louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01366482: Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease
Official title: Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication
Keywords: Peripheral arterial disease,
claudication,
atherectomy,
plaque excision,
drug-coated balloon
drug-eluting balloon
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
Collaborators: name: MEDRAD, Inc.
First posted: 2011-06-06
Enrollment: 121
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: The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.


Eligibility criteria: Inclusion Criteria:

* Rutherford Clinical Category 2-4
* At least 18 years of age
* Is able and willing to provide written informed consent prior to study specific procedures

Exclusion Criteria:

* Has a life expectancy of less than 24 months
* Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
* Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs

Primary outcomes:
measure: Target Lesion Percent Stenosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
Study officials:
affiliation: Herz-Zentrum Bad Krozingen Germany
name: Professor Thomas Zeller
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Rosenheim Germany
name: Professor Gunnar Tepe
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
Clinical trial NCT04353882: Mu Opioid Receptor 1 Expression and Activation Patterns in Colorectal Cancer
Official title: Evaluation of the Difference in Expression of the Mu Type 1 Opioid Receptor and of the Markers of Its Activation (Cyclic Adenosine Monophosphate and Protein Kinase A) in Colorectal Cancer. Case-control Study in Patients With Tumor Recurrence Versus Disease-free Patients at 5 Years.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Surgery for Stage II / III Primary Colorectal Cancer
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled colorectal surgery for stage II and III primary colorectal cancer during the period 01/01/2010 and 12/31/2014.

Brief summary: Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery.

Detailed description: Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery. Period January 2010-December 2014. Patients must have had at least 5 years of follow-up to define disease-free survival. From the cohort of patients previously studied in our center by immunohistochemistry, 31 we will select 10 cases with recurrence by random sampling and we will match 10 controls by leveling the propensity score (propensity score matching).

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age.
* Colorectal surgery scheduled between January 2010 - December 2014.
* Stage II or III colon or rectum neoplasm (T3 / T4 N + M0).

Exclusion Criteria:

* Neoplasia of colon or rectum in Stage I or Stage IV.
* Non-oncological colorectal surgery.
* Urgent surgery

Primary outcomes:
measure: MOR-1 expression by polymerase chain reaction (RT-qPCR) in tumor tissue and adjacent healthy tissue.
timeFrame: Day 1
Secondary outcomes:
measure: Cancer-free survival 5 years after surgery (disease-free survival-DFS).
timeFrame: Day 1
measure: Degree of MOR-1 activation measured by immunohistochemistry through cAMP and PKA levels.
timeFrame: Day 1
measure: MOR-1 expression by immunohistochemistry in tumor tissue and adjacent healthy tissue.
timeFrame: Day 1
Other outcomes:
measure: Use of halogenated vs intravenous hypnotic agent
timeFrame: Day 1
measure: Carcinoembryonic antigen
timeFrame: Day 1
measure: Cancer antigen
timeFrame: Day 1
measure: Neoadjuvant or adjuvant chemotherapy or radiation therapy
timeFrame: Day 1
measure: Surgery time
timeFrame: Day 1
measure: Surgery date
timeFrame: Day 1
measure: Hospital discharge
timeFrame: Day 1
measure: Surgery complications
timeFrame: Day 1
measure: Type of surgery
timeFrame: Day 1
measure: ASA test
timeFrame: Day 1
measure: Concomitant Diseases
timeFrame: Day 1
Locations:
Study officials:
References:
Clinical trial NCT05921682: Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
Official title: Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heat Stroke
Keywords: heat stroke, body temperature, outcomes
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yiwu Central Hospital
name: Jinhua People's Hospital
name: Jinhua Municipal Central Hospital
name: Dongyang People's Hospital
name: Lanxi People's Hospital
First posted: 2023-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Comprehensive tertiary hospital

Brief summary: The goal of this observational study is to explore the optimal target body temperature in first 24 hours and the relationship between body temperature and adverse outcomes of heat stroke.

The main questions it aims to answer are:

* the optimal target body temperature at 0.5 h, 2 h, and the lowest body temperature of heat stroke.
* the best body temperature at the cutting point of stop cooling.
* The relationship between the volume and speed of ice saline infusion and the cooling effect.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members.

Exclusion Criteria:

* need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.

Primary outcomes:
measure: mortality
timeFrame: up to 90 days
measure: organ damage
timeFrame: up to 90 days
Secondary outcomes:
measure: continuous renal replacement therapy
timeFrame: up to 90 days
measure: length of ICU stay
timeFrame: up to 90 days
measure: length of hospital stay
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Yiwu
country: China
facility: Yiwu Central Hospital
state: Zhejiang
city: Dongyang
country: China
facility: Dongyang People's Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Jinhua
country: China
facility: Jinhua People's Hospital
city: Lanxi
country: China
facility: Lanxi People's Hospital
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Lan Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06186882: Gene x Environment Interplay in Developmental Dyslexia Treatment: A Round-trip Translation Between Humans and Animal
Official title: Gene x Environment Interplay in Developmental Dyslexia Treatment: A Round-trip Translation Between Humans and Animal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reading Disorder
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: Università degli studi di Bergamo
First posted: 2024-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Developmental dyslexia affects 7% of school-age children (Male:Female ratio of 1.5:1) and incurs disadvantages in education and occupation. Scientific progress concerning the etiology of developmental dyslexia evidenced the complex gene-environment interaction. The DCDC2-READ1 deletion associates with reading skills and affects the magnocellular-dorsal stream in humans and animals. DCDC2 modifies neural activity within the excitatory pathways. The magnocellular-dorsal stream mediates the function of the attention network. Difficulties in spatial and temporal attention shifting impair letter-to-speech sound integration increasing neural noise. Action video games improve the efficiency of the magnocellular-dorsal stream. The aim of this cutting-edge, round trip translation study is threefold: 1.to unravel new insights behind the pathophysiology of developmental dyslexia, 2. to assess gene-environment interaction effects on developmental dyslexia endophenotypes, and 3. to identify useful clues to foster the identification of new, personalized treatments.


Eligibility criteria: Inclusion Criteria

* 5-years old pre-readers,
* normal intelligence quotient,
* no main counter indications for magnetic resonance acquisition,
* no previous diagnosis of any neurodevelopmental disorders.

Exclusion Criteria:

* intelligence quotient below the average range,
* presence of counter indications for magnetic resonance acquisition,
* previous diagnosis of any neurodevelopmental disorders.

Primary outcomes:
measure: Short-term memory
timeFrame: 3 years
measure: Phonological awareness
timeFrame: 3 years
measure: Rapid automatized naming
timeFrame: 3 years
measure: Reading skills
timeFrame: 3 years
measure: Visual attention
timeFrame: 3 years
measure: Visual motion processing
timeFrame: 3 years
measure: measurement of neurotransmitters
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS E Medea
state: LC
Study officials:
References:
Clinical trial NCT06146582: The Impact of a Personalized Care Intervention on 90-day Post-Discharge Care
Official title: The Impact of a Personalized Care Intervention on 90-day Post-Discharge Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Readmissions
Behavioral Health
Care Transitions
Social Determinants of Health
Contextualizing Healthcare
Virtual Coaching
Lead sponsor: Laguna Health, Inc
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2023-11-24
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned upon consent randomly to an intervention or control group. The intervention group received support from Laguna Coaches and Laguna's mobile app for 90 days, the control group did not receive any support from Laguna coaches or Laguna's app.
Primary purpose: TREATMENT

Brief summary: The purpose of this 90 day study is to demonstrate the extent to which participants with cardiovascular conditions can improve their recovery at home through a mobile app, support and resources made available to them after hospitalization. The study will evaluate the effectiveness of personal care intervention support, including one-on-one guidance, educational information, check-ins, and Laguna's mobile app to help participants recover better after hospitalization.

Detailed description: This study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. Laguna integrated hospital provided clinical guidance and Laguna's personalized contextual care protocols, with the goal of improving health outcomes and reducing readmissions within 90 days post-discharge.

Particiants in the intervention group received support from Laguna Health via Laguna's mobile app, phone, video, text, or web chat. Laguna provided contextual support to remove recovery barriers to these intervention participants.

Eligibility criteria: Inclusion Criteria:

* Admitted to the hospital with a diagnosis of a cardiovascular disorder as defined by the coded diagnoses for that admission
* Discharged to home
* Converse in English
* Uses a telephone (landline or cell phone)

Exclusion Criteria:

* Participant unable to provide informed consent
* Participant lacks cognitive ability to participate in the study interventions as judged by the individual initiating the consenting process

Primary outcomes:
measure: Unplanned All Cause Readmission Rate
timeFrame: 90 Days Post-Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas P Olson, Ph.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149482: Isolated Deficits of the Lateral Semicircular Canal
Official title: Evolutionary Profile of Isolated Lateral Semicircular Canal Deficits on the Video Head Impulsed Test (VHIT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Vestibular Disorder
Keywords: Peripheral Vestibular Disorder
Lateral semicircular canal
Video Head Impulsed Test
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated in the ENT department for dizziness between June 2020 and July 2021.

Brief summary: There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature.

In addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile.

The population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the University Hospitals of Strasbourg for an acute unilateral vestibular deficit whose examination at the VHOT shows a reduced and isolated gain of a lateral semicircular canal.


Eligibility criteria: Inclusion criteria

* Major patient
* Man or woman
* Patient who has given their consent to the use of their data.
* Patient treated in the ENT department for dizziness between June 2020 and July 2021.

Non-inclusion criteria

* Patient who expressed his opposition to participating in the study
* Inability to provide the subject with enlightened information (difficulties in understanding the subject, cognitive disorders)
* Subject under safeguard of justice
* Subject under guardianship or guardianship
* Neurological signs on clinical examination

Primary outcomes:
measure: Establish the evolutionary profiles of patients with isolated lateral canal involvement
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpitaux Universitaires de Strasbourg
name: Anne CHARPIOT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179582: Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS
Official title: A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: IBS
Keywords: IBS
Functional bowel disorder
Diarrhea
probiotic
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 180
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: To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS

Detailed description: The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms.

Eligibility criteria: Inclusion Criteria:

* IBS diarrhea

Exclusion Criteria:

* \< 18 years of age
* Pregnancy/breast feeding
* concomitant medications to reduce bowel function

Primary outcomes:
measure: Global improvement in IBS symptoms
Secondary outcomes:
measure: Frequency of bowel movements
measure: Changes in abdominal pain
measure: Changes in bloating
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Anthony Lembo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niv E, Naftali T, Hallak R, Vaisman N. The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome--a double blind, placebo-controlled, randomized study. Clin Nutr. 2005 Dec;24(6):925-31. doi: 10.1016/j.clnu.2005.06.001. Epub 2005 Jul 27.
Clinical trial NCT06939582: Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
Official title: A Single Center, Open Label Phase II Clinical Trial of Hydroxychloroquine Sulfate Tablets for the Treatment of Radiation Stomatitis and Taste Disturbance in Intensity Modulated Radiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Radiation-induced Oral Mucositis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 158
Sex: ALL
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: Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy


Eligibility criteria: Inclusion Criteria:

* Patients pathologically diagnosed with non-metastatic head and neck malignant tumors
* Aged 18-80 years
* Eastern Cooperative Oncology Group performance status of ≤2
* Planning to receive definitive RT or postoperative adjuvant RT
* Normal liver, kidney and bone marrow function
* Sign informed consent

Exclusion Criteria:

* Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
* Had a history of head and neck radiotherapy
* Patients with non head and neck parts in the radiotherapy area
* Poor oral hygiene or severe periodontitis
* Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
* Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
* Retinopathy
* Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study

Primary outcomes:
measure: the WHO grade of RIOM
timeFrame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Radiation Oncology
state: Sichuan
Study officials:
References:
citation: Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):155-166. doi: 10.1038/s41584-020-0372-x. Epub 2020 Feb 7.
Clinical trial NCT00919282: Gemcitabine (GFF) in Patients With Pancreatic Cancer
Official title: A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: pancreatic cancer
gemcitabine
combination
Lead sponsor: CONKO-Studiengruppe
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-06-12
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

Detailed description: This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.

Eligibility criteria: Inclusion Criteria:

* histological proved pancreatic cancer
* inoperable disease
* informed consent
* adequate bone marrow reserve

Exclusion Criteria:

* under 18 years
* brain metastasis
* lactating woman
* life expectancy under 3 months

Primary outcomes:
measure: overall survival
timeFrame: 1 year
Secondary outcomes:
measure: safety of treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin
Study officials:
affiliation: CONKO-Studiengruppe
name: helmut oettle, MD
role: PRINCIPAL_INVESTIGATOR
References: