cyrilzakka/clinical-trials huggingface dataset:
Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia

This study is being conducted to examine the safety of the investigational drug, Xilonix(™), in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a syndrome that includes involuntary weight loss and physical deterioration that can contribute to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass in advanced cancer patients. This increase could lead to improved weight maintenance and quality of life.

This study will prospectively evaluate advanced pancreatic adenocarcinoma patients. The intervention will be interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy. The first aim is to assess the safety and identify the maximum tolerated dose of Onivyde with 5-fluorouracil/folinic acid in combination with the study agent, Xilonix. The study will also create a repository of serum, tissue, and fecal specimens to investigate novel biomarkers related to cachexia with pancreatic adenocarcinoma and interleukin-1-alpha blockade. Lastly, the study will assess for a correlation between cachexia, activity, and PROs on domains of quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy that has progressed through or intolerant to gemcitabine based chemotherapy
* Cachexia defined as greater than 5% unexplained weight loss within any 6 month period prior to screening visit OR as documented by the medical physician based on standard diagnosis of cachexia
* Age ≥ 18 years
* ECOG performance status 0-2 or Karnofsky PS \>60%
* Patients must have normal organ and marrow function
* Ability to understand and the willingness to sign a written informed consent
* Negative pregnancy test for WOCBP
* WOCBP and men must agree to use of adequate contraception

Exclusion Criteria:

* Patients who are currently receiving any other investigational agents
* Patients who have received more than one chemotherapeutic regimen in metastatic setting
* Patients with CNS metastases
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment
* Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix or Onivyde
* Women who are pregnant or breastfeeding
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* Patients with known Dihydropyrimidine dehydrogenase deficiency (DPD deficiency)
* Patients known to be UGT1A1\*28 allele homozygous
* Patients who have had a live vaccine within 3 months of enrollment
Symphony IL-6 Study in Patients at Risk of Severe Sepsis

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment in a near patient setting.

This study is to establish an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 and/or influenza infection.


Eligibility Criteria:
Inclusion Criteria:

* Whole-blood specimen collected in EDTA anticoagulant tube
* Subject is 22+ years of age
* A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
* Subjects who have concurrently received CRP test results
* Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.

Exclusion Criteria:

* Subject is receiving an anti-IL-6 treatment
* Hemolyzed specimens
Non-surgical Spinal Decompression in Patients with Chronic Low Back Pain

The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.

The main questions it aims to answer were:

* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?
* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?

Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 years old.
* Chronic (at least six months) low back pain (LBP) and/or sciatica.
* Abnormalities of intervertebral disc on magnetic resonance imaging (MRI).

Exclusion Criteria:

* Patients with prior spine surgery.
* Vertebral instability.
* Cancer.
* Current infectious disease.
* Pregnancy.
* Kinesiophobia.
* Fibromyalgia.
Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.

To Check the effects of the low dye taping technique versus the Robert Debre method on foot posture and range of motion in children with club feet.

This study was a Randomized clinical trial. It was carried out in the physiotherapy department of children hospital Lahore,those patients were taken who had congenital clubfoot.40 patients were taken with the predetermined inclusive and exclusive criteria through non probability convenience sampling technique.All participants informed about the study,Group A received Low Dye taping Technique 2 times in a week for 6 weeks,while the group B received the Robert Debre Methpod daily 30 minutes session for total 6 weeks.Foot posture, range of motion and gait will be assessed by Demiglio bensahel and pirani scoring system with the help of goniometer and compared the results.Data analyzed by SPSS 25.0 statistical software. After checking the normality of data nonparametric tests applied to check the difference between and within the groups.

Eligibility Criteria:
Inclusion Criteria:

1. (1month to 6months ).
2. Children having idiopathic club foot
3. Unilateral or bilateral
4. Severity by Dimeglio Bensahel scale we include moderate ,severe and very severe feet

Exclusion Criteria:

1. Benign or non idiopathic.
2. An associated syndrome or neurological disease.
3. Positional club foot.
4. Those previously treated with another method in other hospitals.
5. Children with systemic diseases.
6. Juvenile Arthritis.
A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection


Eligibility Criteria:
Inclusion Criteria:

* Chronically infected with HCV genotype 1
* Treatment naive or treatment non-responders or treatment intolerant
* HCV RNA viral load of ≥10\*5\* IU/mL
* BMI 18 to 35 kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
* Co-infection with HIV or HBV
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
* Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.

Exclusion Criteria:

* All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
* Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
* Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice

Background: Clinical trials often include patients from large hospitals or university clinics. Information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps.

Aims/Objectives:

The present study has three aims: First, to systematically describe the patient population of a large group practice for internal medicine. Second, to identify high-risk patients using established risk scores. And third, to include routine imaging data to optimize patient management.

Methods/Facility Enrolling Participants: This is a prospective, observational study assessing patients' baseline characteristics, risk evaluation and integrating data from imaging test. The setting of the present study is a large group practice for internal medicine which consists of statutory health insurance-accredited physicians. Study participants will be included during daily routine, real-world clinical care and therefore represent all-comers fulfilling the inclusion criteria:

1. Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules.
2. Routine laboratory results available within the last 3 months.
3. Available imaging data within the last 3 months performed on site. Perspective: The study is designed to evaluate the current situation and quality of health care in defined patient populations in the routine clinical setting of a large-scale public office. These data will provide a profound rationale to identify quality issues and limitations in our performance of guideline-conform treatment in routine patient care.


Eligibility Criteria:
1. Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules.
2. Routine laboratory results available within the last 3 months.
3. Available imaging data within the last 3 months performed on site.
Observational Study in Bariatric Surgery

Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.

According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.

Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.


Eligibility Criteria:
Inclusion Criteria\*:

* Adult obese patients (≥ 18 years and BMI ≥ 35 Kg/m²), both sexes
* Any elective bariatric surgery
* Neuromuscular blockade with rocuronium
* Maintenance of anesthesia with a halogenated agent
* Free patient, without guardianship or subordination
* Patients with a social security coverage
* No opposition given by the patient after clear and fair information

Exclusion Criteria\*:

* Patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine,
* Emergency surgery,
* Severe renal and / or hepatic insufficiency,
* Persons benefiting from enhanced protection, namely pregnant women, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally sick people in emergency situation.
Self-management Education in Multi-professional Health Centres

The goal of this observational study is to learn about the best educative and organizational dimensions favouring the development of self-management education in multiprofessional health centres. The main question is to identify the favorable characteristics in creation, implementation and maintenance in developing self-management education programme in multiprofessional health centres.

The study wil be composed of 2 phases. Phase 1 will consist of a national questionnaire survey of French Regional Health Authorities (ARS) to identify and characterize all multiprofessional health centres running a self-management programme in France. It will be supported by the informal inter-ARS network of self-management project managers.

Phase 2 will consist of a qualitative survey of multiprofessional health centres. On the basis of the various significant variables identified in phase 1, different multiprofessional health centres will be selected to provide a varied sample (location, number of healthcare professionals, themes, etc.). This will enable an in-depth analysis of the findings of the quantitative survey, and a comparison with the realities of the multiprofessional health centre's health care professionals.

Eligibility Criteria:
First phase (quantitative survey): All regional health authority agencies will be surveyed on all self-management programmes developed by multiprofessional health centres since 2014 (estimated number of 270 in France in 2021).

Second phase (qualitative survey): In the first time, for the selection of the multiprofessional health centres , we will realized a varied sampling in search of maximum variation of the multiprofessional health centres according to the results of the first phase (continuation or not of the program, location of the programme, number of health care professionals in the educational team and presence of expert patients, theme of the programme...). In a second phase, for the individual interviews, we will carry out a varied sampling in search of maximum variation reflecting the plurality of the educational team observed in the documentary survey of each multiprofessional health centres.

The educational team includes healthcare professionals from the multiprofessional health centres and expert patients.

There is no exclusion criteria.
Role of Leptin in the Neuroendocrine and Immune Response to Fasting

The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.

Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to decrease appetite and increase energy use. Leptin levels usually go down with fasting. This study will evaluate the secretion of an investigational agent called leptin in lean and overweight individuals while fasting and investigate the potential role of leptin as a regulator of immune function and mediator of the neuroendocrine response to food deprivation in humans. Data derived from these studies will provide insights into the mechanisms underlying altered hormone levels and immune function in malnutrition and obesity and thus may provide the basis for future therapeutic interventions for obesity.

Comparison: fed state vs. fasting state vs. fasting + leptin state

Eligibility Criteria:
Inclusion Criteria:

* Healthy lean women (with body mass indices \[BMI\] \< 25 kg/m2)
* Overweight otherwise healthy men (with BMI \> 27 kg/m2)
* Overweight otherwise healthy women (with BMI \> 27 kg/m2).

Exclusion Criteria:

* A history of any illness that may affect the concentrations of the hormones to be studied, e.g. infectious diseases, renal or hepatic failure, type 1 or type 2 diabetes mellitus, cancer or lymphoma, hypogonadism, malabsorption or malnourishment, hypo- or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, anemia, or eating disorder
* On medications known to affect the hormones to be measured (glucocorticoids, anti-seizure medications, and thyroid hormones)
* A known history of anaphylaxis or anaphylactoid-like reactions, or a known hypersensitivity to E. coli derived proteins
Prevalence of Femoroacetabular Impingement in Asymptomatic Patients

Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. In this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The purpose of this study is to investigate whether patients without hip pain have variations at the hip joint such as those seen in hip impingement syndrome.

Participants in this study will be asked to come to the hospital after regular work hours for an MRI of the hip joints. Prior to the MRI, a physician will perform a range of motion check of the participants hips. The MRI will take approximately 20 minutes during which the participant will have to lie still in a closed space. Participants will receive a letter which can be forwarded to their family doctor if the MRI has any abnormal findings including signs of hip impingement.

Eligibility Criteria:
Inclusion Criteria:

* No hip problems
* No containdications to MRI

Exclusion Criteria:

- Patient does not meet above criteria
PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma

This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed nasopharyngeal carcinoma.
2. Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
3. ECOG performance status ≤1.
4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
7. Patients must be informed of the investigational nature of this study and give written informed consent.
8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

Exclusion Criteria:

1. Age \> 65 or \< 18.
2. Hepatitis B surface antigen (HBsAg) positive and HBV DNA \>1×10e3 copies/ml
3. Hepatitis C virus (HCV) antibody positive
4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
5. Has a known history of interstitial lung disease.
6. Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
7. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
8. Is pregnant or breastfeeding.
9. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
10. Has known allergy to large molecule protein products or any compound of sintilimab.
11. Has a known history of human immunodeficiency virus (HIV) infection.
12. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.