cyrilzakka/clinical-trials huggingface dataset:
Cognitive Function of Alcoholic Compensated Liver Cirrhosis

Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis

Hepatic encephalopathy (HE) is one of the important complications of liver cirrhosis (LC). HE exhibits alterations in cognitive, psychomotor-intellectual, emotional, behavioral, or fine-motor functions. Approximately 22-74 % of patients with non-fulminant HE have MHE with a frequency proportional to the patient age and the severity of the liver disease. Patients with MHE exhibit disability in most functional behaviors such as social connection, alertness, emotional behavior, sleep, work, and leisure.

Alcohol consumption itself has a toxic effect on the brain. It has been documented that there is a neuronal loss in the cerebral cortex, hypothalamus, hippocampus, septal region, and cerebellum of an alcoholic brain.

The major causes of LC are hepatitis B/C viral infection and chronic alcohol consumption. The most widely accepted theory of HE pathogenesis is that toxic substances derived from the gut affect cerebral function after liver dysfunction or portosystemic shunting. This proposed pathogenetic mechanism could apply to viral compensated LC. However, it is difficult to explain the development of MHE in patients with alcoholic LC in this manner.

Therefore, patients with alcoholic LC may have different cognitive dysfunction as compared to patients with viral LC.

Eligibility Criteria:
Inclusion Criteria:

* Those who agreed to participate in this study and signed a written consent
* Those who have no evidence of neurological impairment

Exclusion Criteria:

* Those who have decompensated liver cirrhosis
* Those who have a high MELD score (≥20)
* Those who have OHE during admission
* Those who have parients' refusal
Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)

The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).

Prior to transplantation, subjects will receive BUSULFAN via the central venous line, six times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's leukemia. As well, these drugs will destroy the subject's own immune system to help ensure the new bone marrow takes and grows after transplantation.

On the day of transplantation, bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line. These new cells will replace the subject's bone marrow.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML):

  * Leukocytosis (\> 13,000) with absolute monocytosis (\> 1,000)
  * The presence of immature myeloid cells in the peripheral blood
  * Less than 30% marrow blasts
  * Absence of t(9:22) or BCR-ABL transcript
  * Adequate major organ function including:

    * Cardiac: ejection fraction \> 45%
    * Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
    * Karnofsky performance status \> 70% or Lansky score \> 50%
    * Creatinine must be \< 2 x normal for age
* Written informed consent.

Exclusion Criteria:

* Active uncontrolled infection within one week of HCT.
The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes

To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

A randomized control trial of two clusters :

1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.

Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.

In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.

Ultrasound examination was performed for both cluster since 1st until 3rd trimester.

Eligibility Criteria:
Inclusion Criteria:

* First trimester pregnancy
* Gestational age \< 10 weeks gestation
* Agree as research participant
* Living in DKI Jakarta

Exclusion Criteria:

* Assisted Reproductive
* History of PCOS
* History of Chronic Hypertension
* History of Diabetes Mellitus
* History of Preeclampsia
* Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)
* Plan to move from Jakarta prior or during pregnancy
* History of Recurrent pregnancy loss
Research Engagement With People With Intellectual and Developmental Disabilities

The objectives of this project are to to build sustainable regional communities of Intellectual or Developmental Disabilities (IDD) stakeholders to provide ongoing input to research priorities, methodological processes, and relevant person-centered health outcomes; leverage existing Special Olympic infrastructure to nationally disseminate the toolkit in order to increase participation and engagement in research and improve health outcomes; conduct comparative effectiveness trials that incorporate people with IDD focusing on their research priorities.

This project will develop a skilled community of stakeholders through collaboration with Special Olympics to create capacity building working groups. Groups will collaborate to develop stakeholder training modules focused on leadership, research fundamentals, and health. Collaboratively developed trainings will be piloted to support revising of the Toolkit for the engagement of people with IDD in research. A range of stakeholders will be essential members of the team to design and provide critical feedback on the effectiveness of the Toolkit, research priorities, and ecologically valid methodologies. Finally, research priorities will be refined, and the research engagement Toolkit will be nationally disseminated to Special Olympics and relevant community organizations. The toolkit will include necessary training for people with IDD, as well as paid and unpaid caregivers to be engaged partners in research.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Intellectual or Developmental Disabilities (IDD)
* Caregiver or family member of the individual with IDD
* Patients/consumer
* Clinician
* Complete informed consent or assent

Exclusion Criteria:

-
Hypovitaminosis D Prediction Score

Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (\<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (\<20ng/ml) and 5% with severe deficiency (\<10ng/ml).

Because of the possible consequences of hypovitaminosis D (osteomalacia in adults...), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.

We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.


Eligibility Criteria:
Inclusion Criteria:

- Men and women aged 18 to 70 years old

Exclusion Criteria:

* Participation in a study related to vitamin D
* Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
* Pregnancy or breast-feeding
* Renal failure : severe renal impairment, dialysis, having kidney transplant
* Known hepatic impairment
* Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma
* Known primary hypo/hyperparathyroidism
* Bone cancer/metastases current or in the last 2 years
* Treatment with antiepileptics
* Long-term treatment with glucocorticoids (\> 3 months)
* Treatment with antiretroviral
* Legal incapacity or limited legal capacity
* Non-recipient of French Social Security
Characteristics and Clinical Significance of Gut Microbiota in Patients With Monoclonal Gammopathy

This is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (MGUS). The study will collect blood and stool samples from MGUS patients, non-MGUS patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. It will comprehensively analyze the abnormal features of the gut microbiome in MGUS patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of MGUS.

This is a case-control, observational single-center study aiming to investigate the impact of common comorbidities on gut microbiome structure and disease progression in patients with monoclonal gammopathy. We plan to collect samples from 11 disease categories, with each category including two groups (monoclonal gammopathy and non-monoclonal gammopathy), as well as 700 age- and gender-matched healthy controls, for a total of 2,990 samples. At enrollment, we will collect whole blood, plasma, serum, and fecal samples from the study participants, and obtain relevant information such as demographic characteristics, lifestyle, family medical history, and medication use.We will perform metagenomic, proteomic, and serum biochemical and immunological analyses on the samples to directly obtain association data between gut microbiome characteristics (as exposure factors) and clinical outcomes (as endpoints). This study will systematically analyze the dysbiosis characteristics of the gut microbiome in monoclonal gammopathy patients, identify key microbial biomarkers, and compare the microbiome structure and clinical laboratory indices between MGUS patients and different comorbidity subgroups, to explore their impact on the disease diagnostic model.

Eligibility Criteria:
(I) Inclusion Criteria:

1. Age 45 years or older;
2. Negative screening for monoclonal protein by MALDI-TOF MS;
3. No significant diseases found upon medical examination, and confirmed not to have any diseases related to this study;
4. Sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided.

(II) Exclusion Criteria:

1. History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization;
2. Antibiotic treatment received in the past month; Presence of severe systemic diseases, including malignant tumors;
3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.

The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.

The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.


Eligibility Criteria:
Inclusion Criteria:

* Adult dialysis patient
* Patient able to understand the information necessary for the study and having signed his written consent to participate
* Affiliated patient or beneficiary of a social security scheme.

Exclusion Criteria:

* Medically unstable or frail patient
* Patient with hemoglobin less than 7g/dl
* Patient with HIV+ or AIDS, patient with replicating hepatitis B or C
* Patient participating in another clinical study requiring an additional blood sample
* Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
Factors Affecting Medical Student Learning in Simulation Scenarios

Simulation is used to teach undergraduate and postgraduate healthcare professionals, however it is not known how best to use this resource. Using qualitative methods, this study aims to investigate how medical students learn during simulation scenarios and will compare students who are paired with peers with those who are solo during their scenarios. Video and audio data from simulations will be collected and analysed with anxiety and empathy questionnaire data and semi-structured interviews.

Medical students attending a simulation day will either perform their simulation paired with another student from the group or solo. Video data from the scenario and audio data from the feedback session will be retained. One week later students will perform a second scenario and the feedback following this will be retained. Students will also have a semi-structured interview and complete anxiety and empathy questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* All final year medical students at the study university who are allocated to attend the anaesthesia special study module

Exclusion Criteria:

* Non-English speakers
* Visiting students who will be unable to complete the study
* Students who refuse to participate
Does Laryngoscopic Tecnique Facilitate cLMA Insertion?

it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique

Is there any releation between insertion succes rate and difficult intubation criteria. success of the first attempt laryngeal mask insertion, patient response of laryngeal mask placement. And also during the implementation of these two techniques; the effects on heart rate and blood pressure and postoperative complications were investigated.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 age
* under urologic surgery patient

Exclusion Criteria:

* Uper respiratory infection
* Full stomach
* BMI over 40
Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke participants.

Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke patients. Methods: This study included 72 acute ischemic stroke participants were treated with intravenous thrombolytic therapy. All participants were subjected to general and neurological evaluation including assessment of stroke severity using National Institute of Health Stroke Scale (NIHSS) at admission and investigations including measurement of serum level of T-I on admission. Outcome was assessed three months after stroke onset using NIHSS and modified Rankin scale (mRS).

Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible for inclusion in the study if they had evidence suggesting acute ischemic stroke that lasted for ≤ 4.5 hours .
* Those Participants were treated with intravenous thrombolytic therapy ((recombinant tissue plasminogen activator (rt-PA)).

Exclusion Criteria:

* Those who had hemorrhagic stroke
* participants presented with acute myocardial infarction, cerebrovascular stroke in the previous three months.
* serious head trauma in the previous three months.
* urinary tract, lung, or gastrointestinal hemorrhage within the three weeks.
* serious trauma or major surgery within the previous two weeks.
* lumbar or arterial puncture at a non-compressible site within one week.
* those received heparin within 48 hours, resulting in an activated partial thromboplastin time greater than the upper limit of normal.
* systolic pressure \> 185 mmHg or diastolic pressure \> 110 mmHg.
* blood glucose \<50 or \> 400 mg/dL.
* current use of anticoagulants with an International Normalized Ratio \> 1.7 or prothrombin time\>15 sec; platelet count \< 100,000/mm3.
* pregnancy; serious heart, lung, kidney or other organ dysfunction.
* allergy to active ingredients of rt-PA; patients with \> 4.5 hours from the last time known to be asymptomatic.
* those in whom troponin was not measured at admission were excluded from the study
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.

This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with Alzheimer's disease. The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease. Study drug taken orally twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
* Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
* Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period

Exclusion Criteria:

* Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
* Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
* Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
* Patients with clinically significant cardiovascular disease
* Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism
Ictal SPECT With Intra-arterial Injection

Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an established technique to localize the ictal onset zone during presurgical evaluation of refractory focal epilepsy. When seizures last less than 10 seconds, localizing information is often not obtained. Since it takes around 30 seconds before the tracer reaches the brain after intravenous injection, ictal hyperperfusion most likely has already switched to postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta proximal to the cerebral arteries, which will allow a true ictal injection in patients with seizures of short duration.

In this study, the investigators will select one patient with refractory focal epilepsy with frequent seizures of short duration, which can not be localized with early ictal SPECT with intravenous injection in a cubital vein. An arterial catheter will be inserted. The right groin will be disinfected using an alcoholic disinfectant and locally anaesthetized. The artery in the groin, the femoral artery, will be punctured. A catheter is inserted in the artery and slided towards the heart. To determine the correct position of the catheter proximal to the cerebral arteries, a contrast agent will be injected, and at the same time radiographs will be taken. The catheter will be attached and taped in the groin. The patient will be monitored with video-EEG recording. During an epileptic seizure, the perfusion tracer 99m-Technetium Ethyl Cysteinate Dimer (99mTc- ECD) dissolved in 30 cc normal saline will be injected with a pressure injector over 2 seconds. After injection, the catheter will be removed and the ictal SPECT scan will be performed. Subtracted ictal SPECT images co-registered with MRI (SISCOM) will be obtained. The investigators plan to do this study in one patient in order to assess whether this procedure is logistically possible and to determine whether subtraction images of ictal SPECT with intra-arterial injection minus interictal SPECT with intravenous injection allows localization of the ictal onset zone.

Eligibility Criteria:
Inclusion Criteria:

* Refractory unifocal epilepsy
* Early ictal SPECT with intravenous injection did not localize the ictal onset zone
* Several seizure per day, or clusters of several seizures per day
* Seizures are of short duration (i.e. less than 10-15 seconds)
* Patient asks for epilepsy surgery

Exclusion Criteria:

* Renal failure
* Allergy to contrast agents
* Fever
* Anemia
* Usage of anticoagulants
* Pregnancy