cyrilzakka/clinical-trials huggingface dataset:
Message Framing for Telephone Quitline Callers

The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.

This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions.

Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a "quit date" within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered.

Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years)
* New York State residents
* English-speaking
* Current smokers who utilize Quitline services seeking quitting assistance for themselves

Exclusion Criteria:

* Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county
Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
* HbA1c for diet treated subjects 6.5-12%, both inclusive
* HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
* Body mass index (BMI) at least 27 kg/m\^2
* Euthyroid subjects
* Fasting blood glucose 7-14 mmol/l

Exclusion Criteria:

* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Recurrent severe hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment

Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g. rheumatoid arthritis, psoriasis) a complex interaction between a genetically altered immune response, the gut microbiota and environmental factors is causing the disease. Systemic suppression of the immune response with corticosteroids, immunomodulatory, biologicals and combination therapies increases the risk of opportunistic infections in IBD patients.

Data on mild and moderate infections in medically treated IBD patients is scarce, mainly since infections treated by the general practitioner or in an outpatient setting are not systematically registered in real life. To help gastroenterologists with clinical decision making, real world data with long term follow-up concerning the risk for infectious complications, is warranted.

Several observations underline the importance of real world data on mild and moderate infections in medically treated IBD patients. Mild and moderate infections mostly have a benign course, but they take longer to clear and have a large impact on (work)disability and quality of life in IBD patients. Recurrent infections influences peoples willingness to use a drug and negatively effects adherence. Furthermore, recurring mild and moderate infections might prognosticate serious infections, and systematic assessment of all infections could be used to timely adjust treatment regimens and prevent serious infections.

The investigators of this study previously developed a questionnaire on self-reported infections according to the FDA guideline for patient-reported outcome measures (PROM) by interviewing 36 patients with IBD and through input of expert meetings with gastroenterologists, IBD specialists, rheumatologists, immunologists and IBD-nurses. This questionnaire has already been implemented in myIBDcoach, a validated telemedicine system implemented in routine care for over 4000 patients with IBD in the Netherlands. Assesment of reliability and validity are the last steps in validation of this remote monitoring tool.

In the current study the investigators aim to:

1. Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation
2. Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments
3. Identify the predictors and risk factors of mild and moderate infections.
4. Assess the relation between patient reported infections and the risk for serious infectious complications


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and diagnosed with IBD
* Included in eHealth clinical care-pathway using myIBDcoach

Exclusion Criteria:

* Patients with insufficient knowledge of the Dutch language
* Patients not able to provide written informed consent
Diagnostic Value of HS-CRP in Stable Angina.

The aim of this study was to assess the amount of additive value of HS-CRP levels to a positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using coronary angiography as the gold standard. The investigators concluded that HS-CRP can be used as a single predictor of coronary vessel involvement in patients with stable angina and positive ETT.

the investigators included 97 patients with positive ETT and stable angina and saw that Hs-CRP is the only predictor of severity of CAD as compared with coronary angiography in stable angina patients.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina
* Positive ETT

Exclusion Criteria:

* Unability to perform ETT
* Contraindications for ETT and angiography study
Intelligent Oxygen Therapy During Sleep

Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia) especially during sleep which may be harmful. In order to overcome this, the investigators have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent intermittent hypoxia during sleep in patients already on long-term oxygen.

Long-term oxygen therapy (LTOT) improves survival in patients with chronic obstructive pulmonary disease (COPD) and severe persistent hypoxia. LTOT is prescribed at a fixed-flow rate with the aim of maintaining a partial pressure of oxygen greater than or equal to 8 kilopascals (kPa). However, a number of studies have demonstrated that patients on home LTOT experience episodes of intermittent hypoxia during rest, activities and especially sleep. Simply increasing the oxygen flow rate at night can relieve this hypoxia but at the expense of hyperoxia with its detrimental effects of hypercapnia and respiratory acidosis. Therefore, a more targeted approach is needed to oxygen delivery. The investigators have devised an auto-titrating oxygen system (intelligent oxygen therapy \[iO2Ts\]) which delivers variable flow oxygen to maintain a pre-set specific oxygen saturation ( SpO2) target. The system can avoid the dual hazards of hypoxia and hyperoxia and potentially optimise LTOT.

This study will be investigating whether the iO2Ts can reduce intermittent hypoxia during sleep compared to usual fixed flow oxygen in patients on LTOT. Nineteen patients will be recruited to undergo two sleep studies each on two different nights; one on their usual LTOT flow rate and one of the iO2Ts. During both sleep studies, all participants will have full polysomnography, oxygen and transcutaneous carbon dioxide monitoring. The primary outcome will the percentage of time spent with SpO2 \< 90% during sleep.

Eligibility Criteria:
Inclusion Criteria:

* On or eligible for long-term oxygen therapy

Exclusion Criteria:

1. Nocturnal use of non-invasive ventilation (NIV) or continuous positive airways pressure (CPAP)
2. A diagnosis of obstructive sleep apnoea
3. A diagnosis of a neuromuscular disease
4. Daytime partial pressure of carbon dioxide \> 8.0 kPa
5. Inability to consent for the study
6. Exacerbation of the underlying lung disease or chest infection in the previous 4 weeks
7. Pregnancy
8. Severe co-morbidities
9. Patients with a tracheostomy
10. Long-term oxygen therapy flow rate ≥ 4 litre per minute
11. Inability to understand the English language
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706

This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers

This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs

The management of multiple endocrine neoplasia type 1 (MEN1-1)-related pancreatic neuroendocrine tumors (pNETs) remains controversial. In general, surgical resection is currently the first-line therapy for MEN1-1-related pNETs. However, the surgical resection of pNETs is conditional for specific patients, and the incidence of postoperative adverse events is still high. Recently, several studies have demonstrated that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may provide an alternative to surgical resection of pNETs. Nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. Therefore, a multicenter prospective study is being performed to further access the efficacy and safety of EUS-FNI for MEN1-1-related pNETs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing.
2. Patients who refuse surgery.
3. Patients who have given their fully informed consent.

Exclusion Criteria:

1. Patients who are not suitable for the endoscopic procedure.
2. Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.
Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation

Patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. Laser therapy, phonophoresis, transcranial direct current stimulation (tDCS) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (KOA).However, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (KOA). Aim is to establish the benefits of High intensity Laser therapy, phonophoresis, tDCS and conventional physiotherapy in the treatment of patient with chronic KOA living in the hilly terrain. A total of 160 patients with chronic KOA will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. Recruited patients with chronic KOA will be randomly divided into four groups, high intensity-laser therapy (HILT) group, ibuprofen gel phonophoresis (IGP) group, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group. Duration of the treatment will be 8 minutes in one session/knee joint for HILT and IGP and 30 minutes in one session for tDCS each day for 3 days/week for 8 weeks. Thus, each patient with chronic KOA will receive 24 sessions in total. The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC), Digitalized pain pressure algometer (ALGO-DS-01) and 36-Item Short Form Health Survey (SF-36) questionnaire are the outcome measures will be recorded at baseline, end of 8-week post-intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with clinical chronic knee OA according to the diagnostic criteria of American College of Rheumatology (ACR) were included in the study
* Age between 45-70
* Both sex male and female

Exclusion Criteria:

* Unwillingness to participate in the study,
* Recent history (within the last 3 months) of physical therapy to the same joint,
* Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee,
* History of knee surgery/fracture,
* Acute synovitis/arthritis including the infectious conditions,
* Presence of malignancy,
* Pregnancy
* Taking pain relief medications
* Any metal implants near the site of stimulation
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies

Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed.

Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect.

The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
3. Patients with refractory or relapsed acute leukemia able to receive myeloablative conditioning but with the following factors:

   AML- 2 or more of the following: duration of CR1 \< 6 months, poor cytogenetics, circulating blasts, karnofsky \< 90.

   ALL- age \> 40 or second and additional relapse, or 2 or more of the following: BM blasts \> 25%, age 18-39,first refractory relapse, donor CMV positive.
4. Patients with 2 matched siblings and donor age \> 18 years old.
5. Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
6. Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.

Exclusion Criteria:

1. Patient age \< 18 years.
2. Donor age \< 18 years.
3. Patients in remission or not fulfilling above disease criteria -
Functional Implications of Rare Gene Mutations in AHUS Open the Door to Personalized Therapy

Hemolytic Uremic Syndrome (HUS) is a rare disease characterized by rupture of red blood cells (hemolytic anemia), low platelet count (thrombocytopenia), and thrombotic occlusion of small vessels (thrombotic microangiopathy), with prevalent involvement of the kidneys.

SEU, in its typical form is caused by gastrointestinal infection with Escherichia coli.

The atypical form of SEU (aSEU), which is not caused by an Escherichia coli infection, is a very rare disease that may have a genetic origin; it affects both children and adults and may occur in a sporadic or familial form. Many studies have shown that about 60% of cases of atypical HUS are associated with genetic abnormalities of the complement system (particularly the so-called "alternative pathway"), which is a key part of the immune system for responding to infection. Complement consists of a series of proteins that, when activated, create a so-called "cascade," which leads to the elimination of the infectious agent, either directly or through other cells. Complement is finely regulated in such a way as to prevent damage to healthy cells in one's own body. Genetic defects in some of these complement regulatory proteins cause reduced protection of the endothelial surface (thus the vessel wall) against complement activation.

Recently, new mutations have been described in a gene unrelated to the complement pathway, the DKGE gene, which codes for the intracellular isoform of diacylglycerol kinase . In these patients, small renal vessel occlusion appears to occur as a result of altered endothelial cell proliferation and angiogenesis through mechanisms apparently unrelated to complement activation. However, to date these mechanisms are poorly studied. Throughout the entire project statistical methods will be applied to optimize the characterization of the abnormalities in phenotype and function of iPSC-EC derived from aHUS patients with either DGKE or MCP genetic abnormalities as compared with control iPSC-EC, including identifying potential drugs that could correct the abnormalities


Eligibility Criteria:
Inclusion Criteria:

* Adults and children with aHUS defined by history of microangiopathic hemolytic anemia and thrombocytopenia (hematocrit (Ht) \<30%, hemoglobin (Hb) \<10 g/dL, LDH \>500 IU/L, undetectable haptoglobin, fragmented erythrocytes in the peripheral blood smear with negative Coomb's test, and platelet count \<150,000/microL), associated with acute renal failure.
* Written informed consent

Exclusion Criteria:

* TTP (ADAMTS13 activity \<10%)
* STEC-HUS (presence of stx and eae genes or Shiga-toxin in the stools and/or serum antibodies against Shiga-toxin and/or STEC LPS).
* Disseminated intravascular coagulation (prolonged thromboplastin time and lower than normal fibrinogen levels).
Prevention of Postoperative Delirium in Elderly Patients

Prevention of Postoperative Delirium in the care of Elderly Patients. A Monocentric, Prospective Intervention Study With the Question of Whether the Incidence, Length and Severity of Postoperative Delirium Can be Reduced by Implementing a Standardised, Multidimensional Delirium Management Protocol.

Within the framework of a six-month observation period, the investigators intend to identify risk factors of the patient collective for the development of postoperative delirium. For this purpose, a preoperative risk assessment is performed, which includes cognitive and physical performance as well as premedication and concomitant diseases. Included are patients of at least 65 years of age of defined specialties. Postoperatively, patients who have undergone the assessment are tested for delirium once per shift until the third postoperative day and severity and duration are documented. After completion of the observation period, risk factors favoring the development of postoperative delirium will be identified. In the subsequent intervention period, patients from the age of 65 years with an additional identified risk factor will receive standardized, targeted perioperative care. This includes both adherence to preventive measures in accordance with guidelines and the recommendation of therapeutic measures if a delirium is diagnosed. Through the standardized, interprofessional and interdisciplinary application of the described approach, the investigator aim to reduce the incidence, duration and severity of postoperative delirium. Furthermore, the evaluation of the identification of the weighting of risk factors as well as the identification of risk factors by the tests performed, length of hospital stay, three-month mortality and daily living skills after three months. In addition, a baseline EEG (standardized awake EEG before initiation) is recorded in a subgroup to determine whether patients at risk for delirium can be identified and whether intraoperative EEG parameters support the delirium risk assessment.

Eligibility Criteria:
Inclusion Criteria:

* \>= 65 Years
* intervention in one of the following departments: general and visceral surgery, urology, vascular surgery, orthopedics, trauma surgery,
* Written consent by patient or legal guardian

Exclusion Criteria:

* Foreign language patients without interpreter
* non-consenting patients without a legal representative