cyrilzakka/clinical-trials huggingface dataset:
MR Elastography for the Herniated Intervertebral Disc

Low back pain is a major cause of disability, especially in the working-age population. A total of 149 million working days are lost every year as a consequence of back pain. Intervertebral disc (IVD) degeneration is thought to play a major role in chronic back and neck pain. Decades of bench-top research in tissue mechanics have shown clear relationships between changes in mechanical properties and abnormal changes IVD structure and composition. Our overall hypothesis is that measurements of IVD mechanical properties can provide valuable information about its structure and composition for early diagnosis of degeneration, quantification of degeneration progress, and evaluation of treatment strategies. Magnetic Resonance Elastography (MRE) is an imaging method to quantify mechanical properties from soft tissues. The objectives of this study are to evaluating repeatability and collecting base line data from healthy individuals; and to apply MRE to patients with disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy controls must be generally healthy individuals in the age range of 18-65.
* Patients, 18 to 65 years old, who have undergone or will undergo MRI as part of the diagnosis of back pain and are diagnosed with one or more herniated discs in the lumbar spine (aka, disc rupture).

Exclusion Criteria:

* Participants with a history of neurological injury or disease will be excluded.
* Participants with contraindications to MRI scanning will be excluded (e.g., electric/mechanical implant, device such as a pacemaker).
* Participants who are claustrophobic will be excluded.
* Participants who are \>250 lbs will be excluded (due to weight and physical constraints of - the scanner, i.e., 55 cm bore).
* Those unable to consent, pregnant women, children, and prisoners will be excluded.
* People under the age of 18 will be excluded as well.
* Individuals who do not understand English (written or spoken) will be excluded
ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

VAY736 dose testing; VAY736 efficacy and safety testing.

This is a randomized, placebo-controlled, double-blind dose range study in autoimmune hepatitis. The study population consists of female and male adult autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care. The diagnosis of autoimmune hepatitis has to fulfill the IAIHG criteria and must be confirmed by liver histology.

Patients will be randomly assigned to different doses of VAY736 or placebo. The primary analysis is planned at 24 weeks. A subsequent study part will then test the efficacy and safety of VAY736 in a parallel group design. For this part of the trial a new group of autoimmune hepatitis patients will be enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

1. AIH diagnosed per International Autoimmune Hepatitis Group
2. Liver biopsy with Ishak modified HAI indicating active AIH
3. Incomplete response to OR intolerance of standard therapy (per AASLD)

Key Exclusion Criteria

1. Prior use of any B-cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb) within 1 year prior to Screening or as long as B-cell count \<50 cells/µL
2. Required regular use of medications with known hepatotoxicity
3. Decompensated cirrhosis
4. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
5. Drug related AIH at screening or a history of drug related AIH.
6. History of drug abuse or unhealthy alcohol use
7. History of malignancy of any organ system
8. Pregnant or nursing (lactating) women
ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve health state quality of life and increase chemotherapy tolerance

Malnutrition is a major public health issue in low- and middle-income countries and forms part of the United Nations 2030 Agenda for Sustainable Development Goals .Cancer is a systemic disease, since even in the early stages malignancies are accompanied by homeostatic imbalance, including metabolic deregulation and increased catabolism. These abnormalities may initially seem poorly discernible in the clinic, but with disease progression they may aggravate; and may cause overt cancer-related cachexia.GI cancers show higher mortality than any other kind of cancer. In 2020, they accounted for an estimated 3.5 million deaths worldwide, with a further 5.0 million new cases diagnosed in the same year . Colorectal cancer (CRC) is the most common type of GI cancer, being the third most common of all organ cancers after lung and breast cancers, whereas gastric, liver, esophageal, and pancreatic cancers are ranked the fifth, sixth, eighth, and 12th most commonly diagnosed cancers, respectively

Eligibility Criteria:
Inclusion Criteria:

-

GI cancer patients will be included in the study if they meet the following criteria:

1. Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.
2. Age above 18 years old
3. Be accessible for chemotherapy treatment and follow-up
4. Availability to administer oral supplements
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
6. Life expectancy ≥3 months.
7. Written informed consent according to the local Ethics Committee requirements
8. Willing to fill Nutrition questionnaires.
9. Negative pregnancy test for pre-menopausal women before inclusion in the trial

Exclusion Criteria:

* The patients will be excluded from the study if they have the following criteria:

  1. Known hypersensitivity reaction to the investigational compounds or incorporated substances
  2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism)
  3. Pregnancy or lactating
  4. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
  5. Age \< 18 years
  6. Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS
Distal Radius Fracture: Clinical Outcome After Conservative Treatment in the Elder Patient

This study is performed to evaluate the outcome of conservative treatment after distal radius fractures in patients of 65 years or older at the time of the injury, primarily with respect to the prognostic value of the Adolfsson-score for the functional demands of the patient on his hand.


Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture with conservative treatment
* Treated in 2014 or 2015
* X-ray of injury
* Informed consent by the patient to participate in the study

Exclusion Criteria:

* No X-ray
* No signed informed consent
* Demented patients
Vancomycin-Associated Nephrotoxicity

The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at time of hospital admission
* Had an absolute neutrophil count of ≥ 1000 cells/mm\^3
* Received \> 48 hours of intravenous vancomycin therapy
* Had one or more vancomycin trough levels reported within the 96 hours after therapy initiation
* Had a baseline serum creatinine level of \< 2.0 mg/dL and baseline creatinine clearance level of ≥ 30 mL/min

Exclusion Criteria:

* Previous diagnosis of cystic fibrosis
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder

This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

Attention deficit hyperactivity disorder (ADHD), previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether cognitive behavioral therapy (CBT) is more effective than ADHD education and relaxation techniques in treating adults with ADHD.

Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or training in which they will learn relaxation techniques and receive detailed information about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry and at study completion.

The study is being conducted at Massachusetts General Hospital in Boston and requires 5 assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston on a weekly basis in order to participate in the study.

Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and relaxation techniques.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult ADHD of at least mild clinical severity (CGI score of 3 or greater)
* Stable on medications for adult ADHD for at least 2 months
* Between 18 and 65 years old
* Be able to give informed consent and comply with study procedures

Exclusion Criteria:

* Moderate to severe major depression, clinically significant panic disorder (CGI for depression or panic greater than 4), bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
* Active suicidality (HAM-D suicidality item rated 3 or 4)
* Current substance abuse or dependence
* IQ less than 90
* Suicide risk
* Prior participation in cognitive behavioral therapy for ADHD
Furosemide Use to Fill the Bladder of Pediatric Females Awaiting Pelvic Ultrasound

The purpose of this study is to investigate whether or not furosemide causes the bladder to fill faster than IV fluids alone so that a pelvic ultrasound exam can be performed.

Trans-abdominal pelvic ultrasound is the standard imaging modality for diagnosis of ovarian torsion in the pediatric population, however this requires that the patient have a full bladder at the time of imaging. This study will investigate whether low dose furosemide in addition to IV fluid boluses may provide a fast, effective, and non-invasive means to fill the bladder of pediatric females awaiting pelvic US. The target population are females age 8 to 18 years seen in the emergency room at Connecticut Children's Medical Center who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion. Enrolled patients will be randomized to the control (IVF bolus only) group vs. the intervention (IVF bolus + furosemide) group and will undergo point-of-care US (POCUS) and bladder scanner evaluation of the bladder every 30 minutes until the bladder is determined to be full.

Eligibility Criteria:
Inclusion Criteria:

1. Females age 8-18yrs seen in the ED at CCMC who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion
2. Ability of patient (if 18yrs) or parent/legal guardian to sign a written informed consent

Exclusion Criteria:

1. History of renal, genitourinary, or pelvic anomalies

   a. Eg: Chronic kidney disease, anuria, vesicoureteral reflux, ureteral obstruction, urologic reconstructive surgery, suprapubic or pelvic surgery, indwelling urethral catheter, oophorectomy, bicornate uterus
2. Patients with multiple chronic illnesses or systemic neurologic abnormality

   a. Eg: Bronchopulmonary dysplasia, tracheostomy, gastrostomy tube dependence, cerebral palsy, severe developmental delay, mitochondrial disorder, congenital heart disease, cardiomyopathy, chronic kidney disease, diabetes
3. Patients with known pregnancy
4. Patients deemed to be critically ill

   a. Mental status changes, signs of end organ damage, hypotension
5. Contraindication to giving Furosemide

   a. Allergy to sulfonamide medications, severe dehydration, hypotension, underlying electrolyte abnormality, underlying renal disease
6. History of previous diuretic use within the past year
7. Patients who self-report their bladder as being full at the time of enrollment
Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients

The primary objective of this study is to assess whether adding modified-release dipyridamole to aspirin (Asasantin Retard) has measurable effects on markers of platelet function (for example, platelet aggregation) in patients with cardiovascular disease who are known to be resistant to aspirin alone


Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular disease (including history of stroke or transient ischaemic attack)
* Documented evidence of resistance to aspirin
* Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent.
* Willing to give informed consent prior to participation in the trial.

Exclusion Criteria:

* Any clinically significant condition other than cardiovascular disease.
* Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings.
* Use of dipyridamole, clopidogrel, ticlopidine or any non-steroidal anti-inflammatory agent (NSAID)(including COX-2 inhibitors) during the two weeks before randomisation and during the trial.
* Active peptic ulceration or history of peptic ulcer disease.
* Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs.
* History of any bleeding disorder.
* History of cerebral haemorrhage.
* Resting seated blood pressure less than 90/60mmHg.
* Participation in any drug clinical trial within sixteen weeks prior to the start of the trial.
* Any indication of current or previous abuse of alcohol, solvents or drugs.
* Asthma.
* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile).
* Previous participation in the randomisation phase of this clinical trial.
A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C infection
* Unsuccessful prior HCV treatment
* Liver impairment (either AST or ALT 1.5-10.0 x ULN)
* Alpha-fetoprotein \<= 50 ng/mL
* Adequate hematologic parameters

Exclusion Criteria:

* Decompensated or severe liver disease
* Hepatocellular carcinoma
* HIV infection
* Co-infection with hepatitis B virus (HBV)
* Renal impairment
* Pancreatitis
* Use of illicit or drugs of abuse
* History of alcohol abuse
* Presence of clinically significant cardiac arrhythmias
* If female, pregnant or lactating
Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients

Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients

The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients \> 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated

Exclusion Criteria:

* renal failure determined by glomerular filtration rate (GFR) \< 30 ml/min or need for renal replacement therapy
* liver cirrhosis
* intravascular disseminated coagulation
* contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,...)
* patients receiving low dose of vasopressor (norepinephrine \< 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)
Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR

Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR

Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR

Eligibility Criteria:
Inclusion Criteria:

* all staphylococcus isolates resistant to clindamycin

Exclusion Criteria:

* non
Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets

This study will measure the effect of cinacalcet (Sensipar) on parathyroid hormone (PTH) secretion in children and adolescents with hypophosphatemic rickets (XLH). The investigators are seeking evidence that patients with XLH may benefit from treatment with cinacalcet by achieving better control of PTH secretion.

X-linked hypophosphatemic rickets (XLH) is an X-linked dominant genetic disorder. Common findings are low serum phosphate and inadequate 1,25(OH)2 vitamin D production. It is generally believed that the primary defect in XLH is impaired renal tubular transport of phosphate coupled with abnormal regulation of the enzyme responsible for the 1-alfa hydroxylation of 25(OH) vitamin D. The current treatment of children with XLH is large oral doses of phosphate and 1,25-dihydroxyvitamin D. There are two common side effects to this treatment; nephrocalcinosis and secondary hyperparathyroidism (HPT). The latter at times may cause hypertension, hypercalcemia, and permanent renal damage. The complication of secondary hyperparathyroidism is seen in 20% of the patients. The release of PTH from the glands into the circulation is tightly regulated by serum calcium concentration. The glands "read" serum calcium concentration via Ca sensing receptors (CaR) which are located at the surface of the glands. Calcimimetics are compounds that allosterically modulate the CaR, thereby enhancing its sensitivity to circulating serum calcium concentrations and consequently decreasing PTH secretion. When used in primary HPT, they rapidly reduce PTH level and normalize serum calcium concentration.

Cinacalcet is a calcimimetic agent recently approved by the FDA for treating hypercalcemia in patients with parathyroid carcinoma and secondary HPT in patients with chronic renal disease. Cinacalcet was found to be effective in decreasing both PTH level and the calcium X phosphorous ion product in dialysis patients.

The goal of our proposed acute study is to see whether concomitant administration of Cinacalcet and phosphate, to patients with XLH, will block completely or partially secretion of PTH (day 2), expected to be seen following administration of phosphate alone (day 1). We will also monitor serum phosphate, total calcium, and ionized calcium concentration to learn to what extent, if any, blockage of PTH secretion affects mineral homeostasis under this condition.

If found to be effective in blocking PTH secretion, Cinacalcet will become a candidate for a long-term study in children with XLH to protect them from developing secondary hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Established patients with XLH
* Age 5 years old and above
* Normal serum calcium and creatinine concentrations

Exclusion Criteria:

* Patients with hypersensitivity to any component(s) of cinacalcet
* Hypocalcaemia
* Elevated serum creatinine
Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy

As children with cerebral palsy (CP) become teenagers, they experience a decrease in their physical function and mobility. Decreased mobility leads to increased social isolation for the teens and impacts negatively on their quality of life. This loss of function is multifactorial, but poor physical fitness and muscle weakness secondary to disuse are significant contributors. Exercise video games are a novel approach to engage youth in physical exercise and social interaction with their peers. The objective of this study is to evaluate the impact of an exercise video gaming intervention to improve physical fitness and social wellbeing. Our over-arching research questions are whether "exergames" can provide health benefits (improved physical fitness) and improved social wellbeing in youth with CP.

The primary objectives of this study are to evaluate the impact of exergaming on cardiovascular fitness and social wellbeing related to friends/peers in youths with CP. The secondary objectives of the study will be to evaluate the impact of the exergaming intervention on additional components of physical fitness including anaerobic fitness, and muscle strength. In addition, the effect of the exergaming intervention on overall health-related quality of life (HRQL), self-esteem and motor participation will also be measured. Finally, the effectiveness of a technique for balancing performance in multiplayer exergames will be evaluated. The objectives will be investigated using a randomized crossover study design.Outcomes will be measured a total of four times: at study entry and after the first ten-week period (either comparison or intervention), at the end of a six-week washout period, then again after second period (either intervention or comparison). Outcomes will be assessed by physiotherapists and research staff members who will be blinded to the condition of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP and GMFCS level III
* Between 9 and 18 years of age inclusive
* Ability to operate a handheld videogame controller
* High-speed internet in the home
* Able to commit for the entire study duration

Exclusion Criteria:

* Orthopedic surgery in the preceding six months
* Exercise-induced asthma
* Any underlying heart condition
* Seizure disorder
* Visual, auditory or cognitive disabilities that will interfere with game play