cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Drug Monitoring of Anti-infectious Drugs in Intensive Care Unit

This research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules.

Antibiotics, and especially beta-lactams, are among the most used drugs in the world. The good use of antibiotics and the prevention of selection of resistant strains has been a public health priority for many years. In this context, it is essential to obtain effective antibiotic concentrations at the site of infection. In order to obtain effective concentrations, ceftazidime, cefepime, cefotaxime, piperacillin and meropenem are administered in this population by continuous infusion at high dose. Although beta-lactams are mostly well tolerated, they can cause adverse effects such as severe neurological toxicities.

The critically ill patient has physiological alterations that can significantly alter the pharmacokinetics of drugs. Several studies have clearly shown that the pharmacokinetics of beta-lactams in the critically ill patient is different from those of other patients. Depending on the clinical context and the co-morbidities of the patient, sub-therapeutic or potentially toxic concentrations can be observed for the same dosage. The risk of ineffective treatment and the development of resistance remains, despite the high doses administered. In addition, this pharmacokinetic variability may be responsible for the observation of toxic concentrations and the occurrence of adverse effects in this population.

Following these arguments, therapeutic drug monitoring (TDM) of beta-lactams accompanied by personalized dosage adjustment appears to be an essential tool to optimize the management of critically ill patients. Although strongly recommended, the TDM of beta-lactams in the critically ill patient accompanied by a dosage adjustment is not currently performed systematically in all patients.

The objective of this study is to evaluate the impact of the use of a systematic therapeutic drug monitoring of beta-lactams in the critically ill treated with cefotaxime, ceftazidime, cefepime, meropenem or piperacillin, in terms of efficacy and prevention of neurotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age\> 18 years)
* Patient hospitalized in intensive care for a duration greater than 7 days, treated with cefotaxime, ceftazidime, cefepime, piperacillin or meropenem according to a standardized dosing regimen.

Exclusion Criteria:

* Age \<18
* Pregnant woman
* Patient allergic to beta-lactams
* No written informed consent by the patient or his/her (legal) representative
Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy

This trial is designed to assess the efficacy of a novel carbon-fibre adjustable reusable accessory (CARA) for breast support to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during whole breast RT.

This study is designed to assess the effectiveness of utilizing the CARA positioning device for reducing the incidence and severity of acute skin reactions in the infra-mammary fold in patients undergoing WBRT. Secondary outcomes include patient reported outcomes and dose to normal body tissue and organs at risk. This is a randomized controlled trial. Participants will be randomly assigned to the following two arms:

Arm 1 patients will receive CARA breast support. The known benefits to using CARA for breast positioning are reduction in IMF skin folds during treatment, reduction in breast separation, and reduction in V50% body, V105% body and lung V20 Gy in treatment planning. No known risks to using CARA have been identified.

Arm 2 patients will not receive CARA breast support. Patients in arm 2 may be treated with no breast support, a small foam wedge, a thermoplastic shell or alternate supine breast support method according to the current standard of care at the treating centre. These methods have entered RT clinical practice over decades of practice without published evidence of impact on rates of MD. Published rates of MD for the control arm thus pertain to a cross section of these methods. The control arm of this study will look at all of these methods combined. There may be centre specific preference for the control method and stratification by centre will be done.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Able to provide informed consent
* ECOG performance status 0 - 2
* Stage 0-3 invasive breast cancer or DCIS scheduled to received adjuvant radiotherapy to the whole breast
* Any infra-mammary skin fold of \>= 0.5 cm in the supine treatment position and/or palpable lateral breast tissue falling posterior to the mid-axilla line while in supine or treatment position.

Exclusion Criteria:

* Inability to give informed consent or comply with experimental arm of trial
* Previous RT to either breast or to the chest
* Planned boost to infra mammary area
* Use of Mepitel while on treatment
* Failure to heal surgical wound or significant post-operative wound infection
* Presence of significant connective tissue disease (e.g. systemic sclerosis, SLE)
* Known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc.)
* Breast reconstruction
* Planned partial breast irradiation, unless the treated area includes the infra-mammary fold
Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine

The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Docetaxel followed by Gemcitabine.

This is an open, multicenter, two-armed Phase III study

Patients will be randomized to either of the following two arms:

Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.

Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.

For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
* Females, 18 to 75 years of age
* pre-treated with ONE anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study
* Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria
* Performance status of 70 or higher on the Karnofsky Performance Scale
* Adequate bone marrow reserve
* Adequate liver function
* Adequate renal function
* Informed consent form patient or guardian
* Childbearing potential either terminated by surgery, radiation, or menopause, use of an approved contraceptive method

Exclusion Criteria:

* Active infection (at the discretion of the investigator).
* Known or suspected brain metastases requiring steroid or radiation treatment.
* Pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory)
* Breast-feeding
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
* Bone metastases, pleural effusion, or ascites as the only site of disease.
* Bone marrow transplantation or autologous stern cell infusion following high-dose chemotherapy for adjuvant or metastatic disease.
Effect of Learning on Vegetable Acceptance by Toddlers

The aim of this study is to understand the formation of food preferences from an early age.

The main purpose of this research is to compare the effectiveness of two mechanisms (mere exposure, flavour-flavour learning) in the short and medium term (up to six months after the learning phase) on 2-3 year-old children's vegetable acceptance. the research is conducted on children aged 2 to 3 years in daycares.

Eligibility Criteria:
Inclusion Criteria:

* children between 2 and 3 years,
* attending daycares
* returned signed consent form parents

Exclusion Criteria:

* children with food allergies or manifestations, chronic disease
* or being preterm (\<36 weeks gestational age at birth)
THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE

* Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. In subcutaneous adipose tissue (SAT)
* The radiofrequency uses high-frequency electromagnetic waves to produce heat at the cutaneous and the subcutaneous levels. The mechanism of action, through the vibration of water molecules, transforms the electromagnetic energy into thermal. The heat generated by conversion occurs under 30 kHz to 300 MHz, and the most frequently used frequency is set between 0.5 and 1.5 MHz. The RF mechanism of fat reduction occurs by the generation of thermal stimulation of adipocyte metabolism, occurring through enzymatic degradation by lipase-mediated triglycerides, apoptosis, and adipocyte rupture and the objective of study to show the positive effect of radiofrequancy on postmenopausal adipose tissue

About 90% of menopausal women experience some amount of weight gain. It is a natural and common aspect of getting older. It occurs because the body mass increases, as a result of fat deposits. However, weight gain associated with menopause typically involves increased amounts of fat around the abdomen. On an average, women gain between 8-10 kilogram between the ages of 45 and 55, the stage in life when menopause occurs. This extra weight generally does not evenly distribute itself throughout a woman's body. The weight tends instead to accumulate around the abdomen or thighs (Singh et al., 2013).

Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and android fat redistribution it is mostly attributed to estrogen depletion though other factors such as chronological aging and decline in physical activity play a significant role. The deleterious health consequences of obesity and visceral fat deposition after menopause encompass a variety of problems; from dyslipidemia and metabolic syndrome to increased risk of cardiovascular disease (CVD), osteoporosis, malignancies and mortality (Stachowiak et al., 2015) This emphasizes the need of effective methods for treating central adiposity in post-menopausal woman. No prior studies have investigated the effect of radiofrequency on adipose tissue. So this may add a new physical therapy method for treating this problem.

Eligibility Criteria:
Inclusion Criteria:

* 1-Their ages will be ranged from 45 to 60 years 2- BMI \> 25 kg/m² and \< 35 kg/m². 3- Waist circumference more than 88cm

Exclusion Criteria:

* 1-Cancer. 2-Renal failure 3-tumors 4-Hepatic diseases 5-skin disease that prevent the use of radiofrequancy
Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy).
* Males and females between the ages of 3 and 30 years old
* Life expectancy ≥ 12 months
* karnofsky/Lansky ≥ 80 %
* Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/l, Hemoglobin ≥ 10 g/dl, Platelet count ≥ 50 x 109/l
* Adequate liver function: Total bilirubin ≤ 2.5 x ULN, ALT/AST ≤ 5.0 x ULN
* Adequate renal function:Serum creatinine ≤ 1.5 x ULN
* Written informed consent from the patient, parents or legal guardians
* Patient's willingness during treatment and ability to comply with the protocol

Exclusion Criteria:

* Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease)
* Performance of a course of 1st-line chemotherapy at the same time as study initiation
* Concurrent participation in other research projects
* Pregnancy or lactation status
* Use of inappropriate contraceptive methods
EBUS TBNA After PET/CT in Diagnosing Patients With Stage I-IIA Non-small Cell Lung Cancer Evaluated for Stereotactic Body Radiation Therapy

This clinical trial studies how well endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) after positron emission tomography/computed tomography (PET/CT) scan works in diagnosing patients with stage I-IIA non-small cell lung cancer evaluated for stereotactic body radiation therapy (SBRT). Performing EBUS-TBNA after PET/CT scan may help doctors learn more about the accuracy and ways to find early stage lung cancer.

PRIMARY OBJECTIVES:

I. To assess the use of EBUS-TBNA after a PET/CT as a means of improving the accuracy of lymph node staging in patients considered for SBRT.

SECONDARY OBJECTIVES:

I. To assess the usefulness of PET/CT as a diagnostic test in identifying N1 versus N0 staging.

II. To compare survival and recurrence rates in patients with discordant PET/CT and EBUS-TBNA.

III. To describe EBUS-TBNA and SBRT related complications.

OUTLINE:

Patients undergo EBUS-TBNA before SBRT.

After completion of study, patients are followed up at 6 weeks, then every 3 months for the first 2 years then twice a year for the following 3 years, and annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be \> 18 years old
2. Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)
3. Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA
4. Patient is being considered for SBRT
5. Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures
6. If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a) Patient has undergone potentially curative therapy for all prior malignancies b) No evidence of active / recurrent disease within 5 years

Exclusion Criteria:

1. Patient has received prior chemotherapy or radiotherapy for this cancer
2. Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression)
3. Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology
4. Patients who are planning to undergo treatment in a different institution
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD

To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).


Eligibility Criteria:
Key Inclusion Criteria:

Participants must meet all of the following key inclusion criteria:

1. Completed written informed consent.
2. Aged 18 to 65 years, inclusive, at the time of informed consent.
3. Primary diagnosis of MDD.
4. Participants must meet one of the following criteria:

   * must have been taking ≥1 antidepressant medication(s) for ≥8 weeks prior to screening.
   * must have received ≥1 antidepressant medication(s) for ≥8 weeks in the current or most recent episode of depression.
5. Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following key criteria:

1. Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary.
2. Have a significant risk of suicidal or violent behavior.
3. A history of seizure disorder, stroke, Alzheimer disease, Parkinson disease, multiple sclerosis, head injury associated with loss of consciousness for more than 15 minutes, or other neurodegenerative disorder.
Validity and Reliability of Korean Version of AM-PAC Inpatient Short Form (Low Function) in Critically Ill Patients

The Activity Measure for Post Acute Care (AM-PAC) inpatient short form (low function) evaluates the level of assistance a patient requires another person to provide for distinct functional mobility and daily activities. The objective of the study was to translate and cross-culturally adapt the AM-PAC (low function) into Korean version and assess its reliability and validity .

Independent raters assessed 38 patients from ICU using the Korean version of AM-PAC, respectively. Intra-class correlation coefficients (ICCs) and Bland-Altman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency. Validity was evaluated using Spearman's correlation analysis with other physical function assessment tools (functional status score for the ICU(FSS-ICU), Medical Research Council-sum score(MRC-SS), hand grip strength) and other unrelated factors (body mass index, glucose level).

The Activity Measure for Post Acute Care (AM-PAC) inpatient short form (low function) evaluates the level of assistance a patient requires another person to provide for distinct functional mobility and daily activities. The objective of the study was to translate and cross-culturally adapt the AM-PAC (low function) into Korean version and assess its reliability and validity.

An expert committee in intensive care unit (ICU) rehabilitation supervised the forward and backward translation process and to finalize the Korean version of AM-PAC (low function).

First evaluation of AM-PAC basic mobility and daily activity inpatient short forms was conducted on the first rehabilitation treatment day in ICU by the primary therapist. Subsequently, follow-up evaluations are conducted at 2 weeks and 4 weeks until the patient is discharged. Paired raters observed and recorded the scores independently. Each therapist was unaware of the other rater's scores, and they did not communicate verbally during the assessment. Starting with the first evaluation in the ICU, the same inter-rater reliability evaluation was performed in week 2 and week 4.

Raters assessed 38 patients from Medical ICU using the Korean version of AM-PAC. Intra-class correlation coefficients (ICCs) and Bland-Atman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency.

Then, convergent validity was evaluated using Spearman's correlation analysis between AM-PAC score and other physical function assessment tools (FSS-ICU, MRC-sum score, hand grip strength), and divergent validity was evaluated using correlation analysis between AM-PAC score and BMI or serum glucose level.

Eligibility Criteria:
Inclusion Criteria:

* All patients above 18 years who were admitted to the Medical ICU and were expected to remain in the ICU for at least two days, were eligible for inclusion.

Exclusion Criteria:

* Patients who were medically unstable to start rehabilitation in ICU or when mobilization was contraindicated by the medical team were excluded
Comparative Effectiveness of Muscle Energy Technique and Trigger Point Release in Plantar Fasciitis

This study aimed to investigate the comparative efficacy of Muscle Energy Technique (MET) and Trigger Point Release in the treatment of Plantar Fasciitis. A single-blinded, randomized clinical trial was conducted, wherein thirty participants were randomly assigned to two parallel groups. One group received MET, while the other received Trigger Point Release, with both groups performed self-stretching exercises as part of their home program. Outcome measures included pain intensity and foot function. Treatments were administered three times a week for a duration of four weeks.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral plantar heel pain that worsens with weight-bearing activities
* Age range: 25-45 years
* Pain exacerbation with initial morning ambulation (i.e., walking a few steps)
* Presence of at least one identifiable trigger point in the calf muscles

Exclusion Criteria:

* Bilateral heel pain
* History of tumors in the leg or foot
* Previous lower limb fractures
* Recent or unresolved lower limb injuries
* Achilles Tendinitis
* Ankle arthritis
* Surgery
* Vascular Disease