louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03631446: Drug Use-Results Survey on Picoprep® Combination Powder
Official title: Drug Use-Results Survey on Picoprep® Combination Powder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Cleansing
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 1298
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being prepared for colonoscopy and colorectal surgery

Brief summary: The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.


Eligibility criteria: Inclusion Criteria:

Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.

Primary outcomes:
measure: Bowel cleansing assessment for colonoscopy
timeFrame: 48 hours after drug administration
measure: Bowel cleansing assessment for colorectal surgery
timeFrame: 48 hours after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Shibuya
country: Japan
facility: Investigational Site (there may be other sites in this country)
state: Tokyo
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT04935346: Dysphagia Awareness In Medical and Nursing Students
Official title: Awareness of Dysphagia in Medical and Nursing Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Awareness
Students
Keywords: dysphagia
awareness
medical students
nursing students
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-23
Enrollment: 1203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study was conducted with students at medical and nursing faculties in Turkey

Brief summary: A survey consisting of questions about swallowing and dysphagia was provided to universities' medicine and nursing students. The answers of students were analyzed

Detailed description: The undergraduate training of health care professionals may provide the necessary theoretical and practical approach to future nurses and physicians. This study was planned to investigate students' dysphagia knowledge level and awareness in the medicine and nursing faculties. A survey consisting of questions about swallowing and dysphagia was provided to universities' medicine and nursing students. The answers of students were analyzed

Eligibility criteria: Inclusion Criteria:

* The fourth, fifth, and sixth-grade students in the faculty of medicine
* The second, third, and fourth-grade students in the nursing faculty

Exclusion Criteria:

* The first, second and third-grade students in the faculty of medicine
* The first grade students in the nursing faculty

Primary outcomes:
measure: A survey
timeFrame: Participants completed the survey at once. 20 minutes required to complete the survey
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Study officials:
affiliation: Istanbul physical Medicine and Rehabilitation Training and Research Hospital
name: Betül Yavuz Keleş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Sibel Eyigör, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04009746: Italian Registry of ERCP With Spyglass
Official title: Italian Registry of ERCP With Spyglass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Condition
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients will be recruited at the UO of Gastroenterology and digestive endoscopy of the participating centers

Brief summary: Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used for the diagnosis and treatment of diseases of the biliary tract, pancreas and papilla of Vater. The ERCP allows an indirect vision of the ductal and pancreatic system by means of the endoductal injection of contrast medium and the evaluation of these by X-rays. Recently, cholangioscopy has been developed using the Spy Glass system, introduced on the market in 2007. This allows a direct visualization of the bile duct and pancreatic pathway through the introduction of an optical probe inside the ductal system. SpyGlass was developed to overcome the limitations of traditional cholangioscopy and allow optically guided therapies for the treatment of stenoses and calculations. This is the first cholangioscopy system performed by a single disposable operator (SOC), with two dedicated irrigation channels, an optical channel and a therapeutic channel with a diameter of 1.2 mm. Everything is placed inside a 10 Fr Spy Scope ™ access and delivery catheter (3.3 mm), which allows the tip to flex in 4 directions to facilitate maneuverability and directionality in small ducts.

The irrigation channels of the SOC system allow a fluid flow rate of four to five times higher than that which can be obtained through the operating channel of conventional systems. In bench simulations with loaded Spy Bite ™ biopsy forceps, the SOC system presented a success rate in obtaining access to sites of double interest compared to that of a conventional 2-way limited bending choledocoscope.

Some studies have confirmed the adequacy of the Spy Glass system in providing adequate samples for histological diagnosis and successfully facilitating the treatment of stones.

The new single-use Spy Glass digital display system was introduced in 2014 and no multi-center experience on the use of this device is described to date.


Eligibility criteria: Inclusion Criteria:

* With an age above or equal to 18,
* From which informed consent has been obtained,
* Subjected to ERCP carried out by expert operators,
* Subject to ERCP with SpyGlass.

Patients who do not meet all of the listed inclusion criteria will be excluded from this study

Primary outcomes:
measure: Data collection of characteristics of ERCP with Spyglass
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT01574846: Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer
Official title: Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 142
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: • Male patients for whom hormone treatment for advanced prostate cancer is indicated

Brief summary: The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas® for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.


Eligibility criteria: Inclusion Criteria:

* Male patients for whom hormone treatment for advanced prostate cancer is indicated
* Age \> 18 years.
* Documented elevated PSA levels.

Exclusion Criteria:

Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))

Primary outcomes:
measure: Treatment duration follow-up for each patient.
timeFrame: 1 year
Secondary outcomes:
measure: Blood samples
timeFrame: 1 year
measure: Quality of Life measurements
timeFrame: 1 year
Other outcomes:
Locations:
city: Malmoe
country: Sweden
facility: Urology Dep. Skane Univeristy Hospital
Study officials:
affiliation: Urology Dep. Skane University Hospital, Malmoe, Sweden
name: Thomas Björk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853681: Study on the Response to Tetanus Vaccination of People Living With HIV
Official title: Study on the Response to Tetanus Vaccination of People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Centre Hospitalier de Niort
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The response to primary tetanus immunization of HIV-infected children is lower than that of uninfected children.

Response to tetanus toxoid (TT) booster doses in adults living with HIV who have received primary vaccination prior to infection is not known.

Currently, it is recommended to have a TT booster for people living with HIV (PLHIV) every 10 years. In general population, this recall is made only at 25, 45 and 65 years, then every 10 years.


