cyrilzakka/clinical-trials huggingface dataset:
Echo vs. EGDT in Severe Sepsis and Septic Shock

Echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). Early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use.

Our study goals/objectives are as follows:

1. To conduct an unblinded, two-group randomized controlled clinical trial to compare an echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy (EGDT) protocol in patients with severe sepsis or septic shock.
2. Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and other non-invasive assessments of cardiac output will result in more rapid resolution of septic shock compared to invasive EGDT.
3. Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Suspected infection
* Two or more systemic inflammatory response syndrome (SIRS) criteria

  * White blood cell count less than 4,000 per mm3, greater than 12,000 per mm3, or differential with greater than 10% immature forms
  * Heart rate greater than 90 beats per minute
  * Respiratory rate greater than 20 breaths per minute or paCO2 less than 32 mmHg
  * Temperature less than 36°C or greater than 38°C
* Evidence of refractory hypoperfusion attributed to sepsis (one or more of the following):

  * Systolic blood pressure less than 90 mmHg despite an intravenous fluid challenge of at least 30ml/kg (a portion of this may be albumin equivalent)
  * Blood lactate level at least 4 mmol/L.
* Intention to place an arterial catheter.
* Intention to place a central venous catheter.

Exclusion criteria:

* Known pregnancy
* Requirement for immediate surgery
* Hypotension attributed to alternative cause
* Treating physician deems the patient is moribund
* Treating physician deems aggressive care is unsuitable
* Contraindication to central venous catheterization or arterial catheterization
* Advanced directives restricting implementation of the protocol
* Significant pathology of the chest or abdominal wall that would make transthoracic echocardiography impossible (burns, chest trauma, etc.)
* Children under the age of 18 will not be included in this study
Longitudinal Follow-up of Male Soccer Players Prone to Developing CAM Hip Deformity

Femoroacetabular impingement (FAI) is a clinical problem in which abnormal contact occurs between the thighbone and the hip socket. In intensive, mostly still young, male athletes, this problem seems to be related to a bony deformity on the head of this thighbone, a so-called CAM. FAI itself gives rise to pain symptoms, but in time can even lead to premature osteoarthritis. However, the cause of a CAM deformity itself, nor how FAI then arises, is insufficiently known. In view of FAI prevention and its better treatment, this project thus tries to better understand the underlying mechanisms. For this purpose, we will combine detailed biomechanical evaluations of specific movement patterns with advanced medical imaging and state of the art clinical evaluations to longitudinally follow up a group with a known high risk of developing a CAM deformity, being young male elite soccer players. Findings within this study will be additionally compared with similar analyses performed in patients with FAI. This research aims to thus form a basis to define novel (sports-specific) training schemes for the prevention of FAI, but also to define the actual treatment and rehabilitation plans in more patient-specific and a better-informed way.

This is a longitudinal follow-up study in which subjects are invited for data collection twice, the baseline time-point and the two years time-point.

Population:

12-16 years old male soccer players (40 elite level players , and 40 recreational level players)

In both data collection time-points the following measurements are preformed:

1. Clinical screening of hip joint
2. Radial MRI of bilateral hips
3. Biplanar and conventional x-ray Imaging of hip and pelvic region
4. Athlete-specific 3D motion analysis
5. Questionnaires on injury history and physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

* For the the Elite Group: Playing soccer at high level and training for more that 10 hours a week
* For the Control group: Playing soccer or any other sport recreationally for a less than 5 hours a week

Exclusion Criteria:

* No prior history of major trauma or injury to the lower limbs and spine
* No prior history of neurological conditions that can effect movement and mobility
Age and Gender Effects on the Pharmacokinetics of BAY85-3934

Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.


Eligibility Criteria:
Inclusion Criteria:

* No diagnosis of any specific disease or condition
* Subjects are expected to be in good general health for their respective age range
* Male or female gender
* Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive)
* Racial group: Caucasian

Exclusion Criteria:

* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease.
* Clinically relevant findings in the physical examination
Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients

The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction)
* Having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. Previous gastrectomy, neoadjuvant and adjuvant therapy received \> 6 months ago are acceptable
* Having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position

Exclusion Criteria:

* A history of poorly controlled hypertension or resting BP \> 150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy or patients who are requiring maximal doses of calcium channel blockers to stabilize BP
* Significant Haemorrhage (\> 30 ml bleeding/episode in previous 3 months) or haemoptysis (\> 5 ml fresh blood in previous 4 weeks)
* Arterial thromboembolic event (including ischemic attack) in the previous 12 months
BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment

In this study patients presenting to the pediatric ER with abdominal or pelvic complaints will be randomized to urethral bladder catheter or bladder ultrasound to compare time to completion of successful pelvic ultrasound, as determined by full visualization of uterus and ovaries.

