cyrilzakka/clinical-trials huggingface dataset:
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)

Introduction Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment syndrome in Finland and worldwide. Nowadays carpal tunnel release (CTR) surgery is often done in local anaesthesia. Often the most painful event during CTR is the injection of the local anaesthetic. Multiple different methods have been trialed and buffering the local anaesthetic seems to have good results in reducing the pain caused by the injection. However, no study has buffered long-acting local anaesthetic in CTR surgery, and no study has accounted for the patient's individual pain tolerance in the groups. There are no comparisons of the results to minimal clinically important difference (MCID) for pain.

Hypothesis In this study the investigators will evaluate the effects of buffering long-lasting local anaesthetic in wide-awake local anaesthesia no tourniquet (WALANT) CTR. This study's hypothesis is that buffering long-acting local anaesthetic with sodium bicarbonate decreases the pain of the injection.

The investigators also expect that buffering will reduce the number of needle stings felt during injection, will result in as good perioperative pain control, will lengthen the effect of anaesthetic, will reduce postoperative painkiller usage, will have at least as good functional outcome and greater patient satisfaction.

Methods This study will enlist 116 patients and divide the patients into two groups in this double blinded randomized controlled trial. One group receives non-buffered, and the second group buffered local anaesthetic. This study's primary outcome is to compare burning, pressure, needle sting and total pain the patient experienced between the groups. The investigators will assess this using VAS, and will compare the results to MCID. The investigators secondary outcomes are comparisons of expected injection pain level and pain during CTR with VAS, individual pain tolerance/catastrophising tendency with preoperative PCS-FINv2.0 form, the number of needle stings the patient feels during the injection, functional outcome and improvement of the patients' symptoms with The Boston Carpal Tunnel Questionnaire (Likert 5) before and after the surgery, evaluation of patient satisfaction with net promoter score (NPS) and the use of painkillers, duration of analgesia and pain levels using VAS after the surgery until the 3rd postoperative night.


Eligibility Criteria:
Inclusion Criteria:

* Clinically and electrophysiologically diagnosed carpal tunnel syndrome
* Patients who are scheduled for carpal tunnel release surgery.

Exclusion Criteria:

* Associated disease or conditions, including earlier injury to median nerve, cervical radiculopathy, cubital tunnel syndrome and other peripheral neuropathy
* Chronic renal failure
* Rheumatoid arthritis
* Allergies to lidocaine
* Pregnancy
* Profound cognitive impairment
* Previous ipsilateral carpal tunnel decompression
Innate Immunity and the Allergic Response

The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is associated with the presence or development of allergic disease.

A specific subset of neutrophils (CD49d+) will be recruited to the nasal tissue of individuals with allergic disease, and that these cells will also be found in the peripheral blood of allergic subjects. Normal subjects (those without atopy) and those treated for atopic disease will lack the presence of these cells.

Eligibility Criteria:
Inclusion Criteria:

1. Must give written informed consent before any study related activity is performed
2. Male and female adult and adolescent patients aged ≥18 years and ≤ 65 years.
3. Allergic or non-allergic subjects as proven by allergy skin tests in the past 2 years.

Exclusion Criteria:

1. The presence of any of these diseases: Atopic dermatitis, persistent controlled asthma, any level of severity of uncontrolled asthma, immunodeficiency or suspected immunodeficiency, any co-morbid disease (cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, and oncologic).
2. Any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease.
3. The use of any intranasal and inhaled corticosteroids within the last month.
4. Current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use.
5. Current pregnancy.
6. Women of childbearing potential not using an acceptable birth control method, as well as women who are breastfeeding
7. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
8. Use of any other investigational agent in the last 30 days
Local Evaluation of Real Relationships

This project evaluates Real Relationships, a program provided by the Children's Aid Society (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible Fatherhood) program. Research questions focus on recruitment and retention of participants, and short- and long-term participant outcomes associated with different formats for offering the program.

Only adult participants living in the community are included in the local evaluation. Three research questions are examined in detail by the local evaluation. First, what recruitment strategies are most effective in the rural service area of Real Relationships? The answers to this research question will increase the CAS's and the funder's understanding of recruitment in rural areas. Secondly, what are barriers to Real Relationships class/workshop attendance for adults who enrolled but did not participate in any workshops? Again, answers to this research question will increase CAS's and the funder's understanding of barriers to retention (from the point of entry into the program to when participation begins), particularly in rural areas. A better understanding of barriers at this point of the enrollment process can be used to develop programming that helps to avoid these barriers, and the development of programming aimed at reaching populations that have been missed due to specific barriers. Third, how do short- and long-term outcomes for participants who complete their Real Relationships class/workshop differ by the format of the class/workshop format (i.e., weekend workshop, multi-week classes)? The answers to this research question will increase CAS's and the funder's understanding of programming in this field by adding to the knowledge base regarding the most effective formats for achieving the outcomes relevant to the goals of Real Relationships. Results will also speak to the importance of other activities, such as case management and parenting classes, for achieving desired outcomes.

Eligibility Criteria:
Inclusion Criteria:

* living in the community

Exclusion Criteria:

* living in an institution
The Hemodynamics Effect of Glibenclamide on Levcromakalim Assessed by High Resolution Magnetic Resonance Angiography (MRA) Technique in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.

15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration.

The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration.

Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception

Exclusion Criteria:

* A history of serious somatic disease
* Migraine or any other type of headache (except episodic tension-type headache less than once a month)
* Daily intake of any medication except contraceptives
* Contraindications for MRI scan.
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).

Bloodsamples will be collected and frozen and later examined for potential predictive factors


Eligibility Criteria:
Inclusion Criteria:

* Histological proven adenocarcinoma of the colon or rectum
* Measurable or non-measurable disease
* Performance status 0-2
* Adequate renal and hepatic functions
* Adjuvant chemotherapy must have ended 180 days before inclusion
* Written informed consent prior to randomization

Exclusion Criteria:

* Prior treatment with Eloxatin or Xeloda
* Peripheral neuropathy
* Evidence of CNS metastasis
* Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
* Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
* Administration of any other experimental drug under investigation within 2 weeks before randomisation
* Pregnant or breast feeding women
* Fertile patients must use adequate contraceptives
Heliox and Posture in Patients With Asthma

The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.

When associated with inhaled bronchodilators, the heliox, a mixture of helium and oxygen in obstructive lung diseases with asthma, reduces the turbulence of airflow despite high rates, due to its low density.

Although the first report of the use of heliox in the treatment of asthma dating to 1935, few controlled studies are available clarify the impact of the use of heliox in hospital admission of patients with acute asthma attacks refractory to standard treatment.

The severe airflow obstruction, observed in cases of acute asthma, also leads to lung hyperinflation that favors the increase of respiratory work by increasing the load for the inspiratory muscles by placing them at a mechanical disadvantage.

Various body positions were studied relating them to muscle activity with mechanical disadvantage. These studies suggest that the influence posture acts mainly in the position of the diaphragm, thus, increasing the stress related to other muscles such as the abdominals and the effect of gravity on these.

This study aims to: assess the efficiency of the positioning body associated with nebulization with bronchodilators carried by heliox during acute severe asthma in adults, using as the primary outcomes FEV1, FVC and PEF and secondary outcomes as the Borg scale, inspiratory capacity, RR, HR and SpO2.

Eligibility Criteria:
Inclusion Criteria:

* reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in FEV1
* a clinical diagnosis of acute severe asthma
* a history of asthma over 1 year
* duration of the crisis of current asthma lasting less than seven days

Exclusion Criteria:

* were unable to understand or perform the spirometric maneuver
* smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year)
* other pulmonary comorbidities
* lower to upper airways
* heart failure
* heart rate greater than 150 bpm
* systolic pressure below 90 mmHg or greater than 150 MHG
* pregnancy
* inability to stay inline with the trunk forward
Diagnosis Value of SEMA4C in Breast Cancer

Breast cancer remains the most common cancer in women worldwide. Early diagnosis can greatly improve the prognosis. To date, imaging examination is still the most important diagnostic and grading tool for breast cancer. Semaphorin4C (SEMA4C) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs). The study is undertaken to evaluate the diagnostic efficiency of SEMA4C.

Breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. Meanwhile the incidence of breast cancer continues to increase. Early diagnosis and access to optimum treatment are crucial to reduce mortality associated with breast cancer. Currently, mammography and breast ultrasonography are essential for the detection and diagnosis of disease, and breast magnetic resonance imaging is the choice to estimate the extent of disease and guide appropriate treatment. However, there is no robust biomarkers for early detection of breast cancer.

Semaphorin4C (SEMA4C) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs) using in situ laser capture microdissection of lymphatic vessels, followed by cDNA microarray analysis. Moreover, membrane-bound SEMA4C is cleaved by matrix metalloproteinase (MMPs) to release a soluble form of this protein. Therefore, this prospective project aims to assess the early diagnostic value of SEMA4C as a biomarker for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Receiving no treatment before diagnosis
* Establishing Diagnosis according to biopsy or surgery

Exclusion Criteria:

* Patients who are not mentally capable of giving written informed consent
* Clinical data missing
* Serum samples doesn't qualified
* Patients with a diagnosis of other severe acute or chronic medical conditions that may interfere with the interpretation of the study results
Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome

The purpose of this study is to optimize the traditional treatment scheme and explore the cure scheme for the elderly by combining the existing mature treatment technology. The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of MDS patients.

Objective Myelodysplastic syndrome (Myelodysplasticsyndromes,MDS) is a highly age-related malignant clonal disease of the hematological system, which is characterized by pancytopenia and transformation to leukemia. In China, the median age of onset of MDS is 70 years old, and the incidence increases with age. It is the most common malignant tumor in the elderly, which seriously threatens the health and survival of the elderly. The 3-year survival rate of traditional combination chemotherapy or demethylation therapy is less than 20%.

Eligibility Criteria:
Inclusion Criteria:

1. elderly MDS patients;
2. aged more than 60 years old, general condition, ECOG score less than 1;
3. normal function of heart, liver and kidney, serum bilirubin ≤ 35 umol / L; serum creatinine ≤ 150 umol / L;
4. patients are unsuitable or unwilling to receive hematopoietic stem cell transplantation;
5. subjects sign informed consent.

Exclusion criteria:

1. serious infection was not controlled before treatment;
2. contraindications for the use of dexitabine and azacytidine;
3. other cases that did not meet the admission criteria.
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer

This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.

Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 if judged fit for surgery
* WHO performance status 0-1
* Histologically proven rectal adenocarcinoma located below the peritoneum
* T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI
* No distant metastases
* Adequate haematological, cardiac, liver and renal function
* Signed informed consent
* Appropriate measures for contraception for men and women, if applicable

Exclusion Criteria:

* Prior radio- and/or chemotherapy
* Others synchronous cancers
* History of other malignant disease
* Significant heart disease
* Known hypersensitivity to biological drugs
* Pregnant or lactating patient
DIGEST I Drug Coated Balloon for Biliary Stricture

DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on biliary tract stricture.

Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
3. Restenosis after plain balloon dilation with at least 2 previous balloon dilation sessions and recurrence of biliary obstructive symptoms/signs or being managed with implantable prosthetics (e.g. plastic stents).
4. Greater than 40% stenosis of the biliary tract via ERCP.
5. Total serum bilirubin \>2 mg/dL. Alkaline phosphatase level \>3 times higher than normal level. \*Note: This IC is waved if the patient is being managed with implantable prosthetics.
6. Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
7. Stricture length \<4 cm.
8. Not currently listed for liver transplantation.
9. Voluntary participation and provided written informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
2. Benign biliary strictures caused by pancreatic pseudocyst compression.
3. Malignant biliary obstruction.
4. Biliary obstruction associated with an attack of acute pancreatitis.
5. Inability to pass guidewire across stricture.
6. Subjects with cholangitis or bile leak or duct fistula.
7. Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
8. Subject with an internal/external biliary drainage catheter.
9. Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
10. Subject with symptomatic duodenal stenosis (with gastric stasis)
11. Active systemic infection.
12. Allergy to paclitaxel or any components of the delivery system.
13. Currently undergoing required thoracic or abdominal cavity radiation therapy.
14. Has life expectancy \<12 months.
15. Unwilling or unable to comply with the follow-up study requirements.
16. Lacking capacity to provide informed consent.
17. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
18. Currently participation in another pre-market drug or medical device clinical study.
Coccygeal Nerve Radiofrequency Treatment in Coccydynia

Coccydynia or coccygeal pain is a painful syndrome that affects the coccyx region. The most important etiological factors in the formation of coccidynia are; external and internal trauma. Patients with coccydynia typically complain of coccyx pain. This pain increases with prolonged sitting, bending backwards during sitting, standing for long periods of time, and standing up after sitting. Conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), levator sudden relaxation exercises, seat cushions, and transcutaneous electrical simulation have all been used to relieve pain, but these methods are ineffective in 10% of patients. In the patient group unresponsive to conservative treatments, there are various interventional treatment options, including caudal epidural steroid injection, ganglion impar blocks, radiofrequency ablation of the sacral nerves, block of the coccygeal nerves and radiofrequency ablation, and coccygectomy.

In algoloji clinic, routinely apply ultrasound-guided coccygeal nerve block and radiofrequency ablation to patients with coccydynia. During the procedure, after imaging the sacral and coccygeal corns with ultrasonography, a radiofrequency ablation needle is inserted at the level of the coccygeal horn and radiofrequency ablation is applied at 90 degrees for 60 seconds. Patients are followed for a while in our post-procedure service for possible hypotension and allergic reactions. In this study, it was planned to apply the Visual Pain Scale (VAS) and Paris Functional Coccydynia Questionnaire at the 1st week, 1st month and 3rd months after the treatment to patients who had coccygeal nerve block and radiofrequency ablation in our clinic due to the complaint of coccydynia resistant to conservative treatment methods. In this way, it is planned to evaluate the efficacy of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Coccygeal pain

Exclusion Criteria:

* Malignancy
* İnfection
* Coagulation disorders
Smoking: Cytokines in Vitreous and Aqueous Humor

Smoking is a risk factor for ophthalmologic diseases. Inflammation might play a role in their pathogenesis.

This study elucidates intraocular cytokine profiles in smokers and non smokers.


Eligibility Criteria:
Inclusion Criteria:

* scheduled vitrectomy and/or cataract surgery
* signed informed consent

Exclusion Criteria:

* diabetes
* uveitis
* rheumatologic disease
* anti-inflammatory/immunomodulatory medications
* st.p. intravitreal injections
* st.p. glaucoma surgery
* cataract surgery on the eye to be examined within the past 6 months