cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours

Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan \& 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.

Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.

Eligibility Criteria:
Inclusion Criteria: (major)

* non-metastatic pancreatic cancer
* Performance status 0-1
* Bilirubin \< 1.5 UNL
* Written informed consent

Exclusion Criteria: (major)

* no prior abdominal radiotherapy
* no prior chemotherapy for pancratic cancer
* no severe comorbidity
* patients must be able to undergo potential abdominal surgery
Taste and Palatability of Orfadin Suspension

The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

This is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric patients. The treatment period is three days, and during the study the subjects will rate the taste and palatability of the suspension or (for younger children) their parents will rate the child´s acceptance of the suspension.

The study consists of a screening period, a 3 day treatment period and a 1 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HT-1 currently managed on Orfadin (nitisinone) capsules.
* Age from 1 month to less than 18 years.
* Signed informed consent.

Exclusion Criteria:

* Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
* Enrollment in another concurrent clinical study, or intake of an investigational medicinal product (IMP), within one month prior to inclusion in this study.
* Foreseeable inability to cooperate with given instructions or study procedures.
A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin

This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years old and above diagnosed with neuropathic pain.

Exclusion Criteria:

* Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.
The Research of Constructing a Risk Assessment Model for Gastric Cancer Based on Machine Learning

Based on the gastric cancer database established earlier, this project explored the PG standard suitable for Chinese people, and further explored the establishment of machine learning model to stratify gastric cancer risk in the population, guide the frequency of gastroscopy screening, and extract important gastric cancer risk factors from it.Establish electronic health records of gastric organs, track the development and outcome of gastric diseases through deep learning method, in order to predict the development and outcome of gastric diseases;Then, the simulation hypothesis deductive method is used to compare the outcomes that may be caused by different lifestyles with the help of deep learning model, so as to guide patients to develop a better lifestyle and explore the establishment of health management paths for gastric cancer patients and high-risk groups in China.


Eligibility Criteria:
Inclusion Criteria:

* 1） intention to undergo gastroscopy during health checkup examination; and 2) 25-75 years of age

Exclusion Criteria:

* 1) a history of gastric ulcer, gastric polyp, or GC; 2) a history of gastrectomy; 3) treatment with a proton pump inhibitor in the last month; 4) contraindications to gastroscopy; 5) a history of Hp eradication; 6) a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month or 67) incomplete data.
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment

The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or have renal impairment
* Females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy
* Negative drug, alcohol, and HIV tests.

Exclusion Criteria:

* Taking a medication or therapy not approved by the study doctor
* Rapidly changing kidney function
* Drug or alcohol abuse within past 6 months
* Used an investigational drug in the past 30 days
* Females who are pregnant or nursing
* Have active hepatitis B or C
Correlation of Cerebral Oxygen Saturation Measured From 2 Sensor Sites: Forehead vs. Temporal

Cardiac surgery and neurosurgery may decrease cerebral blood flow leading to cerebral dysfunction. Regional cerebral oxygen saturation (rScO2) monitor via Near-infrared spectometry (NIRS) is recommended for early detection and correction. The standard site of NIRS sensor is forehead area which is impractical in operation with incision at forehead area. The investigators suggest an alternative sensor site at temporal area. The objective of this study is to assess the correlation of rScO2 measured from sensor attached at forehead vs. temporal area.

Cardiac surgery and neurosurgery may decrease cerebral blood flow leading to neurologic morbidity, e.g., postoperative stroke, delirium, or postoperative cognitive dysfunction. Regional cerebral oxygen saturation (rScO2) monitor via Near-infrared spectometry (NIRS) is thus recommended for early detection and correction. Murkin et al.(2007) conducted a randomized controlled trial in coronary artery bypass graft (CABG) with NIRS monitoring showed that patients who received intervention to avoid rScO2 \< 75% of baseline had less major organ morbidity including stroke, and mortality. Senanayake et al.(2012) revealed that NIRS could decrease neurologic complication in patients undergoing ascending aortic replacement with moderate hypothermic circulatory arrest.

The standard site of NIRS sensor is forehead area. There are some types of surgery involving incision at forehead area which makes it not possible to attach sensor at this site. The investigators propose an alternative sensor site at temporal area to be used in such situation.

The objective of this study is to assess the correlation of rScO2 measured from sensor attached at forehead vs. temporal area.

Eligibility Criteria:
Inclusion Criteria:

* age =/\> 18 y
* undergoing elective cardiac surgery
* American Society of Anesthesiologists (ASA) classification II-III

Exclusion Criteria:

* history of intracranial or carotid vascular disease
* previous surgery at face or brain
* abnormal anatomy of face
* re-do surgery
Adoptive Immunotherapy for CMV Disease

Treatment strategy of patients:

Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.

Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.

Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.

Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.

Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.


Eligibility Criteria:
Inclusion Criteria:

* For Patient:
* Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
* Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
* Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
* Patients with HLA phenotype for which a relevant peptide for CMV exists.
* For Donor:
* Consenting sibling \>18 years old.
* HLA phenotype for which a relevant peptide for CMV exists.

Exclusion Criteria:

* For Patient:
* Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
* For Donor:
* Consenting sibling \>18 years old.
* HLA phenotype for which a relevant peptide for CMV exists.
* Donor with an infectious disease (e.g. HIV-1; HBV, etc.)
FGR Diagnostic Criteria in Predicting Adverse Neonatal Outcomes

The purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW \<10th percentile according to the Hadlock growth standard).


Eligibility Criteria:
Inclusion Criteria:

* Participants included in this study will have the following criteria:

  * Pregnancies complicated with FGR (EFW \<10th percentile).
  * Singleton pregnancy.

Exclusion Criteria:

* • Fetal structural malformations or chromosomal abnormalities as detected by neonatal examination and anomaly scan during pregnancy.

  * Identified infectious etiologies detected during immediate postnatal examination or during pregnancy.
  * Gestational age cannot be calculated accurately.
  * Missing antenatal or perinatal outcome data.
An Anti-inflammatory Diet Effect on Metabolic, Inflammatory and Immune Status of Obese Younger Adults

Diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. The present intervention study aims to evaluate the effect of an anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among young adults of the obese younger adults.

Obesity pandemic presents a major challenge to chronic disease prevention worldwide. A low-grade chronic inflammation is associated with obesity and related cardiometabolic disorders, such as cardiovascular diseases, type 2 diabetes and some type of cancers. Diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. The present intervention study aims to evaluate the effect of an anti-Inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among younger adults. A nutritional intervention based on an energy-restricted anti-inflammatory diet will be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein). The inflammatory potential of the diet will be assessed with the Dietary Inflammatory Index®.

Eligibility Criteria:
Inclusion Criteria:

* adults age of 18 to 50 years
* body mass index ≥ 30 kg/m2
* with or without obesity related complications

Exclusion Criteria:

* smoking
* chronic hearth, renal and/or liver diseases,
* active carcinoma or having carcinoma in last year
* anti-inflammatory and/or immunosuppressive drugs intake
* changing the existing medication therapy
* persons older than 50 years
* active infection and/or surgical procedure in last 3 months
* nutritive allergy or intolerance to any anti-inflammatory diet constituent
* pregnancy
Intelligent Control Approach to Anemia Management

First clinical evaluation of "Smart Anemia Manager" algorithm.

The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.

Eligibility Criteria:
Inclusion criteria:

1. ages 18 to 80,
2. receiving dialysis treatment,
3. receiving or expected to receive ESA treatment,
4. adequacy of dialysis Kt/V \>= 1.2,
5. adequate iron stores (Ferritin \> 200 ng/mL, TSat \> 20%).

Exclusion criteria:

1. life expectancy less than 12 months,
2. frequent uncontrolled blood loss,
3. frequent dialyzer clotting,
4. frequent access related problems,
5. active infections,
6. severe cardiac disability,
7. coronary bypass within three months prior to the study
8. documented resistance to ESA
9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age over 18 years
* Histologically proven squamous cell cancer of the head \& neck (SCCHN)
* Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3

Exclusion Criteria:

* Hypersensitivity to ZD1839 or any of the excipients of this product
* Tumour stage M1
* Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
* Absolute neutrophil counts \<1.5 x 109
Adaptive Response of Brain Towards Resistance Training in Healthy Individuals

The novelty of this study is to identify the mechanism of nervous system by applying resistance training intervention in healthy individuals.

Resistance training is a form of exercise that is popular particularly for its role in improving athletic performance by increasing muscular strength, power and speed, hypertrophy, local muscular endurance, motor performance, balance and coordination. The objective of the study is to find out the effects of resistance training on Central and Peripheral Nervous System in healthy individuals. A total of 100 participants will be included in the study including both male and female. The study will be divided into two main groups. Experimental group will perform 8-12 Reps with 1.5 sec concentric and 1.5 sec eccentric contraction of bench press with 90 sec of rest between sets with 2 sets per week for 2 months.

1RM of control group will be calculated through the same method and the training protocol for the Control group consisted of 5 attempts to lift as much weight as possible one time for that training visit with 90 seconds of rest between attempts. The load was progressively increased each attempt to try to reach or exceed their previous 1RM.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index should be 18.5-24.9 kg/m2.
* Participants were untrained and had not engaged in resistance exercise within 6 months prior to beginning the study.

Exclusion Criteria:

* Participants with any kind of Gastrointestinal Tract disturbance will be excluded from the study.
* Participants with any kind of Musculoskeletal injury will be excluded from the study.
* Participant with any kind of Neurological disturbance will be excluded from the study.
* Participants who use tobacco products within the previous 6 months.
* Participants who take any type of medication within the previous 6 months.
HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes

Targeted therapies offer promise to improve oncologic outcomes in esophagogastric adenocarcinoma (EGA). The landmark 'Trastuzumab for gastric cancer (ToGA)' trial established the therapeutic value of Human Epidermal Growth Factor Receptor 2 (HER2) directed therapy in advanced gastric and esophagogastric junction adenocarcinoma, setting a standard of care. Further studies, such as DESTINY-gastric01 and DESTINY-gastric02, have demonstrated the efficacy of antibody-drug conjugates (ADCs) targeting HER2-positive gastric and junctional tumours. The use of HER2-directed therapies in the curative intent setting has more recently been evaluated with favourable outcomes in phase II studies. However, data regarding the prevalence and prognostic significance of HER2 overexpression among patients undergoing treatment with curative intent are limited. Furthermore, few studies have evaluated the clinical significance of intratumoural and tumour-metastatic heterogeneity of HER2 expression, and the finding of HER2-low, in this context, which may have important implications for implementation of neoadjuvant targeted therapies in future. While limited single centre series have evaluated the clinicopathologic significance of HER2 status in EGA, no previous international multicentre study of this nature has been reported.

The goal of this international, multi-center, retrospective observational study is to elucidate the prevalence and clinical significance of HER2 expression in patients with EGA across different regions globally. The study also aims to assess the clinical significance of HER2 heterogeneity in a large, international cohort of patients with EGA, and its association with clinicopathological outcomes in patients with advanced and recurrent disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed EGA from 2000 to April 2024 across all stages of disease
* Primary tumour HER2 status tested as routine in all patients with EGA
* Patients aged 18 years or over

Exclusion Criteria:

- Patients with esophageal squamous cell carcinoma
Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma

The purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women 18 years and older
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Histologically-confirmed unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular melanoma
* Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects may have had other prior systemic treatment for localized or metastatic disease
* Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in Immunosuppression (\>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration

Exclusion Criteria:

* Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
* Life expectancy \< 6 weeks
* Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
* Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab