louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03294928: Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
Official title: Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam

Exclusion Criteria:

* pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.

Primary outcomes:
measure: hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects.
timeFrame: at rest and after 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
References:
citation: Belfiore J, Brogi E, Nicolini N, Deffenu D, Forfori F, Palombo C. Hemodynamic variations in arterial wave reflection associated with the application of increasing levels of PEEP in healthy subjects. Sci Rep. 2022 Feb 28;12(1):3335. doi: 10.1038/s41598-022-07410-1.
Clinical trial NCT03778528: Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
Official title: Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract
Down Syndrome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2018-12-19
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Down syndrome having cataract surgery or age-matched control.

Brief summary: This study involves the collection ocular lens tissue from individuals with Down syndrome and age-matched controls at the time of cataract surgery.

Detailed description: Individuals with Down syndrome have an increased rate of cataract. The reason for this increase is unclear. Normally, once cataracts become a significant impairment, an ophthalmologist will determine when cataract surgery should be performed. When this surgery is performed, cataractous tissues are cut out and discarded with medical waste. In this study, these tissue will be collected and protein analysis performed to determine what changes in different proteins are found in Down syndrome lenses as compared to normal cataractous lenses.

Eligibility criteria: Inclusion Criteria:

* Undergoing cataract surgery for lens extraction.

Exclusion Criteria:

* Known genetic cause other than Down syndrome causing cataract.

Primary outcomes:
measure: Change in protein composition
timeFrame: one week after collection of tissue
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT05454228: Biomarkers and Postoperative Delirium in Elderly Patients
Official title: Relationship Between Neuroinflammatory Biomarkers and Postoperative Delirium in Elderly Patients With Hip Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients undergoing hip replacement surgery in Henan Provincial People's Hospital were selected during the trial

Brief summary: This study intends to verify and explore the correlation of neuroinflammation biomarkers in cerebrospinal fluid and plasma of elderly patients undergoing hip replacement with postoperative delirium, so as to achieve a new method to predict whether patients will develop postoperative delirium and improve the prognosis of elderly patients with postoperative delirium. Reduce the probability of postoperative complications, improve the long-term survival rate of patients after surgery.


Eligibility criteria: Inclusion Criteria:

1. age≥65
2. Patients undergoing hip replacement under spinal anesthesia
3. ASA grade I\~III;
4. Voluntarily participate in this study, and informed consent was signed by the patients themselves and their families

Exclusion Criteria:

1. Patients with multiple fractures and trauma
2. Patients with preoperative cognitive dysfunction determined by MMSE scale;
3. Severe impairment of hearing, visual and language system functions;
4. Not suitable for or unwilling to undergo subarachnoid anesthesia
5. Patients who refuse to participate or cannot cooperate.

Primary outcomes:
measure: neuroinflammatory biomarkers
timeFrame: preoperative、24 hours after surgery、48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan People's Hospital
state: Henan
Study officials:
References:
Clinical trial NCT01468961: Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
Official title: Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 41
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: This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. Participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of fibromyalgia

Exclusion Criteria:

* Current diagnosis of severe psychiatric disorder

Primary outcomes:
measure: The Fibromyalgia Impact Questionnaire
timeFrame: Once, 1 week before start of treatment
measure: The Fibromyalgia Impact Questionnaire
timeFrame: Once, immediately after treatment
measure: The Fibromyalgia Impact Questionnaire
timeFrame: Once, 6 months after treatment
Secondary outcomes:
measure: Short form 12-item Questionnaire
timeFrame: Once, 1 week before start of treatment
measure: Short form 12-item Questionnaire
timeFrame: Once, immediately after treatment
measure: Short form 12-item Questionnaire
timeFrame: Once, 6 months after treatment
measure: Hospital Anxiety and Depression Scale
timeFrame: Once, 1 week before start of treatment
measure: Hospital Anxiety and Depression Scale
timeFrame: Once, immediately after treatment
measure: Hospital Anxiety and Depression Scale
timeFrame: Once, 6 months after treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Study officials:
References:
citation: Ljotsson B, Atterlof E, Lagerlof M, Andersson E, Jernelov S, Hedman E, Kemani M, Wicksell RK. Internet-delivered acceptance and values-based exposure treatment for fibromyalgia: a pilot study. Cogn Behav Ther. 2014;43(2):93-104. doi: 10.1080/16506073.2013.846401. Epub 2013 Nov 12.
Clinical trial NCT01133561: Pioglitazone in Psoriasis- A Clinical and Molecular Study.
Official title: The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
insulin resistance
metabolic syndrome
pioglitazone
randomized control trial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.

The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and less than 65 years.
* Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).

Exclusion Criteria:

* Age less than 18 years and more than 65 years
* Mild psoriasis less than 10% body surface area
* Erythrodermic or pustular psoriasis
* Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.
* Pregnant and lactating females.

Primary outcomes:
measure: Treatment success detected as clinical improvement of skin condition
timeFrame: 10 weeks
Secondary outcomes:
measure: Fasting serum insulin reduction from baseline before treatment
timeFrame: 10 weeks
measure: C-reactive protein titre reduction from baseline value before treatment
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dermatology department of cairo university faculty of medicine
Study officials:
affiliation: Cairo University-Dermatology department
name: Manal AW Bosseila, MD
role: STUDY_CHAIR
affiliation: Cairo university- Dermatology department
name: Mona RE Abdel Halim, MD
role: STUDY_DIRECTOR
affiliation: Cairo university- Internal medicine department
name: Mohamed I Sheta, MD
role: STUDY_DIRECTOR
affiliation: Cairo University- Biochemistry department
name: Olfat G Shaker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06596161: Iron Therpay and Fatigue in Women of Reprodcutive Age
Official title: Effect or Iron Therapy on Fatigue Symptoms in Non-anemic Iron Deficient Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Fatigue
Keywords: fatigue
Lead sponsor: Central Park Medical College
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the assessment of anemia and then assessment of fatigue levels in non-anemic women followed by assessment of iron levels and intervention of iron and placebo


Eligibility criteria: Inclusion Criteria:

reproductive age non-anemic fatigued

Exclusion Criteria:

anemiac males

Primary outcomes:
measure: Fatigue Score improvemnt
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Central Park Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03390361: Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery
Official title: Intraindividual Comparison of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device Compared to Manual Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Cataracts
Keywords: Laser Cataract Surgery
Prostaglandin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients' eyes will be randomized into two groups receiving either MCS or LCS. In the LCS group aqueous humour will be collected exactly five minutes after laser pretreatment. In the MCS group aqueous humour will be collected before manual manipulation of anterior chamber. Aqueous humour will be screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
Primary purpose: TREATMENT

Brief summary: Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.

After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.
* Pupil dilation of ≥ 6.5mm
* Age 40 and older

Exclusion Criteria:

* Corneal abnormality
* Pseudoexfoliation
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease
* Pregnancy
* Lactation

Primary outcomes:
measure: Proinflammatory cytokines (IL-1β, IL-6) and total-PG
timeFrame: 5 minutes after laser procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rupert Menapace, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00655161: A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
Official title: A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Keywords: NSCLC
Cancer Immunotherapy
Lead sponsor: GlobeImmune
Sponsor class: INDUSTRY
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2008-04-09
Enrollment: 24
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: This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.

Detailed description: NSCLC is the deadliest form of human cancer, killing approximately 150,000 people a year in the United States. The best treatment for NSCLC is surgical resection. For patients with inoperable or unresectable NSCLC chemotherapy and radiation is used as first line therapy. This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment. These subjects must also have a ras mutation.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven stage I-III NSCLC
* Confirmed product related ras mutation
* ECOG performance status of less than or equal to 2
* greater than or equal to 18 years of age

Exclusion Criteria:

* History of a previous cancer
* History of splenectomy
* History of Crohns disease or ulcerative colitis
* History of major organ transplantation
* Concurrent or chronic steroid therapy
* History of allergy to yeast
* Presence of an unstable or poorly controlled medical condition
* Pregnant or nursing mothers
* Positive skin test to yeast

Primary outcomes:
measure: Immune response to GI-4000
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Chaft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076461: Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
Official title: Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vomiting in Infants and/or Children
Acute Gastroenteritis
Lead sponsor: Tehsil Headquarter Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-13
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. The findings of present study will give valuable evidence about the effectiveness of these antiemetic agents to prevent vomiting among children suffering with acute gastroenteritis at a resource limited setting of South Punjab, Pakistan.

Detailed description: to compare the efficacy of ondansetron versus domperidone for treating vomiting in acute gastroenteritis in children at a resource limited emergency setting of South Punjab, Pakistan.

Eligibility criteria: Inclusion Criteria:

* Children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of Acte Gastroenteritis.

Exclusion Criteria:

* Children who took any kinds of antiemetic in the last 6 hours of presentation of emergency department.
* Children having chronic liver disease, chronic kidney disease or congenital heart disease, neurological disorders, any kinds of malignancy, severe dehydration (requiring intravenous fluid replacement), severe acute malnutrition (weight-for-height below -3 standard deviation (SD) adopting WHO child growth protocols) or history known to allergy to antiemetics.

Primary outcomes:
measure: Cessation of vomiting
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Liaquatpur
country: Pakistan
facility: Tehsil Headquarter Hospital
state: Punjab
Study officials:
affiliation: Tehsil Headquarter Hospital, Liaquatpur, Pakistan.
name: Tauseef Ahmad, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02719561: Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer
Official title: Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer patients. Despite this, there has been virtually no research evaluating treatment for cancer-related fatigue in this young patient group. The investigators are undertaking a small qualitative study to co-design a fatigue intervention, that will then be evaluated in future research to assess its effectiveness.

Detailed description: This small qualitative study will involve 7-10 patients who are within one year of completing cancer treatment, as well as some parents. Participants will be recruited from one centre, the Cambridge Teenage and Young Adult cancer Principal Treatment Centre. The three phases will involve a) participants being interviewed individually and attending a focus group, b) patients receiving the prototype co-designed intervention, and c) participants being interviewed after the intervention to provide feedback to allow further refinement of the intervention. The intervention will be delivered by an Allied Health Professional in the setting that participants have chosen. It is likely to involve, at a minimum, education about fatigue and support with increasing activity. It will not include administration of any medication.

Eligibility criteria: Inclusion Criteria:

Patients:

* Aged 16-27 with a diagnosis of cancer
* Currently or previously known to the Cambridge Teenage and Young Adult cancer service
* Primary cancer treatment completed within one year of recruitment OR on maintenance treatment for leukaemia.
* A screening score of ≥5 in a 10-item numerical rating scale of fatigue severity over the last month
* Able to give informed consent

Parents:

* The parent of a patient participant or a patient who would be eligible to participate
* The patient consents to the parent being approached about the study
* The parent is able to give informed consent

Exclusion Criteria:

* Current participation in another clinical trial

Primary outcomes:
measure: Participant-reported feedback on design content as assessed via interviews
timeFrame: 3 months
measure: Participant-reported feedback on design acceptability as assessed via interviews
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Anna Spathis, MA MB BChir
role: PRINCIPAL_INVESTIGATOR
References: