cyrilzakka/clinical-trials huggingface dataset:
Functional Status in COPD Patients After Exercise Rehabilitation Program

To evaluate the effectiveness of the exercise program in improving physical fitness and exercise capacity in COPD patients like walking distance, muscle strength, endurance will be measured before and after the program.

To assess whether the program helps reduce COPD symptoms like shortness of breath and fatigue during daily activities. Quality of life questionnaires will be used.

Pulmonary rehabilitation is a comprehensive, multidisciplinary program that utilizes exercise training and patient education to improve the physical and psychological condition of people living with chronic respiratory diseases Exercise therapy and education work in an integrated manner to help patients better manage their condition.

Exercise therapy is a core component of pulmonary rehabilitation. Regular physical activity helps build endurance, strengthen respiratory muscles, and improve overall functional capacity . Both aerobic and resistance exercises are prescribed according to individual abilities and needs .Studies have shown exercise training can reduce symptoms, increase quality of life, and decrease healthcare utilization among pulmonary patients .Patient education teaches self-management skills like breathing techniques, medication management, coping strategies, and how to prevent or deal with exacerbations . Educating patients empowers them to better understand their condition and play an active role in their care. It also helps address anxiety and depression that often accompany chronic lung disease .

Recent reviews continue to support the benefits of pulmonary rehabilitation's holistic, exercise-education approach meta-analysis found multidisciplinary programs significantly improved outcomes such as hospital admissions compared to usual care . Additionally, study showed telerehabilitation with remote exercise monitoring and video classes achieved comparable benefits to traditional center-based programs . In summary, exercise therapy and education are core components of effective pulmonary rehabilitation

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate-severe chronic obstructive pulmonary disease (COPD) based on spirometry results and clinical assessment.
* Age between 40 and 75 years. Stable disease status, defined as no exacerbations requiring admission to respiratory intensive care unit
* Willingness and ability to participate in a 12-week pulmonary rehabilitation program.

Exclusion Criteria:

* Presence of significant comorbidities or medical conditions that may interfere with participation in the pulmonary rehabilitation program (e.g., severe cardiovascular disease, musculoskeletal disorders, uncontrolled hypertension).
* Inability to perform the required exercise activities due to physical limitations or disabilities.

Cognitive impairment
Maintaining Abstinence in Chronic Cigarette Smokers - 1

The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.

The work adapts interventions that have been successful in the general populations, and tailors them to chronic smokers, who may have numerous previous smoking treatment failures. If successful it will: (1) make available a treatment intervention that produces hight long term abstinence rates; (2) provide information on variables that predicts success and failure in this population of smokers; (3) examine the cost-effectiveness of more intensive, longer term treatments.

Eligibility Criteria:
Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?"

Inclusion Criteria:

-Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?"

Exclusion Criteria:

* History of seizure or head injury resulting in unconsciousness
* Any condition that might predispose to seizures (brain tumor or stroke)
* A current or history of anorexia nervosa or bulimia
* Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol
* Use of a protease inhibitor of MAO inhibitor within the last two week
* Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants
* Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol
* Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded
* Suicidal or homicidal ideation
* Current major depression
* History of bipolar disorder
* Recent (within twelve months) myocardial infarction
* Any other medical condition that would contraindicate use of NRT or bupropion
* Physical limitation so severe that participation in a program of moderate exercise is not possible
* Pregnancy or lactation
A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Age related cataracts are responsible for about 51 percent of blindness worldwide and according to the WHO affect about 20 million people, according to the WH . As cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (IOL).

As for this study, the investigators seek to compare four different IOL designs in in a psychophysiological setting, allowing to assess the impact of these IOLs on vision and psychological processing of visual information.

As these IOLs also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. The healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different IOLs. This would allow subjective testing of IOLs before surgery.


Eligibility Criteria:
Inclusion Criteria:

Men and women aged between 18 and 35 years

* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, between -1 and +1 diopters

Exclusion Criteria:

* \> 0,5 diopters of cylinder
* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.

This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Eligibility Criteria:
Inclusion Criteria:

* Incomplete upper motor neuron lesion
* Detrusor overactivity
* Two leaks or two notices of leaks per day
* Mean functional bladder capacity (volume voided per episode) of ≥100 ml

Exclusion Criteria:

* Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
* Degenerative disease of the central nervous system
Relationship Between MAFLD and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study

This multicenter retrospective study aims to study the association between the presence of MAFLD and change in liver stiffness over time in untreated and treated patients with chronic hepatitis B

This project is a multicenter retrospective cohort study. All CHB patients who underwent at least 2 liver stiffness assessments with a Fibroscan device at least 6 months apart are eligible for enrolment. At baseline (defined as the first liver stiffness assessment) patients will be allocated to one of 4 groups (figure) based on use of antiviral therapy and presence of MAFLD. MAFLD is defined as presence of steatosis (based on ultrasound, histology or controlled attenuation parameter) in the presence of overweight (BMI \>23 for Asians or \>25 for Caucasians), diabetes mellitus, or at least 2 minor metabolic dysfunction criteria.(9) Baseline and follow-up data on biochemistry, virology, liver stiffness and clinical outcomes will be collected for all eligible patients. In case of initiation of antiviral therapy or development of MAFLD during follow-up, patients will transition to the appropriate cohort from that time-point onwards.

To ascertain the influence of the presence of MAFLD on liver stiffness progression, changes in liver stiffness will be compared within study groups (ie. cohort A vs B and cohort C vs D). To study the influence of antiviral therapy on liver stiffness progression in relation to presence of MAFLD, liver stiffness dynamics will be compared in cohort B vs cohort D (figure). The latter analysis will also be performed in the subgroup of patients with low levels of viremia (HBV DNA \<2,000 IU/mL) and/or low levels of ALT (\< 2 times the upper limit of normal).

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B monoinfection
* At least two liver stiffness measurements more than 6 months apart
* Availability of data on hepatic steatosis (ultrasound, controlled attenuation parameter or histology) within 1 year of baseline

Exclusion Criteria:

* antiviral therapy with drugs other than entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide (for group 2 only)
* Presence of concomitant liver disease such as Wilson's disease, autoimmune hepatitis, hemochromatosis or alcohol abuse (\>21 alcoholic drinks/week, female's \>14/week)
* Presence of secondary causes of hepatic steatosis (medication, alcohol abuse)
* Coinfection with HCV, HIV, HEV
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 1 (ALKS 2680-201)

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Has a BMI ≥18 and ≤40 kg/m2
* Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:

  * Is HLA-DQB1\*06:02-positive
  * Has residual excessive daytime sleepiness and cataplexy
* Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
* Is willing to adhere to additional protocol requirements

Exclusion Criteria:

* Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening
Impact of Stress Management Training on the Resilience and Stress of Student Nurse Anaesthetists

The study aims to evaluate the effectiveness of stress management training provided to student nurse anaesthetists on: their level of chronic perceived stress in the last month, their level of acute perceived stress each day for one month, their level of resilience and their level of sleep quality.

This trial will be conducted at the CHU Grenoble Alpes (CHUGA). Volunteer nurse student anaesthetists trained in stress management will complete questionnaires assessing resilience, perceived stress over the past month, sleep quality and will assess perceived stress on each working day using the visual analogue stress scale over 3 periods of the working day.

The results of the trained students will be compared to the results of the untrained students who participated in the Anaesthesia worker stress in the Operating Room survey registered under the clinical trial number: NCT05392972

The main objective is to evaluate the impact of stress management training provided to nurse anaesthetist students on their chronic perceived stress over one month assessed with the Perceived Stress Scale 10.

The secondary objectives are:

1. To compare the level of resilience of students who have received training in stress management methods with that of students who have not received such training. (Comparison of the average of the Connor-Davidson resilience scale for each population)
2. Compare the perceived stress during a working day in students who have received stress management training to those who have not. (Comparison of the average of the two visual analogue stress scales (VAS Stress) (start of shift/end of shift) collected on working days over a period of one month for both populations)
3. Compare the stress peaks experienced (acute stress) by students who have received stress management training and those experienced by students who have not. (Comparison of the median of the stress VAS peaks of the two populations followed over one month).
4. Determine whether the quality of sleep of the students is influenced by the stress management training (comparison of the pittsburgh sleep quality index (PSQI) of the nurse student anaesthesist population that received stress management training with the PSQI of population that did not receive this training).
5. Conduct a satisfaction survey among the nurse student anaesthesist regarding the training provided by the Grenoble training institute and identify the stress management methods retained as useful by the nurse student anesthesist following this training.

Eligibility Criteria:
Inclusion Criteria:

* Student nurse anaesthetist

Exclusion Criteria:

* Student objecting to the use of their personal information
* Student on study leave.
* Student on sick leave during the study period.
Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study

The purpose of this study is to determine the impact of eliminating traditional resident work shifts (i.e. greater than 24 hours in length) on patient safety and resident educational outcomes. In addition, the investigators will explore with key stakeholders (patients and their families, nurses, resident physicians and attending physicians) their experiences when residents are undertaking shifts greater than 24 hours in length as compared to 16 hours or less.


Eligibility Criteria:
Inclusion Criteria:

* Residents completing Intensive Care Unit rotations
* For focus groups and interviews, patients and families members admitted during the study period and nurses and attending physicians working during the study period

Exclusion Criteria:

* None
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants

To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.

To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:

i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (\< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 23 0/7 - 27 6/7 weeks
* Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
* Postnatal age between 21 days and 70 days
* Informed written consent obtained from at least one of the parents.

Exclusion Criteria:

* Need for mechanical ventilation, NCPAP or O2
* Sepsis or other known causes of apnea.
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease (CD) of at least 3 months in duration
* Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

* Current diagnosis of ulcerative colitis or indeterminate colitis
* Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
* Unstable doses of concomitant Crohn's disease therapy
Effects of Supervised Physical Therapy With Early Activation of the Rotator Cuff Versus Home Exercises in Patients After Arthroscopic Subacromial Decompression

The objective of this study was to evaluate and compare two different post-surgical rehabilitation strategies, Rehabilitation supervised by a physical therapist including exercises with progressive early activation of the rotator cuff versus basic home exercises regarding shoulder function, pain, health related quality of life and return to work after arthroscopic subacromial decompression.

Patients scheduled for surgery (arthroscopic subacromial decompression)and in the age 25-65 were offered to participate in the study. After surgery they were randomized to either Supervised Physical therapy with early activation of the rotator cuff (PT-group) or to home exercises (H-group). Patients in the PT group met the physical therapist twice a week for exercises and in between these visits they did their exercises at home daily. The H-group did home exercises daily. Shoulder function and pain(primary outcomes)and health related quality of life, returning to work(secondary outcomes)were assessed before surgery, one week after(baseline), 1,2,3 and 6 months after surgery by an independent physical therapist.

Eligibility Criteria:
Inclusion Criteria:

* Subacromial impingement verified with Neer impingement test
* At least 6 month duration of pain
* Treated in primary care without satisfactory results for at least three months.
* Typical history and pain location. Scheduled for surgery (subacromial decompression)
* Three of these four tests must be positive:

  * Neer impingement test
  * Hawkins-Kennedy impingement sign Jobe supraspinatus test
  * Painful arc 60-120 degree

Exclusion Criteria:

* Radiological findings of malignancy osteoarthritis, fractures
* Polyarthritis or fibromyalgia
* Pathological hyper laxity
* Lack of communication skills that prevent the use of outcome measurements
* Cervical spine pathology
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)

A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer.
* Age ≥ 18 years and \<80 years.
* Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy.
* Any T, any N, M0.
* Intention of resection R0.
* Informed consent signed by the patient and the investigator.

Exclusion Criteria:

* Colorectal tumor with histology other than adenocarcinoma or adenoma.
* Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon.
* Metastatic disease (M1).
* History of colorectal cancer surgery, different from a local excision.
* Inflammatory bowel disease with anatomopathological confirmation.
* Patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent.
* Inability to read or understand any of the languages of the informed consent (Catalan, Spanish).
* Another synchronous malignant disease.
* Emergency surgery.
Erector Spinae vs TAP in Lower Abdominal Surgery

The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.

Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction.

The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.

Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.

Both blocks haven't been compared to each other in this type of surgery before.

Eligibility Criteria:
Inclusion Criteria:

* Physical status ASA II.
* Age ≥ 18 and ≤ 65 Years.
* Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
* Patient is able to provide a written informed consent.
* Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

Exclusion Criteria:

* Age \<18 years or \>65 years.
* BMI \<20 kg/m2 and \>40 kg/m2.
* Known sensitivity to local anaesthetics and morphine.
* History of psychological disorders and/or chronic pain.
* Significant liver or renal insufficiency.
* Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Pregnancy.
* ASA III-IV.