cyrilzakka/clinical-trials huggingface dataset:
Examining Rehabilitation Training Methods

Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of acute stroke
* admission to acute inpatient rehabilitation
* impairment in cognitive functions (as indicated by 14-item Executive Interview ≥ 3)

Exclusion Criteria:

* diagnosis of dementia in the medical record
* inability to follow two-step commands 80% of the time
* severe aphasia (score of 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale)
* current untreated major depressive, bipolar, or psychotic disorder (PRIME-MD)
* drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
Quality of Life in Patients With Chronic Urticaria

Urticaria is one of the most frequent presenting complaints in dermatology, allergy, and emergency departments. The term chronic urticaria (CU) is understood as the appearance of recurrent wheals more than twice a week for over 6 consecutive weeks .Urticaria is not a single disease but a reaction pattern that represents cutaneous mast cell degranulation, resulting in extravasation of plasma into the dermis. The incidence of chronic urticaria is unknown, but it is thought to occur in 0.1%-3% of the population

Chronic urticaria signs and symptoms include: patches of red or white wheals, usually on the face, trunk, arms or legs. Wheals vary in size, change shape, and appear and fade repeatedly as the reaction runs its course. Itching is common, which may be severe. Swelling may occur that causes pain or burning (angioedema), especially inside the throat and around the eyes, cheeks, lips, hands, feet and genitals.

It is characterized by a tendency for signs and symptoms to flare with triggers such as heat, exercise and stress as well as a tendency for symptoms to recur frequently and unpredictably, sometimes for months or years The significance of chronic urticaria is sometimes trivialised because it is a non-life-threatening disease, but the condition can be very uncomfortable and interfere with sleep and daily activities. It is one of the most common and frustrating diseases for both patients and physicians Chronic urticaria has a major impact on quality of life (QoL) , with impact on activities of daily living. Chronic urticaria patients reportedly suffer considerable loss of energy, sleep disturbance and emotional upset as well as restrictions in the social life. Depression and anxiety are the most common psychiatric diagnoses. These psychiatric disorders could also influence QoL

Eligibility Criteria:
Inclusion Criteria:

Patients with chronic urticaria defined as a 6-week or longer history of daily or almost daily itchy cutaneous weals with individual lesions lasting less than 24 h.

Age between 18 and 60 years.

Exclusion Criteria:

Patients who are unable to understand the questions, are unwilling to complete the questionnaire, or who have a psychiatric disorder, or obstructive sleep apnea.

Patients with malignant or central nervous system disease. Patients with cognitive impairment due to a current cerebral or psychotic illness.

Patients with current psychotherapy . glucocorticoids therapy in the last month.
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation


Eligibility Criteria:
140 patients (7 study groups, up to 20 implanted patients per study group)

Fecal Incontinence groups:

Main Inclusion Criteria:

* Fecal incontinence (defined as incontinence to solid or liquid stool \> 1 / week);
* Failed biofeedback or medical therapy;

Groups 1 - 5 patients with:

* Group 1) Circumferentially intact external anal sphincter, no previous surgery;
* Group 2) Circumferentially intact external anal sphincter after surgical repair;
* Group 3) Rectal prolapse repaired with a rectopexy;
* Group 4) Spinal injury including disc prolapse;
* Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis

Constipation groups:

Main Inclusion Criteria:

* Chronic constipation (defined as \</= 2 weekly bowel movements; and/or \>25% of bowel movements required straining; and/or \>25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year
* Failed biofeedback or medical therapy;

Groups 6 - 7 patients with:

* Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;
* Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.
TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435

The purpose of this study is to compare the levels of TMC435 in the blood circulation after intake of 2 tablet formulations with the level of TMC435 in the blood circulation after intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood circulation after intake of the capsule formulation fasted or following a meal.

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), single dose, crossover (volunteers will receive different interventions sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 as a capsule formulation taken fasted (Treatment A) and following a meal (Treatment B). In addition, the study will evaluate the levels of TMC435 in the blood circulation after intake of a single dose of 150 mg TMC435 as 2 different tablet formulations (Treatments C and D). There will be a 14-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all four treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (day of first dosing) and/or Day 4 of each treatment period, and 4 weeks after the last treatment. Each volunteer will receive 4 treatments, about 14 days apart from each other. Each treatment consists of one single dose of 150 mg TMC435.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker for at least 3 months
* Body Mass Index of 18.0 to 30.0 kg/m2
* Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria:

* Infection with Hepatitis A, B or C virus
* Infection with the human immunodeficiency virus (HIV)
* Women who are pregnant or breastfeeding
* History of, or any current medical condition which could impact the safety of the participant in the study
PET/CT Based Radiomics for Lung Cancer (PERL)

The investigators investigate the utility of FDG PET/CT based radiomics in lung cancer, including diagnosis and prognosis.

Recent studies have shown that, in addition to inter-tumor heterogeneity, tumors often display startling intratumoral heterogeneity in various features including histology, gene expression, genotype, and metastatic and proliferative potential, which is often associated with adverse tumor biology. Unfortunately, it is difficult to assess intratumoral heterogeneity with random sampling or biopsy as this does not represent the full extent of phenotypic or genetic variation within a tumor. Given the limitations of current biopsy strategies, there is an important potential for medical imaging, which has the ability to capture intratumoral heterogeneity in a non-invasive way.

Borrowed from the concept in genomics and/or proteomics, radiomics was specifically proposed for medical or radiological images. It is a promising technique for improving diagnosis, staging, prognosis, treatment response prediction and potentially allowing personalization of cancer treatment. It is a process of extraction and analysis of high-dimensional image features from radiological images obtained with CT, MR or PET, which could be either qualitative or quantitative. The basic assumption of radiomics is that tumor biology could be captured by radiomic features .

The purpose of this study is to investigate the utility of FDG PET/CT based radiomics in lung cancer. Four PET/CT centers will be involved in this study, in which more than 1000 patients diagnosed as lung cancer will be retrospectively enrolled.

Eligibility Criteria:
Inclusion Criteria:

- All patients diagnosed as lung cancer patients who had a FDG PET/CT scan before treatment between 1 Jan, 2013 and 30 December, 2016 in the four collaborative hospitals.

Exclusion Criteria:

- The patient without follow-up information
Continued Access to RXDX-105

This study is being done to see if people with Non-Small Cell Lung Cancer (NSCLC) or ovarian cancer benefit from continued treatment with the study drug, RXDX-105.


Eligibility Criteria:
Inclusion Criteria:

* This individual patient protocol includes treatment for 3 patients previously enrolled on IRB #15-270 (phase1/1b clinical trial RXDX-105-01):

Exclusion Criteria:

* Any patients other than those described above are excluded.
Low Intensity Focused Ultrasound for Binge Eating Disorder

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with Binge Eating Disorder (BED)

The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for BED

Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females, 22 - 65 years of age.
* Participant meets DSM-5 criteria for moderate to extreme BED.
* Weight ≤450lb to accommodate in MRI.
* Shoulder width of ≤65 inches to accommodate in MRI.
* The neuromodulation targets are visible on MRI for target selection.
* Participant is able and willing to give informed consent.

Exclusion Criteria:

* Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
* Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
* Participants with known untreated or unstable cardiac status or hypertension
* Evidence of substance (alcohol or other drug) use disorder during the previous 12 months (assessed via SCID-5).
* Past or present diagnosis of schizophrenia, psychotic disorder or bipolar disorder (assessed via SCID-5)
* Participant who is currently participating in another clinical investigation with an active treatment arm.
* Use of any medications that, in the opinion of the Investigator, may put the participant at higher risk for AEs, or impair the participant's ability to perform complete study procedures.
* Participant is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
* Participant is pregnant/lactating or planning to be pregnant.
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure

The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

1. Before any study-specific procedures, the appropriate written informed consent must be obtained.
2. Male and female older than 18 years of age.

   For the cardiac patients:
3. Being accepted for cardiothoracic surgery with the use of open chest surgery
4. A known left ventricular ejection fraction, either assessed by echocardiography, MUGA or MRI. If LVEF \<40% a subject will be assigned to the chronic heart failure group, if LVEF \>40% a subject will be assigned to the control group.

   For the non-cardiac patients:
5. Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.

Exclusion Criteria:

1. An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
2. Younger than 18 years of age.
3. Clinical history of chronic kidney disease (at any point prior to registration).
4. Any known hepatic disease.
5. Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
6. Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
7. Participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
8. Any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
9. Legally incompetent adults, for which reason what so ever.

   For the non-cardiac patients:
10. A known history of cardiovascular disease.
Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients

The purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly patients.

In western countries, sudden cardiac death (SCD) represents the most common form of cardiovascular death. SCD is often caused by ventricular arrhythmias in patients with a known history of ischemic heart disease but it may also occurs in healthy persons.

In the last years has been extensively studied the protective role of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) against SCD both in healthy persons and in patients affected by coronary artery disease.

The hypothesis that these evidences could be ascribed to an antiarrhythmic effect of n-3 LCPUFA, has been corroborated by the observation of a direct relationship between the dietary intake of these nutrients and a better cardiac autonomic control.

This pathway, in particular, has been confirmed by the analysis of changes in heart rate variability.

Most studies in this field used n-3 LCPUFA derived from fish oil, composed by a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At our knowledge there are few studies available evaluating the isolated role of DHA, derived from alternative sources of n-3 LCPUFA, as the microalgae, in the prevention of fatal arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

* Age above 65 years

Exclusion Criteria:

* Treatment with or allergy to polyunsaturated fatty acids
* Diagnosis of arrhythmia or antiarrhythmic therapy
* Anticoagulant therapy (except acetylsalicylic acid)
* Pacemaker
* Bleeding diathesis
* Recent cerebral hemorrhage (less than 6 months)
* Thyroid dysfunction
Evaluation of the Safety and Tolerability of Ocular Lubricants

The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.

This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects.

At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2.

This study will be conducted in Australia.

Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to understand and sign an Ethics Committee-approved informed consent form.
* Willing and able to attend all study visits as required by the protocol.
* Exhibits symptoms of dry eye at the Screening Visit.
* Currently uses habitual artificial tears to alleviate dry eye symptoms.
* Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Has any known active ocular disease and/or infection.
* Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator, may affect a study outcome variable.
* Has had an ocular injury to either eye in the past 12 weeks prior to screening.
* Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
* Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
* Is pregnant, intends to become pregnant, or is breastfeeding.
* Other protocol-specified exclusion criteria may apply.
Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)

The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following photodynamic therapy with verteporfin for the treatment of exudative age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

1. A male or female with evidence of exudative age-related macular degeneration with clinical/angiographic/optical coherence tomography (OCT) findings of subfoveal choroidal neovascularization (CNV) which has not responded to current therapy
2. Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640
3. Patient must be willing and able to comply with the protocol and provide informed consent.

Exclusion Criteria:

1. Patients on intravenous, subcutaneous, or anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day holiday from therapy prior to the injection procedure. Note: Patients on oral anticoagulant therapy may be considered to participate if the physician responsible for monitoring the anticoagulant therapy agrees that the patient may take a 5 day holiday from therapy prior to each anecortave injection. The attending doctor must notify the principal investigator and this notification will be made part of the source documentation. Anticoagulant therapy may resume either the evening of or the morning after the injection procedure.
2. Patient with known glaucoma or steroid induced ocular hypertension
3. Intraocular pressures of 21 mmHg or greater at time of entry into the study
4. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions
5. Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye
6. Patient participating in any other investigational drug study
7. Inability to obtain photographs to document CNV (including difficulty with venous access)
8. Concomitant oral steroids or topical ophthalmic steroid use
9. Sub-Tenon's injection of steroids within the past 6 months
10. Patient with significant liver disease or uremia
11. Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone
12. Patient is pregnant or nursing
13. Age less than 50 years old
Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy

The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only.


Eligibility Criteria:
Inclusion Criteria:

* Male and female recently diagnosed symptomatic stable Angina patients
* Age ≥18 years old
* Patient already treated by one first line antianginal haemodynamic agent (ß-blocker or Ca-channel blocker) (according to CCS management guidelines 2019) and still symptomatic after initiation of this antianginal treatment.
* Patient for whom the physician intends to prescribe trimetazidine based on her/his daily medical practice in the management of symptomatic Angina pectoris, respecting the SmPC in force in the country. Such treatment decision must be taken independently from the participation of the patient in the study.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Any contra-indication to trimetazidine according to SmPC
* Patient already treated with trimetazidine before entry into the study.
* Pregnancy or intention to become pregnant or lactating women during the study.