cyrilzakka/clinical-trials huggingface dataset:
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
* Acute depressive episode at inclusion

Exclusion Criteria:

* Inability (in investigator´s opinion) to carry out the follow-up plan
* Patients participating or having participated within previous 6 months, in clinical trials
* Mental retardation or any other medical condition affecting cognitive performance
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Prospective randomised controlled study. Patients with Crohn's Disease who have symptomatic inflammatory intestinal strictures will be randomised to receive standard drug therapy (Anti-TNF monotherapy at standard dose) or intensive drug therapy (Intense Anti-TNF dose induction and escalation for continued inflammation in combination with thiopurine) for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

Exclusion Criteria:

* Acute bowel obstruction requiring urgent surgical intervention
* Deemed by treating physician to have high risk of acute bowel obstruction
* Concurrent active perianal sepsis
* Internal fistulising disease in association with strictures (entero-enteric stulas)
* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Pregnancy
* Inability to undergo MRI small bowel due to a contraindication.
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease

In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and/or Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.

The purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) and end-stage renal failure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Ability to give informed consent
* Documented NVAF (paroxysmal, persistent, or permanent)
* CHA2DS2VASc risk score ≥2
* Chronic kidney disease KDOQI stage 5 (eGFR \<15 ml/min/1.73m2) with or without hemodialysis

Exclusion Criteria:

* Absolute contraindication to aspirin and/or clopidogrel
* Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
* Present LAA thrombus
* Mobile aortic atheroma
* Age ≤18 years
* Patients presenting with pregnancy
* Patients without informed consent
* Participation in another trial
* Expected life expectancy \<2 years
ND-YAG Laser Iris Depigmentation for Cosmoses

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study safety will be assessed by measuring IOP using Goldman applanation tonometry pre and post-session.

visual acuity assessment in Log-Mar pre and post-session. Refraction assessment pre and post-session. Lens and fundus assessments on slit-lamp and using auxiliary lens 78D

Eligibility Criteria:
Inclusion Criteria:

* clear cornea
* clear lens
* normal IOP \< 20 mmHg
* adults aged more than 18 years old
* normal fundus
* dark pigmented iris (black or brown)

Exclusion Criteria:

* Glaucomatous patients and those receiving anti-glaucoma treatment.
* corneal or lens opacity.
* any fundus abnormality
The Effectiveness and Safety of Electromagnetic Navigation Real-time Guided Percutaneous Lung Biopsy

The goal of this clinical trial is to evaluate the diagnostic efficacy and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology in peripheral lung lesions. The main question it aims to answer are: the effectiveness and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.

Participants will undergo CT-guided percutaneous lung biopsy or percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old
* Imaging examination showed peripheral lung lesions
* Selected patients need to complete routine preoperative examinations such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc
* There is no contraindication for puncture biopsy
* Good compliance, able to cooperate with research and observation
* Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form

Exclusion Criteria:

* Severe cardiopulmonary insufficiency, extreme weakness and intolerance of patients
* The patient is allergic to lidocaine and midazolam
* The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer
* Unstable angina pectoris, congestive heart failure, severe bronchial asthma
* The patient did not agree to participate in the study
* Participation in other studies within three months without withdrawal or termination will affect the observation of this study
* The researcher believes that there is any person who is not suitable for the selection
Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors

The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers

Primary Objectives

* to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
* to evaluate the toxicity profile of the combination therapy Secondary Objectives
* to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®) and TAS-102 (LONSURF®)
* to study the pharmacokinetics of the combination therapy

A phase 1 study with a classical 3 + 3 dose escalation design. The target population is patients who have pathologically confirmed malignant solid tumors with no standard treatment available.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 20 to 70 years old
2. Histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed standard treatment or have no standard treatment currently available
3. ECOG performance status 0 or 1
4. Normal ECG or ECG without any clinically significant findings
5. Adequate hematologic parameters, and hepatic and renal function i. White blood cell (WBC) count 3000/μL and absolute neutrophil count (ANC) 1500/μL ii. Platelet counts 100,000/μL without platelet transfusion within 14 days iii. Hemoglobin level 10 g/dL iv. Serum total bilirubin- within normal range v. Serum albumin 3.0 g/dL vi. Serum alanine aminotransferase (ALT) 3 x the upper limit of normal (ULN) vii. Serum creatinine 1.5 x ULN

Exclusion Criteria:

1. Received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) therapy
2. Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
3. Have liver cirrhosis with Child-Pugh B or Child-Pugh C
4. With active CNS metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
5. With clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 1
6. Life expectancy of less than 3 months
7. Use any anti-cancer or investigational product within 14 days prior to the first date of study dosing
8. History of any second malignancy in the latest 5 years except curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ
9. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, and psychiatric illness or social situation that would preclude study compliance
10. Homozygous for the UGT1A1 28 allele (TA7/TA7), homozygous for UGT1A1 6 allele (A/A), or double heterozygous for both UGT1A1 28 allele (TA6/TA7) and UGT1A1 6 allele (G/A) (only for dose-finding phase)
11. Pregnant or breastfeeding women
Mixed Presentation on Social Media

This study is to understand how the presentation of information on social media influences processing and recall of information, particularly in relation to modified risk tobacco products. Participants will see a social media site where either (a) the topic of discussion varies between each post or (b) posts on the same topic are grouped together. They will then be asked to recall information about the posts they saw on the site.


Eligibility Criteria:
Inclusion Criteria:

* Must be a current or former smoker

Exclusion Criteria:

-
Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control

A prospective, non-blinded, multi-center study to assess the impact of early Catheter Ablation (CA) in patients with a new diagnosis of Atrial Fibrillation(AF) at the time of stroke. 100 patients will be enrolled.

A prospective, non-blinded, multi-center study to assess the impact of early CA in patients with a new diagnosis of AF at the time of stroke. At least 100 patients who meet the inclusion and exclusion criteria will be randomized 1:1 to receive early CA or SOC (Standard of Care). The primary outcome will be the functional neurologic outcomes, including mRS (modified Rankin Scale) and QOL(Quality of Life), recurrence, major bleeding, and mortality after stroke for each group. Secondary outcomes will be changes in cognitive assessment, success of rhythm control, recurrent hospitalizations, and cumulative cardiovascular outcomes. Participants will be followed at 3, 6, 9, and 12 months following the discharge date to measure these outcomes, and the study will enroll for one year. The primary endpoints will be functional recovery and enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Ages \>18 and able to provide consent.
* Presenting with an acute stroke and new-onset AF
* Modified RANKIN score (mRS) \< 6
* Must be able to undergo some form of cardiac monitoring \[implantable loop recorder (ILR), electrocardiogram (ECG), Holter monitor\] to quantify AF burden

Exclusion Criteria:

* Patients \< 18 years of age
* Unable to provide consent, including mRS = 6.
* Not able to read and write at an 8th-grade level \[to complete AFEQT and EQ-5D surveys\]
* Positive B-hCG
* Will not follow up with our practice/clinic afterward.
* Cannot tolerate OAC or AAD for any reason.
* Cannot undergo CA for any reason.
Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. It requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of hospitalisation.

Data underline the importance of afferent input integrity in the maintenance of muscle characteristics and postural control, and suggest that countermeasure programs based on the stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls. In particular, fundamental studies performed in rodents by the investigators laboratory have demonstrated that the adverse structural and functional adaptations which occur during muscle deconditioning can be counteracted through adequate physiological stimuli such as activation of proprioceptors. Based on this scientific expertise, the investigators aim is thus to prevent muscle atrophy and its functional consequences on posture and locomotion, following a surgical intervention in humans .

The investigators will develop a device allowing stimulation of foot and ankle proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be tested on a selected population confined to bed during a post-operative period (knee replacement). It efficiency will be evaluated by means of three parameters: muscle force of ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and balance analysis).

The technique developed in the present project could bring benefits to patients confined to bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate to health and quality of life of these patients. In addition, this device might allow to consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.

The aim of the study is to study the efficacy of a proprioceptive stimulation device on prevention of calf muscle atrophy after a total knee replacement.

The investigators developped a safe vibration and pressure stimulation device for le lower limb. The investigators want to carry out a RCT in order to demonstrate the efficacy of the stimulation device, compared to a not stimulated controle group.

Eligibility Criteria:
Inclusion Criteria:

* patients waiting for knee replacement

Exclusion Criteria:

* neurologic disease
Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study

Automated titration of propofol and remifentanil guided by the bispectral index (BIS) has been used for numerous surgical procedures. Orthotopic liver transplantation (OLT) uniquely combines major volaemic changes, an anhepatic phase, and ischaemia-reperfusion syndrome. We assessed the behaviour of this automated controller during OLT


Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for OLT

Exclusion Criteria:

age younger than 18 years, pregnancy, allergy or hypersensitivity to propofol or remifentanil, a medical history of psychiatric illness, and supraspinal neurological disorders
Nutritional Intervention For The Treatment Of Uncomplicated SAM

nutritional intervention with ready to use therapeutic food (plumpy nut. by Unicef) and Prebiotics supplimentation ( Galactooligosaccarides). will be given to uncomplicated severe acute malnourished children of 06 months to 59 months of age in southern Punjab Pakistan.one group will be given Ready to use therapeutic food and placebo the other group will be given Prebiotics supplementation (Galacto oligosaccharides) with RUTF ( Ready to use therapeutic Foods).for 60 days primary out will be Mid Upper Arm Circumference \>11.5 centimetre

it will be a double blind Randomised Controlled trial in Out Therapeutic Program centres of Teaching Hospital of Dera Ghazi Khan Pakistan children age of 06 months to 59 months of age from the community will be screened out at health centres . Uncomplicated SAM children will be enrolled for study Before intervention there blood sample and stool sample will be sent to the labs for complete blood examination and complete stool examination.

