cyrilzakka/clinical-trials huggingface dataset:
Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations

The purpose of this study is to evaluate the impact of the last recommendations of the European Anemia Working Group ERBP in the anemia management in the achievement of the therapeutic goal of Hb 11-12 g/dL.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
* Patients starting anemia treatment (naïve) after six months of the last recommendations of the European Anemia Working Group ERBP (January 2011).
* Patients in treatment who changed from previous ESA treatment since January 2011 (converted patients

Exclusion Criteria:

* Patients in Erythropoiesis Stimulating Agents (ESA) dose adjustment period.
* Kidney transplant patients.
Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.

Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children.


Eligibility Criteria:
Inclusion Criteria:

1. Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
2. Children aged 5-8 years old.
3. Patients who need maxillary buccal infiltration anesthesia.

Exclusion Criteria:

1. Children with any neurological or psychological disorders.
2. Children with known allergy to topical or local anesthetic agents.
3. Parental refusal for participation.
4. Children with previous history of local anesthesia injection.
Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder

The goal of this clinical trial is to learn if neuromodulation of the dorsal genital nerve works to treat symptoms related to Persistent Genital Arousal Disorder in women. The main questions it aims to answer are:

What is the effect of neuromodulation on PGAD symptoms in women?

Participants will:

Use a neurosimulator every day for 3 weeks. Keep a diary of their symptoms and the number of times they used the neurostimulator Fill in questionaires


Eligibility Criteria:
Inclusion Criteria:

* Women with PGAD

Exclusion Criteria:

* Women \< 18 years
* Women not able to handle the neuromodulator
* Women in whom the anatomy of the genitals precludes proper electrode placement
Smoking Cessation in Hispanic Construction Workers

Construction workers have the highest rate of smoking among all occupations, and are frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with smoking to increase their health risks. Minority construction workers, in particular, have higher smoking and lower cessation rates compared to other groups, and they generally show lower access and participation in cessation and health promotion services. The number of Hispanic workers employed in the construction industry in the US has tripled in the past decade to 2.6 million (23% of all construction workers). This study will develop, administer, and evaluate a novel smoking cessation program in a hard-to-reach and underserved population of Hispanic male construction workers using using pilot cluster randomized clinical trial (RCT) to test the developed intervention for feasibility and potential efficacy.

A two-arm, cluster-randomized controlled trial will be conducted with up to 15 construction sites, selected from one Construction Company in south Florida. Cluster randomization is used with construction site chosen as the unit of allocation because it is most practical in this setting and minimizes the risk of spillover effects from the intervention to the control group. In conjunction with the site's safety manager, the investigators will recruit 9 adult Hispanic construction workers per site (126 total) who smoke ≥5 cigarettes/day in the last year. Participants in the enhanced care will receive one culturally adapted brief face-to-face behavioral counseling session developed in phase 1 and delivered at a lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida quitline (QL), and provision of up to 6 weeks of free NRT. Participants in the standard care will receive fax referral to the Florida QL, and provision of up to 8 weeks of free NRT.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic
* Construction worker
* Have smoked ≥ 5 cigarettes/day in the past year.
* Have access to telephone
* Have no plans to move in the next six months
* Are interested in making a serious quit attempt in the next 30 days
* Have no contraindication to NRT (e.g., history of hypersensitivity to nicotine, recent (past month) myocardial infarction, any history of serious arrhythmias or unstable angina pectoris, chronic dermatological disorder (e.g., psoriasis)).

Exclusion Criteria:

* Inability to understand consent procedures
* Not Hispanic
* Not a construction worker
* Haven't smoked ≥ 5 cigarettes/day in the past year.
* No access to telephone
* Has plans to move in the next six months
* Not interested in making a serious quit attempt in the next 30 days
* Has a contraindication to NRT
* Has a generalized chronic dermatological disorder (e.g., psoriasis)
Evaluation of Carbohydrates Part 2

The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females in good health.
* Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

* Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes, cardio-vascular disease or GI disease.
* Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.
Validation of a Newly Developed Liquid Jet Aesthesiometer

A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular surface sensitivity by employing a liquid jet.

This study aims to validate this new prototype by means of correlating its measurement with a previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.

Currently, no aesthesiometer is available that delivers reliable and repeatable measurement of ocular surface sensitivity in a routine clinical setup. The only commercially available Cochet- Bonnet aesthesiometer uses a tactile-mechanical stimulus (the tip of a nylon thread), which can cause a microerosion when applied to the corneal surface. Additional disadvantages represent poor stimulus reproducibility, a limited stimulus bandwidth and the influence of humidity and age on the bending capibility of the nylon thread. For research purposes prototypes of non-contact air aesthesiometers (eg by Murphy et al. and Belmonte et al) are being used.

This study aims to correlate ocular surface sensitivity measurements of a newly developed prototype, the liquid jet aesthesiometer, with the non-contact air jet aesthesiometer by Murphy et al. 1996 and to explore its repeatability of measurement.

In this repeated measures design 60 subjects participate in corneal sensitivity measurements during two appointments with each described aesthesiometer.

Eligibility Criteria:
Inclusion Criteria:

* Ocular surface index score \< 13.0

Exclusion Criteria:

* systemic disease such as diabetes, diseases, injuries and operations in the anterior segment of the eye
* systemic medication and / or eyedrops / ointments that may have an influence of the tearfilm.
* contact lens wear less than 48 hours before commencement of study measurements.
The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in PD

Depression is common in Parkinson's disease (PD), but the effective treatment is not established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The tDCS on the depression in general population were already conducted, but not in PD. This study is to know whether transcranial direct current stimulation (tDCS) is effective for the treatment of depression in PD. Participant will be asked to visit three consecutive days for the non-invasive stimulation.


Eligibility Criteria:
Inclusion Criteria:

* UK Parkinson's disease brain bank criteria
* more than 19 years old
* Able to provide consent for the protocol
* Depression (based on DSM-IV criteria)

Exclusion Criteria:

* Dementia
* Unpredictable symptom fluctuations
* Contraindication to tDCS (i) irritations, cuts, lesions in the brain (ii) any preexisting unstable medical conditions, or conditions that may increase the risk of stimulation such as uncontrolled epilepsy (iii) history of severe cranial trauma with alteration of the cranial anatomy or metallic intracranial implants (iv) history of seizure
* Subjects without the capacity to give informed consent
* If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension
Hypnotherapeutic Olfactory Conditioning for Posttraumatic Stress Disorder (PTSD)

Chronic combat-related posttraumatic stress disorder can be difficult to treat. The investigators believe that hypnosis, with a stress on the sensation of scent which often plays a role in the traumatic memories, can offer help for victims of this disorder who continue to suffer after receiving other treatments.

Our study examines the effect of hypnosis upon 36 individuals who suffer from posttraumatic stress disorder incurred in battles or training. The hypnotherapy stresses elements of odor, both in conditioning the subject to relate certain pleasant odors with security and calm, and in gradually reexposing the patient to the olfactory aspects of the traumatic memories. All subjects are taken form the Israel Defense Forces Mental Health Clinic, treated with 6 one-and-a-half-hour hypnotherapy sessions, and evaluated at baseline, end of treatment, after 6 months, and after 12 months, on a battery of clinical scales.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of chronic combat-related PTSD according to DSM-IV criteria (APA, 1994), as determined by semi-structured psychiatric interview conducted by a psychiatrist with over ten years of experience treating PTSD
2. Flashbacks and/or panic attacks with olfactory components
3. Prior attempt at treatment with unsatisfactory results
4. Competence and agreement to sign an informed consent.

Exclusion Criteria:

1. Evidence of psychosis
2. Severe traumatic brain injury
3. Post-concussion syndrome
4. Uncontrolled substance abuse.
The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients

Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.

The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.

Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status.

An ongoing prospective longitudinal observational study of SARS-CoV-2 infected individuals that did not require hospitalisation and their HH members was initiated on March 2020, at the start of the pandemic in the Netherlands.

Enrolled individuals comprised the identified laboratory COVID-19 index positive patients plus all their HH members. The average number of HH inhabitants in the Netherlands and the northern region is 2.14 \[44\], thus for each enrolled patient we expected to enrol an average of 1-2 HH members in addition. Patients were followed daily at home approximately during 3 weeks post-infection to characterize their acute clinical phenotype, and are currently being followed at 3, 6, 12 and 18 months to determine their long-term clinical and serological evolution. During the follow-up, clinical data and different types of samples were/are collected, as described below.

Eligibility Criteria:
Inclusion Criteria:

* Onset of symptoms \<5 days before inclusion
* Positive diagnostic RT-PCR for SARS-CoV-2 performed within 48h of inclusion
* Index person should supply all required samples in the protocol for the duration of the study
* All HH members should join the study
* Signing of informed consent form

Exclusion Criteria:

* False positive RT-PCR test
* Non compliance with study follow-up
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea

This research study will test a laboratory test called Film-Array Gastrointestinal (GI) Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause diarrhea. This test will enable the ED doctor to better understand the cause of diarrhea to try to determine the best treatment.

The primary objective of this study is to determine if testing ED patients who complain of diarrhea will lead to more optimal use of antibiotics. Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen.


Eligibility Criteria:
Inclusion Criteria:

* Presumed infectious diarrhea (3 or more loose stools in past 24 hours)
* Must have one of the 3 following features or symptoms lasting more than 7 days.

  1. Symptoms greater than 24 hours;
  2. Dehydration (defined as the need for intravenous fluid or per clinician's judgement ((based on the general appearance and alertness of the patient, the pulse, the blood pressure, the presence or absence of postural hypotension, the mucous membranes and tears, sunken eyes, skin turgor, capillary refill, and jugular venous pressure.))
  3. Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.)

Exclusion Criteria:

* Chronic Symptoms (\>14 days)
* Inability to Follow- Up (i.e. no telephone)
* Prisoner
* Likely non-infectious cause of diarrhea (Crohn's disease, radiation colitis, irritable bowel syndrome, or celiac disease)
* Confirmed C. Diff Diarrhea
* Unable to provide written consent
* Non- English speaker
Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors

In this research project, the effect of different polyphenol-containing beverages with varying alcohol content of \< 0.4 vol% on immune function as well as muscular growth factors will be investigated


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 20 - 60 years
* Written informed consent

Exclusion Criteria:

* severe gastrointestinal disease or known malabsorption
* use of proton pump inhibitors
* malignancies
* rheumatoid diseases
* metabolic syndrome
* acute or chronic infections or inflammatory diseases
* use of medications or supplements to interfere with immune function
* alcohol and/or drug abuse or addiction
* dependent relationship with the project manager or his or her employees
* pregnancy or breastfeeding
* chronic illness or regular use of medication (except hormonal contraception)
* smoker
Neurological Effects of Goal-directed Fluid Therapy in Beach Chair Position Shoulder Surgery

Patients receiving beach chair position shoulder surgery are vulnerable to perioperative cerebral desaturation, which is reported to be a risk factor for postoperative cognitive dysfunction. Investigators design this study to test the efficacy of perioperative goal-directed therapy in preventing cerebral desaturation and postoperative cognitive dysfunction in patients receiving beach chair position shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving scheduled beach chair position shoulder surgery

Exclusion Criteria:

* pregnant women
* patients in intensive care units
* patients with respiratory failure \[forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) \< 70 % and FEV1 \< 50%\]
* patients with heart failure(NYHA score =III、IV)
* patients with chronic kidney disease (eGFR\< 60 ml.min-1.1.73m-2)
* patients with liver failure
* patients with ongoing infection
* patients allergic to voluven
Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)

This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma

This is an open-label, dose-escalation study PhaseI Treatments repeats for 28 days for 1 course in the unacceptable toxicity

Cohort of 3 patients receive escalating doses of Z-208 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients experience dose-limiting toxicity.

PhaseII Treatments repeats for 28 days for 6 courses until absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed hepatocellular carcinoma
* At least one measurable site of disease according to RECIST criteria that has not been irradiated.
* Child-Pugh classification A \& B
* ECOG performance status of 0-1
* Life expectancy is more than 90 days
* Adequate organ function as defined by the following criteria, Hemoglobin ≥ 8.0 g/dL WBC ≥ 3,000/mm\^3 \<12,000/mm\^3 Absolute neutrophil count ≥ 1,500/mm\^3 Platelet count ≥ 50,000/mm\^3 AST and ALT ≤ 5 times upper limit of normal (ULN) Albumin ≥ 2.8 g/dL Bilirubin ≤ 2.0 mg/dL Creatinine ≤ 1.5 times ULN
* Must provide written informed consent prior to the implementation of any study assessment or procedures

Exclusion criteria

* Patients received treatment with any of the following within the specified timeframe;Any surgical procedure, radiofrequency ablation, intraarterial chemotherapy within 30 days prior to signing the ICF, any treatment with transfusion, albumin preparation, G-CSF within 15 days prior to signing the ICF
* CNS involvement must have completed appropriate treatment
* Prior deep vein thrombosis
* Has ascites, pleural effusions or pericardial fluid refractory
* Active clinically serious infection excluding chronic hepatitis
* Any history of deep vein thrombosis, pulmonary embolism, myocardial infraction, cerebrovascular accident
* Allergy or hypersensitivity to Vitamin A
* Women who are pregnant or breast feeding
Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation

In spite of the development of a lot of airway devices in the past 2 decades, tracheal intubation problems were the most common primary airway problems.

The GlideScope® Video Laryngoscope (Verathon, Bothell, WA) is a video laryngoscopy system with a two-segment blade, the distal portion of which houses a charge-coupled device that contains a micro-video camera that transmits images to a 7-inch video liquid crystal display (LCD) monitor. The GlideScope® can be used for routine intubation but is also commonly used as an alternative device for difficult or failed airways. It is particularly useful in cases where cervical motion or mouth opening is limited, preventing creation of a "straight line" of sight from the operator to the glottis .

GlideScope improves the laryngeal view as one of its advantages due to the blade angle of 60° which is designed to improve the glottic view without the need of alignment of the oral, pharyngeal, and tracheal axes and also without adding additional lifting force.

Fibreoptic intubation with a flexible bronchoscope is an important airway management skill in which anaesthesiologists should be proficient. Unfortunately, clinical experience shows that even with reasonable experience and practice, fibreoptic intubation can be challenging. It requires a high degree of manual dexterity, an ability to manoeuvre quickly under stressful clinical situations, and rigorous training and practice to maintain a high level of skill.

Thus, whereas fibreoptic intubatThus, whereas fibreoptic intubation can be used rapidly for intubation, video laryngoscopy may be an effective alternative, especially in patients with an anticipated difficult airway. However, it remains unclear whether video-assisted airway management using the GlideScope provides significant advantages over flexible bronchoscopy in patients with potentially difficult airways , Video laryngoscopy is increasingly used for difficult airway management in anaesthesia, intensive care units and emergency departments. Recently, video laryngoscopy has been incorporated into various difficult airway management algorithms, being recommended as one of the initial steps in the management of difficult airways .


Eligibility Criteria:
Inclusion Criteria:

* patients who will be scheduled for elective surgery requiring orotracheal or nasotracheal intubation with anticipated difficult intubation.
* physical status American Society of Anesthesiologists (ASA) I - III.

Exclusion Criteria:

* Patients who refuse to participate
* patients with body mass index (BMI) \>35 kg/m2
* coagulopathy, severe thrombocytopenia \<50×103.
* Pregnant females
* physical status American Society of Anesthesiologists (ASA)\>IV
* patients requiring rapid sequence induction
* patients with closed mouth opening who are candidates only for nasal intubation