cyrilzakka/clinical-trials huggingface dataset:
Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma

Autologous hematopoietic cell transplantation is currently considered the standard therapy of multiple myeloma (MM) for elegible patients. On the contrary, despite new developments in transplant procedures and supportive care, allogeneic bone marrow transplantation is less commonly used due to high transplant related mortality (TRM).

No consensus statement about allografting in MM has so far been reached and only a minority of patients undergoing allografting are enrolled in prospective clinical trials.

Moreover, use of unrelated donors is considerably increased over the time and the recent activity survey of European Group for Blood and Marrow Transplantation (EBMT) showed that the number of allografts from unrelated donor is higher than that one from HLA-identical siblings in Europe.

In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients, the investigators plan to conduct a restrospective study through the Italian Bone Marrow Transplantation Registry (IBMDR) over a period ranging since 2000 to 2009. Data will be collected from the central data management system Promise (Project Manager Internet Server) used by EBMT and from IBMDR.

The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma over the last decade and hopefully offer recommendations on patient selection. Primary endpoints of the study are: a) Overall Survival (OS) from diagnosis and from the allograft b) Event-Free-Survival (EFS) from the allograft. Disease response criteria will be defined according to the International Uniform Response Criteria for multiple myeloma. Transplant related mortality, Graft-Versus-Host-Disease (GVHD), either acute or chronic (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate analysis will be calculated for the transplant-related and patient-related characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma patients treated with allogeneic bone marrow transplantation from unrelated donors (from 2000 to 2009: Centri Trapianto GITMO)

Exclusion Criteria:

* No exclusion criteria
Time to Total Hip Replacement After Supervised Exercise and Patient Education

The purpose of this study is to evaluate the time to total hip replacement in patients with hip osteoarthritis going through both a supervised exercise program and patient education compared to patients going through patient education only.

The null hypothesis is: There are no differences in time to total hip replacement between patients with hip osteoarthritis who went through a 12 week supervised exercise program and patient education compared to patients who went through patient education only.

Material and methods:

109 patients with both symptomatically and radiographically verified hip osteoarthritis were included in this randomized controlled trial between april 2005 and october 2007. They were randomized to either a 12 week supervised exercise program and patient education (n=55) or patient education only (n=54).

Information on if and when total hip replacement is performed will be collected between April 1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will be collected directly from the study participants by telephone.

The main outcome is time to total hip replacement.

Status:

This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to evaluate the effect of supervised exercise and patient education.

The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 80 years old with uni- or bilateral hip disability.
* Hip pain for more then 3 months.
* Harris Hip Score between 60 and 95. Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for total hip replacement surgery.
* Radiographic verified hip OA (Danielsson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: \< 4 mm \< 70 years, \< 3 mm ≥ 70 years, or 1 mm difference between hips).

Exclusion Criteria:

* Patients who have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA).
* Patients with co-morbidities not tolerating physical activities
Surrogate Markers of Portal Pressure

This is a prospective longitudinal study that will evaluate if changes (pre and post therapy) in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS) as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.

Subjects will be recruited from the outpatient setting of the West Haven VA Medical Center and the Yale Liver Clinic. Subjects between 18-85 years of age with compensated cirrhosis due to chronic hepatitis C virus (HCV) infection who will be starting anti-viral therapy to treat HCV within the next 3 months will be eligible for this study. 33 subjects (assuming 10% loss to follow-up) will be recruited and their participation will last from 6-12 months. The expected duration of the study is 2 years.

The primary end point of the study is to correlate the change (from baseline to after completing anti-HCV therapy) in ICG retention test, LS and SS as measured by ARFI with HVPG. After consent has been obtained, subjects will undergo ICG retention test, ARFI imaging and HVPG measurements before and after HCV therapy. Blood samples, demographic and clinical data will be collected before and after HCV therapy. Correlations between changes in HVPG and changes in ICG, LS and SS will be assessed. With 30 patients , we will have 80% power to perform a hypothesis test of the Pearson correlation assuming an observed correlation of 0.70 and a two-sided type I error rate of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* HCV infection (HCV-RNA positive)
* Compensated cirrhosis will be defined histologically and/or clinically (presence of compatible lab findings (platelet count ≤ 150,000, total bilirubin ≥ 2, serum albumin ≤ 3.5, INR ≥ 1.2) PLUS compatible physical exam features (cutaneous stigmata, gynecomastia in men, or splenomegaly) OR compatible radiological findings (nodular liver surface, splenomegaly, and/or collaterals). (The ultimate confirmation of the diagnosis of cirrhosis will be a baseline HVPG \> 5 mmHg)
* Planned anti-HCV therapy in the next 3 months

Exclusion Criteria:

* Any clinically-evident complication of cirrhosis that defines decompensation : jaundice, ascites, variceal hemorrhage, overt hepatic encephalopathy)
* Hepatocellular carcinoma
* Co-infection with HBV or HIV
* Ongoing alcohol abuse
* Occlusive portal thrombosis,
* Presence of comorbid conditions conferring a life expectancy\<1 year, history of allergy to iodides, pregnancy
Clinical and Molecular Phenotyping in IBD

Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses.

Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.


Eligibility Criteria:
Inclusion Criteria:

* inflammatory bowel disease
* indication for biological therapy

Exclusion Criteria:

* pregnancy, breast feeding
* no written informed consent to participate in the study
Integrating Depression Care in Acute Coronary Syndromes Care in China

The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS patients from 20 rural county hospitals selected from a well-established research network across China.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 79 years old
* Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS)
* ACS is stable (as judged by the treating cardiologist/internist)
* Signed patient informed consent

Exclusion Criteria:

* Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer)
* Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline)
* Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.)
* Non-permanent local residents or permanent residents planning to move out within 12 months
* Pregnant or breast-feeding or planning pregnancy within 12 months
* Affected by bipolar disorder, schizophrenia or severe depression that meet criteria for referral including patients with acutely suicidal risk (Beck Depression Inventory Item9=3)
* Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.


Eligibility Criteria:
Inclusion criteria :

* Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.
* Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute (mL/min)/1.73 square meter (m\^2).
* Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
* Signed written informed consent.

Exclusion criteria:

* Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
* Planned coronary procedure or surgery after randomization.
* Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
* Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight?

VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows:

1. Primary Objective:

   To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
2. Secondary Objective:

To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.

Validation Ancillary Endpoints

1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.

Validation methodology:

Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.

Assumptions: The population and sampling sizes chosen for each subject category will meet the goal to attain sufficient diversity to satisfy representation that supports the efficacy of the device across the population samples. Any failures or results from the acceptance criteria may require an increase in the sampling size to ensure coverage representation of all subject demographics.

Eligibility Criteria:
1. Inclusion Criteria: All subjects will be automatically enrolled on a walk-in basis.
2. Exclusion Criteria: No walk-in subjects will be excluded from enrollment.
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu

To assess Family-unit Helicobacter Pylori Infection rates and antimicrobial resistance rates in Jiangsu,China

The study is a sample survey of the community population in cities of Jiangsu where the centers are located.The Helicobacter pylori infection and drug-resistant gene mutations are detected by real-time PCR performed on the stools of subjects.

Eligibility Criteria:
Inclusion Criteria:

1. community population
2. Fecal samples can be obtained, and the sample volume meets the requirements of the collection tube instructions
3. Only one person per family can be selected
4. Voluntarily participated in this study and signed an informed consent form

Exclusion Criteria:

1. The collector does not cooperate or has poor compliance;
2. Adequate and qualified fecal samples could not be obtained;
3. Stool samples were collected during diarrhea or constipation;
4. Antibiotics, bismuth preparations, proton pump inhibitors and other Hp sensitive drugs have been used within one month.
Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)

The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of NKTT120 in adult patients with stable sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years
* Subject has a confirmed diagnosis of HbSS or HbSβ0thal
* Subject has stable SCD defined as not having acute VOC, ACS, or other major SCD associated event during the month prior to enrollment

