cyrilzakka/clinical-trials huggingface dataset:
Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube

The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery

This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.

Eligibility Criteria:
Inclusion Criteria:

Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma

Exclusion Criteria:

1. Age ≤ 18 years old.
2. Any type of glaucoma other than those listed in the inclusion criteria.
3. Less than 3 months of other ocular surgery.
4. Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
5. Patients with connective tissue disorder.
6. Patients with congenital or developmental glaucoma.
7. Patients with severe dry eye syndrome.
8. Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.
9. Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
10. Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
11. Patients with any prior history of allergy to the active compound.
12. Pregnancy or breast-feeding.
13. Patients enrolled in other prospective clinical trials.
14. Patients that plan to use contact lens after surgery.
Inhaled Nitric Oxide and Neuroprotection in Premature Infants

The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.

With the advances in modern neonatal intensive care medicine in the last 20 years, survival of extremely preterm infants weighing less than 1500g (\< 3 lbs, 5 oz) has risen markedly. However, with this increased survival has come a marked increase in the number of infants with serious neurodevelopmental disabilities: Premature infants with birth weights less than 1500g who survive to go home are at significant risk for serious neurodevelopmental problems: cognitive and motor delays, blindness, deafness, and cerebral palsy. In a recent randomized, placebo-controlled clinical trial, we assessed whether giving mechanically ventilated preterm infants inhaled nitric oxide gas (iNO) for 1 week after birth decreased the incidence of death and chronic lung disease. An unanticipated outcome of that study (Schreiber et. al. 2003) and a subsequent study of those infants at 2 years of age (Mestan et. al. 2005) was that premature infants treated with inhaled nitric oxide (iNO) have improved neurodevelopmental outcomes and physical growth at 2 years corrected age, compared with placebo-treated infants (Mestan et. al. 2005). INO therapy, therefore, appears to be a new treatment to protect the premature brain during development outside the womb. The overall goal of this application is understand the efficacy of iNO treatment in improving neurodevelopmental outcomes in at-risk premature infants.

Eligibility Criteria:
Inclusion Criteria:

* Prematurity (birthweight ≤ 1500g, \< 31 weeks gestation)
* Requiring respiratory support
* Admitted to the NICU at the University of Chicago

Exclusion Criteria:

* Severe congenital anomalies
* Genetic syndromes
* Extremely sick preterm infants requiring very high ventilatory pressures (OI ≥ 20)
* Premature infants judged by the physician as nonviable
Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS).

The aim of the study is determining the non-inferiority in the overall success rate and the safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary sarcoidosis.


Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 70 years
* parenchymal pulmonary involvement at Chest X-Ray (CXR) AND one of the follows: physiologic abnormalities on pulmonary function testing and/or respiratory symptoms, and/or exercise-induced abnormalities.

Exclusion Criteria:

* Unable to understand protocol and to sign informed consent or not suitable candidate to comply with the requirements of this study, in the opinion of the investigator
* Cardiac and neurological sarcoidosis or any other organ involvement
* End stage lung disease at high-resolution computed tomography (HRCT)
* Clinical evidence of active infection
* Documented exposure to beryllium
* Patients with Forced Expiratory Volume at one second (FEV1) changes after salbutamol inhalation ≥20%
* Comorbidity: advanced liver cirrhosis or abnormal liver function, unstable cardiac disease, moderate to severe renal insufficiency, poorly controlled diabetes
* Pregnancy or lactation
* A tuberculin skin test (5 I.U.) more than 5 mm
* Psoriasis
* Homozygous glucose-6-phosphatase deficiency
* Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
* Visual field changes attributable to 4-aminoquinolines
* Concomitant therapies: any patient enrolled in the study must be off all prohibited medications at least 4 weeks before screening. Once patients completed the washout period, they may enter the screening period that may last up to 30 days
* Previous therapies: any patient enrolled must be off all medications for sarcoidosis at least 4 weeks before screening.
Is it Necessary to Set External PEEP in AECOPD Patients

Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level compared with pressure-support ventilation (PSV)

All patients randomly underwent a 30 mins PSV and NAVA crossover ventilation (15 mins each) at progressive PEEPe levels. Progressive levels of PEEPe were applied stepwise in increments of 40% of baseline static PEEPi, every 30 mins, from zero to 160% of baseline static PEEPi during the protocol (0, 40%, 80%, 120% and 160% of static PEEPi, respectively). During PSV, pressure support level was set to meet a Vt 6ml/kg, I/E cycling was 30% of the maximum inspiratory peak flow, flow trigger was 1L/min, and inspired fraction of oxygen (FiO2) was set to the similar level before the study protocol. During NAVA, NAVA Level was set at 15 cmH2O / µV and a peak airway pressure limit was set in order to apply the same inspiratory pressure support at each PEEPe level during PSV. The new setting of NAVA was defined as NAVA15. Moreover the trigger was set at 0.5 µV and the I/E cycling fixed at 70% of the peak of EAdi. During the entire protocol, FiO2 and peak air way pressure were maintained the same levels at each PEEPe level between PSV and NAVA. Arterial blood gases were measured at the end of PSV or NAVA15 ventilation at each PEEPe level.

Eligibility Criteria:
Inclusion Criteria:

1. mechanical ventilation AECOPD patients with Static PEEPi measured by End-expiratory airway occlusion method ≥ of 5 cm H2O
2. Hemodynamics stability (heart rate \< 140 beats/min, no vasopressors required, or \<5 μg/kg/min dopamine) without any evidence
3. no sedation or on minimal sedation with low dose of morphine (\<3mg/h, by continuous intravenous infusion
4. Breathing spontaneously
5. Awake and with positive cooperate

Exclusion Criteria:

1. tracheostomy
2. treatment abandonment
3. history of esophageal varices
4. gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days
5. coagulation disorders (INR ratio\>1.5 and Activated partial thromboplastin time \> 44 s)
6. history of acute central or peripheral nervous system disorder or severe neuromuscular disease
The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics

In this clinical study, a single-center retrospective cohort study was used to explore the clinical characteristics and risk factors of patients with multiple myeloma myocardial amyloidosis. An exploratory study was conducted to compare the effects of various sublayer factors (M protein, electrocardiogram, echocardiography, CD138, chromosome abnormalities, etc.) on patients' survival. On this basis, a hierarchical diagnostic model (1-2-3-4) for patients with multiple myeloma complicated with myocardial amyloidosis was established based on the phenoomics of NMR and mass spectrometry, and the prognosis was evaluated simultaneously, in order to create an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and lay a foundation for the early application of effective treatment.

The purpose of this study was to collect clinical data of patients with multiple myeloma complicated with myocardial amyloidosis, analyze and collate the data through statistical methods, and explore the clinical characteristics of patients with MM complicated with myocardial amyloidosis, the factors that may lead to the occurrence of myocardial amyloidosis and the differences in the data of cardiac ultrasound and other biochemical tests, so as to evaluate the prognosis of patients.

To investigate the clinical features, risk factors and prognosis of patients with multiple myeloma myocardial amyloidosis. The clinical experience of diagnosis and treatment of this complication was summarized. On this basis, a standard database suitable for the northwest population was established based on NMR phenoomics, and a hierarchical diagnostic model (1-2-3-4) was explored for multiple myeloma patients with myocardial amyloidosis, and the prognosis was evaluated simultaneously. In order to establish an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and to provide clinical basis for further research on early diagnosis, early prevention and early treatment of the disease. To provide the basis for individualized stratified prevention and treatment of patients with multiple myeloma myocardial amyloidosis, reduce the family medical burden and related side effects, improve the quality of life of patients with myeloma myocardial amyloidosis, prolong the survival period, and improve the cure rate

Eligibility Criteria:
Inclusion Criteria:

A patient with multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018

Exclusion Criteria:

A patient without multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018
Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subjective chronic tinnitus
* Duration of tinnitus more than 3 months

Exclusion Criteria:

* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery;
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Prior treatment with TMS
Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents

This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:

1. Laughter yoga is acceptable to children with ASD and their parents.
2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.
3. Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group.

The intervention is a laughter yoga programme consisting of twelve sessions (biweekly). Sixty-six children with ASD and their father or mother from local autism support groups will join this study. Participants will be given an information sheet. Participants will be fully informed about laughter yoga's details, benefits and risks. All participants voluntarily take part in this study. If the family agrees to participate in this study, the parent will sign the consent form. Families will be randomized into an experimental group or a wait-list-control group. Before the laughter yoga programme, baseline data (T0) will be collected. The experimental group (n=33) will attend the twelve classes led by a certified laughter yoga trainer in an activity room that is suitable for indoor exercise. A research assistant will assist the laughter yoga teacher and provide first aid if needed. Parents will complete the questionnaire again immediately at the Programme End (T1) and at a 3-month follow-up (T2). The wait-list-control group (n=33) will receive the same laughter yoga programme after 3-month follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

THE CHILD should:

* aged 8 to 12
* be diagnosed with autism spectrum disorder (according to either The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or International Classification of Diseases 11th), and
* able to read and understand Chinese and Cantonese, and
* have a parent (father or mother) participating in this study together.

THE PARENT should:

* be able to read and understand Chinese and Cantonese, and
* willing to attend the laughter yoga classes with their child, and
* willing to complete the required post-test.

Exclusion Criteria:

THE CHILD:

* has recently undergone surgery, or
* has a primary diagnosis not ASD, or
* has an intelligence quotient lower than 70, or
* has been diagnosed low functioning ASD, or
* has severe behavioral problems, or
* is receiving medical treatment for anxiety or depression at the start of the laughter yoga program.

THE PARENT has:

* recently undergone surgery, or
* been diagnosed with a psychiatric disorder, or
* no child with ASD is willing to participate in this study.
Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation

The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.

End point: To evaluate the effect of long term administration of albumin and midodrine on the prevention of complications associated with cirrhosis in patients with cirrhosis awaiting for liver transplantation.

Secondary end points:

* To evaluate improvement in the ascites control
* To evaluate survival at 6 and 12 months.
* To evaluate the relationship between the development of complications and the activity of vasoconstrictor systems( renin, aldosterone and norepinephrine) as well as the levels of cytokines (TNF, IL6 and IL10)
* To evaluate quality of life
* To evaluate the presence and outcome of MHE

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis in the waiting list for liver transplant
* Patients with ascites or diuretic treatment
* To have written inform consent

Exclusion Criteria:

* Systolic blood pressure ≥150 mmHg and or diastolic blood pressure≥90 mmHg
* To have been treated with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
* Antibiotic treatment in the previous week before the inclusion in the study
* Respiratory or cardiac failure
* HIV positive
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot

The aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes over the age of 18
* Patients with diabetes of any type, balanced or not, with or without a history of mal perforating
* Giving their oral agreement to participate after information

Exclusion Criteria:

* Patients seen in an emergency
* Patient with lower limb amputee (even partial)
* Patients with a foot wound, whatever the etiology of the wound
* Presence of lymphedema
* History of foot trauma with sequelae
Primary Hepatobiliary Cancer Cohort of Central China

This registry is designed as a longitudinal cohort study of patients diagnosed with primary hepatobiliary cancer in Tongji Hospital, Wuhan. This study collects the clinical-pathological features of hepatic malignant tumors and the current status of patients who received comprehensive treatment based on surgical treatment since 1998.

This longitudinal observational cohort study was designed to make standardized settlements, statistical treatments, and comprehensive analysis of primary hepatobiliary cancers in middle China, which summarize and estimate the population, tumor staging, treatment mode, clinical-pathological characteristics, and the prognosis, to provide evidence for standardized treatment of hepatobiliary cancers.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old,
2. life expectancy is at least 6 months.
3. Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the AASLD or guidance for the diagnosis and treatment of primary liver cancer of China (version 2022).
4. At least one measurable lesion (RECIST v1.1)
5. Subjects volunteer to participate in the study and sign informed consent.

Exclusion Criteria:

Patients with one or more of the following criteria should be excluded:

1. CT or MRI shows no measurable lesions (RECIST v1.1).
2. Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.
3. Incomplete baseline or follow-up data
4. Suffering from more than two kinds of primary tumors
Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity

The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery.

Other objectives were:

* To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it.
* To asses other pharmacokinetic parameters, demographic parameters and drug safety.

Study design It was planned a mixed design which intended to compare the bioavailability in patients with gastric bypass (before and after surgery) and control subjects matched by sex and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover bioavailability study of omeprazole in surgical group and controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients who wish to participate in the study (men and women) after receiving adequate information about the study design, objectives and risks by signing and date of the written informed consent.
* Age between 18 and 60 years old.
* Patients who come to the endocrinology and nutrition Service and on treatment with omeprazole.
* Patients who are to undergo bariatric surgery (Roux en Y gastric bypass) according to the recommendations of Endocrinology and Nutrition Service and the Department of General Surgery and Digestive Diseases hospital Clinico San Carlos.
* No significant abnormalities on clinical examination and laboratory analysis before inclusion in the study.

Exclusion Criteria:

* Any postoperative complication that interferes with the regular intake of medication such as stenosis of anastomotic, fistula, persistent vomiting, diarrhea (\> 4 stools per day), evidence of protein malnutrition (albumin \<3.5 g / l).
* High consumption of stimulating beverages (equivalent to 400 mg of caffeine per day, a cup of coffee contains approximately 100 mg of caffeine).
* Consumption of any medication that may interfere with the objectives of the study: \* Use of enzyme inhibitors or inducers within 2 weeks prior to study inclusion (barbiturates, carbamazepine, erythromycin, phenytoin, oral contraceptives, etc.) \* Any concomitant medication will be assessed by the investigator based on data recorded in the log-book for the medication (potential interactions) and registered in the CRF.
* History of clinically significant disease in the opinion of the investigator does not allow safe participation of the patient.
* Inability to relate to and / or cooperate with investigators.