louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02730702: Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Official title: Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Lead sponsor: American BioOptics, LLC
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be obtained in the gastroenterology clinics.

Brief summary: This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).

Detailed description: The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Eligibility criteria: Inclusion Criteria:

- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance

Exclusion Criteria:

* age \<50
* personal/family history of colonic neoplasia
* personal history of coagulopathy
* (retrospectively) failure to complete or inadequate colonoscopy
* any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)

Primary outcomes:
measure: Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: American BioOptics
name: The Quyen Nguyen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radosevich AJ, Mutyal NN, Eshein A, Nguyen TQ, Gould B, Rogers JD, Goldberg MJ, Bianchi LK, Yen EF, Konda V, Rex DK, Van Dam J, Backman V, Roy HK. Rectal Optical Markers for In Vivo Risk Stratification of Premalignant Colorectal Lesions. Clin Cancer Res. 2015 Oct 1;21(19):4347-4355. doi: 10.1158/1078-0432.CCR-15-0136. Epub 2015 May 19.
Clinical trial NCT02780102: Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
Official title: Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Cognitive-motor rehabilitation
Active Control Group
Stimulant Medication
Lead sponsor: Allameh Tabatabai University
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 48
Sex: MALE
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.


Eligibility criteria: Inclusion Criteria:

* Receiving ADHD diagnosis
* aged between 9 and 12 years
* Intelligence Quotient (IQ)\>90

Exclusion Criteria:

* Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder
* A history of seizures during past 2 years
* Disability or handicap preventing the child from participating cognitive-motor exercises
* Sever medical conditions requiring immediate medical treatment

Primary outcomes:
measure: Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
timeFrame: 12 months
measure: Span board task from the Lumosity.com online brain training software
timeFrame: 12 months
measure: Listening span task (L.SPAN)
timeFrame: 12 months
measure: Stroop color-word test
timeFrame: 12 months
measure: Tower of London test (TOL)
timeFrame: 12 months
measure: Restricted academic situation scale (RASS)
timeFrame: 12 months
measure: Arithmetic task from WISC-IV testing battery
timeFrame: 12 months
measure: Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
timeFrame: 12 months
measure: Dictation and Spelling examination
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Counseling and guidence Center of the Department of education of region 9 of Tehran
Study officials:
affiliation: Semnan University
name: Saeed Azami, PhD
role: STUDY_DIRECTOR
affiliation: Tehran University of medical Science
name: Zeynab AliMadadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521102: Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
Official title: An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 162
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.


Eligibility criteria: Inclusion Criteria:

1. Age equal to 65 or greater
2. Pain onset within 7 days with severe pain
3. Has capacity to provide informed consent
4. Understanding English or Spanish

Exclusion Criteria:

1. Use of tramadol or opioids within 7 days
2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
3. Chronic pain syndrome: daily pain for \> 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
5. Alcohol intoxication
6. Systolic blood pressure: \< 100 mmHg
7. Heart rate: \< 60 beats per minute
8. Oxygen saturation: \< 95% on room air
9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days
10. Use of transdermal pain patch or oral opioid \> 10 days in the prior month
11. Prior enrollment in the same study

Primary outcomes:
measure: Clinical Improvement in NRS Pain Score
timeFrame: 60 minutes following administration of medication
Secondary outcomes:
measure: Need for Rescue Medication
timeFrame: 120 minutes following administration of medication
measure: Improvement in NPS Pain Score by >=50%
timeFrame: 60 minutes after administration of medication
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644202: A Pilot Weight Control Intervention at HPHC
Official title: A Pilot Weight Control Intervention at Harvard Pilgrim Health Care (HPHC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight control
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Harvard Pilgrim Health Care
First posted: 2008-03-26
Enrollment: 101
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: The purpose of this study is to examine how adults can improve their physical activity levels and eating habits using an interactive web-based weight control program and regular contact with a dietician.

Detailed description: * All study participants must have regular access to the Internet, however, the study will not provide this access. Participants will be randomly placed in one of two study groups (Group 1 or Group 2).
* Group 1 participants will be asked to make 3 in-person visits, each lasting 75-90 minutes. The following information will be collected: name, mailing address, telephone number, and email address. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.
* Group 1 participants will also receive counseling around diet and physical activity from a registered dietician and be asked to use a specialized website that will allow them to track eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants.
* Group 1 will also receive 5 telephone counseling calls with a health counselor. During the telephone calls, we will teach the participant new skills such as tracking diet and physical activity, goal-setting and staying motivated.
* Group 2 participants will be asked to make 2 in-person visits, each lasting 75-90 minutes in length. The following information will be collected: your name, mailing address, and telephone number. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.

Eligibility criteria: Inclusion Criteria:

* 25 to 65 years of age
* Body mass index between 30-40 kg/m2
* Non-smoker (quit within previous 6 months)
* Comfort reading and speaking English
* Stage 1 hypertension
* Not currently pregnant
* Regular web access from home

Primary outcomes:
measure: Weight
timeFrame: 24 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 24 weeks
measure: Diet
timeFrame: 24 weeks
measure: Physical activity
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Department of Ambulatory Care and Prevention
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Gary Bennett, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03054402: First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845
Official title: Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pelvic Inflammatory Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject
* Age: 18 to 50 years (inclusive) at the first screening visit
* Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²

Exclusion Criteria:

* Clinically relevant findings in the physical examination
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration

Primary outcomes:
measure: Frequency of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 25 days after last drug administration
measure: Severity of treatment-emergent adverse events
timeFrame: Up to 25 days after last drug administration
measure: Area under the plasma concentration vs. time curve (AUC)
timeFrame: Baseline to up to 14 days post drug administration
measure: Maximum drug concentration in plasma after single dose administration (Cmax)
timeFrame: Baseline to up to 14 days post drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06984302: A PREDICTIVE ALGORITHM IN AORTIC SURGERY
Official title: HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodynamic
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the Hemosphere platform. In the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.


Eligibility criteria: Inclusion Criteria:

* planned aortic surgery acceptance of written informed consent

Exclusion Criteria:

* body mass index \> 35 kg/m2
* atrial fibrillation
* urgent surgery
* end-stage renal disease
* pregnancy
* refusal of the consent

Primary outcomes:
measure: time weighted average of mean arterial presure under 65 mmHg
timeFrame: at the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02085902: Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?
Official title: Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystectomy
Laparoscopy
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.

The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.

Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.


Eligibility criteria: Inclusion Criteria:

* Programmed Cholecystectomy
* Laparoscopy
* Man and woman
* ≥ 18
* ASA 1 or 2
* Not living alone
* Patient receiving social security coverage
* Signature of Informed Consent Form

Exclusion Criteria:

* Cholecystectomy emergency
* Patient minor
* Pregnant woman (pregnancy test) or during breastfeeding
* Conversion to laparotomy
* Patient anticoagulant curative dose
* Living alone
* Patient addict
* Peptic Ulcer
* Refusal to enter the protocol
* Chronic requiring analgesics long-term
* Immunosuppression
* Long-term Treatment with corticosteroids
* Discovery intraoperative calculation in the bile duct
* Contraindication to ropivacaine (see cons-indications to ropivacaine)
* Hypersensitivity to study treatment or concomitant medications anesthesia
* Cardiac or unbalanced epileptic patients (due to the risk of cardiovascular and neurological local anesthetics)
* Patients ASA ≥ 3
* Patient \<50 kg

Primary outcomes:
measure: Time to discharge patient after surgery
timeFrame: 6 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre hospitalier départemental Vendée
Study officials:
affiliation: CHD Vendée La Roche sur Yon
name: Emeric ABET, Dr
role: STUDY_DIRECTOR
References:
citation: Abet E, Orion F, Denimal F, Brau-Weber AG, de Kerviler B, Jean MH, Boulanger G, Dimet J, Comy M. Interest of Using Ropivacaine for Outpatient Laparoscopic Cholecystectomy: Prospective Randomized Trial. World J Surg. 2017 Mar;41(3):687-692. doi: 10.1007/s00268-016-3797-2.
Clinical trial NCT06838702: Structured Data Collection of Patients Undergoing Liver Transplantation and Evaluated for Bone Mineral Metabolism
Official title: Structured Data Collection of Patients Undergoing Liver Transplantation and Evaluated for Bone Mineral Metabolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Liver Transplant
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver transplantation and followed at the Endocrinology Operating Unit for bone mineral metabolism.

Brief summary: Observational cohort study offered consecutively to every liver transplant patient who arrives for the first endocrinology visit or returns for follow-up visit for bone metabolism assessment.

Detailed description: The retrospective and prospective single-center observational cohort study will be offered consecutively to every liver transplant patient who arrives for the first endocrinology visit or returns for follow-up visit for bone metabolism assessment at UO Endocrinology of Policlinico S. Orsola-Malpighi.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patients undergoing liver transplantation for any cause.
* Performance of bone densitometry
* Performance of examinations pertaining to mineral metabolism
* Obtaining informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Bone Mass in Liver Transplant Patients
timeFrame: through study completion, an average of 4 years
measure: Calcium Metabolism Indices in Liver Transplant Patients
timeFrame: through study completion, an average of 4 years
measure: Fracture Incidence in Liver Transplant Patients
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
measure: Prevalence of Fractures in Patients Undergoing Liver Transplantation
timeFrame: through study completion, an average of 4 years
measure: Relationship Between Biochemical Parameters and Bone Mineral Density (BMD) Trends in Liver Transplant Patients
timeFrame: through study completion, an average of 4 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Uberto Pagotto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220402: Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome
Official title: Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.

Subjects completing the 12 week treatment period of SP583 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis.

Two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy.

Secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF).

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.


Eligibility criteria: Inclusion Criteria:

* Participated in SP583

Exclusion Criteria:

* Failure to complete 12 week treatment with SPM 907

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monheim
country: Germany
facility: Schwarz
Study officials:
affiliation: UCB Pharma
name: Axel Steinert
role: STUDY_DIRECTOR
References: