louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06005129: Personality Change Study for Borderline Personality Disorder
Official title: Engaging Higher-Order Mechanisms of Psychopathology: a Parsimonious Approach to Precision Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
name: National Institute of Mental Health (NIMH)
First posted: 2023-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants with borderline personality disorder will undergo an a 2 - 4 week baseline assessment to determine level of outcomes of interest in the absence of treatment. After the baseline period, participants will receive six weekly 50-60-minute treatment sessions. After the 6 treatment sessions, participants will complete a 4-week follow-up period to determine the sustainability of the treatment module.


Eligibility criteria: Inclusion Criteria:

* Speak English fluently
* Diagnosis of Borderline Personality Disorder

Exclusion Criteria:

* diagnosed psychological conditions that would be better addressed by alternative treatments
* concurrent psychotherapy
* medication instability
* substance use disorder

Primary outcomes:
measure: Change in clinician-rated borderline personality disorder symptoms
timeFrame: up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)
measure: Change in patient-reported borderline personality disorder symptoms
timeFrame: weekly up to 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Clinic for Emotional Health at the University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shannon Sauer-Zavala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817829: Oral Paracetamol as Preemptive Analgesia for Labor Pain
Official title: Oral Paracetamol as Preemptive Analgesia for Labor Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Labor Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

Detailed description: It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

Eligibility criteria: Inclusion Criteria:

* primigravida
* The gestational age between 37- 42 weeks
* Not seeking analgesia
* Singleton pregnancy
* vertex
* Spontaneous onset of labour
* 1st stage of labour (less than 5 cm)

Exclusion Criteria:

* Extreme of age (below18-above 40)
* Multiparous
* Multiple gestation
* Malpresentation
* Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
* Any medical disorder with pregnancy
* Induction of labour
* Advanced 1st stage \> 5 cm
* Use of any other kind of analgesia before recruitment in the study
* Scared uterus
* Fetal distress

Primary outcomes:
measure: Efficacy
timeFrame: intrapartum
Secondary outcomes:
measure: Safety
timeFrame: Start of medication till 24 hours postpartum
measure: Duration of labor
timeFrame: Start of medication till delivery of fetus.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02493829: B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)
Official title: A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2015-07-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
* Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).

Key Exclusion Criteria:

* Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12\~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
* Patients unsuitable for standard induction chemotherapy.
* Patients who have previously undergone or will be able to undergo allogeneic transplantation.
* Patients who have had previous or current treatment with any form of investigational immunotherapy.

Primary outcomes:
measure: Vaccine-related toxicity based on the NCI criteria V4.0
timeFrame: 52 weeks
measure: Frequency, severity of adverse events to the AML cell vaccine
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02759029: Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test
Official title: Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.


Eligibility criteria: Inclusion Criteria:

1. positive results of rapid urease test

Exclusion Criteria:

1. liver cirrhosis,
2. chronic kidney disease,
3. bleeding tendency,
4. pregnant,
5. allergy to antibiotics

Primary outcomes:
measure: eradication rate of Helicobacter pylori
timeFrame: the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT01612780: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Official title: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: Sinusitis
Sinus balloon dilation patients
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 82
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: The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

Detailed description: This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Eligibility criteria: Inclusion Criteria:

1. Be at least age 18 years old or older.
2. Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
3. Have a sinus CT scan within 12 months of the procedure date.
4. Be able and willing to provide consent.
5. Be willing to comply with the protocol requirements.

Exclusion Criteria:

1. Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
2. Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
3. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
4. Have presence of features consistent with sinus fungal disease.
5. Be allergic to nickel or barium sulfate.
6. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Primary outcomes:
measure: Change in SNOT-20 Score
timeFrame: Baseline and 1-year post procedure
Secondary outcomes:
measure: Revision Sinus Surgery
timeFrame: 1-year post procedure
measure: Number of Participants With Serious Device and/or Procedure-related Adverse Events
timeFrame: Through 1-year post procedure follow-up
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Entellus Medical
state: Minnesota
Study officials:
References:
citation: Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14.
Clinical trial NCT04418180: Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
Official title: Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Jaundice
Keywords: Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-05
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD

Brief summary: Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions.

Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for treatment of pathological jaundice in full term infants.

Design/Methods: We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate.


Eligibility criteria: Inclusion Criteria:

* we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines

Exclusion Criteria:

* Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were excluded

Primary outcomes:
measure: Total serum bilirubin
timeFrame: 24 hours of treatment
measure: Total serum bilirubin
timeFrame: 48 hours of treatment
measure: Total serum bilirubin
timeFrame: 72 hours of treatment
Secondary outcomes:
measure: length of hospital stay
timeFrame: expected 3 days of treatment
measure: duration of photo therapy
timeFrame: expected 48 hours of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Awad MH, Amer S, Hafez M, Nour I, Shabaan A. "Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.". J Perinatol. 2021 Apr;41(4):865-872. doi: 10.1038/s41372-020-00861-2. Epub 2020 Oct 17.
Clinical trial NCT04167280: Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma
Official title: Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: ipratropium bromide
methacholine PD20
tolerance
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.

Detailed description: This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.

Eligibility criteria: Inclusion Criteria:

* airway responsiveness to methacholine
* adequate baseline lung function
* no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks

Exclusion Criteria:

* pregnancy
* current smoker
* requirement for medications other than salbutamol that will interfere with airway response to methacholine

Primary outcomes:
measure: Methacholine PD20
timeFrame: Pre treatment
measure: Methacholine PD20
timeFrame: Day 7 after starting treatment
measure: Methacholine PD20
timeFrame: 24 hours after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Don Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01172080: Utility Analysis of an Endoscopy Follow-up System
Official title: Utility Analysis of an Endoscopy Follow-up System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Adherence
Keywords: colonoscopy
adherence
reminders
quality
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 830
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although systems are in place to ensure results of tests are communicated to patients, there is currently no generalized accepted strategy to ensure that patients undergo recommended follow-up testing. When follow-up tests are recommended months to years into the future, there is a high likelihood that the test will either be delayed or not performed resulting in the potential for poor outcomes and litigation. For this reason, there is a clear need for systems to be developed which automatically trigger patient communication when the date of a recommended follow-up test is approaching. The investigators propose to design a protocol for ensuring that patients are reminded to schedule follow-up tests and that this communication is documented in the online medical record. This work will provide the foundation for the creation of systems that significantly improve patient care, and can be easily adapted for use in many clinical departments and institutions.

Aim 1. To use patient focus groups to help design a system for improving adherence to endoscopy follow up recommendations

Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the system on a cohort of patients due for a surveillance colonoscopy.


Eligibility criteria: Inclusion Criteria:

* due for a repeat surveillance colonoscopy for follow up of polyps during the study time period

Exclusion Criteria:

* not due for a repeat surveillance colonoscopy for follow up of polyps during the study time period

Primary outcomes:
measure: percentage of individuals scheduling colonoscopy
timeFrame: within three months of due date
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: Leffler DA, Neeman N, Rabb JM, Shin JY, Landon BE, Pallav K, Falchuk ZM, Aronson MD. An alerting system improves adherence to follow-up recommendations from colonoscopy examinations. Gastroenterology. 2011 Apr;140(4):1166-1173.e1-3. doi: 10.1053/j.gastro.2011.01.003. Epub 2011 Jan 13.
Clinical trial NCT00307580: Cathflo Activase Pediatric Study
Official title: Cathflo Activase (Alteplase) Pediatric Study (CAPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysfunctional Central Venous Access Devices (CVADS)
Keywords: CVADS
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-28
Enrollment: 300
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at \~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.


Eligibility criteria: Inclusion Criteria:

Subjects had to meet the following inclusion criteria to be eligible for study entry:

* Less than 17 years of age
* Clinically stable
* Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
* For subjects who weighed \>= 10 kg, inability to withdraw 3 mL of blood from the CVAD
* For subjects who weighed \< 10 kg, inability to withdraw 1 mL of blood from the CVAD
* Ability to infuse fluids at the volume necessary to instill Cathflo Activase into the CVAD
* Written informed consent and assent (if appropriate) provided by parent or legal guardian and compliance with study assessments for the full duration of the study

Exclusion Criteria:

* Ability to withdraw blood following subject repositioning
* CVAD insertion \< 48 hours prior to enrollment
* Selected study catheter implanted specifically for hemodialysis
* Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
* Previous enrollment in this study
* Use of fibrinolytic agent (e.g., alteplase, reteplase, tenecteplase, urokinase, streptokinase) within 24 hours of enrollment
* At high risk for bleeding events, embolic complications (i.e., recent pulmonary embolism, deep vein thrombosis, endarterectomy, clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constituted a significant hazard
* Known hypersensitivity to alteplase or any component of the formulation

Primary outcomes:
measure: To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.
Secondary outcomes:
measure: To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Martha Blaney, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03588780: Stent Thrombosis After Tandem Lesions Thrombectomy
Official title: PREDICTEURS ET IMPACT CLINIQUE DE LA THROMBOSE DU STENT APRES LES THROMBECTOMIES CEREBRALES POUR LES OCCLUSIONS EN TANDEM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke With Large Vessel Occlusion
Keywords: acute stroke
thrombectomy
tandem lesions
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018

Brief summary: The aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis


Eligibility criteria: Inclusion Criteria:

* Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
* Association of extracranial internal carotid artery (ICA) occlusion or stenosis ≥70% using NASCET criteria and an intracranial arterial occlusion in the anterior circulation

Exclusion Criteria:

- Endovascular treatments for complication of surgical carotid endarterectomy

Primary outcomes:
measure: Stent thrombosis rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neuroradiologie Interventionnelle
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Rémy BEAUJEUX, MD, PhD
role: STUDY_DIRECTOR
References: