cyrilzakka/clinical-trials huggingface dataset:
Perioperative Glutamine Supplementation and Cachexia

Background Sarcopenia is characterized by the degenerative loss of skeletal muscle and is associated with increased adverse surgical outcomes. Glutamine is considered as an immune-modulating formula, which may stimulate protein synthesis in the skeletal muscle but also inhibited protein-degradation. In this study, the investigators calculate the area and volume psoas major muscle (PMMA; PMMV) of the third lumbar vertebral body as the reference of skeletal muscle. The aim of this study is to investigate whether perioperative glutamine supplementation restores atrophy of psoas muscle.

A total of 550 gastric adenocarcinoma (GA) patients undergoing gastrectomy were enrolled for the study. Computed tomography was used to assess the short axis of the psoas muscle, and the change was calculated between preoperative day and three months after gastrectomy. Perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use. A linear regression model was performed to predict this association by adjusting clinic-demographics and nutritional calories.

Eligibility Criteria:
Inclusion Criteria:

* gastric cancer patients undergoing gastrectomy

Exclusion Criteria:

* hepatic or renal failures
Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of non-childbearing potential.
* Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
* Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
* Able to comply with all study procedures, including the 19-night stay for those participating in Part 1 or 24-night stay for those participating in Part 2 at the Clinical Research Unit and follow-up phone call.

Exclusion Criteria:

* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  * liver disease
  * pancreatitis
  * peptic ulcer disease
  * intestinal malabsorption
  * gastric reduction surgery
  * history or presence of clinically significant cardiovascular disease.
* Participants with out-of-range, at-rest vital signs.
* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
* Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
* Receipt of blood products within 2 months prior to Check-in (Day -1).
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).
Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who signed informed consent.
2. Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
3. Weight within a BMI range of 19.0-35.0 kg/m2.
4. CLCr according to Cockcroft Gault equation of:

   * 50-80 mL/min (mild renal impairment)
   * 30- \<50 mL/min (moderate renal impairment)
   * \<30 mL/min (severe renal impairment)
   * subjects receiving dialysis for ≥3 months before dosing (ESRD)
   * \>80 mL/min (normal renal function)

Exclusion Criteria:

1. Unwilling or unable to give informed consent.
2. As a result of the medical screening process, the study physician considers the subject unfit for the study.
3. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
4. Subjects who smoke more than 10 cigarettes a day.
5. Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week.
6. Any history of hypersensitivity to the IMP.
7. For subjects with renal impairment: No clinically significant change in disease status within at least 1 month prior to study entry, as determined by the investigator.
8. The subject had donated a unit of blood (450 mL) within the 3 months before dosing, or intends to donate in the month after the last scheduled visit.
9. Participation in another clinical study with an investigational drug or device within the last month.
10. Subjects with clinically significant telemetric ECG abnormalities on Day -1
11. Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
12. Positive test for human immunodeficiency virus (HIV) antibodies.
13. Acute Hepatitis B or C infection.
14. The subject has tested positive for drugs of abuse at screening.
15. Subjects who have received any prescribed systemic or topical medication within 4 weeks prior to dosing (excluded are those drugs the renally impaired subject is currently taking for treatment of the renal or concomitant disease).
16. Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment).
17. Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis).
18. Subjects with significant liver function abnormalities
19. Subjects with acute myocardial infection or unstable angina pectoris
VR Education in Patients Undergoing Coronary Angiography

The aim of this study is to compare standard education with VR augmented education in patients undergoing selective coronary angiography.

The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior toa selective coronary angiography. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help them to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures the patient need to take after the procedure.

Patients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for undergoing coronary angiography

Exclusion Criteria:

* Visual impairment
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)

GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial.

Primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 and \< 70 years of age
* Karnofsky Performance Score \>= 60
* histologically confirmed supratentorial GBM
* interval between primary diagnosis and registration for the study \< 4 weeks
* patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3
* adequate blood values (not older than 14 days prior to initiation of RCHT)
* neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3
* platelets ≥100.000/mm3
* hemoglobin ≥10g/dL
* BUN \<1.5 times the upper range
* Total and direct bilirubin \<1.5times the upper laboratory limit
* Adequate liver enzymes \<3 times the upper laboratory limit
* Life expectancy \>12 weeks
* Written informed consent

Exclusion Criteria:

* refusal of the patients to take part in the study
* previous radiotherapy of the brain or chemotherapy with DTIC or TMZ
* known allergy against extrinsical proteins
* previous chemotherapy or therapy with an EGFR-inhibitor
* Previous antibody therapy
* Patients who have not yet recovered from acute toxicities of prior therapies
* Acute infections requiring systemic application of antibiotics
* Frequent vomiting or a medical condition preventing the oral application of TMZ
* Clinically active kidney- liver or cardiac disease
* Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin)
* HIV
* Pregnant or lactating women
* Participation in another clinical study
Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.

The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured respiratory quotient (RQ) from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room.

Unipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and protects the operated lung.

However, no study has examined the impact of these mechanisms on the indirect measurement of RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ measurement during unipulmonary ventilation. The secondary objective was to assess the predictability of postoperative complications of indirect QR.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation

Exclusion Criteria:

* Cardiac surgery
* Laparoscopy
* Preoperative oxygen therapy
Prediction of Risk of Hypotension in Hemodialysis

The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

The duration of the study is 4 weeks for each patient. It will first be carried out a spectral analysis of heart rate variability (CHU of Clermont Ferrand only) and a measurement of intracellular and extracellular volumes by bioimpedancemetry. During the next 9 sessions, the decrease in the VSR will be recorded using an optical haematocrit measurement system. Blood pressure and heart rate will be measured every 30 minutes using an automatic blood pressure monitor and whenever the patient's nurse deems it necessary.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old minimum patients
* Patients with chronic end-stage renal failure
* Patients treated with hemodialysis for at least 3 months, 3 times a week (duration of sessions 3 to 5 hours)
* Patients with at least 2 episodes of intradialytic hypotension in the last month
* Patients without acute events within 3 months prior to inclusion
* Patients affiliated with or receiving social security benefits

Exclusion Criteria:

* Hemoglobin levels outside the limits of measurement (\<7 g/L or \>15g/L)
* Patients whose probable survival does not exceed 6 months
* Patients with progressive acute pathology
* Patient following another research protocol that may influence results
* Patients with psychiatric pathology or cognitive impairments that make them unable to give informed consent
Intra-carotid Anesthetic Agent Delivery

Intra-Carotid delivery of propofol.

Propofol injection into carotid artery . detection of response of experimental subjects to pain

Eligibility Criteria:
Inclusion Criteria:

* 5 experimental animals (rabbits)

Exclusion Criteria:

* none
Periprosthetic Distal Femur Fracture

A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.

Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.

The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.


Eligibility Criteria:
INCLUSION CRITERIA:

Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent

EXCLUSION CRITERIA:

Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) \> 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up
Thoraco-Lumbar Fascia Mobility

The purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). This study will compare baseline measurements, measurements after a single high velocity low amplitude spinal manipulation (HVLA-SM) and after a course of up to 16 HVLA-SM.

The investigators will conduct a single arm pilot (proof-of-concept) clinical trial. Approximately 30 participants with self-reported chronic low-back pain (LBP), defined as pain for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be enrolled.

This trial will consist of two separate enrollment phases. Phase 1 consists of enrollment at baseline followed by 3 separate ultrasound measurements. Phase 1 ends after a 4-week no treatment run-in phase.

Phase 2 begins twice-weekly HVLA-SM treatments to the thoracolumbar region for 8-weeks. Two ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). Pre-treatment ultrasound evaluations will be obtained at 4-weeks and 8-weeks.

The primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound) at the level of the lumbar L2-L3 vertebrae bilaterally. Ultrasound measures will be obtained with a Terason t3000 system using a 12L5 linear array probe with 10 MHz setting. Because shear strain may differ between sexes, we will attempt to recruit equal numbers of male and female participants.

Eligibility Criteria:
Inclusion:

1. Adults between 21 and 65 years
2. LBP of ≥ 1-yr duration with at least ½ of days with pain over the prior 6-months
3. Able to understand study procedures and willing to sign informed consent document
4. Willing to forgo any manual therapy for LBP for the initial 4-week study period
5. Willing to forgo any manual therapy for LBP other than study treatments during the 8-week treatment period
6. Able to tolerate and safely receive study procedures

Exclusion Criteria:

1. Chiropractic care or other manual therapy for at least 90 days prior to baseline visit
2. Unable to visualize necessary tissue layers using musculoskeletal ultrasound
3. Weight above 350 lbs
4. Unable to tolerate or safely receive study procedures
5. Need for referral
6. Unable or unwilling to comply with study procedures
7. Current or planned pregnancy (self-reported) within the study timeframe
8. Any prior surgery to the thoracolumbar region
9. Needing a proxy
10. Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome
Specific Electrophenotypes in Atrial Fibrillation

This study will investigate a common heart rhythm disturbance (arrhythmia), atrial fibrillation (AF), to improve understanding of how best to treat it in different patients. Direct current cardioversion (DCCV) is a procedure that can revert the heart to a normal rhythm, however almost all patients will only have a transient benefit, and their heart will return to the abnormal rhythm, AF. Ablation is an invasive procedure that creates scar tissue within the heart to reduce the arrhythmias, with a longer lasting effect than DCCV. It has been used with success in AF that occurs occasionally (paroxysmal) but is not as effective in AF that is more long-lasting, also known as persistent AF. Persistent AF is major cause of symptoms of breathlessness and palpitations and significantly increases the risk of stroke. Doctors are unable to accurately predict which patients will benefit most from an ablation, this can lead to as many as 50% of patients not benefitting from the procedure. The aim is to better predict which patients will benefit from an ablation. The study will include patients undergoing AF ablation or DCCV and perform additional tests including blood tests a heart MRI scan, a special type of heart tracing with up to 252 points and a short period of extra recordings from within the heart during the ablation procedure. Several techniques will be used to analyse this data, including machine learning, to develop a means predict which patients will benefit the most from the ablation procedure, without needing to use any recordings from within the heart.


Eligibility Criteria:
Inclusion Criteria:

* Suitable candidate for catheter mapping/ablation for arrhythmias or direct current cardioversion for atrial fibrillation
* Signed Informed Consent

Exclusion Criteria:

* Severe cerebrovascular disease
* Moderate to severe renal impairment (eGFR \< 30)
* Active gastrointestinal bleeding
* Active infection or fever
* Short life expectancy
* Significant anaemia
* Severe uncontrolled systemic hypertension
* Severe electrolyte imbalance
* Congestive heart failure - NYHA Class IV
* Recent myocardial infarction
* Bleeding or clotting disorders
* Uncontrolled diabetes
* Inability to receive IV or oral Anticoagulants
* Unable to give informed consent
* Pregnancy
Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after surgery were assessed through mechanical pain measurement. Comparative analysis of postoperative hyperalgesia levels, pain and analgesic requirements between morning group and afternoon group were performed.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classification I-II
* Abdominal endoscopy surgery
* Estimated surgery duration 1-2h
* Right handedness
* Voluntarily receive postoperative intravenous controlled analgesia

Exclusion Criteria:

* Heavy smoking or alcohol dependence
* Puerpera or lactation women
* History of chronic pain
* Analgesic use within one month before surgery
* Allergy to opioids
* Can not follow with the study procedure
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Female or male aged 18 years and over
* Histologic or cytologic confirmation of advanced gastric cancer
* Stage III-IV (AJCC 7th)
* ECOG: 0-2
* Have tumor sample that can be tested for BRCA1 mRNA expression
* Negative pregnancy test for women of childbearing potential
* Neutrophile granulocyte greater than 1.5×10\^9/L
* Hemoglobin greater than 10g/dL
* Platelet greater than 100×10\^9/L
* Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)
* ALT or AST not greater than 1.5x ULRR
* Creatinine clearance no less than 60ml/min

Exclusion Criteria:

* Have at least another primary malignant tumor
* Active infection
* Chemotherapy with experimental drug within 3 weeks before the start of study therapy
* Women who are pregnant or breast feeding
* Weight loss greater 10% within 6 weeks before the start of study therapy
Cerebral and Cognitive Markers of Treatment Resistance in Obsessive Compulsive Disorder

This study aims to define individual profiles of treatment resistants in order to find indicators and predictors of the therapeutic response.


Eligibility Criteria:
Inclusion Criteria:

* Obsessive compulsive disorder diagnosed according to Diagnostic and Statistical Manual 5 criteria (patients will be included regardless of the severity and resistance of their pathology and their levels of executive functions)
* Understand and accept the constraints of the study
* Be a beneficiary or affiliated to a Health Insurance scheme

Exclusion Criteria:

* Present one of the diagnoses according to the criteria of the DSM 5: schizophrenic disorders, substance abuse or dependence to a substance according to the criteria of the M.I.N.I. version 5.0 (Sheehan et al., 1998)
* Generalized anxiety disorder, social anxiety, nicotine dependence and history of a major depressive episode are not exclusion criteria according to the M.I.N.I. version 5.0 (Sheehan et al., 1998)
* Have a serious intercurrent pathology
* Being a pregnant woman
* Being a woman of childbearing age without effective contraception.
* Being hospitalized under duress or on an outpatient basis in a care program
* Being under judicial protection (reinforced curatorship, guardianship)