louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01194986: Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration
Official title: An Open-label Positron Emission Tomography Study to Evaluate Use of Histamine H3 Receptor Radioligand [11C]AZ12807110 and to Determine Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Distribution of [11C]AZ12807110 and AZD5213
Keywords: Receptor binding
Histamine H3 receptor
binding
radioligand
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-03
Enrollment: 13
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate features of radioligand \[11C\]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel)
* Female must be of non-child bearing potential (pilot panel)
* BMI between 18 to 30 30 kg/m2
* Normal MRI scan
* Provision of signed, written and dated informed consent

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity
* Healthy volunteer suffers from claustrophobia

Primary outcomes:
measure: Distribution volume (VT)
timeFrame: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. Single PET measurement will take maximum 2 hours.
measure: Estimation of the plasma concentration resulting in 50% receptor occupancy (Ki, pl).
timeFrame: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose.
Secondary outcomes:
measure: Adverse events
timeFrame: Collected from Day 1 to follow-up
measure: Vital signs (body temperature, BP and pulse)
timeFrame: Measured at screening, study days -1 to day 3 and at follow-up
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Björn Paulsson, MD
role: STUDY_DIRECTOR
affiliation: Quintiles AB, Uppsala
name: Wolfgang Kühn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jucaite A, Takano A, Bostrom E, Jostell KG, Stenkrona P, Halldin C, Segerdahl M, Nyberg S. AZD5213: a novel histamine H3 receptor antagonist permitting high daytime and low nocturnal H3 receptor occupancy, a PET study in human subjects. Int J Neuropsychopharmacol. 2013 Jul;16(6):1231-9. doi: 10.1017/S1461145712001411. Epub 2012 Dec 10.
Clinical trial NCT03460886: Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
Official title: Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Keywords: transcranial direct current stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.


Eligibility criteria: Inclusion Criteria:

* Chronic stroke patients with 6 months after onset.
* Functional ambulation category ≥ 3

Exclusion Criteria:

* patients who needs assist in surface level walking
* patients with mini mental status exam score under 9
* patients with implantable electronic device
* metal device inside skull
* history of epilepsy
* pregnancy

Primary outcomes:
measure: Changes in motor evoked potential
timeFrame: before and after intervention (approximately 30 minutes)
Secondary outcomes:
measure: Changes in motricity index
timeFrame: before and after intervention (approximately 30 minutes)
measure: Changes in Fugl Meyer Assessment
timeFrame: before and after intervention (approximately 30 minutes)
measure: Changes in 10 meter walking test
timeFrame: before and after intervention (approximately 30 minutes)
measure: Timed up and go test
timeFrame: before and after intervention (approximately 30 minutes)
measure: Functional ambulatory category
timeFrame: before and after intervention (approximately 30 minutes)
measure: Modified ashworth scale
timeFrame: before and after intervention (approximately 30 minutes)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06220786: Low Level Laser Therapy for Better Wound Healing
Official title: Prospective Double Blind Controlled Trial of Low Level Laser Therapy - Cesarean Section or Vaginal Tear or Episiotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy
Lead sponsor: St. Elisabethen Krankenhaus Frankfurt GmbH
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy.

Doctors \& Patients do not kown which laser is the "true" laser or the "fake" laser
Primary purpose: TREATMENT

Brief summary: Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy.

Outcome: Pain score \& would healing at discharge, 1 months \& 3 months

Detailed description: After surgical suture application of low level laser therapy of ca. 72 Joules / cm2.

Evaluation at discharge, after 1 months \& 3 months.

Eligibility criteria: Inclusion Criteria:

* Caesarean section or perineal tear grade 1-4 or episiotomy
* competent in German language

Exclusion Criteria:

* no caesarean section or birth without perineal tear grad 1-4 / episiotomy
* No consent given

Primary outcomes:
measure: Pain score
timeFrame: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth
Secondary outcomes:
measure: subjective would healing
timeFrame: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Prof. Dr. Joscha Reinhard
state: Hessen
Study officials:
affiliation: St. Elisabethenkrankenhaus Frankfurt
name: Joscha Reinhard, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06570486: Contrast Between Traditional Regression Model and AI in Predicting Prolonged Stay Stay After Head and Neck Tumors
Official title: Contrast Between Traditional Regression Model and AI in Predicting Prolonged Stay Stay After Head and Neck Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Head and neck tumor postoperative patient transferred to icu

Brief summary: This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck tumors. First retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient ICU stay time is greater than 24 hours, the prediction model after the ICU duration of head and neck tumor surgery after more than 24 hours. At the same time, clean the data, train the AI with the data, and compare the effectiveness of both sides with the ROC. After the establishment of prediction model and AI training, the patients included in the cohort were evaluated by prediction model and AI immediately after being transferred to the ICU, predicting the possibility of transferring out of the ICU within 24 hours.


Eligibility criteria: Inclusion Criteria:

1. Patients after head and neck tumors;
2. older than 18 years.

Exclusion Criteria:

1. Patients transferred to ICU twice after head and neck tumors;
2. Patients with unplanned transfer to the ICU.

Primary outcomes:
measure: roll-out icu
timeFrame: From the date of ICU admission until the date of ICU discharge or death, whichever occurs first, assessed up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03597386: ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy
Official title: ConfirmMDx Assay is Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were selected due to increased risk of prostate cancer with prior elevated prostate specific antigen (PSA), mpMRI, prostatic lesions and negative MRI-ultrasound guided fusion biopsy due to the potential for prostate cancer that was not detected prior.

Brief summary: The purpose of this study is to see if the ConfirmMDx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated PSA and prostate lesion identified on mpMRI.


Eligibility criteria: Inclusion Criteria:

* Prior documented elevated PSA (\> 4.0 ng/ml)
* MRI lesion based on PIRADS scoring within the past 3 years
* Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed.
* May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy
* Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy
* Ability to give informed consent

Exclusion Criteria:

* Any metastatic cancer
* Any prostate cancer
* Active infection: urinary tract infection or prostate infection precluding prostate biopsy
* Anal stenosis or severe anal disease preventing prostate biopsy

Primary outcomes:
measure: Detection of prostate cancer based on rebiopsy of lesions on multiparametric MRI (mpMRI) following a negative MR/US fusion biopsy with concurrent systematic biopsy with correlation of ConfirmMDx assay testing performed on negative MR/US fusion biopsy
timeFrame: baseline
Secondary outcomes:
measure: Correlation of PIRADS scores with ConfirmMDx testing outcomes
timeFrame: baseline
measure: Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes
timeFrame: baseline
measure: Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy
timeFrame: baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05107986: Laparoscopy in Complicated Groin Hernia
Official title: Outcomes of Laparoscopic Repair in Complicated Groin Hernia: a Single Institutional Based Cohort Study in Nepal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: Complicated groin hernia
Totally extra-peritoneal repair
Transabdominal preperitoneal repair
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 22
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 with diagnosis of complicated groin hernia

Brief summary: This study assessed the outcomes of laparoscopic repair in complicated groin hernia. Laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. This study provides an insight to the outcomes from the procedure in low resource setting of Nepal.


Eligibility criteria: Inclusion Criteria:

* Patients with age greater than 18 years with diagnosis of complicated groin hernia

Exclusion Criteria:

* Patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia

Primary outcomes:
measure: intraoperative complications
timeFrame: during surgical procedure
measure: Postoperative complications
timeFrame: upto 6 months post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: BP Koirala Institute of Health Sciences
state: Province 1
Study officials:
References:
Clinical trial NCT01122186: Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)
Official title: Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Medication Adherence
Methamphetamine Use
Sexual Risk
Poly-substance Use
HIV Infections
Keywords: Medication Adherence
Methamphetamine Use
Sexual Risk
Poly-substance Use
HIV
Treatment
Motivational Interviewing
Cognitive Behavioral Skills Training
Men Who Have Sex With Men
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 210
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim is to test an innovative 8-session intervention, based on Motivational Interviewing and Cognitive Behavioral Skills-Training for the co-occurrence of methamphetamine use and highly active antiretroviral therapy (HAART) non-adherence among methamphetamine using HIV+ MSM in NYC, compared to an 8-session educational (ED) condition. Participants in the intervention condition will report greater reductions in the number of days of methamphetamine use and viral load, and greater increases in CD4 counts and self-reported and objectively measured adherence than those in the education condition.


Eligibility criteria: Inclusion Criteria:

* HIV+ (confirmed at baseline through documentation)
* Biologically male
* report sex with another man at least once
* report methamphetamine use at least three times in the past three months
* report less than 90% HAART medication adherence, as measured by the total number of days a participant missed an HIV medication in the last 30
* able to communicate with staff and complete a survey that is in English.

Exclusion Criteria:

* Unstable, serious psychiatric symptoms
* Currently suicidal/homicidal
* Evidence of gross cognitive impairment
* Self-reported current enrollment in a drug or HIV-related intervention or research study.
* Methadone use

Primary outcomes:
measure: Adherence to HIV medication
timeFrame: every three months over the course of a year
measure: Methamphetamine use.
timeFrame: every three months over the course of a year
Secondary outcomes:
measure: Sexual Risk
timeFrame: every three months over the course of a year
measure: Polysubstance use
timeFrame: every three months over the course of a year
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
state: New York
Study officials:
References:
Clinical trial NCT00230386: Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma
Official title: The Role of MRI Perfusion to Detect Locally Recurrent or Persistent Disease in Prostate Carcinoma Treated With Radiation Therapy - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-30
Enrollment: 50
Sex: MALE
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: This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.


Eligibility criteria: Inclusion Criteria:

* Previously have had radical radiotherapy for localised prostate cancer
* Due to undergo routine post-treatment prostatic biopsies
* Suitable for MRI scan
* Adequate renal function
* No previous reaction to gadolinium
* Able to give informed consent
* No recent prostate biopsy within 6 weeks of enrolment
* Performance status (Eastern Cooperative Oncology Group \[ECOG\]) 0 or 1

Exclusion Criteria:

* Not suitable for MRI scan
* Previous reaction to gadolinium
* Impaired renal function
* Inability to give informed consent

Primary outcomes:
measure: To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05010486: Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions
Official title: Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Rectal Surgery
Patient Satisfaction
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients between 18 and 65 years who will have a rectal surgery at the Centre Hospitalier Universitaire de Sherbrooke

Brief summary: Sexual dysfunction after rectal surgery varies widely in the literature. Prevalence of sexual dysfunction before surgery and desire of patient to treat this condition is also not well established.

Objectives of this prospective cohort study were to determine prevalence of sexual dysfunction with a questionnaire before and after surgery. Patient's satisfaction and quality of life were also collected regarding preoperative information given.


Eligibility criteria: Inclusion Criteria:

* Male between 18 and 65 years old
* Will undergo one of the following surgeries in the 12 months after the initial visit:

  * Low anterior resection
  * Abdominoperineal resection with end colostomy
  * Total proctocolectomy with ileostomy
  * Total proctocolectomy with ileoanal reservoir
  * Proctectomy
* Having had a sexual intercourse in the 4 weeks prior to the initial visit
* Having the desire to maintain sexual activities in the post-operative period

Exclusion Criteria:

* Tadalafil allergy/hypersensitivity
* Having received treatment for erectile dysfunction or medical treatment in the 4 weeks prior to the initial visit
* Active consumption of nitrate derivatives (NO)
* History of non-arteritic ischemic optic neuropathy
* Severe renal or hepatic insufficiency
* Stroke in the last 6 months
* Myocardial infarction in the last 3 months
* Unstable angina pectoris or angina pectoris during sexual relations
* Cardiac insufficiency Class ≥ 2 in the last 6 months
* Uncontrolled arrhythmia, hypotension or hypertension

Primary outcomes:
measure: Prevalence of sexual dysfunction after rectal surgery
timeFrame: 3 years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 years
measure: Sexual dysfunction and quality of life
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Nathalie McFadden, M.D
role: PRINCIPAL_INVESTIGATOR
References: