louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02814721: Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique
Official title: Coronal Mode Ultrasound Guided Hemodialysis Cannulation: A Pilot Randomized Comparison With Standard Cannulation Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula, Cannulation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Analogic Corporation
First posted: 2016-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.


Eligibility criteria: Inclusion Criteria:

* End-stage renal disease with new arteriovenous fistula being started for cannulation

Exclusion Criteria:

* End-stage renal disease with grafts

Primary outcomes:
measure: Infiltration Due to Dialysis Access Cannulation
timeFrame: 3 weeks from use of fistula
Secondary outcomes:
measure: Patient Pain Scale
timeFrame: 3 weeks from use of fistula
Other outcomes:
Locations:
city: Detroit
country: United States
facility: GHS West pavilion dialysis center
state: Michigan
Study officials:
References:
Clinical trial NCT03512821: A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Official title: A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-05-01
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions

Detailed description: A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 18 years of age or older
* BMI ≥ 19.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of chilbearing or nonchildbearing potential

Exclusion Criteria:

• Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0-72hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0-72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Pharma medica research Inc.
state: Ontario
Study officials:
References:
Clinical trial NCT05117021: Comparative Study Between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries
Official title: Comparative Study Between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Post Operative Analgesia in Children Undergoing Infraumblical Surgeries
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia

Detailed description: Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries

Eligibility criteria: Inclusion Criteria:

- 120 children, aged between 4 and 7 years undergoing infraumblical surgeries as ( hypospadias , inguinal hernia and orchopexy ).patients will be selected according to ASA physical status class I to II from both genders who be able to swallow tablets.

Exclusion Criteria:

* parents' refusal.
* urgent cases.
* other contraindications of regional anesthesia (e.g. infection at injection site, coagulopathy and allergy to bupivacaine)
* Insulin dependent diabetes
* Thyroid disease

Primary outcomes:
measure: post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. No abstract available.
citation: Kumar A, Dogra N, Gupta A, Aggarwal S. Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative analgesia in children undergoing inguinal hernia surgery: A comparative study. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):172-176. doi: 10.4103/joacp.JOACP_100_19. Epub 2020 Jun 15.
citation: Willschke H, Kettner S. Pediatric regional anesthesia: abdominal wall blocks. Paediatr Anaesth. 2012 Jan;22(1):88-92. doi: 10.1111/j.1460-9592.2011.03704.x. Epub 2011 Nov 14.
Clinical trial NCT03973021: Very Small Embryonic-like Stem Cells for Erectile Dysfunction
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Organic Erectile Dysfunction
Keywords: erectile dysfunction
very small embryonic-like stem cell
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
First posted: 2019-06-04
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this group, the patients will receive intracavernous injection of autologous VSELs. The check indexes are International Index of Erectile Function 5(IIEF-5), Erection Hardness Score(EHS) and penile vascularization assessed using color duplex Doppler ultrasound (CDDU), mainly including erectile function, stretched penile length, sexual drive, intercourse satisfaction, and overall satisfaction.
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to organic erectile dysfunction, such as those associated with metabolic syndrome or the treatment of prostate cancer.

Detailed description: By enrolling patients with organic erectile dysfunction adapted to enrolled criteria, this study will document for the first time the safety and efficacy of underlying penile cellular damage.

The safety will be evaluated by tolerance degree. The efficacy will be evaluated validated scores and color duplex Doppler ultrasound.

Eligibility criteria: Inclusion Criteria:

* Metabolic and systemic changes in diseases such as diabetes and atherosclerosis or more localized causes such as direct injury to the penile neurovascular supply during prostate surgery
* Diagnosed as an organic erectile dysfunction by at least 2 urological surgeons

Exclusion Criteria:

* Non-organic erectile dysfunction, such as psychological factors
* Solid cancer patients other than early prostate cancer
* Blood disease patients, thrombocytopenia or dysfunction, hypofibrinogenemia or anticoagulant therapy, long-term use of aspirin
* Older than 70 years

Primary outcomes:
measure: Tolerance
timeFrame: 1-4 weeks after each injection
Secondary outcomes:
measure: Short-term effects on erectile function
timeFrame: 3-6 months after each injection
measure: Long-term effects on erectile function
timeFrame: 12 months after final injection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03274921: Biomarkers of Cardiovascular Complications in Chronic Kidney Disease
Official title: Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Disease
Keywords: cardiovascular complications
biomarkers
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 130
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: Cohort of patients consulting in University Hospital toulouse

Brief summary: Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.


Eligibility criteria: Inclusion Criteria:

* patient with stage 4 or 5 CKD.

Exclusion Criteria:

* patient with stage 1, 2 or 3 CKD
* patient with solid tumor
* patient with malignant blood disease
* patient with acute kidney disease in the past 3 months
* patient with acute glomerulonephritis in the past 6 months.

Primary outcomes:
measure: Plasma accumulation of new retention solutes
timeFrame: Day 0
Secondary outcomes:
measure: determine their plasma concentration
timeFrame: Day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hosptial Toulouse
name: Stanislas FAGUER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180321: Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniosynostosis Patients Undergoing Distraction Osteotomy
Keywords: Tranexamic acid
pharmacokinetics
craniosynostosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. Since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and the transfusion during and after the surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the changes in coagulopathy will be defined using thromboelastography.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for distraction osteostomy under the diagnosis of Craniosynostosis.
2. Patients aged from 2 months to 6 years, either of whose patients had consented
3. ASA class 1 or 2

Exclusion Criteria:

1. Coagulopathy with either PT \> INR 1.5 or PLT \< 50,000/dL
2. Patients took any NSAIDs within 2 days, or aspirin within 14 days prior to surgery
3. History of convulsive seizure, epilepsy, any brain surgery
4. Known drug allergic reaction to tranexamic acid

Primary outcomes:
measure: Bleeding loss
timeFrame: from every each hour during intraop, periodImmediate postop, postoperative 24hr to postoperative 48hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04054921: Safety Study for Beta Thalassemia Subjects on PTG-300
Official title: An Open Label Extension Study of PTG-300 In Non-Transfusion Depenent (NTD) and Trasfusion-Dependent (TD) B-Thalassemia Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: β-thalassemia
Ineffective Erythropoiesis
Keywords: Chronic anemia
β-thalassemia
Lead sponsor: Protagonist Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia patients.

Detailed description: The PTG-300-03 study will study beta thalassemia patients on PTG-300 for two years. The dose and dose frequency for each subject enrolling in the PTG-300-03 study will be based on the last dose and frequency received by the subject in the previous study PTG-300-02 and the subject's response at that dose. Patients dose will be increased in a manner similar to that used on PTG-300-02 study. The maximum PTG-300 dose allowed is 80 mg/week.

Eligibility criteria: Inclusion Criteria:

* NTD and TD β-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02.

Exclusion Criteria:

* Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD).

Primary outcomes:
measure: Proportion of subjects with side effects and severity of side effects will be tabulated
timeFrame: Over two year Period after receiving PTG-300
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Athens
country: Greece
facility: Athens General Hospital 'G Gennimatas'
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Hazmiyeh
country: Lebanon
facility: Chronic Care Center
city: Ampang
country: Malaysia
facility: Hospital Ampang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Pathum Wan
country: Thailand
facility: Chulalongkorn University
city: Phitsanulok
country: Thailand
facility: Naresuan University
city: Sousse
country: Tunisia
facility: University Hospital Farhat Hached
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
References:
Clinical trial NCT06127121: A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients
Official title: A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To look at how a digital art activity may help cancer patients improve their ability to express their distress, symptoms, and lived experience.

Detailed description: Primary objective:

* To evaluate how engaging in a digital art activity might potentially cause changes in symptom reporting, based on pre/post self-reporting on the Edmonton Symptom Assessment System (ESAS) at time T3.

Secondary objectives:

* To evaluate the changes in symptom reporting, based on pre/post self-reporting on ESAS at different times of the study (T1, T2).
* To evaluate how a specific creative art making activity (T3), compared to an active control condition (T2; music listening) may or may not impact reporting ESAS.
* To monitor potential changes in distress disclosure, based on the self-report scoring on the Distress Disclosure Index score at T0, T2 and T3.

Eligibility criteria: Inclusion Criteria:

1. Age equal or greater than 18 years
2. Patients who are admitted in the hospital and have received a cancer diagnosis.
3. Suffering from solid cancer or hematological malignancy and receiving active treatment for their cancer.
4. Voluntary written consent.
5. Fluent in English or Spanish.

Exclusion Criteria:

1. Not being able to use a digital tablet
2. Being speech impaired or vision impaired
3. Patients who are cognitively impaired and unable to read or consent for the study
4. Pregnant women

Primary outcomes:
measure: The Edmonton Symptom Assessment System, (ESAS) questionnaires
timeFrame: through study completion; an average 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carlos Roldan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06090721: DMT310-009 Topical in the Treatment of Acne Vulgaris
Official title: A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Dermata Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 555
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Patient sex at birth, male or non-pregnant female at least 9 years of age
* Clinical diagnosis of moderate to severe acne vulgaris as determined by:

Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflammatory lesions on the face

* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy on the face which may affect the patient's acne

Primary outcomes:
measure: Efficacy as measured by lesion counts
timeFrame: 12 weeks
measure: Efficacy as measured by Investigator Global Assessment (IGA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Austin
country: United States
facility: DermResearch
state: Texas
Study officials:
References: