louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04341272: Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
Official title: Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboses
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
First posted: 2020-04-10
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Venous thromboembolism (VTE) is an important cause of morbidity and mortality following surgery.A combination of chemical and mechanical prophylaxis using lower extremity compression devices (CD) is recommended in patients who are considered at 'moderate risk' (Caprini score 2 - 4) or 'high risk' (Caprini score \> 4) of developing VTE.

The aim of this study was to determine whether upper extremity (UE) CD are as effective as lower extremity (LE) CD in preventing VTE following surgery. A total of 106 patients were recruited.

Detailed description: Hospitals throughout the United States currently utilize mechanical compression devices on patients' limbs for prevention of blood clots, in addition to blood thinning medication - heparin. The compression devices act by affect blood clotting mechanism and there is evidence from previous research studies that blood is less likely to develop clots when these compression devices are placed on the arms or legs.

The use of compression devices on arms and legs is within standard of care, but use on legs tends to be more common.

Research studies have shown that use of compression devices in combination with heparin is more effective in preventing blood clots than either one alone.

Not many clinicians remember the option of placing compression devices on arms, and patients who do not get compression devices placed on their legs following surgery, often get only medication (heparin) with no compression device placed at all.

This study will compare the effectiveness of compression devices used on patients' arms with those used on patients' legs, at preventing blood clots. Non-invasive ultrasound studies will be used after surgery to check for blood clots in the legs.

Eligibility criteria: Inclusion Criteria:

• Males aged \> 18 years who could provide informed consent

Exclusion Criteria:

* Patients on coumadin or post-operative therapeutic heparin
* Known history of venous thromboembolism (VTE)
* Known history of hematological disorders
* Diagnosed malignancy requiring or undergoing treatment
* Presence of upper extremity arterio-venous access for hemodialysis
* Females were excluded to eliminate the confounding thrombogenic effect of estrogen.

Primary outcomes:
measure: venous thromboembolic event following surgery
timeFrame: within 45 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baltimore VA Medical Center
name: Preeti R John, MD, MPH, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00641472: Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children
Official title: An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Pulmicort
Children
paediatrics
budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 380
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.


Eligibility criteria: Inclusion Criteria:

* Aged 2 to 8 at study entry
* At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
* use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in

Exclusion Criteria:

* Severe or unstable asthma
* any significant finding at a physical exam
* an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor

Primary outcomes:
measure: Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
timeFrame: Each clinic visit
Secondary outcomes:
measure: Incidence and Severity of Adverse Events
timeFrame: Each clinic visit
measure: Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
timeFrame: Each clinic visit
measure: Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks
timeFrame: Each clinic visit
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Bertil Andersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02050672: Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome
Official title: Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Couple Sterility
Keywords: Myoinositol
ART
EMBRYO QUALITY
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 249
Sex: MALE
Minimum age (years): 30
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.

In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.

Detailed description: Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.

Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.

Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.

Eligibility criteria: Inclusion Criteria:

* couple counselled for IVF

Exclusion Criteria:

* cryopreserved sample

Primary outcomes:
measure: Fetilization rate
timeFrame: Day 1
Secondary outcomes:
measure: Embryo quality
timeFrame: Day 2 to Day 5
Other outcomes:
Locations:
city: Milan
country: Italy
facility: TECNOLAB
Study officials:
References:
citation: Condorelli RA, La Vignera S, Bellanca S, Vicari E, Calogero AE. Myoinositol: does it improve sperm mitochondrial function and sperm motility? Urology. 2012 Jun;79(6):1290-5. doi: 10.1016/j.urology.2012.03.005.
citation: Nomikos M, Swann K, Lai FA. Starting a new life: sperm PLC-zeta mobilizes the Ca2+ signal that induces egg activation and embryo development: an essential phospholipase C with implications for male infertility. Bioessays. 2012 Feb;34(2):126-34. doi: 10.1002/bies.201100127. Epub 2011 Nov 16.
citation: Condorelli RA, La Vignera S, Di Bari F, Unfer V, Calogero AE. Effects of myoinositol on sperm mitochondrial function in-vitro. Eur Rev Med Pharmacol Sci. 2011 Feb;15(2):129-34.
Clinical trial NCT02717572: 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
Official title: Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease).
* Patient must have at least one lesion measuring ≥ 2.0 cm.
* 18 years of age or older.
* Ability to provide informed consent.

Exclusion Criteria:

* Cancer therapy within 30 days of baseline imaging.
* Uncontrolled intercurrent illness including, but not limited to active infections.
* Patients with insulin-dependent diabetes.
* Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants.
* Patients who are pregnant or nursing.
* Inability to tolerate 60 minutes of PET imaging.
* Inability to comply with study procedures.

Primary outcomes:
measure: Variability of repeated quantitative measures of FDG uptake as measured by SUVmax
timeFrame: Completion of study (up to Day 7)
measure: Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak
timeFrame: Completion of study (up to Day 7)
measure: Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC
timeFrame: Completion of study (up to Day 7)
measure: Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC
timeFrame: Completion of study (up to Day 7)
Secondary outcomes:
measure: Evaluation of the ratio of SUVmax and ADCmin
timeFrame: Completion of study (up to Day 7)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Richard L Wahl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01929772: German Lactat Clearance in Severe Sepsis
Official title: German Lactat Clearance in Severe Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe sepsis or septic shock

Brief summary: The aim of this study is to investigate if there is a correlation between lactate clearance and the course at patients with severe sepsis and septic shock at german intensive care units.


Eligibility criteria: Inclusion Criteria:

* Patients with severe sepsis or septic shock
* signed informed consent

Exclusion Criteria:

* severe sepsis or septic schock within 4 weeks before inclusion of study
* shock of other genesis
* persons being accomondated in an institution because of court or official order
* persons being interdependet to the investigator
* employees of the investigator

Primary outcomes:
measure: Lactate Clearance
timeFrame: Within 6 hours after diagnoses
Secondary outcomes:
measure: SOFA Score
timeFrame: Day of hospitalization, day 7, day 8
Other outcomes:
measure: Mortality
timeFrame: After 28 days
measure: Duration intensive care unit and hospitalization
timeFrame: 28 days
Locations:
city: Aachen
country: Germany
facility: Department for Operative Intensive Care and Intermediate Care - University Hospital Aachen
state: North Rhine Westfalia
Study officials:
References:
Clinical trial NCT05643872: A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Official title: A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pachyonychia Congenita
Lead sponsor: Palvella Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial.

The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or "PTX-022".


Eligibility criteria: Key Inclusion Criteria:

* Completed the PALV-05 (VAPAUS) study
* Agree to contraceptive use

Key Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical)
* Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study
* Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Prior to dose, 12 hours and 24 hours
Other outcomes:
Locations:
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
Study officials:
References:
Clinical trial NCT06299072: A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast
Official title: 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet, Healthy
Keywords: whole grain
breakfast
habit
consumer
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three cities in Saudi Arabia, with representation across regions, gender, age group, and education status.

Brief summary: In this online survey conducted suing the YouGov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the Saudi Arabia adult population and the he estimated consumption amongst Saudi consumers.

Secondary Objectives are to assess the breakfast habit, oat consumption \& health concerns amongst Saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods.


Eligibility criteria: Inclusion Criteria:

* Participants in online panel survey
* Age between 18 and 40 years
* Current resident of urban Saudi Arabia in Jeddah, Riyadh, \& Dammam

Exclusion Criteria:

N.A.

Primary outcomes:
measure: Consumer awareness regarding wholegrains
timeFrame: Approximately 20 minutes
measure: Consumer definitions of wholegrains
timeFrame: Approximately 20 minutes
measure: Consumer knowledge of potential benefits of wholegrains
timeFrame: Approximately 20 minutes
measure: Wholegrain consumption
timeFrame: Approximately 20 minutes
Secondary outcomes:
measure: Breakfast habits
timeFrame: Approximately 20 minutes
measure: Oat consumption
timeFrame: Approximately 20 minutes
measure: Health concerns
timeFrame: Approximately 20 minutes
measure: Socio-demographics associated with breakfast consumption
timeFrame: Approximately 20 minutes
measure: Consumer characteristics associated with breakfast consumption
timeFrame: Approximately 20 minutes
measure: Types of foods consumed at breakfast
timeFrame: Approximately 20 minutes
measure: Fill gaps in knowledge regarding breakfast eating habits
timeFrame: Approximately 20 minutes
measure: Commonly consumed breakfast foods
timeFrame: Approximately 20 minutes
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Remote, no facility visits
Study officials:
affiliation: College of Medicine and Health Sciences, Abu Dhabi - UAE
name: Ayesha Al Dhaheri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04005872: Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment
Official title: Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
Primary purpose: TREATMENT

Brief summary: The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.

Detailed description: This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).

This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).

Eligibility criteria: Inclusion Criteria:

Patients:

* Cooperative children.
* Both genders.
* In age range from 4 to 7 years.

Teeth:

* Vital second primary molars with deep caries limited to occlusal surface.
* No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
* No radiographic abnormalities
* Restorable teeth.

Exclusion Criteria:

* • Children with known history of allergy to any of the tested materials.

  * Children with systemic conditions.
  * Parents who refused to participate.

Primary outcomes:
measure: Spontaneous pain or pain on biting
timeFrame: 12 months
measure: Pain on percussion
timeFrame: 12 months
measure: Swelling
timeFrame: 12 months
measure: Mobility
timeFrame: 12 months
measure: Sinus or fistula tract
timeFrame: 12 months
Secondary outcomes:
measure: Furcation or perapical radiolucency
timeFrame: 12 months
measure: External or internal root resorption
timeFrame: 12 months
measure: Widening periodontal membrane space
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Heba Mohamed Refaat Fouad Genena
Study officials:
References:
Clinical trial NCT06071572: San Raffaele IBD Biobank
Official title: San Raffaele IBD Biobank: Accelerating Research From the Bed to the Bench Side
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We will enroll Patients with IBD affering to OSR

Brief summary: The developments of knowledge and possibilities of investigation in the biomedical field, and in particularly in the field of inflammatory bowel diseases need to be analyzed and study vast cases of biological material carefully collected, preserved and correlated with complete clinical-pathological-instrumental data. In order to organize and make uniform the collection, storage and management of samples and the clinical data associated with them, a biobank is being set up, called "IBD Biobank" aimed at studying inflammatory intestinal diseases. THE subjects/patients who decide to authorize the collection, storage and use of biological material for future research purposes which are not currently identifiable will be called, in this document, donors. The IBD Biobank involves the recruitment of adult subjects. To each donor will be given informed consent DSAN 1178/6 ("Regulation e informed consent for the collection, conservation and use of human biological material spontaneous monocentric or multicentric studies with promoting OSR") or the most updated version of this informed consent, according to the directives of the OSR Ethics Committee. The biological material of the IBD Biobank will be processed at the laboratories of the Biological Resources Center (CRB) e preserved at BIOREP srl (Via Olgettina, 60, c/o San Raffaele Hospital-DIBIT2 - Palazzina San Michele 20132 Milan). Generally biological materials will be collected during the already scheduled surgery and the routine clinical examination as part of outpatient visits, day hospitals and hospital admissions. The biological samples will come stored in tubes equipped with barcode identification (2D) which guarantee a code unique to each rate and preserve its anonymity. The clinical-pathological-instrumental data, demographic and anamnestic information will be entered by trained personnel on a computerized database anonymously by assigning a UPN code identifying the patient. Access the database is managed via personal login and password. All data entered is recorded and stored on the server of the IRCCS San Raffaele Hospital in Milan.


Eligibility criteria: Inclusion Criteria:

* Patients with IBD (min 18 years)

Exclusion Criteria:

* Patients without IBD

Primary outcomes:
measure: To perform DNA, RNA and protein extraction, cell isolation, serum isolation and metabolomic analysis from IBD patients blood, tissue, feces and saliva
timeFrame: 1-36
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: