cyrilzakka/clinical-trials huggingface dataset:
Exercise for Fighting Oncology Repercussions After Treatment

Cancer survival rates are currently on the verge of 70% at 5 years since diagnosis. Recent improvements in main cancer therapies including chemotherapy, radiotherapy, surgery and immunotherapy as well as developments of new biological therapies have significantly improved survival rates but unfortunately, cancer-related side effects continue to affect many patients even years after completion of main treatments. Exercise has been shown to not only ameliorate cancer-related effects before, during and after treatment but also improve disease-free and overall survival rates by decreasing risk factors associated with cancer risk and improving resilience to treatment. In this non-randomised, three-arm study, we aim to assess the effects of three forms of exercise (i.e: Nordic Walking, Aquatic Exercise and Functional Exercise) on physical performance, cancer-related fatigue, health-related quality of life and cancer-specific symptoms in a wide range of cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Adults diagnosed with cancer
* Completion of any cancer therapy in the previous 3 months with the exception of hormonal therapy
* Patients living within the Maresme Area
* No contraindications for exercise (oncology clearance or Physical Activity Readiness Questionnaire negative)

Exclusion Criteria:

* Patients with any neurologic, cognitive or musculoskeletal impairments that prevent them to engage in any assessment test or exercise modality.
* Patients with unstable cardiac, respiratory or metabolic diseases
* Unable to speak or read Catalan or Spanish
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)

This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.

This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit (ICU) adult patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age;
* Patients who are anticipated to require \>12 hours of invasive mechanical ventilation and continuous sedation in the ICU; and
* Receipt of continuous sedation due to clinical need for sedation to RASS \<0.

Exclusion Criteria:

* Need for RASS -5;
* Sedation for invasive mechanical ventilation immediately prior to Baseline for \>72 hours;
* Severe neurological condition before ICU admission that causes the patient to lack ability to participate in the study (ie, unable to be assessed for RASS and CPOT);
* Ventilator tidal volume \<200 or \>1000 mL at Baseline;
* Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive ventilation (HFPV) at Screening;
* Comfort care only (end of life care);
* Contraindication to propofol or isoflurane;
* Known or family history of MH;
* Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;
* Allergy to isoflurane or propofol, or have propofol infusion syndrome.
* History of ventricular tachycardia/Long QT Syndrome;
* Requirement of IV benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal
* Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc);
* Concurrent enrollment in another study that, in the Investigator's opinion, would impact the patient's safety or assessments of this study;
* Participation in other study involving investigational drug(s) or devices(s) within 30 days prior to Randomization;
* Anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for \>4 hours;
* Female patients who are pregnant or breast-feeding;
* Imperative need for continuous active humidification through mechanical ventilation circuit;
* Attending physician's refusal to include the patient; or
* Inability to obtain informed consent.
Registry of Cardiovascular Disease Patients

A computerized registry of cardiovascular disease patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify cardiovascular disease patients and to follow the courses of their illnesses and risk factors.

The registry was initiated in 1998 by Maccabi Healthcare services, which is the second largest publicly funded HMO in Israel,serving 24% of the total population with a nationwide distribution.

The registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of the following:

Ischemic Heart Disease,MI,non-MI,congestive heart failure,peripheral vascular disease, cerebrovascular disease CVA,TIA,patients with first AMI diagnosis from community physicians if they were hospitalized for lasting at least 3 days during a 30-day period prior to diagnosis.

* Patients with prior coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI), using relevant Current Procedural Terminology (CPT) codes

Exclusion Criteria:

* patients who were diagnosed as suffering from CHD by primary physician or general hospitals prior to 2000 with no further indication
* Patients whose primary physician reported that the patient is CHD-free providing adequate medical records
Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis.

This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program.

The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of endometriosis made by imaging techniques (MRI or ultrasound) or by surgery.
* A period of 3 months or more since the last surgery if they have undergone surgery.
* Who are receiving hormone treatment and have their disease under control.
* Persistent pelvic pain for at least 3 months.
* With pain and hypertonus in the pelvic musculature, myofascial syndrome, vestibulodynia or pudendal neuropathy.
* Consent to participate in the study
* Capable of carrying out the follow-up of the study until the final visit.
* Who have audiovisual resources and the internet at their disposal.

Exclusion Criteria:

* Women in the menopausal phase
* Women undergoing fertility treatment or planning to undergo fertility treatment in the next 3 months.
* Pregnant women.
* Women undergoing physiotherapy treatment or who have undergone physiotherapy treatment in the last 3 months.
* Having suffered a fracture in the last 3 months in the lower limb that limits their functional capacity.
* Cognitive illness that prevents correct comprehension of the exercises.
* Musculoskeletal pathology or neuropathy in acute phase.
* Having suffered or suffering from a neoplastic disease.
* Untreated endometriosis
* Acquired genital abnormalities of the pelvis or pelvic floor.
* Women in a situation of litigation or economic compensation, or pending the granting of a degree of disability.
* Severe mental illness (schizophrenia, borderline personality disorder, etc.)
Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery.

Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures.

This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.


Eligibility Criteria:
Inclusion Criteria:

1. children in need of deep sedation for dental treatment aged 3-7 years.
2. anticipated operation time 1-2hours

Exclusion Criteria:

1. any known medical records with neural or mental disorder
2. any known medical records with severe systemic disorder
3. history of sedation drug administration in recent 1 months
4. any known allergic history of dexmedetomidine, midazolam or propofol
5. morbid obesity
6. history of OSAHS or acute respiratory infection in 2 weeks
7. other conditions which the attending considers to be unfit for the trial
Development of a Training Intervention to Improve Mental Health Treatment for Gender Minority Youth

The overall goal of the larger 3-aim study is to develop and pilot test a training intervention to increase mental health providers' use of gender-affirming practices with gender minority youth (GMY; children, adolescents, and young adults whose gender is different from their birth-assigned sex). Aim 3 (registered here) of the study is an open trial pilot study at a multi-clinic mental health agency, aimed at examining the feasibility and acceptability of conducting a future randomized controlled trial (RCT).

The overall goal of the larger 3-aim study is to develop and pilot test a training intervention to increase mental health providers' use of gender-affirming practices with gender minority youth (GMY; children, adolescents, and young adults whose gender is different from their birth-assigned sex). The Boston College Institutional Review Board (IRB) approved protocol #21.247.01-15. Aim 1 involved designing the training intervention through an extensive literature review and community-engaged methods that centered on collaborations with providers, GMY, and caregivers. Aim 2 (in progress) entails refining the training intervention via human centered design methods. Aim 3 (registered here) of the study is an open trial pilot study at a multi-clinic mental health agency, aimed at examining the feasibility and acceptability of conducting a future randomized controlled trial (RCT). Effectiveness and implementation data from both providers (n=49) and clients (i.e., GMY and their caregivers; n=50 GMY and n=30 caregivers) will be collected and analyzed. Primary outcomes are measured at the provider-level and secondary outcomes are measured at the patient-level (i.e., GMY and their caregivers).

Eligibility Criteria:
Inclusion Criteria:

For provider participants:

* Mental health care providers (e.g., psychologists, social workers) employed by the pilot site at the time of the pilot test and who work with clients ages 12-25
* Age 18 or older
* Fluent in English

For GMY participants:

* Identify as a gender-minority (e.g., nonbinary, transgender, genderqueer)
* Age 12-25
* Currently receiving mental health services from the pilot site
* Fluent in English

For caregiver of GMY participants:

* Caregivers of GMY currently receiving mental health services at the pilot site
* 18 or older
* Fluent in English

Exclusion Criteria:

* Provided that participants meet the aforementioned inclusion criteria, there are no explicit criteria for exclusion.
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.

Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years (male or female) at time of providing written informed consent
* Documented diagnosis of SSc according to ACR / EULAR criteria 2013
* mRSS ≥ 15 and ≤ 45
* Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
* Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation.

Exclusion Criteria:

* Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
* Positive anti-centromere autoantibodies at Screening
* Evidence of severe chronic kidney disease with estimated glomerular filtration rate \< 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR \< 90 mL/min/1.73m2 will be excluded from the study.
* History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
* Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
* Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
* Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
* Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
* Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
* Known IgA deficiency or serum IgA level \< 5% lower limit of normal
Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.


Eligibility Criteria:
Inclusion Criteria:

Patients who completed the first year of treatment in the main study are allowed to enter the (Long Term) Open Label Extension (OLE) study.

Exclusion Criteria:

1. Children with past or present intracranial tumor growth as confirmed by an MRI scan (with contrast).
2. History of radiation therapy or chemotherapy.
3. Malnourished children defined as:

   1. Serum albumin below the lower limit of normal (LLN) according to the reference ranges of central laboratory;
   2. Serum iron below the lower limit of normal (LLN) according to the reference ranges of central laboratory;
   3. BMI \< -2 Standard Deviation for age and sex;
4. Children with psychosocial dwarfism.
5. Children born small for gestational age (SGA - birth weight and/or birth length \< -2 SD for gestational age).
6. Presence of anti-hGH antibodies at screening.
7. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc.
8. Patients with diabetes mellitus.
9. Patients with impaired fasting sugar (based on WHO; fasting blood sugar \>110 mg/dl or 6.1 mmol/l) after repeated blood analysis.
10. Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi Syndrome, Russell-Silver Syndrome, short stature homeobox-containing gene (SHOX) mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia.
11. Closed epiphyses.
12. Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids and methylphenidate for attention deficit hyperactivity disorder (ADHD), with the exception of hormone replacement therapies (thyroxine, hydrocortisone, desmopressin (DDAVP))
13. Children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of greater than 400 µg/d of inhaled budesonide or equivalents for longer than 1 month during a calendar year.
14. Major medical conditions and/or presence of contraindication to r-hGH treatment.
15. Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.
16. Drug, substance, or alcohol abuse.
17. Known hypersensitivity to the components of study medication.
18. Other causes of short stature such as coeliac disease, hypothyroidism and rickets.
19. The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.
20. Participation in any other trial of an investigational agent within 30 days prior to Screening.
the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor

Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation potential, the incidence increased year by year. The surgical resection is the primary treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of the delicate sense of touch, it could lead to the incomplete resection and disorders of digestion. More than 33% of postoperative patients have the gastric dysfunction. Laparoscopic endoscopy combined surgery is different from the past technology. It is a new radical resection of GIST presented by Japanese scholars. LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .This method conforms to the idea of the modern minimally invasive surgery, and avoids many problems，such as incomplete resection and disorders of digestion caused by excessive tissue resection. our team will spearhead the GIST treatment of LECS. First of all, the investigators will collect 120 cases of GIST patients, randomly assigned for the laparoscopic group, the LECS, single-arch the LECS surgical treatment. Secondly, to analyzing the basic treatment and follow-up data, including the operation time, blood loss, the number of transfer laparotomy, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.The purpose of this subject is to observe the effectivity and safety of LECS and single-arch the LECS, invent serval LECS equipment patents and provide some references for LECS applying to the minimally invasive surgery of the digestive tract tumor and multidisciplinary treatment mode .


Eligibility Criteria:
Inclusion Criteria:

* Patients without contraindications gastroscope，surgery and anesthesia;
* Gastroscope found submucosal lesions, qualitative hard;Endoscopic ultrasonography (EUS) confirmed the lesions come from the muscularis propria
* Tumors diameter \> 2 cm;Or tumors had \< 2 cm, but the position is located in the stomach wall, after nearly cardia and it is a difficult position for gastroscope ;
* Tumors diameter \< 5 cm, the tumors had complete, no broken feed and bleeding
* Not found the tumor metastasis
* There is no history of abdominal surgery, no severe abdominal cavity adhesion
* Patients signed informed consent

Exclusion Criteria:

* Patients with preoperative assessment of distant metastasis;
* Patients with preoperative radiation and chemotherapy or hormone therapy;
* Patients with acute obstruction, bleeding or perforation of the emergency surgery
* Patients with a history of abdominal trauma or abdominal surgery.
* Patients with contraindications gastroscope，surgery and anesthesia;
Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy

Caregiver Burden (CB) is expressed as a multidimensional response related to caregiving, including physical, psychological, emotional, social, and economic problems and has been identified as a public health concern. All these factors negatively affect caregiver health and indirectly affect the care of the disabled child .To provide better support for parents of children with CP, we must understand the difficulties faced those parents and identify the key and common areas where assistance can be rendered.

The symptoms of CP vary from person to person. A person with severe CP might need to use special equipment to be able to walk, or might not be able to walk at all and might need lifelong care. A person with mild CP, on the other hand, might walk a little awkwardly, but might not need any special help. CP does not get worse over time, though the exact symptoms can change over a person's lifetime.

Eligibility Criteria:
Inclusion Criteria:

* Age older then 18 years.
* there BMI will be ranged from 18.5 too 24.9 kg/m2 (Misra et al., 2009) .
* They are the main caregiver for there children.
* They are of low or middle socioeconomic status according too socioeconomic status scale (El-Gilany et al., 2012).
* Having at least 7months of experience in taking care of the child.
* They have no congenital spinal anomalies or lower limb deformities.

Exclusion Criteria:

* Children wif congenital anomalies and chromosomal disease.
* Children wif recent musculoskeletal surgery.
* Any associated problems.