cyrilzakka/clinical-trials huggingface dataset:
Intestinal Phosphate Transporter Expression in CKD Patients

The aim of the present study is to study the expression of the various phosphate transporters in patients with normal or moderately impaired renal function or in patients on dialysis. In particular, the investigators want to clarify whether NaPi-IIb expression level decreases in CKD patients, which would render it a potentially inadequate pharmaceutical target in these patients.

Elevated serum phosphate is a potent predictor of death and cardiovascular events in patients with renal disease. Control of serum-phosphate to desired target ranges is insufficient in many patients with advanced chronic kidney disease (CKD), in particular dialysis patients despite dietary restrictions, optimized dialysis regimens and the use of phosphate binders. One reason why for example, phosphate binders are insufficient to control phosphate uptake in the intestine or why they even loose efficacy, is a compensatory upregulation of phosphate transporters in the gut wall.

Thus, several companies attempt to specifically interfere with intestinal phosphate transporters, in particular the NaPi-IIb transporter. However, recent Chugai data obtained in experimental CKD challenge the assumption that NaPi-IIb is the major therapeutic target in this situation. In addition to NaPi-IIb, PiT-1 and -2 also might contribute to phosphate transport.

In normal human intestinal mucosa the most prominent expression of all 3 transporters is observed in the duodenum, i.e. an area, which can easily be assessed by endoscopy.

During endoscopy a biopsy for research purposes will be obtained. Chugai will evaluate the expression level of NaPi-IIb, PiT-1, PiT-2, and villin1 at the mRNA and, if possible, the protein level.

Eligibility Criteria:
Inclusion Criteria:

* Upper endoscopy for suspected or known esophageal or gastric pathology
* Upper endoscopy for screening purposes
* Written consent to take part in the study

Exclusion Criteria:

* Food intake within 8 hours prior to the endoscopy
* Major duodenal pathology, in particular duodenitis or duodenal ulcers or tumor
* Contraindication to duodenal biopsy such as bleeding disorder
* Treatment with medication known to regulate the expression or activity of intestinal phosphate transporters (e.g. nicotinamide)
* Kidney transplant patients
* Alcohol or drug abuse
* Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
* Participation in a parallel clinical trial
* Subjects who are in any state of dependency to the sponsor or the investigators
* Employees of the sponsor or the investigators
* Subjects who have been committed to an institution by legal or regulatory order
Medical Dispatchers' Perception of Visual Information in Real Out-of-hospital Cardiac Arrest

Dispatcher-assisted cardiopulmonary resuscitation is a complex, nonvisual procedure that is challenging for the dispatcher. The aim was to explore the medical dispatchers' perception of bystanders' responses and dispatchers' reflections about the added value of visual information in out-of-hospital cardiac arrests (OHCA) situations.

Ten individual interviews with medical dispatchers who had previously handled an emergency call concerning OHCA captured on closed-circuit television (CCTV) were conducted. First, the medical dispatcher listened to the emergency call and described their perception of the scenario. Afterward, the CCTV recording was shown to the dispatcher, who was then interviewed. The interviews were videotaped, and the audio files were transcribed verbatim. Thematic content analysis was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Medical dispatchers who had previously handled an emergency call concerning OHCA captured on closed-circuit television (CCTV)

Exclusion Criteria:

* None
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)

This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count \<30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study has been completed. Part B treatment dose is 400 mg twice daily.

This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in approximately 60 patients in Part A and approximately 25 patients in Part B.

Part A enrolls patients with ITP who are refractory or relapsed with no available and approved therapeutic options. Eligible patients have a platelet count \<30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. In the dose-finding part of the study, each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term-extension.

Part B of the study will include approximately 25 patients with ITP who have relapsed or have an insufficient response to prior therapies. Eligible patients will have a platelet count \<30,000/µL on two occasions no less than 7 days apart, within 15 days before treatment begins and a platelet count of ≤35,000/µL on Study Day 1 (SD1). The study consists of a 28-day screening period, 24-week active treatment period, and a long-term extension. After the last dose of PRN1008 there will be a 4-week safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged 18 to 80 years old
* Immune-related ITP (both primary and secondary)

Exclusion Criteria:

* Pregnant or lactating women
* Current drug or alcohol abuse
* History of solid organ transplant
* Positive screening for HIV, hepatitis B, or hepatitis C
Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients

Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa (EB).

Itch is the most common complaint reported by patients with EB of all subtypes, and there is no current effective treatment. Itch often triggers scratching that creates new wounds and increases EB disease severity.

This study aims to target the physiological mechanisms of pruritus (itch) in patients with EB. Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 (NK1), which is expressed in the central nervous system and the skin.

VPD-737 (serlopitant), a novel drug that inhibits the NK1 receptor, has been shown to reduce severe itch in a previous study of 257 adult patients with chronic pruritus.

Each patient will be un-blinded individually after completing 3 months of study period.

All patients who complete the study will be offered a 2-month period on active drug. Patient who received active drug in the first period will be contacted and asked if they would like to continue on active drug for an additional 2 months.

Patients who received placebo in the first period will be contacted and asked if they would like to repeat the study on open label for 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Epidermolysis Bullosa (EB) and pruritus

Exclusion Criteria:

* Chronic liver or renal disease
Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection

For all women immediately after ovum retrieval from 80 women undergoing IVF, intra uterine salin flushing will be analyzed using a multiplex immunoassay for soluble regulators of implantation, namely Interleukin (IL)-1b, Tumor Necrosis Factor (TNF)-a,. In order to detect implantation predictors.

This is a prospective cohort study, performed on 80 women attending Obstetrics and Gynecology Department of Benha University Hospital for invitro fertilization/intracytoplasmic sperm injection treatment and private IVF centers. None undergoes more than one prior unsuccessful embryo transfer.

Method of randomization:

Simple random sample, which is a subset of individuals (a sample) chosen from a larger set (a population). Each individual is chosen randomly and entirely by chance, so each individual has the sample probability of being chosen at any stage during the sampling process, and each subset of k individuals has the same probability of being chosen for the sample as any other subset of k individuals (Yates et al., 2008).

Methods:

The patients will be subjected to the following:

* History.
* General examination.
* Endometrial secretion aspiration.
* Determination of the cytokine profile.
* Detection of implantation rate.

Inclusion criteria:

1. Age younger than 37 years.
2. Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
3. Body mass index less than 35 kg/m2.
4. Serum follicle stimulating hormone and estradiol were within normal ranges.

Indications of IVF:

Tubal pathology, unexplained infertility, and male factor.

Exclusion criteria:

Gross uterine pathology.

Steps of performance:

All women having the inclusion criteria were subjected to super ovulation protocols followed by hcg adminstration when the follicles reached 18-20 mm . Ovum retrieval were done at 35 hours following hcg injection.

Five millilitre of salin are injected intrauterine then aspirated after ovum retrieval.Endometrial secretions, aspirated immediately after ovum retrieval from 80 women undergoing IVF, will be analyzed using a multiplex immunoassay for soluble regulators of implantation, namely Interleukin (IL)-1b, Tumor Necrosis Factor (TNF)-a,. In order to detect implantation predictors.

Eligibility Criteria:
Inclusion Criteria:

1. Age younger than 37 years.
2. Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
3. Body mass index less than 35 kg/m2.
4. Serum follicle stimulating hormone and estradiol were within normal ranges.

Exclusion Criteria:

* Gross uterine pathology.
Serum Bupivacaine Concentration Levels After Injection of Liposomal Bupivacaine Into the Knee

Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.

Exclusion Criteria:

* Known hepatic dysfunction or renal insufficiency (creatinine \> 1.5 mg/dL);
* allergy to the study medications;
* pregnancy;
* incarceration;
* inability to communicate with the investigators;
* morbid obesity (body mass index \> 40 kg/m2).
INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP

This study will use specific diagnostic tests on a group of patients who are experiencing symptoms typical of acute hepatic porphyria (AHP) to determine how many have the condition, and to potentially help improve the diagnostic process for patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 16 years of age
* Recurrent and severe episodes of abdominal pain that last for at least 24 hours
* At least 1 episode of severe abdominal pain that required an urgent healthcare visit in the past 12 months
* Other symptoms related to AHP that your doctor will discuss with you
* Willing and able to comply with protocol required assessments and provide written informed consent

Exclusion Criteria:

* Known diagnosis of AHP
* Alternative explanation for abdominal pain with clinical response to treatment specific for alternative diagnosis
Language Learning and Language Experience

The goal of this clinical trial is to learn if text can support children in learning new verbs in healthy children ages three through six. The main questions it aims to answer are:

Does text support help children learn new verbs? Does a child's relative benefit from text support vary according to their literacy skills?

