louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02417844: Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Official title: Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Two tamsulosin HClformulations will be tested in fed state


Eligibility criteria: Inclusion criteria:

Health male volunteers 18 years and older

Exclusion criteria:

History of hypersensitivity or allergy to IMP or its excipients or any related medication

Primary outcomes:
measure: Maximum Measured Concentration (Cmax)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
measure: Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
measure: Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Secondary outcomes:
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
measure: Terminal Elimination Rate Constant (λz)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
measure: Apparent Terminal Elimination Half-life (t1/2)
timeFrame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03011944: Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients
Official title: Assessing the Impact of a Comprehensive Nutrition-Focused Quality Improvement Program (QIP) on Health and Economic Outcomes of Malnourished Adult Patients Across the Continuum of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2017-01-06
Enrollment: 1546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malnourished patients receiving care in the targeted branch of the home health division of the health care system.

Brief summary: A nutrition-focused QIP will be implemented as standard of care at select branches of the home health division of the health care system. The QIP will be comprised of three groups of patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being discharged to home health. Groups will be followed for 90 days post enrollment. The QIP groups will be compared to historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.


Eligibility criteria: Inclusion Criteria:

* Admitted to home health from within the healthcare system's hospitals, skilled nursing facility (SNF) or outpatient clinics
* Patient is screened positive for malnutrition during hospital stay and/or by home health nutrition screening tool upon enrollment into home health
* Patient is able to consume foods and beverages orally and the physician has not indicated otherwise

Exclusion Criteria:

* Enrollment to home health from a hospital, SNF or outpatient clinic not affiliated with the healthcare system
* Patient is pregnant
* Patient is intubated, receiving tube feeding or parenteral nutrition
* Patient has severe dementia or delirium
* History of significant psychiatric disorder
* Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures as per the admitting clinicians
* Subject has stated an allergy or intolerance to any of the ONS ingredients
* Patients receiving hospice care

Primary outcomes:
measure: Hospital readmissions or admissions
timeFrame: Enrollment to Home Health to 90 Days
Secondary outcomes:
measure: Healthcare resource utilization and costs
timeFrame: Enrollment to Home Health to 90 Days
Other outcomes:
Locations:
city: Des Plaines
country: United States
facility: Advocate at Home
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate at Home- South Office
state: Illinois
Study officials:
affiliation: Abbott Nutrition
name: Suela Sulo, PhD, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT04622644: Clinical Investigation to Evaluate the Suitability of StrokeWave in Distinguishing Haemorragic From Ischaemic Strokes
Official title: A Pilot Study Using a Microwave Device for Stroke Detection (StrokeWave) to Discriminate Between Haemorragic and Ischaemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Lead sponsor: Umbria Bioengineering Technologies
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (\<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.

Detailed description: The number of participants will be 60. Patients with hyperacute stroke (within 4 hours from the onset) or with awake or unknow time of onset strokes will be enrolled in the study. All patients will be registered at emergency room of Hospital, and according to the internal procedure will be clinically evaluated by the Neurologist of the stroke team. NIHSS and mRS will be administered and scores registered. The scanning with StrokeWave will be performed in 5 minutes, after NCCT and before the CTA acquisition, in the CT room. StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. After the StrokeWave scanning, the system will be removed. The data collected will be processed through an imaging algorithm which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.

Eligibility criteria: Inclusion Criteria:

* Adult \> 18 years old
* Patients with hyperacute stroke, i.e. which are referred to the emergency room with a 'stroke code'

Exclusion Criteria:

* mRS \>3 before the stroke onset
* Life expectancy \<3 months
* GCS=3

Primary outcomes:
measure: To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT
timeFrame: During the baseline
Secondary outcomes:
measure: StrokeWave sensitivity in the ischaemic stroke
timeFrame: During the baseline
measure: StrokeWave sensitivity in the haemorragic stroke
timeFrame: During the baseline
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Ospedale Nuovo Santa Chiara
Study officials:
References:
Clinical trial NCT06376344: The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy.
Official title: The Effect of Myofascial Release Using a Tennis Ball on Balance and Quality of Life in Cancer Patients With Peripheral Neuropathy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Neuropathy
Therapy-Associated Cancer
Keywords: Cancer pain
Neuropathy pain
Tenis ball
Myofascial release
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Complaints of peripheral neuropathy among patients who have completed the standard chemotherapy treatment protocol due to colorectal cancer, entered the follow-up process and come to the outpatient clinic for routine control.
* Registered to Selçuk University Faculty of Medicine Hospital Medical Oncology Polyclinic
* Karnofsky Performance Scale must be 80 or above
* Over 25 years old, under 65 years old
* Presence of grade 2 or higher peripheral neuropathy,
* Being conscious and cooperative
* Verbal and written approval to participate in the study after an explanation about the study is made.

