cyrilzakka/clinical-trials huggingface dataset:
Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy

Several studies have demonstrated that Turner Syndrome patients have elevated liver enzymes readily suppressible by a short course of HRT. We wanted to estimated quantitative liver functions in a young group of Turner syndrome patients compared to a healthy control group.

Turner syndrome is due to the absence of a part of or the entire X chromosome in females. Stature is short, and morbidity is increased due to risk of osteoporosis and fractures, type 2 diabetes, ischemic heart disease, hypertension, and stroke, but also the risk of cirrhosis is increased. Clinical studies have shown a frequent occurrence of elevated liver enzymes, primarily alanine aminotransferase, g-glutamyl-transferase, and alkaline phosphatase, while bilirubin is normal.

We and others have shown a normalizing effect of hormone replacement therapy (HRT), containing 17bestradiol and a gestagen, on liver enzymes, which may point towards a protective effect on hepatocyte integrity. Marked architectural changes, including nodular regenerative hyperplasia, multiple focal nodular hyperplasia and cirrhosis are observed in some patients and are associated with a risk of liver-related complications. These changes are frequently associated with vascular disorders such as obliterative portal venopathy, probably related to congenitally abnormal vessels. Steatosis, steatofibrosis, and steatohepatitis are seen and may be caused by metabolic disorders. In addition, bile duct alterations resembling small duct sclerosing cholangitis are observed in several patients. Presently, it is not known whether these perturbations in liver morphology and in liver-derived enzymes are related to functional defects in females with TS and whether this may change by HRT. To further explore quantitative liver function in TS, we examined adult women with TS on and off HRT and compared them with a control group of age matched normal women. We used the galactose elimination capacity to assess hepatocyte cytosol activity, the plasma clearance of indocyanine green to assess hepatic blood flow and excretory liver cell function independently of hepatic blood flow, the antipyrine plasma clearance to estimate hepatic microsomal system activity, and the functional hepatic nitrogen clearance to assess mitochondrial- cytosolic metabolic capacity for conversion of amino-nitrogen.We assumed that one or more these metabolic liver functions would be diminished in untreated TS and normalized by HRT. Our principal objective was to understand mechanistically how HRT improves liver function in TS.

Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome by karyotype

Exclusion Criteria:

* Thyroid abnormality
* Glucocorticoid treatment
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).


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

Inclusion Criteria:

* Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
* Men and women, 18 years or older
* Adequate hepatic function
* Adequate renal function
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects who are eligible and willing to undergo transplantation during the screening period
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* Uncontrolled or significant cardiovascular disease
* Medications that increase bleeding risk
* Medications that change heart rhythms
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* History of significant bleeding disorder unrelated to CML
* Concurrent incurable malignancy other than CML
* Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.

This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75
2. Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0)
3. Eastern Cooperative Oncology Group (ECOG) status 0-1
4. Signed written informed consent prior to the implementation of any trial-related rocedures
5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) \> 5 x ULN Bilirubin \> 1.5 х ULN

Exclusion Criteria:

1. Patients diagnosed with any other malignant tumor
2. Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
3. Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor
4. Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
5. Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
6. Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
7. A history of interstitial lung disease or non-infectious pneumonia
8. Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
10. Patients who have received allogeneic stem cell or solid organ transplantation
11. Women during pregnancy or lactation
Platelet Rich Plasma (PRP) in Total Knee Replacement

Clinical study to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR).

The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is less dramatic in patients who undergo TKR with the addition of PRP when compared to patients who undergo TKR without PRP.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later PRP in Total Knee.
2. Patient agrees to be blinded to their treatment group assignment.
3. Patient is willing and able to return for follow-up over at least a six (6) week post-operative period although longer follow-up is desired
4. Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria:

1. Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery
2. Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
3. Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
4. Patient has hemoglobin \< 12.0 (males), \< 11.0 (females)
5. Patient clinically significant anxiety disorder
6. Patient is on therapeutic anticoagulation medication and has an INR \> 1.3
7. Patient has a severe bleeding disorder
8. Patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery
9. Patient is pregnant
10. Patient is a prisoner
11. Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
12. Patient is actively participating in an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics

The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) aged \> 18 years
* Life expectancy \> 6 months
* Patients with tumour or hematological malignancy being treated at Gustave Roussy
* Patients with oral therapy (cytotoxic or targeted therapies)
* Patients starting therapy
* Patients living in France
* Patients affiliated to a social security system or equivalent
* OMS score from 0 to 2 at the time of inclusion
* Signed inform consent
* Patients able to follow protocol

Exclusion Criteria:

* Patients being treated with hormonotherapy only
* Patients enrolled in a clinical trial ongoing treatment with an experimental compound except in the case where the sponsor agrees that the CAPRI protocol is not intefering with the trial
* Not French speaking patients
* Patients deprived of liberty
* Patients with no internet access or telephone line
Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders

Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic agonists (AD).

Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic agonists (AD). They constitute a major public health issue due to their sometimes dramatic socio-occupational and judicial consequences. Most often the therapeutic strategy is to reduce or even stop AD, which can lead to withdrawal symptoms, apathy or aggravation of motor signs.

N-acetylcysteine (NAC) may have an interest in the treatment of ICD. This molecule reduces "craving" in addictions by substance abuse, but also in behavioral addictions, with as a potential mechanism a reduction in levels of plasma alphasynuclein.

The main objective of this randomized, double-blind, placebo-controlled, multicenter controlled trial is to demonstrate that a 10-week NAC add-on treatment, compared to placebo, improves the behavioral addictions of Moderate in the MP. The main endpoint will be the variation of the subdivision of the hyperdopaminergic behaviors of the Ardouin Parkinson's Disease Behavioral Assessment (ECMP) scale between the baseline and after 10 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease according to UKPDSBB criteria
* Subject aged 18 to 80
* Presence of a mild to moderate impulse control disorder defined by an ECD hyperdopaminergic sub-score (part IV) between 3 and 22 associated with the investigator's assessment
* MMSE ≥ 24
* Ongoing treatment with dopaminergic agonist and / or levodopa
* No change in antiparkinsonian and / or psychotropic treatment in the month preceding inclusion
* Expected stability of antiparkinsonian and / or psychotropic treatment during the study period
* Informed patient consent
* Patient supported by social security
* Presence of a caregiver

Exclusion Criteria:

* Severe TCI defined by a hyperdopaminergic sub-score at ECMP (part IV) greater than 23 associated with the investigator's assessment
* Patient with TCI suspected of having serious legal and / or relationship problems during the study period
* Adaptation of the anti-parkinsonian and / or psychotropic treatment (cf section 6.2) probably necessary during the duration of the study
* Patient treated with naltrexone, amantadine, antipsychotic in the 6 weeks prior to inclusion
* Patient under tutorship or curatorship
* History of hypersensitivity to any of the components or to any of the excipients
* Fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency
* Gastrointestinal duodenal ulcer in progress
* Pregnancy, breastfeeding
* Patients with contra-indicated treatments in association with NAC
* Patient with phenylketonuria
* Patients with proven difficulty in expectorating
* Patients with an asthmatic risk that can lead to bronchospasm
* Patients with intolerance to histamine
Late Effect of Ablation on Premature Ventricular Complex Ablation

Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation

On tissue level ablation lesion deepens and enlarges by time following the procedure. Based on this, investigators aimed to seek patients who has no acute success but late success. This phenomenon occurs in some patients. Investigators investigate the characteristics of those patients on both procedural and clinical aspects. Investigators enroll patients applied during prespecified dates

Eligibility Criteria:
Inclusion Criteria:

Patients who had both of the criteria below

* Presence of premature ventricular complex requiring ablation
* Successfully abolition of premature ventricular complex hours after the procedure

Exclusion Criteria:

Patients who had either of below mentioned criteria

* Abolition of premature ventricular complex during the procedure
* Unsuccessful procedure
Brain Dopamine Function in Adults With ADHD

The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must give informed consent
* Must be between the ages of 18 and 45 years old.
* Must have a confirmed diagnosis of ADHD
* Must have scored on a rating scale that indicate a significant level of symptom severity.
* Must have a childhood history of ADHD must be documented using established test criteria.
* Must have had no previous medication treatment for ADHD except for a short term treatment period of less than three months, which should have occurred at least six months prior to the study.
* Must have an interest in receiving long-term medication treatment for ADHD.

Exclusion Criteria:

* Must not test positive for psychoactive drugs during a urine drug screen.
* Must not be pregnant.
* Must not be breastfeeding.
* Must have no past or present history of dependence on alcohol or other drugs of abuse except nicotine or caffeine.
* Must have no past or present history of a psychiatric disorder except ADHD.
* Must have no medical illness that may affect brain function.
* Must not have taken medication that may affect brain function.
* Must not have had head trauma with loss of consciousness (\> 30 minutes).
* Must not have significant anxiety or depression as determined by an established test.
* Must have no history of a significant learning disability.
* Must have no history of cardiovascular or endocrinological disease.
* Must have no history of coagulation disorder.
* Must have no history of sensitivity to lidocaine and/or prilocaine.
* Must have no history of claustrophobia.
* Contraindication to MRI environment (presence of any implanted metallic objects such as cardiac/neural pacemakers, defibrillators, aneurysm clips, certain heart valves, spinal nerve stimulators, artificial joints/limbs, shrapnel/bullets, metal fragments in their eyes, cochlear implants, hearing aids, dental implants).
* Must have no history of glaucoma.
The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects

The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day.

This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day.

Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
* Age 40-70 years
* BMI ≥ 18 and ≤ 30 kg/m2
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician
* Written informed consent

Exclusion Criteria:

* Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
* Diabetes mellitus
* Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening
* Reported intense sporting activities \> 10 h/week
* Use of over-the -counter prescribed medication which may interfere with study measurements, as judged by the physician
* Use of antibiotics in the three months before screening or during the run-in period.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
* High caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet \& zero) OR consumption of more than 1 energy drink per day
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).

This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia.

It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio.

A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24.

Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1.

Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of NSCLC incurable by other treatments including surgery
* A ≥5 % loss of body weight in the preceding 3 months
* A C-reactive protein (CRP) concentration ≥ 10 mg/L
* Life Expectancy of at least 12 weeks

Exclusion Criteria:

* Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
* AST/ALT ≥ 3 x ULN at screening
* Hemoglobin \< 8 g/dL at Screening
* History of or active diagnosis of Tuberculosis
Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women

Mangos are a rich source of nutrients such as carotenoids, vitamin C and fiber, as well as polyphenols and phenolic acids such as mangiferin, ellagic acid, and gallotannins. Mango extract has been reported to protect against photo-aging of the skin in an animal model exposed to UVB radiation, reducing the length of wrinkles and increasing collagen bundles. Beta-carotene and other carotenoids are known to provide skin protection from sunlight, but other compounds in mangos, may also be important in reducing oxidative damage in aging skin.

We have recently completed a pilot study showing a clear trend in skin wrinkle reduction when postmenopausal women consumed 85g of Ataulfo mangos, four times per week for 16 weeks. To confirm and extend these results, a larger study is proposed.


Eligibility Criteria:
Inclusion Criteria:

* 50 - 70 years old
* Postmenopausal
* Fitzpatrick skin type I, II, or III
* BMI 18.5 - 35
* Must be willing to comply with all protocol requirements
* Must be willing to have flash photo facial images taken with the imaging systems

Exclusion Criteria:

* Smokers
* Allergy to mangos
* Vegans/vegetarians
* Adults unable to consent