louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05744115: Ga-68-PSMA-11 in Men With Prostate Cancer
Official title: Utility of Ga-68-PSMA-11 in Management of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: PSMA
Biochemically Recurrent Prostate Cancer
Lead sponsor: Harry S. Truman Memorial Veterans' Hospital
Sponsor class: FED
Collaborators: name: Harry S. Truman Memorial Veterans' Hospital
name: University of Missouri-Columbia
name: Telix Pharmaceuticals, Ltd
First posted: 2023-02-24
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible and consenting participants (male veterans) will receive a single administration of 3-7mCi Ga-68-PSMA-11 per enrollment in addition to conventional imaging (MRI, CT, and/or molecular imaging bone scan).
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.

Detailed description: Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)

Eligibility criteria: Inclusion Criteria:

* Able to tolerate PET/CT imaging and one or more of the following:
* Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR
* Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies

Exclusion Criteria:

* Claustrophobia or any other condition that would preclude PET/CT imaging.
* Any constellation of medical conditions that indicate expectancy of less than one year

Primary outcomes:
measure: Concurrence with Conventional Imaging
timeFrame: Up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Truman VA Hospital
state: Missouri
Study officials:
affiliation: Truman VA Hospital; Columbia, MO
name: Timothy J Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06624215: Retrospective Acute Care Appendectomy Study
Official title: A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Appendicitis
Keywords: Appendectomy
Robotic-assisted
Acute care
Laparoscopic
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 500 patients who have undergone laparoscopic emergent or urgent appendectomies and approximately 500 patients who have undergone robotic-assisted emergent or urgent appendectomies for acute appendicitis in a reverse chronological order from 30 days prior to IRB approval going back to 2018, will be included in this study.

Brief summary: The purpose of this retrospective study is to compare perioperative data for subjects who have undergone an emergent or urgent robotic-assisted or laparoscopic appendectomy for acute appendicitis.


Eligibility criteria: Inclusion Criteria:

* Subject is 22 years of age or older at time of procedure
* Subject has undergone robotic-assisted or laparoscopic emergent or urgent appendectomy for acute appendicitis between 2018 and 30 days prior to IRB approval

Exclusion Criteria:

* Subject with appendiceal neoplasms
* Subject who underwent a single-port appendectomy
* Subject who was pregnant or breastfeeding at the time of the procedure

Primary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Procedure time
timeFrame: Intraoperative
measure: Conversion
timeFrame: Intraoperative
measure: Adverse events
timeFrame: Intraoperative and postoperative out to 30 days from procedure date
measure: Mortality rate through 30 days
timeFrame: Intraoperative and postoperative out to 30 days from procedure date
measure: Unplanned procedure-related readmission rate through 30 days
timeFrame: Discharge through 30 days
measure: Concomitant procedures
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Severity of appendicitis
timeFrame: Preoperative
measure: Unplanned procedure-related reoperation rate through 30 days
timeFrame: Postoperative through 30 days
measure: Length of stay
timeFrame: Start of procedure to discharge from the hospital (check-out time), up to approximately one week
measure: Discharge disposition
timeFrame: Discharge from the hospital (check-out time), up to approximately one week.
measure: Blood Transfusion
timeFrame: Intraoperative and discharge from the hospital (check-out time), up to approximately one week.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Legacy Emanuel Hospital & Health Center
state: Oregon
city: New Braunfels
country: United States
facility: Christus Santa Rosa Health Care Corporation
state: Texas
Study officials:
References:
Clinical trial NCT03734315: Routine Application of Ostenil® in Patients with Gonarthrosis
Official title: Routine Application of Ostenil® in Patients with Gonarthrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonarthrosis
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.

Brief summary: PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 years of age and in good general health condition
* Signed informed consent
* Existing Ostenil® recommendation for the treatment of gonarthrosis

Exclusion Criteria:

* Known hypersensitivity to one of the Ostenil® components
* Presence of articular effusion in study-relevant knee joint
* Known pregnancy or lactating females
* Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
* Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)

Primary outcomes:
measure: Change of Pain Intensity compared to Baseline (VAS-slider)
timeFrame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
measure: Change of Range of Motion compared to Baseline (Goniometer measurement)
timeFrame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168
measure: Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline
timeFrame: Day 84, Day 168
measure: Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)
timeFrame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to Day 252
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Orthopädisches Versorgungszentrum München-Ost
state: Bavaria
city: München
country: Germany
facility: Orthopädie München
state: Bavaria
city: München
country: Germany
facility: Orthopädie am Altheimer Eck
state: Bayern
city: München
country: Germany
facility: Orthopädische Praxis am Isartor
state: Bayern
city: München
country: Germany
facility: MVZ am Nordbad
state: Bayern
city: München
country: Germany
facility: Orthopädische Praxis
state: Bayern
Study officials:
affiliation: MVZ am Nordbad
name: Michael Krüger-Franke, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01285115: The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form
Official title: Phase 3 The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form : A Randomized, Double Blind, Parallel-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Generalized anxiety disorder
Jingji-zhengchong
Gamisoyosan
anxiety
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2011-01-27
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 20-65
* (Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰ) subjects who meet Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰof generalized anxiety disorder

Exclusion Criteria:

* Currrent or past history of delusions, halucination
* Past history of at least one manic episode, hypomanic episode, or mixed episode
* Current or past history of alcohol abuse or alcohol dependence history
* Taking substances(e.g. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, L-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms
* Medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, Addison disease, Cushing disease, rheumarthritis, cancer, CVA, epilepsy, anemia, pituitarium disease, Vit B12 deficiency disease, PMS) that might affect symptoms
* Current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* Pregnancy, lactation, women not using medically accepted means of birth control
* Considered not apt to carry out clinical trial

Primary outcomes:
measure: Hamilton Anxiety Scale(HAM-A)
timeFrame: 8 weeks
Secondary outcomes:
measure: State-Trait Anxiety Inventory(STAI)
timeFrame: 8 weeks
measure: Beck Depression Inventory(BDI)
timeFrame: 8 weeks
measure: Symptom Checklist-90-Revised(SCL-90R)
timeFrame: 8 weeks
measure: WHO Quality of Life Abbreviated(WHOQOL-BREF)
timeFrame: 8 weeks
measure: Heart Rate Variability(HRV)
timeFrame: 8 weeks
measure: PSWQ
timeFrame: 8 weeks
measure: GSES
timeFrame: 8 weeks
measure: RSE
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Daejon
country: Korea, Republic of
facility: Oriental Hospital of Daejon University
state: Choong-Chung-Do
Study officials:
affiliation: Oriental Hospital of Daejon University
name: In-Chul Jung, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04410315: Hyperlactatemia During and After Tumorcraniotomy
Official title: Elevated Serum-lactate in Patients With Brain Tumor During and After Elective Craniotomy: an Observational Clinical Study of Postoperative Patient Outcome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlactatemia
Brain Tumor
Surgery
Anesthesia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing tumorcraniotomy

Brief summary: This study aims to investigate the association between hyperlactatemia and neurological disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. The risk factors that induce lactat accumulation will also be explored.

Detailed description: Hyperlactatemia is a frequent occurrence in brain tumor surgery. The existing studies, however, are all retrospective, reporting varying effects on clinical outcome. One study reported new neurological deficitis, some found an association with extended hospital stay, while others found no association with outcome. It is therefore important to conduct a prospective study of hyperlactatemia in this patientgroup.

Participants in this study will follow the standard treatment protocol for tumorcraniotomy, aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of neurological disability.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Must undergo elective tumor craniotomy
* Understand oral and written Danish

Exclusion Criteria:

* Adults with incapacity
* Stereotactic biopsy
* Lack of informed and signed consent to participate in study

Primary outcomes:
measure: Neurological disability
timeFrame: Change from baseline mRS at 30 days after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 year
measure: Mortality
timeFrame: After 30 days, 6 months and 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroanesthesiology, Rigshospitalet
Study officials:
References:
Clinical trial NCT05315115: Effects of Intensive Chiropractic Care to Usual Care for Adults With Spinal Cord Injuries.
Official title: To Investigate the Effects of Four Weeks of Intensive Chiropractic Care When Added to Usual Care for Adults With Spinal Cord Injuries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 29
Sex: ALL
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: Research
Primary purpose: TREATMENT

Brief summary: To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in Spinal Cord Injuries in adults.


Eligibility criteria: Inclusion Criteria:

* Adults with both genders (Male and Female).
* Age above 20 years.
* Spinal Cord Injuries adults.

Exclusion criteria

* Spinal Cord Injury due to Traumatic Brain Injury.
* Patients having cognitive impairments.
* Patients having associated Neurological Pathologies.
* Patients who are unable to follow the treatment plan.

