louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01139606: Vibration Training and Muscle Strength Development
Official title: The Effect of Resistance Training With Vibrating Weights on Muscle Strength Development and Everyday Functioning of Upper Limbs in Untrained Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Disabilities of the Arm, Shoulder and Hand
Lead sponsor: Wingate Institute
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction:

Vibration has been used to enhance muscle strength development during resistance training.

Aim:

To assess the effect of adding vibration to a regular resistance training program, using free weights, on muscle strength and everyday functioning of upper limbs in untrained adults

Methods:

60 healthy untrained adults, 30-65 yrs, will divide into two groups: experiment and control. Training program will include 24 sessions, over a course of 8 weeks. The experiment group will use a 1 kg vibrating weights and the control group will use a standard 1 kg free weights. Every session will include 10-15 min of 3-5 standard resistant exercises for upper limbs. Each subject will perform an Isokinetic evaluation of muscular performance, for upper limbs, in 3 occasions: before starting the program, immediately after completing the 8-weeks training program and 4 weeks afterwards, to check the chronic effect of each training regime. Each subject will complete a DASH (Disabilities of the arm, shoulder and hand) questionnaire at 4 occasions- as mentioned above and one more time, when completing the first 4 weeks of the training program, to reject any development of negative effects of the training program, such as pain or inflammation of the joints .


Eligibility criteria: Inclusion Criteria:

* healthy adults, ages 30-65
* not participating in resistance training for upper limbs regularly

Exclusion Criteria:

* unbalanced hypertension
* cardiovascular disfunction or disease
* pain and or/ inflammation of the neck, shoulders and arms
* pregnant women

Primary outcomes:
measure: The effect of vibration on muscle strength development and everyday functioning during a standard resistance training for upper limbs in untrained adults.
timeFrame: 8 weeks of resistance training program
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
affiliation: Wingate Institute, Israel
name: Eyal Shargal, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06246006: Functional Characterization of Thrombopoietin/cMPL Receptor Mutations in Myeloproliferative Neoplasia
Official title: Functional Characterization of Thrombopoietin/cMPL Receptor Mutations in Myeloproliferative Neoplasia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myeloproliferative Disorder
Keywords: leukemia
neoplasm
polymorphism
thrombocythemia
Thrombopoietin receptor,
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with suspected MPN screened at CHU Nîmes

Brief summary: The MPL gene is implicated in two groups of hematological pathologies: congenital amegakaryocytic thrombocytopenia (CAMT) and Phi negative myeloproliferative neoplasia (MPN). Fifty germline mutations have been identified in CAMT, yet only a dozen activating mutations have been described in MPN. Most are somatic, distributed mainly in the transmembrane (TM) and juxtamembrane (JM) domains. However, a few rare germline mutations located in the extracellular domain (ECD) have also been reported: K39N, R102P and P106L.

Next generation sequencing technology has been used to study the complete MPL gene, identifying numerous variants, most of unknown significance. The study investigators have a series comprising 41 variants of unknown significance, whose allelic frequencies suggest a germline origin for 80% of them. Their distribution within the MPL gene is similar to that of inactivating mutations, except that they were discovered in the context of suspected myeloproliferative disease. Characterizing the activity of these variants would confirm the diagnosis of MPN, opening the door to specific treatment (cytoreductive, JAK2 inhibitor or interferon). It also has an important prognostic value, particularly in the case of MPN, for which life expectancy varies from 5 to 7 years, with terminal progression to acute myeloid leukemia (AML in 15 to 20% of cases) or bone marrow failure.

Using a battery of functional assays, this study aims to characterize these variants.


Eligibility criteria: Inclusion Criteria:

• Patient with suspected MPN

Exclusion Criteria:

• Patient with variant of cMPL already described in the literature.

Primary outcomes:
measure: Growth of cultured cells with site-directed mutagenesis of identified variants in the presence of thrombopoietin
timeFrame: Day 0
measure: Ability of cultured cells with site-directed mutagenesis of identified variants to activate the MPL - JAK2 pathway
timeFrame: Day 0
measure: Ability of cultured cells with site-directed mutagenesis of identified variants to phosphorylate proteins in the MPL - JAK2 pathway
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Serge Carillo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772406: Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis
Official title: Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
colonoscopy
Dysplasia
Diagnosis
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone.

Detailed description: Patients with longstanding IBD have increased risk of colorectal cancer (CRC) compared to the general population. The association between duration of the disease and development of CRC is the rationale for endoscopic surveillance. Colonoscopic surveillance of ulcerative colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using Linked color imaging (LCI) of the colon, rather than the usual white light on the colon, will improve the detection of more dysplasia lesions in ulcerative colitis.

Eligibility criteria: Inclusion Criteria:patients with ulcerative colitis who meet surveillance criteria Exclusion Criteria:pregnant patients,unable or unwilling to give informed consent,patients with severe active colitis who would be unsafe to endoscope

Primary outcomes:
measure: The number of Colorectal Dysplasia detected by LCI
timeFrame: 6 months
Secondary outcomes:
measure: The endoscopic scores with LCI
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital to Academy of Military Medical Sciences
state: Beijing
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Yan Liu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leifeld L, Rogler G, Stallmach A, Schmidt C, Zuber-Jerger I, Hartmann F, Plauth M, Drabik A, Hofstadter F, Dienes HP, Kruis W; Detect Dysplasia Study Group. White-Light or Narrow-Band Imaging Colonoscopy in Surveillance of Ulcerative Colitis: A Prospective Multicenter Study. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1776-1781.e1. doi: 10.1016/j.cgh.2015.04.172. Epub 2015 May 5.
Clinical trial NCT04522206: An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Official title: An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Spine Injuries and Disorders
Narcotic Use
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective cohort study
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective spine surgery at NYU Winthrop
* Age over 18 years

Exclusion Criteria:

* History of neuromuscular disorders
* History of inflammatory arthropathies
* History of spine metastases or active cancer in spine
* Medical History including any of the following: renal dysfunction, gastric ulcers, hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic reactions to any of the medications in the study
* Age less than 18 years

Primary outcomes:
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: 24 hours
measure: Opioid Sparing and Rescue Time
timeFrame: 24 hours
Secondary outcomes:
measure: Length of Stay in Hospital
timeFrame: Up to 12 days
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Muhammad Tariq, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183206: Safety and Efficiency of γδ T Cell Against Breast Cancer
Official title: γδ T Cell Immunotherapy for Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Immunotherapy, γδ T Cell, Breast Cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2017-06-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

Detailed description: Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Eligibility criteria: Inclusion Criteria:

Age: 18-75 Karnofsky performance status \>50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 months Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease Insulin dependent diabetes Thyroid disease

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biotherapy center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
name: Jibing Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02483806: Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation
Official title: Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation: a Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are controversial studies whether it is supportive or not. In this prospective, cross-over study, the investigators are planning to investigate the effects of PEEP on intrapulmonary shunt, oxygenation and cardiac function as well.


Eligibility criteria: Inclusion Criteria:

* scheduled for VATS lobectomy
* 40 ≤ age ≤ 80
* American Society of Anaesthesiologists(ASA) physical status classification I\~III

Exclusion Criteria:

* American Society of Anaesthesiologists(ASA) physical status classification IV
* NYHA class III\~IV
* Severe obstructive lung disease and/or restrictive lung disease patients
* those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
* arrhythmia
* esophageal varix
* pregnant women

Primary outcomes:
measure: the effect of differential PEEP (0, 5, 10 cmH2O) by PaO2(P/F ratio)
timeFrame: 20 minutes after each PEEP apply
measure: Cardiac function
timeFrame: 20 minutes after each PEEP apply
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02504606: Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
Official title: A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 30
* Healthy as determined by a responsible physician

Exclusion Criteria:

* History of clinically significant disease
* Any chronic disease
* Creatine clearance less than 50ml/min
* Hypotension (100mmHg/60mmHg)
* Treatment of barbital type drug within 1 month
* Administration of herbal medicine within 7 days

Primary outcomes:
measure: Change from baseline in blood concentration of Amlodipine
timeFrame: 144 hour
measure: Change from baseline in blood concentration of Losartan
timeFrame: 10 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03925506: Predictive Factors of Inadequate Bowel Preparation in Inpatients
Official title: Identification of Predictive Factors of Inadequate Bowel Preparation in Inpatients. The Quality-In-Patients Study (QIPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation Solutions
Colonoscopy
Inpatient
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 1658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients hospitalized in 12 Centers in Italy, who are scheduled elective colonoscopy irrespective of the indication.

Brief summary: About 50-70% only of inpatients who undergo colonoscopy have an adequate bowel cleansing, which is far below the recommended threshold of 90%. Variables associated to inadequate colon preparation have not been assessed yet. Identifying such variables would allow to augment the diagnostic yield of colonoscopy, and also to reduce costs related to the need to repeat colonoscopy. Aim of the present study is to find variables independently associated to an inadequate bowel cleansing and to subsequently build and validate a predictive model, which could prove useful in clinical practice to identify hard-to-prepare inpatients. Secondary endpoints are (i) to assess the proportion of patients with inadequate colon cleansing, (ii) to run a cost-effectiveness analysis between patients with adequate cleansing and patients who need to repeat colonoscopy. Patients undergoing urgent colonoscopy, and patients who take the preparation at home will be excluded.


Eligibility criteria: Inclusion Criteria:

* Inpatient ≥18 y.o. who are scheduled elective colonoscopy during hospitalization irrespective of the indication.

Exclusion Criteria:

* Urgent colonoscopy
* Patients who are not hospitalized when taking bowel preparation or when undergoing colonoscopy

Primary outcomes:
measure: Inadequate bowel cleansing rate
timeFrame: At the end of the study, 3 months after the beginning of the study.
Secondary outcomes:
measure: Rate of patients scheduled for colonoscopy repetition due to inadequate bowel preparation
timeFrame: At the end of the study, 3 months after the beginning of the study.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
Study officials:
References:
citation: Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18.
Clinical trial NCT05148936: Communities Fighting COVID-19!
Official title: Communities Fighting COVID!
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-08
Enrollment: 32750
Sex: ALL
Minimum age (years): 6
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities.

Detailed description: Communities Fighting COVID is a partnership between San Diego State's School of Public Health and numerous communities in San Diego focused on providing community-based testing to specific language-speaking communities and vulnerable populations. This partnership is funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics-Undeserved Populations (Radx-UP), with the aim of ensuring all Americans have access to timely COVID-19 testing and diagnosis. Many communities, particularly immigrant and people of color communities, have a harder time accessing existing COVID-19 resources due to transportation, language barriers, or other barriers.

Eligibility criteria: Inclusion Criteria:

* African American, Arabic speaking, Filipino, and Latino/a populations

Exclusion Criteria:

* Younger than 6, not in focus populations

Primary outcomes:
measure: Test uptake
timeFrame: Through study completion, expected to be 20 months
Secondary outcomes:
measure: Test access
timeFrame: Through study completion, expected to be 20 months
measure: Test Impact (COVID-19 diagnoses)
timeFrame: Through study completion, expected to be 20 months
measure: Test Impact (number needed to screen)
timeFrame: Through study completion, expected to be 20 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Contact Households
state: California
Study officials:
affiliation: San Diego State University
name: Susan M Kiene, PhD
role: PRINCIPAL_INVESTIGATOR
References: