cyrilzakka/clinical-trials huggingface dataset:
The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire

In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence. According to the International EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management is the key for a better treatment outcome. To translate this questionnaire into Thai is essential in our subject of interest in order to effectively apply it to local patients. The Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

1. Adaption of the Cu-Q2oL questionnaire into Thai version by using forward-backward translation that is independently performed by two bilingual translators. The original Italian version is translated into Thai by two Thai native speakers, then the study team reviews the Thai-version Cu-Q2oL questionnaire for items comprehensibility and integrates the first consensus version which re-translated into Italian by an Italian native speaker afterwards. The comparison between the backward Italian version Cu-Q2oL questionnaire and the original Cu-Q2oL is carried out to find out whether there are any misconception and mistranslation in the intermediary forward version of questionnaire. After that, the second consensus version will be tested on 15 chronic urticaria patients to detect any misunderstanding points based on patients' comments. Finally, this Thai-version of CU-Q2oL questionnaire will be used to investigate the validity, reliability, interpretability and minimal clinical important difference.
2. To investigate the validity, reliability and interpretability of Thai-version of Chronic Urticaria Quality of Life Questionaire (CU-Q2oL), the severity of chronic urticaria symptoms will be assessed by investigators and patients using the Urticaria Activity Score (UAS7), the DLQI and CU-Q2oL questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or above
* Diagnosed as chronic urticaria based on "The EAACI/GA(2)LEN/EDF/WAO Guideline
* Literate in Thai language and can complete the questionnaire by themselves

Exclusion Criteria:

* Have other active skin diseases
* Have a psychiatric problem
* Cannot understand the questionnaire by themselves.
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination.

The study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.


Eligibility Criteria:
Inclusion Criteria:

* Having received two doses of Gardasil in 2008-2009, 2009-2010,2010-2011 or 2011-2012 according to 0, 6 months Schedule (between 4 and 12 months)
* Resident of the regions chosen for the study

Exclusion Criteria:

* Being considered immunosuppressed at time of vaccination (9-10 years-old) or at recruitment visit
* Being pregnant at recruitment visit
High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers

Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium.

Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 \<93% for more than 10 seconds.

Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years of age undergoing transfemoral TAVR procedure under local anaesthesia and sedation consenting to participate in the study

Exclusion Criteria:

* \<18 years and/or refusal to give informed consent for participation General anaesthesia required to perform complex cases of TAVR
Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia

The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique.

Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.

The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.

All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.

Aim of

Eligibility Criteria:
Inclusion Criteria:

* patients aged 40 years
* aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).

Exclusion Criteria:

* Corneal decompensation.
* Jeopardized specular microscopy
* retinal or choroidal detachment
* retained Intraocular foreign body
* uveitis, Scleromalacia
* Reubeosis irides
* previous anti-glaucoma surgery.
Prospective PRO/QoL Registry for Patients With Bone Metastases of Breast or Prostate Cancer

Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life patients with bone metastases treated with osteoprotective agents.

The PRO Bone project will recruit a representative cohort of patients with breast or prostate cancer suffering from bone metastases. The aim of this study is to collect data on Patient Reported Outcomes (PRO)/Quality of Life regarding bone pain and the impact of bone pain on quality of life and daily activities. PROs are assessed by a questionnaire consisting of a visual analog scale for bone pain, two questions regarding bone pain management, the bone pain module of FACT questionnaire (FACT-BP) and four questions addressing the impact of treatment on daily life (overall, social life, ability to work and ability to perform routine tasks)

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast or prostate cancer
* Start of first systemic osteoprotective treatment
* Ability to read and understand German
* Written informed consent

Exclusion Criteria:

• None
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the pharmacokinetic profile of an EVP.

The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.

A second part investigates the nicotine delivery of an EVP with four different nicotine doses.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18-35kg/m2
* Subjects must be established smokers
* Subjects must have smoked five to 30 cigarettes per day for at least one year

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy within 14 days of the screening
* Subjects who have donated blood within 12 months preceding study
* Subjects with relevant illness history
* Subjects positive for hepatitis or HIV
* Subjects with history of drug or alcohol abuse
* Subjects with lung function test or vital signs considered unsuitable
* Subjects who are trying to stop smoking
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 6.5-8.9% (inclusive) will be recruited and randomized into either the placebo or intervention group. The study duration for each participant will be approximately 90 days. At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome. After the samples are analyzed, the participant will receive dietary recommendations and either personalized supplements or placebo supplements. The participant will follow the dietary recommendations and take the supplements for 90 days. At the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed
* Females and males aged 18 years or older
* Able to speak and read English
* HbA1c between 6.5-8.9% (inclusive), tested within the past 30 days
* Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)
* Willing and able to follow the trial instructions and Viome's Precision Nutrition Program
* Willing and able to use a smartphone and Viome app.

Exclusion Criteria:

* Antibiotic use within one month of the GI test
* Gestation within previous 6 month
* Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
* Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
* On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and/or weight within the previous month
* Taking diet pills
* Allergy to an ingredient in the MH capsule or stick pack
* Currently on an investigational product
* Significant surgery or medical procedure planned
* Diet or lifestyle change during the trial period, besides those appropriate for trial arm Has followed Viome nutritional recommendations (foods and/or supplements)
Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients with Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement

The aim of this clinical trial is to investigate the development of cardiac decompensation following transjugular intrahepatic portosystemic shunt (TIPSS) implantation in order to draw conclusions for future treatment methods or exclusion criteria prior to TIPS implantation.

The main questions to be answered are:

How often do symptoms of cardiac decompensation develop over a one year period? What laboratory, clinical or imaging morphological changes are associated with this? In addition to the standardised clinical procedure for TIPSS implantation, participants will undergo 3 cardiac magnetic resonance imaging (MRI), extended echocardiographic examinations (both just before, 3 days after and 3 months after implantation) and laboratory chemistry tests for specific endothelial and inflammatory markers (just before, on the day of implantation, 1 day after, 1, 3, 6 and 12 months after implantation).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 99 years
* Written informed consent of the patient
* Decompensated liver cirrhosis, defined by clinical, imaging or laboratory criteria
* Patient receives an elective TIPSS in the appropriate clinical context at the JUH

Exclusion Criteria:

* Pregnancy
* Implants not suitable for magnetic resonance imaging
* Medical/personal reasons against magnetic resonance imaging (claustrophobia, patient cannot lie flat or follow breathing commands)
* Patient in critical condition or incompliant
Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients

The single center, randomized, assessor- and participant-blind, controlled, cross-over on-venous laser irradiation of blood clinical trial was performed to analyze patients with DKD. The information will help to whether integration of laser acupuncture into patient care will help to improve the clinical symptoms and quality of life.

Microalbuminuria is the cardinal symptom of diabetes kidney disease (DKD) and is linked to renal function decline. The cardiovascular risk of patients with DKD is much higher than that of the general population, and cardiovascular diseases is the main cause of death in patients with DKD.

We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to on-venous laser irradiation of blood and low dose OLIB group. Each group will include 36 patients and given intervention three times a week. The intervention will then be crossed over to the other one after 1 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, urine routine analysis.

Eligibility Criteria:
Inclusion Criteria:

1. HbA1C≥6.5 % and ≤ 9%, ±0.5% under past three months
2. eGFR ≥30ml/min/1.73m2 and protinuria ≥30mg/d under ACEI or ARB treatment

Exclusion Criteria:

1. allergic to laser beans
2. Immunosuppressive drugs had been used in the past six months
3. urine protein over 3.5 g /day
4. Autosomal dominant polycystic kidney disease
5. Lupus nephritis
6. People with mental illness or other mental disabilities are unable to cooperate with the researcher.
7. Those who used non-steroidal analgesics and steroids in the trial period
8. Pregnant or lactating women
Analysis of the Persistence, Reservoir and HIV Latency

The APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. The frequency, phenotype and inducibility of HIV-infected cells are then analyzed. These parameters may vary across the different clinical and therapeutic settings.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* Adults (\>18 years)
* Social insurance
* Informed consent

Exclusion Criteria:

* HIV-uninfected
* \<18 years
* Lack of social insurance
* Lack or withdraw of consent
Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial

The purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years;
* Gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan;
* Obesity - body mass index ( BMI ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study;
* Physically inactive - according to the International Physical Activity Questionnaire (IPAC);
* Single pregnancy.

Exclusion Criteria:

* Kidney disease or collagen;
* Previous history of GDM;
* Diabetes type 1 or type 2;
* Hypertensive disorders related to pregnancy;
* Hemodynamic instability;
* Vaginal bleeding;
* Visual, auditory or cognitive impairment.
Investigating Cytokine Genes of Stem Cell Donors

This study seeks to investigate the factors that may account for the differences in the way a stem cell recipient s immune system works after a transplant. It will focus on cytokine genes, which give specific instructions to the genes and which may influence immune system response. More specifically, the purpose of the study is to find out how gene polymorphisms (gene variations among the population) affect the success or failure of a stem cell transplant.

Study participants will have donated blood for a stem cell transplant. They will be asked to give consent for NIH personnel to run special tests on these blood samples, which will have been placed in storage. It is hoped that blood samples will be studied from 600 stem cell donors.

The NHLBI Stem Cell Allotransplantation Program is researching methods to improve allogeneic stem cell transplantation. We are particularly interested in identifying factors, which result in individual variability in outcomes. Cytokines are biological modulators of the immune system known to influence various phases of the immune response. Normal variations in the genetic material coding for cytokines (Cytokine Gene Polymorphisms or CGPs) are believed to account for some of the differences in the inflammatory response between individuals. In the future, we hope to tailor stem cell transplantation to take into account these immunological profiles. In order to characterize the effect of any such intervention, we first need to better understand the role CGPs play in immune responses in normal, healthy persons. This involves testing for the presence or absence of a polymorphism in healthy individuals, and comparing with a validated in vitro assay. None of these polymorphisms are associated with known clinical disease to be classifiable as a 'genetic defect'. Moreover, we will not correlate these polymorphisms with clinical studies to identify traits in the sample donors. We plan to utilize stored blood samples from stem cell transplant donors who have previously participated on a hematology branch protocol as well as consent future donors.

Eligibility Criteria:
* INCLUSION CRITERIA:

Participation as a stem cell donor on a Hematology Branch protocol.

For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian. Informed assent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.

Age greater than or equal to 2 and less than or equal to 80.

EXCLUSION CRITERIA:

Subjects unable to comprehend the investigational nature of the laboratory research.
The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia

All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index will undergo polysomnography and will be randomised to two groups after fulfilling all inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. The treatment will be continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and polysomnography. All patients will be advised regarding sleep hygiene.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology
* Child A and B cirrhosis (for intervention part)
* Cirrhosis patients giving h/o persistent sleep disturbances (PSQI≥5)
* Child A, B and C cirrhosis (for observational part)

Exclusion Criteria:

* Active alcohol intake or intake within 1 month of enrollment
* Active substance abuse or intake within 1 month of enrollment
* Known psychiatric and neurological disorders
* Patient using antidepressant, anticonvulsants, other hypnotics
* Pregnancy or lactation
* Overt hepatic encephalopathy (grade 2,3,4)
* Child C cirrhosis (for intervention part)
* Acute decompensated state of CLD (Chronic Liver Disease) - GastroIntestinal bleed, increased jaundice, HE (Hepatic Encepahlopahty) , SBP (Spontaneous Bacterial Peritonitis).
* HCC (HepatoCellular Carcinoma) with portal vein thrombosis
* Acute febrile illness/ acute infection
* Post TIPS (Transjugular Intrahepatic Portosystemic shunt)patient