In this study, we will enroll female pediatric emergency department (ED) patients presenting with a diagnosis of abdominal pain who may have a transabdominal pelvic ultrasound ordered by their treating physician (or nurse practitioner). In order to maximize the visualization of organs deep within the pelvis such as the ovaries and uterus, the patient's bladder must be full. The current practice at our institution, as well as numerous others, is to have a bladder catheter placed immediately when a transabdominal pelvic ultrasound is ordered, and then to fill the bladder in a retrograde manner in order to provide enhanced visualization of the pelvic structures. The process of inserting a bladder catheter into a pediatric patient is an invasive procedure which can be traumatic and painful to the patient. Additionally, if the patient's bladder is already full, this procedure may be unnecessary.

In this study, a point-of-care bladder ultrasound will be performed, upon enrollment of a patient by a study bedside sonographer (our pediatric emergency department nurse practitioners), to assess degree of bladder fullness. This measurement will then be repeated serially while the patient is receiving hydration and the ultrasound will be performed when the bladder is full. We hypothesize that this work flow will result in an equivalent time to transabdominal pelvic ultrasound completion and will reduce the number of potentially traumatic and painful, invasive urethral bladder catheterizations.

Eligibility Criteria:
Inclusion Criteria:

* Age 8yr-18yrs
* Female
* Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
* No history of pelvic or bladder reconstructive surgery

Exclusion Criteria:

* Pregnancy (known)
* Critically ill patients
* Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
* Chronic renal disease
* Patients presenting outside the defined treatment windows
The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection.

The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix.


Eligibility Criteria:
Inclusion Criteria:

* HR-HPV DNA test positivity

Exclusion Criteria:

* No HSIL
This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep

Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.

Participants will spend nights sleeping in the residential module of the Well Living Lab. Participants will cross over from normal sheets to hygro cotton sheets to assess impact of different sheet types on microclimate (e.g. temperature) and the impact on sleep quality.

Eligibility Criteria:
Inclusion Criteria. Premenopausal women Age 21-45

Exclusion Criteria History of sleep disorders
COVID-19 in Liver Transplant Recipients

Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

Coronavirus Disease 2019 (COVID-19) is a novel viral disease caused by the SARS-Cov-2 infection with a particular predominance of upper and lower respiratory tract symptoms. First diagnosed in China in late 2019, the virus has progressed to a state of pandemia, involving Spain with a important outbreak.

While the outcomes of viral infections in solid organ transplant (SOT) recipients tend to be worse than those from the general population due to chronic immunosuppression, there is little information on the incidence and outcomes of COVID-19 in liver transplant (LT) recipients. LT recipients are usually under less immunosuppression than other SOT and the clinical expression and outcomes of COVID-19 may be different to the reported outcomes in other SOT.

The Spanish Society of Liver Transplantation, which includes 25 LT programs, has promoted a nationwide registry for LT with COVID-19 to help ascertain the incidence and outcomes and help evidence-based management .

Eligibility Criteria:
Inclusion Criteria:

* Liver Transplant recipient
* Confirmed (PCR positive) SARS-Cov-2 infection
* Informed Consent
Evaluation of Plasma Catecholamine Concentration During Surgery

Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients.

Hypothesis: Resection of pheochromocytomas can lead to more than normal stress in surgeons and because of abrupt hemodynamic changes in patients as well in anesthesiologists. Measurements of catecholamine concentrations at baseline, prior to surgery during and after surgery, are to be performed to test this hypothesis.

Eligibility Criteria:
Inclusion Criteria: Patients with pheochromocytoma (Older than 18 years) -

Exclusion Criteria: Patients younger than 18 years. Conservative treatment.

-
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
* Diagnosis of macular edema associated with non-infectious uveitis (NIU)
* Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
* BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

Exclusion Criteria:

* Evidence of active or latent syphilis infection
* Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
* Serious acute or chronic medical or psychiatric illness
* History of major ocular and non-ocular surgical procedures
* Uncontrolled IOP or glaucoma or chronic hypotony
* Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
* Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
* Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
* Topical corticosteroids and/or topical NSAID \> 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
* Diagnosis of macular edema due to any cause other than NIU
* Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Impact of Sensory, Motor and Vestibular Deficit on the Postural Stability of CMT Patients

Charcot-Marie-Tooth (CMT), a therapeutically orphan neuromuscular disease affecting one in 2,500 people, represents a challenge to the medical and scientific communities. Physiotherapeutic-rehabilitative strategies play a crucial role in the management of CMT, particularly addressing balance impairment, a key disabling symptom. However, clinical studies in this field are limited. Our study aims to investigate the impact of strengh and somatosensory deficits on static and dynamic balance in CMT patients. The Investigators also aim to explore the involvement of the vestibular system and its correlation with postural instability. Furthermore, the Investigators seek to evaluate relationships between neurochemical biomarkers offering valuable insights for future targeted clinical studies.

A total of 60 patients will be recruited. To ensure adequate representation of the subgroups of interest, 10 patients with CMT1A (PMP22 gene duplication) and 10 patients with CMT2, regardless of their genotype, will be included. Additionally, three control groups, each comprising 10 subjects, will be included. The first group will consist of patients with motor symptoms, including those with hereditary motor neuropathy (HMN, 10 patients) or distal myopathy (MD, 10 patients). The second group will include patients with solely sensory symptoms, genetic neuropathies, or purely sensory acquired neuropathies such as HSN and neuropathies from anti-MAG antibodies. Finally, the third group will be composed of 10 healthy subjects. Each control subject will have comparable level of disability (motor or somatosensory), age, and gender to the enrolled CMT patients.

All participants must meet the following inclusion criteria to take part in the study:

* Age 18 years or older
* Subject has documented diagnosis of one of the following diseases (except from healthy controls):

  * Hereditary sensory-motor neuropathy (CMT) confirmed by genetic analysis
  * Hereditary motor neuropathy (HMN) confirmed by genetic analysis
  * Hereditary sensory neuropathy (HSN) confirmed by genetic analysis
  * Hereditary distal myopathy (MD) confirmed by genetic analysis
  * Acquired sensory neuropathy: anti-MAG antibody neuropathy confirmed by neurophysiological, clinical and serological assessment.

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

* Inability to maintain an upright position without assistance
* Presence of systemic, neurological (except for the neuropathies and hereditary myopathies under study), psychiatric, orthopedic or rheumatological diseases that may affect evaluation
* Mini Mental State Examination (MMSE)14 score less than 28
* History of alcohol or substance abuse
* Partecipation in intensive motor rehabilitation programs in the last three months.

Eligibility Criteria:
Inclusion Criteria:

* CMT or HMN or sensory neuropathy or distal myopathy

Exclusion Criteria:

* unable to stand
* other neurological, psychiatric, or orthopedic disorders
* MMSE \<28
* alcohol abuse
* intensive rehabilitation program
Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns (Open ARSB Study)

The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a relaxing video intervention for appearance concerns.

Description: Appearance-related safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of appearance-related safety behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. The daily reminder will include the following language: "Hi! This is a friendly reminder to avoid using your checklist behaviors. Please tap the link below to access today's checklist: \[link to checklist\]." Text messages will be delivered using EZtexting a text messaging platform used for research and marketing. Note that no identifying information will be included in this platform. Each participants phone number will be accompanied with a anonymized ID code. Individuals randomly assigned to the relaxing video condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to close their eyes and focus their attention on the present moment while listening to relaxing piano music and songbirds.

Eligibility Criteria:
Inclusion Criteria:

* Seeking treatment for appearance concerns

Exclusion Criteria:

* Currently receiving treatment (therapy, counseling, etc.) for anxiety, depression, eating disorder, or body image/appearance concerns
* If applicable, unstable psychiatric medication usage any time over the past 4 weeks
Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We will assess the effects of exercise training on coronary endothelial function, vascular structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression of diabetes candidate genes.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* preserved left ventricular function (left ventricular ejection fraction ≥ 50%)
* a physical work capacity ≥ 50 W
* at least one significant coronary stenosis \> 50%, whereas either the left anterior descending (LAD) or circumflex artery (RCX) has to be free from disease or stenoses ≤ 25% for the assessment of intracoronary flow measurements

Exclusion Criteria:

* diseases further affecting endothelial function
* untreated hypertension (systolic blood pressure \> 160 mm Hg or a diastolic blood pressure of \> 90 mm Hg)
* cigarette smoking during the previous six months
* LDL-cholesterol \> 4.3 mmol/l
* ventricular tachyarrhythmias
* chronic obstructive pulmonary disease
* severe renal or hepatic dysfunction
* valvular heart disease
* myocardial infarction within the previous 4 weeks
A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Participants who regularly use known drugs of abuse
* Women who are lactating and who are of child-bearing potential
* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
Effectiveness of Reel-time Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy

This study aims to assess the impact of real-time ultrasound (US) use on complication rates and procedural success in percutaneous dilational tracheostomy (PDT) opened with forceps dilatation technique using anatomical landmarks.

This study, patients who were admitted to the intensive care unit of hospital and who had a tracheostomy were examined. This is a retrospective study conducted to evaluate the method used during tracheostomy and themcomplications that occurred during and after tracheostomy opening.

2852 intensive care patients hospitalized in hospital intensive care unit after obtaining ethical permission were investigated retrospectively by scanning their files and digital data, and their complications during and after tracheostomy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in the intensive care unit and tracheostomy was opened and over 18 years.

Exclusion Criteria:

* surgical opened tracheostomy