Exclusion Criteria:

* Subject had an SCD-related VOC or ACS that required hospitalization or treatment in acute care outpatient setting in the month prior to enrollment
* Subject requires a program of prescheduled regularly administered packed red blood cell (pRBC) transfusions or Subject received a pRBC transfusion in the month prior to enrollment
* Subject has evidence of latent or active tuberculosis
* Subject has a major concurrent illness or medical condition
* Subject is pregnant or nursing
Stenting in the Treatment of Aneurysm Trial

The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (\>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial
* The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting
* The endovascular physician is a priori content to use either type of technique
* The patient has not previously been randomized into the trial
* Treatment is elective
* Patient is 18 or older
* Life expectancy is more than 2 years
* Patient has given fully informed consent and has signed consent form

Exclusion Criteria:

* Other aneurysms requiring treatment during the same session
* Patients with associated cerebral arteriovenous malformations
* Patients with recently ruptured aneurysms
* When parent vessel occlusion is the primary intent of the procedure
* Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel
* Patients with recurring, previously stented aneurysms
The Role of Angiotensin Type I Receptor in the Regulation of Human Peripheral Vascular Function

The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve peripheral endothelial function, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on peripheral endothelial function are also due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.

The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve peripheral endothelial function, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on peripheral endothelial function are also due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.

Eligibility Criteria:
Patients over 18 years with endothelial dysfunction requiring diagnostic cardiac catheterization.

Normal volunteers or patients undergoing catheterization who have normal coronary arteries without risk factors for atherosclerosis will be used as controls.

No unstable angina.

No significant left main disease (greater than 50% stenosis).

No recent myocardial infarction (less than 1 month).

No pregnancy, lactation.

No allergy to losartan.

No renal failure (creatinine greater than 2.5 mg/dl).

Ability to withdraw ACE inhibitors.
Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength

The aim of the present prospective controlled study is to compare the trunk muscle strength, quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.

In this study patients underwent inguinal hernia repair will be evaluated for the effect of the surgical procedure on abdominal muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male gender (for minimizing the certain effect of gender to muscle strength)
* Patients aged 18-65 years' old
* Having no previous surgery
* Patients within six months to postoperative first year
* Ability to speak, read, and write Turkish

Exclusion Criteria:

* Infections or tumors of the spine
* Systemic bone or joint disorders (e.g., rheumatoid arthritis)
* Unstable cardiovascular and pulmonary diseases
* Polyneuropathies and musculoskeletal system diseases
* Presence of a diagnosed severe psychiatric disorder
* Presence of severe pain
* Regular exercise habit
* Recurrent operation for a hernia
* Presence bilateral inguinal hernia on concurrent femoral hernia
* If the calculated Body mass index is lower than 20kg/cm2 or over than 35kg/cm2
Nobori And Uncoated Stent In Coronary Attack

Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI between patients receiving Nobori versus uncoated stents.


Eligibility Criteria:
Inclusion Criteria:

* age more than 20 years old
* chest pain lasting more than 20 min
* symptoms beginning within 12 hours before characterization
* electrocardiogram showing ST-segment elevation or new appearance of left bundle branch block
* increase in cardiac enzymes to more than 5-fold the normal laboratory values
* infarct-related vessel are anatomically suitable for percutaneous revascularization
* patients gave their signed, informed consent

Exclusion Criteria:

* previous stent implantation within 30 days
* allergy to any of the followings : aspirin, heparin, clopidogrel, biolimus A9 or its derivatives, stainless steel 316L, PLA (Poly-Lactic Acid) Polymer or its derivatives, and contrast media
* elective surgery scheduled within 6 months
* renal insufficiency with creatinine level of more than 2.5 mg/dL
* patients associated with bleeding and/or clotting disorders, and those refusing blood transfusion
* history of massive gastrointestinal or urinary tract bleeding within 6 months
* patients currently enrolled in other clinical trials
* pregnancy