cyrilzakka/clinical-trials huggingface dataset:
A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19

The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.

The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have a positive SARS-CoV-2 test result;
* Participants who have one or more mild or moderate COVID-19 symptoms.

Exclusion Criteria:

* No specific exclusion criteria in this real world study.
Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice

The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ULS, in whom a decision has already been made to inject botulinum toxin A (BoNT A).
* Patient has provided written informed consent for collection of the data.

Exclusion Criteria:

* Participation in any interventional clinical study of ULS within the 12 weeks prior to the inclusion visit (Visit 1).
* Patient has already been included in the current study, but was subsequently withdrawn.
Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot

The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. The main question to be answered is: What are the normal thermographic parameters in rheumatic foot?

If there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image.

Patients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis of more than 5 years\&#39; duration
* Healthy patients without diagnosed systemic disease
* Patients between 40 and 80 years of age

Exclusion Criteria:

* Patients who are pregnant or may become pregnant
* Patients with degenerative diseases or significant cognitive impairment
* Patients with rheumatic diseases without a diagnosis of rheumatoid arthritis
Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina

This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina. The effect of moderate amounts of physical activity on the spread will be evaluated, and compared to no physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Not at risk for pregnancy
* Willing to abstain from intercourse 24 hours prior to MRI
* Regular menstrual cycles (every 23-38 days)
* At least 10 weeks from most recent pregnancy outcome and had 2 spontaneous menstrual cycles since
* Normal pap smear within previous 12 months
* Negative test for yeast, bacterial vaginosis and trichomonas
* Not allergic to any component of the formulation
* No contraindications to MRI
* Not participated in another investigational trial within 30 days
* No history of condition, or finding on exam, that, in the opinion of the investigator, would make participation unsafe for the volunteer or complicate interpretation of the data
Comparison of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women

The purpose of this study is to compare the efficacy of electrical pudendal nerve stimulation (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.

Tolterodine Tartrate is one of the first-line medications in treatment of Urgency-frequency syndrome (UFS) patients. It is reported to reduce frequency urgency and nocturia and urinary leakage in patients with UFS. However dry mouth and constipation are the most frequently reported adverse events. In other reports blurred vision and increased heart rate are also reported. The side effects limit its application.

Electrical neuromodulation has proved to be valuable in patients with UFS with little adverse effect. The investigators have previously reported electrical pudendal nerve stimulation (EPNS) alone has long term effect in treatment of UFS in women patients. EPNS is developed by combining the advantages of pudendal nerve stimulation (PNS) and percutaneous tibial nerve stimulation (PTNS), and incorporating the technique of deep insertion of long acupuncture needles. Because pudendal nerve (PN) afferents are particularly important for the inhibitory effect on the voiding reflex and SNS only excites part of PN afferents, direct PN stimulation may be more effective. PNS can be used to treat UFS refractory to SNS, but this therapy also has the disadvantages similar to those of SNS. PTNS is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but the results of chronic PTNS treatment are unknown in initially successful patients and PTNS effects diminish over time.

In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Besides the radiographic evidence, simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in the investigators previous study have proved that EPNS can exactly excite PN. The investigators previous study has also proved that EPNS has a good post-treatment effect on UFS in women. The purpose of the present study is to show the long-term efficacy of EPNS for UFS in women.

Eligibility Criteria:
Inclusion Criteria:

* Urgency with a documented daytime frequency of more than eight voids and/or nocturia of more than one void.

Exclusion Criteria:

* Age \<18 years,or \>80 years;
* Urinary tract infections based on results of urinalysis or urine culture;
* Painful bladder syndrome manifested by suprapubic pain related to bladder filling accompanied by frequency and other diseases (including interstitial cystitis, neurogenic bladder, bladder tumor, and vesical calculus)
* Causative of urgency and frequency confirmed by physical examination, B-scan ultrasonography.

urodynamic study, cystoscopy, and radiography
3D VR and Hands-on Horticultural Activities Effects

This study aimed to explore the effects of a combination of 3D virtual reality (VR) and hands-on horticultural activities on the mental health of community-dwelling older adults.

Aging societies are of public health concern worldwide. It is critical to develop strategies that harness technology to enhance older adults' mental health. This study aimed to explore the effects of a combination of three-dimensional virtual reality (3D VR) and hands-on horticultural activities on the mental health of community-dwelling older adults. Used a quasi-experimental design. A total of 62 community-dwelling older adults were recruited. The members of the experimental group participated in an 8-week intervention program. Participants of both groups completed before-and-after intervention measurements for outcome variables that included perceived self-esteem, depression, isolation, mastery and achievement motives, which were analyzed using the generalized estimating equation (GEE). This study found beneficial effects of a combination of 3D VR and hands-on horticultural activities on community-dwelling older adults' mental health.

Eligibility Criteria:
Inclusion Criteria:

Intact cognition, possessing the ability to understand verbal meaning and the ability to operate a VR joystick independently.

Exclusion Criteria:

A history of hand dysfunction, severe visual and hearing impairment, being allergic to plants or pollen, and a current illness such as epilepsy or stroke.
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged \>=10 and \<26 years at the time of enrollment.
* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
* Negative urine pregnancy test for all female subjects.
* Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

Exclusion Criteria:

* Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
* Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Current chronic use of systemic antibiotics.
* Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Effects of Galantamine on Cognition

Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.


Eligibility Criteria:
Inclusion Criteria:

* age range of 18-64 (confirmed by drivers license or other form of identification)
* the presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
* the presence of visuospatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
* relative of an individual with schizophrenia, schizoaffective disorder, or schizophreniform disorder
* able to provide written informed consent (ESC score 10 or above)

Exclusion Criteria:

* subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
* subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
* medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
* received any investigational drug in the preceding four weeks
* pregnant or of childbearing age and not using a medically approved form of birth control
Identification of the Cutaneous Microbiota in Patients With Cutaneous Infection (MICROBIOTA)

Identify the cutaneous microbiota on a cutaneous lesion (cellulite, wound, rash, etc.) on a swab, biopsies or abscess puncture and on "healthy" skin on a skin swab performed for cutaneous mapping to search for staphylococcal deposits.

Cellulite is characterized by inflammation and an alleged infection of the skin and subcutaneous tissues. Previous studies have shown a low yield of samples such as biopsy and needle aspiration of the order of 16%. The most common pathogens are Staphylococcus aureus and Streptococcus pyogenes.

Conventional cultivation has limitations such as the lack of detection of fastidious microorganisms, or the use of antibiotics. Molecular diagnostic methods, such as detection of 16S ribosomal DNA followed by amplification and pyrosequencing, have been used to overcome the limitations of microbial culture.

In a recent study, the authors investigated the causes of acute cellulitis without performing drainage but skin biopsies from the infected site and another non-infected site by quantitative PCR, pyrosequencing, and conventional culture. PCR identified methicillin-resistant S. aureus methicillin in approximately 30% -40% of cases with similar frequency in infected and uninfected sites. In another study R. felis was found in not only bedsores, but also, swabs taken from healthy skin, as well as Streptococcus pneumoniae, S. aureus and Streptococcus group A. Being engaged in the exploration of the human microbiota especially by culture we propose to extend the knowledge of this skin microbiota in patients hospitalized in Infectious Disease services.

Eligibility Criteria:
Inclusion Criteria:

* Patient with skin infections at admission
* Patient requiring skin mapping
* Person informed of the study and having expressed no opposition to participate in the study.
* Affiliate or beneficiary of a social security

Exclusion Criteria:

* Subject not agreeing to participate
* Vulnerable person: pregnant, parturient or nursing woman, person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision.
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past
2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
3. Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of non-childbearing potential

Exclusion Criteria:

1. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
2. Abnormal function of the immune system
3. Received immunoglobulins or any blood products within 180 days prior to informed consent
4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent
5. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
6. Individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination
7. Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding
8. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study
9. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1
10. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients

to compare the effectiveness as well as the safety of prucalopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.

Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbidly malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.

Eligibility Criteria:
Inclusion Criteria:

* Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal

Exclusion Criteria:

* Patients who met the following criteria were excluded:

  * Age less than 18 years or more than 60 years.
  * Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.
  * Clinically significant hepatic dysfunction. (\>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)
  * Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.
  * Patients with arrhythmia or atrioventricular blocks.
  * Any condition or comorbid disease that might interfere with gastric emptying such as diabetes.
  * Patients with head injuries.