cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Severe Kidney Disease

This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;

   Participants with normal renal function only:
3. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
4. Glomerular filtration rate (GFR)≥ 90 mL/min
5. Age, BMI, and sex comparable to those of subjects of severe renal impairment

   Participants with severe renal impairment only:
6. Diagnosis of CKD at least 3 months
7. glomerular filtration rate (GFR)\< 60 mL/min/1.73 m2

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
2. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
3. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
4. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks

   Participants with severe renal impairment only:
5. Participants with acute renal failure, or a kidney transplant history; Or requiring renal dialysis during the study period;
6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm)
7. New York heart association (NYHA) class III or IV congestive heart failure
8. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \> 1.5×ULN;
Study on Fluids Associated to Lung Cancer

The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).

This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.

The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.


Eligibility Criteria:
Inclusion Criterias :

* Patients with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery (Group 1).
* Patients with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies (Group 2).
* Control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco (Group 3).
* Adults patients : over 18 years.
* Persons affiliated to national social security.
* Free signed consent.

Exclusion Criterias :

* Persons referred to in articles L1121-5 to L1121-8 of CSP ( protected people) : pregnants, parturients or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under legal protection.
Exercise Training in Patients With Pulmonary Arterial Hypertension

In this study, the effects of kettlebell exercise training on functional capacity, dyspnea and activities of daily living in patients diagnosed with Pulmonary Arterial Hypertension (PAH) will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pulmonary arterial hypertension (PAH) by a specialist physician in accordance with the 2015 guideline for the treatment and diagnosis of pulmonary hypertension of the European Heart and Respiratory Societies (ERS/ESC),
* Patients with stable pharmacological treatment,
* Patients clinically stable at least last three months.

Exclusion Criteria:

* Presence of orthopedic or neurological problems that will affect functional tests and muscle strength measurement,
* Recent surgical procedures,
* Recent syncope,
* Pregnancy,
* Presence of severe left heart failure,
* Presence of severe ischemic heart disease,
* Hypertensive patients,
* Patients who have problems in communicating.
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 18 - 85 years of age.
2. Signed and dated informed consent document.
3. Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
4. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
5. Requires a minimum of 3 days of IV therapy.
6. Patient willing and able to comply with study procedures.

Exclusion Criteria:

Patients presenting with any of the following:

1. A contra-indication to any required study drug.
2. Pregnant or nursing females.
3. Sustained shock.
4. Participation in another study of an investigational drug or device within 30 days.
5. Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
6. Infection due to a dalbavancin or vancomycin-resistant organism.
7. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
8. Exclusively gram-negative bacterial or a fungal ABSSSI.
9. Venous catheter infection.
10. Infection of a diabetic foot ulcer or a decubitus ulcer.
11. Device-related infections.
12. Gram-negative bacteremia.
13. Infected burns.
14. Infected limb with critical ischemia.
15. Superficial/simple skin and skin structure infections.
16. Concomitant condition requiring non-study antibacterial therapy.
17. ABSSSI requiring therapy for longer than 14 days.
18. Adjunctive therapy with hyperbaric oxygen.
19. More than 2 surgical interventions for ABSSSI anticipated.
20. Chronic inflammatory condition precluding assessment of clinical response.
21. Absolute neutrophil count \< 500 cells/mm3.
22. Human immunodeficiency virus (HIV) infection with a CD4 cell count \< 200 cells/mm3.
23. Recent bone marrow transplant, \> 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
24. Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
25. Life expectancy less than 3 months.
26. Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
27. Prior participation in the study.
Effect of Kinesio Taping in Muscle Fatigue

The aim of this study was to determine the effect of Kinesio taping on lactic acid in an running anaerobic test.


Eligibility Criteria:
Inclusion Criteria:

* They should practice physical activity 2-4 days a week.

Exclusion Criteria:

* History of surgery in the lower limbs
* Muscle-tendon injury or trauma in the lower limbs (LL) in the last six months
* cardiovascular and / or respiratorydisease
* Any allergies related to the bandage material.
Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol

The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.

"Vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with the subjective symptoms of "vulvovaginal dryness" with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VAS value "Overall impairment of daily life due to the condition "vulvovaginal dryness" \> 0 on Visit 1.
* Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1.
* Physical and mental healthy women as assessed by the medical history.
* PAP test performed within the last 12 months before Visit 1 and result less than PAP III.
* Signed written informed consent before participation in the Trial.
* Willingness to actively participate in the trial and to come to the scheduled visits.

Exclusion Criteria:

* Known hypersensitivity against any of the ingredients of the test products.
* Any indication in the medical history regarding an impairment of the hepatic, renal, gastrointestinal, cardiovascular, pulmonary, endocrinological or hematological system (especially venous and arterial thromboembolism, ischemic stroke, myocardial infarction, porphyria) if clinically relevant for this clinical trial (cf. contraindications and warnings for Estriol cream 0.1%).
* Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency).
* Breast cancer (acute and / or in the medical history or suspected).
* Estrogen-dependent tumor (acute and / or in the medical history or suspected, especially ovarian and / or endometrial carcinoma).
* Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (inter alia anti-estrogens) within 3 months before Visit 1 and / or during the conduct of this trial.
* Intrauterine device (IUD) with progestogen (Mirena®, Jaydess®)
* Pathological findings in cancer screening (Papanicolaou III, III D - V in the cervical test)
* Pathological changes in the vaginal or cervix area, which are caused by estrogen deficiency (except symptoms and condition of "vulvovaginal dryness"), e.g. diminution of labia caused by estrogen deficiency, constricted introitus.
* Patients with known infectious diseases (e.g. hepatitis or HIV infection).
Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist

The aim of this study is to investigate the use neurally adjusted ventilatory assist (NAVA) as lung protective strategy in patients with acute respiratory distress syndrome (ARDS).

Background： Acute respiratory distress syndrome (ARDS) should ventilated with a tidal volume of 4-6 ml/kg according to the ARDSnet recommendations. Due to the lack of clinical evidence of the potential role of neurally adjusted ventilatory assist (NAVA) in ARDS, investigators would like to conduct a study comparing the two modes from a lung protective point of view. Investigators believe it may have a great value in defining guidelines for improved lung protection.

Study Design： This is a prospective, pilot-randomized controlled trial n a single intensive care unit from one hospital. The study is expected to close the case a year (2018.08.01-2019.07.31).

Methods： Fifty patients with ARDS according to the Berlin Definition will enroll to this study. Patients are randomized after fulfilling inclusion and none of the exclusion criteria (25 participants will divide into study group and the other 25 participants will be control group). Patients are studied twice daily with collection of data and blood tests. All data are collected and analysis.

Effect： Tidal volumes in ARDS patients ventilated with NAVA will show tidal volumes clearly within the safe range. ARDS patients on NAVA mode will show improvements in oxygenation, gas distribution and inflammatory markers while requiring less sedatives and hemodynamic support.

Key words： Acute respiratory distress syndrome; neurally adjusted ventilatory assist; lung protective strategy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ARDS by Berlin definition
* P/F ratio between 100-300
* Completed the case enrollement within 48 hours

Exclusion Criteria:

* Less than 18 years old
* Pregnancy
* Participants with tracheostomy
* Unable to insert the NG-tube
Outcomes of Different Surgical Procedures After High Level Resection for Patients With Small Intestinal Gangrene

In this cohort study, aim to evaluate and compare short-term postoperative outcomes of different surgical procedures for patients with intestinal gangrene who underwent high level small bowel resection (\< 150 cm from DJ).

Patients with intestinal gangrene have a high mortality rate depending on etiology, degree, and length of an ischemic part, associated comorbidity, and time between the onset of symptoms and final diagnosis. This overall mortality ranges from 50 to 80%. When intestinal gangrene is evident or suspected, surgical laparotomy is mandatory, where the affected segment is resected, and the remaining part is either anastomosed or diverted on the anterior abdominal wall as stoma.

Small bowel anastomoses performed in the emergency settings have a high risk of anastomotic leakage. The leak rate in these settings may reach 35% . Intestinal gangrene is usually associated with peritonitis and sepsis. The performance of ostomy or intestinal anastomosis in cases of peritonitis or sepsis is a controversial theme. This controversy increases when proximal small bowel is involved .

Stomas avoid the risks of anastomotic leakage and re-operation and permit close examination of the bowel by inspection. However, creating stoma after proximal level of resection is associated with catastrophic sequels of high output fistula and short bowel syndrome. Hence, most of the time the risk of a high jejunal anastomosis dehiscence is preferred to the metabolic complications associated with ostomy .

A jejunostomy was defined as having less than 200 cm of proximal remaining small bowel. Since most nutrients are absorbed within the first 100-150 cm of the jejunum, the severity of short bowel syndrome and dependence on TPN is markedly increased if a jejunostomy is created at less than 150 cm from DJ . Distal refeeding of chyme "re-feeding enteroclysis", by reinfusing the chyme collected from the proximal stoma into the downstream small bowel through the distal stoma, was used by some surgeons to alleviate the complications of jejunostomy before re-establishment of digestive continuity . However, this procedure can be technically demanding. On the other hand, some authors prefer to use prophylactic tube enterostomy with primary anastomosis in cases of high risk of anastomotic leak .

The choice between these surgical technical varieties depends upon general health status of the patient, and local abdominal factors e.g. presence of peritoneal contamination, but mostly depends on surgeons' experience.

Eligibility Criteria:
Inclusion Criteria:

* 1) Distance of proximal resection margin less than 150 cm from DJ. 2) Mesenteric vascular ischemia. 3) Strangulating obstruction e.g. due to hernia, volvulus, band, etc.

Exclusion Criteria:

* 1) Patients less than 18 years. 2) Patients with malignant disease. 3) Patients with almost all small bowel loops resected (\< 60 cm remaining).
Project EAT: Eating and Attitudes in Teens

Research suggests there is a connection between mood and weight. People who feel stressed or depressed are more likely to be overweight than people who don't have these feelings. Some individuals turn to food to cope, which can lead to gaining too much weight over time. Adolescence is an important time to understand these connections. Patterns of handling stress learned during adolescence set the stage for stress management in adulthood. This study is a randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic obesity. The investigators will test if taking part in a 6-week group program to lower stress and improve mood will be helpful to teens at-risk.


Eligibility Criteria:
Inclusion Criteria:

* Age 12-17 years
* At-risk for long-term obesity by virtue of current BMI (≥70th percentile for age and sex) or obesity (BMI ≥30 kg/m2) in both biological parents
* Good general health

Exclusion Criteria:

* Current full-syndrome psychiatric disorder that in the investigators' opinion would impede study compliance
* Major medical problem such as type 2 diabetes
* Use of medication affecting mood or body weight such as stimulants or anti-depressants
* Any medical issues that could be acutely worsened by exercise such as asthma or musculoskeletal problems.
* Pregnancy in females
Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block

The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical health status I-II
* patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
* patient is planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
* patient is scheduled for fast track protocol
* patient plans to be available fot follow-up through one year post-operative
* written informed consent

Exclusion Criteria:

* any contra-indication for locoregional anesthesia
* any contra-indication for spinal anesthesia
* traumatic osteoarthritis requiring TKA
* an active, local infection or systemic infection
* known hypersensitivity to amide-type local anesthetics
* known intolerance or contraindication for opioids, nonsteroidal antiinflammatory drugs (NSAIDs) or paracetamol
* a Body Mass Index \> 40 kg/m2
* inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
* scheduled for contralateral TKA within one year postoperative
* scheduled for another operation within 3 months postoperative
* physical, emotional or neurological conditions that would compromize compliance with postoperative rehabilitation and follow-up
* chronic opioid analgesic therapy
* chronic gabapentin or pregabalin analgesic therapy
* rheumatoid arthritis
An Integrative Approach to Improve Child Outcomes Through Research-based Parent and Teacher Interventions

The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a teacher training program, will have an effect on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills. The interventions are designed to specifically target parent use of a responsive, stimulating caregiving style in the home in combination with teacher instructional practices and the use of a responsive interactive style in the classroom.


Eligibility Criteria:
Inclusion Criteria:

* Given that the target population includes EHS agencies, low-income children speaking English and/or Spanish will be eligible for participation.
* In some cases, children with mild delays (e.g., receiving speech therapy services) can participate.

Exclusion Criteria:

* Children with significant developmental disabilities (e.g., intellectual disabilities, significant sensory impairments, and children diagnosed with moderately severe forms of Autism Spectrum Disorders) will not be consented for assessments as the interventions are not specialized to meet the needs of these children.
* Children primarily speaking a language other than Spanish or English will be excluded due to the fact that appropriate assessment procedures are lacking.
* In terms of exclusionary criteria for teachers, those that are participating in other research studies, or who have recently completed other similar studies, will not be recruited.
Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic

This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.

Question 1: Can 30 days of daily use of a mindfulness app during the Covid-19 pandemic reduce anxiety and improve general well-being and future outlook? Outcomes measured: Pre- and post-intervention surveys to assess well-being and anxiety (primary outcomes), future outlook, hopefulness, and sleep habits (secondary outcomes). Many of these survey questions come from well-validated surveys (WHO-5 Well-being survey, GAD7 Anxiety survey). Post intervention surveys will be administered at the end of the 30d intervention, as well as 2 months after the completion of the 30d intervention.

Question 2: Can 30 days of daily use of a mindfulness app during the Covid-19 pandemic improve nutritional habits? Outcomes measured: Pre- and post-intervention surveys to assess general nutrition habits, including frequency of consuming whole foods (fruits, vegetables, whole grains) and frequency of consuming prepared meals (secondary outcomes). Post intervention surveys will be administered at the end of the 30d intervention, as well as 2 months after the completion of the 30d intervention.

Question 3: Will study participants be more likely to continue to use the mindfulness app after completion of the study? Outcomes measured: Post-intervention survey administered at the end of the 30d intervention will be used to assess likelihood to continue using app and frequency of anticipated continued use. The post-intervention survey administered 2 months after the completion of the 30d intervention will ask if participants continued to use the app, and the frequency of use (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 or older. Inclusion criteria are access to a smartphone and ability to download the mindfulness app, fluency in English, and the ability to complete surveys independently.

Exclusion Criteria:

* Exclusion criteria include current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent them from participating.