cyrilzakka/clinical-trials huggingface dataset:
Daily Versus Alternate Day Plasma Exchange in Wilson Disease With Acute Liver Failure in Children

Wilson disease in children has a varied presentation. Wilson disease with acute liver failure is associated with very high mortality and morbidity. The standard therapy i.e chelation (with either D- penicillamine or trientene can be used as a temporizing agent to treat the enormous release of copper into the blood stream; however, substantial removal is not achieved for at least 1 to 3 months. Plasma exchange provides a means of rapid means of removal of copper. As per American Society for Apheresis, TPE in wilson disease with acute liver failure can rapidly remove an average of 20 mg of copper per TPE treatment. Decreased serum copper may decrease hemolysis, prevent progression of kidney failure and provide clinical stabilization. TPE can also remove large molecular weight toxins (aromatic amino acids, ammonia, endotoxins) and other factors, which may be responsible for hepatic coma. The frequency of said TPE is not defined as most evidence is based on case reports and case series.

Copper is highly protein bound and the volume of distribution for copper is large. Under normal conditions, 90-95% of serum copper is ceruloplasmin-bound with the remaining 5-10% being nonceruloplasmin-bound. TPE efficiently removes both ceruloplasmin- and albumin-bound copper. FFP used for exchange can be helpful in treating the associated coagulopathy. TPE has been used as a bridge to liver transplantation as well as seen to improve survival with native liver, the optimum protocol for same remains uncertain.

Study population: Children aged 3 to 18 years with Wilson disease (diagnosed as per Leipzig score \>=4) with fulminant presentation (as defined by New Wilson Index\>= 11 and INR \>= 2.5 ).

Adverse effects: Therapeutic plasma exchange has been shown to be safe and effective in improving native liver survival in Wilson disease patients and is currently standard of care in patients with wilson disease with acute liver failure. However, TPE can be associated with risk of adverse events like infections, fluid overload or circulatory insufficiency, hypersensitivity to blood products.

Stopping rule:

1. Septic Shock
2. Anaphylaxis to blood products
3. HE grade3/4
4. INR \> 5 any time point
5. INR \>3.5 24 hours after 3 HVP Patients fulfilling criteria 3, 4 and 5 would be listed for liver transplantation. In case of 1, 2 appropriate medical management will be done as per department protocol.

Intervention:

Group 1: Daily plasma exchange + SMT (Maximum 3+1 sessions during a period of 7 days) Group 2: Alternate day therapeutic plasma exchange + SMT

Eligibility Criteria:
Inclusion Criteria:

1. Wilson disease with New Wilson Index of ≥ 11 and INR ≥ 2.5
2. Children aged 3 years to 18 years

Exclusion Criteria:

1. Grade 3 or grade 4 hepatic encephalopathy
2. Septic shock
3. Disseminated intravascular coagulation
4. Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine \>0.5 mcg/kg/min)
5. Any severe cardio-pulmonary pre-existing disease
Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance

The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.

The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.

Healthy volunteers are recruited to participate in a parallel study (n 30 per group) for 10 to 12 weeks. Markers of cardiovascular health (FMD, markers of inflammation and fatty acid metabolism) and cognition (neuropsychological tests and plasma neurotrophins) are being measured before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-85
* BMI 20-32 Kg/m2

Exclusion Criteria:

* Mini-mental state examination (MMSE) \< 28
* Systolic blood pressure (SBP) \>139 mmHg
* Diastolic blood pressure (DBP) \> 89 mmHg
* Total cholesterol \> 6.5 mmol/L
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults

The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by laboratory results and medical history
* Females not of child bearing potential
* Self-reported sensitivity to acidic foods
* Agrees to consume a low vitamin C diet

