cyrilzakka/clinical-trials huggingface dataset:
IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.

Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.

As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

This is an observational, open-label, prospective, multi-centre, national study designed to evaluate the factors predictive of Tofacitinib's survival in patients with rheumatoid arthritis

If catastrophisation is described as a distortion of the perception of pain involving a both emotional and cognitive component, pushing the patient to see only the worst, coping involves adaptive strategies by which the patient attempts to find solutions in order to better cope with his/her disease. It has been demonstrated that such behavioural strategies can influence directly or indirectly the intensity of symptoms in patients suffering from chronic disease.

Therefore, as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

The duration of this study will be approximately 48 months including a 24-month recruitment period and a 24-month patient follow-up period.

Patients will be followed prospectively and follow-up visits will be conducted after the initial consultations. No visit or additional test is required by the protocol, since the study is observational

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist
* Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib
* Patient informed of the study

Exclusion Criteria:

* Patient participating in a randomised clinical trial.
* Patient presenting with a contraindication to prescription of Tofacitinib
* Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
Backpack Weight Impacts

Backpacking is an increasingly popular outdoor recreational activity. The base pack weight (BPW) includes gear that is not consumed or worn on the body: shelter, sleep system, weather-proofing layers and personal gear to ensure a degree of comfort and safety. As such, reducing BPW is one of the most important tasks a backpacker manages when preparing for a trip. Available recommendations for ideal BPW are currently inconsistent, lack clear parameters, and rely on anecdotal evidence. The study aims to collect field data on perceived exertion and heart rate (HR) in relation to BPW during a day-long interval of hiking. Such findings can have implications on the cost and safety profiles extending from recreational backpacking to military and wilderness rescue operations.


Eligibility Criteria:
Inclusion Criteria:

* Only adult (age 18-65)
* Have gone on at least two overnight backpacking trips in the past 5 years
* Have hiked at least 8 miles in a day on one of those trips

Exclusion Criteria:

* Lower extremity injuries or surgeries in the past 6-months
* Daily Smokers
* Chronic medical problems:
* Hypertension
* High cholesterol
* Diabetes
* Heart attack
* Heart surgery, cardiac catheterization, or coronary angioplasty
* Pacemaker/implantable cardiac defibrillator/rhythm disturbance
* Heart valve disease
* Heart failure
* Heart transplantation
* Congenital heart disease
* Kidney disease
* Back pain
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years old;
2. Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
3. No contraindication for chemotherapy;
4. ECOG performance scale 0-2;
5. No history of anti-angiogenesis therapy;
6. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria:

1. Concurrent use of other anti-cancer agents;
2. Allergic history to M2ES and biological agents;
3. Pregnant or breast-feeding women;
4. With other malignancy;
5. With severe cardiopulmonary disease;
6. Uncontrolled brain metastasis patients;
7. Other conditions that are regarded for exclusion by the trialists.
Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System

This is a Randomized Clinical Trial to compare two interventions for reducing knee pain and improving knee function of patients with knee osteoarthritis.

Sixty participants will be randomly allocated to one of the intervention groups, either a knee educational program or a combination of knee educational program and medical interventions.

Participants will be assessed primarily on function and pain, as well as other secondary outcomes at baseline, at the end of the interventions, and three months after the end of the interventions.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis;
* Moderate to severe knee pain (VAS \>= 4);
* Knee pain for at least 3 months prior to inclusion;
* Willing to sign the Informed Consent Form.

Exclusion Criteria:

* Untreated severe psychological or psychiatric diseases without treatment;
* Presence of fibromyalgia;
* Presence of systemic inflammatory rheumatic diseases;
* Presence of neoplasia;
* Presence of relevant pain in other joints, according to medical evaluation;
* Presence of intolerance or allergy to Lidocaine or local anaesthetics;
* Concomitant use of anticoagulant drug.
Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

The study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called Fitness Digital (FitD), for individuals with prediabetes or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Hong Kong resident
* Can understand Chinese and Cantonese
* Have self-reported diagnosis of type 2 diabetes or prediabetes
* Have a smart phone and able to use a mobile app

Exclusion Criteria:

* None
Effects of AD on VI in Patients With CF

This study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. Lung clearance index (LCI) is the primary outcome

This is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis.

Electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. Each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis diagnosis
* FEV1 \> 40%
* Able to sustain 30min of chest physiotherapy

Exclusion Criteria:

* Presence of Burkoldheria cepacia or non tuberculous mycobacteria
* Orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system
* Need for supplemental oxygen
* Cardiac pacemaker or internal cardiac defibrillator
Long-term Data Collection for Subjects in MDX-010 Studies

The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.

This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.
2. Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
3. For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.
Caffeine's Effect on Attention

The purpose of this study is to determine whether caffeine improves attention.

Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo

Eligibility Criteria:
Healthy male and female Aged 40-60 years
Clinical Study of the Effects of a SWalker II and VR for Hip Fracture Rehabilitation in the Elderly

This project is structured in two distinct phases. The first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of gait. In the first phase, the aim is to evaluate the effects of the use of the robotic device (SWalker) on the physical improvement of the patient. While in the second phase, the objective is to evaluate the effects of virtual reality technology combined with the use of the SWalker.Therefore, the following specific objectives are identified:

* Phase I: To analyze the effects of SWalker application in patients with acute hip fracture on clinical parameters of rehabilitation.
* Phase II: To study the effects of the application of the SWalker combined with immersive technology in people with impaired gait function after hip fracture.

In the preliminary phase, the usability and acceptance of the SWalker II system combined with virtual reality is evaluated with a group of healthy subjects. For this purpose, an exposure session and the evaluation of the system based on questionnaires are carried out. On the other hand, a gait characterization session (capture of ROM and EMG) is performed inside and outside the walker with different speeds and weight loads.

In the first phase of the clinical study, patients with hip fractures in the early rehabilitation phase were recruited. They are randomly assigned to a control group or experiment group. And for a period of 6 weeks, both groups carry out the same rehabilitation exercise program based on strength, balance and ambulation exercise. The difference is that the experimental group performs the rehabilitation exercises with the SWalker, and the control group performs these exercises with conventional parallel bars.

In the second phase of the clinical study, these same patients who have passed the first pass, move on to a 6-weeks program of maintenance and improvement of gait function. Again, they are divided into 2 groups, control and experimental. So the control group will perform walking exercises with the Swalker and conventional balance exercises and the experimental group will perform walking and balance exercises with SWalker and virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes over 65 years of age,
* Patients with a height of less than 180 cm,
* Patients weighing less than 90 kg,
* Patients who have suffered a hip fracture\* and wish to participate in the study.
* In addition, they must sign and understand the informed consent form.

Exclusion Criteria:

* Cognitive status insufficient to understand and execute instructions given by the physiotherapist.

  * Patients needing rehabilitation after hip fracture may vary from a few days to a few weeks after the period of occurrence of the hip fracture, depending on the complications that could arise and the type of surgery used, with a pre-set limit of one month.
Interscalene Block Versus Superior Trunk Block

Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).


Eligibility Criteria:
Inclusion Criteria:

* Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder
* Age 18 to 80 years
* Planned use of general anesthesia with LMA and interscalene or superior trunk block
* Ability to follow study protocol
* English speaking
* ASA I - III

Exclusion Criteria:

Pre-existing neuropathy of the operative limb

* Younger than 18 years old and older than 80
* Patients with pulmonary severe respiratory disease
* Allergy to one of the study medications
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
* Contraindication to general anesthesia, interscalene or superior trunk block
* Herniated Cervical Disk, Cervical Myelopathy
* BMI \>35
Primary Prophylaxis of Gastric Variceal Bleed

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis
2. Patients with high risk gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Acute bleed or past history of bleed from gastric varices
2. Previous treatment of gastric varices.
3. Non-cirrhotic portal hypertension
4. Contraindications to cyanoacrylate injection or BRTO
5. Portal cavernoma
6. Hepatorenal syndrome
7. Proven malignancy including hepatocellular carcinoma
8. End-stage renal disease under renal replacement therapy;
9. Cardiorespiratory failure
10. Pregnancy or patients not giving informed consent for endoscopic procedures
Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation

This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.

This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. As a result, the Committee on Nutrition of the American Academy of Pediatrics (AAP) recommends daily oral iron supplementation, of at least 2-4 mg/kg/day from 2 weeks of age, to prevent iron deficiency in extremely premature infants. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.

Eligibility Criteria:
Inclusion Criteria:

* NICU inpatients between 26 and 32 weeks of gestation Infants older than two week of age and Iron dosing will be adjusted for weight at weekly intervals to maintain dosing at 4mg/kg/day.

Parental permission obtained prior to start of study

Exclusion Criteria:

* In extremis during consent window (as judged by primary attending provider) Known or suspected genetic disorder Small for gestational age (birth weight below the 10th percentile for gestational age) Unable to return for follow-up evaluation at 6 months of age
Real-time Ultrasound-guided Spinal Anesthesia:A Feasibility Study

The traditional landmarks to locate the injection site and orientation of the spinal needle for spinal anesthesia are based on palpation of surface bony landmarks. However the actual injection target into the CSF is located at an unknown depth inside the patients 3 dimensional spinal anatomy which can itself vary in its orientation relative to these surface markers.Also bony surface markers may not be palpable in some patients or the patient may have altered spinal alignment. Thus an already blind procedure can become even more misguided involving multiple trial and error needle insertions. On the other hand ultrasound allows visualisation of deep target structures which are impalpable, it allows assessment of spinal alignment and thus directs the orientation of the seeking needle more accurately. Performing US in real-time during needle insertion gives continuous feedback about the correct needle approach path which should reduce the number of blind needle passes.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery

Exclusion Criteria (are as for Spinal anesthesia generally)

* Patient refusal
* Sepsis or local infection at the site of injection
* Hypovolemia
* Coagulopathy (INR ≥1.5, Platelets \< 75X 109 /L, anticoagulant therapy)
* Indeterminate neurologic disease
* Increased intracranial pressure
* Local anesthetic allergy
* Infection distinct from the site of injection
* Unknown duration of surgery
Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)

This is a randomized study involving patients with primary aldosteronism (PA) patients with adrenal nodule (≥1cm) who completed AVS or 68Ga-Pentixafor PET/CT.We will enroll 320 PA patients with adrenal nodule (≥1cm) .All paticipants will be randomized into 68Ga-Pentixafor PET/CT group(Intervention group) and AVS group(Control group) to compare the long-term outcomes of patients with PA.

Eligibility Criteria:
Inclusion Criteria:

(1)Getting the written informed consent (2)ARR ≥20 (pg/ml)/ (μIU/ml) or ARR ≥ 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT).

(3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (≥1cm). Exclusion criteria

1. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l.
2. PA patients who meet the by-passing AVS criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \>300pg/ml\]
3. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \<20 years, hypertension and hypokalemia, or with family history\]
4. Suspicion of pheochromocytoma or adrenal carcinoma.
5. Patients with actively malignant tumor.
6. Patients who have adrenalectomy history or with adrenocortical insufficiency.
7. Long-term use of glucocorticoids.
8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders.
9. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb\<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m²) or Underweight (BMI≤18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment
Antihypertensive Response to Losartan and Genetic Polymorphisms

The purpose of this study is to evaluate the antihypertensive response of treatment with losartan with reference to genetic polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

* Both gender less than 60 years old, with mild-moderate hypertension (SBP greater than and DBP equal or greater than 90 mmhg, BP \< 180/110)
* Never treated for hypertension or who have taken antihypertensive agents sporadically (not more than 15 days total therapy) but not in the 30 days prior to the first visit
* Patient in therapeutic wash out for 6 months
* Patient is asymptomatic, absence of significant concomitant diseases, except for non-familial hypercholesterolemia, absence of systemic diseases
* Women with menopause not treated with hormone replacement therapy or women of reproductive age who do not make use of estro-progestagen agents but who use another safe contraceptive method
* BMI \< 30 for men and \< 28 for women

Exclusion Criteria:

* Secondary or malignant hypertension, Na \<130 mmol/l, K \>5,5 mmol/l, or \< 3,0 mmol/l
* Cardiac disease such as ischemic, HF, arrhythmia, cardiac surgery
* Pregnant, breast feeding
* History of nephropathy, metabolic disease, liver disease
* Alcohol or drug abuse
* History of angioedema
* Has a known hypersensibility to study drug(s)
Virtual Reality Exercise in a Community Highschool for Children With Disabilities

The purpose of this study is to work with a community engagement group to develop and pilot a protocol for a virtual reality exergaming program for children with special needs at a high school.

A virtual reality exercise program will be run during school special physical education hours at a public high school. The program will be implemented by a person with cerebral palsy. The exercise will include rhythmic movement to music and fitness games.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in school special physical education or self-reported disability
* Note from physician permitting participation in moderate intensity exercise or cleared for sport participation through physical examination that was on file by the school
* Ability to communicate in English (or a caregiver)

Exclusion Criteria:

* Complete blindness or deafness
* Condition that may make participation unsafe