cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator.

Eligible patients must sign the informed consent form and they will be between 18 and 60 years old and common cold symptoms for no more than 72 hours.

It will be recruited for this study 366 patients, 183 patients per group. It is estimated that the total number of patients can be recruited in 4 to 6 months from the regulatory approval of the study.

The patient will stay in the study approximately 7 to 10 days (including screening visit / randomization, telephone contact in 3 to 5 days after randomization and final visit from 1 to 3 days after last dose).

Study medication (Coristina d and Resfenol) will be provided by the sponsor and will be appropriately labeled for the clinical study, containing the sponsor information, the trial identification, expiration date, batch and storage conditions

Eligibility Criteria:
Inclusion Criteria:

1. Sign and date the informed consent form;
2. Age between 18 and 60 years old;
3. Symptoms of common cold not exceeding 72 hours must be present;
4. It will be considered symptoms of the common cold the presence of at least 2 of the 10 symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throat discomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listed above will receive a score by Likert scale (no symptom = 0, mild symptoms = 1, moderate symptoms = 2, intense symptoms = 3). The minimum total is 0 and maximum one is 30, which included patients with score higher or equal to 4 points.

Exclusion Criteria:

1. Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;
2. Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;
3. Hypersensitivity or contraindication to use of components of the study medications;
4. Pregnant or women of childbearing age without adequate contraception;
5. Use of other anti-influenza drugs programmed during the study or for the last 5 days;
6. Regular active smokers (more than 3 cigarettes a day);
7. Participation in another clinical study in less than one year (unless justified benefit by the investigator).
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain

Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.

Methods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical/vaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes/No). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.


Eligibility Criteria:
Inclusion Criteria:

* All individuals with documented initiation of oral PrEP (daily or event-driven regimens), who have collected the medication at least once and have taken at least one pill, will be included in the study.

The approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Available at http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows:

* People without HIV infection at the time of cohort inclusion
* Age ≥ 16 yr who meet the following criteria:
* MSM and transgender women with at least two of the following criteria during the last year: \> 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI
* Sex worker women who report non-habitual use of condoms.
* Cisgender males/females, who report condomless and present at least two of the same criteria as MSM and transgender.
* PWID with unsafe injection practices

Exclusion Criteria: none

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"Effect of Emotional Freedom Technique "

This study will be conducted to investigate the effect of Emotional Freedom Technique (EFT) Application on infertility stress in women undergoing infertility treatment.

Emotional Freedom Technique (EFT) is an easy-to-apply therapy, one of the types of energy psychotherapy. EFT gives effective and successful results in clinical problems.

Personal energy level and balance are very important, as Gary Craig, the inventor of the technique, stated, "The cause of all negative emotions is due to the disorder in the body's energy system." Because any disruption or blockage in the energy flow brings with it physical and psychological disorders. For this reason, first of all, the negative emotion that causes the negative situation should be eliminated. When the energy flow in the meridians is balanced, the emotional intensity or negative/negative emotion also disappears. Thus, the person starts to feel good.

In energy psychology applications, while the individual is in a relaxed and relaxed state, the electrical energy flow in the meridian system is also comfortable and regular. Emotional reactions such as anger, sadness, stress, disappointment create sudden obstacles in this flow. By focusing on the emotional reactions that hinder the individual, the stimulations on the meridian system (often by touch) regulate the energy flow and provide the individual to relax. The fact that the flow in the meridian system is not interrupted provides relief in the mind, body and emotion areas of the individual.

EFT works on the cognitive and energetic levels. While it is ensured that the individual is conscious and aware of a disturbing symptom or disorder, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release. EFT is applied safely for stress management.

It can be safely applied to individuals of all ages, including the elderly, pregnant and children. EFT was applied in 51 studies, 18 of which were randomized controlled and positive results were obtained with clinical measurements.

With EFT, the energy flow can be regulated safely and consciously, contributing to the individual's "better" feeling. Positive results in past applications reveal the reliability of the method. Since the application procedure is easy, the application areas are versatile and it does not show side effects, it is recommended that EFT be widespread in different clinical areas and evidence-based studies should be increased.

Eligibility Criteria:
Inclusion Criteria:(For the intervention and control group):

* Women who have applied to the IVF clinic for primary infertility treatment,
* in the initial stage of IVF/ICSI treatment,
* literate in Turkish,
* have no chronic disease,
* have no diagnosed psychiatric disease,
* between the ages of 18-40,
* agree to participate in the study.

Exclusion Criteria:

* Women with a diagnosis of secondary infertility who do not meet the conditions for inclusion in the study (for the intervention and control group),
* Women want to leave the study (for the intervention group) before the implementation phases are completed.
Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?

The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. The investigators hypothesize that those patients who receive reattachment of the abductors directly into the prosthesis will have better functional outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective, and reproducible method to assess abductor function at clinical post-operative visits through plain radiographs.

Patients treated for proximal femur replacements at Duke University Medical Center by Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify retrospective patients using the above mentioned CPT codes. Individual chart review of the electronic medical record will then be used to identify those receiving a proximal femur replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300 charts, the investigators plan to consent 25 subjects who have return appointments scheduled. The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.

Eligibility Criteria:
Inclusion Criteria:

• Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon

Exclusion Criteria:

* Non-ambulatory before or after the procedure
* Subjects who, in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)

Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label (non-certificated) use of Pacemaker leads and generators. It is designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. The aim of this study is to demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Need for temporary cardiac stimulation
* Temporary active fixation pacemaker implantation through left or right jugular access.
* Signature of informed consent
* Correct functioning of the electrode after the implantation: sensing of the R wave above 5 millivolts. Ventricular pacing threshold below 1 volt. Electrode impedance between 400-1200 Ohm.
* Pacemaker programming with stimulation output at 5 volts intensity and 1 millisecond pulse duration.
* Placement of the KronoSafe® fastening system after electrode implantation.

Exclusion Criteria:

* Complication during the procedure: pneumothorax, hematoma at the puncture site, cardiac perforation, accidental arterial puncture or other that, in the investigator's opinion, poses an added risk of pacemaker dysfunction.
* Need to transfer the patient to another center with loss of follow-up.
* Absence of surveillance through continuous electrocardiographic monitoring with detection of arrhythmic events.
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma

The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Allergic only to house dust mites
* Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs
* Newly-diagnosed or non-treated asthma
* Must be able to inhale drugs

Exclusion Criteria:

* Other allergic diseases requiring treatment with glucocorticosteroids
* Other chronic diseases
* Asthma exacerbation
* Pregnancy
Association Between Testosterone Levels and COPD Severity

The Aims of the study are estimate the association between the severity of COPD and free testosterone level and the prevalence of hypogonadism in adult men with stable COPD


Eligibility Criteria:
Inclusion Criteria:

* Adults Men ≥ 45 years
* COPD defined according to clinical diagnosis and spirometry American thoracic society ( ATS) criteria
* Stable COPD without recent acute exacerbation (less than 2 weeks)

Exclusion Criteria:

* Refusal to participate or informed consent process
* Those who are under treatment with testosterone replacement or anti-androgens
* Comorbidities: Cirrhosis, Alcoholism, cryptorchidism, panhypopituitarism, Pituitary adenoma.
* Orchiectomy
* Systemic glucocorticoids (equivalent dose ≥ 4 mg of prednisone in the last 3 weeks).
* Relative and absolute contraindications for spirometry.
Peer-coaching to Teach Faculty Surgeons an Advanced Laparoscopic Skill

This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to teach novice surgical faculty an advanced laparoscopic skill.


Eligibility Criteria:
Inclusion Criteria:

* surgical faculty in the division of general surgery or obstetrics and gynaecology.
* novices in laparoscopic suturing (performed \<20 intra-corporeal stiches and knots)

Exclusion Criteria:

* n/a
Statins and Risk of Myocardial Infarction in Real Life in France

The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France


Eligibility Criteria:
Inclusion Criteria:

* Patients can speak French or English
* Patients can be interviewed by telephone
* Place of usual residence in the area of recruitment

Exclusion Criteria:

* Patients refusing to participate in the study
* Patients who cannot be reached by telephone
* Previous history of myocardial infarction
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.

Eligibility Criteria:
Inclusion Criteria

* Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
* Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
* Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
* Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
* Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
* Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
* Subject has a body mass index (BMI) ≤ 38 kg/m2.

Exclusion Criteria

* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
* Subject has clinically infected atopic dermatitis.
* A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer
* Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
* Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
* Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.
Promoting Optimal Treatment Choices in Neonates with Suspected Early-Onset Sepsis

In this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in Dutch hospitals. These include the early-onset sepsis (EOS) calculator, procalcitonin (PCT)-guided therapy, and IV-to-oral switch therapy. These strategies have been proven to be effective and safe and are already applied in several Dutch hospitals. However, this is not the case for all hospitals, leading to significant variations in clinical practice. To facilitate the translation of evidence into practice, active implementation will take place.

The primary research design is a prospective implementation study, using a multicenter, non-randomized pre-post design. The aim is to assess the impact of implementing a bundle of antibiotic stewardship interventions (including the EOS calculator, PCT-guided therapy and iv-to-oral switch therapy) in Dutch hospitals, using a multicomponent implementation strategy, on both clinical and implementation outcomes, with a particular focus on evaluating the employed implementation strategies.

A combination of qualitative and quantitative research methods will be used to assess outcomes. Quantitative clinical data from neonates in the pre- and post-implementation periods will be retrospectively collected by the Business Intelligence units of participating hospitals and pseudonymized before being provided to the central research team. Qualitative data will be gathered through focus groups, interviews, and surveys.


Eligibility Criteria:
Inclusion Criteria:

* Neonates born at 34 weeks of gestation or later
* 0-3 days old

Exclusion Criteria:

* stillborn neonates
Effect of Laughter Yoga on Surgical Fear and Anxiety in Patients Applied Before Ureteroscopy

Surgical fear is a situation where a person experiences excessive fear of surgical procedures. This fear can negatively affect the person's normal life and is usually more intense in the pre-operative period. The causes of surgical fear include factors such as previous negative surgical experiences, lack of sufficient information, post-operative pain and complications. In addition, factors such as age, gender, and level of education can also affect fear. This fear can lead to physical and psychological problems along with stress; symptoms such as increased heart rate, dizziness, and muscle tension can be seen. Methods such as cognitive-behavioral therapy, meditation, and hypnosis can be used in the treatment of surgical fear. In addition, anxiety can also arise from thinking about the surgical procedure, post-operative complications, fear of anesthesia, or pain. High-risk surgeries and past negative experiences can increase anxiety. High anxiety before surgery can lead to psychological and physical problems. Nurses should offer anxiety-reducing techniques (breathing exercises, relaxation) by taking into account the needs of patients. In addition, having relatives with the patient can help relieve anxiety. Laughter yoga is considered an effective complementary therapy to reduce surgical fear and anxiety. Developed in India in 1995, this method involves simulating laughter with yoga breathing techniques. Laughter yoga relaxes muscles, increases pain threshold, and improves overall psychological well-being. This study aims to evaluate the effects of laughter yoga on patients undergoing ureteroscopy.


Eligibility Criteria:
Inclusion Criteria:

It will be applied to patients who agree to participate in the study, are scheduled to undergo ureteroscopy in a urological surgery clinic, have no hearing or vision problems, are over the age of 18, understand and speak Turkish, are literate, and can communicate.

Exclusion Criteria:

Patients with mental retardation and any psychiatric disorder, alcohol or drug addiction, hypertension or heart disease, hernia, glaucoma will be excluded.
A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage

The purpose of the study is to provide a first assessment of safety, tolerability and efficacy of Ir-CPI, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 18 years.
* Written informed consent obtained before any study assessment. If the patient is not able to give the informed consent personally, consent by a legal representative as defined by local law and regulation is acceptable.
* First-ever, spontaneous, supratentorial intracerebral haemorrhage in cerebral cortex or deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 5 mL and ≤ 60 mL determined by non-contrast CT scan.
* Patients with Glasgow Coma Scale (GCS) best motor score no less than 5.
* Modified Rankin Scale (mRS) score 0-2 prior to ICH symptom onset.

Exclusion Criteria:

* History of personal or familial bleeding disorders; including prolonged or unusual bleeding.
* Known deficiency in factor XII (FXII) or haemophilia type A (FVII) or type B (FIX) or type C (FXI).
* Infratentorial (midbrain, pons, medulla, or cerebellum) ICH.
* Secondary ICH due to aneurysm, brain tumour, arteriovenous malformation, thrombocytopenia, coagulopathy, acute sepsis, traumatic brain injury (TBI), or disseminated intravascular coagulation (DIC).
* Planned neurosurgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation.
* Anticoagulation reversal treatment.
* Patients with intraventricular haemorrhage (IVH) having a Graeb score of \>3 on initial presentation. Patients must not have blood in the 4th ventricle and may only have blood in the 3rd ventricle in the absence of ventricular expansion. Trace or mild haemorrhage in either or both lateral ventricles is permitted. Patients with hydrocephalus determined radiologically on initial presentation are excluded regardless of Graeb score.
* Use of immunosuppressive or immune-modulating therapy at admission (e.g., steroids, methotrexate, monoclonal antibodies, etc).
* Patients with active systemic bacterial, viral or fungal infections.
* Women of childbearing potential.
* Have a body weight \> 120 kg at screening.
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m2).
Vitamin D Status and Supplementation in Athletes

The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year.

The study is a double blinded parallel study design.

Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines

Eligibility Criteria:
Inclusion Criteria:

* athletes
* 19-60y

Exclusion Criteria:

* subjects who take vitamin D supplements