cyrilzakka/clinical-trials huggingface dataset:
Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.

Patients with prosthetic mitral valves need a long-term anticoagulation therapy. After mitral valve replacement using mechanical prostheses warfarin is administrated during the whole life. Biological prostheses allows do discontinue anticoagulation 3 months after surgery in the absence of other risk factors of thrombosis especially atrial fibrillation. The common approach to patients with mitral valve disease and atrial fibrillation is mitral valve prosthetic replacement concomitant to Cox-Maze procedure. This allows to maintain sinus rhythm in 65-80% of patients. In the study the safety and efficacy of dabigatran in comparison with warfarin will be evaluated after the mitral valve surgery and Cox-Maze procedure.

Eligibility Criteria:
Inclusion Criteria:

* mitral valve disease;
* atrial fibrillation;
* mitral valve prosthetic replacement with concomitant Cox-Maze Procedure;
* 18-75 years of age;
* signed informed consent form.

Exclusion Criteria:

* mechanical valve replacement;
* repeated mitral valve surgery;
* coronary artery hemodynamically significant stenoses;
* ventricular arrhythmias;
* creatinine clearance \<50 ml/min;
* HAS-BLED score \>3;
* previous stroke or transient ischemic attack;
* liver diseases;
* neoplasia;
* pregnancy;
* simultaneous antiplatelet therapy;
* allergic reactions on Dabigatran or Warfarin;
* cognitive disorders.
Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

The aims of this study are

* Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing
* Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.

After interim analysis of the first part the clinical study will be continued as follows: Double blind, placebo controlled, randomised, multi-centre study with 2-parallel groups for the treatment of acute bronchitis accompanied by coughing in children aged 0 - 6 years to demonstrate efficacy and safety of Prospan® Hustenzäpfchen.

For assessment of cough intensity and severity a specific symptom score has been developed, which gathers the child's frequency and severity of coughing and of cough productivity as well as the severity of rhonchi (each symptom will be assessed on a four-point Likert scale ranging from 0 to 3; total score range: 0-12 points).

Considering the specificities of the study population and the disease, confirmatory evaluation will be based on the change in the symptom score after the first three consecutive days of treatment as assessed by the investigator.

Eligibility Criteria:
Inclusion Criteria:

1. male or female children aged 0 to 6 years
2. acute bronchitis existing not longer than three days and accompanied by coughing
3. symptom rating score of ≥ 5 assessed by the investigator
4. symptom 'frequency of coughing' of ≥ 2 assessed by the investigator
5. the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study -

Exclusion Criteria:

1. hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
2. patients with severe allergies or multiple drug allergies
3. any other pulmonary disease within the last two weeks
4. chronic pulmonary diseases
5. exacerbation of chronic pulmonary disease
6. suspicion of bacterial pulmonary infection
7. fever above 39°C (rectal measurement) -
Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up

The purpose of this study is to evaluate in a randomized controlled trail, an innovative cancer communication strategy to help African American breast cancer patients cope with a variety of challenges during and after treatment and to better adhere to recommended treatment guidelines and follow-up care.

Disparities in incidence and mortality between African Americans and Caucasians for a number of cancers have been well documented. This study builds on previous work in St. Louis to overcome barriers to access to breast screening, identifying and addressing factors associated with access to care once diagnosed, and factors contributing to delay in diagnosis and completion of therapy. African American breast cancer patients randomly assigned to the intervention arm of the trial will have access to the Survivor Stories Tablet, a tablet computer, on which they will browse an archive of 1-3 minute videotaped survivor stories about five topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer. Patients will have the tablet for two weeks after enrollment in the study, and again at 6 and 12 months. Patients in the control arm will receive usual care.

Eligibility Criteria:
Inclusion Criteria:

* African American women
* First primary ductal carcinoma in situ (DCIS) or stages I, II, or III invasive breast cancer.

Exclusion Criteria:

* Prior DCIS or breast cancer diagnosis
* Stage IV or metastatic breast cancer
* Planned to receive a double mastectomy
* non-English speaking,
* Having known psychiatric or neurologic disorders
* Being cognitively impaired according to weighted error scores on the Orientation-Memory-Concentration Test
* Being unwilling or unable to give consent
Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension

To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and \< 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
* Reversed day-night life cycle including overnight workers
* estimated glomerular filtration rate eGFR \< 60 mL/min/1.73 m\^2.
Aiberry AI Mental Health Screening Platform

Aiberry is creating a multi-modal artificial intelligence (AI) platform that analyzes facial, audio and text features to screen for mental illness. This multicenter study will be used to collect data to validate the platform's ability to detect depression and anxiety in a diverse patient population.

Aiberry is developing a proprietary AI platform that leverages machine learning to screen for mental illness using a multi-modal approach that fuses rich visual, audio, text, gestures, and eye gaze information. Our objective in this study is to validate algorithms that predict how individuals will respond to self-report questionnaires used to screen for major depressive disorder (MDD) and general anxiety disorder (GAD). Prior to enrollment, participants will participate in a baseline screening questionnaire to collect demographic information, health history, and current depression severity. If participants meet eligibility requirements and demographic recruitment targets, they will be invited to a single virtual study visit in which they will complete a 10-15 minute recorded interview with a study staff member along with three brief self-report questionnaires: 1) the Quick Inventory of Depression Symptoms Self Report (QIDS-SR-16), 2) the General Anxiety Disorder (GAD-7), and 3) the mini-version of the Mood and Anxiety Questionnaire (mini-MASQ), which will be used as a validity check that participant responses are consistent between this and the previous two questionnaires. We will evaluate how well the AI technology is able to predict self-reported symptoms of depression and anxiety by analyzing facial, audio, and text features from interview videos.

Eligibility Criteria:
Inclusion Criteria:

* Age 13 to 79 years old
* English-speaking

Exclusion Criteria:

* Previous participant in the study, within the last three months
* Individuals unable to verbally respond to standardized questions
* Individuals unable to participate in a virtual visit as they do not have the right hardware (phone/laptop) or no internet connectivity
* Individuals unable to provide consent
Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners

The pelvic floor is a crucial complex for many bodily functions, supporting the pelvic organs and contributing to urinary and anal continence, as well as sexual function. Dysfunction of this structure can lead to a variety of disorders, including urinary incontinence (UI), a common problem in women. Although the prevalence of UI in middle-aged women has been documented at between 20% and 30%, high-impact physical activities, such as certain sports and running, increase the risk of UI. According to the most recently published meta-analysis, the prevalence is 44% \[95%CI 30.2-57.8\]. Although this subject is often taboo, it can have psychosocial consequences and affect sporting activities. Only 31.7% of female runners talk to a health professional about it. Trail running, a fast-growing discipline, differs from road running in its particular physical demands, which could influence the occurrence of pelvic floor disorders (PFD) and exercise-induced UTIs. The unique characteristics of trail running, such as the technical nature of the terrain, the steep gradients and the variety of distances, place intense demands on the female pelvi-perineal system. Nevertheless, despite the growing popularity of this sport, little epidemiological data exists on the prevalence of stress UTI and pelvic floor disorders among female trail runners.


Eligibility Criteria:
Inclusion Criteria:

* Adult runner
* Residing in mainland France, or in French overseas departments and territories such as Guadeloupe, Martinique, French Guiana, Réunion, Mayotte and New Caledonia
* Practising trail running on a regular basis (defined pragmatically by the participant herself), whether or not affiliated to a club
* Able to complete the questionnaire online-

Exclusion Criteria:

* Pregnant or have given birth in the last six months
* Does not understand French
* A protected adult (guardianship or curatorship) or under court protection
Memory T-cell Infusion to Improve Immunity After TCR-alpha/Beta Depleted Hematopoietic Stem Cell Transplantation

The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early post-transplant is a safe way to improve immunity to common infections in recipients of TCR-alpha/beta depleted hematopoietic stem cell grafts.

Graft-versus-host disease (GVHD) remains the most important direct complication of hematopoietic stem cell transplantation. Methods used to prevent GVHD include diverse pharmacologic interventions and ex vivo methods of T-cell depletion, the latter being the most effective ones. Historically depletion of T-cells from the graft is associated with increased rate of graft failure, relapse of malignant disease and prolonged immune deficiency. Selective depletion of TCR-alpha/beta T-lymphocytes is a new method of hematopoietic stem cell graft manipulation which is thought to conserve important cell populations, e.g. NK cells and gamma/delta T cells within the graft. Preliminary results suggest that TCR alpha/beta depletion ensures high engraftment rate, low early mortality and good control of GVHD. The problem of delayed immune reconstitution and life-threatening viral infections remains incompletely resolved.

Depletion of naive (CD45RA-positive) T-cells was developed as a new method of graft manipulation to prevent GVHD. Research data indicate that alloreactivity is associated mainly with naive T-cell fraction. In vitro depletion of CD45RA lowers significantly the alloreactive response while retaining reactivity to pathogens.

In the current protocol we plan to test whether relatively low doses of CD45RA-depleted mononuclear cells can be safely infused after TCR-alpha/beta depleted transplantation. The biologic readout for the protocol will be quantitative assessment of T-cell reactivity to common pathogens after infusion.

Eligibility Criteria:
Inclusion Criteria:

* recipient of allogeneic hematopoietic stem cell graft from haploidentical or matched unrelated donor
* TCR alpha/beta depletion of the hematopoietic stem cell graft
* CMV-seropositive donor
* stable hematopoietic engraftment

Exclusion Criteria:

* active graft-versus-host disease grade 2-4
* any systemic immune suppressive therapy except calcineurin inhibitor monotherapy
* uncontrolled sepsis
Intermittent Hypoxia Therapy in Cardiac Rehabilitation

This is a randomized control pilot study to assess the effect of intermittent hypoxia therapy on functional capacity vs conventional care in old patients with functional impairment admitted to a Phase 2 in-hospital cardiac rehabilitation program.

Because the improvement of exercise tolerance reduces mortality in elderly patients affected by cardiovascular disease, intermittent hypoxia therapy (IHT) - defined as repeated episodes of hypoxia interspersed with normoxic periods delivered by an ad hoc device - might be a valuable tool to be associated to structured cardiac rehabilitation (CR) interventions.

The present study is a pilot, monocentric, randomized (randomization ratio 1:1), parallel group study to assess the effect of IHT on functional capacity vs conventional care in old patients with functional impairment admitted to a phase 2 in-hospital cardiac rehabilitation program.

The study will enroll cardiac patients of both genders, ≥ 75 years and with a functional impairment assessed by a Short Physical Performance Battery (SPPB) score \< 7.

The effect of IHT on functional capacity will be evaluated on top of the conventional multidisciplinary CR intervention, by means of SPPB score variation; variations in quality of life and cognitive status will also be evaluated as secondary goals of the study.

The total amount of IHT sessions per patient will be 10, 1 per day over 2 weeks, the duration of each single procedure will be 45 min and the Hypoxic O2 conc.% will be 14-10. The study was approved by local ethic committee.

Eligibility Criteria:
Inclusion Criteria:

* Admission to a Phase 2 in-hospital cardiac rehabilitation program because of a recent index event;
* Provision of signed and dated informed consent form;
* Age ≥ 75 years;
* Basic venous blood oxygen saturation (SpO2) level \> 93% measured at the fingertip;
* SPPB score \< 7;
* New York Heart Association (NYHA) Class I-III.

Exclusion Criteria:

* Inability to give informed consent (diminished understanding or comprehension);
* Age \< 75 years;
* SPPB Score ≥ 7;
* NYHA Class IV and/or concomitant i.v. therapy with cardiovascular active drugs;
* Uncontrolled angina pectoris;
* Uncontrolled arterial hypertension;
* Uncontrolled atrial or ventricular arrhythmias;
* Active pericarditis or myocarditis;
* Need of continuous or intermittent O2 therapy;
* Hb \< 10 g/dl;
* Severe concomitant non-cardiac diseases such as cancer or any other systemic disease limiting to participate in the study
* Acute inflammatory diseases;
* Acute non-cardiac somatic diseases, or somatic diseases with symptoms of decompensation;
* Currently implanted left ventricular assist device;
* Inability to accept the procedure of breathing via facial mask.
Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)

This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy with infliximab and determine whether changes in the levels of the selected biomarkers can be used to predict endoscopically assessed gut mucosal status changes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time
* History of colonic involvement verified by prior endoscopy or radiography
* Indicated for treatment with infliximab according to current best medical practice
* Body Mass Index (BMI) between 15 kg/m\^2 and 35 kg/m\^2
* Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception
* Negative pregnancy test
* No signs or symptoms of active tuberculosis (TB) and has a negative TB test within 6 weeks of first study drug administration

