cyrilzakka/clinical-trials huggingface dataset:
Wrist Denervation Vs Exercise in Wrist Osteoarthritis

A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.

Backgroud:

High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.

Aim:

To analyze:

1. Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA?
2. Is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion?

Method:

A multicenter parallel group, two-arm, randomized, controlled, assessor blinded, trial of 140 patients. The study is conducted at the departments of hand surgery at Södersjukhuset Stockholm and Malmö University hospital.

Group1:

Self-managed exercise therapy program containing:

* Patient education:
* Exercise therapy program:

The exercise therapy program is designed by Sara Larsson (physiotherapist at the Department of hand surgery in Malmö, Sweden), influenced by previous studies on wrist stability and proprioception. Focus is on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. The program consists of neuromuscular exercises that focus on coordination, wrist stability and strength.

Group 2:

Surgery will be performed under local anesthesia (+ blood-less field or wide-awake local anesthesia no torniquet (WALANT) according to the surgeon's preference) through a single dorsal incision. AIN and PIN neurectomy will be performed as described by Berger (Berger, 1998).

Primary outcome:

Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998) 12 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Chronic wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis.
* Radiological signs of osteoarthritis on posteroanterior and lateral radiograph.

Exclusion Criteria:

* Previous PIN or AIN neurectomy.
* Rheumatoid arthritis or other chronic inflammatory arthritis.
* Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints.
* Ongoing infection.
* Inability to co-operate with the follow-up protocol.
* Systemic or intra-articular glucocorticoids or intraarticular PRP or Hyaluronic acid injections in the affected joint within 3 months prior to enrollment.
Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.

The purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.

Children patients with advanced, recurrent or refractory extracranial germ cell tumor were treated with albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin . This is a multi-center and single arm phase II clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 1-18 years old;
2. ECOG PS score: 0-1;
3. Patients was confirmed pathologically with malignant germ cell tumor.
4. Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
5. Have at least one measurable lesion defined by RECIST standard;
6. The estimated survival time was more than 6 months;
7. Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
8. Bone marrow function met the following criteria:

   1. Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;
   2. Platelet count ≥ 100.0 × 109 / L (not after platelet transfusion);
9. Liver and kidney function should meet the following criteria:

   1. Bilirubin (the sum of bound and unconjugated) ≤ 1.5 × upper limit of normal value (ULN) (corresponding to age). Patients with confirmed Gilbert's syndrome can be classified according to the researcher;
   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
   3. Estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serum creatinine (CR);
10. Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation \> 94% (if there are clinical symptoms);
11. Cardiac function:

    1. LVEF ≥ 50% was detected by echocardiography;
    2. There was no history of arrhythmia requiring drug intervention before enrollment;
12. Seizures that can be fully controlled without enzyme-induced anticonvulsants;
13. During the study period, they were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
14. Parents / guardians of child or adolescent subjects have the ability to understand, agree and sign the study informed consent form (ICF) and the applicable child consent form before starting any program related procedures; subject has the ability to express consent (when applicable) with the consent of parents / guardians.

Exclusion Criteria:

Patients with any of the following items will not be enrolled in this study:

1. Patients with recurrent germ cell tumor were treated by surgery alone previously;
2. Patients with immature teratoma (any grade);
3. Patients with sex cord stroma;
4. HBsAg positive patients;
5. Patients with HIV or syphilis infection;
6. Patients who had received organ transplantation before;
7. Uncontrolled active systemic bacterial, viral or fungal infections;
Interscalene vs Anterior and Posterior Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries

To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia

Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries. However, it is associated with several side effects, in particular, a high incidence of phrenic nerve blockade.

The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches for the suprascapular nerve block, anterior and posterior. The anterior approach may still result in some degree of impairment of lung function.

The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB. Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective arthroscopic shoulder surgery under general anaesthesia
* Patients 21 years old and above
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* BMI 18-35 kg/m2

Exclusion Criteria:

* Patients unable to give consent or inability to communicate/ cooperate
* Patients with chronic use of strong opioids (morphine, oxycodone)
* Patients with allergy to local anaesthetics or any drugs included in the study
* Patients with contraindications for regional anaesthesia such as coagulopathy
* Patients with pre-existing neurological deficits in upper limb/ phrenic nerve palsy
* Patients with pre-existing lung disease (COPD, uncontrolled asthma)
Evaluation of ADG20 for the Prevention of COVID-19

This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

Phase 2/3, multicenter, double-blind, placebo-controlled, randomized study of the mAb ADG20 in the prevention of symptomatic COVID-19 in adults and adolescents with no known history of SARS-CoV-2 infection but whose circumstances place them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19. This objective was independently evaluated in a cohort of participants with reported recent exposure to an individual diagnosed with a SARS-CoV-2 infection (post-exposure prophylaxis) and in a cohort of participants with no reported exposure to SARS-CoV-2 (pre-exposure prophylaxis). These cohorts included participants whose advanced age (≥55 years old) or health status placed them at risk for severe COVID-19 or COVID-19 complications.

Eligibility Criteria:
Inclusion Criteria:

* Tests negative for current or previous SARS-CoV-2 infection by RT-PCR and serology (Pre-exposure population only)
* Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:

  1. Post-exposure population: exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a laboratory-confirmed index case must be asymptomatic and randomized within 5 days (120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic test.
  2. Pre-exposure population: Occupational, housing, recreational and/or social conditions that are likely to increase risk of exposure to SARS-CoV-2.
* Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing

Exclusion Criteria:

* Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine, convalescent plasma, or mAb clinical trial any time prior to participation in the study.
* Receipt of any investigational product within 30 days or 5 half lives before the day of enrollment.
* Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19 symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or smell. Fever is defined as a body temperature ≥38.0°C (≥100.4°F).
* Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing).

NOTE: Other protocol defined inclusion/exclusion criteria apply
Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.

* Cardiovascular disease in the leading cause of death in patients with chronic kidney disease undergoing hemodialysis.
* Traditional risk factors do not adequately predict cardiovascular morbidity and mortality in patients with chronic kidney disease.
* Increased oxidative stress, inflammation and impaired fibrinolysis contribute to cardiovascular risk in chronic kidney disease patients undergoing hemodialysis.
* Activation of the renin-angiotensin-aldosterone system(RAAS) may contribute to oxidative stress and inflammation in individuals with chronic kidney disease
* Activation of the kallikrein-kinin system during hemodialysis may increase fibrinolysis but may also contribute to inflammation in chronic kidney disease
* Despite data from clinical trials demonstrating that ARBs and ACE inhibitors decrease cardiovascular mortality, delay progression to cardiovascular disease and decrease the incidence of diabetes in the general population little is known about the impact of these agents on cardiovascular morbidity and mortality in patients with end- stage renal disease (ESRD) undergoing hemodialysis
* Angiotensin-converting enzyme(ACE) inhibitors and angiotensin receptor blockers (ARB)S differ in their mechanisms of action and their effects on inflammatory biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* On thrice-weekly chronic hemodialysis for at least 6 months
* Clinically stable, adequately dialyzed (single-pool Kt/V\> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Exclusion Criteria:

* Body mass index \> 35 mg/kg
* History of functional transplant less than 6 months prior to study
* Use of anti-inflammatory medications other than aspirin \< 325 mg/d
* History of active connective tissue disease
* History of acute infectious disease within one month prior to study
* AIDS (HIV seropositivity is not an exclusion criteria)
* History of myocardial infarction or cerebrovascular event within 3 months
* Advanced liver disease
* Gastrointestinal dysfunction requiring parental nutrition
* Active malignancy excluding basal cell carcinoma of the skin
* History of ACE inhibitor-associated cough or angioedema
* Ejection fraction less than 40%
* Inability to discontinue ACE inhibitor or ARB
* Predialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
* Anticipated live donor kidney transplant
* Use of vitamin E \>60 IU/d or vitamin C \>500 mg/d
* Pregnancy, breast-feeding or child-bearing potential
* History of poor adherence to hemodialysis or medical regimen
* Inability to provide consent
Water Flosser vs String Floss vs Manual Toothbrush Safety

Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.

Eligibility Criteria:
Inclusion Criteria:

* Written consent prior to participation
* Good general health and non smoker
* Have scorable Ramfjord's teeth

Exclusion Criteria:

* Probing depth \>4mm on Ramfjord's teeth
* Moderate to severe gingivitis
* Advanced periodontitis
* Medications that impact soft tissue.
Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery

The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.

Primary Objective:

To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).

Secondary Objective:

To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction.

Sixty-three patients enrolled for each group (non-opioid and opioid). Approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up \& failure to comply with study protocol).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.

Exclusion Criteria:

* ASA\> 3;
* Coagulopathy;
* Renal disease,
* Liver disease,
* History of recent gastro-intestinal bleeding
* Pregnancy.
* Diagnosis of chronic pain currently taking opioid pain medication or with a history of drug abuse.
* Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine.
* All patients receiving a brachial plexus block for anesthesia and/or analgesia
Mental Stress, Autonomic Function, and Heart Disease

To examine the vagal, vascular sympathetic, and mechno-structural components of baroreflex regulation in coronary artery disease (CAD) patients and healthy age-matched controls during rest and acute laboratory stress.

BACKGROUND:

The strong association between mental stress and morbid cardiovascular events in coronary artery disease (CAD) patients may derive from stress-induced cardiac ischemia due to exaggerated increases in vascular resistance and arterial pressure. In fact, this may explain part of the prognostic relationship of baroreflex cardiac vagal control to cardiovascular outcome among CAD patients. The hemodynamic responses to psychological stress are buffered by the arterial baroreflex; thus, exaggerated pressor responses to mental stress may result from impaired baroreflex regulation in CAD patients.

DESIGN NARRATIVE:

The study has three components. The first component characterizes the relationships between vascular stiffness and baroreflex regulation among CAD patients, also contrasting healthy control subjects with CAD patients. The second component examines, in relation to individual differences in pharmacologically derived estimates of baroreflex function, changes in autonomic and baroreflex control during laboratory psychological stress among CAD patients and among healthy control subjects. The third component tests the hypothesis that impaired baroreflex regulation in CAD patients, due to increased vascular stiffness and/or attenuated autonomic control, is associated with exacerbated hemodynamic reactions to psychological stress. Bolus vasoactive drug infusions in combination with Finapres beat-by-beat arterial pressures and carotid B-mode ultrasonography are used to evaluate baroreflex sensitivity and arterial stiffness. Baroreflex adjustments to psychological stress are assessed by power spectral-derived relations between arterial pressure and cardiac chronotropy during a mental arithmetic task and a speech task. The degree to which indices of baroreflex function are associated with hemodynamic responses to psychological stress among CAD patients is assessed.

Eligibility Criteria:
No eligibility criteria
Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System Reinforced With Patient Specific Pharmacogenetic Data for Minimizing Severe Drug-Drug Interactions

Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+ reinforced with patient specific pharmacogenetic data. The investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).


Eligibility Criteria:
Inclusion Criteria:

* Number of chronic concomitant drugs ≥5
* treated with 1 or more drugs with a well established interaction with 1 or more of the following CYP450 enzymes: 2c9, 2c19, 2d6

Exclusion Criteria:

* Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

The purpose of this study is to evaluate for changes in the proteins produced in white blood cells (basophils) in patients with chronic hives who are treated with and respond to omalizumab.

Eligibility Criteria:
Inclusion Criteria:

* Chronic urticaria (hives) for more than 6 weeks.
* No improvement with standard doses of antihistamines (loratadine 10 mg daily, desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or levocetirizine 5 mg daily)

Exclusion Criteria:

* Taken any oral steroids for 1 month prior to beginning the study.
* Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine, cyclosporine, methotrexate) for 1 month prior to beginning the study.
* Physical urticaria as a primary diagnosis.
* Known allergic precipitant of urticaria such as foods.
* Urticarial Vasculitis.
* Anemia.
* Asthma.
* Serum Immunoglobulin E (IgE) \>700 IU/ml.
* Women of childbearing potential not using contraception method(s), as well as women who are pregnant and/or breastfeeding.
* Known sensitivity to omalizumab or this class of drug.
* Use of any other investigational agent in the last 1 month.
* Untreated intercurrent illness.
Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care

The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.

Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.

The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.

A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.

The subjects will be consecutively allocated to a subject code.

At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.

The following variables will be measured as follows:

Eligibility Criteria:
Inclusion Criteria:

1. Acute wounds/burns
2. Male or female, 18 years and above, both in- and outpatients.
3. Signed Informed Consent Form

Exclusion Criteria:

1. Wound size above 21x24.5 cm
2. Subject not expected to follow the investigation procedures
3. Subjects previously included in this investigation
4. Subjects included in other ongoing clinical investigation at present or during the past 30 days