cyrilzakka/clinical-trials huggingface dataset:
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Providing informed consent to participate in the study
* Age 18 or older
* Burn injury with pain and/or itch that is moderate to severe
* Burn injury occurring at least 3 weeks prior to enrollment

Exclusion Criteria:

* Subjects with burns in scalp in the area of electrode placement
* Psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality
* Learning disorders that may prevent patient's ability to complete assessments
* Unstable conditions preventing travel to study site
* Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin
* Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices
* Pregnancy at time of enrollment
* History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)
Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons

Nearly half a billion people suffer from disabling hearing loss. The most common form of hearing loss in adults is age-related hearing loss (ARHL), which causes a reduced ability to understand speech in noisy environments. The ability of people with ARHL to communicate is therefore greatly impacted, limiting their social interactions and thus their quality of life. Yet, the wear of hearing aids - which is the current standard rehabilitation treatment in such cases - does not lead to optimal satisfactory outcomes when it comes to understanding speech in noisy environments.

The objective of this pilot study is to test a new signal-processing algorithm, based on artificial intelligence, that aims at enhancing the intelligibility of speech-in-noise signals. The efficiency of the algorithm is compared to a standard denoising algorithm commonly used in hearing aids. The primary outcome measure is the word-identification performance of the participants, using the FrMatrix test (Jansen et al., 2012). Two secondary outcome measures are investigated: listening effort (self-assessed using a Likert scale, and measured through response times), and subjective preference (assessed in a paired-comparison task).

The study is conducted in 20 normal-hearing subjects and in 40 older (age ≥ 55 years) hearing-impaired subjects.


Eligibility Criteria:
Inclusion criteria for normal-hearing participants :

* consenting to and available for the study
* age ≥ 18 years and ≤ 25 years
* right-handed
* native French speaker
* pure-tone air-conduction audiometric thresholds at .5, 1, 2, and 4 kHz all ≤ 20 dB hearing loss (HL)

Exclusion criteria for normal-hearing participants :

* score at the Tinnitus Handicap Inventory \> 56
* uncorrected visual impairment
* pregnancy
* subject placed under legal authority (guardianship, tutorship)

Inclusion criteria for hearing-impaired participants :

* consenting to and available for the study
* age ≥ 55 years
* native French speaker
* pure-tone air-conduction average hearing thresholds (PTA) for frequencies of .5, 1, 2, and 4 kHz ≥ 30 dB HL and ≤ 70 dB HL
* right-ear PTA for low frequencies (\< 2 kHz) lower than the right-ear PTA for high frequencies (\> 4 kHz). The difference between the two PTAs must be ≥ 20 dB
* the difference between the PTA for frequencies of .5, 1, 2, and 4 kHz (PTA.5-4kHz) in the right ear and the left-ear PTA.5-4kHz must be ≤ 10 dB

Exclusion criteria for hearing-impaired participants :

* score at the Tinnitus Handicap Inventory \> 56
* history of a hearing impairment that was left uncorrected for more than 10 years
* uncorrected visual impairment
* congenital hearing impairment
* Ménière's disease
* auditory neuropathy
* mixed hearing loss
* fluctuating hearing impairment
* sudden hearing loss
* hearing impairment concomitant with other symptoms (e.g. vertigo)
* score at the Montreal Cognitive Assessment (MoCA) \< 27
* subject placed under legal authority (guardianship, tutorship)
BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients

The purpose of this study is to find out whether acute renal failure is associated with BK virus reactivation in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.

Polyomavirus BK virus (BKV) infection and nephropathy is a significant cause of allograft dysfunction in kidney transplantation. Clinical manifestation ranges from BK viremia and nephritis to renal dysfunction. It has been suggested that BK virus reactivation alone is not sufficient to cause BK viremia and nephropathy, thus a second hit is essential for kidney specific damage, such as an inflammatory reaction or ischemia. Critically ill postoperative/posttraumatic patients via the systemic inflammatory response syndrome (SIRS) and the compensatory antiinflammatory response syndrome (CARS) are at increased risk to develop organ dysfunctions, such as acute renal failure. CARS, reflecting postoperative/posttraumatic immunosuppression, may favor viral reactivation. However, prevalence of BK viremia in critically ill postoperative/posttraumatic patients has up to now not been systematically evaluated. Moreover, it is not known whether BK viremia is associated with a distinct biomarker pattern in these patients. Therefore, the present study is performed to clarify whether postoperative/posttraumatic immunosuppression is associated with BK viremia, and acute renal failure with BK virus reactivation, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill, postoperative/posttraumatic patients with threatening acute renal failure

Exclusion Criteria:

* Life expectancy \< 24 hours
* Participation in other trials
* Known or suspected pregnancy
A Clinical Study of LUNG-CT CAD Decision Support

This product is a computer-aided detection software designed to assist clinicians in detecting lung nodules in chest computer tomography. This product receives from PACS, radiology information system or directly from computer tomography scanner. After receiving the image, the product performs image analysis and provides a mark of suspected lung nodules. Users can use existing medical image capture and transmission systems or reading software to view these annotations on the workstation.

The main purpose of this trial is to verify that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the diagnostic efficiency of clinicians.

The secondary purpose is to evaluate that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the sensitivity, specificity, and image interpretation time (Reading Time) of clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Cases of men or women aged between 20 and 89.
* At Changhua Christian Hospital or Yuanlin Christian Hospital, expert (qualified for interpretation of chest computed tomography lung nodules) confirms that the original low-dose computed tomography image had pulmonary nodules (part solid nodule, solid nodule, and pulmonary nodules greater than or equal to 3 mm), and verified that it is as a true nodule through follow-up clinical imaging examination or clinical determination, or
* At Changhua Christian Hospital or Yuanlin Christian Hospital, the subject has undergone a low-dose lung computed tomography and a physician (qualified for interpretation of chest computed tomography lung nodules) confirmed that there are no lung nodules on the computed tomography scan.

Exclusion Criteria:

* The computerized tomography of the lungs and obvious administrative or technical errors.
* A physician (qualified for interpretation of chest CT pulmonary nodules) confirms cases with severe infections such as tuberculosis and pneumonia from source report or other medical records.
* A physician (qualified for interpretation of chest CT pulmonary nodules) confirms cases with lung fibrosis such as pneumoconiosis from source report or other medical records.
* Test cases used when training physicians to use the lung computer tomography decision support system.
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome

This is an exploratory sub-study to ZX008-1503 \[NCT02823145\]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.

This sub study will include up to 20 participants who meet the entry criteria for the main Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app for 12 consecutive weeks. Those invited to participate will undergo all procedures included in the main study during their participation in this sub-study,

Eligibility Criteria:
Inclusion Criteria:

* Meeting all of the main study ZX008-1503 \[NCT02823145\] inclusion criteria
* Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if needed for younger children). Subjects are asked to wear the watch for as many hours of the day as possible and for the entire night, if possible, for the duration of the sub-study.
* Subject's parent/caregiver is willing to use the Alert App.
* Subject/subject's caregiver is willing to ensure that the Embrace watch remains within close proximity of the paired iPod Touch running the Empatica Alert app.

Exclusion Criteria:

* Subject has a known hypersensitivity to any of the Embrace device materials.
* Subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.

Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide.

The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients.

This study is not recruiting in the US.


Eligibility Criteria:
Inclusion Criteria:

* - Male or female Outpatients 18 years and older.
* Patients with hypertension defined as the following:
* Newly diagnosed hypertensive patients should have a MSDBP \> 95 mmHg and \< 110 mmHg.at Visit 1 and 2, Pre-treated hypertensive patients should have a MSDBP \> 95 mmHg and \< 110 mmHg at Visit 2
* For entrance into the double-blind treatment period (Visit 3), all patients should have a MSDBP of \> 90 mmHg and \< 110 mmHg
* Patients must have given written informed consent to participate and be willing to participate in the entire study

Exclusion Criteria:

-
Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation Treating Recurrent Pterygium Trial

To observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium.

Recurrent pterygium is a common postoperative complication of pterygium surgery, the postoperative recurrence rate is about 1.44% and needs careful treatment. At present, surgical is the main and most effective treatment of recurrent pterygium. Among various surgical methods, autologous conjunctival transplantation is regarded as the first choice in normal conditions. However, the scope of conjunctival transplantation is positively correlated with the degree of ocular surface damage. Therefore, our research aimed to use micro conjunctival transplantation（1.5mm×3.0mm） to reconstruct limbal conjunctiva and amniotic membrane to cover the whole pterygium resection area to better protect conjunctival sac and ocular surface.

Eligibility Criteria:
Inclusion Criteria:

1. age⩾18;
2. relapsed after pterygium surgery once;
3. invading the cornea 2.00\~5.00mm.

Exclusion Criteria:

1. having obvious severe systemic organic diseases and mental diseases;
2. In lactation or pregnancy or planned pregnancy;
3. combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.;
4. used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study;
5. received pterygium surgery twice or more.
A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD)

The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary health care.

Gastroesophageal reflux can result in mild to severe symptoms in some persons. Heartburn, a burning sensation or discomfort rising behind the breastbone, is a common symptom. Gastroesophageal reflux disease (GERD) can be described as a condition with clearly identified clinical symptoms or the change in tissue structure that results from the reflux of contents from the stomach or small intestine into the esophagus. This is a study to confirm the safety and effectiveness of rabeprazole in the treatment of patients with GERD in routine primary health care. The study has two phases. Patients will receive treatment with rabeprazole tablets once daily for 8 weeks. In the second phase, patients will be monitored by their physician for a follow up period to end of study (12 months). Safety assessments include the incidence of adverse events throughout the treatment and follow up phases, and physical examination and laboratory tests at end of treatment and after 4 months. Assessments of effectiveness include the degree of relief of symptoms at beginning and end of treatment and at specific intervals during follow up. The study hypothesis is that rabeprazole is well-tolerated with long term treatment of patients with GERD in routine primary health care. Rabeprazole tablet (20 milligrams\[mg\]) once daily in the morning for 8 weeks. Dose may be increased to 2 tablets daily (40 mg maximum) at investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms of erosive or ulcerative gastroesophageal reflux disease (GERD) during at least a period of 3 months prior to study initiation and symptoms of GERD for at least 3 days per week within the 2 weeks prior to study initiation. The symptoms of erosive or ulcerative gastroesophageal reflux disease includes the following: heartburn, aching behind the breastbone, a need for antacids, and difficulty in swallowing. Patients with evidence by endoscopy of erosive or ulcerative gastroesophageal reflux disease with no Barret-type tissue transformation.

Exclusion Criteria:

* No narrowing or inflammation of the esophagus
* no known gastro-duodenal ulcer
* no infections (other than H. Pylori), inflammations or hemorrhage of the stomach, small or large intestine
* no prior surgery of the stomach or intestine
* no known history of primary kinetic disorders of the esophagus, other than GERD
* no history of enlarged veins of the esophagus or stomach
* no pregnant or nursing females, or those lacking adequate contraception.
Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation

The purpose of this study is to assess the feasibility and acceptability of mPal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment.

In this study, 60 advanced stage lung cancer patients will be randomized to mPal's patient-level component or usual care. Oncology providers will receive the mPal intervention. mPal is designed to help oncology providers integrate outpatient palliative care (non-hospice palliative care; NHPC) into routine clinical practice through: 1) electronic health record enhancements; 2) patient education and preparation for NHPC discussions when patients are in clinic to see their oncology providers; and 3) provider education about NHPC.

This study will examine the feasibility and acceptability of mPal and gather preliminary data on potential outcomes for a future effectiveness trial.

Eligibility Criteria:
Inclusion Criteria:

* new or recurrent AJCC stage IIIb-IV non-small cell lung cancer or extensive stage small cell lung cancer
* ECOG performance status 0-3/Karnofsky 40-100
* at least three weeks into active oncologic treatment (chemotherapy, immunotherapy, chemo-immunotherapy)

Exclusion Criteria:

* unstable brain metastases
* Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate
* Receiving palliative care
* Unable to speak and read English
Amino Acid Supplementation in Continuous Renal Replacement Therapy

ICU patients treated with continuous renal replacement therapy is recruited prior to start of treatment.

Blood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. Then patients are given amino acid supplementation (33.5g/24hrs) for 20-24 hours. New samples are drawn and amino acid supplementation is increased to 67g/24hrs and new samples are drawn after additional 24 hours. Then CRRT will continue with the full amino acid supplementation (standars of care).


Eligibility Criteria:
Inclusion Criteria:

* Dialysis where amino acid supplementation is planned by treating physician

Exclusion Criteria:

* Liver failure
* Muscle disease
* Neurodegenerative disease
Surveillance Versus Bronchoscopy After Airway Stenting

Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting


Eligibility Criteria:
Inclusion Criteria:

* All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.

Exclusion Criteria:

* Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment.
* Lobar or segmental stents alone
* Terminally ill patients considered too sick to undergo a follow-up surveillance bronchoscopy
* Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks)
* Patients with a tracheostomy (as these patients can undergo frequent in-line suctioning that can affect the outcomes being assessed)
Thyroid Medication and Antidepressants for Treating Major Depression

This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD).

The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores compared to placebo in the treatment of Major Depressive Disorder (MDD).

The goals of this proposal are to examine the relationship between Major Depressive Disorder (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD. The focus will be on two overlapping populations: 1) those with evidence of HPT abnormalities, and 2) those who did not respond to a previous adequate SSRI trial

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
* Primary diagnosis of unipolar Major Depressive Disorder
* HAM-D (21 item) score \>18

Exclusion Criteria:

* Alcohol abuse or alcohol dependence within the past year.
* Psychoactive substance abuse or dependence within the past year.
* Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
* ECT within the past 6 months.
* Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
* Serious and unstable medical illnesses.
Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?

Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.

However, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).

moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.

Thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.


Eligibility Criteria:
Inclusion Criteria:

* hospitalisation in geriatric unit
* Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)
* signed inform consent

Exclusion Criteria:

* estimated lifetime less than 6 months
* under guardianship or curatorship
* without support person