cyrilzakka/clinical-trials huggingface dataset:
Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with clinical diagnosis of cyclic vomiting in the ED

Exclusion Criteria:

* pregnancy, allergy to any of the study medicines
A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites

The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.


Eligibility Criteria:
Inclusion Criteria:

1. patients ≥ 21 years of age
2. recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months
3. cirrhosis of any etiology
4. failure to respond to or intolerance to high dose diuretics
5. expected survival of greater than 3 months (MELD score ≤ 21)
6. screened for varices and on optimal management
7. diagnostic paracentesis with neutrophil count \< 250 / µl within 24 hours of implantation
8. written informed consent
9. ability to comply with study procedures and ability to operate the device
10. women of childbearing potential should use adequate contraception

Exclusion Criteria:

1. more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months
2. presence of any current cancer
3. evidence of extensive ascites loculation
4. serum creatinine \> 1.5 mg/dl
5. serum bilirubin \> 5 mg/dl
6. eGFR \< 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method
7. gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study
8. hepatic encephalopathy \> stage II in the two weeks prior to implant
9. presence of a patent TIPS or surgical portosystemic shunt
10. presence of Budd-Chiari syndrome
11. previous solid organ transplant
12. obstructive uropathy (bladder residual volume \> 100ml (determined by catheterization or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux, or history of urinary calculi)
13. International Prostate Symptom Score (I-PSS) ≥20
14. thrombocytopenia \< 45,000 X106/l
15. patient undergoing therapeutic anticoagulation
16. recent (\<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia, abdominal wall or skin infection, or severe malnutrition.
17. history (\>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis.
18. any non-liver disease with life expectancy \< 1 year
19. patients eligible for TIPS (unless they have refused TIPS placement).
20. presence of any active implantable or body-worn devices that cannot be removed
21. pregnancy
22. patients being in another therapeutic clinical study
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora


Eligibility Criteria:
Inclusion Criteria:

* Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for \< 3 days duration) based on clinical observation; matched healthy controls

Exclusion Criteria:

* Cannot have had bacterial conjunctivitis symptoms as reported by parent for \> 2 days
GC-PRO Intervention

The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site
* understand and be able to provide information for study forms and surveys in English.

Exclusion Criteria:

* Unable to provide informed consent
* For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.
Haemodynamic and Geometric Factors in Atherosclerosis

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of hemodynamic and geometric parameters on the progression of atherosclerotic alterations in peripheral vessels (carotids, femoral artery). Atherosclerotic alterations (IMT, plaque volume) will be measured with a ultrasound (IMT measurements and 3D quantitative plaque volumetry) and magnetic resonance imaging (MRI). Geometric parameters (e.g. carotid/femoral bifurcation angle, carotid/femoral bifurcation area) are assessed with magnetic resonance imaging (MRI) and also 3D ultrasonography.

A total of 100 patients with an asymmetrical plaque distribution in carotid and femoral arteries will be tested. Only patients who are already enrolled in the "Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin" (NCT01895725) and who are tested prior for an asymmetrical plaque distribution will be included in this study. MRI will be performed once whereas ultrasound imaging will be be repeated once per year (up to five times) to assess changes in these parameters over time. Also plasma samples will be collected once yearly and tested for traditional and novel cardiovascular risk factors.

The primary endpoint of the planned study will be the correlation between geometrical and hemodynamic parameters as stated above and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries, respectively.

Secondary endpoints will include the correlation of geometrical and hemodynamic parameters with established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, plaque localization, plaque morphology and the additional predictive value of geometrical parameters compared to an established risk score (SCORE card).


Eligibility Criteria:
Inclusion Criteria:

* asymmetrical (side difference) plaque distribution in carotids/femoral arteries which was tested in at least two prior 3D-ultrasound examinations (absolute side difference in carotid arteries ≥ 30 mm3 or in femoral arteries ≥50 mm3 and relative side difference in carotid arteries/femoral arteries ≥50% )

Exclusion Criteria:

* actual pregnancy, lactation period, chronic renal insufficiency (GFR\<20ml/min)
Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets

X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.


Eligibility Criteria:
Inclusion Criteria:

* Tanner stages of puberty B1, G1
* body height \< 2,5 SDS
* growth velocity \< 75%
* confirmed diagnosis of XLHR
* conservative treatment for at least 1 year (phosphate, vitamin D)
* informed consent, written agreement

Exclusion Criteria:

* growth hormone deficiency
* hypothyreosis
* severe rickets
* severe physical deformities
* severe hyperparathyreoidism
* chronic renal failure
* complex syndrome involving failure to thrive
* chronic disease with failure to thrive
* impairment of glucose tolerance
* Tanner stages of puberty greater than B1, G1
* medical history of malignancy
* therapy with growth hormone, glucocorticoides, anabolica
* attending another clinical trial
MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in AMD

Background:

Biofeedback techniques have demonstrated their uselfulness in the treatment of maculopathies. We wanted to evaluate the efficacy of visual rehabilitation by means of two different types of biofeedback techniques in patients with age related macular degeneration (AMD).

Methods:

30 patients bilaterally affected by AMD were enrolled with a mean age of 76,38±8,77 yrs. Patients were randomly divided in two groups: Group A was treated with an acoustic biofeedback, Group B with luminous biofeedback of a black and white checkerboard flickering during the examination. All patients underwent a complete ophthalmological examination. Rehabilitation consisted in 12 training sessions of 10 minutes for each eye performed once a week for both groups. Statistical analysis was performed using t- test. P values less than 0.05 were considered statistically significant.

Results:

Group A: visual acuity at the end of rehabilitation had improved, but this result was not statistically significant (p=0.054), reading speed showed a significant statistical improvement (p=0.031), as well as the fixation stability (p=0.0023) and single point mean retinal sensitivity value (p=0.044).

Group B: visual acuity improvement at the end of rehabilitation was statistically significant (p=0.048), reading speed showed a statistically significant improvement (p=0.024), as well as fixation stability (p=0.0012) and mean single point retinal sensitivity value (p=0.027). Final results for both groups were compared and patients in group B showed results which were statistically more significant.

Conclusion:

A contrast rich flickering biofeedback stimulus showed a statistically significant improvement in training the patients to modify their preferred retinal locus (PRL) in comparison to acoustic biofeedback. It is possible that increased involvement of the various retinal cell populations with visual stimuli create more efficient ganglion cell response that better utilize the residual retinal function.


Eligibility Criteria:
Inclusion Criteria:

* We enrolled 30 patients (18 women and 12 men), ranging in age from 56-89 with a mean of 76.38 ±8.77, bilaterally affected by neovascular AMD from the Medical Retina Unit of the Department of Ophthalmology, University La Sapienza of Rome, Polo Pontino, A. Fiorini Hospital from August 2009 to July 2010.

Diagnosis of neovascular AMD was based on a complete ophthalmological examination including anterior and posterior segment biomicroscopy, Fluorescein Angiography (Heidelberg HRA2 FA module Heidelberg Germany), spectral domain OCT (Heidelberg HRA-2 OCT module Heidelberg Germany), microperimetry with MP-1 (NIDEK Technologies Padua Italy).

Exclusion Criteria:

* Patients with other eye diseases (i.e. glaucoma, myopia, retinal detachment, etc), uncooperative patients and patients with media opacities were excluded.
A Qualitative Mixed Methods Realist Evaluation of Safety Planning

Safety Planning is a recovery-orientated approach to risk management within mental health context. This study wants to answer the question 'how, why, for whom and it what circumstances does safety planning work? It will do this by carrying out a realist evaluation to identify programme theories by conducting a three phase study, reviewing materials of a Safety Planning training course, interviewing service users, carers and mental health professionals who have attended the training course, and/or use safety planning tools and techniques, adopting theory from existing literature and adding evaluator's insider knowledge. This data will be used to describe programme theory of safety planning that can be applied across diverse mental health settings, including NHS inpatient and community, and is designed to be adopted across different contexts. It will use a realist methodology to understand how safety planning works to develop the skills needed to manage risks associated with mental health difficulties in ways which increase an individual's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Service user participants - must have direct lived experience of managing safety from risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered within Norfolk \& Suffolk NHS Foundation Trust (NSFT) / Be accessing a service from NSFT and have an identified care team, lead care professional and/or know how to access help and support.

Carer participants - have cared for someone who lived with risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered by NSFT / know how to access emotional support should they require it during the study Mental health professionals - have either a) supported people in a professional capacity to manage risks associated with mental health difficulties, b) attended either the safety planning recovery college course (NSFT) OR a version of safety planning training delivered within NSFT c) have some responsibility for safety planning and risk management within the trust. MUST HAVE knowledge of how to access staff wellbeing and support systems for emotional support should they require it during the study.

Exclusion Criteria:

* People under 16 years of age / people who are unable to communicate in English / people with no access to computer, internet or basic IT skills /
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.

This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Eligibility Criteria:
Inclusion Criteria:

* Child aged ≤5 years;
* A stool sample has been provided for a rotavirus detection test during the study period;
* Laboratory test result of rotavirus is available.

Exclusion Criteria:

Not applicable.
Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients

The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients

The aim of this interventional study was to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients. 92 hemodialysis patients were selected for the study. Inclusion criteria included: mean age of 17-65 years old; having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment; being dialyzed at least 2 times a week for 3 months. Exclusion criteria included: hospitalization in the last month; active infection; using immunosuppressant drugs or multi-vitamins; pregnancy. The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.Informed consent were signed by all of them for participating in the study. Weight and height of the patients were recorded for BMI (body mass index) calculation. Then, all of the patients were assigned into 4 groups:

1. consumption of 220 milliliters of whey drink three times a week,
2. consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
3. consumption of 400 milligrams of vitamin E three times a week,
4. control group: no intervention. Patients were followed for 2 months. At the beginning and the end of the 2-month intervention period, 10 milliliters of blood were taken from all of the patients and nutritional status of the patients were assessed as the primary outcome. Serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and lipoproteins were also measured. SGA, MIS and SF-12 questionnaires were filled for all of the patients at the beginning and the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* mean age of 17-65 years old;
* having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment;
* be dialyzed at least 2 times a week for 3 months

Exclusion Criteria:

* hospitalization in the last month;
* active infection;
* using immunosuppressant drugs or multi-vitamins;
* pregnancy, consuming whey or soy products
Periodontal Status in Fermented Food and Food Consumption

Lack of certain nutrients and foods may negatively affect oral health. Therefore, nutrition plays an important role in maintaining oral health. This study aimed to evaluate and compare the nutrient intakes, consumption of food groups and some fermented foods of individuals with periodontal disease and health.

Ninety-three patients who applied to Periodontology Clinic were divided into three groups: periodontal health, gingivitis and periodontitis. In addition, plaque, gingival indices, bleeding on probing, periodontal pocket depth, and clinical attachment level were evaluated. To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method. Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.


Eligibility Criteria:
Inclusion Criteria:

* Patients with three teeth other than 20-year-old teeth in each jaw

Exclusion Criteria:

* Pregnancy and lactation,
* Patients with an acute oral lesion or necrotizing ulcerative periodontitis, -
* Patients with history of diabetes, rheumatic fever, lung and kidney disorders, and use of drugs that affect periodontal tissues (regular use of antibiotics, anti-inflammatory and mouthwashes),
* Patients who smoke, or patients who did not quit until last year were not included in the study.
Tumor Molecular Profiling in Early Phase Clinical Trials

Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.

Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials.

Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform.

Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients age at least 18 years.
2. Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
4. Live expectancy of at least 6 months.
5. Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
6. Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure.
7. Willing and able to comply with study procedures

Exclusion Criteria:

1. Presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial.
2. Any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.