louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05259072: carDIo-ttranSSfOrm nucLEar Imaging Study
Official title: carDIo-ttranSSfOrm nucLEar Imaging Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amyloidosis
Transthyretin Amyloid Cardiomyopathy
Keywords: pyrophosphate scintigraphy
bone scintigraphy
eplontersen
tafamidis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Ionis Pharmaceuticals, Inc.
First posted: 2022-02-28
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ATTR-CM

Brief summary: The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).

Detailed description: This is a multicenter trial of 80 subjects enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) who will undergo baseline and follow up Tc-99m PYP to assess for the change in myocardial uptake of the tracer.

Eligibility criteria: Inclusion Criteria:

* Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
* Patients have to meet the inclusion and exclusion criteria of CARDIO-TTRansform trial to be enrolled.
* Patient willing to consent for the study and undergo the study procedures.

Exclusion Criteria:

* None

Primary outcomes:
measure: Primary outcome
timeFrame: 120-140 weeks
Secondary outcomes:
measure: Secondary outcome
timeFrame: 120-140 weeks
measure: Secondary outcome
timeFrame: 61 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ahmad Masri, MD MS
role: STUDY_CHAIR
References:
Clinical trial NCT04026672: Hemp Oil + User Experience Study
Official title: Hemp Oil + User Experience Study: A Retrospective, Non-Interventional Study to Assess Consumer Experience and the Impact of Hemp Oil + on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Wellbeing
Gastrointestinal Health
Physical Discomfort
Sleep
Mood
Lead sponsor: Thorne HealthTech, Inc
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have purchased Hemp Oil +

Brief summary: Presented as an online survey, this study seeks to better understand how Thorne customers are using and experiencing the new Hemp Oil + product and how they feel it compares in the marketplace. Hemp Oil + is a combination product with a proprietary blend of hemp, clove, black pepper, hops, and rosemary extracts. People who have independently elected to purchase and use Hemp Oil + before the study starts will be invited to voluntarily participate. If they meet study requirements and give consent they will answer questions online about their experience with Hemp Oil +. Questions address general demographics and wellness, general impressions of the product, how it compares to other products, and any effect it has had on their gastrointestinal health, physical discomfort, sleep, and mood. The survey is expected to take 15-30 min of participant time. Data will be analyzed to determine whether the customer experience with Hemp Oil + is as favorable as it seems from anecdotal reports. Analysis will also be conducted to find patterns that can inform future studies, marketing, and customer education efforts.


Eligibility criteria: Inclusion Criteria:

* Has personally used at least one bottle (30 gelcaps) of Hemp Oil +
* Provides consent to participate in the study

Exclusion Criteria:

* Cannot access or use the electronic survey for any reason
* Was pregnant or nursing when taking Hemp Oil +
* Is a Thorne employee not willing to participate without compensation

Primary outcomes:
measure: Assess impact to overall quality of life (QoL) after taking Hemp Oil +
timeFrame: 1 Day
Secondary outcomes:
measure: Assess impact to specific QoL factors - GI health, mood, sleep, physical discomfort - after taking Hemp Oil +
timeFrame: 1 Day
measure: Gain insight into user perspective on product quality, efficacy, and rationale for continuing/discontinuing use
timeFrame: 1 Day
Other outcomes:
Locations:
city: Summerville
country: United States
facility: Online Survey for Thorne Research, Inc.
state: South Carolina
Study officials:
affiliation: Thorne Research
name: Jacqueline Jacques, ND
role: PRINCIPAL_INVESTIGATOR
affiliation: Thorne Research
name: Sheena Smith, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05798572: Pre-Op Sildosine and Ureteral Dilation During F-URS
Official title: Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FURS
Ureteral Dilatation
Sildosine
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.

Detailed description: Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.

The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.

Eligibility criteria: Inclusion Criteria:

* Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
* 2. Non stented.
* Age (Above 18 years old).

Exclusion Criteria:

* Acute or chronic renal insufficiency.
* Uncorrected coagulopathy.
* Previous open (lumber or ureteric) surgery.
* Active urinary tract infection unless treated.