Primary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: Baseline
measure: Functional Independence Measure (FIM)
timeFrame: 4 weeks
measure: ASIA scale
timeFrame: Baseline
measure: ASIA scale
timeFrame: 4 weeks
measure: Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)
timeFrame: Baseline
measure: Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)
timeFrame: 4 weeks
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Baseline
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National Institute of rehabilitation medicine.
state: Federal
Study officials:
affiliation: Riphah International University
name: IMRAN AMJAD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04102215: The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
Official title: The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensorineural Hearing Loss
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SIngle arm study
Primary purpose: TREATMENT

Brief summary: To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.


Eligibility criteria: Inclusion Criteria:

Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Distance of the planned trajectory to the facial nerve is \< 0.4mm
* Distance of the planned trajectory to the chorda tympani is \< 0.3mm
* Vulnerability
* Invalid or withdrawn informed consent

Primary outcomes:
measure: The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
timeFrame: Image data aquired during the procedure
Secondary outcomes:
measure: Electrode array insertion depth (Efficacy)
timeFrame: The procedure (day 0)
measure: Number of correctlly inserted electrode contact (Efficacy)
timeFrame: The procedure (day 0)
measure: Insertion depth prediction accuracy (Efficacy)
timeFrame: The procedure (day 0)
measure: Absolute angular accuracy of the drilled tunnel access
timeFrame: The procedure (day 0)
measure: Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)
timeFrame: The procedure (day 0)
measure: Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety)
timeFrame: The procedure (day 0)
measure: Evaluation of the automatic landmark detection (Performance)
timeFrame: The procedure (day 0)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
References:
citation: Topsakal V, Heuninck E, Matulic M, Tekin AM, Mertens G, Van Rompaey V, Galeazzi P, Zoka-Assadi M, van de Heyning P. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation. Front Neurol. 2022 Mar 21;13:804507. doi: 10.3389/fneur.2022.804507. eCollection 2022.
Clinical trial NCT03904615: Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation
Official title: A Phase I Randomized Clinical Trial of In-hospital and Post-hospital Whey Protein vs. Low Quality Protein vs. Isocaloric Placebo Supplementation to Improve Recovery From Hospitalization in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2019-04-05
Enrollment: 116
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized double blind phase 1 trial of 3 interventions
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine the feasibility of nutritional interventions designed to help older patients maintain physical function after being in the hospital. We will test the feasibility and effect of nutritional interventions with whey protein, collagen or placebo on functional recovery from hospitalization in community dwelling older adults.

Detailed description: We will compare in a randomized parallel design double blind pilot phase I study the feasibility of whey protein vs. collagen vs. isocaloric placebo supplementation in older adults during an acute hospitalization for a medical condition, and the treatments' effect size on physical function after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older.
* Admitted to UTMB hospital for any acute medical condition
* English speaking

Exclusion Criteria:

* Inability to consent
* Bed or wheelchair bound prior to hospitalization
* Estimated creatinine clearance 20 ml/min or less, or end stage renal disease not on dialysis
* AST/ALT 2.5 times above the normal limit
* Active cancer
* Palliative care/Hospice
* Estimated protein intake \>1.2 g/kg/day during the previous 24 hours
* Any other condition or event considered exclusionary by the PI and faculty physician

Primary outcomes:
measure: Physical Function
timeFrame: Change from baseline to 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB Acute Care for Elders Unit
state: Texas
city: Galveston
country: United States
facility: Jennie Sealy Hospital
state: Texas
Study officials:
affiliation: UTMB
name: Elena Volpi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06255015: Breastfeeding Planning Card Trial in Scotland
Official title: Breastfeeding Planning Card Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Lead sponsor: University of Stirling
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2024-02-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A regression discontinuity design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the efficacy of a "breastfeeding toolkit" card delivered as part of antenatal care in promoting breastfeeding maintenance.

Detailed description: The project is an evaluation of an intervention that will start on January 1 2024.

From January 1 2024 through to March 31st 2024 midwives will present to patients attending their 24 week antenatal appointment a breastfeeding toolkit card.

The trial compares breastfeeding rates across patients who receive the card and those whose 24-week antenatal appointment occurred in the three months October 1 2023 - December 31 2023.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in NHS Grampian

Exclusion Criteria:

None

Primary outcomes:
measure: breastfeeding rates at 6-8 weeks post-partum
timeFrame: 6-8 weeks
Secondary outcomes:
measure: breastfeeding rates at 10-14 days post-partum
timeFrame: 10-14 days
Other outcomes:
Locations:
city: Stirling
country: United Kingdom
facility: University of Stirling
state: Stirlingshire
Study officials:
affiliation: Stirling University
name: David Comerford
role: PRINCIPAL_INVESTIGATOR
References: