cyrilzakka/clinical-trials huggingface dataset:
Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI

Metabolic alternation and clinicohematological characteristic in chronic phase CML in patient treated with TKI

Chronic myeloid leukemia (CML), a clonal hematopoietic stem cell malignancy, is characterized by unique translocation leading to the formation of the Philadelphia chromo- some.Because of the specific genotype knowledge, tyrosine kinase inhibitors have been used in CML and have significantly improved the prognosis of patients with CML, especially n high-income countries like the United States.Notably, the 5-year survival rates increased from 40% to 90%. So, CML is increasingly seen as a chronic instead of a potentially fatal disease.

Obesity is increasingly prevalent worldwide and is considered o be an important risk factor for adverse outcomes in many cancers.

Obesity is well-known for being associated with metabolic abnormalities like hyperglycemia, hypertension, or dyslipidemia.The metabolic abnormalities and obesity- induced systemic chronic inflammation contribute to tumorigenesis and progression.

Obesity alone may not reflect the actual metabolic health state, and it appears to be more accurate to reclassify patients based on the combination of body mass index (BMI) and metabolic status to further determine the relationship between obesity itself or the combination of metabolic status and prognosis of patients with CML.

Triglyceride-to-high-density lipoprotein cholesterol ratio (TG/HDL-C) has been proposed as a reliable and simple alternative to assess atherogenic index, insulin resistance, and dyslipidemia.\[8\] Furthermore, positive relationships between the TG/HDL-C ratio and various clinical features of many cancers, such as tumor stage and tumor type, have been reported in previous studies.\[9\] These findings warrant further studies to explore TG/ HDL-C ratio with respect to TKI administration in CML and as a factor associated with side effects, and potentially, to assess its role in prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient newly diagnosed with CML and received TKI

Exclusion Criteria:

* patient previously diagnosed CML and started treatment or in post treatment follow up
Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe

Type 2 diabetes is a major problem of public health in the French West Indies, with an estimated prevalence of 8%, twice more than in France. In Guadeloupe, according to the statistical data of hospital morbidity in 2004, 2643 hospital stays were diagnosed with diabetes. These cases mainly concerned woman (62%) and the elderly, from 45 to 74 years old (67%).

The main objective of this research is to describe the insulin protocol used in Guadeloupe for treated type 2 diabetes patients and their characteristics:

* The duration of the type 2 diabetes
* Time elapsing between the diagnosis and the treatment by insulin
* Where the follow up care took place
* Existence of complications

Secondary objectives were to describe the link between the HbA1c rate and the insulin therapy protocol. And also to present the main inconveniences expressed by patients and their degree of autonomy.

Nowadays the set up for insulin treatment is available in general practitioners' offices. However, it is restrained by the reticence of patients and physicians. For type 2 diabetes, insulin therapy is well managed and there is ongoing progress. But there are still some questions about the effect of the treatment in the everyday life of patients: culture, fear, material resources, necessity of education.

Ignorance and prejudices on insulin injection are still prevalent and often it delays for more than a year the time when patients have to switch an insulin treatment for unbalanced chronic disorder.

Type 2 diabetes patients think that the treatment is heavy, can lead to serious hypoglycemia, is uncomfortable for family and can cause fear.

Education of the patients can reduce ignorance and prejudices about insulin treatment.

Nowadays studies show that diabetes patients want to be more involved in the decisions linked to their treatment which impact their perception of the disease and the treatment.

Auto measurement of glycaemia can help the patient better manage his disease and make him understand the importance of controlling his glycaemia levels.

This study could allow to:

* Offer a new care organization for a better use of resources (network, patient therapeutic education...)
* Set up adequate training for professionals and for patients being cared for in medical offices.
* Improve the glycemic balance of patients and slower the growth of degenerative complications.

Eligibility Criteria:
Inclusion Criteria:

* Men or woman
* Age ≥ 18 years old
* Patient with type 2 diabetes, treated with insulin for at least one year
* Patient accepting to participate to the study

Exclusion Criteria:

• Pregnant or breastfeeding woman
Digital CBT-I for Chronic Insomnia

This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.

This multi-site, randomized, wait-list controlled trial investigates the effectiveness and safety of a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program in treating chronic insomnia. Participants will be randomly assigned to start the digital CBT-I immediately or after a wait period. The digital CBT-I program, includes modules on sleep education, cognitive restructuring, stimulus control, sleep restriction, and relaxation techniques. Primary and secondary outcomes will measure insomnia severity, beliefs about sleep, daytime sleepiness, mood, quality of life, productivity, and sleep efficiency. Findings aim to assess the effectiveness of digital CBT-I in improving sleep and daily functioning among chronic insomnia patients in South Korea.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for insomnia disorder according to the International Classification of Diseases, 10th Revision (ICD-10), including: F51: Nonorganic sleep disorders; G47: Sleep disorders
* Has experienced insomnia symptoms for 3 months or longer.
* Scores 8 or higher on the Insomnia Severity Index (ISI).
* Oral and written fluency in Korean
* Owns a smartphone and is independently able to use apps on a smartphone.
* Voluntarily agrees to participate in this clinical study and provides signed informed consent.

Exclusion Criteria:

* Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.
* Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:

  * Obstructive sleep apnea (G47.30)
  * Sleep behavior disorders
  * Restless leg syndrome (G28.8)
  * Narcolepsy (G47.4)
* Has an active, ongoing physical illness that impedes daily functioning, such as:

  * Congestive heart failure
  * Chronic obstructive pulmonary disease (COPD)
  * Acute pain
  * Neurological disorders (e.g., cerebrovascular disease)
  * Neurodegenerative disorders (e.g., dementia, multiple sclerosis)
  * Unstable medical conditions or life expectancy of less than 6 months
* Adjustments in schedule or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within the past 3 months, or use of PRN (as needed) prescribed sleep medications.
* Engaged in shift work.
* Pregnant individuals or those planning to become pregnant during the study period.
* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia

The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.

This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.

Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated low density lipoprotein (LDL), premature onset of atherosclerosis and development of xanthomata. Patients with homozygous familial hypercholesterolemia (HoFH) have a severe disease that presents in childhood with total cholesterol typically in the 650 to 1000 mg/dL range.

This was a randomized, double-blind, placebo-controlled study, which consisted of a 4-week screening period, 26 weeks of treatment, and a 24-week post- treatment follow-up period (with the exception of patients who enrolled in the open-label extension study, Study 301012-CS6; NCT00694109). Eligible patients were randomized in a 2:1 ratio to receive 200 mg mipomersen or matching volume placebo subcutaneous (SC) injections weekly. Patients who weighed \<50 kg received a lower dose of 160 mg mipomersen or matching volume of placebo SC injections weekly. Patients were to have been on a stable (\>=12 weeks) regimen of allowed lipid-lowering therapies at screening, and were required to remain on the same dose and regimen throughout the study.

Patients returned to the study center for clinical evaluation every other week during the first 4 weeks of treatment, once every 4 to 5 weeks for the remainder of the treatment period, and monthly during the post-treatment evaluation (follow-up) period. The primary endpoint assessment was at Week 28. Following treatment and Week 28 evaluations, eligible patients who tolerated the study drug could elect to enroll in the open-label extension study (Study 301012-CS6; NCT00694109). Patients who did not participate in the open-label extension study were required to return to the study center for clinical evaluation at least twice during the post-treatment follow-up period, including an end-of-study termination visit at the end of this 24-week period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Homozygous Familial Hypercholesterolemia (HoFH)
* Stable lipid-lowering therapy for 12 weeks
* Stable weight for 6 weeks
* Stable low fat diet for 8 weeks

Exclusion Criteria:

* Significant health problems in the recent past including heart attack, stroke, blood disorders, cancer, or digestive problems
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)

This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.


Eligibility Criteria:
Inclusion Criteria (Patients must):

* Be at least 18 years old
* Have gained weight while taking olanzapine
* Be able to visit the doctor's office seven times over 4 months (17 weeks)

Exclusion Criteria (Patients must NOT):

* Have started a weight loss program within the last 8 weeks
* Have an illness that might affect patient's weight during the study
* Have an allergy to phenylalanine, mannitol or saccharine
* Be taking any medication (except for olanzapine) that might affect patient's weight
External Oblique Intercostal Plane Block for Liver Transplantation Donors

Postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. External oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. The aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block and subcostal transversus abdominis plane block in living liver donors.

Researchers will compare the external oblique intercostal plane block group with subcostal transversus abdominis plane block to see if the external oblique intercostal plane block is effective for postoperative analgesia in living liver donors.

Patients scheduled for living donor hepatectomy will be separated into 2 groups: Subcostal Transversus Abdominis Plane Block Group and External Oblique Intercostal Plane Block Group. Patients in Subcostal Transversus Abdominis Plane Block will be performed subcostal transversus plane block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Patients with American Society of Anesthesiology (ASA) physical status I-II
* Patients scheduled for a living donor hepatectomy

Exclusion Criteria:

* Allergy to local anesthetics
* Coagulopathy
* Skin infection at the block area
* Advanced renal failure
* Chronic pain syndromes
* Alcohol or drug abuse
* Psychiatric disorders
Diabetes and Metabolic Postprandial Responses

The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese volunteers
* Healthy for one group nd type 2 diabetic for the second group
* Age between 30 and 65 years old
* Total cholesterol \< or = 7 mmol/l and triglycerides \< or = 4 mmol/l
* For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c \< 6%
* Stable weight over last 3 months
* Informed consent

Exclusion Criteria:

* No compliant subjects
* Participation in an other trial 2 months before starting this one
* Ward of court or under guardianship (sheltered adults)
* Person deprived of freedom by judicial or administrative decision
* Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose
* Existence of a previously diagnosed pathology (other than type 2 diabetes)
* Previous gastro-intestinal pathology
* Treated by corticoids, anorexigens, weight loss medicines
* Alcoholism or severe tobacco consumption
Different Ultrafiltration Rates and Intradialytic Hypotension.

Finding relationship between different ultrafiltration rates and intradialytic hypotension in attempt to find the optimal cut off points.

This observational study will be carried upon hemodialysis patients with different ultrafiltration rates at each session to study the association between ultrafiltration rates and intradialytic hypotension.

Thus identifying the optimal cut off of ultrafiltration rate points for each patient

Eligibility Criteria:
Inclusion Criteria:

All patients aged 18 Year or older on maintenance haemodialysis for at least 3 consecutive months receiving 3 sessions weekly.

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Exclusion Criteria:

Patients aged \< 18 years old.

Patients on recent haemodialysis \< 3 months.

Pregnant women.

Patients with malignancy, severe infections or sepsis.

Patients with major bleeding.

Patients who cannot go upper limb monitoring of blood pressure.

Patients with severe heart failure (NYHA) class 3 or more.

Patients with severe anemia, Hemoglobin less than 6 g/dl.
Effects of Lycra Suits in Children With Cerebral Palsy

Lycra garments have recently been used for children with cerebral palsy, with favorable effects on alignment, biomechanics and neuromuscular activity. The aim of the present study is to determine the efficacy of a Lycra suit in improving motor function and static balance in children with cerebral palsy. The children included in this study will be part of a prospective project on children with cerebral palsy, older than 4 years of age, and their families regularly followed at the Child Neurology Unit of the Catholic University of Rome.

A total of 10 children with cerebral palsy will be recruited and included in the study. Five of them will be considered as study group and will wear a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. The other 5 will be considered as control group, matched for age and sex to the study group, and will not wear the lycra suit. The evaluation of static balance and the gross motor function measure will be used as outcome measure. The children of both groups will be assessed twice, at baseline and 6 months after, each child acting as his/her own control.

The motor function assessments will be performed without the Lycra suit, whereas the static balance assessments were performed with and without the suit.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cerebral palsy based on the predominant type of motor impairment and classified according to the criteria proposed by Himmelmann.

Exclusion Criteria:

* Presence of major congenital malformations or metabolic or haematological complications.
* The investigators will also exclude children who had previously worn a lycra garment and who received Botulinum toxin injections or orthopaedic surgery in the year before the study.
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada

This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg \[FTC/TDF\]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.

This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.

Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:

* A. Truvada (substitution of their current NRTIs by Truvada \[FTC/TDF\] with continuation of their current NNRTI or PI at the same dose)
* B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).

This phase of the study served the primary objective of the study.

Study Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).

Patients were assessed for efficacy and safety during both phases of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients displaying abnormal fasted triglycerides (\> 2 g/L \[2.26 mmol/L\] and less than or equal to 10 g/L \[11.29 mmol/L\]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; \> 1.6 g/L \[4.15 mmol/L\])
* Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load \< 400 copies/mL for at least 6 months prior to screening
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children

India's poor tribal communities have far worse health and social indicators than the general population. Most tribal people live in remote forested or desert areas where illiteracy, trying physical environments, malnutrition, inadequate access to potable water, and lack of personal hygiene and sanitation make them more vulnerable to disease.The aim of Chhatralaya initiatives taken by Arsha Vidya, Jaipur was to address the exclusion of the socially and economically disadvantaged children of the tribes and to provide a fair opportunity to all.


Eligibility Criteria:
Inclusion Criteria:

* Children selected from Udaipur tribal areas as lacking parental care and basic services;
* Children living in Udaipur tribal areas;
* Children from 8 years to 16 years of age

Exclusion Criteria:
Influence of Main Psychological and Social Factors on Primary Headaches

This study aims to describe the psychological and social characteristics of patients suffering from primary headache and monitored in Neurology department of Besançon University Hospital

The aim of our study is to describe the psychological patterns in a population of patients suffering of episodic migraine or chronic migraine with and without medication overuse and the level of disability.

Data about migraine characteristics will be obtained using a standardized questionnaire.

Socio-demographic data will be obtained for all patients including gender, age, educational level and professional status.

A booklet of 10 self-administered questionnaires will permit to measure psychological factors such as depression, anxiety, alexithymia...

Eligibility Criteria:
Inclusion Criteria:

* Patients from 25 to 60 ans y.o suffering from primary headache and monitored in the Neurology department of Besançon University Hospital

Exclusion Criteria:

* Patients with former or current psychic troubles
Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery

This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Major patient, age ≥ 18
* Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy
* Affiliated with a social security plan
* VEMS \< 80% and/or DLCO\<80%
* High-intensity training achievable for at least 10 days before surgery
* Acceptant to participate in the protocol
* Ability to follow the STIMUL program of education focused on adapted physical activity
* Have a smartphone that can download the mobile app
* have the ability to understand, read and write French

Exclusion Criteria:

* Patient unable to consent: under guardianship or curatorship
* Patient refusing surgery
* Non-operable patient due to comorbidities or unseable tumour
* Poor understanding of the smartwatch
* Severe cognitive or psychiatric disorders
* Pregnancy in progress