cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

The purpose of this study is to evaluate whether a therapy that uses a machine called a continuous high frequency oscillator (CHFO) is more successful at removing mucus than medications that thin out the mucus.

Both of these therapies (CHFO and medication) are currently used in the Pediatric Intensive Care Unit and Pediatric Cardiac Intensive Care Unit. This research study is being done because the investigator is trying to learn if the mechanical removal of mucus with CHFO will effectively re-inflate the collapsed area of lung. Specifically, the study team will determine if CHFO can improve lung inflation with the same or improved vital signs (heart rate, blood pressure, and breathing rate), and the same or improved ability to help the lungs move oxygen into the blood.

One of the problems with the medication approach is that while it thins out the mucus, actual removal from the lung requires a strong cough which is difficult for infants and children to produce when they are sedated and on a ventilator (breathing machine).

Thus, the aim of this research study is to test whether children with atelectasis on a ventilator are more likely to improve with mechanical removal of their mucus with the CHFO as compared with medications that thin out the mucus. CHFO and all the medications used in this study are part of the standard of care for atelectesis. However, there is no information on which combination works best and no one agrees that one approach is more effective than another. Usually patients are evaluated for 48 hours after starting treatment, before adding or making any changes.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent from parent or legal guardian.
2. Age \< 18 years and admitted to the PICU or PCICU.
3. Conventionally ventilated.
4. Mucolytics are being initiated by clinical team for treatment of atelectasis.
5. Endotracheal tube ≥ 3.5 mm internal diameter.

Exclusion Criteria:

1. Receiving chronic mucolytic or continuous high frequency oscillation therapy.
2. Clinically significant pleural effusion.
3. Status post cardiothoracic surgery with open chest.
4. Pneumothorax.
5. Pulmonary hemorrhage.
6. Escalating doses of vasoactive agents (i.e. dopamine or epinephrine).
Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions

This trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions. The health-related quality of life index may help to capture the symptoms and related experiences of living with or being treated for high-grade squamous intraepithelial lesions.

PRIMARY OBJECTIVES:

I. To develop a Spanish-language version of the anal cancer/high-grade squamous intraepithelial lesions outcomes research (ANCHOR) high-grade squamous intraepithelial lesions (HSIL) health-related quality of life (HRQoL) index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.

OUTLINE:

Participants take part in cognitive interviews in Spanish over 45-60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Human immunodeficiency virus (HIV)-1 infection.
* Biopsy-proven anal HSIL within the prior nine months.
* Participant must have received anal HSIL treatment in the last nine months. If the participant's treatment plan is observation? the participant must have been diagnosed with anal HSIL in the last nine months.
* Life expectancy of greater than 5 years.
* Fluent in Spanish with limited English proficiency, per self-report.

Exclusion Criteria:

* History of anal cancer.
* Inability to understand a written consent form.
Single-Case Study on Therapeutic Change in Chronic Low Back Pain

Exploration of treatment processes during exposure and cognitive-behavioral therapy in the context of chronic low back pain in a multiple baseline single-case design.

The present study intends to specifically investigate treatment elements during exposure and cognitive-behavioral therapy, which are especially powerful in electing time contingent therapeutic change. hereby, it is the goal to explore further change processes, which play an important role during psychological treatment of individuals with CLBP and high levels of fear-avoidance.

Eligibility Criteria:
Inclusion Criteria:

* \> 6 months chronic low back pain
* Sufficient level on fear avoidance scores (PCS \> 35, PASS \>20, QBPDS \> 30, PDI \> 20 and Phoda harm ratings of 13 activities \> 50, including 8 \> 80)
* German-speaking
* Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

* Red flags
* Pregnancy
* Illiteracy
* Psychoses
* Alcohol addiction
* Surgeries during the last 6 months or planed surgeries
* Specific medical disorders or cardiovascular diseases preventing participation in physical exercise
* Participating in another psychotherapy
Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 20 years or older at enrollment
* Serum AMH level \>0.5 ng / mL (with the latest result tested within 12 months)
* Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
* Participating in an interventional clinical trial in which any medication treatment is mandated
* Women with a contraindication for prescription of REKOVELLE treatment
* Oocyte donors
* Undergoing ovarian stimulation for fertility preservation
Predisposing Factors for Chronic Postherniotomy Pain

Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.

The current study will assess the above factors in a prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years)
* Male
* Primary unilateral groin hernia
* Ability to use pain scales

Exclusion Criteria:

* Neurological disease
* Diabetes with late stage complications
a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

The aim of the study is to improve care practice related to gastrostomy management. This a before-after study, aimed at evaluating knowledge of care givers, families and patients about gastrostomy management. The intervention includes 1) A training in a care protocol for hospital care givers, and 2) A booklet for patients, families, and outpatient care givers. The evaluation criterion is a questionnaire to assess knowledge of hospital care givers, patients, families, and outpatient care givers.


Eligibility Criteria:
Inclusion Criteria:

* parents and hospital care givers of children undergoing gastrostomy who accept to participate.

Exclusion Criteria:

* family unable to understand French language, caregiver who has previously answered to the study questionnaire
Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?

Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate \& good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.


Eligibility Criteria:
Inclusion Criteria:

1. Children age more than 12 months to 12 years.
2. De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)

Exclusion Criteria:

1. Circumcised
2. Ventral Penile curvature ≥30° after penile degloving \& artificial erection, (requiring transection of urethral plate).
3. Uretheral plate less than 6mm
4. Megameatus intact prepuce
5. Albumin less than 3.5 g/dL
Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. Hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (\>5% of a woman's pre-pregnancy weight). Hyperemesis gravidarum is also surprisingly common. In fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. Hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. However, capsaicin cream, a potent TRPV1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. Smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. To begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. The project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. If effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the first trimester (0-14 weeks gestation)
* Presenting to the emergency room at Women \& Infants Hospital in Rhode Island with a chief complaint of nausea and vomiting
* English or Spanish speaking
* Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior to presentation

Exclusion Criteria:

* Allergy to Reglan, capsaicin or Zofran
* Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis)
* Molar pregnancies,
* Patients with a history of gastroparesis
* Patients with a history of preexisting diabetes mellitus
Elderly Hodgkin Lymphoma Patients Treated With Chemoradiotherapy

Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients over than 60 years
* Newly diagnosed Hodgkin lymphoma

Exclusion Criteria:

* Data not available
Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV130 in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with a placebo group.

Double blind parallel placebo controlled study. The subjects will receive medication during 12 months and will be followed up during another six months

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Both gender
* Age between 35 and 85.
* Must be able to follow the treatment regimen
* Diagnosis of moderate COPD according to GOLD criteria
* Consumption of 10 or more packs of cigarettes/year
* Fertile women of must use an approved contraceptive method

Exclusion Criteria:

* Pregnant women, breastfeeding
* Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion
* Subject with severe COPD
* Subject with a history of hypersensitivity to any component of the vaccine
* Subject outside of age range
* Subject diagnosed with asthma
* Subject who has had an exacerbation 4 weeks before starting the trial.
* Subject that have needed corticosteroids in the last 4 weeks before starting the trial

  * Subject diagnosed with Primary or Secondary Immunodeficiency Subjects with chronic lymphoproliferative disease
  * Subjects with chronic infectious disease
  * Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
  * Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa
Age Influence on Cortical Bone Measured by Ultrasound

The study of this study is to evaluate the age influence on cortical bone strength properties by two methods:HR-pQCT (HighResolution-peripheral quantitativeComputedTomography) and ultrasound. The main objective consists in the evaluation of the age influence on cortical thickness at 1/3 distal radius measured by US.

The study of this study is to evaluate the age influence on cortical bone by two methods: HR-pQCT and ultrasound.

84 patients will be measured. The cohort will be:

* 21 women less than 70
* 21 women more than 70
* 21 men less than 70
* 21 men more than 70 Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.

The participation to the study implies only a participation of one hour from the patient (30min for HR-pQCT measurements, 30 min for US).

The main objectives consist in :

* evaluating the age influence on cortical thickness at 1/3 distal radius measured by US
* evaluating the age influence on cortical thickness at distal tibia measured by US
* comparing porosities values measured by US to vBMD obtained by HR-pQCT
* comparing cortical thickness values measured by HR-pQCT at 1/3 distal radius position to ultra-distal radus position and to the tibia
* comparing vBMD values measured by HRpQCT at 1/3 distal radius position to ultra-distal radius position and to the tibia

Eligibility Criteria:
Inclusion Criteria:

* being 18 or older
* coming from the rheumatology consultation at Lariboisière Hospital

Exclusion Criteria:

* BMI \> 28
* BMI \< 15
* cortisone treatment
* recent fracture at non-dominant arm
* wound on measuring zone
* treatment interfering with bone architecture or bone density : oral of transdermic oestrogenes, bisphosphonates (Alendronate, Risedronate, Zoledronate) or Denosumab during the past 6 months-
Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.


Eligibility Criteria:
Inclusion Criteria:

* operative rectal cancer

Exclusion Criteria:

* known allergy toward indocyanic green
Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

The investigators will assess the feasibility of activity monitoring armbands for continuous measurement of physical activity level in ME/CFS patients, during 6 months follow-up. The main purpose is to assess if continuous measurement of activity level may be incorporated in outcome measures in future clinical interventional trials.

The purpose is to assess feasibility of activity monitoring armbands for continuous measurement of physical activity level in patents with Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS), during 6 months follow-up.

The investigators will assess which physical activity parameters that best seem to reflect the participant's own perception of activity level, such as mean number of steps per 24 hours.

The investigators will assess the agreement between continuous activity measurements by activity armbands, and self-reported questionnaires for health-related quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF).

The investigators will assess the agreement between activity monitoring by armbands, and previously validated activity monitoring bracelets for 5-7 consecutive days, at baseline, at 3 months and at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients wit ME/CFS according to Canadian Consensus Criteria (2003)
* ME/CFS disease duration at least 2 years
* Mild, Mild/moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
* Signed informed consent

Exclusion Criteria:

* Patients with fatigue, who do not meet the diagnostic "Canadian" criteria (2003) for ME/CFS
* ME/CFS disease duration \< 24 months
* Patients where the diagnostic workup uncovers other pathology as possible cause of symptoms
* Serious endogenous depression
* Lack of ability to complete the study including follow-up
A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)

In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study is an extension study and will enroll only those participants who have completed treatment in the parent study, 232SM203.

The main goal of the study is to learn about the long-term safety of nusinersen. The main questions researchers want to answer are:

* How many participants have adverse events and serious adverse events during the study?
* How do the results of electrocardiograms (ECGs), vital signs, and laboratory tests including blood and urine tests change after treatment?
* How many participants have a low platelet count after treatment?
* How many participants had a change in the time it took for their heart to recharge between beats after treatment?
* How does each participant's height and other measures of growth change after treatment?
* How much do the results of neurological exams that check movement, reflexes, and brain function change after treatment?

Researchers will also learn about the effect of nusinersen on mobility using various tests. They will study body movements, reflexes, balance, and coordination. They will also record if participants need help with breathing.

The 232SM302 study will be done as follows:

* Participants will be screened to check if they can join the study.
* Participants will receive their 1st dose of nusinersen in this study about 4 months after their final dose in the parent study.
* Each participant will receive nusinersen once every 4 months during the treatment period.
* Nusinersen will be given through a lumbar puncture, which involves injecting the drug into the fluid around the spinal cord in the lower back.
* The treatment period will last for up to 64 months (1921 days).
* There will be a follow-up safety period that lasts from 4 to 8 weeks.
* In total, participants will have up to 19 study visits. Participants will stay in the study for close to 6 years.

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566).

The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

Eligibility Criteria:
Key Inclusion Criteria:

* Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol

Key Exclusion Criteria:

* Treatment with another investigational therapy or enrollment in another interventional clinical study
* Treatment with an approved therapy for SMA after the Day 302 Visit of Study 232SM203 (NCT04089566)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections

This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.

The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.

Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed/suspected NG infection
* Willingness to give written informed consent as well as to participate in and comply with the study.

Exclusion Criteria:

* Currently taking or having taken any antibiotics in the preceding 14 days
* English fluency below level required to understand study procedures
* Unwilling or unable to comply with study procedures
Diagnostic Reasoning and Sense of Alarm at Dyspnoea and / or Chest Pain

Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.

Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.

The objective of the research is to calculate the precision of the sense of alarm the general practitioner facing a consultant for chest pain or dyspnea and patient

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years
* Patients consulting on primary care for chest pain or dyspnea