louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02260583: Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients
Official title: EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Patients
Chronic Respiratory Failure
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed.

Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal device, in reducing the PaCO2 level

Detailed description: Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed.

Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients Recently extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot physiological study we want to assess the safety and efficacy of this technique in reducing the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non responding to chronic NIV.

Eligibility criteria: Inclusion Criteria:

* COPD ( FEV1/CVF \<0.70 post bronchodilation)
* stable PaCO2 \>55 mmHg non respondent to long-term NIV (at least one week). This means a decrease in PaCO2 during spontaneous breathing, at least 4 hrs after the termination of NIV, of\< 6%
* pH \> 7.35
* clinical stability

Exclusion Criteria:

* Mean Arterial Pressure \< 60 mmHg
* contra-indication to heparin
* Body Mass Index (BMI) \> 30 kg/m2;
* presence of sleep apnea or overall syndrome

Primary outcomes:
measure: arterial blood gases
timeFrame: 30 days
Secondary outcomes:
measure: respiratory rate, dyspnea
timeFrame: 30 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: san'Orsola Malpighi Hospital, Bologna ITALY
Study officials:
affiliation: sant'orsola malpighi hospital
name: stefano nava
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05917483: Evaluation of Mechanical Characteristics of Tendons of Athletes Using Sonography
Official title: Evaluation of Mechanical Characteristics and Prevention From Overuse Injury of Tendons of Elite Athletes Using Dynamic Sonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overuse Injury
Rotator Cuff Injuries
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Baseball pitcher from city baseball team and actively participating season games

Brief summary: The investigators analyzed the strain of the rotator cuff tendon of baseball pitchers obtained using ultrasonography and compared the change in peak tendon strain before and after the regular season.


Eligibility criteria: Inclusion Criteria:

* Baseball pitchers in city baseball team

Exclusion Criteria:

* History of shoulder disorder or surgery

Primary outcomes:
measure: Peak tendon strain
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tianmu Sports Park/ Baseball Stadium
Study officials:
References:
Clinical trial NCT04321083: Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
Official title: Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obstructive Sleep Apnea
Pediatric Sleep Apnea
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: INVOS Medtronic device will be applied simultaneously with sleep lab monitoring
Primary purpose: DIAGNOSTIC

Brief summary: The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements.

Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.

Detailed description: a prospective cohort study study group - pediatric population referred to PSG in Dana Duek Hospital. After informed consent received from the parents, the parents will fulfill "Connors" (age 6 +) \& "Brief" (age 4-6) questionnaires.

During the PSG, the brain saturation will be monitored by INVOS(TM) Medtronic device. They will be monitored \& synchronized with the peripheral saturation documented performed as part of the PSG examination.

The brain saturation \& peripheral saturation levels will be compared and both will be correlated to the questionnaires \& AHI.

Eligibility criteria: Inclusion Criteria:

* 4-16 y/o pediatric population referred for PSG in Dana Hospital

Exclusion Criteria:

* down synd.
* craniofacial malformation
* PPD

Primary outcomes:
measure: correlation between brain o2 levels to peripheral measurements
timeFrame: procedure (during the examination PGS)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Dana Duek pediatric hospital TASMC
Study officials:
affiliation: Dana Duek pediatric hospital, TASMC, TA, ISRAEL
name: Ari Derowe, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03603483: Aortic Root Enlargement in Aortic Valve Replacement
Official title: Short Term Outcome of Aortic Root Enlargement in Management of Small Aortic Annulus Among Patients With Severe Valvular Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Replacement
Keywords: patients- prosthesis mismatching
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus
Primary purpose: TREATMENT

Brief summary: Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. Prosthesis-patient discrepancy results in worse outcomes.

Detailed description: Prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. In this study the investigators will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic Annulus in Patients with severe valvular aortic stenosis

Eligibility criteria: Inclusion Criteria:

* 17-75 years old
* patients with sever aortic valve stenosis undergoing valve replacement surgery
* informed consent has been obtained

Exclusion Criteria:

* Planned off-pump cardiac surgery
* Patients required intra-aortic balloon pump
* under 17 years of age

Primary outcomes:
measure: Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg
timeFrame: Baseline 6 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt
name: Mohamed mahmoud ahmed, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dumani S, Likaj E, Dibra L, Llazo S, Refatllari A. Aortic Annular Enlargement during Aortic Valve Replacement. Open Access Maced J Med Sci. 2016 Sep 15;4(3):455-457. doi: 10.3889/oamjms.2016.098. Epub 2016 Sep 2.
citation: Rocha RV, Manlhiot C, Feindel CM, Yau TM, Mueller B, David TE, Ouzounian M. Surgical Enlargement of the Aortic Root Does Not Increase the Operative Risk of Aortic Valve Replacement. Circulation. 2018 Apr 10;137(15):1585-1594. doi: 10.1161/CIRCULATIONAHA.117.030525. Epub 2017 Nov 22.
Clinical trial NCT03591783: Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease
Official title: Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis c
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chronic HCV infection with type 2 DM, who are eligible for antiviral therapy.

Brief summary: Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4


Eligibility criteria: Inclusion Criteria:

* Chronic HCV infection will be diagnosed based on positive testing for serum HCV RNA and anti-HCV Ab.
* Diagnosis of type 2 DM will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of HbA1c more than 6.5 % on oral hypoglycemic therapy.

Exclusion Criteria:

* Chronic hepatitis due to causes other than HCV infection
* Coinfection with HBV infection
* Hepatocellular carcinoma
* Child C stage of liver cirrhosis.
* Patients with type I diabetes mellitus.
* Cardiopulmonary diseases.
* Major illness.
* Patient receiving corticosteroids.
* Patient refused consent.

Primary outcomes:
measure: the percentage of patients with glycemic control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02332083: Innovative Training Program for Elderly in Need of Care
Official title: Skilling-up Exercise for Elderly in Need of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Performance Status
Cognition - Other
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2015-01-06
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled study was to examine the effects of a 8 weeks innovative training regime (stochastic resonance whole-body vibration \[SR-WBV\] and virtual virtual games \[VG\]) in the skilling up phase on physical performance, cognition and falls in elderly in need of care population.

Detailed description: Sensorimotor and strength exercise are methods to increase strength \& power in the field of geriatrics. The question that arise what exercises are best suited to and most effective for elderly in need of care individuals. Such populations are advised first to enter a "skilling up program" before more traditional forms of training exercises are implemented.

Goals in the skilling up phase: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.

The aim of the study in the skilling up phase:

Study the effect on physical performance Study the effects on muscle strength. Study the effects on cognition. The participants will be recruited in Canton Zurich, Swizerland and will be randomly allocated to an intervention group or sham group

Eligibility criteria: Inclusion Criteria:

* RAI (Resident Assessment Instrument) \>0
* live in canton Zurich
* in terms of training load be resistant.

Exclusion Criteria:

* acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute

  * surgical scars
  * seniors with prosthesis.
  * alcoholic
  * acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
  * acute inflammation or infection tumors
  * fresh surgical wounds
  * severe migraine
  * epilepsy acute severe pain

Primary outcomes:
measure: Short physical performance battery (SPBB)
timeFrame: 8 weeks
Secondary outcomes:
measure: Cognition
timeFrame: 8 weeks
measure: The falls efficacy scale-international (FES-I)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University of Applied Science, Department Health
Study officials:
affiliation: BUAS
name: Heiner Baur, PD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ETHZ
name: Eling de Bruin, PD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00404183: A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis
Official title: A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Pain associated with osteoarthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Males or females ages 21 to 75
* Has osteoarthritis of the hip or knee
* Requires therapeutic doses of medications for osteoarthritis
* If female, must be of non-childbearing potential or practicing birth control
* Has sufficient pain to justify the use of round-the-clock opioids

Exclusion Criteria:

* Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
* Has certain medical conditions which may interfere with pain assessments
* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
* Has had certain infections, injuries or illnesses within the last month
* Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
* Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
* Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
* Cannot discontinue pain medications, even for a short time, prior to the study start

Primary outcomes:
measure: Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
timeFrame: 4 weeks
Secondary outcomes:
measure: WOMAC Osteoarthritis Index, SF36
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Rita Jain, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05133583: Effect of Laughter Yoga Therapy on Postpartum Depression
Official title: Effect of Laughter Yoga Therapy on Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 104
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with light warm-up techniques that include movements. These are to break down all kinds of inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. LY In order to provide group dynamics in therapy, the group should consist of at least 5-12 people.

provided. Real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. Laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals.

has been done.

Detailed description: Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with light warm-up techniques that include movements. These are to break down all kinds of inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. LY In order to provide group dynamics in therapy, the group should consist of at least 5-12 people.

provided. Real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. Laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals.

has been done. Therapy sessions are between 40-45 minutes. Sessions started on time and was completed on time. In the research, a total of 6 sessions of laughter, once a week, yoga was done. The experimental group was interviewed in an online meeting prepared by a certified LY trainer.

She received LY exercises once a week (40 minutes per session) for 6 weeks (6 sessions). Each The meeting was organized with a maximum of 12 people.

Eligibility criteria: Inclusion Criteria:

* have a healthy baby

Exclusion Criteria:

* Absence of a psychiatric illness No chronic disease The newborn has no health problems

Primary outcomes:
measure: Effect of Laughter Yoga therapy on postpartum Depression
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Didem Simsek Kucukkelepce
Study officials:
References:
Clinical trial NCT07017283: Effect of Nasopharyngeal Airway-Assisted Deep Sedation vs. Endotracheal Intubation General Anesthesia on Respiratory Complications During ERCP
Official title: Effect of Nasopharyngeal Airway-Assisted Deep Sedation vs. Endotracheal Intubation General Anesthesia on Respiratory Complications During ERCP: An Open-Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Biliary and Pancreatic Diseases
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the impact of nasopharyngeal airway-assisted deep sedation versus endotracheal intubation general anesthesia on perioperative respiratory adverse events during ERCP.

Detailed description: This study aims to investigate the impact of nasopharyngeal airway-assisted deep sedation versus endotracheal intubation general anesthesia on perioperative respiratory adverse events during ERCP.

Eligibility criteria: Inclusion criteria：

1. ≥ 18 years old
2. American Society of Anesthesiologists classification (ASA) 1-3.
3. Patients who require elective ERCP
4. Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.

Exclusion criteria：

1. Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction
2. Coagulopathy or epistaxis tendency
3. Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias)
4. Pulmonary diseases (e.g., asthma, COPD)
5. Prior hypersensitivity to anesthetic agents
6. Active upper respiratory infection
7. Hepatic/renal dysfunction
8. Difficult airway (e.g., severe OSA)
9. Psychiatric disorders, cognitive impairment, critical illness, or pregnancy

Primary outcomes:
measure: Respiratory adverse events
timeFrame: Perioperative period
Secondary outcomes:
measure: cardiovascular events
timeFrame: intraoperative
measure: recovery time
timeFrame: Perioperative period
measure: QoR-15 score on POD1
timeFrame: Postoperative day 1
measure: respiratory failure/ARDS incidence
timeFrame: Perioperative
measure: patient/endoscopist satisfaction
timeFrame: Perioperative
measure: hospital stay duration
timeFrame: Perioperative
Other outcomes:
Locations:
Study officials:
References: