cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors

This is a single-center, single-arm clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-XT117 injection in patients with FAP-positive advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* ≥18 years old
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1
* Confirmed as malignant solid tumor by histopathology
* Have measurable lesions based on RECIST 1.1
* Have failed standard treatment (disease progression or intolerance) or lack standard treatment
* Positive FAP expression confirmed by FAP PET/CT
* Sufficient bone marrow capacity and organ function

Key Exclusion Criteria:

* High intensity and large amounts of off-target uptake by FAP molecular imaging, and were assessed as inappropriate for \[177Lu\]Lu-XT117 therapy by the investigators
* Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before receiving study therapy; previous treatment with Chinese medicine with anti-tumor indications within 2 weeks before receiving study therapy
* Uncontrolled diabetes, with baseline fasting blood glucose \> 2×ULN
* Clinically significant serious cardiovascular disease, including but not limited to: a. \>Grade II congestive heart failure as per New York Heart Association (NYHA) ; b. Unstable angina pectoris or myocardial infarction within 6 months before the first administration of the study drug; c. Severe arrhythmia within 6 months prior to the first administration; d. Poorly controlled hypertension (patients who keep the blood pressure to ≤ Grade 2 hypertension \[CTCAE5.0\] with hypotensor are allowed for enrollment); e. QTc\>450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, and use of medications that prolong QT
* Clinically serious thromboembolic disease within 6 months prior to the first administration of the study drug
* Major surgery within 4 weeks prior to the initial administration of the study drug
* History of severe gastrointestinal ulcers or perforations or history of intestinal obstruction within 6 months prior to the first administration
* Active infection requiring systemic treatment (oral or intravenous administration) within 2 weeks prior to the first administration, except for topical treatment
* History of non-infectious interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis, idiopathic interstitial pneumonia, pneumoconiosis, and drug-related interstitial pneumonia, or severe impairment of lung function
* Had other malignancies within 5 years prior to screening (except clinically cured early stage malignancies)
* Primary central nervous system (CNS) tumor or symptomatic CNS metastasis, expect:

  * Subjects with asymptomatic brain metastases;
  * Subjects whose CNS lesions were stable for ≥4 weeks after local treatment and who stopped glucocorticoid or anticonvulsant therapy at least 2 weeks prior to study drug administration could be enrolled;
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery

This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP \<65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.

not provided

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned.

Exclusion Criteria:

* Emergency surgery,
* pregnancy,
* American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:

I. Primary outcomes:

* Duration of the non- invasive respiratory support.
* Need of invasive ventilation in the first 72 hours.
* Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma.

II. Secondary outcomes:

* Need for surfactant administration.
* Days on invasive mechanical ventilation.
* Days on supplemental oxygen.
* Duration of hospital stay.
* Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

Moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to WHO definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion criteria:

* Any baby intubated for resuscitation or for other reasons.
* Obvious major congenital malformations or known complex congenital heart disease.
* Pulmonary hemorrhage.
* Cardiopulmonary arrest needing prolonged resuscitation.
Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

This is a four-week randomized controlled single blinded trial of subjects presenting with resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to routine intensification of antihypertensive regimen , all added to previous regimen with unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four following add-on therapy initiation. The primary outcome is change in office and self-measurement blood pressure recorded at each visit, and secondary outcomes are variations in serum potassium, sodium, and creatinine levels.


Eligibility Criteria:
Inclusion Criteria:

* Resistant hypertension
* Diabetes mellitus

Exclusion Criteria:

* T2DM with overt acute/chronic complications,
* serum potassium ≥ 5.5 mmol/l,
* estimated Glomerular Filtration Rate (eGFR) calculated using the Modification of Diet in Renal Disease formula ≤ 30 ml/min/1.73m² of body weight,
* absolute contraindication to any of the drug regimen of the trial,
* and current aldosterone antagonist treatment or cessation within the last 15 months
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function

Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines.

Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis with ascites, with or without hepatorenal syndrome

Exclusion Criteria:

* Age \< 18 and \> 75 years
* Shock or bacterial infection present at the inclusion or during the previous week
* Bleeding present at the inclusion or during the previous week
* Multifocal HCC
* Organic renal failure
* Hearth or pulmonary failure
Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants

The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations by investigator
* Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, as measured at screening visit
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Women who are of childbearing potential
* Women who are pregnant or breastfeeding
* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study, including a history of or active liver disease
* Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs

The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: 91 neonates presenting to a neonatal intensive care unit who met the inclusion criteria were included in the study. Vital signs of neonates were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).

Term and preterm are exposed to many stimuli during their stay in the neonatal intensive care unite (NICU). These stimuli; operation and alarm sounds of devices, continuous and high level ambient lighting. These stimuli can cause deviations in the physiological indicators of newborns, and hearing and vision loss. The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: This study is a prospective repeated measure pretest-posttest repeated-measures design. 91 term and preterm newborns who were hospitalized in the neonatal intensive care unit and met the inclusion criteria were included in this study.

Neonates were admitted to the study if they satisfied all of the following criteria: (1) term and preterms, (2) admitted to NICU, (3) clinically stable, (4) verbal and written consent from the parent. Term and preterm neonates were randomized into two groups (term group = 44, and preterm group = 47 neonates). Vital signs of both groups were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).

Eligibility Criteria:
Inclusion Criteria:

* Parents giving verbal and written consent,
* Hospitalized in the II. Level NICU
* Those born at 38-42 weeks of gestation
* Those born at 24-38 weeks of gestation
* Newborns with a body weight of 1500-2500 grams

Exclusion Criteria:

* Having life-threatening health problems
The Role of SNP of ECM and MMP on the Development of Pathological High Myopia

To study the clinical characteristics and inheritance of pathological myopia in Taiwanese patients.

High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Pathological myopia often accompanied by glaucoma, cataracts, macular degeneration, and retinal detachment, leading to blindness when the damage to the retina is extremely severe. Population and family studies in Chinese have provided evidence for a geneticcomponent to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia. The retina receives the signal from the retina-RPE complexes and affects the growth of scleral coats. The changes of scleral components, collagen fibrils and proteoglycans, are noted in experimental and human myopia and induce the pathology of high myopia. It is interesting to know that individual difference of SNP in the components of scleral coat affects the response to the signal from retina-RPE complexes. The most important effectors in scleral coats are collagens, proteoglycans, MMPs and TIMPs. Therefore, the difference of SNPs in different genes might contribute the formation of scleral thinning during myopia development. In this project, we will focus on this subject by using GenomeLab SNPstream Genotyping System which is powerful and helpful for identify some specific SNPs in the regard.

Eligibility Criteria:
Inclusion Criteria:

* They are unrelated Chinese subjects with high myopia ≦-6.00D. The diagnosis of myopia is determined by the refractive error. Anisometropic individuals, with a refractive error of ≦-6.00 D for one eye and ≦-6.00 D for the other eye, with at least a 2-D difference between the two eyes, are considered unaffected

Exclusion Criteria:

* Individuals are excluded if there is known ocular disease or insult that could predispose to myopia, such as retinopathy of prematurity or early-age media opacification, or if they had a known genetic disease associated with myopia, such as Stickler or Marfan syndrome.
Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections

Calprotectin extracted from stool can be detected easily using ELISA. Numerous studies have shown that fecal calprotectin concentrations demonstrate a good correlation with intestinal inflammation This study aims to detect the relationship between fecal calprotectin and Blastocystis hominis and Entamoeba histolytica infections.


Eligibility Criteria:
Inclusion Criteria:

120 fecal samples will be collected as the following:

* 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
* 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
* 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).

Exclusion Criteria:

* persons received antiparasitic drugs or antibiotic 2 weeks before sample collection Patients with mixed intestinal protozoa Patients with intestinal protozoa rather than Entamoeba histolytica and Blastocystis
An Evaluation of Clotting Factor Activity Before and After Total Hip Arthroplasty

The objective of the study was to analyze both the concentration and the activity of the clotting factors, D-dimer levels, as well as fibrinogen concentration in patients who underwent primary total hip arthroplasty due to idiopathic arthrosis.

Blood loss is often related to perioperative period and may result in decrease of concentration of coagulation factors, which in turn may lead to increased bleeding. We analyzed data of thirty patients scheduled for primary hip arthroplasty: the activity of clotting factors II, VIII, X, as well as fibrinogen concentration in the following time points: (i) before surgery, (ii) six hours after the procedure, and (iii) two, (iv) four, and (v) six days after the operation. All laboratory tests were performed using automatic analyzer. At the same time intervals, an immunoenzymatic assay was used to determine D-dimer levels.


Eligibility Criteria:
Inclusion Criteria:

* patients qualified for primary hip arthroplasty for idiopathic osteoarthritis

Exclusion Criteria:

* hip osteoarthritis because of non-idiopathic etiology
* history of venous thromboembolism or arterial embolism
* anticoagulation treatment,
* coagulopathy
* infection, and
* renal failure defined as a creatinine clearance below 50 ml/minute.
Microsatellite Instability in Colorectal Cancers

In this study, we aimed to identify the different histopathological features of tumors with microsatellite instability (MSI) compared to microsatellite stable (MSS) in patients who underwent surgery for colorectal cancer. We also planned to determine how MSI affects prognostic parameters.

According to Global Cancer Statistics, higher than 1.9 million new cases of colorectal cancer (CRC) and 935,000 deaths are estimated to occur in 2020, representing about one in 10 cancer cases and deaths. Overall, it ranks third in colorectal incidence but second in mortality.

In CRC evolution, the acquisition of genomic instability is a critical point, and there are at least two different pathways in the pathogenesis of CRC: the chromosomal instability (CIN) pathway (85%) and the microsatellite instability (MSI) pathway (15%).

Microsatellite instability (MSI) is a phenotype that occurs due to a malfunction in the DNA repair mechanism and is seen in approximately 15% of colorectal cancers (CRCs). CRCs with MSI have different clinical features, such as a tendency to settle in the proximal colon, poor differentiation, and more lymphocytic infiltration in the tumor. It has been shown that CRCs with MSI have a better prognosis and respond differently to chemotherapy than CRCs with microsatellite stable (MSS).

We aimed to evaluate the different histopathological features of tumors with MSI compared to MSS in patients who underwent surgery for colorectal cancer. We also planned to determine how MSI affects prognostic parameters such as mortality rate, recurrence, disease-free survival, cancer-specific survival, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal surgery patients
* Complete follow-up information

Exclusion Criteria:

* Whose MSI status was not studied in the pathology material
* Missing follow-up information
* Colorectal resection for non-neoplastic diseases
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.


Eligibility Criteria:
Inclusion Criteria:

1. Gender : male or female
2. Age : 18-55 years, inclusive
3. Body Mass Index (BMI) : 18.0-30.0 kg/m2
4. Medical history without major pathology
5. For males only: Willingness to use adequate contraception from the time of dosing and not donate sperm until 3 months after the follow-up visit
6. Females who have a negative pregnancy test at screening and on each admission, and are of non-childbearing potential. Females of non-childbearing potential are defined as women who are surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses and follicular stimulating hormone (FSH) \>23.0 mIU/mL)
7. Willing and able to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

1. Previous participation in the current study
2. Evidence of clinically relevant pathology
3. History of relevant drug and/or food allergies
4. Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs
Sport as a Treatment in Chronic Diseases and Healthcare Sustainability

Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.

With automation equipment and the comfort, it has brought, less natural physical activities are required and people do not take the time to do some. Therefore, obesity, associated with obstructive sleep apnea (OSA) up to 60% of cases, has become a heavy burden on the society and the healthcare system, besides the fact that it often involves cardiovascular diseases. Assistance is urgently needed and the investigators want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. In order to do that, the investigators will integrate sport in the patient pathway and support in his/her involvement. This last point means that a link between medical and sport specialists should be established, and this is missing today.

This study aims to reconcile the world of patients and the world of sport, by offering a trajectory and an organization that help patients to initiate physical activity.

The investigators plan to measure the physical activity of overweight or moderate obese, apneic patients in the different programs at the end of the 3-month period by physical activity objective parameters: number of steps/day.

The secondary objectives of this study are to:

* Evaluate the effect of the different programs of sport "prescription" on patient motivation, over a 3-month period by a motivational questionnaire.
* Analyze the cost effectiveness of the different programs of sport "prescription" over a 3-month period.
* Evaluate the effect of the different programs of sport "prescription" on weight and blood pressure (BP), assessed by home self-measurements each month, over a 3-month period and recorded in the application.

Eligibility Criteria:
Inclusion Criteria:

* 25 y ≤ age ≤ 70 y
* 27 \< BMI \< 32
* Weight \< 120 kg
* Apneic patient (Apnea-hypopnea index \> 15/h) treated or not by CPAP (continuous positive airway pressure )
* Be able to practice sport (according to a Cardiologist decision)
* Be able to use the personal health monitoring devices jointly to a personal Touch phone
* Consenting patient based around Grenoble France
* Be legally able to give consent
* Person affiliated to social security

Exclusion Criteria:

* Being unable to understand, follow objectives and methods due to cognition or language problems
* Pregnant women, feeding and parturient
* Physical activity score \> 9, calculated by Baecke's questionnaire (Annex 1)
* Subject under administrative or judicial control, person who are protected under the act.