controlled groups will be given Ready To use Therapeutic Food and Placebo (starch) 4 grams per day for 60 days Intervention group will be given Ready to use Therapeutic Food and Prebiotic ( Galactoligosaccharides 4 gram per day for 60 days

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria:

* Severely Acute Malnourished children with complication
Fluctuation of Rhymicity to Predict Recovery

BRIEF SUMMARY :

In the most severe cases of brain injuries, intensive care may allow patients with altered consciousness to survive despite a significant risk of heavy sequelae. Persistent impairments of consciousness are currently categorized according to behavior in three main neurological categories: comatose state, vegetative state (recently named unresponsive wakefulness syndrome) and minimally conscious state. Refining the diagnosis of internal state is a major goal to determine the abilities for an optimal recovery of cognitive deficit. Circadian rhythms are implicated in the regulation of sleep-wake cycles but also in cognitive functions. Their role is actually revaluated in the mechanisms of consciousness impairment. First, it is well known that cognitive performances partially depend on such rhythms as they are more elevated during the day and correlated to the hormonal secretion. In a prognostic point of view, fewer rhythmic perturbations during the initial resuscitation period (with reorganized sleep rhythms and the presence of paradoxical sleep) could be associated to a higher functional outcome.

However, this internal state of alertness could be highly variable during the day as it might be influenced by specific rhythms such as the circadian rhythm. Only a continuous assessment could help defining them properly.

Thus, investigators hypothesize that the circadian restauration, assessed in a dynamic perspective, is associated with the improvement of content and level of awareness. The main challenge of our study is to capture the long-term changes in the evolution of circadian and ultradian rhythms and to keep a part of the natural history of the clinical recovery of these patients.

To achieve this goal, the investigators plan to analyze during more than 2 days both neurophysiological rhythms (EEG) and behavioral rhythms of alertness ("Eyes" scale from of the Glasgow coma scale) in a dataset collected retrospectively from the population of patients continuously monitored by EEG for medical purposes (to identify seizures and prevent status epilepticus) in an intensive care unit of teaching hospital as far as acquisitions last more than 48h and present no prolonged epileptic discharges or artifacts leading to uninterpretable EGG.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Admitted in ICU
* Altered level of consciousness not explained by a continuous sedation
* EEG during more than 48h consecutively

Exclusion Criteria:

* Prolonged epileptic discharges leading to uninterpretable EEG rhythms
* Prolonged artifacts leading to uninterpretable EEG trace
Comparison of MR Enteroclysis and MRI With Per Oral Contrast Using a 6 % Mannitol Solution.

The purpose of this study is to compare MRI enteroclysis with MRI of the small bowel with a per oral 6%mannitol solution.Our hypothesis is that the peroral technique preform the same way as MRI Enteroclysis.


Eligibility Criteria:
Inclusion Criteria:

* above 18 years
* known Crohns disease or strong suspicion.
* need of a small bowel examination

Exclusion Criteria:

* pregnant
* electrolyte disturbances.
* Any MRI contraindications.
Eversense® Non-adjunctive Use Post Approval Study

This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has diabetes
2. Subject is ≥18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
5. Subjects is willing and able to provide written signed and dated informed consent

Exclusion Criteria:

1. Subject is critically ill or hospitalized
2. Prior use of CGM defined as:

   * No more than 1 week of continuous CGM use in the last 6 months, and
   * At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing
Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

This is a single-center, prospective, observational study to explore the clinical features and risk factors of impaired cardiac function detected by two-dimensional speckle tracking echocardiography in patients with diabetes mellitus. The risk factors include traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones, and novel serum biomarkers.

Cardiovascular complications are a leading cause of death in patients with diabetes mellitus. However, early cardiovascular disease screening presents several challenges, particularly for those who have no cardiovascular symptoms. Novel imaging techniques, such as tissue Doppler imaging and speckle tracking echocardiography, allow for the more frequent detection of early subclinical left ventricular systolic dysfunction in asymptomatic patients with diabetes. Based on speckle tracking echocardiography and other techniques, this study evaluated cardiovascular function in diabetic subjects to achieve the following objectives:

A) Investigate the clinical characteristics of diabetic patients with early cardiovascular function impairment. B) Investigate the role of traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones in diabetic patients with early cardiovascular function impairment. C) Explore novel biomarkers of early cardiovascular dysfunction in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, aged ≥18 and ≤80 years.
2. Diagnosed type 2 or type 1 diabetes

Exclusion Criteria:

1. Moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation.
2. History of coronary heart disease or stroke
3. Typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (\>NYHA II)）
4. LVEF \<60％
5. Malignant tumor, acute infection, abnormal liver and kidney function (ALT \> normal upper limit 3 times or eGFR \< 60 ml/min/1.73 m2)
6. Diabetic ketoacidosis
7. Pregnancy