cyrilzakka/clinical-trials huggingface dataset:
Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

The aim of the study is to investigate the effectiveness of the Daring Birth digital coaching solution (the Natal Mind app) in enhancing the experience of childbirth. Natal Mind is designed for mobile phones and features a unique blend of emotion tracking, avatar-based interaction, and mass-customized psychoeducation and exercises. These features collectively work to improve the childbirth experience, alleviate pain experience during labor, and mitigate perinatal mental health (PMH) issues namely fear of childbirth (FOC), anxiety, and postpartum depression. The primary outcome of this study is the improvement of the childbirth experience, as it has been recognized to be a fundamental step in preventing postpartum problems.

The study uses a randomized controlled trial (RCT) with two arms: an intervention arm, where participants will have access to the Natal Mind app with its full functionalities, and a control arm, where participants use the app only for answering the study questionnaires while receiving standard care.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous status Estimated time of delivery (ETD) between 15.5. and 15.9.2024 Between 20 and 28 weeks gestational age at the time of recruitment Fluency in Finnish Intended maternity care and birth hospital located in Finland Aged 18 or above

Exclusion Criteria:

* Referral to a fetal medicine unit Diagnosed psychotic or bipolar disorders Active substance abuse Participation in another clinical study focusing on perinatal mental health
The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19

This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo in patients with mild to moderate COVID-19.

100 patients diagnosed with COVID-19 by RT-PCR were randomized in a ratio of 1:1 into TADIOS group and placebo group to evaluate efficacy and safety after intake over 10 days.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, aged between 18 to 65 years (both inclusive)
2. Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples.
3. Patients who are hospitalized into designated hospital for COVID-19 treatment
4. Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19
5. Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India.

   * Mild Illness: Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, and headache. The elderly may present with atypical symptoms. These patients do not have any signs of dehydration, sepsis or shortness of breath.
   * Moderate Illness: Patient with pneumonia and no signs of severe pneumonia (Chest X-ray will be performed to rule out pneumonia in the suspected subjects).
6. Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study
7. Those who can comply with the requirements and processes in the clinical study
8. Women of childbearing age must be negative to urine pregnancy test during screening

Exclusion Criteria:

1. Patients with severe COVID-19
2. Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigator's judgment
3. Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding
4. Patients with cardiovascular, liver, cancer and kidney disease.
5. Self-reported patients being a recipient of immunosuppressive therapy
6. Self-reported patients who are allergic to this dietary supplements
7. Patients taking a health functional food or medicine that may affect the body's antioxidant, anti-inflammatory activity, and lungs within 6 weeks of the first visit
8. Patients who participated in another clinical trial within 1 month before screening
9. Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study
10. Patients consuming any herbal medicine
11. Self-reported patients with cases of surgical menopause (hysterectomy, oophorectomy of both ovaries) or sterilization procedures (tubal ligation or tubectomy of both fallopian tubes). Menopause refers to 1 year of no menstruation.
Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

- arrested preterm labor

Exclusion Criteria:

- ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis
Memantine for Spasticity in MS Patients

Participants (n=20) will be identified at routine care visits performed at the Rochester Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity muscle group. Participants will be seen at screening, one, and three months, and will be evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.

This is a randomized, placebo controlled, double-blind, parallel group trial of memantine in patients with MS and spasticity. Participants will be identified at routine care visits at the Rochester Multiple Sclerosis Center. After obtaining informed consent, patients will undergo screening, which will include a physical/neurologic exam and an assessment of the Expanded Disability Status Scale, spasticity, and functional abilities. Eligible patients will return for a baseline evaluation, will initiate their randomly assigned study medication, and will return after one and three months for re-evaluation. The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.

Eligibility Criteria:
Inclusion Criteria:

1. Multiple sclerosis by McDonald Criteria.
2. Spasticity. A minimum score of two on the Ashworth spasticity scale in at least one lower extremity muscle group and a total score of at least four in the lower extremity muscles tested.
3. Age 18-70.
4. Normal renal function (estimated CrCl \> 50 ml/min).
5. Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods (including barrier methods, IUD, and oral contraceptives) for the duration of the study.
6. Willing and able to perform all procedures related to the clinical trial and to provide informed consent.

Exclusion Criteria:

1. Evidence of clinically significant thyroid, gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, neoplastic, endocrine (including diabetes mellitus), neurologic (other than MS), or other medical or psychiatric disorder at screening.
2. Women must not be pregnant or lactating. Serum or urine pregnancy tests will be required prior to randomization for women of childbearing potential unless the last menstrual period started less than 28 days prior to randomization.
Preventing Sexual Violence Among Middle School Boys With a Strengths-Based Curriculum

This research will examine if participation in a strengths-based curriculum, the Brothers as Allies program adapted from the Council for Boys and Young Men, reduces risk for future sexual violence perpetration among middle school-aged boys in New York State.

Using a longitudinal waitlist control design, this study will evaluate the efficacy of a strengths-based curriculum, the Brothers as Allies program from the Council for Boys and Young Men, to reduce risk for future sexual violence perpetration with middle school-aged boys (ages 12-14) in New York State. This research will examine if participation in the program decreases negative behaviors (such as later sexual violence perpetration and sexual aggression) and increases positive behaviors (such as bystander intervention and caring/cooperative behaviors) amongst program participants, in comparison to participants who participate in programming-as-usual. Other potential moderators and outcomes linked to sexual violence victimization and sexual assault perpetration (including attitudes related to gender roles, acceptance of sexual violence, and interpersonal relationships) will also be measured. The research team will also assess the extent to which the curriculum, when implemented with fidelity and quality, leads to improved relationships and stronger connections with adults in afterschool or other community-based youth-program settings. All participants will complete surveys at baseline, immediate post-intervention, and at 3 and 6 months post-intervention. Finally, the investigators will also assess the implementation factors which impact the efficacy of this program, such as fidelity and quality of program delivery. The research team hypothesizes participants in the Brothers as Allies program will show post-intervention decreased sexual violence perpetration, less acceptance of sexual violence, less stereotypic gender role attitudes, greater youth-adult connectedness, and increased bystander intervention, caring, and cooperation behaviors compared to peers in the non-intervention group. In order to complete this work, the research team is collaborating with the New York Rape Prevention and Education (RPE)-funded Regional Centers for Sexual Violence Prevention and a Research Advisory Board of community members and professionals from New York State.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be males of middle school age (12-14 years), participating in afterschool/youth programming at one of the intervention or control sites.

Exclusion Criteria:

* None.
Effects of (1,3), (1,6)-Beta-D-glucan on Insulin Sensitivity and Inflammatory Markers of the Metabolic Syndrome

Insoluble (1,3),(1,6)-beta-D-glucan from bakers yeast are indigestible polysaccharides. Previous studies indicate that the intake of insoluble dietary fiber is strongly associated with reduced risk of type 2 diabetes and cardiovascular disease. However, the mechanisms leading to this phenomenon are largely unknown.

There are close relations between metabolic and inflammatory pathways, and a number of hormones, cytokines, signal proteins, bioactive lipids, and transcription factors have been shown to be involved in both systems.

Beta-D-glucans have been suggested to play a role as so called biological response modifiers. Studies in animals indicate that even small doses of (1,3),(1,6)-beta-D-glucan may have beneficial effects on immune activity, i.e., by reducing the secretion of inflammatory factors.

The investigators hypothesize that the intake of isolated (1,3), (1,6)-beta-D-glucan from bakers yeast improves inflammatory makers and insulin-sensitivity in overweight subjects with increased C-reactive protein concentrations at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with normal glucose tolerance (NGT)
* Impaired glucose tolerance (IGT)
* Impaired fasting glucose (IFG)

Exclusion Criteria:

* Any severe cardiac disease
* Liver
* Kidney diseases
* Type 1 or type 2 diabetes
* Chronical and acute inflammatory diseases
* Lipid lowering drugs
* Cortisone
* Antibiotics
* Non-steroidal antiinflammatory drugs
* Including low dose acetylsalicylic acid
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring

From the scarce literature it showed that computer/internet-aided cognitive behavior therapy (CBT) was superior to waitlist and placebo assignment across outcome measures, and the effects of computer/internet-aided CBT were equal to therapist-delivered treatment across anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based relaxation with biofeedback treatment for panic disorder.

All participants had access to a computer with an internet connection and received the treatment via internet.

Eligibility Criteria:
Inclusion Criteria:

1. The participant must fulfill DSM-IV criteria for panic disorder.
2. The participant must be between 20 and 60 years of age.
3. The participant must have the Panic Disorder Severity Scale(PDSS) score ≧8.
4. If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 6 weeks before starting treatment, and b) the participant have to agree to keep the dosage constant for 2 months after starting treatment.
5. If the participant was already in therapy, the contact must have lasted at least 3 months and not be based on cognitive behavior therapy.
6. All participants have access to a computer with an Internet connection.

Exclusion Criteria:

1. The participant suffers from any other psychiatric disorder in immediate need of treatment.
2. The participant fulfills DSM-IV criteria for major depression.
3. The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension.
4. The participant has alcoholism or substance dependence.
Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.

For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.

The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.

Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone

Looking at the same drugs and doses the variable is the timeframe of the medication

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Negative urine culture within 1 month prior to procedure
* Renal Calculi which would optimally require PCNL for treatment.

Exclusion Criteria:

* Patients \<18 years old.
* Patients who are not able to give consent for study
* Patients currently on antibiotics immediately prior to the procedure
* Previous history of sepsis or SIRS from stone manipulations
* Foley catheter in place for greater than 1 week duration
* Patients under going planned, multi-staged procedures
* Immunosuppressed patients
99m Tc-ANNexin-V-128 Scintigraphy for the Identification of Complicated Carotid Atherosclerotic Plaques

The aim of this trial will be to test and validate the value of scintigraphy with injection of 99mTc-Annexin-V-128 for the detection of complicated carotid plaques

Introduction Stroke represents the third cause of death, the first cause of handicap and the second cause of dementia in Europe. Carotid atherosclerotic plaques are the cause of ischemic stroke in about 15 to 20 % of the patients. In presence of carotid stenosis \> 50 %, the risk of ischemic stroke is estimated at about 10% per year when the patient has presented symptoms of cerebral ischemia but only at 2% per year in asymptomatic patients. Clinical benefits of surgical carotid endarterectomy have been demonstrated in symptomatic patients with high degree of carotid stenosis, but remain debatable in asymptomatic patients and should be balanced with the risks associated with the revascularization procedure. There is an urgent need to develop imaging tools that improve the identification of patients at highest risk of developing an ischemic stroke Cellular apoptosis is a key feature of ruptured plaques. Apoptotic macrophages release large amounts of tissue factor within the plaque thereby fostering thrombus formation when plaques rupture. Annexin-V is a 36-kDa protein that binds with high affinity and high specificity to phosphatidylserine (PS) head groups expressed on the cell surface at early stages of the apoptotic process. In addition, activated platelets express large amounts of PS at their surface. In a proof-of-concept study, 99mTc-Annexin-V uptake was detected by scintigraphy in carotid atherosclerotic plaques of 4 patients who presented an acute ischemic stroke and was associated with the presence of apoptotic cells on corresponding carotid plaques obtained after carotid endarterectomy procedure.

Design : Monocentric interventional non comparative study Investigational medicinal product(s): 99mTc-Annexin-V-128 Statistical procedure : Statistical analysis will be performed at the end of the study after blinded review and data freezing.

99mTc-Annexin-V-128 uptake will be analyzed as a binary variable considering the presence or absence of detection and as a quantitative variable for the intensity of signal.

Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤ Age ≤ 90 years
* Patients with clinical indications to carotid endarterectomy
* Signed the consent form.
* Affiliation of a social security regime

Exclusion Criteria:

* Non-menopausal women
* Chronic kidney disease (eGFR \< 45 ml/min/1.73 m2)
* Waldenstrom disease
* Multiple myeloma
* Previous severe adverse reaction to iodinated contrast agent
* Impossibility to stay immobile and maintain the supine position during 20 minutes.
* Altered consciousness or inability to understand the consent form.
* Urinary incontinence without implantation of urinary catheter (risk of urinary contamination).
* Non-atherosclerotic carotid stenosis (history of cervical radiation).
* Patient deprived of liberty or under legal protection measure
Study Evaluating PAZ-417 in Healthy Young/Elderly

This study is to evaluate the safety and tolerability of single, ascending doses of PAZ-417 in healthy young and healthy elderly subjects. The effect of a high fat meal on the metabolism of PAZ-417 will also be studied, along with blood levels of PAZ-417 . Changes in cognitive function will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women, aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years inclusive (elderly subjects) on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with estradiol ≤25 pg/mL\[92 pmol/L\] and FSH ≥40 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile or post-menopausal must provide documentation of the procedure by an operative report or by ultrasound and have a negative serum pregnancy test result within 48 hours before administration of test article.
2. The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well-controlled, and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results which are associated with stable, chronic, well-controlled, medical conditions.
3. The estimated creatinine clearance must be within the age-appropriate normal range.

Exclusions Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
3. Exclude subjects with a history of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (e.g., rheumatoid arthritis), hematologic disorders, and bleeding disorders (e.g., hemophilia, idiopathic thrombocytopenic purpura, von willebrand's disease).
DENTAL CARE OF PATIENTS LIVING WITH HIV

This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.

In the purpose of identifying oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV, we would recruit from 15 10 2021 to 15 04 2022 affiliated to social security scheme PLWHIV adults followed-up in the infectious diseases department of Clermont-Ferrand university hospital who accept participate in order to propose dental individual clinical exams. Anonymous socio-demograpic, medical and dental data will be reported in Redcap. Primary outcomes are the number and type of pathologies identified linked to HIV or not. Statistical analysed will be performed with Stata software. The population will be described by associated numbers and percentages for the categorical variables and by the mean ± standard deviation or median \[interquartile interval\] for the quantitative variables, with respect to their statistical distribution.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient infected with HIV or co-infected with HIV / HBV or HIV / HCV followed in the Infectious Diseases department of Clermont-Ferrand University Hospital and affiliated to a social security scheme.

Exclusion Criteria:

* Minor patient
* Adult patient unable to express his non-opposition to participating in the study or patient who refuses to participate in the study.