cyrilzakka/clinical-trials huggingface dataset:
Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab in Subjects with Hepatocellular Carcinoma

This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

15 subjects will be enrolled in each of the 3 cohorts. Once enrollment of the first 3 of 15 subjects is completed, Safety and Efficacy Review Committee (SERC) meeting involving the study Investigators and the Sponsor's clinical study team will be held after Day 43 (Week 6) visit of the third subject enrolled. After the data from enrolled subjects is reviewed in the meeting, dose escalation to the next dose will be determined, based on the number of subjects experiencing dose-limiting toxicity (DLT).

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females
* Hepatocellular carcinoma diagnosis (BCLC stage B or C)
* hTERT positive expression confirmed during the screening period
* ECOG score of 0 or 1
* Child-Pugh score of A
* Life expectancy \>= 3 months

Exclusion Criteria:

* Moderate or severe ascites
* History of hepatic encephalopathy
* Carcinomas other than HCC
* Current or history of HIV positive
* Not suitable for inclusion judged by the investigator
A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients

This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.

This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone.

This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 88 years of age.
2. Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
3. Subject willing and able to sign the informed consent.
4. Subject is fluent in verbal and written English.
5. Subject agrees to take Liposomal bupivacaine or standard of care equivalent.

Exclusion Criteria:

1. Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
2. Subject is pregnant or planning to become pregnant while enrolled in the study.
3. Subject has a history of narcotic or alcohol abuse.
4. Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) \< 30 ml/min within 30 days of surgery).
5. For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
Oxaliplatin-induced Portal Hypertension

Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Sign written informed consent
* Male or female patients aged 18-75
* diagnosed as portal hypertension by contrast-enhanced computed tomography
* and confirmed gastroesophageal varices by upper digestive endoscopy;
* had a history of oxaliplatin-based chemotherapy after colorectal cancer surgery;

Exclusion Criteria:

* combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
* with colorectal cancer required further anti-tumor treatment
* Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP pancreatitis.

Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the Holliday-Segar method given peri-procedurally as described earlier (standard hydration). Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation of amylase or lipase \>3 times the upper limit of normal.

Eligibility Criteria:
Inclusion Criteria:

* patients at age between 18-65 years old undergoing first time ERCP

Exclusion Criteria:

* Ongoing acute pancreatitis
* Chronic pancreaittis
* Prior sphincterotomy
* Ongoing hypotension including those with sepsis
* Cardiac insufficiency (CI, \>NYHA Class II heart failure)
* Renal insufficiency (RI, creatinine clearance \<40mL/min)
* Severe liver dysfunction (albumin \< 3mg/dL)
* Respiratory insufficiency (defined as oxygen saturation \< 90%)
* Pregnancy
* Hyponatremia (Na+ levels \< 130mEq/L))
* Hypernatremia (Na+ levels \> 150mEq/L)
Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

This is a phase IV, 12-month observational, prospective, open-label, multi-center study that will be conducted across approximately 50 sites in Canada for an estimated study duration of 32 months. All eligible adult participants who are enrolling into the SILIQ Patient Support Program (PSP) and initiating brodalumab as per routine care may be offered participation in the study. If the participant agrees, their verbal consent and details will be entered into the study platform by the enrolling physician so that the participant can access the electronic informed consent form. Participants who meet the eligibility criteria and provide electronic informed consent will be enrolled in the study. The study observation period will be 12 months (±15 days). Data will be collected on approximately 500 participants across academic and community centers.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years old at the time of verbal consent to participate in the study.
2. Initiating brodalumab as part of routine clinical care through the SILIQ (brodalumab) Patient Support Program (PSP) for the treatment of plaque psoriasis but has not yet received their first dose. Decision to treat with brodalumab must have been reached prior to and independently of recruitment in the study.
3. Must be able to read, understand, and communicate in English or French.
4. Willing and able to provide informed consent on an online platform using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved electronic Informed Consent Form (ICF) in English or French.

Exclusion Criteria:

1. Not willing or able to complete ePROs (electronic Patient Reported Outcomes) on an online platform (using a computer or mobile device).
2. Participation in brodalumab phase IV study (NCT04149587).
3. Participation in an interventional clinical trial concurrently or within the last 30 days prior to providing verbal consent to participate in this study.
4. Patient with Crohn's disease or with clinically significant hypersensitivity to brodalumab or to any of the excipients or component of the container (contraindications as per the Product Monograph).
5. Presence of any other serious and/or uncontrolled medical condition that, in the opinion of the investigator, prohibits the patient from participating in the study.
Contralateral ReSTOR / Monofocal or Phakic Eye

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral operable cataract
* Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria:

* Ocular comorbidities compromising primary outcome
* Bilateral cataracts
Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus

The aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus
* Poor glycemic control

Exclusion Criteria:

* Heart failure
* Renal disease
* Liver disease
* Cardiovascular event
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer

The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the breast;
* Documented metastatic disease previously untreated by chemotherapy;
* HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
* Karnofsky Performance Status 70%.

Exclusion Criteria:

* Local relapse alone after conservative treatment or contra-lateral tumor;
* Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
* Concomitant hormonal therapy for metastatic breast cancer;
* Prior chemotherapy in the metastatic setting;
* Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
* Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia

Preconditioning of regional skin is known to reduce post surgery complications due to increased perfusion and better skin condition. The aim of this study is to prove that local heating through a standardized device in patients with spinal cord injury induces no burnings or other relevant side effects. The investigators expect an increased regional perfusion, temperature and redness.


Eligibility Criteria:
Inclusion Criteria:

* men and women
* aged from 18 to 65 years
* paraplegia Th2-Th12
* spinal cord injury had occurred \>12 weeks ago

Exclusion Criteria:

* infections
* fever
* diabetes
* heart failure stadium III
* renal insufficiency stadium III.
* scars, wounds or other injuries in the area of treatment
* skin type V and VI on Fitzpatrick scale
The Role of Genetics in Weight Loss

The prevalence of both overweight and obesity is increasing at an alarming rate worldwide. In fact, it is estimated that 2.16 billion adults (38%) will be overweight and 1.12 billion adults (20%) will be obese by 2030. Among other risk factors (e.g., environmental, behavioral, and medical), genetics holds an important role. Genome-wide association studies have discovered hundreds of loci associated with body mass index (BMI). Polygenic scores (PS) are generated from a combination of millions of genetic variants that are associated with BMI. Several diet intervention studies aimed at reducing body weight in overweight and obese individuals. However, the effect of genetic background on the effectiveness of diet interventions is largely unknown. To our knowledge, the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial is the only prospective study that has been designed to evaluate the effect of genotypes in modifying the impact of a healthy low-fat diet vs a healthy low-carbohydrate diet on weight change, but this study did not consider PS.

The aim of our study is to determine whether BMI PS impacts the effectiveness of dietary intervention in reducing BMI among individuals with elevated BMI.

To achieve this, the investigators will leverage the unique opportunity provided by the Finnish biobanks research environment to re-contact 1200 individuals who have extreme genetic predisposition for high/low BMI as measured by a PS for BMI and evaluate how a randomized diet intervention effect varies between the two extreme groups. In brief, the investigators will invite overweight (25-35 BMI) individuals with very high (Top 5%; n=600) and very low (Bottom 5%; n=600) PS for BMI. Half of the participants in each group will be subsequently randomized to enroll in a dietary/lifestyle coaching intervention program or the placebo group and not receive any dietary advice or information. All participants will be asked to answer an online questionnaire and provide a fasting blood sample at baseline and at the end of the study.

This well-powered prospective study leverages the unique opportunity to re-contact individuals at the extremes of BMI PS from a large pool of individuals with already available genetic information. This study will determine whether BMI PS can be used to identify overweight and obese individuals who are more likely to succeed in a reduced-energy dietary intervention, which will assist our efforts in curbing the overweight and obesity epidemic.


Eligibility Criteria:
Inclusion Criteria:

* 30-65 years old
* body mass index (BMI) of 25-35
* participants with genetic data available
* participants with a valid recontacting informed consent to their biobank

Exclusion Criteria:

* diagnosis of type I and II Diabetes Mellitus
* history of bariatric surgery
* diagnosis of schizophrenia and intellectual disability
* diagnosis of dementia and Parkinson's
* diagnosis of visual impairment
* diagnosis of multiple sclerosis
* pregnancy or breastfeeding during enrollment screening
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial

Incisional negative pressure therapy (INPWT) has previously been shown in certain patient populations to decrease wound healing complications, decrease the rate of hematomas and seromas, as well as have better scar quality. We have found a group of patients, those who have panniculectomies in preparation for renal transplant, with significantly higher rates of wound healing complications. We believe the best way to demonstrate benefits of incisional negative pressure wound therapy will be in this group of patients known to have significantly higher rates of wound complications.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing panniculectomy in preparation for renal transplantation at the University of California Davis Medical Center. Patients who are entered into the trial and have 30 days of follow up, and those in the INPWT study arm who successfully complete 7 days of treatment, will be included.

Exclusion Criteria:

* All patients who previously demonstrated a hypersensitivity reaction to adhesives and qualify for panniculectomy in preparation for renal transplantation, or all patients who are undergoing panniculectomy for reasons other than in preparation for renal transplantation (i.e. after massive weight loss or for cosmetic reasons). Patients who do not complete the duration of treatment of negative pressure wound therapy (7 days), or patients who do not follow up for a minimum of 30 days from the date of surgery will be excluded. Adults unable to consent, infants, children, teenagers, pregnant patients and prisoners will be excluded. It is also extremely unlikely, based on our study population, that we will encounter any of these patients.
Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)

The purpose of this study is to show that the Kineflex\|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.

The Kineflex\|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.

Eligibility Criteria:
Inclusion Criteria:

* have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
* have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
* have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
* have moderate disability neck disability index (NDI) score; AND
* be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation

Exclusion Criteria:

* marked cervical instability;
* non discogenic neck pain or non discogenic source of symptoms;
* radiographic confirmation of severe facet disease or facet degeneration;
* bridging osteophytes;
* prior surgery at the level to be treated;
* prior fusion at any cervical level;
* more than one neck surgery via anterior approach;
* previous trauma to the C3-C7 levels resulting in compression or bursting;
* documented presence of free nuclear fragment at any cervical level;
* severe myelopathy;
* any paralysis;
* history of chemical or alcohol dependence;
* active systemic infection;
* infection at the site of surgery;
* prior disc space infection or osteomyelitis in the cervical spine;
* any terminal, systemic or autoimmune disease;
* metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
* any disease, condition or surgery which might impair healing;
* known metal allergy;
* arachnoiditis;
* currently experiencing an episode of major mental illness;
* pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
* morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
* currently a prisoner;
* currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
* lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery
Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.

This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma

according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD

Eligibility Criteria:
Inclusion Criteria:

* primary open angle glaucoma
* ocular hypertension
* age \>18 years

Exclusion Criteria:

* bradycardia
* obstructive pulmonary disease
* hypersensitivity to the drug
Early Antibiotic Therapy and Vaccination

Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Eligibility Criteria:
Inclusion Criteria:

* born at University Hospital Tübingen
* at least one dose of antibiotics within the first week of life

Exclusion Criteria:

* genetic disorders
* chronic infections
* hematological disorders
* immunoglobulins within the first 60 days of life
* immunological disorders
* infants from Hepatitis B positive mothers