cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects
* 18-60 years old
* Body mass index \>19 and \<30 kg/m2
* Weight at least 50 kg
* Written informed consent obtained

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
* Any condition requiring regular concomitant treatment.
* Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.
* Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.
* Pregnant or lactating females and females of childbearing potential not using proper contraception.
* Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration
Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.

It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.

The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.

The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI\>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old;
* arterial hypertension defined as: a) office systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg AND either 24-hour ambulatory systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg OR b) the presence of antihypertensive treatment;
* non-dipper pattern at 24-hour BP monitoring (confirmed on repeated ABPM including one performed within 3 months prior to enrolment and one after enrolment, both on the same antihypertensive treatment, if any), defined as a nocturnal decrease systolic and/or in diastolic BP values \<10% compared to the corresponding daytime values;
* signed written informed consent;

Exclusion Criteria:

* shift workers
* atrial fibrillation/flutter;
* pregnancy and lactation;
* terminal malignant disease, life expectancy \<6 months;
* limb amputation;
* dementia.
Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease

Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

Primary objective : Retrospectively collect and describe the real life efficacy (SVR 12)\* and safety data of EBR 50 mg/GZR 100 mg based therapy, 12 or 16 weeks dosed in HCV-infected patients with chronic kidney disease. These data are collected following French ATU allocation.

Eligibility Criteria:
Inclusion Criteria:

* documented chronic (at least 6 months) HCV Genotype1 (GT1) and Genotype 4 (GT4) infection
* Mono infected by HCV or co-infected by HCV and HIV
* Have an HCV treatment status corresponding to one of the following:

  1. Treatment-naïve: Naïve to all anti-HCV treatment
  2. Prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers)
  3. Prior Interferon (IFN) or pegylated (PEG)-IFN + ribavirin + telaprevir or boceprevir or simeprevir treatment failures
  4. Prior sofosbuvir based therapy failures
  5. Pegylated interferon ribavirin intolerant
* Have CKD defined as:

Subjects with glomerular filtration rate (GFR) ≤30 ml/min who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).

Exclusion Criteria:

* none
Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

The goals of the trial are:

* To determine the prevalence of osteoporosis in subgroups of COPD patients.
* To look for risk factors of osteoporosis in COPD patients.
* To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Background:

Osteoporosis is defined as a systemically skeletal disorder characterized by a low bone mass and deterioration of the micro-architecture of the bone and is therefore associated with a higher risk of fractures. Large epidemiological studies to determine the incidence and prevalence of osteoporosis in COPD patients in different stages of their disease are not available. The etiology of osteoporosis in COPD patients is complex and depends on multiple factors.

Goals of the Trial:

* To determine the prevalence of osteoporosis in subgroups of COPD patients.
* To look for risk factors of osteoporosis in COPD patients.
* To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Study Design:

Patients diagnosed with COPD (according to the American Thoracic Society \[ATS\] guidelines and divided in stages according to the Global Initiative on Obstructive Lung Diseases \[GOLD\]-classification) who visit the out-patient clinic of pulmonology of the Catharina Hospital Eindhoven will be asked to participate in the trial. A database will be created (prospectively) of the (medical) information about these patients, which will be analysed retrospective. To gather information we will use the medical records, a questionnaire, a blood sample, long function testing including a 6-minute walking test and a DEXA-scan.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Men and women
* COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria
* Written consent

Exclusion Criteria:

* Age \< 18 years
* No written consent
Study of Late-foetal Human Organ Development

Knowledge about abnormal organ development is important to understand pathology and to develop novel treatment approaches for individuals with congenital and acquired disease. Most of our current understanding is based on examination of tissues from the embryo and early fetus, collected from women undergoing termination of pregnancy in the first trimester (third) of pregnancy. There is very little known about normal and abnormal organ development from a developmental perspective during the crucial last two-thirds of pregnancy when much remodelling of fetal tissues occurs. We aim to collect tissue from a variety of developing fetal organs in the last two-thirds of pregnancy from women who decide to undergo a termination of pregnancy and who wish to undergo a clinical fetal postmortem (PM) examination.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old pregnant women who attend the Fetal Medicine Unit for concerns about a fetal abnormality where they decide to proceed to termination of pregnancy

Exclusion Criteria:

* Screening labs positive for maternal HIV, Hepatitis B and Hepatitis C, Chlamydia and Herpes.
* Subject unable to make an informed decision about termination of pregnancy.
An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease

The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung Institute's treatment is limited to self- funded patients with chronic lung disease - chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are collected through venous harvesting.

The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their ability to be more physically active; walking greater distances with or without oxygen and improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability to reduce their use of oxygen and possibly to stop it., the ability to function well without the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

Through the collection of outcome data, Lung Institute aims to explore and describe the safety and efficacy of autologous cellular therapy for chronic lung disease with dissemination to the public and to the medical community for the advancement of regenerative medicine. The study aims to confirm the safety of autologous cell therapy, explore the effect of autologous cell therapy treatment on pulmonary function, and to describe the anecdotal quality of life changes of patients following treatment using both quantitative and qualitative measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients are included in treatment by self-referral and after consultation with a designated patient coordinator, who determines initial eligibility, and then by the nurse practitioner or physician of the Lung Institute who determines final eligibility for treatment. All eligible and thereby traded patients are eligible for the study

Exclusion Criteria:

* Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. In addition, patients on prescribed blood thinners, with a history of breast or prostate cancer of any time frame or with a history of osteoporosis are excluded from the bone marrow harvest option.
Validation Study of Selfie Technology for Assessment of Vital Signs

The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.

Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.

The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.

Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.

DocMe Health Technologies has developed a system of obtaining these data using a 15 second video selfie.

At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.

The aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 - 90 years old).
* Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.
Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety

This study would like to compare manual acupunture treatment for anxiety in COVID Health workers population in Cipto Mangunkusumo Hospital using filiform needles and press needle.

This study wanted to know would press needle be having better outcome for anxiety treatment, compared with filiform needles, because press needle taken home and could be manipulated as needed at home, unlike filiform needle where an acupuncturist must be available to do the treatment. Furthermore, the press needle needed to be changed once within 5 days, that is 2-3 times in week. So we hope to have better acupuncture option (in effectivity and timewise) for COVID healthcare workers anxiety treatment. There are no study to compare the usage of the two types of needles for anxiety treatment to date.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 health workers.
* Rapid test COVID-19 t or PCR swab non reactive within 7 days before intervention
* HAM-A score below 25
* Could still do daily activities
* Willing to enroll this study and sign the informed consent
* Willing to comply with the study procedure

Exclusion Criteria:

* Contraindicated for acupuncture : having medical emergencies, pregnancy, blood clotting issue, uncontrolled diabetic mellitus, fever.
* Having acupunture treatment within 7 days prior to study intervention
* Having tumor or infection at the pucture site
* Cognitive or consciouseness impairment
* Having anxiety therapy with a psychiatrist
COPD: A Multi-center Supervised Tele-rehabilitation Study

Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.


Eligibility Criteria:
Participants with a clinical diagnosis of and meeting the following criteria are eligible:

1. Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks.
2. Motivated for participating in the project (and acceptance of randomization)
3. Sufficient mobility to attend PR

Exclusion Criteria:

1. Certain comorbidities (e.g. unstable coronary complications)
2. Severe cognitive disabilities (e.g. dementia)
3. Inability to cope with the program because of severe hearing or visual disorder.
CUstodiol Versus RInger: whaT Is the Best Agent?

Postoperative renal failure is the most significant risk factor for early mortality after elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).

To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair, the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since the most studied crystalloid solution is the Ringer's lactate solution, this can be considered the standard of care for evaluating the effectiveness of other substrates.

An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr. Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during transplantation and for cardioplegia during open-heart surgery in most EU countries. This solution may provide a better grade of renal protection to ischemic damage than the standard crystalloid solutions.

A recent observational study published by our group suggested a lower incidence of postoperative renal kidney injury in patients undergoing open TAAA surgical repair using renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's lactate solution.

Objective of this study is the confirmation of the promising findings about the effectiveness of renal perfusion with Custodiol during repair of TAAA compared with other crystalloid.

The study will be a prospective, single-center, randomized, double-blind, controlled trial, investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult patients undergoing elective TAAA open repair. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

Ability to provide written informed consent; Patient undergoing open surgical repair of TAAA requiring renal perfusion.

Exclusion Criteria:

1. Patients who have participated to experimental trials during the previous 3 months
2. Intervention under emergency / urgency
3. Patient uncooperative and / or affected by mental disease
4. Allergy or intolerance to the study drug
5. Patient under renal replacement treatment (dialysis) before surgery
6. Pregnant or breast-feeding women
EXPert System, ALImentary

Eating disorders (ED) are often undetected in the general population resulting in delayed treatment. The SCOFF questionnaire has been validated for eating disorders screening in primary care, but does not identify the type of eating disorder.

Objective: Investigators evaluated the performance of a clinical algorithm (ExpaliTM) combining answers to SCOFF questionnaire with Body Mass Index (BMI) to identify four Broad Categories of ED derived from DSM-5.

Design: Clinical algorithm (ExpaliTM) was developped from 104 combinations of BMI levels and answers to five SCOFF questions. Two senior ED specialists allocated each combination to one of the four Broad Categories of ED (DSM-5 diagnostics): restrictive disorder (anorexia nervosa typical, atypical and restrictive food intake disorders), bulimic disorder (typical and with low frequency or duration), hyperphagic disorder (binge eating disorders typical and with low frequency or duration) and other specified ED. The performance of ExpaliTM was evaluated on data from patients referred to the Nutrition Department including a precise DSM-5 diagnosis of ED, a positive SCOFF test (at least 2 "yes" answers) and BMI. Sensitivity, specificity values with a 95% confidence interval (95% CI) and Youden index were calculated for each category.


Eligibility Criteria:
Inclusion Criteria:

* eating disorders
* SCOFF test = 2 or more

Exclusion Criteria:

* no eating disorders
* SCOFF test = 0 or 1
Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate

Cleft lip and/or palate (CLP) are the most common oro-facial congenital anomalies. These anomalies have an impact on feeding, speech and speech development, facial aesthetics \& oral health, all of which are factors that heavily impact the quality of life of CLP patients. CLP also has an effect on the families' social and psychological health.

Qualitative research helps understand the perspectives of the participants by exploring the psycho-social aspects of care. Phenomenological approach is a qualitative research method that aims to borrow participants' lived experiences to better understand a specific phenomenon. Currently, there is no clear understanding of the fears, anxieties, and challenges faced by parents of CLP patients in Egypt.


Eligibility Criteria:
Inclusion Criteria:

* Parents of Patients with non-syndromic CLP.

Exclusion Criteria:

* Parents of Patients presenting with dental pain.
Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)
2. Achalasia patients who underwent POEM

Exclusion Criteria:

1. Lack of written consent for participation in the study
2. Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry
Nutrition Impact on Immunotherapy of Cancer

This study investigates nutritional status and outcomes of immuntherapy in cancer patients.

Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer, malnutrition Age \>18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study.

For all oral medications patients must be able to comfortably swallow capsules;

Exclusion Criteria:

* Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation.

Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.