louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06180460: CALM: Managing Distress in Malignant Brain Cancer
Official title: Managing Distress in Malignant Brain Cancer - Phase IIc RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Tumor
Brain Metastases
Brain Cancer
Metastatic Lung Cancer
Metastatic Breast Cancer
Metastatic Melanoma
Metastatic Colon Cancer
Metastatic Kidney Cancer
Keywords: Service Members
Veterans
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.


Eligibility criteria: Inclusion Criteria:

* Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)\*
* At least 2-weeks post-surgical resection or biopsy of the brain (if applicable)
* Score \> 20 on the TICS
* Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
* Ability to read, speak, and understand English
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Major communication difficulties which would prohibit the psychotherapeutic interaction
* Inability to meet with the interventionist via an electronic device for telehealth intervention sessions
* Inability to understand and provide informed consent
* Prisoners
* Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.

Primary outcomes:
measure: Assess the feasibility of the CALM intervention- Screening Rate
timeFrame: Day 0
measure: Assess the feasibility of the CALM intervention- Consent Rate
timeFrame: Day 0
measure: Assess the feasibility of the CALM intervention- Intervention Retention Rate
timeFrame: 3 months
measure: Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
timeFrame: 3 months
measure: Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
timeFrame: 6 months
measure: Assess the acceptability of the CALM intervention- Participant Satisfaction
timeFrame: 4 months
measure: Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee Loughan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02358460: Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns
Official title: Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: neonatal
respiratory
mechanical ventilation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

Detailed description: Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.

Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated
* Born at gestation 34 weeks and above

Exclusion Criteria:

* Congenital diaphragmatic hernia
* Congenital heart disease

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Neonatal Intensive Care Unit
Study officials:
affiliation: King's College Hospital NHS Trust
name: Anne Greenough, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267760: Clinical and Biochemical Effects of Multipass Hemodialysis
Official title: Clinical and Biochemical Effects of Multipass Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uremia
Keywords: dialysis
hemodialysis
Effect of recycled low-volume dialysate on dialysis efficacy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Flexdialysis ApS
First posted: 2010-12-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

Detailed description: Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate per dialysis. In vitro investigations show that this results in adequate dialysis.

12 HD patients will be studied during two dialysis sessions. The first HD will be a conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be recorded.

Eligibility criteria: Inclusion Criteria:

* Stable chronic HD patients
* Informed consent

Exclusion Criteria:

* Age \<18 years
* Psychiatric disease

Primary outcomes:
measure: Urea Kt/V
timeFrame: 9 hours
Secondary outcomes:
measure: Creatinine clearance
timeFrame: 9 hours
measure: Patient symptoms
timeFrame: 9 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: James G Heaf, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heaf JG, Axelsen M, Pedersen RS. Multipass haemodialysis: a novel dialysis modality. Nephrol Dial Transplant. 2013 May;28(5):1255-64. doi: 10.1093/ndt/gfs484. Epub 2012 Nov 7.
citation: Eloot S, Van Biesen W, Axelsen M, Glorieux G, Pedersen RS, Heaf JG. Protein-bound solute removal during extended multipass versus standard hemodialysis. BMC Nephrol. 2015 Apr 18;16:57. doi: 10.1186/s12882-015-0056-y.
Clinical trial NCT05206760: Severe Head Injury Brain Analysis
Official title: Severe Head Injury Brain Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury Traumatic Severe
Keywords: Traumatic Brain Injury
Brain injury classification
Histology
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 25
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 who have suffered severe traumatic brain injury and require craniotomy or ICP bolt insertion.

Brief summary: Safety and feasibility study investigating brain biopsy in severe head injury. When a patient undergoes craniotomy or ICP bolt insertion for trauma, a biopsy of brain tissue is taken.

Blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy.

CSF is collected if a CSF drainage device is used.

Detailed description: A minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.

Eligibility criteria: Inclusion Criteria: Severe traumatic brain injury -

Exclusion Criteria: Coagulopathy

-

Primary outcomes:
measure: Feasibility of brain biopsy
timeFrame: immediately after the intervention/procedure/surgery
measure: Safety of brain biopsy
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Classification of TBI
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Queen Mary University of London
name: Chris E Uff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05748860: PRecision Ecmo in CardIogenic Shock Evaluation
Official title: PRecision Ecmo in CardIogenic Shock Evaluation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiogenic Shock
Keywords: ECMO
cardiogenic shock
ECPR
critical illness
intensive care
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL: HREC Project 534/18).

Brief summary: Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.

The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.


Eligibility criteria: Inclusion Criteria:

* Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)
* 18 years old or older
* Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18)

Exclusion Criteria:

* Patients who are already on ECMO, or where
* There are inadequate resources to complete the study

Primary outcomes:
measure: Disability-free survival at day 180
timeFrame: Day 180
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Australian and New Zealand Intensive Care Research Centre
name: Aidan JC Burrell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778660: Standard Versus Mnemonic Counseling for Fecal Incontinence
Official title: Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Counselling
Patient Satisfaction
Keywords: Fecal Incontinence
Treatment options
Patient Satisfaction
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares standard versus mnemonic counseling for the treatment of fecal incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women randomised to mnemonic counseling will higher recall of treatments, satisfaction with the physician visit and greater improvement in their quality of life when compared to women who received standard counseling.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Diagnosed with fecal incontinence by on of the attending physicians
* Bothersome fecal incontinence symptoms for at least 3 months
* Able to give informed consent
* Able to speak, read and comprehend English

Exclusion Criteria:

* Younger than 18 years
* Fecal Incontinence \<3 months
* Unable to give informed consent
* Unable to speak, read and comprehend English
* Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse

Primary outcomes:
measure: Recall
timeFrame: We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling
Secondary outcomes:
measure: Questionare on the Quality of the Physician and Patient Interaction
timeFrame: Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.
measure: Modified Manchester
timeFrame: We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Sara Cichowski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cichowski SB, Dunivan GC, Rogers RG, Murrietta AM, Komesu YM. Standard compared with mnemonic counseling for fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1063-1070. doi: 10.1097/AOG.0000000000000755.
Clinical trial NCT04792060: Management of Distal Ulna Fractures Using Hook Plate
Official title: Prospective Study of the Management of Distal Ulna Fractures Using Hook Plate in Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Ulna Fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures.

Detailed description: The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion

Eligibility criteria: Inclusion Criteria:

* Skeletally mature distal ulna fracture with or without radius fracture.

Exclusion Criteria:

* Pathological fracture Skeletally immaturity Neurovascular problems

Primary outcomes:
measure: Management of Distal Ulna Fractures Using Hook Plate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: salah roshdy ahmed, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04168060: Crural Dissection in Sleeve Gastrectomy
Official title: The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleeve Gastrectomy
Keywords: sleeve gastrectomy
crura dissection
bariatric surgery
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.


Eligibility criteria: Inclusion criteria:

1. All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
2. Age between 18-69 years
3. Able to provide consent

Exclusion criteria:

1. History of anti-reflux procedure
2. History of foregut surgery
3. Narcotic dependence
4. History of gastroparesis
5. Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study

Primary outcomes:
measure: Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire
timeFrame: Day 1, 12 months
measure: Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire
timeFrame: Day 1, 12 months
measure: Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q)
timeFrame: Baseline, 12 months
measure: Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ)
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Correlation of the presence of hiatal hernias
timeFrame: Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Medical Campus
state: Florida
Study officials:
affiliation: University of Miami
name: Nestor De La Cruz-Munoz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00265460: Smoking Cessation in Groups and With Tobacco Pastils
Official title: Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: smoking cessation,
nicotine,
smokeless tobacco,
cigarettes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2005-12-14
Enrollment: 240
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.

Detailed description: The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.

Eligibility criteria: Inclusion Criteria:

* smoking \> 13 cigarettes/day
* healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
* motivated for cessation
* motivated to use tobacco pastils
* motivated for group support

Exclusion Criteria:

* severe diseases
* psychiatric diseases
* using antipsychotic drugs
* used NRT/bupropion in the last 3 months
* consuming \> 6 drinks/day
* pregnant/lactating
* stopped smoking more than 2 days during last 3 months

Primary outcomes:
measure: Continuous Smoking cessation quit rate after 6 and 12 months
Secondary outcomes:
measure: Side effects from tested tobacco product
measure: Intake of nicotine and thiocyanate
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. pulmonary medicine Y, Gentofte University Hospital
state: Hellerup
Study officials:
affiliation: Chair dept. pulm. medicine, Gentofte Hospital
name: Philip Tønnesen, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Tonnesen P, Mikkelsen K, Bremann L. Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial. Nicotine Tob Res. 2008 Aug;10(8):1365-72. doi: 10.1080/14622200802238969.