Participants will

* Watch videos of actions and hear novel words
* Name alphabet sounds to determine their literacy skills


Eligibility Criteria:
Inclusion Criteria:

* Primarily exposed to English
* Typical development
* Hearing and vision within normal limits or corrected to be so
Staged Versus Simultaneous Bilateral Knee Arthroplasty

The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"

This is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral KA. The primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. Secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs.

This trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients considering bilateral knee arthroplasty
* Patients must sign the consent form
* Patients must be willing to complete the study questionnaires for the duration of the study

Exclusion Criteria:

* Patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee
* patients who are unable to complete the questionnaires
Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

Many people with spinal cord injury are no longer able to walk and must use wheelchairs for mobility. These individuals experience greater rates of depression and lower quality of life. Many of these individuals express a strong desire to walk again, and report many psychosocial benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs allow only limited community access, creating an additional obstacle to seeking out meaningful social roles in the community. Currently, there is new technology called robotic exoskeletons that would allow people with spinal cord injury to walk. These robotic exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to community access. Current research has examined training with robotic exoskeletons indoors over level surfaces in clinical settings. This study will examine the potential for everyday use, including ramps, stairs, curbs and indoor and outdoor use.


Eligibility Criteria:
Inclusion Criteria:

* SCI level C6-8, T1-T12; L1-L5 incomplete or complete
* Be able to physically fit into the exoskeleton device;
* Be able to tolerate upright standing for a minimum of 30 minutes;
* Have sufficient upper body strength to use forearm crutches in standing and during ambulation (including full triceps strength and good hand function);
* Have hip, knee, and ankle range of motion within normal functional limits of walking;
* Have the ability to follow directions and demonstrate learning capacity;
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Cervical level SCI above C6
* History of severe osteoporosis;
* Weight above 220 pounds;
* Femur length above 47 cm or below 36 cm
* Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation;
* Cognitive and/or communication disability (e.g. due to brain injury);
* History of significant problems with skin break down or current skin break down;
* Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
* Pregnancy;
* Cardiovascular conditions such as history of heart attack, high blood pressure, pacemaker, arrhythmia, heart failure, or stroke.
Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients

Glycemic variability in critically ill patients is a recognized negative prognostic factor. The molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to influence glucose homeostasis by interfering in intracellular insulin signaling.

Aim of this study is to ascertain whether differential expression of PTEN in critically ill patients correlates with glycemic variability and clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* trauma
* provision informed consent

Exclusion Criteria:

* diabetes
* impaired fasting glucose levels
Weight in Lower Limbs Improves Gait Ataxia of in Machado-Joseph Disease Patients

Few studies evaluated the efficacy of adding weights on the lower limbs in patients with ataxic disorders. There is no current evidence on which would be the most appropriate weight for use in this context. To assess progress and benefits of using this load, gait of symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective of the study is to evaluate the gait with and without different load weights on lower limbs. Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about which weight they prefer for walking.


Eligibility Criteria:
Inclusion Criteria:

* Patients should have between 18 and 65 years of age and independent gait

Exclusion Criteria:

* Were the need of assistive devices for walking ≤ 10m (such as crutches, wheelchairs and orthotics)
* Item gait of Scale for the Assessment and Rating of Ataxia (SARA)19≥, presence of other neurological disease that affect motor system
* Orthopedic impairments of lower limbs (fractures or surgeries in the past 6 months)
* Difference between the lower limbs greater than 3.0 cm
18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients

A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.


Eligibility Criteria:
Inclusion Criteria:

1. age \>= 18 years old;
2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024;
3. Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
4. Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.
Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma

This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months

The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed ovarian cancer
* Stage IIIB/IV
* Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval \> 6 months
* Presence of two-dimensional measurable disease.
* Life expectancy of more than 3 months.
* Age ≥ 18 years.
* Performance status (WHO) 0-2
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
* Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl)
* Informed consent

Exclusion Criteria:

* Pregnant or nursing
* Psychiatric illness or social situation that would preclude study compliance'
* Other concurrent uncontrolled illness
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* Other concurrent investigational agents
Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation

The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. The purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. Sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. Based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at less than or equal to 30 0/7 weeks gestation
* Infants will be enrolled within the first 48 hours of life

Exclusion Criteria:

* Gastrointestinal anomalies
* Lethal malformations
* Parental denial of consent or request for removal from study
A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies

Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Patients who received at least one administration of the following therapies: casirivimab-imdevimab, bamlanivimab-etesevimab, tixagevimab-cilgavimab, regdanvimab, sotrovimab or adintrevimab

Exclusion Criteria:

* Patients opposed to the collection of their personal data