusion Criteria:

* 18-50 year old women
* Low consumption of fish and fish products
* Low intake of vitamin D containing supplements
* No use of sunning facilities
* No planned sun-holiday between October 2015 and May 2016

Exclusion Criteria:

* Pregnancy and breastfeeding
* Menopause
* Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).

Primary outcomes:
measure: The change in vitamin D status measured as serum 25-hydroxyvitamin D
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Technical University of Denmark
Study officials:
affiliation: Technical University of Denmark
name: Inge Tetens, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gronborg IM, Tetens I, Christensen T, Andersen EW, Jakobsen J, Kiely M, Cashman KD, Andersen R. Vitamin D-fortified foods improve wintertime vitamin D status in women of Danish and Pakistani origin living in Denmark: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):741-753. doi: 10.1007/s00394-019-01941-6. Epub 2019 Mar 9.
Clinical trial NCT01867229: Breast Cancer and Chemo-amennorhea
Official title: Etude Prospective Multicentrique de l'aménorrhée Chimio-induite et de sa réversibilité Dans le Cancer du Sein Chez Des Patientes préménopausées Recevant Une chimiothérapie Adjuvante ou néoadjuvante. Etude Améno-Chimio.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: pre-menauposal
neo-adjuvant or adjuvant chemotherapy
no metastases
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 7
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pre-menauposal breast cancer treated with chemotherapy

Brief summary: Relation between chemotherapy and amennorhea


Eligibility criteria: Inclusion Criteria:

pre-menauposal breast cancer needed to be treat with chemotherapy -

Exclusion Criteria:

metastases menopausal

-

Primary outcomes:
measure: incidence and duration of the amenorrhea induced by chemotherapy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rocourt
country: Belgium
facility: Clinique Saint Vincent
state: Liège
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liège
country: Belgium
facility: Centre Hospitalier Université de Liège
city: Liège
country: Belgium
facility: CHR Citadelle
city: Verviers
country: Belgium
facility: Centre hospitalier Peltzer La Tourelle
city: Toulouse
country: France
facility: Institut Claudius Renaud
Study officials:
affiliation: UCL-Saint Luc
name: jean-Pascal Machiels
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02963129: Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT
Official title: Treatment of Nasal Staphylococcus Aureus Colonization in Patients With Hereditary Hemorrhagic Telangiectasia With Recurrent Epistaxis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hereditary Hemorrhagic Telangiectasia
Epistaxis
Keywords: Hereditary Hemorrhagic Telangiectasia
Epistaxis
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the frequency of epistaxis and quality of life related to nasal bleeding in patients with HHT colonized with sataphylococo before and after being treated with mupirocin ointment.

Detailed description: Hereditary hemorrhagic telangiectasia is a vascular dysplasia characterized by the development of mucocutaneous telangiectasia and arteriovenous malformations in organs such as brain, lung, liver and tube digestivo. Is considered a rare disease, although It means that there is a substantial underdiagnosis. The overall prevalence is 1/5000.

Approximately 60% of the general population hosts strains of Staphylococcus aureus (S. aureus) intermittently and are called intermittent carriers, 20% represent persistent carriers harboring the same strain of S. aureus and 20% of the population are never carriers.

On this concept, one might think that HHT patients in whom there is an active and pathological vascular remodeling that causes bleeding, and inflammation is a known activator of abnormal angiogenesis; reducing an inflammatory factor as microbial through the eradication of nasal S. aureus could be useful to reduce bleeding in this population, directly impacting on quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years with possible or confirmed HHT as diagnostic criteria Curaçao.
* Patients with nasal S. aureus colonization culture positive

Exclusion Criteria:

* Refusal to participate in the study or the informed consent process.
* Hypersensitivity or contraindication for topical mupirocin.

Primary outcomes:
measure: Nosebleed by sadick scale
timeFrame: 60 days
Secondary outcomes:
measure: Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive
timeFrame: 60 days
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Peron 4190
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Gascon 450
Study officials:
affiliation: Staff of the Department of Clinical Medicine
name: Marcelo MS Serra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03373929: Stitch Closure of PFO and Septal Repair
Official title: Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Foramen Ovale, Patent
Septal Defect, Atrial
Septal Defect, Heart
Lead sponsor: HeartStitch.Com
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 250
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
Intervention model description: Non-randomized, single-center, observational study
Primary purpose: TREATMENT

Brief summary: The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.


Eligibility criteria: Inclusion Criteria:

* PFO
* ASD (less than 1 cm with redundant septal tissue)
* Trans Septal Puncture Sites
* ASA (when an appropriate PFO or small ASD defect is present)
* Stroke
* Trans ischemic Attack (TIA)
* Platypnea Orthodeoxia Syndrome
* Decompression Illness

Exclusion Criteria:

* Patients under 18 and over 65
* Patients who are not fluent in English

Primary outcomes:
measure: Closure Rates of PFO and ASD
timeFrame: 12 months
Secondary outcomes:
measure: Recurrent Stroke Rate
timeFrame: 4-6 weeks, 6 months, 1 year and annually up to five years
Other outcomes:
measure: Migraine
timeFrame: 4-6 weeks, 6 months, 1 year and annually up to five years
Locations:
city: Falls Church
country: United States
facility: Inova Cardiovascular Institute
state: Virginia
Study officials:
affiliation: Inova Cardiovascular Institute
name: James Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03371329: Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Official title: Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemorrhagic Stroke
Intracerebral Hemorrhage
Keywords: mesenchymal stem cell
stroke
intracerebral hemorrhage
cell therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation study
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

Detailed description: The overall clinical development strategy of this project is to conduct this Phase I dose escalation study entitled "A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells Therapy in Patients with Recent Intracerebral Hemorrhage". This study will be performed under this current IND application and will be limited to the proposed 12 subjects (3 IV and 1 IT dose groups).

In this application the investigators are proposing to evaluate safety and feasibility of allogeneic, bone marrow (BM) derived mesenchymal stem cells (MSC) to induce neuroregeneration, improve neurological function and alleviate inflammation.

Eligibility criteria: * Age range: 18 years or older
* Gender: Male or female
* Acute spontaneous supratentorial ICH documented by head CT with ICH Score between 2 - 4 inclusive
* Stable ICH hematoma volume 60mL or less as measured by ABC2 method by 24-72hrs
* Ability to be enrolled within 72 hours of onset of stroke symptoms
* Ability to provide written personal or surrogate consent. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR50.
* Subject must have adequate renal function; creatinine \<1.5g/dl.
* Subject must be available for all specified assessments at the study site through the completion of the study.
* Subject must provide written ICF and authorization for use of and disclosure of PHI.

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Changes in neurological function test
timeFrame: Pre infusion and post-infusion days 1, 2, 3, 7, 30, 90, 180
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Abba C Zubair
role: PRINCIPAL_INVESTIGATOR
References: