cyrilzakka/clinical-trials huggingface dataset:
Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients

The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the duration on vasopressor treatment compared to a conventional protocol.

Background

Septic shock is a frequent and severe entity with a mortality of 55%. The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients.

For hemodynamic stabilization the SSC recommends as treatment goals a mean arterial blood pressure \> 65mmHg (MAP), a central venous blood pressure of 8-12 mmHg, a mixed venous oxygen saturation \>65%, a central venous oxygen saturation \> 70% and a diuresis \> 0.5 ml/kg/h (1). According to the SSC guidelines a MAP \> 65 mmHg should be aimed because at this blood pressure level tissue perfusion is preserved. This is based on a study in ten septic shock patients where norepinephrine was titrated to three levels (65, 75 and 85 mmHg) and the authors concluded that parameters of tissue perfusion did not differ between the each level (2).

Objective

To evaluate if a hemodynamic protocol guided by parameters of tissue perfusion could reduce the duration of vasopressor treatment in septic shock patients.

Methods

Patients suffering from septic shock requiring vasopressor support are randomly assigned to a control group (usual care) and an intervention group (tissue perfusion guided protocol). In the intervention group parameters of tissue perfusion are used to guide hemodynamic therapy.

Eligibility Criteria:
Inclusion Criteria:

* 2 or more SIRS criteria according to ACCP/SCCM definition
* Documented infection or strong suspicion of infection with adequate antibiotic treatment
* Shock according to ACCP/SCCM definition with the necessity of vasopressor treatment

Exclusion Criteria

* Patients admitted with central nervous diseases
* ST elevation myocardial infarction
* Pulmonary embolism
* Out of hospital cardiac arrest patients
* Patients with therapy limitations
* Known pregnancy
* Inclusion in other interventional trials
Vitamin D Replacement: The Effect on Statin-Related Myalgias

The purpose of this project is to determine if Vitamin D supplementation \[10,000 international units of cholecalciferol (vitamin D3) by mouth weekly\] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days)
* Patients aged 19-89 years old
* Men and women (not of childbearing potential)
* Patients receiving statins with concomitant ezetimibe

Exclusion Criteria:

* history of alcoholism or malnutrition
* receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels
Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants

Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \< 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \>60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action.

The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born \<27+0 weeks gestational age
* Permission given by the attending clinician to approach and then consent obtained from parents
* Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
* Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.

Exclusion Criteria:

* Chromosomal anomaly
* Pre-treatment renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 100 micromol/L
* Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L94
* Platelet count \<50,000 per microliter
* Permission denied by the attending clinician to approach parents
* Parental consent not available
* Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).
Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC

This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
4. Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
5. Has at least 1 measurable lesion per RECIST 1.1;
6. Patients with ECOG score of 0-1;
7. Life expectancy ≥12 weeks;
8. Have adequate organ function;
9. Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.

Exclusion Criteria:

1. Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
2. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
4. Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
5. Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
6. Has a history of a second malignancy;
7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
8. Subjects with active pulmonary tuberculosis infection；
9. Serious infection before the first dose；
10. Uncontrolled cardiac diseases or symptoms;
11. Arterial/venous thrombosis events occurred before the first dose；
12. Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
13. Has a history of active chronic enteritis;
14. Has a history of bleeding prior to the initiation of the study treatment;
15. History of immunodeficiency disease or organ transplant;
16. Subjects with active hepatitis B or active hepatitis C;
17. Has unresolved toxicities from previous anticancer therapy;
18. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
19. Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?

This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or non-BFR group. Both groups will do the same training program: 1) first sitting unilateral knee extension and standing unilateral knee curls (w/ or w/o BFR; 4 sets, 30/15/15/15 reps) and 2) scaption and sidelying external rotation (no BFR for either group; 3 sets x 15 reps each).

This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or a non-BFR group. Both groups will perform the same training program 2 times a week over 8 weeks with one group performing the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant leg).

Prior to starting the study the subjects will have their strength assessed by a blinded physical therapist using a hand held dynamometer. The muscles assessed will be the: quadriceps, the hamstrings, the supraspinatus, and the external rotators of the shoulder. Another blinded physical therapist will assess the cross-sectional area of the quadriceps and the supraspinatus tendon using ultrasonography. These tests will be repeated at the conclusion of the study.

Subjects' training weight will be 30% of their 1 repetition max (1RM). 1RM will be determined using hand held dumbbells for the shoulder exercises and machines (knee extension, knee curl machines) for the lower extremity exercises.

Subjects will be randomized to either the BFR or non-BFR group. Subjects in the BFR group will perform the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant lower extremity). Both groups will perform 4 sets of each lower extremity exercise for 30/15/15/15 reps. After completing the lower extremity exercises the subjects will perform the shoulder exercises (scaption, sidelying external rotation) for 3 sets of 15 repetitions each. The shoulder exercises will not be performed with BFR in either group.

Eligibility Criteria:
Inclusion Criteria:

• Male or female subjects aged 18 and over

Exclusion Criteria:

* Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology;
* Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period;
* Current lower extremity injury and/or having had a lower extremity surgery during the prior 6-month time period;
* Cervical/thoracic spine surgery during the prior 1-year;
* Subject having 1 or more contraindications for BFR training;
* Under the age of 18 years.
Resilience Training for Work-related Stress in Employees and the Influence of the Lecture Format on Training Success

A study to analyze the psychophysiological effects of a preventative, 4-week resilience training with mobile heart rate variability biofeedback (HRV-BfB) in a workplace setting and the influence of the lecture format (digital vs. live) on the training success.

This was a three-arm, non-randomized, controlled trial to examine the effects of a preventative, 4-week resilience training with mobile HRV-BfB on work-related stress in white-collar employees. Participants were asked to exercise autonomously three times per day for five minutes with the mobile HRV-BfB device. They additionally attended three lectures at the beginning of the first, third, and forth week. The aim of the lectures was to mediate a theoretical knowledge and to prepare the participants for the autonomous training. To examine the potential influence of the lecture format, one group attended live lectures (blended learning condition) and one group received access to online lectures (e-learning condition). Results of study's outcome measures were compared with a waitlist control group. Outcome measures were assessed at baseline (T0), after the 4-week intervention (T1), and at 4-week follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Employees of the company at which the study is conducted

Exclusion Criteria:

* Implanted pacemaker
* Medically diagnosed heart failure or arrhythmia
* Medically prescribed cardiac drugs (e.g., beta-blockers, diuretics, ACE inhibitors, calcium channel blockers, or antiarrhythmic agents)
Ready to Use Supplementary Food in Moderate Childhood Malnutrition

Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.

The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.

Compare the longer term effect on nutritional status and morbidity (relapse?).


Eligibility Criteria:
Inclusion Criteria:

* all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
* WHM between 70-79% (1977 NCHS/WHO standard) without edema
* approval from the caretaker

Exclusion Criteria:

* presence of the following signs: bilateral edema, MUAC\<110 mm , WHM\< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
* refusal to participate from caretaker
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)

The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.

NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures. Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100 low dose, NT100 high dose, or placebo, qd for up to 4 weeks.

Screening will include a standard IVF stimulation protocol, followed by fertilization and culture of embryos. If the subject remains eligible, she will be randomized to receive study drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10 of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to assess subsequent pregnancy, delivery, and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal female 21-38 years of age at screening
* History of repeated IVF failures despite transfer of good-quality embryos, defined as follows:
* ...1) 3 or more IVF cycles involving transfer of at least two good-quality cleavage-stage embryos or at least one good-quality blastocyst (2010 SART (Society for Assisted Reproductive Technologies) grading criteria)that resulted in one of the following outcomes:
* \* .....a) no pregnancy
* \* .....b) biochemical pregnancy
* \* .....c) spontaneous abortion of an intrauterine clinical pregnancy before or equal to completed Week 8 of gestation
* ...2) At least two of the eligible IVF failures must have involved transfer of fresh embryos
* ...3) At least two of the eligible IVF failures must have involved retrieval of at least 5 oocytes
* ...4) No live birth, abortion later than Week 8 of gestation, or stillbirth may have occurred since the first of these IVF failures
* Body mass index (BMI) of 19-38 kg per m2 at screening
* TSH (thyroid-stimulating hormone) less than or equal to 4.0 mIU/L(milli-International units per Liter) for subjects with no history of hypothyroidism, or TSH less than or equal to 2.5 mIU/L for subjects with a history of hypothyroidism, at screening

Exclusion Criteria:

* Prior diagnosis of moderate or severe ovarian hyperstimulation syndrome (OHSS)
* Clinically confirmed polycystic ovary syndrome (PCOS)
* History of a major congenital anomaly in the subject, her current male partner, or first degree relative of either the subject or her current male partner
* Known karyotype abnormalities in either the subject or her current male partner / sperm donor
* Any prior pregnancy terminated for a fetal medical condition
* History of severe (stage IV) endometriosis
* Current or past systemic autoimmune disease
* Any uncontrolled clinically significant medical condition (e.g. asthma, Type II diabetes, infection)
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis

Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-55
2. Patients of both genders with Multiple Sclerosis (McDonald criteria 2010)
3. No relapses 28 days before randomisation
4. Expanded Disability Status Scale score 0-5,5

Exclusion Criteria

1. Primary or secondary progression of Multiple Sclerosis
2. Expanded Disability Status Scale score more then 5,5
3. Severe depression, suicide ideas and/or attempts
4. Systemic corticosteroid application in 30 days before randomisation
Comparative Effects of Virtual Reality and Vestibular Exercises on Balance Gait in Older Adults

To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.

It will be a randomized clinical trial where non-probability convenience sampling technique will be used. Total 44 participants will be taken aged 60 to 85 years. All Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment. The Berg Balance Scale for balance assessment, Dynamic Gait Index for gait while Time Up and Go Test, and Modified Barthel Index for Activities of Daily Living will be outcome measure tools.

Eligibility Criteria:
Inclusion Criteria:

* Older adults with or without any assistive device.
* Participants with a Mini-Mental State Examination score greater than 24.
* Participants with a value greater than 10 secs on the Time Up and Go Test.

Exclusion Criteria:

* Severe visual or vestibular impairments (e.g., Meniere's disease, labyrinthitis).
* Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
* Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
* History of epilepsy or seizures.
Obstetrical Outcomes for Planned Deliveries in a French Birth Center

The main objective of this work is to study the obstetrical and neonatal outcomes of women who planned to deliver in the birth centre of Nancy.

The birth centre of Nancy is one of the nine french birth centres opened since 2015 on an experimental basis.

The women who plan to deliver at the birth centre must meet several conditions according to their medical history, pregnancy follow-up, and delivery progress.

The women can be transferred before, during or after (pre-, per- or post-) delivery to the hospital.


Eligibility Criteria:
Inclusion Criteria:

* women who want to deliver at the birth center "Un nid pour naître"

Exclusion Criteria:

* Refusal to participate in the study.
Retinyl Palmitate-loaded Ethosomes in Acne Vulgaris

Acne is a chronic inflammatory dermatosis of the pilosebaceous unit. Topical treatment is the first choice in mild and moderate cases of acne, especially topical retinoids. Although topical retinoids are very effective in the treatment of acne, local cutaneous irritation including burning, itching, erythema, peeling or dryness, is observed in a considerable number of patients, resulting in low patient compliance, compromising the efficacy of the therapy.

Several approaches have been proposed to address these concerns, including the use of esters of retinoic acid (RA) and RA precursors, such as retinol and retinaldehyde, or novel drug delivery systems, which present the potential for controlled release, in turn reducing the aforementioned occurrences.

Encapsulation of retinoids into vesicular carriers as liposomes and ethosomes and nanoparticulate carriers can significantly improve their effects for the treatment of acne compared with commercial formulations , providing better tolerability of irritating retinoid.

The aim of work is to assess the efficacy and tolerability of the topical application of Retinyl Palmitate-loaded ethosome formulation in the treatment of acne vulgaris in comparison to conventional formulation of classic retinoids


Eligibility Criteria:
Inclusion Criteria:

* Patients with facial mild to moderate acne vulgaris
* Patients aged 12-40 years old

Exclusion Criteria:

* Pregnant females
* Patients with skin condition of the face such as rosacea, perioral dermatitis, atopic or seborrheic dermatitis or psoriasis.
* Patients with known hypersensitivity to preparations containing retinoid.
* Patients who take any other cocomitant systemic or topical medications for acne vulgaris