louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02450461: Breath Analysis in Asthma
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Exhaled Breath
Mass Spectrometry
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2015-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from asthma will be included according to the predefined inclusion and exclusion criteria.

Healthy controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.

Brief summary: The purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria: Inclusion Criteria:

1. Confirmed asthma. Diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in FEV1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (PC20 methacholine \< 4mg/ml) at the time of diagnosis.
2. Age between 18 and 80 years at study entry.
3. Healthy controls: never-smokers, normal spirometry (baseline FEV1 \> 85% predicted and FEV1/FVC greater than 0.7).

Exclusion Criteria:

1. Asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids)
2. Any lung disease other than asthma.
3. Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
4. Regular intake of oral steroids.
5. Active smoking habits / positive history of smoking.
6. Acute or chronic hepatic disease.
7. Renal failure or renal replacement therapy.
8. Pregnancy.

Primary outcomes:
measure: The primary outcome will be the asthma specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of asthma in exhaled breath)
timeFrame: 1 day, single measurement, no follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
References:
Clinical trial NCT00302861: A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Official title: Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: B-Cell Chronic Lymphocytic Leukemia
Keywords: B-Cll
Lead sponsor: Genitope Corporation
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.


Eligibility criteria: Inclusion Criteria:

* Have signed a written informed consent
* B-CLL diagnosis
* Rai Stage 0, I, or II
* Previously untreated
* Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured

Exclusion Criteria:

* Anti-leukemia treatment prior to beginning immunization
* Anti-leukemia treatment other than Id-KLH during immunizations
* Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
* Pregnant or lactating
* Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)
* Participation in any other clinical trial in which an investigational agent is administered

Primary outcomes:
measure: The proportion of patients with positive humoral immune responses
measure: Safety and toxicity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Thomas Kipps, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03203083: Single Leg Squat Performance in Physically and Non-physically Active Individuals
Official title: Single Leg Squat Performance in Physically and Non-physically Active Individuals: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single Leg Squat Performance
Athletic Injuries
Keywords: Reproducibility of Results
Clinical Assessment
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of healthy young subjects was recruited.

Brief summary: Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower limb function as a preventive injury strategy. SLS clinical rating is a qualitative evaluation and it does not count objective outcomes as kinematics data and surface electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i) to determine the clinical rating agreement among six raters and (ii) to assess kinematic and sEMG predictors of good SLS performance in physically and non-physically active individuals.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) between 18.5-25.5,
* age between 18-35 years old,
* written informed consent to participate,

Exclusion Criteria:

- musculoskeletal pain or history of lower extremity injuries lasting more than three months

Primary outcomes:
measure: reliability of the clinical assessment
timeFrame: Baseline
measure: reliability of the clinical assessment
timeFrame: 2 weeks after the first evaluation
measure: reliability of the clinical assessment
timeFrame: 1 month after the first evaluation
Secondary outcomes:
measure: kinematic predictors
timeFrame: Baseline
measure: sEMG predictors
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Gianola S, Castellini G, Stucovitz E, Nardo A, Banfi G. Single leg squat performance in physically and non-physically active individuals: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jul 14;18(1):299. doi: 10.1186/s12891-017-1660-8.
Clinical trial NCT05827783: The Effect of Buzzy and Puppet on Pain and Fear
Official title: The Effect of Buzzy and Puppet on Pain and Fear During Phlebotomy in Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Nurse's Role
Keywords: Pain
Fear
External cold and vibration
pediatrics
Puppet
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 105
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy.

Method: This study is a randomized controlled trial. The study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet; group 3, control) by block randomization. Children's pain and fear scores were evaluated using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.


Eligibility criteria: Inclusion Criteria:

* Participants whose child and parents agreed to participate in the study
* Children who had successful phlebotomy on the first attempt

Exclusion Criteria:

* Children with chronic disease, mental disability, or mental retardation
* Children who had taken analgesics in the last 24 hours
* Children who were hospitalized
* Children who had undergone a surgical procedure
* Children who did not have successful phlebotomy on the first attempt

Primary outcomes:
measure: Statistical difference between groups about pain scores
timeFrame: During the procedure, approximately 5-10 minutes
measure: Statistical difference between groups about fear scores
timeFrame: During the procedure, approximately 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Bakırcay University
Study officials:
affiliation: Izmir Bakircay University Hospital
name: Şeyda Binay Yaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457183: Clinical Evaluation of Bedside Pulse Lavage Irrigation Device
Official title: Bedside Pulse Lavage Irrigation Project
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: pulsed lavage
evaluate containment
evaluate tolerability
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2011-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how well the water stream is contained by a new containment device.

Detailed description: Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. This study evaluates how well the device contains the spray from pulse lavage and how well subjects with intact skin tolerate pulse lavage when awake.

Eligibility criteria: Inclusion Criteria:

* Subjects must be healthy and willing to complete the study procedures.

Exclusion Criteria:

* Subjects must not have any chronic pain conditions or take any pain medications on a regular basis. Must not have any chronic wounds. Must not have any medical conditions that interfere with pain sensation. Must not have an allergy to skin adhesives. Patients must not be taking any immunosuppressive medications. Patients must not have any chronic infections.

Primary outcomes:
measure: Leak
timeFrame: up to 1 day
Secondary outcomes:
measure: Seals
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert D Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008683: Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation
Official title: Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: H1N1 Influenza
Keywords: Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 300
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Brief summary: Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

In these patients the investigators will measure the specific antibody production.

Detailed description: Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.

In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

Eligibility criteria: Inclusion Criteria:

* Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Exclusion Criteria:

* Patients with unstable grafts.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah
name: Dan Engelhard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06173583: ARISCAT and LAS VEGUS Risk Scores for Predicting Postoperative Pulmonary Complications After Cardiac Surgery
Official title: ARISCAT and LAS VEGUS Risk Scores for Predicting Postoperative Pulmonary Complications After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Complication
Postoperative Complications
Postoperative Pulmonary Complications
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of either gender, aged between 18-65 years, undergoing elective heart surgery.

Brief summary: The goal of this observational study is to compare the, ARISCAT and LAS VEGUS scales, for predicting postoperative pulmonary complications in patients undergoing cardiac surgery. The study aims to compare the diagnostic accuracies of the two risk prediction scores in predicting postoperative pulmonary complications.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective heart surgery

Exclusion Criteria:

* Refusal to consent
* Patients undergoing emergency surgery

Primary outcomes:
measure: Diagnostic Accuracy of ARISCAT and LAS VEGAS Scoring systems
timeFrame: Day 1-5
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT05088083: Paclitaxel-Coated Balloon for the Treatment of AVF
Official title: Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arteriovenous Fistula
Keywords: DCB
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.


Eligibility criteria: Inclusion Criteria:

* Age during 18-85 years old
* Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
* Venous stenosis of the AV fistula
* target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
* the length of target lesion ≤100mm
* Patient able to give informed consent
* residual stenosis ≤30% after predilation

Exclusion Criteria:

* Women who are breastfeeding, pregnant or are intending to become pregnant
* AVF located at lower limbs
* Two or more than two stenosis at the target vessel.
* Obstruction of central venous return
* ISR
* AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
* Vascular access has surgery in 30 days or intending to undergo a surgery
* Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* Patients undergoing immunotherapy or suspected / confirmed vasculitis
* Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
* Vascular access infection or systemic active infection
* Patients's life expectancy is less than 12 months
* Renal transplantation has been planned or converted to peritoneal dialysis
* Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
* Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Primary outcomes:
measure: primary patency of target lesion in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Device Success
timeFrame: Time of procedure
measure: Clinical Success
timeFrame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
measure: Procedural Success
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Lan Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788983: Induced Hypoxia Study for Validation of SpO2 Accuracy
Official title: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Keywords: Induced hypoxia
Pulse oximeter
Nonin Medical
Verification of SpO2 accuracy
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, consenting, non-smoking subjects, 18 years or greater, both genders and a range of skin tones

Brief summary: Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).

Detailed description: The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.

An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Eligibility criteria: Inclusion Criteria:

* Non-smokers
* Healthy; no known blood disorders
* Finger sizes within the sensor specifications
* Minimum 18 years of age

Exclusion Criteria:

* Artificial nails or fingernail polish

Primary outcomes:
measure: SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100%
timeFrame: During Analysis
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Induced Hypoxia Lab
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip E Bickler, MD
role: PRINCIPAL_INVESTIGATOR
References: