cyrilzakka/clinical-trials huggingface dataset:
FAst and SimplE COVID-19 Causing Virus SARS-CoV-2 Detection

Observational study using biological material. The group of subjects in the study is represented by 100 male and female patients hospitalized with COVID-19 symptomatology and 100 non-hospitalized subjects with suspected COVID-19 diagnosis for a total of 200 patients.

The expected recruitment time is about 6 months.

Clinical study using biological material. The group of subjects in the study is represented by 100 male and female patients hospitalized with COVID-19 symptomatology and 100 non-hospitalized subjects with suspected COVID-19 diagnosis for a total of 200 patients.

The expected recruitment time is about 6 months. Each patient will be carried out a nasopharyngeal swab in UTM medium™ which will be tested according to the diagnostic procedure in use, a second nasopharyngeal swab resuspended in MSwab™ and a third oral dry swab that will be transported to the laboratory of Clinical Microbiology and Virology of UNIMIB and resuspersed in the MSwab™ transport medium. The samples will then be treated according to the new workflow defined by the pilot study, i.e. optimization of alternative sample transport systems, in combination with a rapid method of viral RNA extraction, and evaluation of viral inactivation at the end of the extraction phase, by viral culture at the BSL3 laboratory of the Virology laboratory of the University of Milan.

The samples collected and transported on UTM™ medium will be sent to the Microbiology Laboratory of the ASST of Monza and analyzed through the NIMBUS-Seegene platform as per diagnostic routine.

The residual volume of the UTM™ medium sample and all remaining samples taken by each patient will be sent to the Laboratory of Microbiology and Clinical Virology of the University of Milano-Bicocca to be processed through the new preanalytic method in combination with different analytical kits.

A percentage of each sample will be sent to the Virology Laboratory of the University of Milan for testing using the analytical protocol suggested by the CDC.

The study samples will also be used for the validation of a new innovative analytical test for SARS-CoV-2, in Real-Time Multiplex One- Step PCR, developed to be combined with the preanalytic process with thermal extraction, fast and low cost, with high-throughput automation.

All residual volumes of the samples in the study, and related nucleic acids, will be rated and stored in Bio-Bank according to international "standard operating procedures" the validation of further and/or new diagnostic tests for the search for for SARS-CoV-2 (ASST PG23 in collaboration with BBMRI.it).

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the U.O. of Infectious Diseases of the San Gerardo Hospital in Monza with documented COVID-19 symptomatology;
* COVID-19 asymptomatic or post-hospital discharge;
* People of legal age;
* Patients who agree to participate have given their consent by signing a specially prepared form.

Exclusion Criteria:

* none
A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or female and aged between 20 and 45 years of age (inclusive)
* Subject is of normal body weight as determined by a body-mass index (BMI) between 18 and 28 kg/m2
* Subject is healthy as determined by EA (medical history, physical examination, skin evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis)
* Subject is surgically sterile; subject has been postmenopausal for at least 12 consecutive months if female; or subject agrees to remain abstinent or to follow two acceptable methods of birth control from EA to the end of observation period. (fore male and female subjects)

Exclusion Criteria:

* Subject has a history or complication of epilepsy and/or seizures
* Subject has clinically relevant changes in the ECG, such as second- or third-degree AV block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA
* Subject has a clinically relevant hepatic dysfunction
* Subject has a clinically relevant renal dysfunction
* Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
* Subject has a history or complication of atopic or eczematous dermatitis, psoriasis, and/or an active skin disease or skin tumors
* Subject has more than 1 known or suspected drug hypersensitivity, in particular to any component of the trial medication
* Subject has a history of chronic alcohol or drug abuse within the last 5 years
* Subject is tested positive for HIV-1/2Ab, HBsAg or HCV-Ab
* Subject tests positive for alcohol and/or drugs at EA
* Subject is taking any prohibited concomitant medication
* Subject has a history or complication of narrow angle glaucoma
* Subject has a history or complication of respiratory or cardiovascular disorders (e.g., heart failure, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction)
* Subject has a history or complication of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy
* Subject has a history or complication of diabetes mellitus and/or thyroid dysfunction, especially hyperthyroidism or other endocrine disorders
* Subject has a history or complication of malignancy
FH ORTHO Shoulder Observatory

This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.

In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.

This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).

It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.

This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.


Eligibility Criteria:
Inclusion criteria:

1. Any patient undergoing implantation of medical devices distributed by FH ORTHO SAS for shoulder arthroplasty and traumatology, used in accordance with their approved labelling, in one of the centres participating in the Observatory (retrospectively or prospectively)
2. Patient is at least 18 years of age
3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally) In some countries, such as France, the patient will have to be socially insured to be included in the study.

Exclusion criteria:

1. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation

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The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion

The aim of this randomized cross-over study is to investigate how consumption of protein and fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.

Exploratory, and in order to investigate mechanisms behind the potential attenuation in the sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon, triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat and subjective rating of appetite for sweet will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Caucasian
* Healthy men and women
* Age between 18-50 years
* Body mass index (BMI) between 20-27 kg/m2

Exclusion Criteria:

* Chronic diseases or significant health problems that are disruptive for participation in the study (as judged by the principal investigator/clinical responsible)
* Use, currently or within the previous 3 months, of medication that has the potential of affecting any of the blood parameters assessed in the study (as judged by the principal investigator/clinical responsible)
* Blood donation within the last 3 months or during the study period
* Smoking, smoking cessation within the past 3 months, or nicotine use (electronic cigarettes, gum, etc.)
* Currently dieting or having lost/gained a significant amount of weight (±3 kg) in the previous 3 months
* Women who are pregnant, breast-feeding or have the intention of becoming pregnant during the study period
* Food allergies or food intolerance relevant for the study
* Substance abuse (within the last 12 months)
* Alcohol intake above the recommendations from the Danish Health and Medicines Authority
* Simultaneous participation in other clinical studies that can interfere with the current study
* Inability, physically or mentally, to comply with the procedures required by the study protocol
Heterogeneous Distribution of Health Literacy and Emotional State on Patients With Functional Dyspepsia.

Patients with indigestion were often found in gastroenterology clinic, those who about 20 % was caused by organic, while the rest of patients are showed abnormal inspection, and these are so called functional dyspepsia. Functional dyspepsia is a chronic and repeated occurrence of digestive disorders, patients often visit hospitals frequently and unable to get fully cured. Current Symptom diagnoses are based on Rome III criteria as diagnostic criteria. Although functional dyspepsia condition should combine with physical and mental treatments, due to the reasons behind the complex, there is still no effective classification could be acted in health education and drug intervention.

Health literacy can be defined as "ability for obtaining basic health information and understanding medical services." Within 10 years, healthy development and application of knowledge used in medical care and public health fields that have raised more attentions, many European countries set health knowledge as one of the main indicators for health care policy in the future. To promote behavior of self-care health for people, enhance the effective use of medical service , also reduce health care cost and unequally medical information.

Anxiety and depression are two common reactions when it comes to negative emotional states, which related to a body and caused a vicious cycle of disease. Some patients suffer from functional dyspepsia symptoms were diagnosed with anxiety or depression symptoms often ignore body care due to lack of health literacy. The purpose of this study is to investigate the distribution of functional dyspepsia patients with health literacy and emotional status, in order to provide more effective health education mode, thereby reducing the waste of medical resources, and promote patient health.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with functional dyspepsia , can Self-reading and the self-administered questionnaire.

Exclusion Criteria:

* Due to physical illness, cognitive ability is limited and other factors can not were completed self-administered questionnaires.
Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis

This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

The study population was participants with relapsing remitting multiple sclerosis. The traditional rehabilitation program consists of a joint treatment in which lower extremity strengthening and balance exercises are carried out synchronously for the experimental and control groups. Motor imagery and action observation therapy based on telerehabilitation of certain movements will be applied to the experimental group. All treatments will be carried out online via the zoom program. The treatment program will be applied 3 times a week for 6 weeks. Evaluations will be made before and after the treatment program. Assessments include balance, lower extremity muscle strength and functional mobility, fatigue, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with mulltiple sclerosis according to the McDonald criteria
* Expanded Disability Status Scale\<5.5,
* Being between the ages of 18-65,
* Mini mental test score\>24,
* Have a phone that can adapt to participating in a video call

Exclusion Criteria:

* Having another additional neurological disease that may cause balance and coordination disorders,
* Receiving physical therapy in the last 6 months,
* Having an attack in the last 3 months
* Refusal to participate in the study.
QST and Neuropathic Pain

To establish the sensory profile of patients using quantitative sensory testing (QST) and questionnaires as well as the level of sensitisation using temporal summation and diffuse noxious inhibitory control paradigms in all patients undergoing a chronic pain intervention at Barts Health NHS Trust.

Primary objective- To identify the phenotype of responders and non-responders to a chronic pain intervention using QST sensory profile as well as the sensitisation paradigms.

Secondary objective- To establish the correlation between sensory profile, and sensitisation parameters as well as other measures of chronic pain as per Initiative on Methods, Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation.

Common interventions performed at Barts Health NHS Trust includes Neuromodulation, targeted epidural steroid and/or radiofrequency treatment, 8% Capsaicin patch and pharmacological interventions such as anti-neuropathic agent and opioids.


Eligibility Criteria:
Inclusion Criteria:• Male and female patients between the age of 18-80 years who have a lumbar radiculopathy who have not undergone any spinal surgery.

* Minimum baseline pain rating of 50mm on a 100mm NRS in the painful area
* Chronic pain of at least 6 months
* Subject satisfies standard criteria in the study centre for SCS implantation and the NICE 159 criteria for management of intractable neuropathic pain.
* Subject satisfies standard criteria in the study centre for ONS implantation and the NICE 452 criteria for intractable chronic migraine.
* Patients who have given their written informed consent.
* Patient is able and willing to comply with study procedures and follow up schedule.

Exclusion Criteria:• Any inclusion criteria not met

* Female patients of childbearing age who is or plans on becoming pregnant during the course of the study
* Patients who have undergone radiofrequency or injection therapy at or on a target neural structure (DRG) during the past 90 days
* Patients with diabetes or any underlying neurological condition.
* Patients known to have a condition that in the investigator's judgment precludes participation in the study.
* Patients who have received an investigational drug or have used an investigational device in the 30 days preceding to study entry
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.

This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on homeless and at risk for homelessness veterans with chronic pain for 12 weeks.

Methodology: This is a mixed methods prospective design study. A total of 35 subjects will be recruited for this study. The primary study outcome variables are: pain level- pre and post treatment, stress, mood and usual activity levels, sleep patterns and behavioral factors such as ; anxiety, depression, suicidal ideation, substance use and housing stability.

4. Findings: Pending

5. Clinical Relationships: This study is conducted to demonstrate whether or not BFA treatment will decrease pain and improve quality of life for homeless and at risk for homelessness veterans.

6. Impact/Significance: Pending

Eligibility Criteria:
Inclusion Criteria:

Eligibility criteria include:

* they are 18 years or older
* they are homeless or at risk for homelessness veterans who are enrolled in the VA Bedford Healthcare system and registered in one of the HUD-VASH or HCHV programs,
* history of chronic pain.
* Availability to participate in the study for 4 months.

If they meet these criteria, they will be asked to complete the Informed consent to enroll in the study.

Exclusion Criteria:

* female veterans who are pregnant
* history of bleeding disorders or currently on blood thinning medications
* currently being treated for an active infection of the outer ear.
* currently have a PICC line in their body or are receiving IV antibiotics.
* fear of needles/tacks
* undiagnosed pain complaint

Our recruitment plan invites all eligible veterans and is just, fair, and equitable.
Varenicline for Alcohol Dependence

The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age.
2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.
3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking.
4. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
5. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:

   1. oral contraceptives,
   2. contraceptive sponge,
   3. patch,
   4. double barrier (diaphragm/spermicidal or condom/spermicidal),
   5. intrauterine contraceptive system,
   6. levonorgestrel implant,
   7. medroxyprogesterone acetate contraceptive injection,
   8. complete abstinence from sexual intercourse,
   9. hormonal vaginal contraceptive ring, and/or
6. Be able to take oral medication and be willing to adhere to the medication regimen
7. Complete all assessments required at screening and baseline.
8. Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
9. Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study.
10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.
11. Be someone who in the opinion of the investigator would be expected to complete the study protocol.
12. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.
Mild Preeclampsia Near Term: Deliver or Deliberate?

Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops disease progression and recovery can begin. Patients with mild preeclampsia between 34-38 weeks' gestation usually are hospitalized for evaluation and close monitoring of signs, symptoms, and certain laboratory studies as reflectors of disease status. As inpatients mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34 weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when during the third trimester that delivery should be accomplished for maximal maternal safety and minimal fetal risk. In this research project, we will identify patients who are at least 34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial, we will randomize participants to either be delivered immediately or treated with observation and maternal-fetal surveillance in hospital as described previously with delivery at 38 weeks. There will be 110 participants enrolled in each arm of the study for a total of 220 patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal and fetal outcomes including cost comparisons for the care of both mother and fetus in the two groups of randomized patients. The findings should impact care of the pregnant patient with mild preeclampsia in the third trimester with regard to how early and how late in gestation that delivery should be accomplished for optimal maternal and perinatal benefit.


Eligibility Criteria:
Inclusion Criteria:

* Mild Preeclampsia equal to or greater than 34 weeks' and less that 38 weeks' gestation singleton gestation no maternal or fetal contraindications to conservative management

Exclusion Criteria:

* Non-gestational diabetes Chronic hypertension Severe preeclampsia Non-reassuring fetal assessment intrauterine growth restriction fetal anomalies multiple gestation premature preterm rupture of membranes placenta previa unexplained vaginal bleeding antihypertensive use current gestation poor dating criteria contraindication to conservative management active labor at admission