cyrilzakka/clinical-trials huggingface dataset:
Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular, bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant). Participants will be randomized into the TXA treatment arm or a placebo. They will begin taking the medication after three consecutive days of bleeding. Participants will track their bleeding using an automated text message service


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* In good general health
* Have etonogestrel (ENG) subdermal contraceptive implant (must be palpable to prove that an ENG implant is in place at time of screening and enrollment)
* Experience frequent or prolonged bleeding while using ENG implant (\>7 days of continuous bleeding/spotting in the last 30 days, or 2 or more episodes of bleeding/spotting in the last 30 days)
* Implant use for at least 30 days prior to screening visit
* Willing to continue using the implant for at least 30 days from study enrollment
* Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
* Negative gonorrhea/chlamydia screening performed at screening visit

Exclusion Criteria:

* Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4 for contraceptive usage
* Currently pregnant
* Less than 6 months postpartum, less than 6 weeks abortion, not breast/chest feeding (cessation of lactation at least 6 weeks prior to enrollment)
* Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
* Bleeding dyscrasia
* Anticoagulation use
* Active cervicitis
* Allergy to Tranexamic Acid
* Known renal insufficiency
* History of venous thromboembolism
* Current or past breast or uterine malignancy
* Concurrent use of P450 pathway inducing drug
* Implant is due to be switched out in 2 months or less from enrollment
* Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or \>= 14 days per month)
* Currently using oral contraceptives in addition to implant (to be eligible, needs to have 4-6 week washout period)
* Prior pregnancy occurred while Nexplanon/Implanon was in place
* Chronic use of Cannabidiol, THC, or marijuana (\>3 times per week) (patients could have used Cannabidiol, THC, or marijuana chronically in the past, but must have a washout time period of no use for at least one month prior to the study)
* Chronic use of cigarettes (\>1 cigarette per week) (patients could have used cigarettes chronically in the past, but must have a washout time period of no use for at least six months prior to the study)
Effect of CGF on Postoperative Pain After Third Molar Surgery

The purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on pain after bilateral impacted third molar surgery and to determine its contribution to the healing process.

The main question it aims to answer is:

Is CGF effective on reducing the pain in impacted third molar surgery? Researchers compare the pain on the CGF-applied and CGF free sides after impacted third molar surgery. Postoperative pain is assessed using the Visual Analogue Scale. TThe postoperative outcomes including pain are clinically assessed at different-time intervals (1-7 days).


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted wisdom teeth in the mandible, regardless of gender
* Patients without any systemic disease
* Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.

Exclusion Criteria:

* Having a disease affecting general health that requires the application of prophylactic antimicrobial agents
* Having a systemic viral, fungal or bacterial infection
* Patients with acute or chronic maxillary sinusitis
* Suspected or diagnosed pregnancy and nursing mothers
* Patients with heart and vascular diseases
* Patients with liver disease, haematological disease and neoplastic disease
* Patients who have recently received anti-inflammatory therapy
* Patients with chronic medication use (antihistamines, NSAIDs, steroids and antidepressants)
* Patients predisposed to psychotic or psychopathic tendencies
* Patients with rheumatic diseases, blood diseases, diabetes mellitus
* Patients at cardiological risk of infective endocarditis
* Patients under antibiotic pressure
Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder

The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of patient factors such as age, weight, gender, origin, and smoking status on olanzapine pharmacokinetics in adolescents with schizophrenia or bipolar I disorder. This study will also assess the safety of olanzapine delivered orally.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 13 through 17 years of age (must not have reached their 18th birthday prior to Visit 1).
* Female patients must not be pregnant or nursing.
* Patient and patient's parent/authorized legal representative must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must have given informed consent.
* Patient must have a previously documented diagnosis of schizophrenia or bipolar I according to the DSM-IV-TR, and either confirmed previously by K-SADS-PL or be confirmed by K-SADS-PL at Visit 1.

Exclusion Criteria:

* Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or bipolar I disorder.
* Patients are not allowed into the study if they currently meet the criteria for the depressed phase of bipolar disorder or are diagnosed with Bipolar II Disorder.
CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

A randomized open-label, multiple dose, three-treatment, three-period, six-sequence, crossover study to investigate the pharmacokinetic drug interaction between Atorvastatin and Ezetimibe after oral administration in healthy volunteers

Outcome Measures

1. Primary endpoint AUCτ,ss, Cmax,ss of atorvastatin and free ezetimibe
2. Second endpoint 1) AUCinf,ss, Cavg,ss, %fluctuation, tmax,ss, t1/2, CL/Fss, Vd/Fss of atorvastatin and free ezetimibe 2) AUCτ,ss, AUCinf,ss, Cmax,ss, tmax,ss, t1/2, metabolic ratio of 2-hydroxy atorvastatin and free ezetimibe

Eligibility Criteria:
Inclusion Criteria:

1. Age Eligible for Study : 19 Years to 45 Years
2. If males, Body weight ≥ 55kg, If females, Body weight ≥ 50kg
3. BSA ≥ 18.5, \<25
4. Accepts healthy volunteers
5. If female, Negative for pregnancy test at the screening and pre dose of Day 1
6. The subjects who agree with performing contraception during the study
7. The subjects who agreed with written informed consent

Exclusion Criteria:

1. The subjects with impaired hepatic function, renal function, nervous system etc.
2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
3. The subjects with high blood pressure or low blood pressure (Systolic blood pressure\>150mmHg or \<90mmHg, Diastolic blood pressure\>100mmHg or \<50mmHg
4. The subjects with abnormal Laboratory test (AST, ALT\>1.25 fold of upper normal limit, Total bilirubin\>1.5 fold of upper normal limit, CPK\>2 fold of upper normal limit, Estimated Glomerular filtration rate\<60mL/min/1.73m2 by Modification of Diet in Renal disease formula
5. The subjects have drug abuse history within 1year or Positive for urine drug test at screening
6. The subjects who took prescription only medicine whch can be effected in metabolism of Investigational product within 14days
7. The subjects who took over the counter drug whch can be effected in metabolism of Investigational product within 7days
Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation

This is a randomized placebo-controlled trial studying the effects of intraoperative continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer undergoing lobectomy.

Pulmonary lobectomy induces an inflammatory response of this lung caused by intraoperative atelectasis and re-expansion. This inflammatory response can be attenuated with treatment, also decreasing postoperative pulmonary complications (PPC). Thus, avoiding complete atelectasis with partial insufflation of the lung during surgery could be useful to decrease inflammatory response and PPC.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-80 aged) with American Society of Anesthesiologists physical status I-III, scheduled to undergo elective thoracic surgery with lung resection performed through thoracotomy, and requiring OLV (one lung ventilation)during surgery.

Exclusion Criteria:

* Ongoing treatment with any dose of systemic or topical steroids, acute pulmonary or extrapulmonary infections (elevated C-reactive protein \[CRP\]), history of recurrent pneumothoraces, previous thoracic surgery.
User Evaluation of BGM JS200B

Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015


Eligibility Criteria:
Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015
Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.

Psoriasis is an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. There is a study showed that PEDF level is up-regulated in the sera of psoriasis patients.


Eligibility Criteria:
Inclusion Criteria:

Patients with psoriasis and group of age and sex-matched healthy volunteers will be included as a control group.

Exclusion Criteria:

* Pregnancy.
* Patients with other inflammatory skin disorders.
* Patients on antioxidants or anti-inflammatory drugs.
* Patients on topical or systemic treatment for psoriasis in the last 4 weeks prior to enrollment in the study.
* Patients on systemic retinoids (Acitretin).
* Obesity: body mass index (BMI ) \> 30.
* Malignancies e.g squamous cell carcinoma.
* Viral warts.
* Diabetes.
* Hypertension.
Ultrasound Achilles Tendon Assessment

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

Achilles Tendon pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. Many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing Achilles Tendon injuries by using a radiofrequency stimulus.

The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the Achilles Tendon will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

The stimulus will be carried out on the Achilles Tendon region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 years
* Sporty people with at least 3 days of training per week and presenting an upper limb dominance.

Exclusion Criteria:

* Suffer from any painful Achilles Tendon condition.
* History of significant Achilles Tendon trauma, such as fracture or ultrasonography Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.
Avoidance-driven Decision Making and Learning in Anorexia Nervosa and Bulimia Nervosa

The purpose of this study is to investigate areas of the brain responsible for avoidance learning in adults with eating disorders using brain imaging techniques, computer tasks, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 78 women with an eating disorder (26 with anorexia nervosa \[AN\], 26 with bulimia nervosa \[BN\]) and 26 healthy controls (HC) aged 18-39.

Aim 1: Evaluate behavioral differences in active and passive avoidance learning in eating disorders and associations with symptoms.

Aim 2: Evaluate whether corticostriatal and limbic-prefrontal fMRI BOLD response associated with avoidance learning differs in eating disorders relative to healthy controls and relates to symptoms.

Aim 3: Evaluate whether functional connectivity of avoidance learning neural circuity differs in eating disorders relative to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

Eating Disorder Group:

* Between the ages of 18 and 39 years old
* Meet DSM-V criteria for anorexia nervosa or bulimia nervosa

Healthy Controls:

* Between the ages of 18 and 39 years old
* Have maintained 85% to 120% ideal body weight since menarche

Exclusion Criteria:

* Psychotic illness/other mental illness requiring hospitalization
* Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
* Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* Neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness
* Any contraindication to undergoing an MRI
* Primary obsessive compulsive disorder or primary major depressive disorder

Additional Exclusion Criteria for ED Group:

* If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning

Additional Exclusion Criteria for Healthy Control Group:

* Meet criteria for the diagnosis of any psychiatric disorder currently
* Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
* Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months
Practice Experiences for School Reintegration

This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.

This study follows a multiphased optimization (MOST) research design; this clinical trial is considered to be a pilot optimization component of the MOST framework. For the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (N=5-6 per group). Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.

Eligibility Criteria:
Inclusion Criteria:

Adolescent Participants:

* current hospitalization for suicidal thoughts and behaviors
* ages 13-18
* expected return to school following discharge
* ability to speak, read, and understand English sufficiently to complete study procedures,
* consent of a parent/legal guardian (in English or Spanish; for minor participants)
* adolescent assent or consent (in English)
* clinician approval.

Hospital professionals:

* Works as a clinician at the hospital site who delivers treatment including CBT to hospitalized adolescents,
* Hospital professional consent (in English)
* consent of patient's parent/legal guardian (in English or Spanish; for minor participants)
* adolescent patient assent or consent (in English).

Exclusion Criteria:

Adolescent Participants

* evidence of active psychosis,
* evidence of intellectual disability
* Risk for Cyber-sickness (greater than or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire)
Diets, Lipoproteins and Inflammation Markers

Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810).

Aim:

To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass.

Design: Randomized crossover design


Eligibility Criteria:
Inclusion Criteria:

Patients with dyslipidemia (at least one of the following)

* TG ≥ 150 mg/dL
* TC ≥ 200 mg/dL
* LDL-c≥ 130 mg/dL,
* HDL-c \< 45 mg/dL for male or \< 55 mg/dL for female or receiving statin treatment

Exclusion Criteria (fulfill one of the following condition):

* chronic kidney disease
* history of coronary artery disease
* ischemic heart disease,
* heart failure,
* stroke,
* cancer of any type
Surgical Repair of Spigelian Hernia in a Cohort of Patients

Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure

The surgical treatment of Spigelian hernias is mainly carried out with prosthetic meshes made of biocompatible material. In prosthetic repair of abdominal protrusions, mesh fixation and overlap of the mesh are source of complications. To avoid these problems, for a fixation free repair of Spigelian hernias has been developed a tentacle shaped implant, that should also assure a broader defect overlap. This study should highlight in a cohort of patients the long-term results of fixation free repair of Spigelian hernias carried out with tentacle mesh.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Spigelian hernia

Exclusion Criteria:

* Patients not having Spigelian hernia,
Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes

The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France.

Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.

Only two hospitals in France can take care patients with TIA or MS in an outpatient setting :Bichat hospital in Paris and Toulouse University Hospital. The effectiveness of this management has been demonstrated since recurrence stroke risk is reduced by 80% at one year. An English study (EXPRESS study) \[2\] showed a gain of 624 pounds with an ambulatory management compared to a conventional one. No studies are available in France on this subject.

The aim of this study is to test the feasibility of a collection of medical and economic data on a prospective way. The investigators collect medical (Cerebrovascular events, Stroke) and economic (direct and indirect costs) data concerning patients who were managed in TIA clinic in Toulouse Hospital. The medical data will be compiled with available French and International literature. The economic data will be compiled with available data in PMSI and health insurance database. This study aims to prepare a multicenter cohort to compare the cost effectiveness ratio between ambulatory and conventional management.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in the TIA clinic in Toulouse Hospital (a day clinic)
* Having presented within the previous 7 days a transient ischemic attack or a minor stroke
* Affiliated to a social protection system
* To have given no opposition to participation in the study

Exclusion Criteria:

* Patients with a transient ischemic attack - mimic (such as migraine or seizure)
* Patients under protection of justice
* Pregnant and / or breastfeeding woman