cyrilzakka/clinical-trials huggingface dataset:
Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.

First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Despite overall good response rates, some patients do not respond to treatment and others lose their response over time. Both situations are associated with worse survival and there are to date no clear predictive factors for response although the existence of additional mutations seems unfavorable.

In this exploratory study, we hypothesize that biological factors at diagnosis are associated with hematological response at 12 months. We will more specifically study the association between mutational profile, assessed by next-generation sequencing, and cytokine profile with hematological response.

This study will help in identifying patients who will not respond to hydroxyurea or pegylated interferon and give the opportunity to try other treatments upfront, in the perspective of precision medicine. On the basic science side, this study will help in understanding the molecular and immunological factors involved in resistance to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis.
* Indication for first-line treatment with hydroxyurea or pegylated interferon.
* Consent to participate.
* Affiliated to social security.

Exclusion Criteria:

* Previous treatment.
* Other on-going malignancy, including overt myelofibrosis.
* Other treatment such as phlebotomy solely, ruxolitinib, anagrelide, or pipobroman.
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.

Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy. Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving. It appears to be well tolerated with a low abuse liability. Thirty dependent cocaine users will be randomised to 2 equal groups. The experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program. The control group will receive placebo under equivalent conditions. Primary outcome will be a between group comparison of cocaine negative urine samples collected over the 10 week study period. Adverse events, side effects, compliance, retention, self reported health, psychosocial and drug use outcomes will also be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV cocaine dependence diagnosis
* Cocaine positive urine sample at intake
* Regular current cocaine use (2-3 days per week)
* Aged 18 years or older

Exclusion Criteria:

* Pregnant or nursing females
* Concurrent uncontrolled physical or mental illness
Vulvar Mucosal Specialty Clinic Chart Review

This study aims to develop a clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in management of vulvar disease.

Vulvar disorders are common, but their frequency and importance are often under-recognized. The spectrum of vulvar disease is vast and includes congenital malformations, inflammatory mucocutaneous diseases, blistering and erosive diseases, benign and malignant tumors, autoimmune disorders, infectious diseases, and various idiopathic conditions. Evaluation and management of genital complaints and dermatoses are complicated by the frequent multifactorial nature of vulvar symptoms and variable clinical expressions of disease on the vulva. In many cases, empiric treatment is instituted in the absence of a definitive diagnosis. Of note, expertise in the diagnosis and management of vulvar disorders is often lacking on the parts of gynecology, dermatology and primary care physicians.

The investigators seek to analyze the data on this patient population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of the Northwestern Memorial Faculty Foundation (NMFF) to better define the clinical spectrum of vulvar disease. The investigators will also assess approaches to the diagnosis and management of patients with vulvar disease with attention given to clinical outcome and the impact on quality of life. This information with help the investigators to better understand the scope of care these patients currently receive, to identify deficits in current practice, and to advance potential new standards of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients seen at Northwestern Medical Group Department of Dermatology who were seen by Dr. Bethanee Schlosser and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings.

Exclusion Criteria:

* Patients who refuse complete mucocutaneous examination.
* Patients who refuse recommended diagnostic procedures.
* Pregnant women or prisoners.
Creatine Supplementation and Cognition

Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.


Eligibility Criteria:
Inclusion Criteria:

* women older than 60 years old

Exclusion Criteria:

* cardiovascular diseases or muscular disturbances precluding exercise training
* drugs affecting the cognition
Shivering Control After Percutaneous Nephrolithotomy

Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia.

A written informed consent was taken from the patients. Patients were assigned randomly to two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid starting just before and during anesthesia (group A) or an iv magnesium sulphate starting just before and during anesthesia (group M) in the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia.

Exclusion Criteria:

* Hepatic inefficiency
* Renal inefficiency
* Spinal anesthesia because of a different mechanism of hypothermia
Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Bangladesh

Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.

Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.

Life for a Child (LFAC) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) Hospital in Dhaka, Bangladesh. In 2022, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Bangladesh.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 diabetes (T1D). Diabetes was diagnosed in accordance with World Health Organization (WHO) criteria. Determination of diabetes type was made by the local investigators according to available clinical features and history: T1D was diagnosed upon abrupt onset of typical symptoms of diabetes with insulin required from diagnosis, and no acanthosis nigricans. They were usually non-obese.
* Duration of T1D at enrolment \>12 months
* Aged 10-25 years (inclusive) at time of enrolment
* Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
* Attending Life for a Child, BIRDEM Hospital, Dhaka for their usual diabetes care

Exclusion Criteria:

• Previous use of analog insulin
Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid

It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.

Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.

To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.

Aims:

* The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint
* The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling
* If concentration measurements by point-of-care testing are non-inferior to mass spectrometry
* If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels


Eligibility Criteria:
Inclusion Criteria:

* All sexes
* Referred to undergo an elective lumbar puncture procedure in the outpatient clinic at Department of Neurology, Aarhus University Hospital.
* Age 18-80 years
* Written and oral consent

Exclusion Criteria:

* Referred to the clinic suspecting severe neuroinflammation
* Special diet habits, including ketogenic diet, fasting, intermittent fasting etc.
* Daily use of insulin or other medication affecting blood glucose and/or glucose metabolism
* Not able to speak or understand Danish and/or give written and oral consent
Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia

Links between sleep and food intake are manyfold. In healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (GI) foods. Conversely, high GI foods induce sleepiness. Obesity is observed in 30-50% of patients with Narcolepsy type 1 (NT1). Its determinism may involve transient changes in basal metabolism at the early stage of the disease, eating disorders, disrupted nighttime sleep and sleepiness. In contrast, patients suffering from idiopathic hypersomnia (IH), whose nocturnal sleep is generally long and of good quality, rarely present with obesity. By studying the relationships between diet, body composition and sleep patterns in these two populations and in healthy controls, the NARCOFOOD study aims to provide a better understanding of the determinants of obesity in narcolepsy and, more generally, of the effects of food intake on sleepiness.

Patients will be recruited at the Lyon and Clermont-Ferrand sleep centers and Controls at the Lyon Neuroscience Research Center. Data from clinical evaluation (including body mass index and body composition), and questionnaires (sleep quality, insomnia, sleepiness, anxiety and depression, impulsivity, eating behaviors) will be collected. During 4 days, at home, the following parameters will be explored : 1) eating behaviors (meals' photos) and sugar consumption (FreeStylePro sensor measuring interstitial glucose) 2) sleep/wake rhythm (diary and actigraphy) 3) nocturnal sleep parameters (Somfit device) 4) sleepiness (Karolinska sleepiness scale and EEG markers of sleepiness with the Somfit device) before and after meals.

The hypothesis is that increased sleepiness would favor food intake of high GI foods, which would worsen sleepiness in all 3 groups, with a more pronounced effect in NT1. Compared to IH patients and controls, NT1 patients may present more snacking of high GI foods, especially at night if sleep is disrupted, and this would be correlated with body composition.

The findings will help to better understand the mechanisms of obesity in narcolepsy and may lay the ground for the development of new therapeutic strategies in disorders of hypersomnolence, targeting dietary behaviors.


Eligibility Criteria:
Inclusion Criteria :

* Patients with NT1 or IH (ICSD-3-TR) or Healthy Controls without sleep disorder
* Familiar use of a smartphone

Exclusion Criteria :

* Untreated moderate or severe sleep apnea syndrome;
* Cognitive disorders incompatible with the protocol;
* Unstable treatment or treatment with sodium oxybate;
* Unstable medical or psychiatric pathology;
* Shift work;
* Pregnancy or breastfeeding;
* Diabetes
Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion

The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Age 20-30 years
* BMI 20-30 kg/m2

Exclusion Criteria:

* Any disease
* Any medication
Single Shot Intrathecal Analgesia in Vaginal Delivery

Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery

Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.

In this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.

Eligibility Criteria:
* Inclusion criteria:

  * Multiparous women who received antenatal care, presented for vaginal delivery of uncomplicated term pregnancy of singleton fetus with engaged fetal head and cervical dilatation of at least 5 cm requiring oxytocin augmentation, and requested analgesia.
  * Age: patients between 22-45 years old.
* Exclusion criteria:

  * Refusal of procedure or participation in the study.
  * Patients with pre-existing or pregnancy-induced hypertension, abnormal fetal heart rate tracings, obesity, endocrinal diseases and/or diagnosed fetal abnormalities.
  * Contraindication to neuraxial block.
  * Allergy to any of the study drugs.
Detection of Circulating Tumor DNA Through Liquid Biopsies in Ovarian Cancer Patients and Evaluation of Prognostic and Predictive Values of Circulating Tumor DNA Assay.

Ovarian cancer is the eighth most common cancer in women in Korea, with 2,600 cases occurring annually, and the number of cases is steadily increasing. There is no practical method for early detection of ovarian cancer, and 75 percent of patients are diagnosed with advanced stage. The treatment of ovarian cancer is based on surgical removal and platinum-based chemotherapy. The cell-free DNA (cfDNA) test has the advantage of being able to track and monitor mutations of tumor origin noninvasive.

The objective of this study was to assess the feasibility of circulating tumor DNA (ctDNA) as a biomarker for cancer recurrence in ovarian cancer after surgery. Diagnosis and prognosis evaluation using conventional methods such as CA-125, radiologic examination (CT), had limitations in diagnosing and prognostic observation of ovarian cancer. For precise diagnostic purposes, CA-125 had limitations because it was detected as positive value when the tumor size is enough large or states of metastasis, and CT-based diagnosis is practicable only when the size of tumor is detectable.

However, cell-free DNA can be detected even if the tumor size is small because it detects very small amount of mutation gene in the blood. In addition, the detection of tumor cell DNA from circulating blood can be a clinical decision making point whether to continue or stop chemotherapy.

In this study, the investigators collect whole blood from patients with ovarian cancer undergoing surgery. Control samples will be obtained from patients undergoing surgery for benign adnexal disease with CA125 \>35U/ml. In ovarian cancer patients, blood samples will be collected prospectively every 3 months after surgery. Mutations found at the initial sample will be monitored during chemotherapy to investigate the ctDNA pattern. The primary outcome will be progression free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

1. Female, over 19 years of age;
2. Patients with epithelial ovarian cancer
3. Patients with Serum CA-125 \>35 U/mL

Exclusion Criteria:

1. Patients in pregnancy
2. Patients being treated for cancer of other organs, including gynecological cancer.
3. Patients who has difficulty reading and understanding Korean.
4. The tester's determination that the patient will not be able to comply with the clinical trial procedures.
5. Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.
EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Cerebral Palsy (CP) is the most common motor disability in children. It is due to damage that occurs during brain development in the fetus or infant. Early treatment (before 2 years) will allow the child to promote brain plasticity to compensate for the effects of the lesion and reduce the severity of CP. The goals of early intervention are to increase motor, cognitive and communication skills, prevent complications and provide parental support. Most authors agree to recognize the benefit of early care by emphasizing home intervention programs with active parental participation. To date, no recommendations exist in France for the management of cerebral palsy in children under the age of two. It is therefore necessary to conduct scientific studies in this population.

Based on published international studies, the PRECOP program (PREcoce intervention in parent-professional COoperation in Cerebral Palsy) consists of individualized care adapted to the specific needs of each child, from the arrival of the infant at home, by a multidisciplinary team during the child's first two years.


Eligibility Criteria:
Inclusion Criteria:

* New born presenting on transfontanellar ultrasound and confirmed on brain MRI (magnetic resonance imaging) at least one of the following brain lesions at high risk of cerebral palsy :

  * Stage 3 intraventricular hemorrhage, requiring at least 2 subtractive lumbar punctures and/or the establishment of a ventriculoperitoneal bypass
  * Stage 4 intraventricular hemorrhage
  * Periventricular leukomalacia : extensive unilateral or bilateral
  * Sequelae of perinatal anoxo-ischemic encephalopathy
  * Extensive neonatal stroke
* Less than 3 months old (corrected age in case of prematurity)
* Hospitalized in neonatology or hospitalized in pediatric intensive care unit or within two months following return home (follow-up visit after initial hospitalization)
* Affiliate to social security
* Parental or legal representative consent to participate in the study (free and informed written consent)

Exclusion Criteria:

* Children who have had an Antenatal Diagnosis of a pathology causing fear of the onset of developmental delay
* Children presenting with a congenital pathology with neonatal revelation, whether of metabolic, genetic or malformative origin
* Palliative care offered by the neonatology team (LATA: Limitation and Discontinuation of Active Therapeutics)
* Children participating simultaneously in another screening and early care program (excluding the COCON program (Soins préCOces et COordonnés du Nouveau-né vulnérable))
NIRS in PDA VLBW Infants

Aim of study:

To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.

Study population/inclusion criteria:

VLBW newborn babies with hemodynamically significant PDA by echocardiography.

Exclusion criteria:

Major malformations Moribund patients

Aim of study:

To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.

Study population/inclusion criteria:

VLBW newborn babies with hemodynamically significant PDA by echocardiography.

Exclusion criteria:

Major malformations Moribund patients

Protocol:

Consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter

The same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.

Eligibility Criteria:
Inclusion Criteria:

* VLBW infants with hemodynamically significant PDA by echocardiography

Exclusion Criteria:

* Major malformation
* Moribund