cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Hypothesis:

1. The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
2. The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
3. The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
4. The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. After undergoing surgery and clinically diagnosed as gastric cancer.
2. Adults over 20 years old.
3. Hemoglobin (above 10 g/dL).
4. Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
5. No lower limb disability and able to walk on their own.

Exclusion Criteria:

1. Suspected or confirmed bone metastasis.
2. Poorly controlled cardiovascular disease such as heart failure, arrhythmia, angina, myocardial infarction, chest pain during activities or rest in the past three months, and valvular heart disease using anticoagulants.
3. Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)\>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
4. Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure than 100mmHg when quiet, and heart rate is greater than 100bpm when quiet.
5. Diagnosed as recurrent depression.
6. Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.
Covid-19 Respiratory Sequelae French Cohort

As the investigators need data on long term outcome of Covid-19, especially respiratory sequelae, a national cohort is required. To better evaluate the potential respiratory sequelae after SARS-CoV-2 infection, it is fundamental to include patients with different management at the acute phase of the Covid-19: ambulatory management, hospitalization in non ICU and in ICU units. That is why the investigators will conduct a national cohort study with all components of french pneumology which will give the investigators the opportunity to include patients in general hospital, in university hospital and in private structure. As it is a "real life" study, the investigators will include all patients who will have a consultation with a pneumologist for an evaluation 5 to 7 months after a Covid-19 infection whatever their acute disease management. The investigators will collect all available data on Covid-19 acute phase, on patients characteristics and comorbidities, on persistent symptoms after Covid-19, on exams results during the outcome evaluation (CT-scan, 6 min walk test, spirometry and DLCO, blood gas, VO2 max if realized).


Eligibility Criteria:
Inclusion Criteria:

* adults, older than 18
* SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) in nasopharyngeal swab in patients who are evaluated by a pneumologist 5 to 7 months after their Covid-19 disease

Exclusion Criteria:

* patients for whom follow-up would be difficult owing to psychotic disorder
* dementia
* patients who have declined to participate.
E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research

Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.

Paperbacked pPRO data from up to a total of 100 patients from the cohort of PRAEGNANT are planned to be included in the Pepper I PRO study. Additionally 200 patients will be recruited in the web based ePRO cohort. The study duration per patient is at least 8 weeks. In cases of stable disease the study duration can be extended to up to 6 months with monthly PRO assessments, according to the attached visit matrix, taking approximately 20 minutes per visit.

The documentation at baseline should be performed during clinical routine with trained study personnel followed by remote self-reporting to minimize the patient effort. Pepper I will be conducted as sub-protocol of the PRAEGNANT trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in PRAEGNANT
* Women aged ≥18 years
* Patients with the diagnosis metastasized breast cancer undergoing any form of systemic therapy
* Patients who are willing and able to sign the informed consent form
* Patients with therapy change

Exclusion Criteria:

* Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
* Patients who are not able to handle a tablet computer or are unable to write
* Patients who are not able to understand the nature and extent of the trial and the procedures require
Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients

The main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.

It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension.

Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure of about 3,3 mmHg in OSAS patients. Unfortunately, 40% of the patients either refuse being treated by cPAP or give up treatment. In parallel, alternative medications are proposed to patients with moderate OSAS and hypertension, in order to decrease their cardiovascular risks. A study led on rats has shown the superiority of the beta adrenergic blocking agents in the decrease of hypertension in OSAS patients.

Our study has also the objective to compare the effects of Valsartan and cPAP on hypertension in OSAS patients. Those one will be randomized either in the group "treatment by Valsartan and then by cPAP" or in the group "treatment by cPAP and then Valsartan" (cross-over study).

Eligibility Criteria:
Inclusion Criteria:

* male/female over than 18 years old
* patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15)
* patient with weak or moderate hypertension (140 \<= SBP \< 180 mmHg and 90 \<= DBP \< 110 mmHg). Patient with antihypertensive monotherapy must stop their treatment and respect a washout period of at least 4 weeks before the screening visit. For patient treated by antialdosterone, the washout period will be of at least 8 weeks.
* negative pregnancy test
* ambulatory patient
* patient who have signed the informed consent form
* patient affiliated to social security

Exclusion Criteria:

* pregnant or nursing woman
* woman who refuses to use contraceptive method
* acute hepatic failure, biliary cirrhosis, cholestasis
* clearance of Cockcroft \< 30 ml/min/1.73m2
* kaliemia \>= 5.5 mmol/l
* acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
* acute daytime sleepiness (Epworth rating scale \> 15)
* patient with a profession that is inconsistent with the continuous positive airway pressure (CPAP) treatment
* known cardiovascular pathologies
* contraindication to CPAP
* allergy to Valsartan
* patient treated with lithium
* patient treated with drug(s) acting on arterial blood pressure
* patient on tutelle or curatelle
* patient kept in detention, major protected by the law, hospitalised person
* patient currently participating in another clinical trial
Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life

The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet.

The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.


Eligibility Criteria:
Inclusion Criteria:

* patients implanted with a cardioverter-defibrillator (ICD)
* between 18-75 years of age
* speaking and understanding Dutch
* with access to the internet and ability to use the internet
* providing written informed consent

Exclusion Criteria:

* a life expectancy less than 1 year
* a history of psychiatric illness other than affective/anxiety disorders
* on the waiting list for heart transplantation
* with insufficient knowledge of the Dutch language
Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers

In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer.

We wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.


Eligibility Criteria:
Inclusion Criteria:

* Children aged \>12 y.o and \<18 y.o
* BMI \> 30
* with a previous pulmonary function test (PFT) available in the medical record
Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer

The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it.

Design: As randomized controlled trial (RCT) with un-blinded design will be done.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participation will be enrolled based on diagnostic criteria.
* Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS).
* Diagnosis of advanced cancer
* Patients who are willing to be subject with taking part in this research voluntarily.
* No prior experience with TCM music therapy.
* Newly admitted to TCM oncology department for 3 weeks treatment course.

Exclusion Criteria:

* Complicated diagnose or one who don't consistent with inclusion criteria.
* Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia).
* Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy.
* One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision
* One suffering from hearing disturbance
* Accepted TCM five elements music therapy in the past.
GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients

In recent literature, the potential of guided growth of the proximal femur to modify hip growth in patients with cerebral palsy has been shown. Using medial hemi-epiphysiodesis of the proximal femur (TMH-PF) morphology of hips at risk of symptomatic (sub)luxation in cerebral palsy (CP) can be changed, aiming to reduce further hip migration and the need for more invasive surgical treatment modalities. Further research is necessary to assess if the results of TMH-PF in combination with adductor tenotomies are significantly better than the results of the current standard of care; adductor tenotomies alone.

The investigators objective is to determine whether guided growth of the proximal femur decreases the risk of further hip migration and need for further surgery in cerebral palsy patients.


Eligibility Criteria:
Inclusion Criteria:

* Spastic CP
* GMFCS level IV-V
* Aged 2-8 years
* At least one hip with an abduction in flexion ≤ 40 degrees
* Migration percentage of 30-50%
* Head shaft angle \> 145

Exclusion Criteria:

* Not fit for surgery
* History of bony hip surgery to the affected hip
* Severe acetabular dysplasia defined as a gothic arch, an incongruent joint or an acetabular index \> 30 degrees, consistent with A2 and A3 acetabular deformity according to Robin and Graham in an adequately performed radiographs
Comparison of a Laser Keratome to a Mechanical Microkeratome

The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for bilateral wavefront-guided LASIK
* Myopia up to -7.00 D
* Astigmatism of 0.00 to -1.50 D

Exclusion Criteria:

* History of ocular pathology
* Previous ocular surgery
* Very large pupils (greater than 8mm diameter, infrared measurement)
* Thin corneas (preoperatively calculated minimal residual bed \< 250 um)
* Irregular astigmatism
* Asymmetric astigmatism
* Unstable refraction
* Any other criteria that precludes subject to undergo LASIK
Dynamic Ventilatory and Asymmetry of the Chest Wall During Breath Stacking and Volume-oriented Incentive Spirometer

The purpose of the study was to analyze the effect of IS and BS on dynamics ventilatory and asymmetry of the chest wall in patients after stroke .

All volunteers were undergone to two types of pulmonary expansion therapy (PET) techniques: volume incentive spirometry (VIS) and BS.

Procedures involved two distinct phases: assessment and intervention. In the first day was performed assessment of the participants to obtain the following data: anamnesis, initial evaluation using the Ashwouth Scale, Barthel Index and Mini Mental State Examination, anthropometric data and pulmonary function using spirometry and respiratory muscle pressures.

Intervention phase was performed in two different days, each day for only one PET techniques (VIS or BS), with a minimal wash-out period of one day according to the randomization sequence. Optoelectronic Pletysmography (OEP) was recorded during quite breathing at rest and during the execution of five maneuvers form each PET technique tested.

Eligibility Criteria:
Inclusion Criteria:Subjects with right hemiparesis due to stroke for more than three months, of both genders, most than 20 years, with scores between 1 and 3 for Ashworth Scale for upper limb, up to 85 for Index score Barthel and minimum score of 18 on the Mini Mental State Examination.

-

Exclusion Criteria: Facial paralysis, rheumatic or orthopedic diseases or deformities / abnormalities in the spine that could compromise the respiratory mechanics; reported respiratory conditions (asthma, chronic obstructive pulmonary disease, cystic fibrosis) or presenting spirometry with forced expiratory volume in one second (FEV1) below 80% predicted and compared VEF1/Capacitate Forced vital ≤ .7; history of recent abdominal or thoracic surgery and hemodynamic instability or pregnancy.

-
BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction

To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.

Our previously designed single-center retrospective cohort study (NCT03533543) suggested that patients with a greater burden of NOAF complicating AMI were challenged by a poor prognosis. In the present study, we aim to design a multicenter, prospective, hospital-based registry to validate the preceding findings. We plan to enroll patients who were admitted for AMI in 9 tertiary medical centers from Shanghai, Henan, and Zhejiang provinces and developed NOAF during the index hospitalization. All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, and medications will be collected. NOAF burden is calculated by dividing the total AF duration by the total continuous electronic monitoring (CEM) duration. Other NOAF related characteristics, such as AF pattern, AF frequency, and symptomatic or silent AF, and the longest AF episode duration will also be evaluated. All patients who are discharged alive will be followed for at least 2 years and cardiovascular outcomes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old);
* Patient with AMI (including STEMI and NSTEMI) who developed NOAF during the index hospitalization;
* Patients must have received in-hospital CEM for at least 5 days;
* Patients must give informed consent.

Exclusion Criteria:

* Patients with a medical history of pre-existing AF;
* Patients with a medical history of rheumatic valvular disease;
* Patients with a medical history of sick sinus syndrome;
* Patients undergoing emergent coronary artery bypass surgery;
* Patients who suffer malignant tumors with an expected lifetime less than 1 year ;
* Patients who refuse to receive CEM during hospitalization and the data of heart rhythm cannot be retrieved;
* Patients who refuse to receive percutaneous coronary intervention (PCI) or have contraindications for PCI;
* Patients who have died during the index hospitalization.
A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG

Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.

Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .

Eligibility Criteria:
Inclusion Criteria:

1. Fully understand the study and voluntarily sign the informed consent form;
2. Age between 18 and 75 years;
3. Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;
4. Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;
5. R0 resection after neoadjuvant chemotherapy;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
7. Life expectancy of at least 2 years;
8. No prior anti-cancer treatment received;
9. Good compliance and cooperation with follow-up.

Exclusion Criteria:

1. Inability to comply with the study protocol or procedures;
2. History of prior gastric cancer surgery;
3. Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
4. Distant metastasis to organs other than the liver, such as lung, brain, and bone;
5. Known HER2-positive patients;
6. Uncontrolled hypertension despite medication prior to enrollment;
7. Poorly controlled diabetes despite medication prior to enrollment;
8. Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g;
9. Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
10. Patients deemed ineligible for this study by the investigator.
The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia

The objective of this research is to investigate the impact of oral facial facilitation and oral motor therapy dysphagia in individuals with spastic cerebral palsy. Specifically, the study aims to:

* Evaluate changes in dysphagia and severity following a regimen of oral motor therapy and oral facial facilitation.
* Assess improvements in swallowing function, including ease of swallowing and reduction in dysphagia symptoms, after implementing oral motor therapy and oral facial facilitation.


Eligibility Criteria:
Inclusion Criteria:

* 1. Confirmed diagnosis of spastic cerebral palsy (CP) by a qualified medical professional.

  2. Participants aged 3 to 7 years, as this is a common demographic affected by spastic CP.

  3. Clinical diagnosis of dysphagia, confirmed by a speech-language pathologist or related healthcare provider.

  4. No recent significant changes in neurological status or medical condition within the last six months.

  5. Sufficient cognitive ability to follow simple instructions during therapy sessions, as assessed by a qualified professional.

  6. Parental or guardian consent obtained for participants under 18, along with assent from participants when appropriate.

  7. No recent (within the last three months) oral motor therapy interventions that could confound results.

  8. Willingness and ability of the participant to engage in therapy sessions consistently.

  9. Clearance from a physician to participate in oral motor therapy and related interventions.

Exclusion Criteria:

* 1. Diagnosis of other neurological disorders or conditions that may affect swallowing or motor skills.

  2. Serious medical conditions or comorbidities that could interfere with therapy (e.g., severe respiratory issues).

  3. Any surgical interventions affecting the oral or pharyngeal region within the last year.

  4. Concurrent participation in other clinical trials or interventions that could affect swallowing outcomes.
Breast Cancer Tumor Care Observational Programme

The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Already on upfront Arimidex Therapy (Start 1-4 weeks before)
* HR+

Exclusion Criteria:

* Premenopausal women
* Tamoxifen switch patients