cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and PK/PD of SHR1459 in Healthy Volunteers

This was a phase I, single-center, double-blind, randomized, placebo-controlled study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of the investigational medicinal product in healthy volunteers.

The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any ethnic origin, age ≥18 and ≤45 years of age;
* BMI ≥19 and ≤26 kg/m2; Men's weight≥ 50kg, Women's weight ≥ 45kg;
* Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator; all clinical tests of blood, urine, ECG and X-ray are within the normal range or show no clinically relevant deviations as judged by the Investigator;
* There is no birth plan during the trial and within 1 month after the completion of the trial, and the subject must agree to use one of the effective contraceptive methods;
* Able to comprehend and abide by the study restrictions, and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria:

* Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
* Has a history of malignant or lymphoproliferative disorders;
* Has a history of bleeding tendency or coagulopathy (eg, uncontrolled autoimmune hemolysis and thrombocytopenic purpura, severe hematopoietic defects, gastrointestinal bleeding), or recent bleeding events;
* Has a history of stroke or intracranial hemorrhage within 6 months prior to screening;
* Has any surgery performed within 3 months prior to screening, or during the study period and within 1 month after the end of the study;
* Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
* Has diseases affecting drug absorption, distribution, metabolism, and excretion (eg, gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc);
* Has active tuberculosis by clinical symptoms, signs, laboratory tests, or X-ray examinations;
* Has infections including acute and chronic infections, local infections such as sepsis, abscesses, and opportunistic infections that were clinically significant by the investigator in the 3 months prior to screening;
* Has blood donation and donated ≥400 mL within 3 months before screening ; or received any blood product infusion; or received plasma exchange or blood cell clearance treatment;
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).


Eligibility Criteria:
Inclusion Criteria:

* ≥15 years of age
* intubated and mechanically ventilated on a volume controlled mode
* head injury or other intracranial pathology with ICP of ≥15 mmHg
* arterial line in place
* SpO2 ≥95%
* MAP \>60
* in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
* inclusion presents no significant delays to planned emergent neurosurgery
* prior written informed consent

Exclusion Criteria:

* cardiac or pulmonary injury impacting intrathoracic pressure
* confirmed pneumothorax or hemothorax
* PaO2/FiO2 \<300
* serious neck injury resulting in neck swelling with jugular venous compression
* evidence of ongoing uncontrolled bleeding
* respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
* congestive heart failure
Malnutrition in People With Complex Multiple Disabilities

Underweight is more prevalent in people with a mental handicap than in people without a mental handicap, especially in people with a severe mental handicap. It is unknown if these people are malnourished. There is no validated screening instrument available to determine the nutrition status in people with complex multiple disabilities. Research regarding malnutrition based on body composition and nutrients in stead of anthropometric data is important.

The aim of the study is to understand the nutritional status of people with complex multiple disabilitiest through measurement of body composition and nutritients. The primary objective of the study is: What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? Understanding the nutritional status of these patients is important in order for them to receive appropriate and effective treatment. This treatment is of interest for general health and the quality of daily life.


Eligibility Criteria:
Inclusion Criteria:

* Person with complex multiple disabilities;
* Living in a care institution participating in the Governor Kremers Centre (GKC);
* Chronically confined to a wheelchair or bedridden;
* 18+ years

Exclusion Criteria:

* Parenteral nutrition;
* Serious infection;
* Terminal illness
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.

OBJECTIVES:

* To develop a new multi-modal screening strategy and integrated methods to detect lung cancer early in current and former smokers.
* To evaluate the impact of the screening modalities on the quality of life of these participants.
* To develop a decision analytic framework for determining the cost and effectiveness of a novel lung cancer screening strategy in Canada.

OUTLINE: This is a multicenter study.

Participants undergo spirometry at baseline. Participants also undergo spiral CT scan at baseline and then at 1 and 2 years. Participants with semi-solid or solid nodules of 5-10 mm or ground glass opacity (GGO) 8-10 mm or those with growth of an existing nodule, development of a solid component in GGO, or a new nodule undergo an additional CT scan at 3 months. Some participants also undergo autofluorescence and white light bronchoscopy and bronchial biopsies.

Blood samples are collected at baseline and then annually for 2 years for biomarker studies. Participants diagnosed with lung cancer undergo additional blood sample collection for biomarker studies.

Participants complete questionnaires on sociodemographic factors, smoking, occupational exposure, family history, medical data, quality of life, and anxiety at baseline and then every 6 months for up to 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Current or former smoker

  * A former smoker is defined as one who has stopped smoking ≥ 1 year but \< 15 years ago
* Estimated 1-year lung cancer risk ≥ 1%

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Not pregnant
* Willing to undergo a spiral chest CT scan
* No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
* No acute or chronic respiratory failure
* No bleeding disorder
* No other medical condition that, in the opinion of the investigator, would preclude the participant's safety during study participation or that would unlikely benefit the participant from screening due to shortened life expectancy from the co-morbidity
* No diagnosis of cancer, except for any of the following that were previously treated ≥ 5 years ago:

  * Non-melanomatous skin cancer
  * Localized prostate cancer
  * Carcinoma in situ of the cervix
  * Superficial bladder cancer
* No known reaction to xylocaine, salbutamol, midazolam, or alfentanil

PRIOR CONCURRENT THERAPY:

* More than 2 years since prior chest CT scan
* No concurrent anti-coagulant treatment (e.g., warfarin or heparin)
Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure

The purpose of this study is to investigate whether in patients with early persistent atrial fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control approach, including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm compared with conventional rhythm control after one year of follow-up.

A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5 years to investigate the long term effects on persistence of sinus rhythm and cardiovascular morbidity and mortality of the two treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* Early symptomatic persistent atrial fibrillation
* Mild to moderate early heart failure
* Optimal documentation and treatment of underlying heart disease
* No contra-indication for oral anticoagulation
* Eligible for cardiovascular rehabilitation
* Age \>= 40 years

Exclusion Criteria:

* On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year
* Heart failure NYHA class IV
* LVEF \< 25%
* Left atrial size \> 50 mm (parasternal axis)
* Present aldosterone receptor antagonist use
* Previous use of class I or III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with betablocker)
* Cardiac resynchronization therapy
Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

OBJECTIVES:

I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.

II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.

PROTOCOL OUTLINE:

This is a randomized, multicenter study.

Patients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II).

Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7, 8, or 9.

Arm II patients receive serial plasmapheresis treatments. The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days.

Patients are followed at weeks 1, 2, 3, 4, 8, 12, and 24.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS

Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study

No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study

No CNS involvement

--Prior/Concurrent Therapy--

Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg)

Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma)

Radiotherapy: Not specified

Surgery: Not specified

Other: No concurrent mechanical ventilation

--Patient Characteristics--

Age: Under 18 but with at least 3 months of independent walking

Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3

Hepatic: No liver failure

Renal: No kidney failure

Neurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy

Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled infection; No known IgA hypersensitivity; No other preexisting disease that would interfere with assessment of disability grades; No other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder

No such study has been conducted in Pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in ASD among children aged 3 to 14 years.


Eligibility Criteria:
Inclusion Criteria:

* Children of both genders aged 3 to 14 years with diagnosis of autism spectrum disorder established by DSM-5 Criteria, Childhood Autism Rating Scale (CARS) scoring and clinical examination along with documentation of Language Impairment

Exclusion Criteria:

* All children having autism with seizure disorder, autism with serious medical illness within last 6 months or those with autism with well-defined genetic syndrome.
The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning

The purpose of this study is to find out whether a new device can help obtain more accurate CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung tumors may also move during breathing. Liver tumors may also move with breathing; as the lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely obtained as part of planning for lung or liver radiation therapy. Since patients breathe during this CT scan and their lung or liver tumors move, these CT scans can sometimes be inaccurate. We are now testing a device to only obtain the CT and an additional PET scan while patients are breathing in or out. This will hopefully allow us to deliver radiation with more accuracy.

The objectives are to measure the amount of tumor motion with respiration, measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and to determine the fraction of patients whose radiation treatment plans would be modified based on this information. Eligible patients are those receiving radiation treatment for thoracic or liver tumors.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Ability to sign informed consent form indicating investigative nature of this study, in keeping with the policies of the hospital.
* Patients must have thoracic disease visible on a Chest CT scan, or liver disease visible on a abdominal CT scan.

Exclusion Criteria:

* Pregnant women are ineligible. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study.
* Patients with thoracic or liver disease that is not visible on CT scan
* Patients who are unable to follow directions either due to language difficulties or hearing impairment.
* Patients who are too ill to hold their breath.
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.

patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.

group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.

weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)

outcomes: death within first year

postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation

Eligibility Criteria:
Inclusion Criteria:

* Pertrochanteric femur fracture
* Unilateral
* Age over 60 years
* Low energy trauma
* ASA score 0-3

Exclusion Criteria:

* Reverse oblique fractures
* Pathological fractures
* Severe osteoarthritis of the hip joint
* Previous operations on same leg
* ASA score 4-5
Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.

Experimental evidence suggests that NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index \[BMI\] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese women. The increased risk of SSIs is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. Thus, prophylactic NPWT may be particularly effective in this patient population.

During the 5-year project period, investigators from 4 collaborating perinatal centers in the United Stated (two university and two community) will randomize 2850 obese women undergoing cesarean delivery to receive either prophylactic negative pressure wound therapy with the Prevena device or standard wound dressing. Women will be followed up to 30 days postoperatively to ascertain study outcomes.

The primary outcome for the trial is superficial or deep SSI after cesarean according to the CDC's National Healthcare Safety Network definitions. The investigators will also assess other wound complications, adverse events potentially attributable to NPWT and cost-effectiveness as measured by incremental cost per case of SSI prevented and per quality-adjusted life year (QALY).

Eligibility Criteria:
Inclusion Criteria

* Gestational age ≥23weeks
* BMI≥30 Pre-pregnancy or BMI at first prenatal visit
* Planned or unplanned cesarean delivery

Exclusion Criteria:

* Non-availability for postoperative follow-up
* Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)
Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones

The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).

Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.

Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.

FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.

The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.

Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Both sexes.
* Patients with upper ureter and renal stones scheduled for flexible ureteroscope.

Exclusion Criteria:

* Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
* Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
* Known ureteric strictures.
* Concomitant ureteric stones.
* Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.
Ceftaroline in the Treatment of Bone and Joint Infections

This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.

Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age with the following osteoarticular infections:

  1. Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.

     Criteria for infected joint:
     1. Sinus tract which communicates with the joint
     2. Preoperative diagnosis by diagnostic, culture positive arthrocentesis
     3. Intraoperative diagnosis-evidence of purulence/inflammation is seen by the surgeon and/or the pathologist, and at least 2 intraoperative samples grow the same organism (only 1 needed if S. aureus) OR
  2. Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)

     1. Onset less than 4 weeks prior to evaluation
     2. Radiographic (plain, MRI, TC) evidence of osteomyelitis
     3. Positive culture from bone or blood culture with organism known to cause osteomyelitis
     4. Orthopedic consultant must concur with diagnosis. PLUS: Positive bone/joint or blood culture for an organism known to cause osteomyelitis which is Ceftaroline susceptible

Exclusion criteria:

1. Immunocompromised hosts:

   1. AIDS/HIV patients
   2. Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.
   3. Any condition requiring \> 20 mg prednisone or equivalent
   4. TNF (tumor necrosing factor) inhibitor use (ongoing)
   5. Organ transplant list
2. Diabetic foot infections
3. Osteomyelitis in association with decubitus ulcers
4. Vertebral osteomyelitis/spinal epidural abscess
5. Septic bursitis
6. Gonococcal arthritis
7. Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.
8. Infected external fixation devices
9. Calculated creatinine clearance \< 50 mL/min at baseline
10. History of severe penicillin/B lactam allergy (ID to evaluate)
11. Intravenous drug use - lifetime exclusion
12. Patients with a nail puncture wound to foot
13. Patients at high risk for MDR (multidrug resistant) Gram negative organisms

Please note the use of antibiotic containing cement is not exclusion, as it represents standard of care in some of the infections to be studied