Eligibility criteria: Inclusion Criteria:

* Person aged ≥ 18 years
* Person infected with HIV followed in the infectious diseases department of CH Niort
* Born in France
* Affiliate or beneficiary of a social security scheme
* Being able to give free and informed consent to participation in research

Exclusion Criteria:

* Persons with a contraindication to tetanus vaccination
* Persons under guardianship or curatorship or without civil law

Primary outcomes:
measure: the vaccine response to tetanus vaccination
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Niort
country: France
facility: Centre Hospitalier de Niort
Study officials:
affiliation: Centre Hospitalier de Niort - France
name: Simon SUNDER, Doctor
role: STUDY_DIRECTOR
affiliation: CH Niort
name: Simon SUNDER, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05794581: A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
Official title: A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Obesity
Overweight
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Female or male adults with Type 1 diabetes
* Ages 18-65 years
* Type 1 DM for at least 3 years
* Using an insulin pump or multiple daily injections (MDI) for at least 3 months
* BMI 25.0 - 35.0

Exclusion Criteria:

* Significant medical history
* Uncontrolled diabetes
* History of surgical treatment for weight loss
* History of malignancy

Primary outcomes:
measure: To assess area under the curve (AUC) in glucose metabolism during MMTT
timeFrame: Baseline up to 4 days
Secondary outcomes:
measure: To assess changes in continuous glucose monitoring (CGM) measures
timeFrame: Baseline up to 4 days
measure: Area under the acetaminophen concentration-time (AUC)
timeFrame: 0 - 300 minutes
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Carmot Clinical Research Unit 101
state: California
Study officials:
References:
Clinical trial NCT04891081: Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease
Official title: Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acyanotic Congenital Heart Disease
Cyanotic Congenital Heart Disease
Pheochromocytoma
Paraganglioma
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
name: University Rehabilitation Institute, Republic of Slovenia
First posted: 2021-05-18
Enrollment: 50
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: Adult patients with congenital heart disease attending regular follow ups.

Brief summary: The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.


Eligibility criteria: Inclusion Criteria:

* patients with congenital heart disease attending regular follow up

Exclusion Criteria:

* missing main data in medical documentation

Primary outcomes:
measure: Plasma metanephrine level
timeFrame: baseline, one point of time in a cross-sectional study
measure: Plasma normetanephrine level
timeFrame: baseline, one point of time in a cross-sectional study
Secondary outcomes:
measure: Hypoxemia
timeFrame: baseline, one point of time in a cross-sectional study
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
Study officials:
References:
Clinical trial NCT02413281: A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users
Official title: A Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteer
Abuse Liability
ALKS 5461
Alkermes
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 56
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: This study will evaluate the abuse potential of ALKS 5461.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg
* Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime
* Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal
* Be willing and able to abide by all study requirements and restrictions
* Additional criteria may apply

Exclusion Criteria:

* Have evidence of drug or alcohol dependence within the past 2 years
* Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic
* Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting
* Be currently pregnant, breastfeeding, or planning to become pregnant during the study
* Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone)
* Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Have donated or lost more than 500 mL whole blood
* Additional criteria may apply.

Primary outcomes:
measure: Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
timeFrame: Approximately 14 weeks
Secondary outcomes:
measure: Safety: Incidence of adverse events (AEs)
timeFrame: Up to 14 weeks
measure: Pharmacokinetics: Plasma concentrations of ALKS 5461
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References:
citation: Pathak S, Vince B, Kelsh D, Shram MJ, Setnik B, Lu H, Nangia N, Stanford AD, Ehrich E. Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial. J Clin Pharmacol. 2019 Feb;59(2):206-217. doi: 10.1002/jcph.1280. Epub 2018 Aug 13.
Clinical trial NCT02118181: Assessment of Physical Performance With A Supplementation Containing HMB in a Sample of Old Women in Good Health
Official title: Role of Oral Supplementation of Proteins and β-hydroxy-β-methyl Butyrate (HMB) in a Sample of Older Women in Good Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Muscle Loss
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a supplementation containing β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a group of older women compared to a non interventional group


Eligibility criteria: Inclusion Criteria:

* People over 65 years, not residents in nursing home, in good health
* Mini Mental State Examination (corrected for scholarity) more than 23

Exclusion Criteria:

* Previous oral supplementation with proteins or minerals
* important co-mordidities, such renal or hepatic failure

Primary outcomes:
measure: Change in Short Physical Performance Battery
timeFrame: Baseline and after 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padua
country: Italy
facility: University of Padova
Study officials:
affiliation: University of Padova
name: Giuseppe Sergi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berton L, Bano G, Carraro S, Veronese N, Pizzato S, Bolzetta F, De Rui M, Valmorbida E, De Ronch I, Perissinotto E, Coin A, Manzato E, Sergi G. Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial. PLoS One. 2015 Nov 3;10(11):e0141757. doi: 10.1371/journal.pone.0141757. eCollection 2015.
Clinical trial NCT01663181: Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
Official title: Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Overactive Bladder
Pelvic Organ Prolapse
Recurrent Urinary Tract Infections
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 109
Sex: FEMALE
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: women, aged \>= 18 years with pelvic floor dysfunction, undergoing diagnostic work-up at a tertiary referral center for urogynecologic conditions

Brief summary: At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health.

The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing.

According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05.

Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.


Eligibility criteria: Inclusion Criteria:

* women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.

Exclusion Criteria:

* age ≤ 18 years
* insufficient ability to understand German
* pregnancy
* participation in another clinical study at the same time

Primary outcomes:
measure: subjective pain perception immediately after examination as measured by a standard visual analog scale
timeFrame: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
Secondary outcomes:
measure: difference between anticipated pain and actual pain perception
timeFrame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna Austria
name: Wolfgang Umek, Prof
role: PRINCIPAL_INVESTIGATOR
References: