cyrilzakka/clinical-trials huggingface dataset:
A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers

The purpose of this study is to determine the safety of the study drug known as abemaciclib in native Chinese participants with advanced and/or metastatic cancers.


Eligibility Criteria:
Inclusion Criteria:

* The participant must have histological or cytological evidence of cancer which is advanced and/or metastatic, and is an appropriate candidate for experimental therapy in the judgment of the investigator, after available standard therapies have ceased to provide clinical benefit.
* Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Are native Chinese men or women.
* Have adequate organ function, including:

  * Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/Liters (L), platelets ≥100 x 109/L, and hemoglobin ≥9 grams per deciliter. Participants may receive erythrocyte transfusions to achieve this hemoglobin level or platelet transfusions to achieve platelet levels at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after transfusion.
  * Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3.0 times ULN.
  * Renal: Serum creatinine ≤1.2 milligrams per deciliter (mg/dL) for males or ≤1.0 mg/dL for females.
* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Recovered from the acute effects of therapy (treatment- related toxicity resolved to baseline) except for residual alopecia.
* Have an estimated life expectancy of ≥12 weeks.

Exclusion Criteria:

* Have received previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) within 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.
* Have an acute leukemia or other relevant cancers at the discretion of the investigator.
* Females who are pregnant or lactating.
* Participants consuming drugs or foods that are known to be inducers (for example, grapefruit juice, phenytoin, carbamazepine) or strong inhibitors of CYP3A4 should be excluded during Cycle 1.
* Have history or evidence of central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic participants without history of CNS metastases is not required for enrollment.
Analysis of Bacterial Microbiome of Endodontically Infected Primary and Permanent Teeth

Recognition of community profiles in endodontic infections may allow a better understanding of the pathogenesis of the disease and the establishment of more effective treatment protocols.

Therefore, the aim of the present study was to investigate bacterial diversity in endodontically infected primary and permanent teeth using 16S rRNA gene sequencing and QIIME 2TM (Quantitative Insights Into Microbial Ecology 2) bioinformatics pipeline

Endodontic infections are defined as an infection of the pulp and periapical tissues. This infection is caused by microorganisms that invade the pulp via dental caries or dental trauma. In these mixed population infections, anaerobic bacteria have been reported to be conspicuously dominant and the number of microorganisms per canal may vary. Traditionally, the endodontic microbiome has been identified by culture-based (phenotype-based) techniques. Inability to cultivate approximately 40-55% of bacteria in the endodontic microbiome, bias or inexperience of researchers may limit the results of cultural research. Microbiome-based new generation sequencing (NGS), which was initially used in ecological studies, has been widely used in recent years to identify bacterial diversity using the 16S ribosomal RNA (rRNA) gene in endodontic infections microbiome, bias or inexperience of researchers may limit the results of cultural research. There are few studies investigating the endodontic microbiome in primary teeth. However, to the best of our knowledge, to date, there is no metagenomic study that investigates the endodontic microbiome of the primary and permanent teeth. It is a still question of whether there is a difference in the endodontic microbiomes during the mixed dentition period when both dentition types can be seen.

Eligibility Criteria:
Inclusion Criteria:

* have intact roots or \<1/3 of physiological root resorption
* have clinical crowns that permit effective rubber dam isolation
* no mobility, fistula, pus discharge, gingival swelling, periapical abscess or internal resorption.

Exclusion Criteria:

* have marginal periodontitis, a history of pharmacological treatment, antibiotics or fluoride intake within the last 2 months
* a history of cancer, diabetes or immunodeficiency disorders
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients

Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.


Eligibility Criteria:
Inclusion Criteria:

* ARDS defined by Berlin Criteria longer than 24 hours
* Undergoing mechanical ventilation
* Noradrenaline demand \>0.1 mcg/kg/min

Exclusion Criteria:

* Not meeting ARDS criteria
* Noninvasive mechanical ventilation
* ARDS resolved shorter than 24 hours
* Shock resolved
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.


Eligibility Criteria:
Inclusion Criteria:

* patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection

Exclusion Criteria:

* Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases
Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes

primary outcome is vitamin D intake in first trimester for pregnant women with history of gestational diabetes in previous pregnancies and incidence of gestational diabetes recurrence secondary outcome is effect of vitamin D intake on mode of delivery, apgar score and neonatal birth weight

it is a prospective randomized controlled study to determined the effect of vitamin D supplementation in pregnancy in reducing the incidence of gestational diabetes recurrence. it will be conducted at the department of obstetrics and gynecology kasr el ainy hospital faculty of medicine Cairo university from August 2018 to April 2020. we include in our study 430 pregnant women who had history of gestational diabetes in their previous pregnancies. patients with multiple pregnancy or with any medical disorder are excluded from study. BMI will be calculated for each participant at the time of admission and glucose challenge test will be performed for all patients in the first trimester to exclude diabetic patients from the study then a blood sample is taken from all patients enrolled in the study to measure the vitamin D level by ELISA (after fasting 12 hours and not have a fatty dinner) the participants will be assigned to one of three main groups according to the serum 25 OH vitamin D level. pregnant women with normal vitamin D level assigned as group A, pregnant women with lower serum level of vitamin D (\>20 nmol/L) randomly divided into two groups: group B and C. Group B will be given oral vitamin D 2800 units daily till 26 week pregnancy and group C will be given Omega 3 as placebo till 26 week pregnancy. incidence of gestational diabetes will be measured in 24-26 week pregnancy with OGTT and compared in the three groups. All patients will be followed up till delivery. Mode of delivery, Apgar score and neonatal birth weight will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with history of gestational diabetes in previous pregnancies

Exclusion Criteria:

* multiple pregnancy
* pregnant patient with medical disorders
Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from patients with Wilms tumor.

OBJECTIVES:

* To determine whether Wilms Tumor (WT) patients without WT1-associated congenital anomalies or syndromes, but with end-stage renal disease (ESRD) unrelated to progressive bilateral tumors, carry germline WT1 mutations.
* To determine whether non-syndromic WT1 germline mutation carriers have a substantially higher incidence of ESRD than do WT patients who do not harbor WT1 mutations.

OUTLINE: Archived blood and tumor tissue specimens (or DNA isolated from these samples) are analyzed for WT1 mutations by gene sequencing and PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Wilms Tumor (WT)
* Patients who participated in the NWTS-5 protocol

  * Non-syndromic patients who developed end-stage renal disease (ESRD) during 5-10 years for reasons other than progressive bilateral WT
  * Matched control patients who had not developed ESRD by the time (since WT onset) of ESRD diagnosis
* Blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.

Eligibility Criteria:
Inclusion Criteria:

* Advanced-stage solid tumors
* ≥ 18 years of age
* Adequate liver and kidney function

Exclusion Criteria:

* Any other active malignancy
* No known HIV, Hepatitis C or B
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
* Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
* Bi-measurable disease
* ECOG Performance Status of 0 - 2
* Meet all screening laboratory values

Exclusion Criteria:

* Previous treatment with any other anti-CD30 antibody
* History of allogeneic transplant
* Any tumor lesion greater than or equal to 10 cm in diameter
* Any active or chronic significant infection
* Underlying medical condition which will make the administration of MDX- 1401 hazardous
* Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
Early Vascular Ageing Among Cypriots

The LifeEVA project aims to tackle the significant public health challenge of cardiovascular disease (CVD) by addressing early vascular ageing (EVA), characterized by increased arterial stiffness and reduced vascular compliance, particularly in young adults. The project seeks to develop and implement innovative, personalized lifestyle interventions targeting Cypriots aged 18-40 who are overweight or obese. Utilizing genetic data from biobank.cy, LifeEVA aims to understand the progression of EVA and reduce CVD risk through tailored dietary and physical activity counseling.

The methodology involves a prospective, randomized, open-label, blinded endpoint trial over one year. Participants will be recruited from biobank.cy's database, ensuring a robust sample. They will receive personalized interventions based on their genetic profile, including a hypocaloric diet, physical activity plan and taking into account other factors (i.e. sleep, anxiety etc). The project's work is divided into five work packages: project management, dissemination and exploitation activities, baseline assessment and recruitment, intervention implementation and data collection, and data analysis and manuscript preparation.

Anticipated results include significant reductions in vascular stiffness, improved cardiovascular health markers, and enhanced understanding of the interplay between genetics and lifestyle in EVA. The project's impact extends to the establishment of a vascular health assessment clinic, contributions to public health by reducing CVD prevalence, and advancing the field of personalized preventive healthcare. LifeEVA is positioned to make significant contributions to cardiovascular research, promote innovation, and enhance the scientific and public health landscape in Cyprus.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years old.
* BMI≥25 kg/m².
* WC≥0.9 m for men and ≥0.8 m for women

Exclusion Criteria:

* Individuals with a history of eating disorders.
* Those with significant chronic diseases like advanced cardiovascular diseases
* Pregnant or breastfeeding women or women to intend/are in the process of trying to get pregnant within 1-year after intervention onset.
* Individuals currently on medication or diets that significantly affect metabolism or body weight.
* Those who have participated in another weight loss program or study within the last six months.
* Taking any vasoactive medications.
Surveillance and Proactive Intervention for Dialysis Access

Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. Methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. It is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
2. Ability to give informed written consent
3. Aged over 18 at time of referral

Exclusion Criteria:

1. Inability to give informed written consent
2. Aged under 18 at time of referral
3. Inability to attend follow-up appointments

Specific exclusion;

1. Previous arteriovenous access procedures in target limb
2. Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
3. Known thrombophilic or thrombotic pathology
A Study of FT-7051 in Men With MCRPC

This is a Phase 1, open-label study that will evaluate the safety and tolerability of FT-7051 and determine the recommended Phase 2 dose (RP2D) as well as pharmacokinetics (PK), preliminary anti-tumor activity, and pharmacodynamics (PD) of FT-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy.

The starting dose, 25 mg once daily (QD), of FT-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC)
* Previously failed at least one potent anti-androgen therapy
* Castrate levels of serum testosterone
* ECOG performance status 0-2
* Adequate bone marrow function
* Adequate kidney, heart and liver function

Exclusion Criteria:

* Prior solid organ transplant
* Prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment
* Prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation)
* Prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks
* Prior radium-223 therapy within 6 weeks
* Symptomatic, untreated or actively progressing central nervous system (CNS) metastasis
* Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, active or uncontrolled infection requiring systemic therapy) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgement, increase the risk to the patient associated with participation in the study
* Concomitant medications that cause Torsades de Pointes that have not reached steady state before first dose of the study drug
* Concomitant medications that are strong inhibitors or inducers of CYP3A4 or an inhibitor of P-gp
* History of infection with human immunodeficiency virus (HIV)
* Active infection with hepatitis B, or hepatitis C virus
EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section

The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.

The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.

There is a real variability in the volume administered by practitioners repository fault.

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

The secondary objectives are to determine the failure risk factors, the hemodynamic consequences related to the volume administered and evaluate maternal satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant \> 37SA
* Between 150 and 190cm
* IMC between 20 and 40
* Single pregnancy
* Elective cesarean indication during obstetric labor

Exclusion Criteria:

* Presentation of siege
* Extreme and semi emergency caesarean indication
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D

Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter

The study collects a data set for each patient receiving a PROSPACE 3D, PROSPACE 3D Oblique, or TSPACE 3D implant. It is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing

* Basic medical history
* Type of surgical procedure
* Treated segments
* Implant characteristics (including additional implants for anterior/posterior stabilization)
* Scores: ODI, Pain (VAS), EQ-5D
* Patient satisfaction

Eligibility Criteria:
Inclusion:

* Patient is minimum 18 years old
* Written informed consent for the documentation of clinical and radiological results
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion:

- Patient is not willing or able to participate at the follow-up examination
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: a Relation to Periodontal Inflammaging

Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging

Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Aged below 40 or above 60.
3. Have at least 16 natural teeth excluding wisdom.
4. Provide informed consent and willingness to cooperate with study protocol.
5. Periodontitis stage II patients (23):

   * CAL from 3-4 mm.
   * Radiographic bone loss (15% to 33%).
   * No tooth loss due to periodontitis.
   * Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

* 1- Patients with any smoking habits 2- History of antibiotics in the previous three months. 3- Pregnant or lactating female. 4- Treatment with any systemic drug. 5- History of systemic disease. 6- Patients who received periodontal treatment in the last 6 months
Corneal Collagen Cross-linking for Progressive Keratoconus

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of keratoconus
* Documented progression over previous 24 months
* Decreased BSCVA
* Must complete all study visits

Exclusion Criteria:

* Prior corneal surgery or Intacs
* History of delayed wound healing