cyrilzakka/clinical-trials huggingface dataset:
Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.

Overall Aims:

1. To assess the immune response to COVID-19 vaccination in patients with IBD.
2. Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.
3. To evaluate the different variables affecting immunity of these patients.
4. To assess adverse reactions to COVID-19 vaccines and IBD related complications.

Specifically:

1. To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to

   1. Healthy controls
   2. Patients with IBD not treated with anti-TNF (+/- immunomodulators)
2. To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD
3. To identify factors associated with serologic response
4. Side effects to vaccines
5. IBD exacerbation compared to activity at baseline
6. Symptomatic COVID-19

Eligibility Criteria:
Inclusion Criteria:

* 1. Adults \>18 years of age 2. Patients with either Crohn's disease, ulcerative colitis, ileostomy, pouch 3. Not vaccinated to COVID-19 \[i.e. before 2 mRNA Pfizer vaccines provided, or before any vaccine provided as one injection 4. Ability to attend follow up visits 5. Ability to understand and sign an informed consent form

Exclusion Criteria:

* 1. Pregnant women
Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients

The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the maintenance dose (MD).

Elevation of myocardial infarction markers after coronary stenting reflects periprocedural myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel pre-treatment methods for preventing PMI among patients undergoing conventional CAG for stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized, multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were randomized to receive either an additional 300-mg reload (the RL group) or no additional loading (the maintenance dose \[MD\] group). The 600-mg or 75-mg treatment regimens were selected at the physician's discretion. The primary outcome was creatinine kinase myocardial band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h, and 24 h, while troponin-I levels were measured at 8 h after the PCI.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below

  1. Treadmil test positive
  2. ST-T change in resting ECG or 24-hour ECG
  3. Regional wall motion abnormality in Echocardiography or cardiac MRI
  4. Myocardial ischemia at MIBI scan
  5. moderate to severe stenosis at coronary CT angiography
  6. chest pain or dyspnea

Exclusion Criteria:

* AST or ALT \> 3 times upper normal limits
* Serum creatinine \> 2.0 mg/dL
* chronic malaborption status (disorder or operation)
* planned surgery within 1 year
* pregnancy or breast-feeding patients
* life expectancy \< 1 year
Intermittent Preventive Treatment for Malaria in Patient With Sickle Cell Disease

Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current policy is not effective due to poor compliance and drug resistance. Intermittent treatment with a long acting drug regimen administered under supervision at clinic visits may be more effective. The aim of this trial is to compare the tolerability and acceptability of supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) or mefloquine plus artesunate (MQ+AS), with the daily proguanil. Two hundred and seventy patients with sickle cell disease attending the paediatric sickle cell disease clinic in Ilorin hospital who meet the eligibility criteria and have parental consent, will be randomized to one of three prophylactic regimens: daily proguanil, bimonthly sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. Patients will be asked to return to clinic every two months and whenever they are sick. At enrollment, the study paediatrician will conduct a physical examination of the child, and collect a venous blood sample for a complete blood cell count and biochemical screen, determination of G6PD genotype, preparation of blood smears for malaria microscopy and a blood spot for determination of molecular markers of resistance. Four days after each clinic visit, patients will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about compliance and adverse events. Participants will be followed for one year. The parents or carer will be encouraged to bring their child to the Outpatient Department clinic if the child becomes unwell. The primary outcome of the trial is tolerability, secondary outcomes are adherence to the regimen, and incidence of malaria and the number of hospitalizations over 12 months. If the bimonthly regimens are well tolerated and the preliminary data from this study are promising, a larger multicentre trial will be required to determine efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age 6months or older and \>=5kg
* Sickle cell clinic attendant
* Both males and females
* Agree to abide by the study protocol
* Give informed consent and assent
* Not acutely sick at the time of recruitment
* Not having additional chronic disease
* Hb genotype of SS and SC confirmed by electrophoresis

Exclusion Criteria:

* known allergy to any of the antimalarial drugs use in the trial,
* severe illnesses requiring urgent admission,
* treatment with sulfadoxine-pyrimethamine or mefloquine in the previous 2wks
* patients on cotrimoxazole prophylaxis
Vitamin D and Functional Outcomes After Total Hip Arthroplasty (THA)

The investigators would like to evaluate the effect of serum 25-hydroxy vitamin D level on post-operative short-term functional outcomes after total hip arthroplasty (THA).

Hypothesis: Patients with low serum vitamin D level will have less within-patient improvement in pre- to 6 week, 1 year, 2 year and 5 year post THA WOMAC scores, SF-36 scores, and performance-based tests(get up and go test and 2 minute walking test) compared to patients who do not have a low vitamin D levels.

Also, Patients with low serum vitamin D level will have a higher rate of postoperative thigh pain or periprosthetic fracture.

Vitamin D is an important nutrient to maintain both skeletal and non-skeletal function. In this study, we have 4 specific aims:

The primary aim of this prospective observational study is to compare the pre- to 6 week, 1 year, 2 year and 5 year post-THA within-patient change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level. Low serum vitamin D will be defined as serum 25-hydroxy vitamin D level less than 32 ng/ml.

The secondary aim is to compare the pre- to 6 week, 1 year, 2 year and 5 year post-THA within-patient change in performance-based tests (get up and go test, 2 minute walking test) between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level.

The third aim is to compare the pre- to 6 week, 1 year, 2 year and 5 year post-THA within-patient change in Short-form 36 health survey (SF-36) scores between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level.

The fourth aim is to compare the rate of postoperative fracture or thigh pain between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level.

Postoperative thigh pain is defined as pain at the anterolateral aspect of mid thigh which corresponds to the level of the prosthetic stem tip. Thigh pain is characterized by pain in the start-up phase, diminishes during movement and is absent at rest.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 40 and 100 years old, and are scheduled for primary total hip arthroplasty with two surgeons (Drs. Sculco and Cornell) at Hospital for Special Surgery.
* Patients who have a serum 25-OH vitamin D drawn as part of their preoperative work-up.

Exclusion Criteria:

* Bilateral one-stage total hip replacements
* Patients who required a complex surgical procedure including extensive bone grafting, osteotomy, extensive soft tissue release, or a need of adjunctive internal fixation with cables, wires or plate
* Those with serious medical co-morbidities that need adjusted rehabilitation protocol due to their medical problems
* Those who require immediate postoperative revision due to dislocation, infection or component malalignment
Safety and Pharmacokinetic Study of PF-06700841 in Japanese Healthy Volunteers

This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841 in Japanese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have four Japanese grandparents who were born in Japan.
* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* BMI of 17.5 to 27.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
* Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Screening blood pressure \>140/90 mm Hg.
* Screening laboratory abnormalities as defined by the protocol.
* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis

HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who give voluntary signed informed consent
* Patients affiliated with the French universal health care system or similar
* For women of childbearing potential: serum or urine negative pregnancy test
* Patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment)
* Bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture
* Patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis)

Exclusion Criteria:

* Pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months)
* Patients not affiliated with the French universal health care system
* Minor patients
* Patients who are protected adults according to the terms of the law (French public health laws).
* Refusal to give consent
* Patients simultaneously participating in another trial that may interfere with the study results
State-wide Health Approach to Increase Reach and Effectiveness: Study 2

Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.

This is a randomized trial. Participants will be randomly assigned to 1 of 3 treatment arms: (1) Shape Up Rhode Island (a community-based weight loss campaign) plus and Internet-based behavioral weight loss program (SURI+IBWL), (2) SURI + IBWL + optional group sessions (SURI+IBWL+Group), or (3) SURI+IBWL + monetary incentives for submitting self-monitoring information and achieving clinically significant weight loss. The primary outcome is weight loss at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index \>=25 kg/m2
2. English speaking

Exclusion Criteria:

1. Health problems that make weight loss or unsupervised exercise unsafe
2. Current pregnancy or plan to become pregnant in the next 12 months
3. Planned relocation
4. Previous participation in Shape Up Rhode Island research studies
DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use

The goal of the study is to show the concordance between the dual-task test achieved usually on an electronic treadmill and the dual-task test achieved with a cyclo-ergometer.

Usually, dual task tests are only achieved on electronic treadmills. Patients who are coming to perform these tests are mainly subjects with various levels of cognitive disorders and with a high risk of fall because of potential motor and cognitive disorders.

The investigator will select patients referred for double task walking tests. After the walking test, investigator will perform dual-task tests with a new bicycle device "Cycléo BRAU" which allows the patients to achieve mental tasks while cycling. The aim of using a bicycle is to limit the risk of falls compared to the treadmill or walking task. The "Cycléo BRAU" device is equiped with a video projector which projects an environment of virtual reality. It allows cycling without resistence and thus is not based on any incremental worload. The mental tasks on bicycle will be of increasing difficulty and parameters such as cycling speed will be recorded. Loss of speed regularity will be considered as an abnormal response. The task for which cycling is stopped will be recorded and compared to the results of the usual walking test.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years old
* Patient with a near visual acuity upper or equal to 2/10
* Patient with a score of MMSE upper than 10
* Patient able to walk on a treadmill for 15 meters on straight line without help
* Patient covered by the French health insurance
* Patient (or support person or legal representative) able to understand the protocol
* Patient (or support person or legal representative) agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* Patient has a wash-out period for another clinical trial
* Patient with a medical contraindication to practice bicycle
* Patient with locomotor disorders preexisting, whatever the reason
* Patient needing extern help to walk like a walking frame, rollator or tricycle
* Patient with a medical or surgical disease acute from less of 3 months
* Patient with cerebrovascular accident history or any other cerebro-medullary diseases with sensorimotor consequences
* Patient with severe depression (Geriatric Depression Scale 15 items upper than 10)
* Patient with a low proficiency of French (oral or written)
Osteopontin as a Biomarker in Pancreatitis

In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.

In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.

Patients admitted and diagnosed with pancreatitis (according to the Atlanta criteria) will have serial testing of se-osteopontin in addiation to rutine blood work. Computet tomograpy and chest x-ray are mandatory as is blood culture.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatitis

Exclusion Criteria:

* Pregnancy, lactation, unable to understand the study
Novel Screening Modality for Early Gastric Cancer

Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for pathology analysis, per standard clinical practice.

Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for histologic analysis, with planned study of the diagnostic yields of each method.

Eligibility Criteria:
Inclusion Criteria:

* Subject is informed of the investigational nature of this study and given verbal and written informed consent in accordance with local, U.S., and international guidelines.
* Both males and females at least 18 years.
* Patients with clinical indications for upper endoscopy

Exclusion Criteria:

* Patients should not have an advanced medical or psychiatric conditions which that may limit their ability to participate in the study, as judged by the physician.
Symptoms and Wellbeing of People Infected With Covid-19 Virus in Iceland

The purpose of this cross-sectional study is to explore symptoms and well being of people diagnosed with COVID-19 from the outset of the pandemic until June 2020.

All patients diagnosed with COVID-19 in Iceland were referred to the COVID-19 outpatient clinic at Landspitali National University Hospital in Iceland. In the clinic risk assessment was conducted and the patients were accordingly provided with individualized care be it telephone surveillance, onsite examination and treatment, or admission to the hospital. As the the first wave of the pandemic was curbing the necessity of exploring how the patients did and continue to fare after being infected became apparent.

The research questions are:

What were the symptoms that patients expressed during and about three months after being diagnosed with COVID-19? What is the prevalence and intensity of the symptoms that patients expressed during and about three months after being diagnosed with COVID-19 ? How do patients value their health related quality of life, what is their health literacy and sense of security in care during and about three months after being diagnosed with COVID-19 ? How do patients value the nursing care in the outpatient COVID-19 clinic? What are the patients' perception of having caught COVID-19?

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic

Exclusion Criteria:

* Young than 18 y.o.
* Do not understand Icelandic
* Died