louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00836680: Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
Official title: Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Internal Rectal Prolapse
Pelvic Floor Ptosis
Internal Hernia Into the Douglas Pouch
Lead sponsor: Gerhard Pejcl Medizintechnik GmbH
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 15
Sex: FEMALE
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 determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

Detailed description: Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.

Eligibility criteria: Inclusion Criteria:

* female patients
* patients with ODS-Symptome-Score according Longo of \>7
* existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch
* patients who correspond to to the ASA 1 - ASA 2 criteria

Exclusion Criteria:

* male patients
* female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation
* female patients with diarrhea
* pregnant patients because of the x-ray examination
* female patients who get anticoagulants
* serious cardiopulmonary disorders
* disorders of the blood coagulation
* female patients who correspond to the ASA 3 to ASA 4 criteria

Primary outcomes:
measure: Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.
timeFrame: 4 months
Secondary outcomes:
measure: Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort.
timeFrame: 4 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: St. Elisabeth Hospital
Study officials:
name: Michaela Abrahamowicz, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03058380: Stated-Preferences in Knee Arthroplasty
Official title: Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Knee Osteoarthritis
Arthropathy of Knee
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Zimmer Biomet
First posted: 2017-02-20
Enrollment: 348
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Orthopaedic Clinics, Adult Reconstructive Surgery Clinics

Brief summary: The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.


Eligibility criteria: Inclusion Criteria:

* Age 40-80
* Knee Pain

Exclusion Criteria:

* Inability to read, understand and give effective English consent

Primary outcomes:
measure: Patient Preference Measurements
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard C Mather III
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059680: Effects of Implementing a High Potassium Diet in Heart Failure Patients
Official title: Safety and Physiologic Effects of Implementing a High Potassium Diet in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Potassium
Nutrition
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 30
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: This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.


Eligibility criteria: Inclusion Criteria:

* All patients classified as having HF, both systolic and diastolic.
* New York Heart Association class II-III symptoms.
* Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous month
* Intake at baseline of ≤ 3 servings of fruits and vegetables per day. Servings defined by Health Canada's food guide.

Exclusion Criteria:

* Patients with an episode of decompensated heart failure, acute coronary syndrome, or revascularization within the previous 3 months of study inclusion.
* Patients receiving insulin therapy
* Glomerular filtration rate \< 40mL/min/1.73 m2
* Pregnancy and lactation (women of childbearing potential will be included but will have to have a negative pregnancy test prior to inclusion).
* Inability to provide informed consent.

Primary outcomes:
measure: Serum potassium concentration
timeFrame: 10 days and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04494880: Marcaine Post-Operative Pain Study
Official title: Marcaine Post-Operative Pain Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Effect of Drug
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 22
Sex: ALL
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery. Patients who consent will be randomized to which breast receives a Marcaine injection and the other breast will have saline injected. Pain will be assessed one time post-operatively using a 1-10 pain scale.


Eligibility criteria: Inclusion Criteria:

* Must be receiving bilateral breast reduction surgery

Exclusion Criteria:

* Unilateral breast reduction surgery

Primary outcomes:
measure: Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Upstate University Hospital
state: New York
Study officials:
affiliation: SUNY Upstate Medical University - Syracuse, NY
name: Prashant Upadhyaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00728780: Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adverse Events
Pharmacokinetic Variables
Keywords: Adverse events
Pharmacokinetic variables
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Condition of good health

Exclusion Criteria:

* Currently enrolled in another study
* Females who are pregnant or breast feeding

Primary outcomes:
measure: Adverse events and safety laboratory assessments
timeFrame: 7 days
measure: Pharmacokinetic parameters
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Site Reference ID/Investigator# 11101
state: Indiana
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström
role: STUDY_DIRECTOR
References:
Clinical trial NCT03335280: 68Ga-citrate PET/MR Imaging for Glioma
Official title: 68Ga-citrate PET/MR Imaging for the Evaluation of Glioma in Adults
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Brain Tumor Association
First posted: 2017-11-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with WHO grade 3 or 4 glioma planning to undergo surgery with availability of immunohistochemistry of tissue

Brief summary: This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.


Eligibility criteria: Inclusion Criteria:

* World Health Organization (WHO) grade 3 or 4 glioma planning to undergo surgery
* Age \>= 18 yrs.
* Karnofsky performance status of \>= 60
* Ability to understand a written informed consent document, and the willingness to sign it.

Cohort A:

- Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy

Cohort B:

- Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy

Exclusion Criteria:

* Contraindications to Positron Emission Tomography (PET) imaging (e.g. pregnant or breast-feeding woman)
* Contraindications to magnetic resonance (MR) imaging (e.g. pacemakers, metallic implants, etc.)

Primary outcomes:
measure: Maximum standardized uptake value (SUVmax)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Susan Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04364880: Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
Official title: Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Treatment
Keywords: depression
transcranial magnetic stimulation
theta-burst stimulation
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-04-28
Enrollment: 80
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: This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.

Detailed description: This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.

Eligibility criteria: Inclusion Criteria:

* The diagnostic criteria of DSM-IV for MDD
* The range of the age from 18 to 70-year-old
* Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
* Competent for a full explanation of the study and written informed consent is obtained.

Exclusion Criteria:

* Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
* Pregnant
* History or family history of seizure disorder
* Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
* Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAMD)
timeFrame: From Weeks 0 to 24
Secondary outcomes:
measure: Response rate
timeFrame: From Weeks 0 to 24
measure: Remission rate
timeFrame: From Weeks 0 to 24
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Kuan-Pin Su, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605380: Learning Management of Open Fractures on Virtual Patient
Official title: Validating Virtual World Simulation to Assess Decision-making of Managing an Open Lower Limb Fracture: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Educational Problems
Simulation of Physical Illness
Fractures, Bone
Emergencies
Keywords: virtual reality
simulation
resuscitation
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postgraduate orthopaedic trainees and Attendings/Consultants

Brief summary: * A novel virtual world programme with over 240 multiple choice questions was developed to assess the competencies in managing an open fracture of the lower limb according to the British Orthopaedic Association Standards for Trauma (BOAST) and Advanced Trauma Life support (ATLS) guidelines.
* A longitudinal, observational, multi-centre prospective cohort study was conducted at Imperial College London.
* Primary objective consisted of objective scores calculated in real-time from the 240 multiple choice questions between Novices, Intermediates and Experts.
* Participants who had either completed ATLS training, or had familiarised themselves with BOAST guidelines were also identified and correlated with objective scores.

Detailed description: This is a multi-centre prospective randomised controlled educational trial observing for validity and training effect of managing an orthopaedic emergency using a virtual patient within an online world. Cohorts consist of junior, intermediate and expert surgeons being tested on 240 multiple choice questions to assess for competency as well as face, content and construct validity.

Eligibility criteria: Inclusion Criteria:

* Postgraduate orthopaedic trainees and naïve to surgical simulation

Exclusion Criteria:

* undergraduates and previous exposure to surgical simulation involving cognitive task analysis

Primary outcomes:
measure: Objective test score
timeFrame: Immediately after the intervention/procedure/surgery - objective test scores collected immediately after a single attempt
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Kapil Sugand, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05208580: Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
Official title: Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preoperative Anxiety
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Vilnius University Hospital Santaros Klinikos
First posted: 2022-01-26
Enrollment: 500
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: The aim of the study is to investigate the effect of preoperative patient education on the level of properative anxiety and postoperative psychosocial outcomes. Participants will be assigned to one of the 3 study groups: on-line education, contact education and control (no preoperative education). The investigators will evaluate preoperative anxiety level at different time points (baseline at 2 weeks before the surgery, at the evening before the surgery and postoperatively) and investigate dynamics of anxiety in the perioperative period. Additional qualitative interview by psychologists will be performed to evaluate the potential causes of increased/decreased preoperative anxiety.

Impact on postoperative complications, well-being of the participant, quality of recovery and satisfaction with medical care will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* agreement to participate in the study
* elective cholecystectomy or colon surgery

Exclusion Criteria:

* refusal to participate in the study
* do not speak Lithuanian
* do not pass the PHQ-2 depression screening test

Primary outcomes:
measure: Change in preoperative anxiety level the day before the surgery in study groups
timeFrame: The day before the surgery
measure: Change in preoperative anxiety and information level the day before the surgery in study groups
timeFrame: The day before the surgery
Secondary outcomes:
measure: Satisfaction with medical services
timeFrame: 48 hours after discharge from the hospital
measure: Postoperative recovery
timeFrame: 48 hours after discharge from the hospital
measure: Postoperative well-being of the patient
timeFrame: First 3 days of the postoperative period
measure: Postoperative pain levels
timeFrame: First 3 days of the postoperative period
measure: Postoperative delirium
timeFrame: First 3 days of the postoperative period
Other outcomes:
measure: Causes of preoperative anxiety
timeFrame: Up to second postoperative week
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
Study officials:
affiliation: Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania
name: Egle Kontrimaviciute, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412980: Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD
Official title: Importance of Ionized Magnesium Measurement for Monitoring of Continuous Venovenous Haemodialysis With Citrate Anticoagulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Keywords: Continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA)
Ionized hypomagnesemia
Monitoring of ionized magnesemia
Morbi-moratlity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Novamedica Laboratories
First posted: 2020-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ICU and requiring CRRT-RCA

Brief summary: It has been reported in several studies that ionized hypomagnesemia is associated with higher morbidity and mortality rates. During continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered by magnesium concentration in ordinary dialysis fluid. This may lead to ionized hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium monitoring could be of interest. This study aim to assess the incidence of ionized hypomagnesemia induced by CRRT-RCA.


Eligibility criteria: Inclusion criteria:

* Consecutive patients admitted to the ICU and requiring continuous renal replacement therapy with regional citrate anticoagulation
* age \> 18 ans

Exclusion criteria:

* Persons under protection
* Paritcipation rejections

Primary outcomes:
measure: assess the systemic ionized magnesemia change after 24h of CRRTsystemic variations of iMg
timeFrame: Day 0 and Day 1
Secondary outcomes:
measure: Proportion of patients with heart rhythm disturbances
timeFrame: 1 day
measure: Assessment of morbidity and mortality
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Romaric Larcher, MD PhD
role: STUDY_DIRECTOR
References: