cyrilzakka/clinical-trials huggingface dataset:
Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75
2. Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):

   * PaCO2 \> 45 mmHg
   * Night time oxygen saturation \< 88% at least for 5 consecutive minutes
   * In neuromuscular diseases, PIM \< 60 cmH2O or FVC \< 50% of theoretical.
3. Stable disease.
4. Airway access through nasal mask.
5. Ability to provide written informed consent.
6. Ability to attend the visits

Exclusion Criteria:

1. Contraindications for mechanical ventilation:

   * Patient with terminal disease or vegetative state
   * Lack of motivation of the patient
   * Lack of family or social support
   * Patients clinically unstable
   * Agitation or lack of co-operation
   * Depression.
2. Patients with acute symptoms requiring hospital admission.
3. Need for airway access through tracheostomy, face mask or mouth piece.
4. Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
5. Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.
6. Lack of understanding of the study procedures.
A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome

This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015.

The primary objective of this study is to assess the long-term safety and tolerability of RAD011.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a parent/legal guardian that is able to consent for their participation. Parent/caregiver/legal guardian can complete the required assessments throughout the study. Patient Consent/Assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent;
* Patient completed treatment on the SCOUT-015 study through Visit 14 (Week 34);
* If female, is either not of childbearing potential (defined as premenarchal or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of

RAD011 or placebo:

Exclusion Criteria:

* Significant acute condition (active infection, uncontrolled diabetes, any other uncontrolled chronic condition) including but not limited to clinically significant laboratory abnormality, or medical or psychosocial condition that may preclude the patient from participating in the study, at the Investigator's discretion;
* Positive urine test for drugs of abuse, including tetrahydrocannabinol (THC), or known history of drug, alcohol, or substance abuse;
* Significant risk of committing suicide based on history, psychiatric examination, or based on the Investigator's judgment;
* Significant non-compliance issues (IP misuse or abuse, study visit participation, etc.) during the patient's SCOUT-015 participation based on the Investigator's judgement.
* Pregnant (determined by a positive urine pregnancy test) or lactating female;
* Concurrent participation in any other interventional study involving an investigational product, gene therapy, or device.
REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial

The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.

Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed.

Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis.

The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively.

   OR
2. Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively

Exclusion Criteria:

1. Active treatment of Benign Prostatic Hyperplasia (BPH)
2. Hypersensitivity or allergy to tamsulosin HCL
3. Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
4. Active urinary tract infection
5. History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy
6. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
7. Underlying neurological disorders resulting in impaired bladder function
8. Any known contraindication to the use of tamsulosin HCL
VivAer: A Correlation Between Symptom Scores and Objective Findings

This is a prospective, single-center study. This study seeks to determine the objective improvement in nasal airflow in patients after undergoing the VivAer procedure, which involves the use of a stylus to deliver controlled and targeted low energy radiofrequency heating (heating by applying high-frequency radio waves) to the nasal sidewall to gently reshape the tissues. Patients who experience refractory, or medically unexplained, nasal obstruction often have symptoms that are not alleviated or resolved by standard non-surgical treatment options. VivAer, a recently developed, FDA-approved procedure, is one of the standard surgical treatments for nasal obstruction. Unlike most of the other established surgical treatments for nasal obstruction, however, VivAer is a minimally-invasive procedure, and it is an outpatient intervention that can be performed under local anesthetic. Eligible patients who are enrolled in the study will undergo the VivAer procedure, and will return to the clinic for three in-office follow-up visits at 4, 12, and 24 weeks after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
* Nasal obstruction, defined as ≥60 by the NOSE scale.
* The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy.
* Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek).
* Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen.

Exclusion Criteria:

* Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months.
* Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy.
* Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention.
* Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
* Known or suspected pregnancy, or lactation.
* Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.
Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.


Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
* Both genders
* Esophageal squamous cell carcinoma confirmed by pathology
* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th)
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* PS ECOG 0-2
* Life expectancy of more than 3 months
* Hemoglobin（Hb）≥9 g/dL
* WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
* platelet count (Pt) ≥100x 109/L
* Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN
* Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction
* Deep esophageal ulcer
* Esophageal perforation
* Haematemesis
* After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
* Drug addiction
* Alcoholism or AIDS
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* Patient who has metastasis such as lung, liver metastasis
Effect of Auricular Vagus Stimulating in Non Specific Chronic Neck Pain

The aim of our study is to compare the efects of conventional treatment and vagus nerve stimulation on pain, normal joint movement, disability and sleep in non-specific chronic neck pain.

36 patients aged between 18 and 65 years with non-specific neck pain participated in our randomly planned study. All these patients were divided into 2 groups. Demographic and physical characteristics of the patients were recorded. The first group was treated with auricular vagus nerve stimulation. Conservatire treatment that consists of hotpack, transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound was applied to the second group. In addition to their treatment, some home exercises were given and tought. Pain was assessed with a visual analog scale (VAS). Muscle strength was evalvated with a digital hand dynamometer. Neck normal joınt motion was evaluated with goniometer clinometer which is a mobile phone application. While disability was mensured with the neck disability index, sleep quality was evalvated with the Pittsburg sleep questionnaire. All the measurements were recorded before the trearment and after the 15 session treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* people with non-specific neck pain

Exclusion Criteria:

* Who has neurological problems,
* who has vision and hearing loss,
* who has a tumor and infection in the cervical region,
* who has undergone surgery related to the cervical region,
* who has had a cervical streroid injection in the last 3 months
Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity

To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.

Most of the patients with obstructive sleep apnea (OSA) are obese. It has been noted that significant weight loss could improve the severity of sleep apnea. Significant weight loss is difficult to achieve especially in morbidly obese patients. Endoscopic gastric balloon insertion is minimally invasive procedure is employed by surgeon for weight reduction for morbidly obese patients. This study would assess the parameters of sleep which could be affected by weight reduction. If results are positive, this procedure might be considered as treatment for obstructive sleep apnea in morbidly obese patients.

Patient population would be selected from patients who would undergo gastric balloon insertion in the surgical department. There would be no sex or age limit. Patient recruited would have BMI \> 35. Consent would be signed for sleep studies. Baseline sleep study, lung function, Epworth Sleepiness Scale (ESS) and quality of life would be assessed in patients who have symptoms suggestive of OSA. If a patient is confirmed to have OSA, a continuous positive airway pressure (CPAP) titration would be offered if the patient is willing to try CPAP. Otherwise patients would be discharged home and wait for balloon insertion. The same assessment would be repeated 3 months and 6 months after the surgical procedure. All sleep studies would be done as in-patient.

Leptin and ghrelin are hormones control satiety, which are also related to the degree of obesity. Blood for plasma leptin and ghrelin would be taken before and 6 months after gastric balloon insertion to assess the relationship of weight reduction by reducing appetite and plasma level of the hormones

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese patients with BMI \> 30
* confirmed obstructive sleep apnea with RDI \> 10/hr
* able to sign consent

Exclusion Criteria:

* patients undergoing weight reduction surgery
* sleep apnea other than obstructive sleep apnea
* untreated endocrine disorder
* patient refusal
Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer

Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreatic head
* Age ≥ 18 years
* Signed informed consent
* ECOG performance status of 0-2

Exclusion Criteria:

* Curative resection is not feasible or presence of metastatic disease
* Patients not eligible for surgery (ASA ≥ 4)
* Participation in an other clinical trial
* Unable or unwilling to sign the informed consent
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial

The goal of this clinical trial is to learn the clinical and cost effectiveness of intrathecal morphine (ITM) in addition to usual care as a postoperative pain relief strategy following major laparoscopic abdominal surgery compared with current usual care. The main questions it aims to answer are:

An enhanced analgesic technique, consisting of ITM in addition to usual care , improves the postoperative quality of recovery at day 1 after surgery by at least 6 points on the 15-item quality of recovery questionnaire (QoR-15) compared to usual care alone, in patients undergoing major laparoscopic abdominal surgery?

Researchers will compare ITM + Usual care to Sham ITM + Usual Care (The sham ITM mimics the ITM procedure, but the dura is not breached) to see if ITM works to postoperative pain relief.

Participants will:

Receive ITM + Usual care or Sham ITM + Usual care on surgery day Have interview with outcome assessors and complete the CRFs on the day of surgery, postoperative day 1, day 2, day 3 and up to postoperative day 30


Eligibility Criteria:
Inclusion criteria:

* Age 18 years or over AND able to give informed consent (with interpreters provided where necessary)
* Elective (i.e., planned) laparoscopic or robotic abdominal surgery within one or more of the following specialties:

  * Colorectal
  * Gynaecology
  * Hepato-biliary (including pancreatic surgery)
  * Upper gastrointestinal
  * Urology/Renal
* Anticipated duration of surgery ≥ 2 hours (from knife-to-skin to end of wound closure)
* Anticipated hospital stay ≥ 24 hours (from the end of surgery)

Exclusion criteria:

* Allergy to study drugs
* Anatomical factors making intrathecal injection impossible
* Anticipated requirement for postoperative invasive ventilation
* American Society of Anesthesiologists (ASA) Score \<IV
* Coagulopathies (i.e. INR\>1.3 and/or platelet count\<100×10\^9/L)
* Cognitive impairment leading to inability to complete the study processes and questionnaires
* Drugs affecting coagulation (except aspirin), which have not been suitably and timely paused preoperatively
* Infection near the planned site of intrathecal injection
* Ongoing sepsis
* Patients previously included in the trial and who need to return to theatre for a new abdominal surgery
* Pregnancy or breast feeding
Nitrous Oxide for Lumbar Puncture

Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot single-center study, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this multi-center trial is to confirm these results in a larger and more heterogeneous group of patients having a LP.

Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has only been investigated in a single-centre study.

Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period of time. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding).

The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming in the neurology department for a lumbar puncture
* at least 18
* no previous use of nitrous oxide

Exclusion Criteria:

* contra-indication to nitrous oxide use
* Body Mass Index\>35
* Mini Mental State Examination \<24/30
* Temperature \>38°C
* Confusion
* Patient unable to communicate verbaly
Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)

This is a Phase II randomized, double-masked study comparing the safety and efficacy of ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with neovascular ("wet") age-related macular degeneration (NV-AMD).


Eligibility Criteria:
Implementing an Interdisciplinary Eating Disorder Screening and Treatment Program for Post-Bariatric Surgery Patients in Nova Scotia

The goal of this interventional study is to evaluate the Treatment and Evaluation for After Metabolic Surgery with Eating Disorders (TEAM-ED) program, which is a combined screening and treatment program for managing disordered eating in adults who have recently had weight loss surgery in Nova Scotia. The main question it aims to answer is 'can an interdisciplinary program for screening, diagnosing, and treating disordered eating after weight loss surgery be implemented in Nova Scotia?

This study will determine the feasibility and impact of the TEAM-ED program by assessing the following objectives:

1. Reach (how effectively the program engages the target population \[post-weight loss surgery patients\])
2. Effectiveness (the extent of the program's impact on key clinical outcomes related to disordered eating and weight management)
3. Adoption (the extent to which the program is adopted and accepted by clinicians)
4. Implementation (how consistent program delivery is and factors impacting consistent delivery)

Participants will complete a disordered eating screening questionnaire online every 3 months after weight loss surgery until they reach 18-months post-surgery. Participants found to have disordered eating will be offered TEAM-ED treatment (Cognitive Behavioral Therapy, and treatment plan oversight by both weight loss surgery and eating disorder specialists). Standard outcome measures will be collected at baseline, during eating disorder treatment, post-treatment, and at follow-ups. Participants may also be asked to do a one-on-one research interview about their experiences with the program.


Eligibility Criteria:
Inclusion Criteria:

* ≥19 years old
* Between 3- and 18-months post-weight loss surgery.
* Able to complete English computer-based self-report questionnaires (with adequate accommodation, if necessary).
Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities

The goal of this clinical trial is to assess the effect on reading skills of the digital medical device Poppins Clinical for cognitive and musical training in pediatric participants (ages 7-11) with a specific learning disability with reading deficit. The main objective of the study is to assess the evolution in reading skills through a word reading task before and after the intervention.

Participants will be asked to train with the digital medical device Poppins Clinical 5 times per week for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLD with reading deficit, based on a speech-language assessment. SLD with reading deficit is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR, 2022) and the International Classification of Diseases (ICD-11, 2022). The speech-language assessment should consist of at least three reading and/or transcription tests with a SD (standard deviation) of at least - 1.4 or a result below the 20th percentile or two reading and/or transcription tests with a SD of at least - 2 SD or a results below the 10th percentile;
* Subject aged between 7 and 11, enrolled from CE1 to CM2;
* French mother tongue or French bilingualism at home and more than 3 years schooling in France;
* Tablet or smartphone available at home;
* Subject affiliated to the French National Insurance (Securite Sociale)
* Subject and parental/legal guardians consent to participate, and commitment to follow the protocol.

Exclusion Criteria:

* Subject has previously used Poppins Clinical or Mila-Learn;
* Uncontrolled chronic illness (at investigator's discretion);
* Previous epileptic seizures;
* Participant actively participating in an interventional study that may affect results.