cyrilzakka/clinical-trials huggingface dataset:
Is it Effective to Treat Patients With Blastocystis Hominis Infection?

The objective of this study is to determine whether in the setting of primary health care it is effective to treat with metronidazole returning travellers with gastrointestinal symptoms and B. hominis in the stool or not.

Prevalence of B. hominis is between 30-50% in developing countries. Many travellers visit developing countries and are therefore at risk to be infected by this parasite. It's frequent that travellers return from developing countries with gastro-intestinal symptoms and approximately 10% of them have B. hominis as the sole parasite identified in the stools. Some anti-infective drugs, including metronidazole, trimethoprim-sulfamethoxazole and nitazoxanide, have shown to have activity against B. hominis, but there is still controversy about the pathogenic potential of B. hominis and there is no consensus about the indications for treatment.

It is hypothesised that metronidazole is more effective than placebo in returning travellers with gastrointestinal symptoms and B. hominis as the sole intestinal parasite identified in the stool.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Gastrointestinal symptoms for more than 10 days
* B. hominis in any quantity in at least one stool specimen out of 3 examined
* No other pathogenic micro-organism identified

Exclusion Criteria:

* Fever \> 37.5°
* bloody diarrhoea
* weight loss \> 10% of usual body weight
* significant decrease of general condition
* oncological diseases
* immune deficiencies
* known chronic intestinal diseases
* use of anti-protozoan drugs in the last 2 weeks
* use of anti-coagulant treatment or antabuse
* pregnant and lactating women
Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation

The goal of this clinical trial is to explore the mechanism of Yisui Granule(YSG) in the treatment of myelodysplastic syndrome(MDS) through demethylation.

Under the same condition of basic western medicine treatment, the treatment group used the same traditional Chinese medicine decoction pieces as YSG, and the control group was given placebo. Through a randomized controlled clinical study, we focused on observing the effects of MDS patients on clinical symptoms (including single symptom), fatigue relief, quality of life, peripheral blood picture, blood transfusion interval and blood transfusion volume, and measured the expression of DNMTs, the expression and methylation level of Wnt3a、β-catenin、SFRP and other indicators, as well as cytokines, were used to explore the mechanism of YSG in the treatment of MDS through demethylation.


Eligibility Criteria:
A. Diagnosed as myelodysplastic syndrome, IPSS score 0-1; B. It meets the syndrome standard of "deficiency of both qi and yin, internal resistance of blood stasis"; C. Newly diagnosed cases or no application of other Chinese and western medicines or treatment schemes in the past month; D. Take the test voluntarily and sign the informed consent form.
A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support

Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support.

Study design:

1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH).

Study arrangement:

1. The collection of patients with selected standard
2. Preoperative evaluation included nutritional status,liver function and tumor characteristics
3. The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing
4. Both groups received conventional therapy after operation
5. The comparation of the clinical outcomes in both groups


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of hepatocellular carcinoma (HCC) was made before operation
2. Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission
Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria

OBJECTIVES:

I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria.

PROTOCOL OUTLINE: This is a multicenter study.

Patients receive a phenylalanine restricted diet based on a medical food such as Phenyl-free, Lofenalac, PKU 3, or Maximum XP (may be supplemented with tyrosine as needed) to achieve a target blood phenylalanine level of 2-6 mg/dL. The diet begins approximately 3 months prior to conception and continues until delivery of the baby. Patients are evaluated once a month before conception and weekly during pregnancy. Patients also undergo sonographic examination at 8, 20, 28, and 34 weeks gestation. At birth, the cord blood is evaluated for plasma amino acids. If the baby is found to have an elevated phenylalanine level, blood and urine are obtained to determine the baby's genetic status. Phenylalanine and tyrosine levels are checked in the baby daily for three days after birth.

The baby is followed for physical and mental development at 3 and 6 months and then annually thereafter.

Eligibility Criteria:
* Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed
Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions

The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix placebo tablets in healthy male volunteers under fasting and fed conditions. The method which is used is an imaging technique.


Eligibility Criteria:
Inclusion Criteria:

* Ethnic origin: Caucasian
* Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
* Good health
* Written informed consent, after having been informed about benefits and potential risks of the trial

Exclusion Criteria:

* Diseases which could influence the gastric emptying and gastrointestinal transport
* Diet which could influence the gastric emptying and gastrointestinal transport
* Surgery in the gastrointestinal tract which may interfere with the safety and transport of test product
* Ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement
* Regular medical treatments which could affect the gastric emptying and gastrointestinal transport
Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft

Partial thickness skin grafts are widely used to cover large losses of substance secondary to trauma, burns, ulcers, neoplasms.

The donor site (SD), in principle, heals by spontaneous re-epithelialization from the epithelial residues of the skin appendages.

In the post-surgical management of the collection area, in order to optimize treatment, the following are necessary: control of nappy bleeding, management of transudate, avoid superinfection, promote rapid re-epithelialization and pain control.

The objective of the research proposed by us wants to compare two methods of dressing of the SD, one of which involves the use of impregnated gauze and cream with Rigenase and poliesanide (Fitostimoline Plus®) while the other the use of impregnated gauze and cream with hyaluronic acid, sodium salt and 1% silver sulfadiazine (Connettivina Bio Plus®) associated with non-adhesive polyurethane foam (i.e. without adhesive edge, i.e. Mepilex).

The prospective, multicentre study will be conducted at the UOC of Plastic and Reconstructive Surgery of our AOU directed by Prof F. D'Andrea and the UOC of Plastic and Reconstructive Surgery of ASUGI of Trieste directed by Prof Z. Arnez.

To date, there is still no standardized protocol on the wound care of the graft harvesting area. If the literature is evaluated, in fact, large variations in the management of SD are observed with a discrepancy between the practice and the evidence reported in the literature.

The purpose of our research is precisely to review the literature on the effectiveness of dressings at the sampling site level in terms of reducing pain and promoting rapid healing.

The management of the removal site of a partial thickness graft is still a subject of heated debate where, despite the published works, it is still often treated with empirical methods, sometimes which also differ within the same working group. The treatment of AD usually, despite what has been exposed in numerous scientific papers, only involves the use of greasy gauze impregnated with substances that promote re-epithelialization or simple paraffin gauze.

The aim of our research is to compare the effectiveness of bioactive dressings containing Rigenase in association with polyhexanide (PHMB) - Fitostimoline Plus®- with bioactive dressings with hyaluronic acid and Silver sulfadiazine - Connettivina Bio Plus®- in improving the outcome of patients, evaluating:

* cure rate
* the healing times
* the AD infection rate
* pain control / discomfort
* assessment of the scar

RESEARCH OBJECTIVES AND HYPOTHESIS The objective of the study proposed by us is to compare two methods of treating DS; the first involves the use of impregnated gauze and cream containing Rigenase® + polyhexanide; the second is the use of impregnated gauze and sodium salt hyaluronic acid cream. The secondary dressing is a non-adhesive polyurethane foam in both groups.

Eligibility Criteria:
Inclusion Criteria:

* informed consent Age \> 18 years

Exclusion Criteria:

* Absence of informed consent Age \< 18 years
Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.

In this observational study, blood samples will be collected from adult and pediatric patients with CGD. The level of circulating adenovirus antibodies and inflammatory cytokines will be measured to characterize the prevalence of these markers in this population.

Eligibility Criteria:
Inclusion Criteria:

* The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive \[DHR+\] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1).
* The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent.
* The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF).

Exclusion Criteria:

* The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy.
* The participant is unable to comply with the sample collection procedure based on investigator judgment.
ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration

Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* Body mass index (BMI) of 19 to 35 kg/m2 at screening
* Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
* Diagnosis of opioid-induced constipation (OIC)
* Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during the study.

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
* Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
* Any gastrointestinal (GI) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
* Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
* Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
* Participation in a clinical trial of a pharmacological agent within 30 days before screening
Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography

The aim of the study is to determine, wheather strict dietary intervention with the use of the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography.

A total of 180 patients with coronary atheroslerotc lesions confirmed in coronary computed tomography (CCT) will be analyzed in a 12-month observation time. Patients will be randomized to two groups in a 1:1 fashion. 1 - optimal medical treatment, 2 - strict dietary intervention with implementation of the DASH diet atop of optimal medical treatment. CCT scans will be performed at screening and at 12 months after randomization. Computed tomography imaging data describing atheroslerotic lesions will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* coronary atheroslerotic lesions confirmed in the screening CCTA with reduction of the artery diameter less than 70% in 2 or more coronary artery segments
* no indications for coronary angiography / revascularization (no documented significant ischemia of myocardium)
* free and informed consent of the person concerned
* willingness to follow the strict directions given by the investigators

Exclusion Criteria:

* any valvular heart disease requiring cardiac surgery (or expected cardiac surgery intervention within 12 moths)
* diagnosis of dilated / hypertrophic cardiomyopathy
* diagnosis of DM t. 2
* past CABG procedure
* women in reproductive age
* known genetic factors with a possible impact on the progres of coronary atherosclerotic lesions (e. i. congenital metabolic disorders, familial hyperlipidemias)
* low quality of the CCTA data
The Study of Ocular Hemodynamics With Glaucoma Progression

To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.

1. To determine whether baseline ocular blood flow values are predictive of glaucomatous progression as determined by visual field analysis.
2. To determine how changes in ocular blood flow are related to visual field progression.
3. To determine how changes in ocular blood flow are related to changes in optic nerve structure and topographic change over time.

Eligibility Criteria:
Inclusion Criteria:

Patients will meet all of the following inclusion criteria to enter the study:

1. Age: 30 years or older.
2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

   1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
   2. glaucomatous optic disc cupping
   3. agreement between two baseline exams for reliability
3. Best corrected visual acuity at least 20/60 in at least one eye.
4. Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Exclusion Criteria:

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields.
2. Evidence of exfoliation or pigment dispersion.
3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
5. History or signs of intraocular trauma.
6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
7. Any abnormality preventing reliable applanation tonometry.
8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
9. Cataract surgery within the past year.
10. Resting pulse \< 50 beats per minute.
11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Genetics Study of Wet Age-Related Macular Degeneration (AMD) Non-Responders to Vascular Endothelial Growth Factor (VEGF) Therapy

To obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly Anti-VEGF therapy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent for participation in this study
* Subjects diagnoses of neovascular AMD who are on a monthly anti-VEGF regimen (have had \>10 or more ranibizumab and/or bevacizumab injections within the last year) and who still have intra-retinal or subretinal fluid as confirmed by the Investigator

Exclusion Criteria:

* Subjects with a Pigment Epithelial Detachment Exclusively
* Subjects with Serous Pigment Epithelial Detachments
* Subjects with history of the following:

idiopathic polypoidal choroidal vasculopathy

* pathologic degenerative myopia
* central serous chorioretinopathy
* familial drusen
* adult onset foveal pattern dystrophy
Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series

Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but carbohydrate restriction. It is followed by millions of people around the word as a life-style, but in the last years was proposed as a treatment for the epilepsy, by its capacity to induce the state of ketosis.

Since Authors observed that ketosis could be also useful in migraine, and migraine shares some pathophysiological features with cluster headache, The aim of the study is to test the efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.

The Atkins diet is a ketogenic high-fat, low-carbohydrate diet for long adopted as lifestyle by people that dislike have an high carbohydrate intake. This nutritional life style seems to account for more energy in the daily activity and an easy weight control. In the last years, researchers showed that a modified Atkins diet (MAD) can be useful to treat drug resistant epilepsy, maybe by the induction of ketogenesis.

Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients following low-carbohydrate high fat diets. Different Authors evidenced a protective effect of ketone bodies also on migraine that shares some pathophysiological features with cluster headache (CH).

CH is the worst form of headache, also called as "suicide headache"; in particular its unremitting form, called Chronic CH (CCH) is regarded as a clinical challenge for neurologist, if refractory to pharmacological treatments. So far, no data are available about a beneficial effect of ketogenesis in CH. However, the beta hydroxybutyrate (BHB) has a chemical formula similar to gamma hydroxybutyrate (GHB) that has shown to be effective in CH. Moreover, ketosis has also a beneficial effect on hypothalamic dysfunctions that are shared by some form of epilepsy and CH.

Aim of this study is verify in an open label observational study if a MAD can be useful in the treatment of CCH. In case of positive outcome, the results could be used as preliminary data to design a double blind versus placebo study, to asses definitively if ketogenesis is really able to prevent/avoid headache attacks in CH.

Methods: By the Italian branch of the Organization for the Understanding of Cluster Headache (OUCH), there will be recruited CCH volunteers that accept to modify their diet according to Atkins Diet for at least three months.

Headache attack frequency will be collected on specific headache-calendars and a comparison between the pre-diet phase and the during-the-diet- phase will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CCH (less than 30 consecutive days of attacks remission in the last year)
* kept a headache diary for at least 1 month
* CH onset before the age of 50

Exclusion Criteria:

* over consumption of acute pain-killers (triptan, analgesic, or ergotamine)
* pregnancy or lactation
* type I diabetes
* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.
The Influence of Fortified Pomegranate Juice (Punica Granatum) on Seasonal Influenza and Swine Flu Patients

It has been shown in laboratory studies that pomegranate juice contains anti-viral action against influenza. The researchers wish to investigate the effect of pomegranate juice on patients suffering from influenza A (seasonal or swine flu).


Eligibility Criteria:
Inclusion Criteria:

* Individuals confirmed and suffering from Influenza A

Exclusion Criteria:

* Individuals suffering from influenza included in the high risk group
PaNeX: Partial Nephrectomy Under Xenon

Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.

A partial nephrectomy is accompanied by ischemia time, followed by reperfusion. This frequently leads to a kidney injury of the remained tissue and decrease of the renal function after surgery. As it was shown that Xenon has protective properties against ischemia/reperfusion injury, the investigators hypothesize that Xenon application during partial nephrectomy leads to a stronger nephroprotection than an anesthesia with Isoflurane.

The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anesthesia for partial nephrectomy and will therefore necessarily be unblinded to the treatment conditions.

Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive Xenon for maintenance of balanced anesthesia for partial nephrectomy. Group 2 (Isoflurane) will receive Isoflurane for the same surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing and able to complete the requirements of this study
* Patients with renal carcinoma restricted to one kidney
* Patients undergoing partial nephrectomy
* Men and women \>= 18 yrs
* Informed consent

Exclusion Criteria:

* Chronic renal failure with a GFR \< 60ml/min/1,73m2 body surface area
* American Society of Anesthesiologists (ASA)\>III
* Hypersensitivity to the study anaesthetics
* Chronic obstructive pulmonary disease (COPD) GOLD IV
* Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
* Severe cardial dysfunction New York Heart Association (NYHA) \>III
* Disabling neuropsychiatric disorders
* Increased intracranial pressure
* pregnant or breastfeeding women
* Women of childbearing potential
* Presumed uncooperativeness or legal incapacity
* Lack of informed consent
* Participation in a concomitant trial within the last 30 days