cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose

This is a retrospective test-negative case-control study of COVID-19 Vaccine (CoronaVac®) manufactured by Sinovac Research and Development Co., Ltd.The main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease.

This is a retrospective test-negative case-control study in São Paulo city, Brazil . The COVID-19 Vaccine (CoronaVac® )produced by Sinovac Research and Development Co., Ltd.The main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease.A total of 14000 subjects will be enrolled,including 7,000 positive cases and 7,000 test negative COVID-19 cases The Statistical Analysis Plan (SAP) will include univariate (and, when required, multivariable) models of logistic regression.Data will be recovered from three health surveillance information electronic health records (EHRs):

1. VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2.
2. E-SUS, mandatory report database for mild to moderate COVID-19.
3. SIVEP-GRIPE, mandatory report database for severe cases of COVID-19. All those RWD sources are available at the São Paulo Municipality Centers for Health Surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Exposure group 1: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022 and received a three-dose homologous vaccination with CoronaVac. Specifically, ≥14 days after receipt of the third vaccine dose using a homologous regimen with CoronaVac.
* Exposure group 2: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received a two-dose vaccination with CoronaVac and did not receive any booster vaccine. Specifically, ≥14 days after receipt of the second vaccine dose and before the third dose of CoronaVac.
* Exposure group 3: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received only one dose vaccination with CoronaVac and did not receive any other vaccine dose. Specifically, ≥14 days after receipt of the first vaccine dose and before the second dose of CoronaVac.
* Non-Exposure group: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who were not vaccinated. No history of vaccination for any type of COVID-19 vaccine, or \<14 days after receipt of the first vaccine of CoronaVac.

Exclusion Criteria:

* Anyone who received other vaccines for the first doses.
* Anyone who received CoronaVac for the two initial doses but other vaccines for the booster (heterologous immunization).
* Subjects with incomplete vaccination history.
Belviq Tablet® Post Marketing Surveillance Protocol

Post-marketing surveillance of Lorcaserin

Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.

Eligibility Criteria:
Inclusion Criteria:

Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected.

1. Obese patients whose body mass index (BMI) is ≧30 kg/m2.
2. Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus)

Exclusion Criteria:

1. Patients with a hypersensitivity reaction to the drug or the ingredient of the drug
2. Female patients of childbearing potential and pregnant or lactating women
3. Patients taking another weight control drug
4. Patients with the medical history of drug abuse
Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients

Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol

Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of propofol in anaesthetized patients.

The investigators will test the accuracy and stability of such measurements in comparison With plasma propofol Levels.

The investigators will test during target Control infusion (Marsh model) and assumed stable plasma Levels.

Plasma samples of propofol will be taken for comparison With exhaled propofol.

Eligibility Criteria:
Inclusion Criteria:

* • Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic bariatric surgery or elective laparoscopic cholecystectomy.

  * Both genders.
  * Age 18-60 years, both inclusive.
  * BMI ≥ 20 kg/m2, 10 patients with BMI 20-30, and 10 patients with BMI \> 40
  * ASA classification I-III

Exclusion Criteria:

* • Known hypersensitivity or other contraindication to propofol administered as Target Controlled Infusion.

  * Patients which during a preoperative visit are deemed not to tolerate propofol bolus or infusion as administered by Target Controlled Infusion.
  * Ongoing neuroleptic medication.
Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone

Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.

This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.

Eligibility Criteria:
Inclusion Criteria:

* Patient-related criteria:
* Adults at or above the age of 18.
* Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
* The failing tooth will have adjacent and opposing natural teeth.
* Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
* Able to tolerate surgical periodontal procedures.
* Full mouth plaque and bleeding scores less than 20%.
* Compliance with the maintenance program.
* Provide informed consent.
* Accepts the one-year follow-up period.

Teeth related criteria:

* Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
* Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
* Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

Exclusion Criteria:

* Patients diagnosed with periodontal diseases.
* Current or previous smokers.
* Pregnant and lactating females.
* Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
* Patients with active infection related at the site of implant/bone graft placement.
* Patients with parafunctional habits
The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies

The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress.

The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes.

The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.


Eligibility Criteria:
Inclusion Criteria:

* Third trimester post delivery
* Intrauterine growth restriction
* Preeclampsia
* Diabetes
* Control - low risk normal pregnancies

Exclusion Criteria:

* Patients who do not want to participate
* Known HIV or Hepatitis
Gaze Contingent Feedback for Anxiety Disorders in Children

The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. Attentional threat bias and Attentional control will also be measured to explore potential mediators of ABMT's effect on anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of GAD, SOP, or SAD.
* Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
* Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.

Exclusion Criteria: To be excluded youth must:

* meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
* show high likelihood of hurting themselves or others.
* have not been living with a primary caregiver who is legally able to give consent for the child's participation.
* be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
* be involved currently in another psycho-social treatment.
* have a serious vision problem that is not corrected with prescription lenses.
* have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.


Eligibility Criteria:
Inclusion criteria:

1. Patients must experience significant allergic symptoms on visit 2
2. Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
3. Specific IgE against birch allergens (CAP RAST ≥ 2)

Exclusion criteria:

1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
2. FEV1 or PEF value ≤ 80 %
3. Persistent asthma (GINA ≥ 2)

Other protocol-defined inclusion/exclusion criteria may apply.
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

To assess the performance of the CGM System in comparison to a blood glucose comparator method in non-critically ill hospitalized patients who need glucose control.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Admitted to the hospital in a non-ICU bed or once transferred out of ICU
* Anticipate at least 48 hours of hospital stay
* On treatment for glucose control.
* Willingness to complete the study.
* Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen.
* Subject and/or caretaker are able to speak, read, and write English

Exclusion Criteria:

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
* Currently in an intensive care unit (ICU) of the following type (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas)
* Known allergy to medical-grade adhesives
* Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)
* Women admitted to give birth or any other admission related to pregnancy
* Patients receiving Hydroxyurea
* Bleeding disorder
* Participants that are currently being treated for malignancies, cancer
* Participant that are hospitalized to receive an organ transplant
* Require a Magnetic Resonance Imaging (MRI) scan
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Current participation in another investigational study protocol (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 7 days prior to being enrolled in this study.)
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C)
"Machine Learning Analysis of Lingual Colorimetry and MADRS Anxiety-Depression Score in Acupuncture Patients"

This observational study aims to assess the potential relationship between tongue colorimetry (using standardized photographic techniques) and anxiety-depression scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) in acupuncture patients. Data will be analyzed using machine learning methods to determine whether tongue color features correlate with MADRS scores, possibly contributing to a novel, non-invasive diagnostic tool for anxiety and depression assessment in clinical practice.

Participation involves only tongue photography and completion of questionnaires, without any invasive procedures or treatment modifications.

This prospective observational study investigates the correlation between lingual colorimetry, captured using readily available and standardized modern photographic tools (iPhone cameras), and anxiety-depression scores evaluated by the Montgomery-Åsberg Depression Rating Scale (MADRS) among patients attending routine acupuncture consultations.

Participants will undergo a simple and non-invasive photographic recording of their tongue using an iPhone, ensuring consistent lighting and standardized positioning to minimize variability. Simultaneously, participants will complete the MADRS questionnaire, a widely validated instrument for assessing anxiety and depression severity. No invasive procedures or therapeutic interventions beyond their usual acupuncture care will be performed.

The acquired photographic data will be analyzed using machine learning algorithms to identify potential predictive relationships between distinct colorimetric characteristics of the tongue and the MADRS scores. The objective is to determine whether lingual imaging could serve as a reliable, non-invasive biomarker or complementary diagnostic tool for assessing psychological status in clinical practice.

This approach leverages everyday technology (smartphones), promoting ease of replication and broader accessibility in clinical environments. Ultimately, findings from this study could facilitate early detection and monitoring of anxiety-depressive disorders, thus enhancing individualized patient care in complementary and integrative medicine.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Native French speakers
* No medical conditions or medications affecting tongue coloration
* Consulting for acupuncture with symptoms involving an anxious component

Exclusion Criteria:

* Presence of psychosis or substance abuse
* Eating or taking medication within one hour before the examination
* Refusal to complete the Montgomery-Åsberg Depression Rating Scale (MADRS) questionnaire
* Refusal to have their tongue photographed
The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy

Extrinsic - atopic dermatitis is characterized by increased of IgE serum levels. Acute extrinsic - atopic dermatitis is a type 1 hypersensitivity that involve various inflammatory mediator including Interleukin-4, Interleukin-12, and Interferon-Ɣ. Recent treatment of atopic dermatitis mainly focused on reducing the inflammation through topical and systemic regiments. However, no systemic medication could control the atopic dermatitis remission yet, and the current immunosuppressive agent used may cause many side effects if administered on a long term basis.

In the future, treatment of atopic dermatitis were specifically targeted to inhibit the role of Th2. Cimetidine is H2 receptor antihistamine that has been widely used as gastrointestinal medication for a long time. Cimetidine could modulate the immune system by activating the Th1 and lowering the Th2 activity, and lowering the IgE levels thus reducing the severity of atopic dermatitis.

The aim of this study is to measure the efficacy of cimetidine for acute, extrinsic-atopic dermatitis treated with standard therapy using SCORAD as the clinical outcome. This study also measure Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ serum levels before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Atopic dermatitis patients diagnosed with Hanifin Rajka criteria
* Acute extrinsic atopic dermatitis
* IgE levels above 200 IU/mL
* Minimum weight 15kg

Exclusion Criteria:

* Consumption of corticosteroid and systemic immunosuppressant within the last 2 weeks
* Chronic lesion
* Consumption of drugs that reacts with cimetidine
* Disturbance in lab results including complete blood count, liver function, and renal function.
* Other conditions that might increase IgE levels
Taekwondo Training and Postmenopausal Women With Stage-2 Hypertension

Aging is associated with hormonal imbalances and progressive decreases in arterial health and function. It is crucial to prevent or reduce the negative effects of aging on hormonal balance and the vasculature by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a 12-week Taekwondo training program on blood catecholamines, arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), resting heart rate, and muscular strength in postmenopausal women with stage 2 hypertension.

Using a parallel experimental design, participants were randomly assigned to either a Taekwondo exercise training group (n=10) or non-exercising control group (n=10) for 12 weeks.

Participant in the Taekwondo training group trained 3 days/week for 60 minutes per session, and the intensity progressed weekly. Participants in the control group performed no exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with stage-2 hypertension
* Be postmenopausal
* Be between 65 and 85 years old

Exclusion Criteria:

* Known cardiovascular, metabolic or renal diseases
* Physical limitations that prohibit exercise
* Participates in regular exercise
Evidence-informed Choice for Women Participating in Mammography Screening

Study objectives: to evaluate the effects of information about benefits and risks of mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and risks of mammography screening increases the women´s knowledge of it; allows women to make an informed decision on whether to stop or continue the screening program, changing the actual participation rate; anxiety and fear are not increased. Design: randomized controlled clinical trial with non-pharmacological intervention. Subjects and setting of study: women referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions: random assignment of women in two arms according to the information provided. Control arm is the standard information; it consists of receiving information normally provided to women attending the screening program for breast cancer. Intervention arm is the experimental information and consists of receiving accurate verbal and written information about the benefits and real risks of mammography screening programs by a physician investigator. Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision.


Eligibility Criteria:
Inclusion Criteria:

* Women living in the Bay Health District Cádiz-La Janda
* Women aged between 45 and 69 years
* Women invited to breast screening program and who attend it
* Qualified women to give informed consent to participate in the study

Exclusion Criteria:

* Women with a history of breast cancer
Glyceryl Trinitrate Ointment vs Posterior Tibial Nerve Stimulation in the Treatment of Anal Fissure

A prospective randomized study was performed. Compliance with the treatment and healing rate of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and subjects undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .

Patients were randomly assigned to experimental and control groups: those patients undergoing PPTNS (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).

Treatments:

Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

PPTNS: The Urgent PC Neuromodulation System® (Uroplasty, Minnetonka, MN, USA) was used. Subjects underwent one 30-min session 2 days per week for 8 consecutive weeks in an outpatient clinic. Patients were placed in the supine position without anesthesia. PPTNS was delivered using a needle electrode that was inserted 3-4cm cephalad and 2 cm posterior to the medial malleolus at a 60º angle towards the ankle joint to a depth of approximately 0.5-1cm. Successful placement was confirmed by the presence of electric sensation 5 cm above and below the insertion site or a digital plantar flexion. PPTNS was undertaken at the highest amplification (0-20 mA) at a frequency of 20 Hz, causing neither a motor response nor pain.

Compliance with the treatment and healing rate of chronic anal fissure was investigated.

Eligibility Criteria:
Inclusion Criteria:

* persistent anal fissure after the failure of hygienic and dietary measures over at least a 6-week period

Exclusion Criteria:

* associated anal pathologies
* intestinal inflammation disorders
* fissures secondary to underlying diseases
* patients with previous history of headaches