louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04342949: The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Study to Investigate the Auxiliary Effects of Fucoidan in Patients With Locally Advanced Rectal Cancer Who Receive Combined Radio-chemotherapy Before Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: we enrolled the patients with locally advanced rectal cancers and received neoadjuvant CCRT (concurrent radiochemotherapy) before.

Brief summary: This is a double-blind, randomized, placebo-controlled, parallel study. The main goal is to investigate the auxiliary effects of Fucoidan for the patients with locally advanced rectal cancer who receive neoadjuvant CCRT before surgery. The quality of life is our primary endpoint for this study. The study is an observational study.


Eligibility criteria: Inclusion Criteria:

1. Age was more/equal to 20 year-old and less/equal to 80 year-old
2. Diagnosed as locally advanced rectal cancers by pathological biopsy and image study.
3. ECOG performance status within 0 to 2 points
4. Excepted life remaining at least 4 months
5. Females with fertility are willing to use effective contraception during the period of study
6. Willing to follow the test procedures and tracking procedures
7. sign the inform consent form

Exclusion Criteria:

1.Suffering from other primary malignant tumors 2.Females who are pregnant, planning to become pregnant, or breastfeeding 3.Participate in other interventional clinical trial within the first 30 days 4.Suffering from major mental illness such as mental retardation and mental disorders 5.Unable to understand and answer research questions (oral or written) 6.Abnormal laboratory data within 14 days before joining the study 7.Evidence that subject has a severe or uncontrolled disease

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Primary outcomes:
measure: auxiliary effects of Fucoidan
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Jaw-Yuan Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479349: Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
Official title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.


Eligibility criteria: Inclusion criteria

* Men aged 20 to 45 years, inclusive, at screening.
* Elderly men or women aged 65 years and above as of screening.
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
* Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 9 months
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics
timeFrame: 9 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01385449: Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks
Official title: Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: nerve block
shoulder surgery
physical therapy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* 18-79 years of age, inclusive
* body mass index of \< 36 kg/m2.
* The ability to understand local anesthetic related complications and care of a CPNB
* Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
* The ability to communicate with the practitioner managing the catheter.
* Residence within 2 hours of University of Wisconsin Hospital and Clinics

Exclusion Criteria:

* Any contraindication to a continuous interscalene catheter placement
* Clinically significant pulmonary disease
* Clinically significant cardiac disease
* Allergy to ropivacaine
* Peripheral or central nervous system disease
* Current (or planned) anticoagulation therapy or disease
* Local infection over area of catheter placement
* Renal or hepatic failure
* History of opioid dependence
* Significant psychiatric disease
* Pregnancy or lactation (Subjects will be asked if it is possible they could be pregnant. If a subject responds in the affirmative, a pregnancy test will be done.)
* Seizure Disorder

Primary outcomes:
measure: pain on post-operative day 1
timeFrame: 24 hours
Secondary outcomes:
measure: Pain post operative day 2 (POD2)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: U of Wisconsin
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02604849: Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Colonized by Klebsiella Pneumoniae.
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 44
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: The sample consists of all patients who received therapy desconolizacion against Klebsiella Pneumoniae versus those not receiving such therapy.

Brief summary: The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae:
* Surgery in two weeks
* Transplant in two weeks
* Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia)
* Recurrent or severe infections
* Institution admission
* Fragile patients at high risk of readmission.

Exclusion Criteria:

* The presence of an active infection for Klebsiella Pneumoniae.
* Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.

Primary outcomes:
measure: Mortality for any cause during a six-months period after oral therapy gut decontamination.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Machuca I, Gutierrez-Gutierrez B, Perez Cortes S, Gracia-Ahufinger I, Serrano J, Madrigal MD, Barcala J, Rodriguez-Lopez F, Rodriguez-Bano J, Torre-Cisneros J. Oral decontamination with aminoglycosides is associated with lower risk of mortality and infections in high-risk patients colonized with colistin-resistant, KPC-producing Klebsiella pneumoniae. J Antimicrob Chemother. 2016 Nov;71(11):3242-3249. doi: 10.1093/jac/dkw272. Epub 2016 Jul 26.
Clinical trial NCT06770049: Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
Official title: Phenotype-Tailored Lifestyle Intervention for Obesity: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-01-13
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this 12-month, randomized, active-controlled trial, we aim to compare the effect of guiding lifestyle intervention tailored to a sub-classification of obesity based on physiological and behavioral alterations, called phenotypes.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop an evidence-based precision medicine approach for obesity that enhances weight loss and promotes weight loss maintenance.


Eligibility criteria: Inclusion:

• men or women between 18 to 65 years with obesity (BMI\>30kg/m2).

Exclusion:

* weight change greater than 3% in the previous 3 months
* history of bariatric surgery and bariatric endoscopy
* untreated psychiatric disorders including binge eating disorders and bulimia
* current use of AOMs
* history of use of medications affecting weight or energy intake or energy expenditure in the last 6 months
* history of type 1 diabetes mellitus or uncontrolled medical conditions (e.g., uncontrolled hypertension)
* women who are pregnant or plan to become pregnant,
* any condition that limits their participation in the study
* Principal Investigator discretion

Primary outcomes:
measure: Total Body Weight Loss (TBWL)
timeFrame: Baseline, 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andres Acosta, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639649: STHLM3 - Prostate Cancer Diagnostic Trial
Official title: STHLM3 - Prostate Cancer Diagnostic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2018-08-21
Enrollment: 58818
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer


Eligibility criteria: Inclusion Criteria:

* Age 50-69
* Residential address in Stockholm County

Exclusion Criteria:

* Previous Prostate Cancer Diagnosis
* Not able to comprehend inform consent material

Primary outcomes:
measure: Number of biopsies
timeFrame: Recorded directly after biopsy
Secondary outcomes:
measure: Number of Gleason Score ≥ 7
timeFrame: Recorded directly after biopsy
measure: Number of Gleason Score 6
timeFrame: Recorded directly after biopsy
measure: Number of benign
timeFrame: Recorded directly after biopsy
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT02972749: Modifiable Factors and Glaucoma - RCT
Official title: Modifiable Factors in the Management of Glaucoma - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-23
Enrollment: 22
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: There is growing awareness that environmental factors, behaviors and diet are intimately related to patient health and may play a role in the pathogenesis and progression of glaucoma. Evidence from recent years has shown that some behaviors and environmental factors can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to investigate whether simple and common lifestyle inteventions such as sleeping with a head elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake could affect intraocular pressure and other outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with glaucoma.

Exclusion Criteria:

* Not able to attend follow-up
* Contraindication for treatment or follow-up

Primary outcomes:
measure: Intraocular pressure
timeFrame: Following 1 month of treatment
Secondary outcomes:
measure: Illness perception questionnaire results
timeFrame: Following 1 month of treatment
Other outcomes:
Locations:
city: Holon
country: Israel
facility: The E.Wolfson Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Asaf Achiron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050049: The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department
Official title: The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2010-01-15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the Emergency Department with acute stroke

Brief summary: The objective of this study is to determine if the implementation of guidelines utilizing immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-PA.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect.
* Patients with an NIH Stroke Scale score \> 4

Exclusion Criteria:

* Age less than 19
* Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy.
* Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06484049: Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation
Official title: Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age greater than or equal to 55 years; Patients planning to undergo allogeneic hematopoietic stem cell transplantation.

Brief summary: To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

Detailed description: To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT.

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 55 years;
2. Patients planning to undergo allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria:

1. Patients with active diseases;
2. Presence of central nervous system tumor invasion;
3. Planning to undergo two or more transplantations;
4. Severe cognitive impairments or mental illnesses;
5. Inability to communicate in Mandarin.

Primary outcomes:
measure: To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT.
timeFrame: 1YEAR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03169049: Nerve Conduction Block Using Transcutaneous Electrical Currents
Official title: Peripheral Nerve Conduction Block Using a High Frequency Alternating Stimulation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Electric Stimulation
Keywords: nerve conduction block
high frequency stimulation
handgrip
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2017-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.

Detailed description: In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents).

It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason the investigators decided to applied 20KHz to observe the effects on maximal manual force and to compare versus sham stimulation.

Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy

Primary outcomes:
measure: Baseline Hand Muscle Strength
timeFrame: Baseline at 0 min
measure: Hand muscle strength after treatment 20 min
timeFrame: After treatment 20 min
Secondary outcomes:
measure: Change from baseline in Muscle strength
timeFrame: baseline at 0 min, immediately after treatment at 20 min
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Nacional de Parapléjicos, Toledo
name: Diego Serrano-Muñoz, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. Effect of high-frequency alternating current transcutaneous stimulation over muscle strength: a controlled pilot study. J Neuroeng Rehabil. 2018 Nov 12;15(1):103. doi: 10.1186/s12984-018-0443-2.