cyrilzakka/clinical-trials huggingface dataset:
Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.

The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy more than three months
* diagnosed with multiple myeloma (MM)
* relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
* Karnofsky performance status = 60
* no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
* no history of myocardial infarction within last 6 months
* serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN)
* total serum bilirubin = 2X ULN
* Calculated or measured creatinine clearance \>30 mL/min
* platelet count = 30 x 10(9)/L
* hemoglobin concentration = 8 g/dL
* white blood cell count = 2.0 x 10(9)/L

Exclusion Criteria:

* Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
* major surgery within four weeks of enrollment
* severe elevated serum calcium
* heart failure
* receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
* receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
* known allergies to agents used in bortezomib (e.g., boron or mannitol)
* poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.

Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years of age.
* Subjects willing to undergo multiple nasogastric intubations.
* Patients with functional heartburn will need to meet ROME II criteria.
* Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)

Exclusion Criteria:

* Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
* Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
* Subjects with Diffuse Esophageal Spasm or Achalasia.

Other protocol-defined inclusion/exclusion criteria may apply.
Radiomics of Hepatocellular Carcinoma

We propose a radiomics approach to identify prognostic biomarkers of HCC and provide patients with some reasonable advice for their therapies.

Radiomics is emerging fields that is based on quantitative analysis of medical images. Tri-phasic CT images are currently the standard imaging modality for the management of HCC. Our goal is to improve treatment decisions of HCC patients through better understanding of their prognosis based on radiomics modeling of HCC. Radiomics is defined as the extraction of quantitative image features from medical images. We will use triphasic CT data of at least 200 patients and develop a robust strategy to extract imaging features from CT. We will use deep learning in the form of a Convolutional Neural Network to segment HCC lesions and use image feature extraction algorithms with supervised classification to predict prognosis.

Eligibility Criteria:
Inclusion Criteria:

* The purpuse of our research is to improve treatment ,therefore we have no creteria.

Exclusion Criteria:

-
Effects of Virtual Reality on Dual Task Performance

This study evaluates the effects of virtual reality treatment in addition to robotic gait therapy on dual task performance, balance and gait in chronic stroke patients. Half of participants will attend virtual reality treatment in addition to robotic gait therapy for 12 sessions, while the other half will attend only robotic gait therapy for 12 sessions.

Following stroke, motor disorders, balance disorders, falls, gait disturbances and cognitive disorders are frequently seen. In stroke rehabilitation, with the use of robots and virtual reality systems with conventional methods, it is aimed to increase patient's motivation, to check if exercise is effective, to provide objective evaluation data and to support the motor learning process and the use of these methods in the field of neurological rehabilitation is increasing.

Multi-task evaluations can be made with the virtual environments created by virtual reality applications and complex tasks.

The traditional approach to stroke rehabilitation is mainly focused on balance and gait training under single task conditions. In everyday life, people should not only have balance and mobility skills, but also have the ability to perform other cognitive and motor tasks with these skills. Therefore, traditional approaches are not sufficient for the individual to return to society after a stroke.

In this respect, this study was planned in order to examine the effects of frequently used virtual reality treatment in addition to robotic gait therapy on the dual task, balance and gait performance.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research
* Stroke for the first time
* To be able to walk independently before the disease
* To score 3 or above in the functional ambulation classification
* 6 months after stroke diagnosis
* Not having open wounds
* Severity of spasticity of the lower extremities to be 3 and below according to the Modified Asworth Scale
* To score 24 or more in the Mini Mental State Examination

Exclusion Criteria:

* Acute internal problems, additional neurological diseases, or orthopedic problems that might limit walking
* To have received botulinum toxin treatment during 6 months before treatment or during treatment
* To have stroke on both sides
* To have neglect
Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint

This observational study is to document the application of a human bone graft in the surgical repair of bone fragment detachment in the knee joint (osteochondral defect) and its subsequent healing process.

For the treatment of bone fractures metal screws have been used for decades. Removal of material is the major disadvantage of conventional osteosynthesis and requires a second intervention, with all the complications and risks for each patient. In order to avoid this second surgery, it is possible to use human bone screw grafts instead of metal screws.

The bone graft helps to create a solid, bony connection. This connection leads to an extension, a bone remodeling, bone installation and optimal reparation process in the affected area.

The comparatively rare occurrence of suitable patients contributes to the fact that there has not been enough systematic research to objectively confirm the benefits of the product, which is why this observational study is being conducted.

In total, 20 patients will be enrolled in several centers in Austria. The low number of cases and the multicenter design is due to the rarity of suitable patients.

This observational study will use Shark Screw® grafts without exception at all participating centers. These grafts are manufactured by two tissue banks, the Austrian Tissue Bank surgebright and the German Institute for Cell and Tissue Replacement (DZIG) and were approved by the competent Austrian authority (AGES) in 2016.

All patients participating in this observational study, due to a medical indication, undergo surgical treatment of osteochondral defects using the bone screws mentioned above.

Postoperatively, the patients are observed over a period of 24 months. In total, there are five follow-up examinations during which clinical examinations, x-rays and a magnetic resonance tomography (MRI) is performed. In addition the KOS-ADL and IKDC Score are collected.

Eligibility Criteria:
Inclusion Criteria:

* Indication for the use of a human bone graft in the surgical treatment of osteochondral defects
* legal capability of adults, guardians and adolescents aged 14 to 17 years, age-appropriate perceptivity for children 8 to 13 years old
* Written consent to participation in the study after previous written and oral education (additional consent for participation of minors in the study after prior written and oral education by at least one parent)
* Age ≥ 8 years

Exclusion Criteria:

* Insufficient knowledge of the German language
* Alcohol and drug abuse
* Pregnant or breastfeeding woman
* Foreseeable compliance issues
* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
* Active osteomyelitis
* Ulcerations in the area of the skin of the surgical area
* Immunosuppressive drugs that can not be discontinued
Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 28 weeks
A Study of Low Dose vs Standard Ticagrelor on Platelet Function After Intervention for Acute Coronary Syndrome in Senior Patients

In this study, the investigates try to confirm our hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in senior （no less than 75 years old)acute coronary syndrome patients . Totally 40 senior ACS patients will be divided into 2 groups randomly one month after PCI . Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group 2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.


Eligibility Criteria:
Inclusion Criteria:

1.Subject must be at least 75 years of age 2 Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Active bleeding
3. Known hypersensitivity or contraindication to study medications
4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
5. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
6. Subjects with Cerebral hemorrhage history
7. Subjects with stroke history in half a year
8. subjects with active malignant tumor
9. subjects with whom oral anticoagulants are needed
10. Other conditions which the investigators think not applicable to the study.
Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study

The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).

This is a prospective registry including patient scheduled for a clinically-indicated percutaneous coronary intervention (PCI) of a de novo epicardial lesion with indication for drug-eluting stent implantation. Following study enrolment and PCI/stent with the Angiolite DES, patients will be scheduled for follow-up surveillance coronary angiography and OCT with the C7-XRTM Fourier Domain OCT system with C7 DragonflyTM catheter (St Jude Medical, Minneapolis, MN) or with the Terumo LunawayTM OCT system with fastview catheter (Terumo Medical Corporation, Tokyo, Japan). An adaptive design component of the study will randomize patients to either 3-month or 6-month angio/OCT follow-up. Clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for clinically-indicated PCI of a de nove epicardial lesion, including those with chronic stable angina, ACS (defined as NSTEMI or ACS with negative cardiac enzymes) or in the setting of elective PCI.
* Indication for DES implantation
* Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia
* Strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up
* Target lesion, if possible, should be predilated/pretreated

Exclusion Criteria:

* Age \>85 years
* Acute ST segment elevation MI (STEMI)
* Cardiogenic shock
* Known left ventricular ejection fraction \<30%
* Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration
* Iodinated contrast allergy
* Renal impairment with serum creatinine \>2.0 mg/dL
* Anticipated medical non-compliance
* Life-expectancy \<12 months
* Chronic total occlusion (CTO) in the target vessel
* Bifurcation lesion requiring a two-stent strategy
* In-stent restenosis
* Severe lesion/segment angulation/tortuosity
* Severe vessel/lesion calcification
* Simultaneous PCI within the same or different vessel during the same procedure
* Lesion unsuitable for OCT (proximal lesions \<10 mm from ostium of left main or right coronary arteries)
* Lesion length \>18 mm
* Stent length \>24 mm
* Stent diameter ≤2.5 mm and \> 4.0 mm
* Unprotected left main coronary artery disease (≥50% diameter stenosis)
* \>1 lesion
* Planned use of 2 overlapping stents
Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication

The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication.

At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study.

Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.

This is a Phase 3, 28-week, double-blind, diet-intervention, randomized, parallel group, three-arm, multi-center, dose-titration study.

The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC. The primary efficacy analysis will be the percent change from baseline in Peak Walking Time (PWT) and Claudication Onset Time (COT), calculated as the logarithm of the quotient of the time walked on treadmill at a visit divided by the time walked at baseline. Other efficacy measures will include Ankle Brachial Index (ABI), QoL measurements, composite of cardiovascular events (MI, stroke, vascular death, and lower limb amputations), and coronary and peripheral artery revascularization procedures. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and AEs. Pharmacokinetic analyses will be conducted as well.

Eligibility Criteria:
INCLUSION CRITERIA:

* Men \& women at least 40 years of age or older. Women must not be pregnant nor breast-feeding \& not planning to become pregnant or to breast-feed.
* History of IC of the lower extremities which has been present for at least 6 months with no change in symptoms in the previous 3 months prior to screening.
* LDL-C of \< 160 mg/dL and Triglycerides \< 800mg/dL.

EXCLUSION CRITERIA:

* Severe neuropathy
* Gross obesity (BMI ≥ 40)
* Presence of critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
* Surgical intervention to alleviate symptoms of claudication within 6 months or endovascular interventions within 3 months
* Documented CAD taking any cholesterol-modifying agent
* Systolic blood pressure ≥ 160 mmHg \&/or diastolic blood pressure ≥ 95 mmHg
* Presence of clinically significant laboratory test abnormalities for liver or renal function tests or HgbA1C.
* History of alcohol abuse or currently drinks alcohol in excess.
Evaluation of Unstained

The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 19 years old who are at risk for or involved in the juvenile justice system. The primary research questions it aims to answer are:

* Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months?
* Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months?

Researchers will compare participants randomized to receive Unstained (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).

Participants randomized to the treatment group will be offered Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Unstained intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).

Eligibility Criteria:
Inclusion Criteria:

* United States resident
* Owns or has regular access to a personal device with internet access
* Comfortable reading, speaking, and writing in English
* Has had vaginal or anal sex in the past 3 months
* At risk for or involved in the juvenile justice system

Exclusion Criteria:

* Currently trying to start a pregnancy
* Currently in jail or being detained in a facility
* Enrolled in an ongoing PRG-run TPP study
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment

Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.

Main objective:

To show that low analgesic doses of ketamine in intravenous infusion during 4 days associated with opioids better relieve refractory cancer pain than opioids without ketamine.

This study is a prospective study, multicenter (11 centres), consisting of 3 phases:

* a randomized controlled double blind phase of 5 days with 2 parallel groups of 38 patients each : ketamine (in association with high opioids), in intravenous injection during 4 days, versus placebo (in association with high opioids), in intravenous injection during 4 days ;
* an open-label phase of maximum 4 days, during which the ketamine Panpharma® is administered in intravenous infusion to the hospitalized patients who are still having uncontrolled pain persisting or recurrent ;
* an observational phase : starting at the discharge of the patient, of a maximal period of 6 months.The inclusion period is during 18 months, the total duration of the study is 2 years.

  76 patients are expected: 38 will be treated with opioids and ketamine; 38 will be treated with opioids and a placebo.

Success is defined by a decrease of the daily pain score of 50 % after 4 days. The expected rate of success in the placebo group is 10 % whereas the expected rate of success in the ketamine group is 30 %.

Primary outcome (pain score on a 11-point numerical scale) will be evaluated everyday as well as secondary outcomes (patient and clinician global impression of change, opioid consumption, adverse reactions, patient satisfaction on pain relief, sleep interference score).

Vital parameters (cardiac frequency, respiratory frequency and arterial blood pressure) will be checked everyday, many times a day : every hour for the four hours after the beginning of the treatment and then, every four hours ; every hour for the two hours following a dose shift).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized cancer patients (informed and conscious of the cancer diagnostic)
* Undergoing opioid treatment for 15 days at least
* Refractory pain (score higher than 5 on an 10-point numerical pain rating scale)
* Ability to score pain on a numerical pain rating scale
* Patient written agreement

Exclusion Criteria:

* Ketamine contraindications
* Methadone or other NMDA-antagonist treatment
* Karnofsky index under 10
* Pregnancy