cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is 18 to 80 years old
2. Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.

2. Participant has had a colonoscopy performed:

* Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
* Since the onset (if applicable) of any of the following alarm features for participants of any age

  * Participant has documented weight loss within the past 6 months
  * Participant has nocturnal symptoms
  * Participant has a familial history of first-degree relatives with colon cancer
  * Participant has blood mixed with their stool (excluding blood from hemorrhoids).

    3. Female participants must be:
* Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
* Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
* Abstinent, or
* If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

1. Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
2. Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
3. Participant has a history of diverticulitis within 3 months prior to Prescreening.
4. Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
5. Participant has any of the following surgical history:

   * Cholecystectomy with any history of post cholecystectomy biliary tract pain
   * Any abdominal surgery within the 3 months prior to Prescreening
   * Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.
Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease

The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. To study the impact of rTMS, investigators will adopt a domestically developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the electroencephalographic and electromyographic signals for PD patients when walking in the gait laboratory or when conducting leg dorsiflexion movement on sitting.

The Bereitschaftspotential (BP), event related synchronization (ERS) and event related dysynchronization (ERD) will be analyzed for the investigation of the possible differences of brain activities prior to leg voluntary movement between patients and controls. In addition, the synchronized recorded gait parameters for gait ignition,turning and termination will also be analyzed. The information gathered will allow us to further understand the pathophysiology of the gait freezing in PD. Investigators will deliver a course of rTMS with intermittent theta burst paradigm of the leg motor cortex to investigate whether the non-invasive brain stimulation can ameliorate the gait freezing in PD patients. The subjects will be assessed before and 4 times after rTMS during an 8-week period with clinical scoring batteries and electrophysiological recording as aforementioned. At the end of the 8th week, the test group and sham group will cross over and undergo the same procedures as aforementioned. The serial comprehensive investigations in this project will not only promote our understanding of the gait freezing pathophysiology but also may charge a novel trail for the management of long suffering symptom of the PD patients.

Eligibility Criteria:
Inclusion Criteria:

Patients with PD will be diagnosed according to the Brain Bank criteria.

Exclusion Criteria:

1. Patients had past history of epilepsy, intracranial operation or brain tumor.
2. Hoehn \& Yahr Stage V.
Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980

The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 12 to 60 years
* Hemophilia A with plasma FVIII level less than 1% (severe hemophilia)
* No history of FVIII inhibitor antibody formation and no current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay (\< 0.6 Nijmegen Bethesda Units \[N.B.U.\]/mL)
* No signs or symptoms of an acute bleeding episode on the day of infusion
* Four or more days without treatment with FVIII prior to the day of infusion
* Subject (or the subject's legal representative) must provide written informed consent and authorization of use and disclosure of Protected Health Information (PHI)
* Subjects must have been previously treated with FVIII concentrate for a total of at least 200 exposure days, including 20 exposure days in the previous 12 months. Previous treatment can have been with any type of rFVIII or plasma-derived FVIII concentrate

Exclusion Criteria:

* Individuals with abnormal renal function (serum creatinine concentrations greater than 1.3 mg/dL) or active hepatic disease (persistent aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] increases to greater than five times the upper limit of normal).
* Individuals with anemia, as defined by hemoglobin level less than 12 g/dL
* Any individual with a past history of severe reaction(s) to FVIII products
* Any individual on interferon treatment or who has received interferon within the previous 3 months
* Any individual with thrombocytopenia (platelets greater than or equal to 100,000 cells/mm3) or known hematologic/bleeding problems other than hemophilia A
* Any individual who is receiving or has received other experimental drugs within 3 months prior to study entry
* Any individual with known dislipidemic disease or actively taking cholesterol lowering drugs for the treatment of hypercholesterolemia or hyperlipidemia (e.g., statins, cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid or fibrates) or individuals taking anaesthetic drugs
* Any individual who requires pre-medication for FVIII infusions (e.g., antihistamines)
* Any individual with high blood pressure (defined as diastolic blood pressure great than or equal to 100 mm/Hg)
* Any patient who cannot forego FVIII treatment for at least 4 days prior to study entry or between study infusions due to a need for more frequent prophylactic treatment because of a pre-existing medical condition
* Any patient with known allergy or severe reactions to liposomes or PEG
* Individuals with any other known disease affecting hemostasis besides hemophilia A
* Any patient who is not suitable for participation in this trial for any reason, according to the Investigator
Motor Imagery Plus Therapeutic Exercise in Women With Menstrual Pain

The researchers will conduct a study that combines motor imagery with therapeutic exercise in women experiencing menstrual pain. Previous research suggests that motor imagery, when used alongside physical exercise, may help improve motor control and alleviate pain, potentially enhancing outcomes for individuals dealing with chronic pain conditions. Through this study, the investigators aim to explore the effectiveness of these interventions in targeting key variables such as pain perception, motor coordination, and overall quality of life, building on existing evidence of motor imagery's benefits in pain management.


Eligibility Criteria:
Inclusion Criteria:

* Women who have experienced menstrual pain for more than 6 months.
* Pain intensity rated higher than 3/10 on a pain scale.
* Participants do not take pain-relief medication during the study period.
* Ages between 18 and 35 years old

Exclusion Criteria:

* Current use of hormonal contraceptives or other treatments that affect menstrual cycles.
* Any chronic pain condition unrelated to menstrual pain (e.g., fibromyalgia, chronic low back pain).
* Diagnosed gynecological conditions such as endometriosis or pelvic inflammatory disease.
* Pregnancy or breastfeeding.
* Current use of psychoactive medications that could affect pain perception.
* Any significant psychiatric condition that could interfere with study participation.
* History of recent pelvic surgery (within the last 6 months).
Post-emergency Management of Patients with Transient Ischemic Attack

A transient ischemic attack (TIA) is a momentary neurological dysfunction due to a brief cessation of blood flow to a region of the brain, resulting in typical signs of stroke (hemiplegia, aphasia, dysarthria), but whose clinical symptoms typically last less than an hour, with no visible lesion on imaging. This diagnosis remains difficult and is essentially based on the clinical judgment of the physician.

Because a TIA can be a "pre-alarm" for stroke in 20-30% of cases, it needs to be treated appropriately and as early as possible in the emergency department. Stroke rates after untreated TIA are 5% within 48 hours, 10% within one month and 20% within one year. This risk is calculated using the ABCD² score which is based on the patient's risk factors and the clinical manifestations of TIA. Patients with a score ≥ 3 should be hospitalized as soon as possible for a complete medical evaluation. However, this score has not been scientifically validated, and several specialists agree that all TIAs should be evaluated immediately. Preventing stroke is a major public health issue because it is a serious, disabling and sometimes fatal disease. Given the seriousness of the progression from TIA to stroke, the French National Authority for Health has issued a series of management recommendations. However, in practice, these guidelines remain complicated to follow and patients management may vary and be more or less effective.

Therefore, the aim of this study is to highlight the differences in how inpatients and outpatients are managed. Following these observations, solutions will be sought to make the care and management of these patients more efficient and more in line with recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Consultation in the emergency department.
* Suspected TIA diagnosed by emergency physician.
* Duration of TIA symptoms \<1 hour.

Exclusion Criteria:

* Validation MRI performed prior to suspected TIA.
* Patient hospitalized for a condition other than TIA, including stroke.
* Patient referred to another hospital for further examination.
* Pregnant women.
* Patient unable to understand and answer a questionnaire.
* Patient under legal protection.
Citrus Extract, Sleep and Mental Wellbeing

This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.

Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with (minor) sleep disturbance
* Age 40-70 years
* BMI 18.5 - 30 kg/m2
* Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study

Exclusion Criteria:

* Excessive caffeine use
* Major psychiatric/mental health disorders .
* Chronic sleep disorders
* Severe sleep disturbance for more than 1 year
* Other clear causes for poor sleep quality or mental wellbeing
* Use of medication or supplements that can affect outcomes
* Nonpharmacological treatment for sleep disorders
* Flight from a time-zone with \>3 h difference ≤1 week before an intervention period
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study
* Use of pre-, pro- or synbiotics within 1 month prior to the start of the study
* Reported weight loss or weight gain of \>3 kg in the month prior to pre-study screening
* Smoking
* Abuse of products
* Known allergy to citruses
* Known pregnancy or lactation
Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention

The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.

Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.

Eligibility Criteria:
* Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU
* Being at "high" or "very high" PU risk according to the Charité PU prevention standard:

  - Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité
* Expected minimum length of stay at least three days
* Informed consent (or by legal representative)
Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment

This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.

This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.

In the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.

In the baseline assessment period and endpoint assessment period, cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).

In the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment
2. 18-85 years old
3. Be able to follow instructions to complete the test
4. Can tolerate the rehabilitation training of this experiment
5. First stroke
6. Patients who signed informed consent

Exclusion Criteria:

1. The test could not be tolerated due to organic disease
2. There is a serious mental illness resulting in inability to cooperate with or tolerate this test
3. is participating in another clinical trial involving an investigational drug or physical therapy
4. Patients who have not signed informed consent
Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments

This is a multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients who failed, refused or ineligible to receive standard treatments


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old, of any sex;
2. Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
3. Confirmed TNM stage is II-III of NSCLC;
4. Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
6. Life expectancy of \> 3 months;
7. Patients volunteered to participate in this study and signed informed consent, with good compliance;

Exclusion Criteria:

1. Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
2. A history combined with other malignant tumors and not cured;
3. WBC\<3×109/L、LYM\<1.5×109/L、NLR≥3、PLT\<50×109/L、HGB\<90 g/L;
4. Insufficient of liver and renal function (Cr\>176.8 µmol/L; AST and/or ALT\>2 folds of normal value)；
5. Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
6. Combined with active affection and need antibiotic treatment;
7. Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms;
8. Known to be hypersensitive to contrast agent;
9. Pregnant or breastfeeding women;
Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study

The purpose of this study is to compare improvement percentage of urinary albumin excretion between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning hypertension.

The cardiovascular diseases such as stroke and myocardial infarction consist 50% of the cause of death in Japanese population. Numerous mega trials have shown that strict anti-hypertensive therapy could reduce cardiovascular morbidity and mortality in hypertensive patients.

It is reported, however, over 50% hypertensive patients have not been controlled below therapeutic target blood pressure that the JSH2004 guideline recommends.

Recently use of Angiotensin II receptor blockers (ARBs) is increasing progressively for their pharmacological action on organ protection as well as potent reduction in blood pressure. However, usual dosage of ARB in Japan is almost half of that in the mega trials executed in Europe and America. Lower dosage compared to western countries might be a reason why cardiovascular events are not fully reduced in Japan.

Valsartan optimal therapy against elevated home blood pressure research (VOYAGER) study will be a multi-center, open-label, randomized, active-controlled study to evaluate the following; improvement percentage of urinary albumin exception, home blood pressure, hospital blood pressure, incidence of stroke, cardiovascular disease, and microangiopathy with valsartan 80 mg- or valsartan 160 mg based therapy in patients with elevated morning home blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged over 20 years and less than 80 years, regardless of sex.
* Patients with stable seated morning home blood pressure of over 135 mmHg and/or diastolic blood pressure of over 85 mmHg within 1 to 2 weeks.
* Patients who are on therapy with conventional dosage of ARB.

Exclusion Criteria:

* Patients who are difficult to measure home blood pressure.
* Patients with secondary hypertension or malignant hypertension.
* Patients with seated systolic blood pressure of over 200 mmHg.
* Patients with seated diastolic blood pressure of over 120 mmHg.
* Patients with a history of cerebrovascular disorder or myocardial infarction or heart failure within 6 months prior to enrolment in the study.
* Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
* Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
* Patients with serious liver dysfunction.
* Patient with HbA1C of over 8 percent.
* Patient with positive albuminuria by dip and read stick test.
* Patient treated with any angiotensin converting enzyme inhibitor
* Pregnant women
* Patients with a history of hypersensitivity to valsartan.
* Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.