Primary outcomes:
measure: Entrance to bladder time (ETBT)
timeFrame: Intraoperatively
Secondary outcomes:
measure: Entrance to ureteric orifice time (ETUOT)
timeFrame: Intraoperatively
measure: Application of access sheath time (AAST)
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha University Hospitals
Study officials:
References:
Clinical trial NCT00790972: The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity
Official title: The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: MRSA Infection
Keywords: MRSA
sinofresh
nasal spray
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 0
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: This is a study to assess the ability of SinoFresh Nasal \& Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* The volunteer is able to adhere to the study requirements and study visits.
* Agrees to abstain from use of other nasal sprays for length of study.
* Diagnosis of an MRSA carrier by PCR testing

Exclusion Criteria:

* History of chronic nose bleeds.
* History of intranasal steroids in the last 2 months
* Nasal obstruction severe enough to prohibit effective delivery of a nasal spray
* Epistaxis
* Significant excoriation in the opinion of the Investigator.
* Known hypersensitivity to any ingredients

Primary outcomes:
measure: This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Irsk Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760172: Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
Official title: Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
name: Puerta de Hierro University Hospital
First posted: 2018-11-30
Enrollment: 7300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all population

Brief summary: NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis.

Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at least in a subset of patients, the development of NASH in the absence of classic metabolic risk factor.

Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes co-exist.

First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome ande second, a predominantly metabolic phenptype, strongly associated to he metabolic syndrome.

In this way, we believe that in a particular subset of NAFLD patients, NASH could be considered as an IMID, as most of the definiting features of IMIDs are present. To demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we will adress the molecular and immunophenotype characterization in liver biopsies of NASH patients with and without the co-existence of IMIDs.


Eligibility criteria: Inclusion Criteria:

* NAFLD with biopsy proven disease above 18 years
* IMID patients above 18 years
* All participants must give informed written consent

Exclusion Criteria:

* Patients who had any clinical evidence of malignancy
* Other secondary cause of chronic liver disease. Alternative causes of liver disease included excessive alcohol intake (higher than 20 g/day in women and 30 g/day in men), viral hepatitis, chronic alcohol consumption, autoimmune hepatitis, Wilson´s disease, alpha-1-antitripsine deficiency, inborn errors of metabolism or drug induced liver injury

Primary outcomes:
measure: Prevalence of NAFLD in patients with IMID
timeFrame: January 2019 - December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
Study officials:
References:
Clinical trial NCT00510172: Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2
Official title: Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache
Migraine
Vasodilatation
Keywords: Headache
Migraine
Vasodilatation
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2007-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial vasodilatation in migraineurs.


Eligibility criteria: Inclusion Criteria:

* migraine without aura and healthy apart from that
* age 18-55 years
* 50-100 kg
* Secure contraceptives

Exclusion Criteria:

* Tension Type Headache more than 3 time a month
* Other primary headaches
* Medication prior to the study (closer than 4 times plasma halflife)
* Migraine or headache 5 days prior to study.
* Hypertension (systolic BP \>150 mmHg and/or diastolic BP \>100 mmHg).
* Hypotension (systolic BP \<90 mmHg and/or diastolic BP \<50 mmHg).
* Heart-vessel disease of any kind incl cerebrovascular disease.
* Anamnestic or clinical signs of psychiatric disease or abuse.
* Anamnestic or clinical signs of disease of any kind relevant for participation in the study.

Primary outcomes:
measure: Headache and accompanying symptoms. Blood flow velocity in the middle cerebral artery, diameter changes in superficial temporal artery and radial artery.
timeFrame: 14 hours
Secondary outcomes:
measure: Blood pressure, pulse
timeFrame: 100 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Troels Wienecke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04811872: Placental Transfusion Effect on Hemodynamics of Premature Newborns
Official title: Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre-Term
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 57
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to perform ultrasound Doppler measurements to evaluate the hemodynamic changes associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life.

Detailed description: This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.

Eligibility criteria: Inclusion Criteria:

* Premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.

Exclusion Criteria:

* Preterm babies \>32 weeks
* Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
* Evidence of head trauma causing major intracranial hemorrhage.
* Monochorionic multiples.
* Concern for abruptions, placenta previa or retroplacental hematoma.
* Cord accident, or avulsion at the time of delivery.
* Refusal to perform the intervention by the obstetrician

Primary outcomes:
measure: Evaluation of superior vena cava flow (SVC) flow by echocardiography
timeFrame: up to 3 days of life
measure: Measurement of fractional shortening (FS) by echocardiography
timeFrame: up to 3 days of life
measure: Evaluation of ejection fraction (EF) by echocardiography
timeFrame: up to 3 days of life
measure: Evaluation of the pulse wave by echocardiography
timeFrame: up to 3 days of life
measure: Evaluation of left ventricular diastolic function by echocardiography
timeFrame: up to 3 days of life
measure: Evaluation of cardiac output (CO)
timeFrame: up to 3 days of life
measure: Evaluation of patent ductus arteriosus (PDA)
timeFrame: up to 3 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
References:
citation: Farag MM, Thabet MAEH, Abd-Almohsen AM, Ibrahim HIAM. The effect of placental transfusion on hemodynamics in premature newborns: a randomized controlled trial. Eur J Pediatr. 2022 Dec;181(12):4121-4133. doi: 10.1007/s00431-022-04619-0. Epub 2022 Sep 21.
Clinical trial NCT04437472: Remote Collection of Patient Reported Toxicity Using SMS Text Messaging (CareSignal)
Official title: Remote Collection of Patient Reported Toxicity Using SMS Text Messaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing radiation therapy at Siteman Cancer Center at Washington University School of Medicine.

Brief summary: CareSignal has developed an application that allows for remote collection of patient-reported data such as symptoms or outcomes on any device compatible with the short message service (SMS), otherwise known as "text messaging". The software can be configured to complete symptom monitoring by surveying patients about toxicity using the PRO-CTCAE tools. PRO-CTCAE is the patient reported outcomes version of the CTCAE that was designed by the National Cancer Institute (NCI) for use in clinical trials.


Eligibility criteria: Inclusion Criteria:

* Currently planning to receive radiotherapy for 2 or more fractions with or without chemotherapy.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
* Age 18 years or older.

Exclusion Criteria:

-Unable to reliably access and use a device compatible with CareSignal software.

Primary outcomes:
measure: Percentage of invited symptom reports completed during the study period
timeFrame: From treatment through 30 days follow-up (estimated to be 3 months)
measure: Percentage of questions completed within each invited symptom report
timeFrame: From treatment through 30 days follow-up (estimated to be 3 months)
Secondary outcomes:
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: Matthew B Spraker, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564472: Validation of Sleepware G3 Autoscoring Algorithm
Official title: Validation of Sleepware G3 Autoscoring Algorithm
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Polysomnography Scoring
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any retrospective, de-identified adult polysomnogram collected using American Society of Sleep Medicine (AASM) criteria.

Brief summary: The objective of this study is to validate the ability of the Sleepware G3 polysomnography software platform to correctly identify and score sleep related events.


Eligibility criteria: Inclusion Criteria:

* AASM Compliant PSG studies

Exclusion Criteria:

* NA

Primary outcomes:
measure: PSG Scoring Validity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05056272: Anxiety and Sexual Malfunction Functions in Infertile Pcos Women
Official title: Anxiety and Sexual Malfunction in Infertile Polycystic Ovarian Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 129
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Polycystic ovary syndrome patients and infertile

Brief summary: Polycystic ovary syndrome (PCOS) is a common hormonal disorder in females in reproductive age associated with signs and symptoms as amenorrhea or oligomenorrhea, obesity,infertility acne and hirsutism tism that mostly Reduce self steem and having negative impact on physical and sexual quality of life , the management of signs and symptoms should result in improvement in the quality of life


Eligibility criteria: Inclusion Criteria:

- Age:20-40 Married infertile

Exclusion Criteria:

* any other diseases could affect quality of life

Primary outcomes:
measure: Prevellance of anxiety and sexual malfunction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
citation: Hahn S, Janssen OE, Tan S, Pleger K, Mann K, Schedlowski M, Kimmig R, Benson S, Balamitsa E, Elsenbruch S. Clinical and psychological correlates of quality-of-life in polycystic ovary syndrome. Eur J Endocrinol. 2005 Dec;153(6):853-60. doi: 10.1530/eje.1.02024.
citation: Akbari Sene A, Tahmasbi B, Keypour F, Zamanian H, Golbabaei F, Amini-Tehrani M. Differences in and Correlates of Sexual Function in Infertile Women with and without Polycystic Ovary Syndrome. Int J Fertil Steril. 2021 Jan;15(1):65-72. doi: 10.22074/ijfs.2021.6206. Epub 2021 Jan 19.