cyrilzakka/clinical-trials huggingface dataset:
StableEyes With Active Neurofeedback

The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.

The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma
4. Willing to adhere to the SWAN and/or vestibular rehabilitation regimen

Exclusion Criteria:

1. Current use of anti-nausea medication
2. Presence of cervical spine pathology that limits head motion to \< 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis)
3. Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery)
4. Legal blindness (20/200 or worse visual acuity)
5. Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days
Effect of Candesartan in Alcoholic Liver Fibrosis

Background:

Alcohol is one of principal causes of hepatic fibrosis. Although the most effective treatment for alcoholic hepatic fibrosis is abstinence of alcohol consumption, additive treatment to reduce the accumulation of scar tissue can accelerate the improvement of hepatic fibrosis in alcoholic liver disease. The renin-angiotensin system can be an attractive antifibrotic target in liver. Several lines of evidence indicate that overproduction of angiotensin II(ANG II) in chronic liver injury stimulates the activation of hepatic stellate cells(HSCs) attributed to fibrogenesis. Additionally, the antifibrotic effect of ANG II blocking agent has been shown in various animal models and hepatitis C patients. Hence, drugs that inhibit the renin-angiotensin system have promise in ameliorating hepatic fibrosis in chronic liver injury. However, no study has been conducted in patients with alcoholic liver disease to evaluate the effect ANG II type I receptor blocking agent on hepatic fibrosis.

Aim:

This study aimed to investigate the safety and the efficacy of chronic administration of candesartan to hepatic fibrosis patients with alcoholic liver disease.

Methods

1) Patients with liver fibrosis(F2) were randomized to receive either the angiotensin receptor blocker(ARB), candesartan(8 mg/day) with ursodeoxycholic acid(UDCA)(600 mg/day)(n = 42), or UDCA alone(n = 43) as control for 6 months. 2)All enrolled patients underwent liver biopsies twice for measurement of fibrosis score, area of fibrosis and alpha-smooth muscle actin(SMA) positive and hydroxyproline. 3) Transforming growth factor-beta1(TGF-beta1), collagen-1, angiotensin II type I receptor(AT1-R), tissue inhibitor of metalloproteinase-1(TIMP-1), Rac1 and p22phox which represent oxidant stress were also measured by real-time RT-PCR before and after 6 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of alcoholic liver disease
* METAVIR fibrosis score ≥ 2 in liver biopsy
* Alcohol intake has stop during at least 6 months until study enrollment

Exclusion Criteria:

* Hepatocellular carcinoma or other malignancy
* Clinically decompensated cirrhosis (Total bilirubin ≥ 5mg/dL or variceal hemorrhage or ascites development or hepatic encephalopathy developement)
* Chronic liver disease related with other causes except alcohol
Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease

This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic liver disease(presented with abnormal serum ALT levels \>6 months and twice continuously or abnormal area of liver through medical imaging test within 6 months
* Abnormal serum ALT levels at screening and baseline

Exclusion Criteria:

* Subjects who have diseases that liver cirrhosis, liver cancer, renal dysfunction etc.
* Subjects who are taking medications or supplements related to chronic liver disease, fatigue.
MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse

A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse

This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring;
2. Successful stem cell engraftment
3. Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;
4. Age 12-70

Exclusion Criteria:

1. Patients who relapsed or died before the first ddPCR monitoring;
2. Patients with only germline mutations.
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects \>= 16 years to 80 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
* Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
* Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
* Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
* Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug \[AED\](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED

Exclusion Criteria:

* Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
* Subject is currently treated with levetiracetam
* Subject has taken levetiracetam within 90 days prior to Visit 1
Evolution of Bone Histomorphometry and Vascular Calcification Before and After Renal Transplantation

A study of the natural history of bone and mineral disease (BMD) in patients with end-stage renal disease before and after kidney transplantation

Disturbances of mineral and bone diseaeses are frequently observed in CKD patients. Renal osteodystrophy is the term to describe the bone abnormalities. Epidemiological data showed adynamic bone disease (ABD) is the most frequent bone disorder in CKD stage 5D diseases. Low PTH, diabetes mellitus, malnutrition, metabolic acidosis, hypogonadism and low 1,25(OH)2D vitamin D deficiency are known risk factors for ABD. Mounting experimental data point towards a role of protein-bound uremic retention molecules (p-cresyl sulfate and indoxyl sulfate) in the pathogenesis and progression of ABD. ABD is not only recognized as a risk factor for fractures but also for arterial calcification.

The aim of the present study is (1) to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5 and (2) to investigate the influence of renal transplantation on bone and arterial metabolism.

Eligibility Criteria:
Inclusion Criteria:

* eligible for renal transplantation and \>18 years

Exclusion Criteria:

* use of biphosphonates within the 6 months before the study entry
Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.

Venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. Preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. An aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. They have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. We propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed venous ulcer (ICD-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33);
* Documented healing of all lower extremity ulcers;
* Ankle-brachial index (ABI) \> 0.8 to rule out arterial insufficiency

Exclusion Criteria:

* Unwilling or unable to sign informed consent;
* No plans to seek care at VA Puget Sound within 6 months;
* Limbs with ulcers or threatened viability
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
* Have been infected with hepatitis C virus for greater than (\>) 6 months
* Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
* Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
* Female subjects must have a negative pregnancy test at all visits before the first dose

Exclusion Criteria:

* Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis
* Diagnosed or suspected hepatocellular carcinoma
* Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
* Alcohol abuse or excessive use in the last 12 months
* Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates

Pre-clinical animal studies provide robust evidence regarding the beneficial effect of stem cells for intestinal disease.

This single-center, randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing NEC in preterm neonates,and influence on growth and development.

Study design and settings:

This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 45 singleton preterm infants (GS\<33 weeks) of fulfilling the eligibility criteria will be enrolled. According to the infusion of umbilical cord blood mononuclear cells and equal dose placebo, the premature infants were divided into infusion group and control group. The two groups were matched with gender, gestational age and birth weight as stratified variables and 1:2 (the gender was the same, and the difference between gestational age and birth weight was the smallest).

Trial treatment methods: Study design and settings:

This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. Subsequently, one baby of each twin will be randomly divided into the ACBMNC infusion group or control (placebo) group.

Trial treatment methods:

Soon after the preterm infant was deliveried, written consent was signed by the parents, and autologous cord blood infusion was applied to the baby in addition to routine treatment. Those assigned to the ACBMNC group received an infusion of ACBMNC . Those in control group received an infusion of a placebo solution. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth, and then their umbilical cord blood will be separated through Guangdong Province umbilical cord blood Bank to obtain mesenchymal stem cells. Within 24h after birth, ACBMNC group received an infusion of mesenchymal stem cells timely, while control (placebo) group received an infusion of a placebo solution which is normal saline with the same volume. Cell dose for all patients was targeted at 5×107 cells per kilogram.

Eligibility Criteria:
Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) 26\<GA \<32 weeks; (4) free of severe congenital anomalies or genetic syndromes;

Exclusion criteria： (1) mothers with clinical chorioamnionitis; (2) the mother was opsitive for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (3) consent was not obtained from the parents or guardians; and (4) after processing, UCB cells were not available.
Awareness During Blended Anaesthesia

the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.

The decreased responsiveness to stimulation defines depth of anaesthesia which is a balance between effects of anaesthetic drugs and surgical stimulations.

Awareness is a rare occurrence with an incidence of 0,1-0,2 % , defined as postoperative recall of events occurring during general anaesthesia.

Different stages of awareness should be defined: conscious awareness with explicit recalls with pain; conscious awareness with explicit recalls without pain; conscious awareness without explicit recall and possible implicit recall; subconscious awareness without explicit recall and possible implicit recall; no awareness .

This memory can be traumatic and may result in developing a chronic posttraumatic stress disorder (PTSD) in more than half of subjects .

Some cases of awareness are caused by inadequate anesthesia and are potentially avoidable through the assessment of depth of hypnosis by an intraoperative monitoring , especially when muscle relaxants are used.

The Bispectral Index ( BIS ), one of the devices designed to monitor brain activity, through a proprietary algorithm , elaborates EEG and provides an index of hypnotic level.

Thus, several variables, derived from EEG time and frequency domain, are combined into a single index indicating the patient's level of consciousness.

A range between 40 and 60, during surgery, permits both to prevent awareness and to reduce the dose of anesthetic agent administered .

In this study, during major abdominal surgery, an epidural analgesia was performed to suppress afferent noxious stimuli and combined with a general anaesthesia based on halogenates.

Thereby the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.

Eligibility Criteria:
Inclusion Criteria:

native Italian speakers American society of anaesthesiologist physical status I-II -

Exclusion Criteria:refusal of placement of epidural catheter neurological or psychiatric diseases hearing impairment use of drugs know to affect central nervous system coagulopathy heart conditions infections allergy to local anaesthetics liver or renal disease

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Attitude of Egyptian Population Toward COVID 19 in Ramadan

During the COVID 19 pandemic and after new cases started to appear in Egypt in march 2020 the Egyptian government issued movement restrictions and placed areas into quarantine to reduce the spread of the virus. Egyptian citizens were encouraged to adopt personal protective measures, such as staying at home , increasing personal hygiene and wearing protective face masks. Ramadan is a holy month and a very special event for all the Muslims worldwide including the Egyptian Muslims . the Egyptians have many rituals and traditions special for Ramadan . normally Egyptian people tend to go to family gatherings and go out for iftar and suhoor in Ramadan .the markets also tend to be very crowded and full of people in Ramadan for buying food and other preparations for Ramadan and Eid Al Fitr. This all can lead to crowdingof people in the streets and markets and increases the chance of the spread of the virus and the chance of infection.Public Awareness play a major rule in reducing the spread of COVID 19 so in this study a survey is done to measure the attitude of the Egyptian population toward COVID 19 in Ramadan and to evaluate if the rituals and traditions in the holy month are affecting the spread of COVID 19 in Egypt.

The survey will enroll as many individuals of the Egyptian population as possible in the survey portion of the study - The number of participates have no limitations, at least 500 participants.

The survey will be enrolled in online google form, face to face interview(this will be reduced to encourage social isolation) \& semi-structured telephone interviews if possible.

The research procedures:

An online survey link will include questions regarding the attitude and behaviour of the Egyptian population during the COVID-19 outbreak in Ramadan and to evaluate if people are practicing their normal rituals and traditions in the holy month and how can this affect the COVID 19 spread in Egypt.

Face to face and semi-structured interviews if possible: For those Egyptian citizens who state that they would like to participate in an interview, a random sample will be contacted.

Inclusion Criteria:

Egyptian population of any age group

Exclusion Criteria:

none

Eligibility Criteria:
Inclusion Criteria:

Egyptian population

Exclusion Criteria:

none
Biology in Patients With Reflux Esophagitis

GERD is a common condition in the western world. In most cases, the diagnostic is established by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms are refractory to therapy, multiple invasive tests are available. The results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to establish the diagnostic. No test however can be use alone because of their poor specificity and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in between distal esophageal cells tissue; unfortunately this marker again failed to diagnose GERD.

In search of more sensitive and specific markers of GERD, we propose to assess if acid exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if correlation exists between the two approaches.


Eligibility Criteria:
Inclusion Criteria (GERD Cases):

* Male or female
* Ages 18 years or older
* Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center
* Esophageal erosion detected at EGD
* Abnormal pH monitoring

Inclusion Criteria (Controls):

* Male or female
* Ages 18 years or older
* Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center
* No complaints or history o heartburn or acid regurgitation
* No erosion at EGD
* Normal pH monitoring

Exclusion Criteria:

* Less than 18 years of age
* Unable to provide informed consent
* Use of acid suppressive therapy within last 14 days
* known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
* contraindications to biopsy such as taking anticoagulants other than aspirin (coumadin, plavix) or allergies to local anesthetic