Exclusion Criteria:

* Pregnancy, intention to become pregnant, or breastfeeding
* Evidence of a colon unaffected by CD
* Indication for surgery
* Perianal disease likely to interfere with study participation
* Presence of a stoma or history of colectomy
* Symptomatic diarrhea unrelated to CD
* Strictures or evidence of bowel obstruction
* Presence of abscess unless completed definitive treatment can be documented one week prior to screening
* Presence of fistulas
* Contraindication to infliximab
* Intolerance to sedatives or other medications required for endoscopy
* Any prior use of anti-inflammatory biologic therapy
* Moderate or severe congestive heart failure
* History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
* Major surgery or donation/loss of at least one unit of blood within 4 weeks of screening
* Positive for hepatitis B surface antigen, hepatitis C antibodies, or Human Immunodeficiency Virus (HIV)
* History of any tumor except adequately treated basal cell carcinoma or carcinoma in situ of the cervix
* History of systemic granulomatous infection
* History of nontuberculous mycobacterial disease, or any opportunistic infection within 12 months of study entry
* Transplanted organ including bone marrow or hematopoietic stem cell-derived marrow
Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)

This study aims to investigate the effectiveness and safety of alpha-lipoic acid in patients with diabetes and ischemic stroke treated with reperfusion therapy.

Despite significant advances in the prevention and treatment of stroke, it is still one of the leading causes of death and debilitating disease. Unfortunately, several neuroprotective strategies have failed in clinical trials. At present, it is reported that there are no pharmacological agents with putative neuroprotective actions that have demonstrated efficacy in improving outcomes after acute ischemic stroke (AIS) in humans. Previous stroke studies have confirmed that oxidative stress plays a vital role in stroke and in reperfusion following stroke. Therefore, the use of antioxidants could be a promising strategy for treating ischemia-reperfusion injury. Alpha-lipoic acid (aLA) is a potent antioxidant commonly used for the treatment of diabetic polyneuropathy (DPNP). The investigators previously demonstrated the neuroprotective and neurorestorative effects of aLA, mediated at least partially via insulin receptor activation, after cerebral ischemia in rats. Moreover, previous observational study of the investigators showed that patients with diabetes treated with aLA have better functional outcomes following AIS after reperfusion therapy than patients not using aLA.

Therefore, the investigators investigate whether patients with diabetes treated with aLA have better functional outcomes after AIS and reperfusion therapy than patients not treated with aLA in this prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke within 6 hours of symptom onset
* Patients with diabetes
* Patients who underwent reperfusion therapy (Intravenous t-PA or endovascular thrombectomy)

Exclusion Criteria:

* Pre-existing disability (Modified Rankin Scale \>= 1)
* Patients with severe renal disease (GFR \<30 ml / min)
* Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure
Urine Testing to Detect Kidney Transplant Rejection

The purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. An increase in the serum creatinine level is often the first clinical indicator of kidney transplant rejection; however, this marker lacks sensitivity and specificity. Rejection is currently diagnosed using an invasive transplant biopsy procedure; in addition to being expensive, transplant biopsies can result in bleeding from the transplant and even graft loss. In early studies, it has been observed that significant increases in the levels of perforin, granzyme B, and CD3 messenger RNA (mRNA) in urinary cells signal the development of acute transplant rejection. The purpose of this study is to evaluate whether the noninvasive procedure of measuring perforin, granzyme B, and CD3 mRNA levels in urine samples can accurately diagnose and predict kidney transplant rejection, make transplant biopsy unnecessary, and provide an opportunity to initiate treatment for early rejection with the aim to minimize damage to the kidney.

This study will last 3 years post-transplant. There will be a total of 14 study visits. Blood and urine collection will occur at all visits. Additional visits may be necessary for those participants who develop abnormal kidney function.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo primary or redo deceased- or living-donor kidney transplantation
* Ability to provide informed consent

Exclusion Criteria:

* Requires combined organ transplantation
* Previously received a solid organ transplant (other than kidney transplant) or islet cell transplant
* HCV infected
* HIV infected