cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study on the Prediction of Radiation-induced Brain Injury in Patients With Nasopharyngeal Carcinoma

Radiation therapy has become the preferred treatment for nasopharyngeal cancer due to the sensitivity of nasopharyngeal carcinoma to radiation. However, even with the use of intensity-modulated radiation therapy (IMRT), radiation-induced temporal lobe injury (RTLI) can be a severe complication. Patients with RTLI may experience long-term memory loss, personality changes, physical dysfunctions, and other symptoms, which seriously impair their quality of life and long-term prognosis. Currently, the diagnosis of RTLI primarily relies on clinical symptoms and imaging examinations such as computed tomography (CT) and conventional MRI. However, these methods only enable the diagnosis of RTLI at a late stage when it is irreversible and cannot be effectively treated. Therefore, the early identification or individualized prediction of RTLI after IMRT holds exceptional importance for improving the quality of life in nasopharyngeal carcinoma patients.

The exact mechanism of RTLI remains unclear. Many clinical covariates have been proven to be associated with RTLI in NPC patients, including stage, age, and dosimetric parameters. In addition, it was reported that each patient's temporal lobe exhibits unique genetic susceptibility to radiation exposure. In this study, we aim to predict the occurrence of RTLI by analyzing clinical factors and heterogeneity of temporal lobe tissue prior to irradiation. Finally, we want to construct and validate a prediction model for RLTI, which can support clinician decision-making in developing individualized treatment plans and providing preventive measures.


Eligibility Criteria:
Inclusion Criteria:

* (1) pathological confirmation of NPC; (2) receipt of IMRT; (3) nasopharynx-neck MRI within 2 weeks before antineoplastic treatment

Exclusion Criteria:

* (1) temporal lobe invasion; (2) with central nervous system diseases except RTLI; (3) receiving additional radiation after IMRT; (4) incomplete clinical or imaging data
National Cancer Institute Thai Cancer Anemia Survey

The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.

Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer

Exclusion Criteria:

* N/A
Prognostic and Predictive Impact of uPA/PAI-1

Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as stratification criteria and randomized high-risk patients to chemotherapy versus observation; low-risk patients remained without any systemic therapy. The trial was designed to answer two principle questions:

1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who are candidates for being spared necessity and burden of adjuvant chemotherapy?
2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?


Eligibility Criteria:
Inclusion Criteria:

* N0 breast cancer patients tumor size \>/= 1 and \</= 5 cm in diameter undergoing standard loco-regional treatment

Exclusion Criteria:

* M1 status
MR Imaging Study Using the Northern Alberta Linac-MR (Northern LIGHTs - 1)

Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). The purpose of this pilot phase of the study is to test whether the Alberta linac-MR P3 system at the Cross Cancer Institute can acquire high quality MR images safely. It will allow the researchers to develop the best collection of MR images possible with this new machine, in order to allow them to visualize tumors for future patients that are treated on this machine.

This prospective, pilot phase, clinical trial is an imaging study to optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy in adult patients with cancer that are treated with high dose external beam radiotherapy. Each participant will undergo a single MR imaging session (30 - 40 minutes) on the Alberta linac-MR P3 system. Towards the end of the study, patients will be approached to participate in an optional sub-study, where they will undergo a total of five MR imaging sessions (performed every two to five days) to allow for an assessment of inter-fraction motion.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist

Exclusion Criteria:

* Patients with contraindications for MRI
* Patients who are unable to lie flat and still for the duration of the expected scan acquisition
* Patients who are unable to provide informed consent
Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)

Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation and antioxidant medication. They are carefully monitored with visits to clinic, laboratory testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts and liver and kidney function. On a serial basis, no more often than once a year, the patients undergo a series of tests under anesthesia, including electroretinogram (ERG), brainstem audiometry (ABR), and ophthalmologic exam under anesthesia to follow pigmentary retinopathy.

Smith-Lemli-Opitz Syndrome (SLOS) is an autosomal recessive disorder caused by a metabolic error in the final step of cholesterol biosynthesis, leading to cholesterol deficiency and accumulation of the cholesterol precursor, 7-dehydrocholesterol.Patients with SLOS display complex medical problems including growth failure, intellectual disability, behavioral disorders, progressive retinal dystrophy, hearing loss and photosensitivity. Dr Elias was one of the original geneticists who discovered the cause of this disorder in 1994, and ever since has been treating SLOS patients with cholesterol supplementation. In 2008, a second medication called AquADEKS, a mixture of vitamins and other compounds with antioxidant properties was added to the treatment regimen. AquADEKS has since been replaced with a comparable medication named DEKAS plus.The purpose of the DEKAS plus is to allow treatment with antioxidant medications in an effort to prevent retinal degeneration, hearing and skin problems associated with SLOS.

This protocol has been approved by the Colorado Multiple Institutional Review Board and supported by the Clinical Translational Research Center (CTRC) since 2001. The following updated information is available about the protocol:

1. Research has revealed that oxysterols are toxic compounds made from the cholesterol precursor, 7-dehydrocholesterol. These oxysterol compounds are severely neurotoxic and toxic to the retina, and treatment with antioxidants may help lower their levels, resulting in slowing of retinal deterioration. Testing of oxysterol levels in patients with SLOS is now ongoing, in collaboration with a laboratory at University of Washington in Seattle (Dr Libin Xu). It is hoped that testing of oxysterol levels in blood may help provide more updated info to help guide treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Smith-Lemli-Opitz Syndrome
* Elevated levels of 7-dehydrocholesterol and 8-dehydrocholesterol
* Must be able to travel to Children's Hospital Colorado annually
* Must have insurance coverage for ERG/ABR studies

Exclusion Criteria:

* absence of detectable 7-dehydrocholesterol/8-dehydrocholesterol
* allergy to Antioxidant medication
Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

PATIENTS \& METHODS Patients that will be offered to join the study are those that will be with either treated by a Methotrexate injection or those that had signs of self resolution with our "Watchful waiting" protocol.

Eligibility Criteria:
Inclusion Criteria:

All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of Gynecology, Lis Maternity Hospital.

Exclusion Criteria:

none
A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor

IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18-80 years.
2. Subjects who are willing to comply with study procedures.
3. Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
4. Subjects with a known diagnosis of primary head and neck cancer, with or without metastases.
5. Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
6. Subjects with a measurable tumor by either ultrasound, MRI or CT.
7. Subjects with ECOG performance status of 0 -2.

Exclusion Criteria:

1. Subjects with life expectancy of less than 3 months.
2. Pregnant or breastfeeding women.
3. Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV\<50% predicted for age.
4. Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance \< 40 ml/min, calculated by using the Cockroft and Gault formula.
5. Reduced hepatic function, defined as ASAT, ALAT, bilirubin \> 1.5xULN and PK-INR \> 1.5, or a known medical history of liver cirrhosis or portal hypertension.
6. Blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl.
7. Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening.
8. Participation in any other clinical trial that included an investigational device or medicinal product.
9. Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female \>/= 18 years old
2. ECOG Performance Status 0 to 1
3. Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.
4. Measurable AND evaluable lesions at baseline per RECIST v1.1.
5. Eligible subjects must meet all of the following criteria:

   * Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting);

     * Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression
   * Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)

     * Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.
   * ≤ 1 prior line of chemotherapy in the metastatic setting
6. Adequate organ function
7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
2. Pregnant or planning to become pregnant
3. Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
4. Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
5. Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. A total of 580 patients will be accrued over 7 years. Treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age: 0 to 18 years
* Prior untreated acute myeloid leukemia (AML) of following cytological types : FAB M0, M1, M2, M4, M4 eosinophil, M5, M6, M7, without FAB classification or showing myelodysplasia (blasts \> 20 %)
* Isolated myeloid sarcoma
* Achieved complete remission
* No HLA identical family donor, except for the patients with t(8;21)
* No contraindication for the use of interleukin-2

Exclusion Criteria:

* Trisomy 21
* Promyelocytic leukemia (M3) or M3 variations
* Secondary AML
Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin

To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.

BACKGROUND:

A baseline study on the vertical transmission of hepatitis B virus in Taiwan revealed that 15 percent of all pregnant women were persistent carriers of hepatitis B antigen and that 40 percent of their new babies developed a protracted antigenemia during the first 6 months of life. The incidence of acute hepatitis, cirrhosis, and hepatoma was high in Taiwan, and patients with these disorders had a fivefold to sixfold higher prevalence of hepatitis B antigen than healthy persons. Given the important public health problems of this disease in Taiwan and the rest of the Third World, this trial sought to answer the important question of whether hepatitis B immune globulin with a high level of antibody against the antigen would be of utility in combating the problem.

Two hundred and five babies were accepted into the study, which was actually conducted on Taiwan through a contract to the Community Blood Council of Greater New York. Only those babies born of mothers who had HBsAg complement fixation titers of 1:8 or greater were included in these studies. At birth, blood was obtained from the mothers and cord blood from the infants. Follow-up bloods were obtained from both the mother and baby when the infants were 1, 3, 6, 12, 24 and 36 months of age. In addition, all household family contacts were bled at least once during this period.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. A total of 205 neonates were assigned to treatment with high-titer hepatitis B immune globulin, standard immune globulin, or albumin placebo within 72 hours of delivery.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface antigen carriers.
Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Age of patient \<40 years
* Irregular astigmatism
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* AMD suspicious eyes
* Complicated surgery
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis

The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis
* stable peritoneal dialysis with Baxter connection system
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* already on icodextrin dialysate prior to acute presentation with peritonitis
* known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease
* participation in another interventional study within last 30 days of randomization
* history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures