cyrilzakka/clinical-trials huggingface dataset:
Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding

The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy.

Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the colon in a single non-invasive examination, opens new perspectives for the management of those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic. The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may allow, in a safe and well tolerated manner, to identify which patients would benefit of further interventions, such as colonoscopy or invasive enteroscopy, guided by findings pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal capsule endoscopy is superior to the current standard strategy of conventional colonoscopy after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding diagnostic yield, safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb \<12.0 g/dL in female gender or \<13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD)

Exclusion Criteria:

1. Lack of informed consent
2. Suspected lesions at index EGD that could justify the anemia or digestive bleeding
3. Known history of gastroparesis or bowel dysmotility
4. Known or suspected intestinal stricture
5. Female patients with potential gynaecological source of bleeding causative of the clinical condition
6. Patients with severe malnutrition
7. Patients unable to walk at least for short periods and/or with neurological and/or psychiatric condition potentially favouring protocol deviations
8. Allergy or contra-indications to any of the drugs or products used in the study
9. Pregnancy or breastfeeding
The Impact of the Covid-19 Outbreak on Emergency Room Attendances of Surgical Patients

Since December 2019, when the novel coronavirus disease (Covid-19) spread throughout the world, data have been needed on the effects of the pandemic on various aspects of healthcare systems. Recommendations for social distancing and quarantine decrees made by local governments, alongside the general public fear from the spread of the virus, are presumed to have markedly affected the trends in hospitals visits. Understanding the exact nature of the effect is critical for better anticipating and preparing health systems in the event of future outbreaks and in the post outbreak period. Therefore we intend to To identify retrospectively all patients who presented to the emergency department at our medical institute between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020. We will examine the impact of COVID-19 on the rates of surgical emergency visits, ratio of surgical visits to non-surgical visits, the ratio of severe presentations to non-severe presentations, and the impact of age on ED attendance.

Since December 2019, when the novel coronavirus disease (Covid-19) spread throughout the world, data have been needed on the effects of the pandemic on various aspects of healthcare systems. Recommendations for social distancing and quarantine decrees made by local governments, alongside the general public fear from the spread of the virus, are presumed to have markedly affected the trends in hospitals visits. Understanding the exact nature of the effect is critical for better anticipating and preparing health systems in the event of future outbreaks and in the post outbreak period. Additionally, deferring hospitals visits can potentially put patients at increased risk for morbidity and mortality, especially in postsurgical patients. Evaluating the impact of the pandemic on patient volume can guide decision-making in future scenarios.

Previous infectious disease outbreaks have been shown to impact ED volumes: The US Hantavirus outbreak in 1993 led to a 2-fold increase in ED visits; Escherichia coli 0157:H7 outbreak in Washington state in 1993 increased ED visits by 17%; However, the 2003 SARS outbreaks in Hong Kong, Taiwan, and Toronto reduced tertiary care ED visits by up to 47 percent.

Eligibility Criteria:
Inclusion Criteria:

* All patients visiting the ER of Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020

Exclusion Criteria:

* Patients less than 18 years of age
Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)

This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 et 70 years
* Patient accepting to give a written informed consent
* Recipients of a first renal allograft
* Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
* Absence of positive DSA using Luminex®, MFI\>1,000
* Negative cross-match in cytotoxicity
* Patient without difficulty to understand and communicate with the investigator and his collaborators
* Patient entitled to Health System benefits or other such benefits.

Exclusion Criteria:

* Multiple organ transplantation
* Recipients of a dual kidney transplant
* Previous renal allograft
* History of any other transplantation
* Receiving a graft from a non-heart-beating donor
* Patient BMI \> 35
* Patients with evidence of severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin \> 3 times upper limit of normal) at screening.
* Significant severe infection, active peptic ulcer and/or difficulty to absorb oral drugs (active upper gastro-intestinal tract malabsorption syndrome)
* HIV-positive patients, or with an active B or C hepatitis
* Patients with de novo malignancy prior to transplantation, other than efficiently treated basal or squamous cell carcinoma of the skin.
* Leucocyte count lower than 2500/mm3
* Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control.
* Known allergy or intolerance to basiliximab, tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
* Participation in a clinical trial or expanded access trial with an investigational drug within 4 weeks prior to enrollment or concomitantly with this study
* Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
Vitamin D3 Supplementation for Heart Failure Patients

The purpose of this study is to determine if treatment with vitamin D3 of 10,000 International Units (IU) daily in vitamin D deficient patients for 6 months will improve B type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in patients with stable congestive heart failure (Class II or III).


Eligibility Criteria:
Inclusion Criteria:

* NYHA Heart Failure Class II or II, stable
* Vitamin D deficiency (32 ng/ml or less)
* No recent medication changes for 3 months
* Females of childbearing age must use effective contraceptive if they are sexually active

Exclusion Criteria:

* Hypercalcemia
* Nephrolithiases
* Sarcoidosis
* Acute cardiac insufficiency
* Pregnancy
* Breastfeeding
* Any clinically unstable medical condition
* Supplements of greater than or equal to 1000 units of vitamin D per day
Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Documented evidence of active multiple myeloma:

  * Newly diagnosed, not candidate for transplant
  * Relapsed/refractory who have received up to 3 prior lines of therapy
* Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:

  * Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
  * Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)

Exclusion Criteria:

* Target Disease Exceptions

  * Plasma cell leukemia
  * Monoclonal gammopathy of undetermined significance (MGUS)
  * Smoldering Myeloma
* Primary amyloidosis
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma

The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported to be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA to have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm). However, to the investigators' knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than TACE alone for the treatment of intermediate-stage HCC. The investigators hypothesized that the combination of TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions, largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or extrahepatic metastases.


Eligibility Criteria:
Inclusion Criteria:

* Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter
* No vascular invasion or etrahepatic metastases
* Eastern Cooperative Oncology Group Performance Status 0-1
* Child-Pugh Stage A or B
* Treatment naive

Exclusion Criteria:

* A platelet counts of \<40×109/L，prothrombin time activity \<40%;
* Albumin \>2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit
* No evaluale target lesions
* Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy
* Severe heart, brain or kidney diseases
* Previous or concurrent cancer that is distinct in primary site or histology from HCC
* Pregnant women or lactating women
* Be allergic to adriamycin, lobaplatin, mitomycin and iodized oil
Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection

Recently, Park et al. introduced a new technique for performing S1 TFESI using ultrasound. S1 TFESI using ultrasound can be considered to overcome the disadvantages of exposure to radiation. We hypothesized that the frequency of intravascular injection differs depending on the type of needle during S1 TFESI under ultrasound guidance.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient diagnosed with S1 radiculopathy because S1 root compression was confirmed on MRI and related symptoms 2. NRS of back and/or radiating pain score of 4 or more 3. Patients aged 19 years or older

Exclusion Criteria:

* 1. Cases in which lumbar count is expected to be difficult due to lumbarization, sacralization, or lumbosacral transition 2. When the S1 posterior foramen is not clearly identified on ultrasound 3. Malignancy 4. Systemic infections 5. Bleeding tendency 6. Contrast allergy 7. Pregnant Women 8. If you cannot read or agree to the consent form 9. If you are unable to sign the consent form yourself
A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.

The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese participants
* No clinical relevant abnormalities
* Body mass index (BMI):17.5-28

Exclusion Criteria:

* Any clinical significant illness
* History of alcohol abuse
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose
* Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)
* Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate
* Blood donation within 60 days
* History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)
* Other medical or psychiatric may inappropriate for the study
Impact of Telehealth Warfarin Education on Patient Retention

The objective of this study is to evaluate the effectiveness of telehealth warfarin education in a charity outpatient clinic. The purpose is to increase patient knowledge with regard to their warfarin therapy and to measure knowledge retention

2. This study is conducted in outpatient ambulatory care clinics at the Baylor Family Medicine Worth Street clinic and the Irving Interfaith clinic. The average census for warfarin patients Friday clinic is 10. The anticoagulation clinic consists of an interdisciplinary team including physicians, medical assistants, nurse practitioners, and pharmacists. Patients initially visit with the provider and subsequent follow up INR checks are performed by the pharmacists or medical assistants. Currently, pharmacists manage the anticoagulation clinic on Fridays and medical assistants manage the clinic on Monday through Thursday. All providers provide patient education through written brochures.

3. Study Design

a. This study is a prospective, single-centered, randomized controlled quality improvement pilot study.

4. Warfarin Education Procedures

1. Each Friday morning, the pharmacist will identify the patients with appointments for INR checks.
2. As each patient checks in for their appointment, the pharmacist will ask the patient for consent to be a part of the study
3. If the patient says yes, the pharmacist will have the patient complete a warfarin questionnaire and health literacy test to see the patient's baseline knowledge on their warfarin therapy
4. Intervention patients (iPAD® video)

   1. The patient will then watch a warfarin education video on the iPAD®
   2. After the video the patient will receive point of care INR check and have their warfarin dose adjusted
   3. Patient will then complete the same warfarin questionnaire
   4. After completion, answers to the questionnaire will be presented to the patient. A written brochure will be given.
   5. A satisfaction survey will be given
   6. 30-60 days days later the pharmacist will follow up with the patient to repeat the warfarin questionnaire

   5. Description of iPAD video

a. Setting: a pharmacy b. Description: A pharmacist will provide education about warfarin using not only verbal instructions but also provide illustrations of directions. Please refer to Appendix for dialogue.

6. Control group

a. Patients' INR will be taken and warfarin education will be given verbally similar to Monday-Thursday clinic. A written brochure will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. English as a first language
3. Currently taking warfarin for an approved indication
4. Having the ability to see, read, and hear for verbal, written, and iPad® warfarin education

Exclusion Criteria:

1. Age \< 18 years
2. Unwilling to receive iPad counseling
3. Cognitive dysfunction and impairments that prevents patient from fully comprehending warfarin education
Living With Long COVID: LONGCOVID-EXPERIENCE

Background: One in ten people infected with COVID-19 presents persistent COVID, which consists of the presence of symptoms three months after the acute manifestations of COVID-19 and their persistence for at least two months, without being explained by an alternative diagnosis. The characteristics and clinical approach to persistent COVID syndrome are fairly well known, but not what the experience of people with persistent COVID is in relation to their daily life, their work life, and their experience with the healthcare received. Objective: to understand the experience of patients with persistent COVID in relation to the disease, the health care received and re-entry into the world of work

Methods: Qualitative, descriptive, phenomenological study, based on individual interviews. The study protocol will be registered in Clinicaltrials.gov. People with persistent COVID treated at the Parc Taulí Hospital will be included. Sampling will be by convenience, purposive and snowball and the sample size will be determined by data saturation. Semi-structured individual or group interviews will be conducted and the data will be analyzed following a reflective thematic analysis (Brawn and Clarke). The preliminary report will be triangulated with some participants and with the results obtained from a scoping review carried out by the research team.


Eligibility Criteria:
Inclusion Criteria:

* women and men diagnosed with persistent COVID between March '20 to the present according to WHO criteria (persistent symptoms three months after the acute manifestations of COVID-19 and lasting at least two months and cannot be explained by an alternative diagnosis).
* treated at the Parc Taulí Hospital
* from 18 to 65 years

Exclusion Criteria:

-people who do not understand or can communicate in Catalan or Spanish.
Immunoadsorption in Patients With Pulmonary Hypertension

The purpose of this study is to investigate, if Immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve haemodynamics in patients with pulmonary hypertension.

Increased pulmonary precapillary vascular resistance due to vasoconstriction and vasoproliferative processes is the basic pathophysiological mechanism in the development of pulmonary hypertension (PH). In patients with pulmonary arterial hypertension (PH) production of endothelin-1 (ET-1) is increased and elevated ET-1 plasma levels correlate with PH severity As recently shown Autoantibodies against the Endothelin-1 Typ A and Angiotensin II Typ-1 Receptor, which have a high Incidence in PH-Patients, may also play an important role in the pathophysiology of PH (Dandel et al.).

The concept of this study is that the elimination of these autoantibodies by Immunoadsorption with protein A may improve haemodynamics and patient wellbeing. Immunoglobulins are substituted after Immunoadsorption to minimize infection risk.

Eligibility Criteria:
Inclusion Criteria:

* pulmonary hypertension (PH)
* NYHA II-IV
* medical treatment of PH respective to current guidelines
* 18 years or older
* written informed consent of the patient

Exclusion Criteria:

* pulmonary hypertension due to left ventricular dysfunction
* decompensated heart failure
* need for Catecholamines
* active infection
* pregnancy
* malign tumor disease
* other secondary disease with life expectancy \< 1 year
* refusal by the patient
A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Database

This is an observational study in which data from the past is collected for a treatment which is already available for doctors to prescribe for venous thromboembolism (VTE). VTE is a condition in which blood clots form in veins, which can lead to disability and death. This study looks at the bleeding risk in Japanese patients who are already receiving long-term rivaroxaban treatment for their VTE.

Some common causes of VTE are surgery, lack of movement, being bed-ridden and cancer. VTE that is caused by cancer is called cancer-associated venous thromboembolism (Ca-VTE).

The study treatment, rivaroxaban, is a blood thinner prescribed by doctors to help treat conditions like VTE. By thinning the blood, rivaroxaban can help keep blood flowing normally and prevent blood clots. But, rivaroxaban can lead to increased bleeding in some people.

There have been studies done in which participants with VTE and Ca-VTE received treatment with rivaroxaban for a long period of time. The overall results of those studies showed that long-term treatment with rivaroxaban helped prevent blood clots in those participants. Some of the participants had increased bleeding after this long-term treatment, while some did not. Participants with certain types of cancers, such as Ca-VTE, also had an increased risk of bleeding.

These studies, however, did not include Japanese participants. So, the researchers in this study want to learn more about the risk of bleeding in Japanese patients with VTE or Ca-VTE who receive long-term treatment with rivaroxaban. To do this, the researchers plan to use a medical database to find information for patients with VTE and Ca-VTE who have already been taking rivaroxaban for their condition. This database will help the researchers collect information about the bleeding risk of long-term rivaroxaban treatment in Japanese patients.

In this study, the researchers will learn more about:

* the characteristics of patients with VTE who are treated with rivaroxaban for a period of less than 3 months to more than 1 year
* the bleeding risk for all of the patients throughout the study
* the bleeding risk for the patients with Ca-VTE throughout the study
* the cause of any bleeding that happens

The researchers will follow and record these results for Japanese patients from October 2015 to December 2020.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of VTE recorded during the selection period (01-Apr-2016 to 31-May-2020 inclusive),
* Having a rivaroxaban prescription claim within 30 days after the VTE diagnosis ,
* Being age 18 years or older at the index date,
* Having at least 180 days baseline period.

Exclusion Criteria:

* Having evidence of atrial fibrillation, atrial flutter, dialysis, CTEPH (Chronic Thromboembolic Pulmonary Hypertension) or pregnancy during the baseline period,
* Having a claim of rivaroxaban during the baseline period.