cyrilzakka/clinical-trials huggingface dataset:
Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy

Primary Objective:

- To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens

Secondary Objectives:

* To determine the RD of cabazitaxel when administered as a single agent every 3 weeks
* To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks
* To estimate the overall survival (OS) and progression free survival (PFS)
* To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1

Patients will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed during and after the study treatment until death or the end of study, whichever comes first.

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (For countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included)
* Signed informed consent

Exclusion criteria:

* Patients who have received \>2 prior systemic chemotherapy regimens for advanced gastric cancer.
* For patients entering part 2, those without at least one measurable lesion at baseline according to Response Evaluation Criteria in Solid Tumors 1.1 criteria
* Eastern Cooperative Oncology Group performance status \>1
* Age \<18 years
* Inadequate organ and bone marrow function
* Prior surgery, chemotherapy, targeted agents, investigational agents, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
* Prior radiation therapy within 6 weeks prior to enrollment (except palliative radiation for a local pain control)
* Previous treatment with cabazitaxel
* Known brain or leptomeningeal involvement of cancer
* Patients with known acquired immunodeficiency syndrome (AIDS) related illness or known HIV infection requiring antiretroviral treatment.
* Patients with active varicella zoster infection, or known hepatitis B or C infection.
* History of severe hypersensitivity reaction ≥ grade 3 to drugs formulated with polysorbate 80 such as docetaxel

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Application of DWI in Diagnosis of Prostate Cancer

This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer.

Diffusion weighted imaging (DWI) plays an important role in the diagnosis and stratification of prostate cancer. Traditional DWI apply the apparent diffusion coefficient (ADC) to reflect the diffusion of tissue water, which is a parameter calculated by a monoexponential model with 2b values. In recent years, the development of multiple b-value DWI facilitates the appearance of many new mathematical models. Different models have different features, but their value of applications in prostate cancer still need to be confirmed. This study was aiming to: (1) compare the parameters derived from monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model between prostate cancer and benign prostatic hyperplasia; (2) compare the difference of these parameters between low-grade (Gleason score ≤ 3+4) and high-grade (Gleason score ≥ 4+3) cancer; (3) find whether these parameters derived from new models are superior to ADC derived from traditional monoexponetial model.

Eligibility Criteria:
Inclusion Criteria:

1. The exam including T1WI、T2WI and multiple b-value DWI.
2. Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam.

Exclusion Criteria:

* 1.No Gleason score data. 2.Awful quality of imagings or artifacts affectting diagnosis. 3.No lesion larger than 0.5cm. 4.Any surgery or treatment before MRI exam. 5.Biopsy in 4 weeks before MRI exam.
Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery

This pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Imaging, using magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. If MRI can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.

PRIMARY OBJECTIVES:

I. Determine the correlation between the genetic and neuroimaging signature of glioblastoma.

II. Determine the correlation between the neuroimaging signature of glioblastoma and prognosis.

OUTLINE:

Patients undergo MRI before and after gadolinium contrast administration, including 3-dimensional (3D) volumetric T1-weighted sequence, fluid attenuated inversion recovery (FLAIR) sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be undergoing surgery for newly-diagnosed glioblastoma
* Subtotal, gross total or biopsy patients will be eligible
* Confirmation of pathology as glioblastoma

Exclusion Criteria:

* Tissue analysis demonstrating pathology other than glioblastoma
* Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction
The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination

According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only 30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be effective. The purpose of this study is comparing pregnancy rates after IUI in women who use CC alone and those who use CC in combination with ethinyl estradiol

The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. All patients will be randomly divided into two groups, A and B. Stimulation will begin on day 3 with the administration of 100 mg of clomifen citrate(CC) daily for 5 days. On day 8, ethinyl estradiol will be given daily for 5 days in group A and placebo will be given for 5 days in group B. Plasma levels of estradiol(E2), Luteinizing hormone (LH) and Follicle-stimulating hormone (FSH) will be evaluated on days 3 and 13 of the menstrual cycle. Ultrasound examination will be done on days 3, 13 and days of HCG administration and IUI for determining of endometrial thickness, number of follicles and size of the dominant follicle.

When the diameter of at least one follicle reached equal or greater than 18 mm, human chronic gonadotrophin (HCG) 10,000 IU will be administered.

The pulsatility index also will be recorded in both uterine arteries on day of HCG administration. A single IUI will be performed 24-36 hours after the administration of hCG. Pregnancy will be confirmed by increasing level of concentration of serum βHCG which will be assessed 14 days after IUI

Eligibility Criteria:
Inclusion Criteria:

* The patients with first treatment cycle
* Age between 25 and 30 years,
* Infertility for at least 2 years' duration,
* Oligomenorrhea or amenorrhea associated with a positive Progesterone challenge test
* Women with normal concentrations of prolactin, free thyroxin and thyroid-stimulating hormone (TSH)

Exclusion Criteria:

* Women whose partners had an abnormal semen analysis according to World Health Organization
* Women who had uterine or tubal abnormalities on hysterosalpingography, and women who had a body mass index of \>30 kg/m2.
Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)

This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of NSAIDs for reasons such as pain management for rheumatoid arthritis or osteoarthritis (3) Patients taking oral NSAIDs at the start of administration of lansoprazole (including patients who start NSAIDs on the same day as the start of administration of lansoprazole)

Exclusion Criteria:

* (1) Patients with gastric or duodenal ulcer (in the active \[A1, A2\] or healing \[H1, H2\] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole
Calcium Levels in Major Trauma

To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .

Primary objective:

* to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage

Secondary objective:

* to build a relation between the level of ionized calcium and the degree of hemorrhagic shock

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old - \< 70 years
2. Major trauma patients.
3. Admission and Ionized calcium measurement before blood transfusions

Exclusion Criteria:

1. patients below 18 years or \> 70 years of age.
2. Pregnant women
3. Arrested patients
4. Patients managed outside the hospital and had received blood transfusions
A Multi-Center Group to Study Acute Liver Failure in Children

The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

The PALF study group will collect clinical, epidemiological and outcome data on children with ALF. This information will be used to develop methods to predict whether a child will recover from the illness without the need for a liver transplant or other life-saving procedure. We believe the methods to predict survival will vary with different patient age groups, but that diagnosis, multi-system organ failure, degree of encephalopathy and level of coagulopathy will be important regardless of patient age. Biological samples, such as blood and liver tissue, will provide opportunities to identify subgroups of patients who have unique treatment requirements and outcomes. In addition, we hope to identify unrecognized mechanisms of liver injury resulting in ALF in children. Eligible study participants will be invited to participate in neurocognitive testing. Since patients that develop acute liver failure experience varying levels of hepatic encephalopathy and cerebral edema, we suspect that there may be residual sub-clinical neurological injury that compromises long-term neurocognitive function. Detailed neurocognitive testing has never been performed in a cohort of children that survive acute liver failure and this study seeks to close that information gap by defining the spectrum of neurocognitive outcomes in this population.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent
* Birth through 17 years of age
* Biochemical evidence of acute liver injury
* Coagulopathy not corrected by vitamin K (or other intervention intended to correct coagulopathy)

  * The presence of encephalopathy (ENC) is required if the INR is at least 1.5 and less than 2.0
  * If INR is at least 2.0, the presence of ENC is not required

Exclusion Criteria:

* Known chronic underlying liver disease
* Multi-organ system failure following heart surgery or ECMO
* Solid organ or bone marrow transplantation
* Acute trauma
* Previously enrolled in the PALF Cohort Study
* Other severe illness, condition, or other reason in the opinion of the investigator that would make the patient unsuitable for the study
Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience

1. To evaluate the role of laparoscopy in diagnosis \& treatment of Non- palpable undescended testis
2. To compare between different laparoscopic techniques
3. To introduce new laparoscopic technique in Assuit university " shehata technique "

Cryptorchidism or undescended testis (UDT) is one of the most common genital anomalies in childhood. Its incidence is 3-5 % in full term newborn, and affect more than one third of premature newborn. The incidence decrease to 1 % at age of 3months. About 20% of UDT are impalpable, and about 50% of these impalpable testes are either vanished or atrophic (1-3).

Many diagnostic methods have been used for the evaluation and management of the undescended testis, including imaging studies and multiple surgical procedures.

Surgical management of UDT is performed to preserve testicular function (spermatogenesis) and to prevent the potential complications of undescended testis(1).

Regarding the optimal age of orchiopexy many recent findings suggest that early intervention (6 -12 months of age) is most beneficial. Other findings suggest that there is high rate of spontaneous descent during the first 3 months of life, so observation of undescended testis is advocated till 3 months of age, if the testis remains non-palpable at 3 months of age, it is unlikely to become palpable by waiting another 3 months. Therefore, diagnostic laparoscopy and orchidopexy could be performed from 3 months of age(2).

For intraabdominal cryptorchidism, laparoscopic surgery has been accepted by most surgeons as the preferred technique for diagnosis \& treatment (4).

Laparoscopic findings in non-palpable testis include ; Absent testis either ; Agenesis ( absence of spermatic vessels and vas deferens ) or vanishing testis ( blind ending of spermatic vessels or vas ) , Canalicular testis ; Penetration of vas and spermatic vessels into the internal inguinal ring with or without directly seeing the testis , Abdominal testis Localized between the inferior renal pole and the ipsilateral internal inguinal ring. Can be low (\< 2cm) or high (\>2cm) from internal inguinal ring , Peeping ; Primarily in intra-abdominal position. The testis introduces itself into the inguinal canal due to the intra-abdominal pressure augmentation during the laparoscopic procedure.(5)

Several techniques have been described for treatment of intra-abdominal testis including microsurgical auto-transplantation, primary laparoscopic orchiopexy (VILO), one- and two-stage laparoscopic Fowler-Stephens procedures, and staged laparoscopic traction orchiopexy (Shehata technique

Eligibility Criteria:
Inclusion Criteria:

* any patient admitted to pediatric unit in Assuit University hospital with non palpable testis ( NPT )below age of 6 years

Exclusion Criteria:

* patients with NPT above age of 6 years
* patients with atrophic or vanishing testis
* patients with previous failed laparoscopic orchiopexy
Measurement of Antioxidant Activity on Postoperative Inflammation in Patients Undergoing Ophthalmic Surgery

This trial hypothesized that novel laser refractive surgery techniques (PRK, LASIK, SMILE) or laser-assisted cataract surgery (FLACAS) could suppress postoperative inflammation and improve recovery in patients by reducing oxidative stress generated by the surgical procedure. It is also intended to verify whether the new laser technology is necessary for clinical use in groups with low antioxidant activity through the detection of antioxidant activity in the eyes of patients.


Eligibility Criteria:
Inclusion Criteria:

* over 20 years old (included)
* corneal refractive surgery or cataract surgery patients

Exclusion Criteria:

* patients with eye infections
* presence of severe retinal disease
* presence of severe eye injury or severe ptosis
Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

There have been considerable efforts to control rising health care costs. One of the more recent developments is the practice of reprocessing single use medical devices. This practice has been shown to provide considerable savings for health care payers. Medical devices have been reprocessed in a number of different medical fields including Orthopaedic Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision saw blades are Health Canada approved and are available at Capital Health.

Beyond the benefits to the environment and cost savings, the investigators do not know if the reprocessed saw blades work better, work worse or the same as non reprocessed saw blades. This study is designed to determine if the reprocessed saw blades used during a TKA work as well as a new saw blade.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic osteoarthritis of the knee indicating surgical intervention
2. Between the ages of 21 and 80 inclusive
3. Ability to give informed consent

Exclusion Criteria:

1. Significant co-morbidity affecting ability to ambulate
2. Flexion contracture greater than 15°
3. Extension lag greater than 10°
4. Tibial subluxation greater than 10 mm on standing AP radiograph
5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
6. Lateral or medial collateral ligament instability (\> 10° varus/valgus)
7. Leg length discrepancy greater than 10 mm
8. Bone quality precluding uncemented fixation
9. Pregnancy
10. Active or prior infection
11. Morbid Obesity (BMI \> 40)
12. Medical condition precluding major surgery
13. Severe osteoporosis or osteopenia
14. Neuromuscular impairment
Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block

the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.

TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* 18-65 aged
* patient undergoing lower abdominal surgery

Exclusion Criteria:

* chronic opioid consumption
* bupivacaine and dexmedetomidine allergies
* coagulopathy
* infection at the needle insertion side
* chronic liver and kidney disease
Impact of SGLT2 on Glucosuria in HNF1A-MODY

Maturity onset diabetes of the young (MODY) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. The most common cause of MODY is due to mutations in the gene hepatocyte nuclear factor 1 alpha (HNF1A) and is consequently named HNF1A-MODY (or MODY3). HNF1A-MODY is associated with urinary excretion of glucose at lower blood glucose levels compared to other types of diabetes. Normally, glucose is reabsorbed by sodium-glucose cotransporter 2 (SGLT2), but SGLT2 is downregulated due to the mutation in HNF1A. Investigators aim to evaluate the impact of the decreased expression of SGLT2 on glucosuria in patients with HNF1A-MODY compared to patients with type 2 diabetes (T2D) using a single dose of an SGLT2 inhibitor during a glucose clamp experiment.

Participants: Patients with HNF1A-MODY (n=12) and patients with T2D (n=12)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* HNF1A-MODY verified by genetic testing (only patients with HNF1A-MODY)
* Type 2 diabetes diagnosis according to World Health Organization (only patients with type 2 diabetes)
* Treatment with diet and/or a glucose-lowering drug (only patients with HNF1A-MODY)
* Normal haemoglobin (males 8.3-10.5 mmol/l, females 7.3-9.5 mmol/l)
* Informed consent

Exclusion Criteria:

* Nephropathy (estimated GFR \<60 ml/min/1.73m2 and/or albuminuria)
* Known significant liver disease and/or plasma alanine aminotransferase (ALT) and/or plasma aspartate aminotransferase (AST) above 2 × normal values)
* Pregnancy or breastfeeding
* Treatment with SGLT2 inhibitor
* Fasting plasma glucose \> 10 mmol/l
* Family history of HNF1A-MODY (only patients with type 2 diabetes)
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)

This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).

Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, male or female
* For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
* Recurrence after previous treatment with glucocorticoids is ineffective or effective
* No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
* Platelet count before enrollment ≤ 30 × 109 / L, or \> 30 × 109 / L but with active bleeding
* Volunteer to participate in the study and sign the informed consent form

Exclusion Criteria:

* pregnant or lactating
* Those with a history of thrombosis
* severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
* Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
* In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
* Severe or uncontrollable infections
* have a history of mental illness
* The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.