Exclusion Criteria:

* Having any skin sensitivity on hands and feet before
* Refused to participate in the study after making a statement about the study
* Development of peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)\]
* Bone or spine metastases

Primary outcomes:
measure: EORTC QLQ C-30- CIPN20 Scale
timeFrame: 10 minutes
measure: One Leg Standing Test
timeFrame: 30 seconds
measure: Lateral Reach Test
timeFrame: 5 minutes
measure: Pain Assessment
timeFrame: 1 minutes
measure: Pressure Pain Threshold Assessment
timeFrame: 5 minutes
measure: Two Point Discrimination
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: ülkü Saygili Düzova
state: Konya
Study officials:
References:
Clinical trial NCT05501444: Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
Official title: Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Residual Limbs
Keywords: Lower limb amputation
Hyperhidrosis
Prosthetic users
Aluminum chloride
Sweating
Lead sponsor: Sophies Minde Ortopedi
Sponsor class: INDUSTRY
First posted: 2022-08-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The project is carried out as a pilot study
Primary purpose: TREATMENT

Brief summary: The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.

Detailed description: Many persons with lower limb amputation report that they have major problems with sweating (hyperhidrosis) on the stump in connection with prosthetic use. Despite the frequency and the negative effect of sweating for prosthetic users, there is a lack of evidence on how the sweating should be examined and treated. In the dermatological literature, the guidelines recommend the use of topical antiperspirants such as aluminum chloride as first-line treatment. No studies have previously been published evaluating the effect of antiperspirant on prosthetic users.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years,
2. used a prosthetic for at least 1 year,
3. HDSS score of ≥ 2,
4. use the prosthetic daily and be able to walk for a minimum of 10 minutes.

Exclusion Criteria:

1. Open wounds on the stump,
2. Known sensitivity or allergy to iodine and/or starch,
3. Known sensitivity to antiperspirant.

Primary outcomes:
measure: Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: Four weeks
measure: Sweating Intensity Visual Scale (SIVS)
timeFrame: Four weeks
Secondary outcomes:
measure: Numerical Ranking Scale (NRS 100)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Sophies Minde Ortopdi AS
Study officials:
affiliation: Sophies Minde Ortopedi
name: Jette Schack, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811980: The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents
Official title: The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects who consent to donate blood.

Brief summary: We will determine if linezolid inhibits cellular activation and production of pro-inflammatory cytokines, providing mechanistic rationale for its clinical efficacy and the justification for further investigations in S. Aureus sepsis.


Eligibility criteria: Inclusion Criteria:

* Healthy, taking no medications, and not recently hospitalized

Exclusion Criteria:

* Infection (active)

Primary outcomes:
measure: IL-6
timeFrame: 12 Months
Secondary outcomes:
measure: MCP-1
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Guy Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03119480: Electronic Warning Systems in Diagnosis and Treatment of AKI
Official title: The Effect of Electronic Warning Systems in the Process of Diagnosis and Treatment of Patients With Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Electronic alerts
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients aged\>18 years,with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China

Brief summary: To set up electronic early warning system of AKI patients; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.

To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.

Detailed description: To set up electronic early warning system according to KDIGO AKI diagnosis standard, real-time monitoring of hospitalized patients with renal function data, real-time detection of AKI patients, notify the diagnosis of renal physician; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.

To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.

Eligibility criteria: Inclusion Criteria:

Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria.

Exclusion Criteria:

Exclusion criteria were initial hospital creatinine 4•0 mg/dL (to convert to μmol/L, multiply by 88•4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease.

Primary outcomes:
measure: all-cause mortality
timeFrame: at 7 days after alert
Secondary outcomes:
measure: dialysis
timeFrame: at 7 days after alert
measure: change in creatinine
timeFrame: at 7 days after alert
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
affiliation: Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
name: Feng Ding, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01543880: Safety and Efficacy of Long-term Somatropin Treatment in Adults
Official title: Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 752
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults in need of somatropin or current users

Brief summary: This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).


Eligibility criteria: Inclusion Criteria:

* In need of somatropin or current user

Primary outcomes:
measure: Number of adverse events
timeFrame: Up to 10 years
Secondary outcomes:
measure: BMI (Body Mass Index)
timeFrame: Up to 10 years
measure: HbA1c change
timeFrame: Up to 10 years
measure: IGF-I (Insulin-Like Growth Factor I)
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05324280: Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Official title: Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvodynia
Chronic Pelvic Pain
Keywords: acupuncture
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled clinical study with waiting list control group
Primary purpose: TREATMENT

Brief summary: Background: Vulvodynia and chronic pelvic pain (CPP) are common and challenging gynecologic pain syndromes. A multidisciplinary approach is recommended.

Study aim: To study the effectiveness of acupuncture as part of a multimodal treatment for women with vulvodynia and CPP.

Design: Randomised controlled clinical study

Study Population: Recruitment from a University outpatient clinic Study groups: Participants will be randomised (1:1)

* Acupuncture group
* Waiting list control group

Sample size: 68 patients

Study outcome

* Subjective Pain Perception (VAS)
* Health-related quality of life (questionnaires)


Eligibility criteria: Inclusion Criteria:

* Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
* multidisciplinary treatment for at least 3 months

Exclusion Criteria:

* Pregnancy
* Current malignancy
* Major neurologic or psychiatric morbidity
* Study participation in Lydia trial (Lasertherapy for vulvodynia)

Primary outcomes:
measure: Change of Subjective Pain Perception
timeFrame: evaluation at 3 and 6 months
Secondary outcomes:
measure: Change of Health-related quality of life - DSF
timeFrame: evaluation at 3 and 6 months
measure: Change of Health-related quality of life - PHQ-D
timeFrame: evaluation at 3 and 6 months
measure: Change of Health-related quality of life - PSQ
timeFrame: evaluation at 3 and 6 months
measure: Change of Health-related quality of life - EHP-30
timeFrame: evaluation at 3 and 6 months
measure: Change of Subjective improvement
timeFrame: evaluation at 3 and 6 months
measure: Patient treatment satisfaction
timeFrame: evaluation at 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Gynecology/ Medical University of Graz
Study officials:
References:
Clinical trial NCT06346080: Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment
Official title: Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: Esophageal cancer
Survey
Gastric cancer
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A survey will be conducted in a single group of participants from different geographical regions and backgrounds
Primary purpose: OTHER

Brief summary: The goal of this survey is to investigate the participants' preference for a specific screening/diagnostic tool to detect and assess gastro-esophageal cancer.

The main question it aims to answer are:

* Which diagnostic modality is preferred by patients and the general population?
* Which features of the diagnostic test are most detrimental in the decision-making for one or the other modality?
* Are geographical differences present in regard to the preference for a diagnostic modality?

Participants will be asked to complete a survey of 20-25min, including a brief intake regarding their socio-economic status. This approach will allow us to correct for confounding factors.


Eligibility criteria: Inclusion Criteria:

1. Individuals \>18yo to 75yo (upper age limit of Barrett's surveillance)
2. Access to computer or smartphone
3. Clear understanding of available languages of the experiment (English, French, Dutch, Spanish, German, Chinese, Japanese)

Exclusion Criteria:

1. Individuals less than 18yo and more than 75yo
2. Incarcerated individuals

Primary outcomes:
measure: The rate of contribution of diagnostic features to the preference of participants
timeFrame: 2 years
measure: The percentage differences in preference of participants between geographical regions
timeFrame: 2 years
Secondary outcomes:
measure: Assess the rate patient-level demographics influence the importance of a test feature, expressed as an odds ratio
timeFrame: 2 years
measure: Assess the rate of trade-off demonstrated as odds ratio between cancer-related mortality reduction and costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Leuven
name: Stijn Vanstraelen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Philippe Nafteux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: