louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02917850: Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
Official title: Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Hemiplegia
Gait
Keywords: stroke
gait
hip flexors
paresis
hemiplegia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 0
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: Post-stroke patients often present with gait disorders due to several physical impairments. Hip flexor deficit is one of the more prevalent trouble and is associated with gait capacities. This study aims at evaluating the impact of an isokinetic hip flexors strengthening rehabilitation program in the subacute phase after stroke. Patients will be randomized to an intervention group (isokinetic rehabilitation) or a control group (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and at 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from a first ever stroke
* At the subacute phase
* Able to walk at least 10m with or without assistive devices
* Hip flexors strength on the paretic side \> 2/5 (MRC)

Exclusion Criteria:

* Uncontrolled epilepsy
* Contraindications to physical activity (severe arterial hypertension, aortic valvulopathy, severe PAD...)
* History of muscular or joint disorders on the paretic hip
* Subject unable to deliver an informed written consent (due to aphasia, cognitive or psychiatric disorders...)
* Protected persons
* Pregnancy

Primary outcomes:
measure: Max gait speed (m/s)
timeFrame: 6 weeks
Secondary outcomes:
measure: Max gait speed (m/s)
timeFrame: 3 and 6 months
measure: Hip flexors strength
timeFrame: 6weeks; 3 and 6 months
measure: Gait endurance
timeFrame: 6 weeks; 3 and 6 months
measure: Gait capacities
timeFrame: 6 weeks; 3 and 6 months
measure: Balance and postural control
timeFrame: 6 weeks; 3 and 6 months
measure: Balance and postural control
timeFrame: 6 weeks; 3 and 6 months
measure: Rate of perceived exhaustion during gait
timeFrame: 6 weeks; 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Etienne Allart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03012750: Angiosome Perfusion After Tibial Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.

Detailed description: Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.

Eligibility criteria: Inclusion Criteria:

* Patients at CLI Rutherford stages IV to VI
* Patients with necessity of tibial Bypass surgery

Exclusion Criteria:

* Allergy against indocyanine green
* Iodine allergy
* Contrast allergy
* Penicillin allergy
* Allergic diathesis
* Liver insufficiency
* Pregnancy
* Hyperthyreosis
* Pulmonary arterial hypertension

Primary outcomes:
measure: Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
timeFrame: 12 months
measure: Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)
timeFrame: 12 months
Secondary outcomes:
measure: Correlation of the wound healing rates with indirect and direct revascularization
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Rother U, Lang W, Horch RE, Ludolph I, Meyer A, Gefeller O, Regus S. Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery. Eur J Vasc Endovasc Surg. 2018 Feb;55(2):215-221. doi: 10.1016/j.ejvs.2017.11.024. Epub 2018 Jan 3.
Clinical trial NCT00594750: Mechanisms of Exacerbation of Asthma
Official title: Mechanisms of Exacerbation of Asthma
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Asthma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-01-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: emergency deparment, admitted patients in the ICU and inpatient wards

Brief summary: The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma.

Detailed description: In this study, we will explore mechanisms of exacerbation in asthma by careful characterization studies in asthmatics presenting in acute severe exacerbation. Specifically, we will determine the frequency of secretor status in these subjects by blood and saliva testing, and we will also perform a detailed cellular and biochemical analysis of their airway secretions. We will collect airway secretions using two methods. One method will be to have subjects cough sputum into a clean plastic container. The other method only applies to asthmatics with near-fatal asthma requiring intubation and mechanical ventilation. In these asthmatics, we will collect airway secretions by tracheal aspirate using methods normally applied in their clinical care.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects with a history of asthma between the ages of 18 to 75 years.
2. Physician diagnosis of asthma.
3. Currently experiencing an acute exacerbation of asthma. This exacerbation may be severe necessitating treatment in the emergency room, ICU, or hospital ward.
4. Ability to provide informed consent.

Exclusion Criteria:

1. Lung disease other than asthma.
2. Females who are lactating or who are pregnant.
3. Use of recreational drugs in the 1 month preceding the study.

Primary outcomes:
measure: rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Airway Clinical Research Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: John V Fahy, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06114550: Resistance Training on Growth Factors
Official title: Acute Effect of Resistance Training With Different Intensity on Circulating Levels of Neurotrophic Growth Factors and Homocysteine in Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Function
Keywords: neurotrophic growth factors
IGF-1
BDNF
VEGF
Irisin
Hcy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinial trial study is to explore the effect of high or low intensity resistance training (LIRT) under similar training volume on change in serum levels of BDNF, IGF-1, VEGF, irisin, and plasma Hcy in young adults.The main questions it aims to answer are:

1. Whether high and low intensity will increase the serum levels of BDNF, IGF-1, VEGF, irisin, and reduce plasma Hcy.
2. whether a greater magnitude of change would be suffer in low intensity group when compared to high intensity group, as an effect of greater physiological adaptation produced by more repetitions required to complete.

Participants will performe two different intensity resistance training (HIRT, at 80%1RM with 12 repetitions and 4-5 sets and LIRT, at 40%1RM with 24 repetitions and 4-5 sets).

Researchers will compare the training effects of two different training on these growth factors.


Eligibility criteria: Inclusion Criteria:

* age between 18 to 30 years
* no experiencing musculoskeletal disorders or sports injuries
* had not participated any regular aerobic endurance or resistance training with in the previous half years
* no smoking habit or intake alcohol and other medication (e.g., steroid hormone)
* good general body condition without any chronic diseases (e.g., osteoarthritis, metabolic syndrome or arthritis)

Exclusion Criteria:

* experiencing musculoskeletal disorders or sports injuries in recent 1 month
* had regular resistance training exercise
* intake any supplementary(drug and hormone)

Primary outcomes:
measure: Rata of perceived exertion
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: Blood lactate
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: BDNF
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: IGF-1
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: VEGF
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: Irisin
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: Hcy
timeFrame: "0 minutes" "60 minutes" "90 minutes"
Secondary outcomes:
measure: Reactive time
timeFrame: "0 minutes" "60 minutes" "90 minutes"
measure: Accuracy rate
timeFrame: "0 minutes" "60 minutes" "90 minutes"
Other outcomes:
Locations:
Study officials:
affiliation: Air Force Medical Center of Chinese PLA
name: chongwen zuo, Doctoral
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01857050: Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins
Official title: Assessment of INR Prolongation in Patients Treated Simultaneously With Warfarin and Antibiotics From the Cephalosporins Family,Observational Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Pulmonary Embolism
Atrial Fibrillation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 236
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: Warfarin-treated patients who were hospitalized for any reason in the department of internal medicine and were treated with antibiotics from the Cephalosporins group during their hospitalization.

Brief summary: Many drug interactions with Warfarin are well documented in the literature, including interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict when the interaction remains theoretical and when it becomes clinically significant and will be reflected in the individual patient. This study's aim is to identify and characterize related conditions (including comorbidities, laboratory test results and other parameters related to the patient)that might be predictors for drug interactions turning from theoretical to clinically significant.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and over
* Patients treated with a combination of Warfarin and Cephalosporins
* Patients who were hospitalized in the department of internal medicine
* Patients who were treated with Warfarin without Cefalosporins

Exclusion Criteria:

* Patients on Warfarin who did not actually receive the drug during their hospitalization
* Patients whose medical records were not accessible or didn't contain full data

Primary outcomes:
measure: Reasons for INR prolongation in patients who were treated with the combination of Warfarin and Cephalosporins
timeFrame: Participants will be followed for the duration of thei hospital stay, an expected average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Hospital, Kfar Saba, Israel
name: Michael Lishner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04441450: ADME Study of [14C]ICP-022 in Healthy Males
Official title: Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022.


Eligibility criteria: key Inclusion criteria:

1. Weight: Body mass index (BMI) is 19\~26 kg/m2
2. signing of informed consent
3. Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process

Key Exclusion Criteria:

1. physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, blood coagulation routine, urine routine, stool routine + occult blood, serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior), abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other abnormalities and clinical significance.
2. ophthalmologic examination shows abnormality and clinical significance
3. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody.
4. Within 1 month before the screening, having not limited to known as hepatic enzyme inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals) ;
5. Within 1 month before the screening, receiving the anticoagulant therapy such as warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022
timeFrame: Up to14 days
measure: Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers
timeFrame: Up to14 days
Secondary outcomes:
measure: Quantitative analysis of the concentration of ICP-022 in plasma
timeFrame: Up to14 days
measure: The biotransformation pathways of [14C]ICP-022
timeFrame: Up to14 days
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04883450: PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer
Official title: PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-12
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kaiser Permanente Southern California with at least 12 months prior to recruitment

Brief summary: Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.

Detailed description: The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

1. Patient must have 6 months of membership
2. Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
3. Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
4. Speaks English or Spanish

Exclusion Criteria:

1. Previous or current history of pancreatic cancer
2. Metastatic cancer
3. Current active cancer or undergoing chemotherapy for cancer
4. Currently pregnant or breastfeeding
5. Class IV heart failure
6. Cirrhosis with ascites and/or varices
7. Currently in a skilled nursing facility or under hospice care
8. Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel
9. End stage renal disease
10. Cognitive impairment such that the person is unable to provide informed consent

Primary outcomes:
measure: Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group
timeFrame: 18-Month
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Bechien U Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907850: Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Official title: A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Muscle Soreness
Keywords: Delayed onset muscle soreness
Ultramarathon
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Racing the Planet
First posted: 2023-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase I randomized, 2 arm single blinded feasibility study
Primary purpose: TREATMENT

Brief summary: The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.

Detailed description: The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or over
4. In good general health as evidenced by readiness to participate in an ultramarathon
5. Ability to take oral medication and be willing to adhere to the study regimen
6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.

Exclusion Criteria:

1. Unable to read or understand English
2. Under 18 years of age
3. Pregnancy or lactation
4. Known allergic reactions to components of the investigational drugs

Primary outcomes:
measure: Muscle soreness measure for long stage of the ultramarathon
timeFrame: Baseline to 6 days
Secondary outcomes:
measure: Muscle soreness measure post-race
timeFrame: Day 7
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Steven Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: