louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01838980: Evaluation of the Motus GI CleanUp System During Screening Colonoscopy
Official title: Evaluation of the Motus GI CleanUp System During Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CRC
Keywords: Colonoscopy Cleaning
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure. The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.


Eligibility criteria: Inclusion Criteria:

1. Subjects in the age range of 50-69 years
2. Subjects who are considered for routine screening colonoscopy
3. Subjects with BMI within the range of 18.5-30
4. Subject is willing to sign informed consent form

Exclusion Criteria:

1. History of GI diseases or history of Colorectal cancer (personal or family)
2. Previous major abdominal surgeries
3. Medical status ASA grater or equal to 3
4. Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
5. Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
6. Life-threatening condition
7. Subjects who are unable or unwilling to cooperate with study procedures
8. Severe Diverticula

Primary outcomes:
measure: Mean of All Subjects Colon Segments BBPS>=2
timeFrame: Following the colonoscopic procedure- Up to 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02517580: Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)
Official title: Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arterial Stiffness
Vitamin K2 Deficiency
Lead sponsor: Lebanese American University
Sponsor class: OTHER
Collaborators: name: Omicron Pharmaceuticals
First posted: 2015-08-07
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: TREATMENT

Brief summary: This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Functional renal graft
* Stable renal function for at least 3 months prior to enrollment

Exclusion Criteria:

* History of thrombotic events
* Diagnosed coagulopathy
* Cardiovascular event in the past month prior to enrollment
* Current or planned pregnancy
* Lactation
* Soy allergy
* Concomitant or recent (past 6 months) use of supplements that contain vitamin K
* Warfarin treatment
* Known intestinal malabsorption or hypomotility syndromes

Primary outcomes:
measure: Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
timeFrame: 8 weeks
measure: Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
timeFrame: 8 weeks
measure: Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ashrafieh
country: Lebanon
facility: Lebanese American University Medical Center - Rizk Hospital
state: Beirut
Study officials:
affiliation: Lebanese American University
name: Sola Aoun Bahous, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13.
Clinical trial NCT01965080: Exemestane in Advanced and Recurrent Endometrial Carcinoma
Official title: Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Lead sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma

Hypothesis: Treatment With Exemestane can give a response rate of at least 30%

Detailed description: Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.

Patients were grouped according to estrogen receptor status.

Eligibility criteria: Inclusion Criteria:

* Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment
* Endometrioid histology
* Age above 18 years
* Post menopausal status
* Performance status 0-2
* Informed consent

Exclusion Criteria:

* Congestive heart disease grade III.IV
* History of thromboembolic signs
* Other primary hormonal therapy
* Patients With symptomatic brain metastasis
* Severe hepatic or renal impairment
* Pregnancy, lactation or child bearing potential without adequate contraception

Primary outcomes:
measure: Response rate
timeFrame: 6 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 2 years
Other outcomes:
measure: Toxicity
timeFrame: Up to 2 years
Locations:
city: Oslo
country: Norway
facility: The Norwegian Radium Hospital
Study officials:
affiliation: NSGO
name: Gunnar Kristensen, MD, PhD
role: STUDY_CHAIR
References:
citation: Lindemann K, Malander S, Christensen RD, Mirza MR, Kristensen GB, Aavall-Lundqvist E, Vergote I, Rosenberg P, Boman K, Nordstrom B. Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO). BMC Cancer. 2014 Feb 5;14:68. doi: 10.1186/1471-2407-14-68.
Clinical trial NCT05556980: Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
Official title: Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: laparoscopy-assisted gastrectomy
totally laparoscopic gastrectomy
distal gastroectomy
postoperative hospital stay
survival
complications
Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.

Detailed description: When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.

Eligibility criteria: Inclusion Criteria:

* aged 18-80 years old, no gender limitation;
* primary gastric cancer and planed for distal gastrectomy;

Exclusion Criteria:

* patients with total or proximal gastrectomy;
* patients with distant metastasis.

Primary outcomes:
measure: postoperative stay
timeFrame: about one week to one month from the finish of surgery
Secondary outcomes:
measure: Survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Xubing Zhang
state: Other (Non U.s.)
Study officials:
References:
Clinical trial NCT01914380: Investigating the Effectiveness of Eylea in Patients With Wet Age-related Macular Degeneration
Official title: PERSEUS - A Prospective Non-interventional Study to Assess the Effectiveness of Aflibercept (Eylea®) in Routine Clinical Practice in Patients With Wet Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Age-related Macular Degeneration
Keywords: Wet age-related macular degeneration
Anti-VEGF-Therapy
Observational study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2013-08-02
Enrollment: 988
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with wAMD treated with Eylea. Participants will be recruited from ophthalmological clinics and practices throughout Germany.

The decision upon treatment is made at the discretion of the attending physician, according to his/her medical practice.

The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.

Brief summary: The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.


Eligibility criteria: Inclusion Criteria:

* Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
* Written informed consent.

Exclusion Criteria:

* Exclusion criteria as listed in the local SPC.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Any concomitant therapy with another agent to treat wet AMD in the study eye.

Primary outcomes:
measure: Mean change of visual acuity for the total patient population
timeFrame: Baseline, 12 and 24 months
measure: Mean change of visual acuity for the subgroup of pretreated patients
timeFrame: Baseline, 12 and 24 months
measure: Mean change of visual acuity for the subgroup of non-pretreated patients
timeFrame: Baseline, 12 and 24 months
Secondary outcomes:
measure: Monitoring of disease activity
timeFrame: after 12 and 24 months
measure: Monitoring of treatment patterns
timeFrame: after 12 and 24 months
measure: Mean time from indication of Eylea-treatment by the treating physician to start of treatment
timeFrame: after 12 and 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03556280: Multi-Center Study of Sensory Stimulation to Improve Brain Function
Official title: Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment
Mild Cognitive Impairment
Dementia Alzheimers
Dementia, Mild
Dementia, Alzheimer Type
Dementia of Alzheimer Type
Dementia
Cognitive Impairment, Mild
Cognitive Decline
Keywords: Dementia
Alzheimer's Disease
Cognitive Impairment
Lead sponsor: Cognito Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

Detailed description: The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.

Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.

Eligibility criteria: Inclusion Criteria:

* \>= 55 Years old
* MMSE 14-26
* Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
* Participation of a caregiver

Exclusion Criteria:

* Profound hearing or visual impairment
* Seizure Disorder
* Use of memantine (Namenda or Namzaric)
* Implantable devices (non-MR compatible)

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
timeFrame: Quarterly over 6 months
Secondary outcomes:
measure: Amyloid PET/CT
timeFrame: Quarterly over 6 months
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
Study officials:
References:
citation: Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
Clinical trial NCT01174680: Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik
Official title: Cardiogoniometry Zur Früherkennung CAD Symptomatik
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina Pectoris
Keywords: cardiogoniometry
stable angina pectoris patients
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 43
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: The register study CGM@CAD will examine whether cardiogoniometry can provide additional information concerning the indication for a diagnostic coronary angiography and if so, which additional value it has. Therefore, an additional cardiogoniometry will be carried out in consecutive patients who have been diagnosed with myocardial ischemia by means of established methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or stress-MRT) and for whom an intracardiac catheter examination is regarded as indicated. The results of the different methods - particularly the results of the exercise ECG and the cardiogoniometry - will be checked against the results of the invasive examination as gold standard and the discharge diagnosis with regards to any correlation.


Eligibility criteria: Inclusion Criteria:

* Indication for a coronary angiography
* Age \> 18 years
* Patients written informed consent

Exclusion Criteria:

* Patients with known CHD (condition after myocardial infarction and/or angio-graphically proven stenosis \> 50% and/ or revascularization )
* Patients with acute coronary syndrome
* Patients with pace maker
* Severe valvular heart defect
* 50% extrasystole
* Patients with dysrhythmia, which make a correct interpretation impossible (e.g. VES, bigeminies and other dysrhythmia with a high impact such as atrial extrasystoles)
* Branch block
* Atrial fibrillation

Primary outcomes:
measure: additional value of cardiogoniometry
timeFrame: at hospital admission
measure: additional value of cardiogoniometry
timeFrame: at hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03738280: Non-hypovascular Solid Pancreatic Lesions: Role of EUS
Official title: Role of EUS in Differential Diagnosis and Malignancy Prediction of Non-hypovascular Solid Pancreatic Lesions: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Pancreatic Neoplasms
Endoscopic Ultrasound
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 154
Sex: ALL
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 consecutive patients fulfilling inclusion and exclusion criteria will be included in the study.

Brief summary: Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.


Eligibility criteria: Inclusion Criteria:

* Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular).

Exclusion Criteria:

* Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications)
* Lesion with hypovascular pattern at CE-EUS.
* Lesion not found or non pancreatic at EUS.
* Patients refusing to be included in the study

Primary outcomes:
measure: Upstream dilation of the main pancreatic duct
timeFrame: 6 months
measure: Vascular pattern (iso or hypervascular)
timeFrame: 6 months
measure: Lesion borders (smooth or irregular)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Stefano Francesco Crinò
state: VR
Study officials:
References:
Clinical trial NCT04659980: Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity: A Prospective Self-controlled Trial Comparing Hilotherapy With Frozen Gloves in Early Breast Cancer
Official title: Hilotherapy vs Frozen Gloves for Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevention of taxane-related toxicities at the extremities is highly important for patients' treatment and quality-of-life. Unlike standard cryotherapy with frozen gloves, hilotherapy produces cooling at a constant temperature. Comparative data with frozen gloves are unavailable. This prospective self-controlled study explores the efficacy of hilotherapy at the right hand and foot compared to frozen gloves at the left in patients with early breast cancer treated with weekly paclitaxel 80 mg/m² or three-weekly docetaxel 75 mg/m².


Eligibility criteria: Inclusion criteria:

* adult (≥18 years) patients with breast cancer
* treated with weekly paclitaxel 80 mg/m² (12 cycles) or three-weekly docetaxel 75 mg/m² (4 or 6 cycles) in an adjuvant or neo-adjuvant setting.

Exclusion criteria:

* peripheral neuropathy or pain in the extremities at baseline, regardless of whether this was related to a prior chemotherapy treatment or another condition
* Raynaud's phenomenon, cold intolerance or any condition to the nails or peripheral blood vessels that could pose a risk to the compliance with the study interventions
* insufficient understanding of the Dutch language for self-reporting the side-effects under investigation

Patients were excluded from the analysis if they received less than two thirds of planned treatment cycles, for other reasons than the side-effects investigated in this study.

Primary outcomes:
measure: any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)
timeFrame: 24 weeks
Secondary outcomes:
measure: grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References: