louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01396863: Brain Swelling During Dialysis
Official title: Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Renal dialysis
Hemodiafiltration
Hemodialysis
MRI
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2011-07-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.

The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa.

Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Informed consent
* Patient with end-stage renal disease (ESRD)
* Stabile hemodialysis treatment (Kt/V ≥ 1.3)
* No contraindications against MRI (pacemaker or other metal implants, claustrophobia, severe adiposity)
* Weight \<140kg

Exclusion Criteria:

* Clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study
* Changes in corticosteroid treatment during the last two weeks
* Change in diuretics during the last two weeks
* Non-compliant with regard to salt and fluid intake
* Acute disease

Primary outcomes:
measure: Percent Brain Volume Change (PBVC)
timeFrame: Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Renal Medicine C, Aarhus University Hospital, Skejby
city: Aarhus N
country: Denmark
facility: The MR-Research Centre, Aarhus University Hospital, Skejby
Study officials:
affiliation: Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
name: Jens D. Jensen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
name: Niels Johansen, BSc Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832663: Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration
Official title: The Influence of Blocking Inflammatory Activity in Vivo on Skeletal Muscle Regeneration in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Damage
Keywords: Muscle regeneration
Satellite cells
electrical stimulation
eccentric contractions
myogenic precursor cells
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: Team Denmark
name: Danish Ministry of Culture
name: Anti Doping Danmark
name: The Danish Rheumatism Association
name: King Christian IX and Queen Louise Jubilee Bursary
First posted: 2009-01-30
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the influence of non-steroidal anti-inflammatory drugs (NSAIDs) on muscle regeneration.

The investigators' hypothesis is that ingestion of NSAID will delay or impair muscle regeneration.

Detailed description: The model employed to induce muscle damage is electrical stimulation. Muscle biopsies will be examined to follow the response of satellite cells and muscle regeneration. Study participants will be randomly assigned to a placebo or NSAID group in a double-blinded manner.

Eligibility criteria: Inclusion Criteria:

* male
* healthy
* does not exercise regularly

Exclusion Criteria:

* displays contraindications for taking NSAID
* well-trained

Primary outcomes:
measure: Muscle regeneration
timeFrame: 1 month
Secondary outcomes:
measure: Muscle strength
timeFrame: 1 month
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
Study officials:
affiliation: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
name: Abigail L Mackey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01056263: Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012
Official title: Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: retrospective trial
5-year survival
metastatic renal cancer cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\].

Brief summary: The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 \[NCT00076011\] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

Detailed description: Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\]. Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\].

5-year survival information to be updated.

Eligibility criteria: Inclusion Criteria:

* Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\] and may have also participated in study A4061008 \[NCT00828919\]

Exclusion Criteria:

* Subjects who withdrew from the original study A4061012 \[NCT00076011\] or the continuing access study A4061008 \[NCT00828919\]

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline until death or up to Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03030963: Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery
Official title: Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss, Surgical
Keywords: Equal ratio ventilation(ERV)
Peak inspiratory pressure(PIP)
Blood loss
Posterior lumbar interbody fusion(PLIF)
Prone position
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ventilator mode change was associated with decrease in blood loss during posterior lumbar interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose of this study was to determine the effect of equal ratio ventilation (ERV), which sets the I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due to decrease in the PIP.

Detailed description: After anesthesia, patients will receive ventilator settings according to theri group. The CVP will be measured before and after the prone position to ensure the proper positioning. Airway pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index. Recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin suture, and 5min after supine position. Amount of bleeding, coagulation profile and Hct will be recorded 72 hrs after the surgery.

Eligibility criteria: Inclusion Criteria:

* 1) Age : 20\~75 yr-old 2) Surgery : Posterior lumbar interbody fusion(PLIF) 2\~3 levels

Exclusion Criteria:

* 1) Urgent or Emergency case 2) Previous lnstrumentation of lumbar spine (Exclusion : Discectomy, Partial hemilaminiectomy, etc) 3) Concurrent other operation 4) Patients who cannot understand informed consent (ex. Illiterate, Foreigner) 5) Obesity (BIM\>30kg/m2) 6) Recent myocardial infarction (within 3 months) 7) Reduced left and right ventricular function (Ejection fraction\<40%) or Congestive heart failure 8) Preoperative dysrhythmia 9) Aspirin or Plavix during perioperative periods 10) Lung disease 11) Chronic kidney disease or Dialysis 12) Severe hepatic disease

Primary outcomes:
measure: The amount of intraoperative surgical bleeding
timeFrame: At the end of the surgery, approximately 4 hrs.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Jiyoung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02243163: Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
Official title: Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Breast Carcinoma
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy)

Detailed description: It is well-known that exercise promote immune regulation for better life quality. However, the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda yoga might benefit breast cancer women with completion of operation and/or chemotherapy and radiotherapy. The benefits could be due to immune modulation, and improve health perception and life quality, and even potential decrease of cancer relapse.

The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1) to improve personal health perception, 2) to improve life quality and 3) to enhance human immunity. The study secondary endpoint will follow up the immunity changes 3 months after the intervention.

We anticipate to reach the primary endpoints and to publish the primary results in one year, the secondary endpoint will complete in the second year.

Eligibility criteria: Inclusion Criteria:

* Able to attend yoga program weekly, and fill out inform consent.
* Patients with breast cancer after complete treatment for at least 3 months (including surgery and / or radiotherapy and/or chemotherapy).

Exclusion Criteria:

* male
* overweight
* unable to do yoga exercise.

Primary outcomes:
measure: Improve personal health and life quality
timeFrame: Change from baseline in personal health and life quality at 6 months.
Secondary outcomes:
measure: Immune modulation
timeFrame: Change from baseline in human immunity at 3 months.
Other outcomes:
Locations:
city: Changhua County
country: Taiwan
facility: Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
name: Shu-Hui Yeh, PhD
role: STUDY_CHAIR
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Kuender D. Yang, PhD
role: STUDY_DIRECTOR
affiliation: Show Chwan Memorial Hospital
name: Shin-Mae Wang, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06381063: Non-steroidal Anti-inflammatory in Cardiac Surgery
Official title: Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Postoperative Pain
Non-steroidal Anti-inflammatory Drugs
Cardiac Surgery
Pain Intensity
Multimodal Pain Management
Keywords: Acute Postoperative Pain
non-steroidal anti-inflammatory drugs
cardiac surgery
pain intensity
multimodal pain management
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
name: University Hospital, Lille
First posted: 2024-04-24
Enrollment: 238
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: Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.


Eligibility criteria: Inclusion Criteria:

* scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
* under cardiopulmonary bypass
* Affiliation to the French national healthcare system
* Written consent obtained

Exclusion Criteria:

* age\<18
* weight\<50 kg
* chronic use of NSAID
* mini-invasive surgery
* NSAID contraindication
* NSAID allergy
* Nefopam contraindication
* Paracetamol contraindication
* Tramadol contraindication
* Urgent surgery
* Endocarditis
* Immunosuppressive drug
* HIV infection with CD4\<200 mm3
* Organ transplantation
* Stage 4 or 5 chronic kidney disease
* Gastro duodenal ulcer
* Pregnancy
* Depression
* Auto immune disease

Primary outcomes:
measure: reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery
timeFrame: at 24 hours
measure: NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
timeFrame: at 24 hours
Secondary outcomes:
measure: Change in pain trajectory during the first 7 days after cardiac surgery
timeFrame: 7 days
measure: Change in cumulative opioid within 48 hours after surgery
timeFrame: 48 hours
measure: Change in pulmonary postoperative complications within 7 days after surgery
timeFrame: 7 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT06661863: Effectiveness of Alveolar Bone Preservation in Alveoli With Infectious Process
Official title: Effectiveness of Autologous Bone and Bioactive Glass for Alveolar Preservation in Alveoli With Infectious Process
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: Alveolar Resorption
Alveolar process
Bone Substitutes
Alveolar Bone Grafting
Lead sponsor: Universidad de Especialidades Espiritu Santo
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes 28 patients who have a tooth extraction indicated in reference to g. avila-ortiz et al. 2020. They will be divided into 2 randomized groups, 14 sockets with an infectious process will be preserved with autologous bone and the remaining 14 with 58s bioactive glass
Primary purpose: TREATMENT

Brief summary: Alveolar ridge preservation (ARP) is a surgical technique that aims to minimize the degree of dimensional changes following extraction. In the healing period after extraction, the alveolar bone (AB) undergoes morphological changes during the remodeling process. The changes become evident immediately after tooth extraction, with greater resorption changes observed during the first two months, and these dimensional changes can be observed 1 year after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patients with indicated tooth extractions
* Patients who have accepted the conditions of the study

Exclusion Criteria:

* Pregnant patients, breastfeeding or using oral contraceptives
* Smoking patients
* Patients with uncontrolled systemic diseases
* History of autoimmune disease
* Previous traumatic extraction
* Patients taking bisphosphonates or anticoagulants
* Patients who are or have undergone chemotherapy and radiotherapy

Primary outcomes:
measure: To evaluate bone formation
timeFrame: The evaluation will occur from enrollment through the end of treatment at 12 months. Assessments will be conducted preoperatively, 7 days post-surgery, as well as at 3, 6, and 12 months following the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Samborondon
country: Ecuador
facility: Universidadees
state: Guayas
Study officials:
References:
Clinical trial NCT03316963: Neostigmine For Snoring During DISE
Official title: Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Snoring
Keywords: Neostigmine
Nerve stimulant medication
Treatments for snoring
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring.

Detailed description: Snoring is a major problem, affecting 40 million Americans. The disease affects patient and partner sleep quality as well as daytime function. Snoring treatment is limited by device compliance (mouth appliance, positive airway pressure) and insurance does not regularly pay for these devices. Surgical treatment for snoring has mixed results. As a result, there is an important need to develop new treatments for snoring.

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring. If successful, development of a topical (non-injectable) version of this drug will be considered, so that the patient can apply him/herself before bedtime.

Eligibility criteria: Inclusion Criteria:

* Snoring or mild obstructive sleep apnea
* English-speaking
* Greater than 18 years old
* Able to give informed consent

Exclusion Criteria:

* On active anti-coagulation medication
* Pregnant women
* Hypersensitivity to neostigmine
* Peritonitis or mechanical obstruction of the intestinal or urinary tract
* Coronary artery disease
* Cardiac arrhythmia
* Recent acute coronary syndrome
* Myasthenia gravis

Primary outcomes:
measure: Change in decibel sound after injection of neostigmine
timeFrame: The DISE will occur up to 30 days after the pre-op visit and study enrollment
measure: Change in soft palate motion after injection of neostigmine
timeFrame: The DISE will occur up to 30 days after the pre-op visit and study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Raj C. Dedhia
state: Georgia
Study officials:
affiliation: Emory University
name: Raj C. Dedhia, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958863: Impact of Facemasks on Running During COVID-19 Pandemic
Official title: Running and Facemasks During COVID-19 Pandemic: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shortness of Breath
Keywords: Oxymetry
Shortness of Breath
Running
Masks
COVID-19
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Randomized crossover clinical trial in which a group of runners are ask to complete a 15 minutes standardized physical test on a treadmill. The same group of participants are randomized to the order in which they use a facemask (surgical mask, polyester reusable cloth mask) or no mask, while running.

Each test, according to the type of mask or no mask, are held on different dates. Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the test.

Detailed description: Between 15-20 recreational runners are included in a crossover trial to run under three different conditions the same 15-minutes treadmill running test. They Will run wtih surgical mask, polyester reusable cloth mask or without mask. The order in which they use or not the mask is randomized. Each test is done on a different day.

Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the test.

The primary outcomes are the differences in heart rate, oxygen saturation and shortness of breath at the end of the test, between groups.

Eligibility criteria: Inclusion Criteria:

* Recreational runners.
* Age between 16-65 years.
* Workers or students from the health area.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Shortness of breath in a visual analogue score (1-10)
timeFrame: At the end of the 15-minutes test
measure: Oxygen saturation
timeFrame: At the end of the 15-minutes test
measure: Heart rate
timeFrame: At the end of the 15-minutes test
Secondary outcomes:
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Juan P Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: