cyrilzakka/clinical-trials huggingface dataset:
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

The study evaluates 3 different populations:

It is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :

1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide

The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome


Eligibility Criteria:
Inclusion Criteria:

* AF: Patients with isolated, idiopathic, sustained, symptomatic, recent onset(\>10 minutes to \<24 hours) atrial fibrillation.
* VT: Patients with ventricular tachycardia with good haemodynamic tolerability attending the emergency room or induced at the electrophysiology lab during testing for ventricular arrhythmias.
* Brugada Sd (BrS): First-degree relatives of a patient with Brugada Syndrome with a ECG non-diagnostic of the BrS.

Exclusion Criteria:

* General: Pregnancy
* AF: Pre-existing heart disease.
* Secondary AF
* 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
* LVF\<40%.
* Moderate-severe liver failure.
* AF with haemodynamic compromise.
* VT:VT with haemodynamic compromise.
* BrS:Pre-existing heart disease.
* 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
* Moderate-severe liver failure.
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser

This study aims to assess if laser treatment can cure fungal infection in toenails.

Nail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Before and after treatment, nail clippings were tested for fungal infection by microscopy and by culture.

This study was carried out as a randomised controlled trial (RCT) including two treatment groups subjected to two different laser treatments. A 1064 nm Nd:YAG-laser (Candela Medical, Ellipse Nordlys (Nd:YAG 1064), USA) was used for all treatments.

Potential subjects were recruited from general practitioners and skin clinics in North Jutland from August 24th, 2021, through December 2021.

All interventions and mycological tests for each subject were performed over the course of one day.

After subjects were included, toenails with a clinical suspicion of onychomycosis (OM) were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.

The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.

Immediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>18 years)
* Clinical suspicion of fungal infection in at least one toenail
* Signed informed consent
* Sufficient nail material to perform two cultures and one nail clipping

Exclusion Criteria:

* Administration of oral antifungal medication in the last 12 months or topical antifungal medication in the last month
* Diabetes mellitus with associated peripheral artery disease (PAD) or neuropathy
* Under the influence of alcohol or illegal narcotics
* Unable to understand written and spoken Danish
Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans

Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. However, bioavailability data from tea infusion is non-existent, even though it reflects better how consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is less understood and no dose response study has been reported so far in the literature. Thus, there is a great need to understand and reinforce our knowledge on the bioavailability of coffee and tea polyphenol compounds.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years, male and female
* Healthy as determined by the medical questionnaire and the medical visit
* Normal weight: BMI 18 - 25
* Coffee drinkers with an average consumption of 2-5 cups per day
* Having given informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
* Have had a gastrointestinal surgery, except appendicectomy
* Difficulty to swallow
* Have a regular consumption of medication
* Have taken antibiotic therapy within the last 6 months
* Alcohol consumption \> 2 units a day
* Smokers (more than 5 cigarettes per day)
* Have given blood within the last 3 weeks
* Volunteers who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 weeks
Prospective Trial of the TriFit™ Web Knee Brace

This is a prospective trial comparing improvements in pain, function, and quality of life in patients with early-stage knee osteoarthritis conservatively managed with the TriFit™ Web Knee Brace. The study design will represent a consecutive series of conservatively managed patients with knee-pain not yet candidates for surgical intervention and is non-comparative in nature.

This clinical study will be conducted at the Florida Orthopaedic Institute (FOI) beginning in 2017. The trial will be a prospective trial of a convenience sample of skeletally mature patients with knee pain treated by the Principal Investigator (Jeff Sellman, MD) at Florida Orthopaedic Institute with clinically and radiographically confirmed early stage knee Osteoarthritis that can be managed without surgical intervention. The study population will be defined as all adult patients (\>21 years) seen by the Principal Investigator and diagnosed with knee osteoarthritis. All patients will be independent in activities of daily living. All patients will be seen in the Prinicpal Investigator outpatient clinic at Florida Orthopaedic Institute. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study Principal Investigator will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or Principal Investigator will obtain informed consent. The patient will still be followed clinically for 12 months after initial brace application.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years;
2. BMI \< 40;
3. Medial or lateral knee Osteoarthritis as clinical diagnosis \[Kellgren-Lawrence grades 1-3 Osteoarthritis\];
4. Persistent knee pain beyond current treatment;
5. No history of corticosteroid injection or viscosupplementation injections in the last 3 months;
6. Able to comply with study requirements;
7. Capable and willing of signing informed consent.

Exclusion Criteria:

1. Age \< 21 years;
2. History of diabetic neuropathy;
3. History of traumatic onset of knee pain;
4. Undergone surgery on either lower limb within 6 months;
5. Unable to comply with study requirements;
6. Had previously received corticosteroid injections or viscosupplementation injections in the affected knee within 3 months of study;
7. KL grade \>3
Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.

This study aims at detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt.

Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection. Patients' serum samples were screened for the presence of anti-HCV antibodies. Patients with positive serology were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection

Exclusion Criteria:

* pregnancy and end organ failure
Safety Study of a Fluorescent Marker to Visualize Cancer Cells

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time, as they operate.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age ≥ 18 years.
* Known or suspected non-metastatic basal cell or squamous cell carcinomas ≥10 mm longest diameter or non-metastatic melanoma ≥6 mm longest diameter scheduled for excision, without advanced disease.
* Written Informed Consent.
* Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential.
* Available for and able to comply with study requirements.

Exclusion Criteria:

* Women who are lactating/breastfeeding
* Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study.
* Life expectancy \<6 months.
* Karnofsky Performance Status of ≤70%.
* The following laboratory abnormalities:

  * Neutrophil count \<1.5 x 10\^9/L
  * Platelets \<75 x 10\^9/L
  * Haemoglobin \<10 g/dL (may be determined following transfusion)
  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x upper limit of normal (ULN)
  * Total bilirubin \>2x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
  * International Normalized Ratio (INR) \>1.5
  * Creatinine \>1.5x ULN
* History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
* Uncontrolled asthma or asthma requiring oral corticosteroids.
* Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator.
* Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening.
* Uncontrolled hypertension.
* QTc (corrected QT interval) prolongation \>450 msec.
* Receipt of photosensitising drugs within 30 days of screening.
* Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
* Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data.
* Known or suspected sensitivity to study product or excipients.
* Prior participation in this clinical trial (has received study product).
Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression

BACKGROUND: Major depression will become the second most important cause of disability in 2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy have been carried out.

AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.

METHODS: The study is made up of 3 phases: 1.- Development of a computerised cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depression. It will be carried out with MINI International Neuropsychiatric Interview + scoring of moderate or mild depression using Beck Depression Inventory II. Cut-off point for this questionnaire is: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression \[34, 35\].
* Aged 18-65 years
* Able to understand and read Spanish
* Moderate or mild major depression
* Duration of symptoms longer than 2 weeks
* Access to Internet at home and having an email address.

Exclusion Criteria:

* Any psychological treatment during last year
* Severe psychiatric disorder in Axis I (alcohol/substances abuse or dependence, psychotic disorders or dementia)patients with severe depression (indicated by a Beck-II score of 29 or higher) who will be advised to consult their GP Receiving pharmacological treatment with antidepressants is not an exclusion criteria meanwhile, during the study period, treatment will not be modified or increased (decrease of pharmacological treatment is accepted).
Stimulant Abuser Groups to Engage in 12-Step

The purpose of this study is to determine whether a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes.

This protocol is to evaluate the degree to which a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes compared to treatment as usual (TAU) without STAGE-12 among stimulant abusers. The primary objective is to evaluate reduction in percent of days of stimulant use as measured by self-report. Secondary objectives include evaluating reduction in percent days of use of other substances, the degree to which STAGE-12 increases involvement in 12-step activities and attendance at 12-step meetings, and the extent to which such 12 -step involvement and meeting attendance mediate substance use outcomes.

Eligibility Criteria:
Inclusion Criteria:

* seeking outpatient treatment for stimulant abuse or dependence
* current diagnosis of stimulant abuse or dependence
* willing to participate in the protocol

Exclusion Criteria:

* not sufficiently medically or psychiatrically stable
* pending legal action that would inhibit their participation in the study
* in need of detoxification from opiates
Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab

Investigational Drug:

Ofatumumab (Azerra)

Route of Administration:

Intravenous (IV)

Hypothesis:

This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone.

Participation:

Approximately 38 previously untreated CLL subjects will participate in this study over two years.

Treatment Plan:

A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.

Follow-up:

Patients will be followed monthly for six months, then every three months for five years then annually thereafter.


Eligibility Criteria:
Inclusion Criteria:

* Must be \>/= 18 years old and able to provide consent
* Must have diagnosis of CLL as defined by NCI criteria
* Must be previously untreated for CLL
* Must require chemotherapy
* serum creatinine \<1.8 mg/dl
* Bilirubin must be \</= 2 mg/d, unless secondary to tumor
* Must have adequate liver function (as defined as \<2x ULN, unless related to CLL)
* Performance status 0-2
* Women of child bearing age must be willing to use accepted/effective method of birth control.

Exclusion Criteria:

* Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.
* Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia
* Not have history of corticosteroid treatment for CLL
* Not have CNS disease
* Not have clinically significant infections
* Patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible.
* Not have positive serology for Hepatitis B or Hepatitis C
* Not have be known to be HIV positive
* Not have New York Classification III or IV hear disease
The Effect of Ruboxistaurin on Small Fiber Function

To determine the effect of Ruboxistaurin on small fiber function.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have Type 1 or Type 2 diabetes mellitus
* Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus
* Patients must have blood glucose control measured as HbA1c=\<11%
* Patients must be 18 years of age or older.
* Patients must be able to return to all follow-up visits

Exclusion Criteria:

* Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies
* Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy.
* Patient currently has uncontrolled high blood pressure
* You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems
* You are a woman of childbearing age and unwilling or unable to use effective contraceptive.
Early Detection of Skin Cancer With Sensor Technology

Skin cancer represents a large problem in today's healthcare setting. The majority of cancer diagnoses are attributed to malignant skin diseases including its major types: basal cell carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early detection of malignant lesions largely increases chances of successful treatment. The current gold standard of diagnosis is histopathological examination of biopsied skin. Biopsies are not only invasive and expensive, they have variable positive predictive value, meaning they may often be preformed unnecessarily. As such, the investigators have developed a skin scanner, which is less bulky and expensive than existing similar technologies, as a tool to evaluate skin lesions prior to determining the need for a biopsy. Their objective is to obtain information in order to validate this skin scanner in the context of its ability to accurately identify basal cell carcinoma skin lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring skin biopsy for suspected basal cell carcinoma skin lesion
* 18 years of age or older

Exclusion Criteria:

-Poor english fluency, Pregnancy
Sleep Enhancement Training Study for Novice Shiftworkers

The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months

Exclusion Criteria:

* \> 6 months experience working night-shift
* current diagnosis of sleep disorder or affective illness
Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery

This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.

The objective of this study was to develop and validate an ex-vivo comprehensive curriculum for a basic laparoscopic procedure. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex-vivo training on learning curves in the operating room (OR), nor the effect on non-technical proficiency has been investigated. This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured-curriculum (STAC) group or conventional residency training. The STAC curriculum consisted of: case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to: learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and non-technical skills.

Eligibility Criteria:
Inclusion Criteria:

* post graduate year 1 and 2 general surgical residents
* completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon