cyrilzakka/clinical-trials huggingface dataset:
A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia

The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in the study and sign the informed consent form;
* The age is between 18 (inclusive) and 85 (inclusive), regardless of gender;
* Body mass index (BMI) ≤ 45;
* Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later;
* Glycated hemoglobin\<8%;
* Not participating in the drug/medical device test within 3 months before the test;

Exclusion Criteria:

* Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score
* Ulcer is red and swollen, or active inflammatory infection;
* The affected limb has lesions such as blackening and gangrene of the toe skin;
* Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors;
* Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects);
* The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets);
* People with allergic diseases and allergic constitution;
* Have a history of drug abuse or drug addiction;
* There are contraindications to pulsed radio frequency therapy;
A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.

Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.

Exclusion Criteria:

* Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).
Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence

Approximately 40% of members with a positive fecal occult blood result do not continue to followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural, process, carer and patient related causes of undertreatment and suggest appropriate organisational interventions. Using both quantitative and qualitative methods, the investigators will identify organisational and personal barriers to completion of followup of positive FOBT.

Colorectal cancer is the second in incidence and mortality among malignant tumors. Early detection of the disease is an effective means of reducing mortality and is possible through a fecal occult blood test. In the case of a positive result colonoscopy is required. In Israel, about 30% of people with a positive occult blood test do not perform a follow-up test.

The aim of the study is to identify existing barriers to undergoing colonoscopy in a normal-risk population and improving adherence through different intervention mechanisms. At the end of the study we will describe effective intervention models at three levels: the patient, physicians and the organisation to improve early detection of colon cancer.

Innovation of the Study

* It will focus on the normal-risk population groups in Israel with a positive occult blood that didn't undergo colonoscopy.
* Will identify the barriers in diverse populations
* Will review the accessibility of diagnostic facilities forcolon cancer in Israel.
* Will propose intervention programs to improve adherence at all levels in the process.

Study Methods: A prospective study sing both both quantitative and qualitative methods in Meuhedet Health Services Target Population: Health system managers, physicians, and patients (a representative sample of 200 patients adhere colonoscopy and 600 that didn't adhere). Data collection databases from Meuhedet. The study will include questionnaires, focus groups and interviews.

Stages of the study:

1. Describe the magnitude of the problem
2. Map the barriers to adherence with colonoscopy recommendations among patients, physicians and geographic availability of colonoscopies facilities.
3. Suggest intervention models for physicians, patients and organisations according to the information provided by data collection.
4. Recommendation to decision makers on the implementation of national policy intervention.

Data processing: will use SPSS statistical analysis with the types of variables.

Eligibility Criteria:
Inclusion Criteria:

Members of MHC aged 50-74 who completed a fecal occult blood test during the study period.

Exclusion Criteria:

None
To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic

The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB treatment. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the pharmacist and the TB patient. The study was conducted in tertiary care hospital TB control centres patients.

Tuberculosis (TB) is the world's biggest killer among infectious diseases, claiming more than 4000 lives each day. The unprecedented coronavirus pandemic seriously impacts people with pre-existing health conditions. People who have TB are usually more vulnerable to other infections, including the novel coronavirus, due to pre-existing lung damage. They are at a higher risk of developing complications from COVID-19. Certain populations are at greater risk of TB, because of where they live, where they work or because of other socio-economic factors which result in them experiencing barriers to accessing health services.

Eligibility Criteria:
Inclusion Criteria:

New, smear-positive drug-susceptible TB who have been on treatment for less than two weeks Access to a mobile phone (self-reported)

Exclusion Criteria:

Patients who do not have regular access to a mobile phone Patients who have previously received TB treatment Patients who have another member in their household who is already a part of the study
Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips

* The goal of this clinical trial is to evaluate the efficacy of the novel polyherbal lip hydrant on dryness, fine lines and color of the lips in 66Thai people aged between 18-40 years old. The inclusion criteria will include subjects with subjective complaint of dry lips.The main question it aims to answer is Does the novel polyherbal lip hydrant improve biophysical barrier of the lips?
* Participant will be asked to apply the lip hydrant or the petroleum gel once a day before bedtime, and refrain from using other lip products throughout the clinical trial period (28 days).
* Researchers will compare control group (Petroleum gel) with lip hydrant group to see whether biophysical barrier (wrinkles, colors, fine lines, roughness) improve or not.


Eligibility Criteria:
Inclusion Criteria:

* subjects with subjective complaint of dry lips;
* agree to comply with the study protocol
* agree not to apply any other products such as lipstick, lip gloss, lip conditioner to the lips other than the test product for the duration of the study
* provide a written informed consent prior to study enrollment.

Exclusion Criteria:

* Participants those having visible skin conditions which might interfere with the outcome assessment
* having a history of sensitivities to cosmetics products, or moisturizers; - having a known or suspected intolerance or hypersensitivity to herbal products or any of its ingredient
* taking medication or under the care of a doctor for one month prior to the commencement of the study, and throughout the entire test period
* having other types of cheilitis except cheilitis simplex.
Antecolic Versus Retrocolic Gastrojejunostomy During Whipple's Procedure

Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy.

Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded.

Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Elective pancreaticoduodenectomy
* Signed consent form

Exclusion Criteria:

* Age under 18 years old
* Patients who are participants in other trials that may affect the results of this study
* Patients who do not consent to participate in the study
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers

This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases
Toolkit for Experiential Well-beiNg in Dementia (TEND)

The goal of this project is to conduct an open pilot (N=5) among dyads (persons living with dementia and their caregivers) to assess the preliminary effects of an online videogame platform. The "Isle of TEND" is an immersive and interactive videogame platform designed for persons living with dementia and their caregivers. Dyads will use the platform three to four times a week for 20-30 minutes across four weeks. The investigators will assess for improvements in relationship satisfaction, wellbeing, and positive emotions and gather feedback on engagement in the platform. Dyads will complete measures at baseline and post-intervention as well as brief measures after each platform use.

The aim of this phase is to assess initial active engagement, sustained attention, and positive emotions of the "Isle of TEND" intervention platform. Our participants (N = 5 dyads) will be persons living with moderate-severe dementia and their caregivers in the Boston area.

The intervention, "Isle of TEND" is an immersive and interactive videogame platform designed for persons living with dementia and their caregivers. Studio Elsewhere, a design and development team, developed the platform in consideration with feedback generated from focus groups and design workshops. Users navigate the online island and explore accompanying modules with varying audio and visual features. The platform aims to engage dyads in an enjoyable, shared, and "error-free" experience (i.e., creating poetry, viewing virtual art).

Participants will use their personal "travel journal" after each platform session, in which they log engagement and positive emotion. Dyads are also encouraged to provide free response feedback on the platform. Once a week, dyads will record themselves as they use the platform. The investigators will conclude the pilot with exit interviews. Baseline and post intervention assessments will include self-reported measures including relationship satisfaction, wellbeing, and caregiver stress. The research team will engage in behavioral observation coding to assess active engagement.

Eligibility Criteria:
Inclusion Criteria:

* Informal caregiver (specifically, a family member) of a person with moderate-severe dementia and person with moderate-severe dementia
* Moderate to severe as determined by Functional Assessment Staging Tool (FAST Scale) taken by caregiver
* Age 18 or older
* English-speaking
* Willing and able to use the platform together 3-4 times a week for 20-30 minutes
* Located in the Boston area

Exclusion Criteria:

* Lack of access to internet and/or a computer with a camera
* Untreated serious mental illness and or substance use diagnosis
Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy

In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.


Eligibility Criteria:
Inclusion Criteria:

* Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III
* Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale \[NRS\] 0-10 points) during rest or during movement \> 5.

Exclusion Criteria:

* History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches
* Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
* Inflamed or injured skin at the application site
* Signs of cognitive impairment
* Known drug or ethanol abuse
Left Atrial Appendage Closure During Open Heart Surgery

Because atrial fibrillation occurs frequently in heart surgery patients, our overall hypothesis is that systematic closing the left atrial appendage during surgery will reduce cerebral embolism coming from the thrombus formation in the left atrium.

The specific hypothesis which sought tested is that closure of the left atrial appendage in connection with elective CABG and / or valve surgery will lead to fewer strokes and micro cerebral infarcts measured by MRI.

Patients are included prior to surgery. An MRI is performed at baseline. At the day of surgery, patients is randomized to closure/left open left atrial appendage.

During surgery, a maximum of 15 ml blood and a right atrium biopsy are taken for further analyses. Additionally, a biopsy of the left atrium appendage is collected from the group of patients randomized for closure.

The study group recommend a double closure. After discharge a second MRI is performed and the final MRI is performed after a minimum of six months.

The final contact with the patient is done one year after surgery at the earliest. Where a clinical interview is done over the phone and the patients clinical records are screened for cerebral ischaemic events and atrial fibrillation.

During the study period, some patients are elected for a bicycle stress test to test for levels of neurohormones, and some are elected for monitoring with Holter.

There will also be performed transesophageal echocardiography on interested patients in order to test for the quality of surgical closure.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old.
* elective open heart surgery By-pass (CABG) and/or valve surgery
* signed informed consent

Exclusion Criteria:

* off pump heart surgery
* endocarditis
* Patients with metal implants not suitable for MRI
* Patients with planned implantation of pacemaker after surgery
Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?

This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patient must sign and date the informed consent form prior to treatment.
3. Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2).
4. Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (EVLA).
5. Maximum diameter of the to be treated veins is ≤ 14mm.

Exclusion Criteria:

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Mean diameter of the to be treated veins \> 14mm.
4. Tortuous or very superficial veins considered unsuitable for laser treatment.
5. Recurrent varicose veins.
6. Pregnancy.
7. Coagulopathy or bleeding disorders.
8. Contraindications to the use of general or regional anesthesia.
Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial

This is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. All participants continue to receive standard of care as prescribed by their treating physician.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced stage colorectal cancer.
* Estimated life expectancy of over 6 months in the opinion of the treating oncologist.
* 18 years of age or older at the time of consent.
* Able to understand, speak, read, and write in English.
* Able to provide voluntary written consent prior to the performance of any research related activity.

Exclusion Criteria:

* Lacks capacity to consent/has diminished capacity to consent.
Maintenance Therapy With Subcutaneous Bortezomib

This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is of a legally consenting age as defined by local regulations.
2. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
3. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
4. Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy.
5. Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of bortezomib therapy.
6. Patient was previously diagnosed with multiple myeloma based on standard criteria.
7. Patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease.
8. Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease.
9. Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib.
10. Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
2. Pregnant or lactating females
3. Known positive for HIV or active infectious hepatitis type A, B or C
4. Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0
5. Infiltrative pulmonary disease.
Rapid Autopsy Protocol for Patients with Small Cell Lung Cancer

This is pilot study to establish a rapid autopsy program in Small Cell Lung Cancer (SCLC) at the Indiana University Simon Comprehensive Cancer Center and outline the components necessary for tumor tissue collection.

The goal of this project to establish a rapid autopsy program in SCLC at the IUSCCC and outline the key components necessary for tumor tissue acquisition. This proposal is a collaboration between scientists, lung cancer physicians, pathologists, and the IUSCCC Translational Research Core. Tumor tissue collected will be used for protein and gene analysis and RNA, whole exome sequencing in addition to the establishment of SCLC. This research is part of a discovery project in which biological and molecular markers of SCLC will be identified.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Written informed consent and HIPAA authorization for release of personal health information.
3. Active SCLC diagnosis.