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the trial
* Use of medications known to interact with vitamin C or cause epigastric effects
* Use of supplements containing containing vitamin C
* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
* Use of antacids and/or acid suppressors within 4 weeks of randomization
* History of irritable bowel syndrome and related disorders
* Alcohol use \> 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year
* History of cardiac disease within the past 6 months
* History of or current diagnosis of cancer
* Uncontrolled hypertension
* Unstable renal and/or liver disease
* History of kidney stones
* Unstable psychiatric disorder
* History of or current immunocompromise
* History of hemoglobinopathies
* Participation in another clinical research trial \<30 days
* Abnormal liver function
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Anemia of any etiology
* Uncontrolled and/or untreated thyroid disorder
* BMI ≥ 35 kg/m2
* Unstable medications \<30 days
* Allergy or sensitivity to test article ingredients
* Cognitively impaired and/or unable to give informed consent
Resveratrol Supplementation in Patients With Mitochondrial Myopathies and Skeletal Muscle Fatty Acid Oxidation Disorders

The purpose of this study is to investigate the potential beneficial effects of a daily supplement of Resveratrol (1000mg/day) on physical ability and on muscle metabolism in patients with verified mitochondrial myopathy and patients with a verified fatty acid oxidation defect of VLCAD and CPTII deficiencies. Investigators hypothesize an improved muscle metabolism, mitochondrial function, fatty acid oxidation and thus improvement of physical ability.

Study design: double-blind, randomized, placebo-controlled, cross-over study.

To ensure enough participants, and due to the risk of a heterogeneous cohort, a cross-over design is chosen, where participants are their own controls. 10 patients with mitochondrial myopathy and 10 patients with fatty acid oxidation defects will be included. Eligible patients will be randomized using a 1:1 assignment ratio to receive placebo or RSV first. Each treatment will be administered orally twice daily for 8 weeks, followed by a 4 weeks wash-out, and afterwards a new 8-week treatment period.

During the 20-week trial period, subjects will visit the trial site on five occasions, for functional assessments (cycle ergometer testing), blood sampling and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing and able to provide written informed consent prior to participation.
2. Patient is ≥18 and ≤80 years of age at baseline.
3. Patients have genetically verified mitochondrial disorder or a fatty acid oxidation deficiency (VLCAD/CPTII).
4. Patient has a clinical presentation, signs or symptoms suggestive of myopathy (e.g., easy fatigability, exercise intolerance, muscle pain) in the opinion of the Investigator.
5. Patient is ambulatory.

Exclusion Criteria:

1. Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
2. Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction (e.g., drug-induced myopathy).
3. Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.
4. Pregnancy or breastfeeding
Assessing the Effects of Tretinoin Cream on Human Skin With Optical Imaging Technologies

The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.

The researchers will evaluate changes in the dermis and skin properties as the effect of treatment with Tretinoin cream (0.1%) by using the following optical imaging techniques.

1. Multiphoton microscopy using a clinical tomograph (MPTflex, Jenlab, Germany)
2. Multispectral Imaging using a device developed at Beckman Laser Institute, UC Irvine

Eligibility Criteria:
Inclusion Criteria:

* Female 45 years of age or older - Skin type scale I to III

Exclusion Criteria:

* Large amount of dark, coarse hair on the arms
* History of allergies to alpha hydroxy acids (AHAs), retinoids, soaps, fragrances, sunscreens or Latex
* Currently using over-the-counter AHA or retinol within one month or prescription retinoid within three months of the start of the study.
* History of skin cancer, including squamous or basal cell carcinoma at the treatment site or history of malignant melanoma.
* History of diabetes
* Currently pregnant or nursing
Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals

Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary heart disease (CHD). The purpose of this study is to identify the specific genes that predispose Mexican individuals to FCHL.

CHD is the leading cause of death in Mexico. Dyslipidemia that is characterized by high total cholesterol, high triglycerides, and low "good" high-density lipoprotein (HDL) cholesterol is a risk factor for developing CHD. Research has shown that the Mexican population has an increased tendency towards dyslipidemia, but it is not known what genetic factors contribute to this predisposition. This study will examine the genetic basis of FCHL, which is an inherited form of dyslipidemia characterized by elevated levels of total cholesterol and triglycerides. FCHL is a major contributing factor in CHD; 20% of individuals with CHD under the age of 60 have FCHL. The purpose of this study is to identify and characterize the specific DNA sequence variations that predispose Mexican individuals to FCHL. Results of this study may aid in the development of appropriate prevention and screening techniques.

This study will enroll individuals in Mexico who have FCHL. Participants will attend one study visit for blood collection and DNA sampling. Family members of participants will be contacted and asked to provide a DNA sample also. A select group of participants will return for a second study visit for RNA sampling. Study researchers will analyze participants' DNA and RNA samples, as well as two FCHL genes identified in previous research studies.

Eligibility Criteria:
Inclusion Criteria:

* Elevated levels of serum total cholesterol, triglycerides, or both
* Elevated levels of serum apolipoprotein B (using the Mexican population percentiles)

Exclusion Criteria:

* Tendon xanthomas
* Kidney disease
* Thyroid disorder
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)

The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis.

It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.

LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in efalizumab treated patients. It is generally papular in nature and does not involve existing lesions. Clinical experience suggests that LMB may not have a clinical impact in patients responding to efalizumab and therefore may be treated without interrupting efalizumab therapy. To relieve discomfort topical therapy may be indicated until the symptoms are resolved.

This is a single arm, open label study. Fifteen patients who are receiving efalizumab before entrance into this study and who develop LMB wil be enrolled. Topical calcipotriene/betamethasone (Taclonex) will be applied to the areas (except face, axillae or groin) once a day for two weeks. The PI may choose to continue two more weeks if needed for a total of four weeks of therapy. All patients will continue with efalizumab without dose modification for the duration of the study. Patients will return for follow up visits at weeks 2, 4 and 6. Topical desonide may be used for LMB involvement of the face, groin or axillae.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written, informed consent and comply with study assessments for the full duration of the study.
* Age 18 years or older.
* Moderate to severe plaque psoriasis being treated with efalizumab.
* Develop LMB during efalizumab treatment.
* PGA of LMB at least mild (2) excluding face, axillae and groin.

Exclusion Criteria:

* Patients with known hypersensitivity to efalizumab, calcipotriene/betamethasone or any of its components.
* Pregnant or lactating women.
* Known or suspected disorders of calcium metabolism.
* Erythrodermic, exfoliative and/or pustular psoriasis.
* Concomitant use of topical thaerapy, phototherapy or immunosuppressive agents.
* LMB (in areas other than face, axillae or groin) constitutes more than 30% of total body surface area.
* Patients with generalized inflammatory flare which is defined as widespread worsening of psoriasis characterized by erythematous and and edematous lesions within exisiting plaques.
* Any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
An Evaluation of 9MW1911 Injection in Healthy Subjects

This study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

- 1. Male or female subjects aged 18 to 65 years (including 18 and 65 years). 2. Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 26.0 kg/m2 (including cut-off value).

3. Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily.

Exclusion Criteria:

* 1. Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.

  2. The clinical laboratory tests show any clinical abnormalities, or abnormalities with clinical significance (including but not limited to diseases of digestive tract, kidney, liver, nervous system, blood, endocrine system, cancer, lung, immune system, mental, heart) , and judged by the investigator to affect participation in this study.

  3. Subjects with prolonged QTcF interval (\> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.

  4. Subjects received any biological treatment (including all vaccines except the coronavirus vaccine) within 3 months before screening, or planned to take biological treatment during the study period, or received the new coronavirus vaccine within 1 month before screening.

  5. Subjects received any prescription drugs or traditional Chinese medicines, including vitamins, trace elements or dietary supplements within 14 days before screening; except for topical products without systemic absorption.

  6. Subjects with a history of smoking within 6 months before screening, or unwilling to stop smoking during the study, or willing to use products containing nicotine during the study.

  7. Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.

  8. Subjects positive screening for viral hepatitis (including hepatitis B and C), HIV antibodies, and Treponema pallidum antibodies.

  9. Subjects who paticipated any clinical trial within 3 months before screening.

  10. Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Buspirone Plus Omeprazole for Functional Dyspepsia

This study is a double-blinded Randomised clinical trial aim to compare buspirone plus omeprazole with placebo plus omeprazole.


Eligibility Criteria:
Inclusion Criteria:

* being over 18-year-old, Rome III criteria for FD
* normal upper endoscopy within five years
* negative Urease test for H-pylori
* acceptance informed concept form.

Exclusion Criteria:

* denied to get these medications
* taking other drugs for FD
* patients with the organic gastrointestinal disorder
Ergometer Training in Patients With OSA

Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected OSA
2. Capable of giving consent

Exclusion Criteria:

1. Symptomatic cardial infarction
2. Decompensated cardiac insufficiency
3. Hemodynamically effective cardiac arrhythmias
4. Hemodynamically significant Vitia (heart disease)
5. Insufficiently regulated arterial hypertension
6. Global respiratory insufficiency
7. Significant partial insufficiency (PAO2 \<50mmHg or SaO2 \< 80% at rest)
8. State after decompensation of Cor Pulmonale
9. Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure \> 20 mmHg)
10. Severe osteoporosis
11. Higher degree of lung functional restriction: FEV1 \<50% oder \>60% of nominal value after bronchospasmolysis
12. Working performance on ergometer \< 50%
13. Unstable bronchial asthma
14. Exacerbated COPD
15. Heavily overweight (BMI \>40 or weight \>140kg)
Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues

Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.

In this trial, patients who were CHB and treated with NA more than 6 months, still on the treatment and achieved HBsAg level ≤250 IU/ml with HBV DNA undetectable will be randomized enrolled into group A (Intervention group), in which patients switch to interferon therapy for 72 weeks, group B(control group), patients continue treated with NA for 72 weeks. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of interferon treatment were devalued by the rate of HBsAg clearance and decline of HBsAg levels on the 72 weeks of interferon treatment compared with control group.

Eligibility Criteria:
Inclusion Criteria:

* patients who were chronic hepatitis B and had achieved HBsAg level ≤250 IU/ml on treatment of Nucleoside (acid) Analogues

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia After Inguinal Hernia Repair

Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Different pharmacological approaches and interfascial plane blocks are used to control postoperative pain. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was reported to be effective in different types of surgeries. In this study, the primary aim is to assess the effect of ESP on recovery of patients following open IHR surgery.

Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Unfortunately, 40% of the patients experience moderate-to-severe acute pain in the early period. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was described in 2016. In this prospective, controlled trial, the primary hypothesis is that ultrasound-guided unilateral ESP block will provide an increase in the quality of recovery-15 scores which will be assessed at the postoperative 24th hour following open IHR surgery. The secondary hypothesis is that ESP block will reduce postoperative pain scores, need for rescue analgesia and time to first mobilization.The study will be conducted as a single-center, prospective, randomized, controlled, double-blinded trial in a university hospital. Patients scheduled for an elective unilateral open IHR under spinal anesthesia, will be screened for enrollment to the study. At the end of the operation, patients will be randomized to receive a unilateral ESP block with 30 ml of 0.25% bupivacaine or 30 ml of normal saline at the level of T12 vertebrae. A blinded anesthesiologist will collect outcome measures in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II
* Elective unilateral open inguinal hernia repair under spinal anesthesia

Exclusion Criteria:

* Coagulation disorder
* Known allergy to study drugs
* Chronic opioid use
* Infection at the injection site
* Use of pain medications
* Psychologic disorder or inability to cooperate Quality of Recovery-15 (QoR-15) test
* Preoperative pain related to inguinal hernia NRS \> 4/10