cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the HARM for the Detection of a Cerebral Ischemia in TIA/TNA Patients

The research project investigates the incidence of the hyperintense acute reperfusion marker (HARM) in patients with transient ischemic attack (TIA) or transient neurological attack (TNA). Initially, HARM was described after acute ischemic stroke and is caused by a blood-brain barrier disorder after recanalization of an acute vessel occlusion and consecutive reperfusion. These result in a contrast agent extravasation into the subarachnoid space, which can be easily detected on fluid attenuated inversion recovery (FLAIR) images.

TIA is defined as a transient focal neurological deficit with a probably cerebrovascular cause. In contrast, TNA is defined as a transient non-focal neurological deficit with multiple causes, including cerebrovascular. The clinical diagnosis of TIA is often flawed and the delineation of TIA and TNA can be difficult. MRI is the most important diagnostic method for the detection or exclusion of cerebral ischemia in patients with TIA/TNA in daily clinical practice. However, on diffusion-weighted imaging (DWI) approximately two-thirds of TIA cases and only one-fifth of TNA cases demonstrate acute cerebral ischemia. Supplementary perfusion-weighted imaging (PWI) scans can only slightly increase this percentage. The well-known HARM could prove to be complementary to DWI and PWI and close or at least reduce the existing gap. In the case of TNA in particular, this could be of clinical relevance in order to avoid mistreatment or even dismissal without further clarification after supposedly inconspicuous imaging.

Therefore, the aim of this study is to record the incidence of HARM in a statistically significant number of cases of patients with TIA and TNA and to investigate relationships with symptom duration and anatomical localization. In addition, the dynamics of contrast enhancement in the subarachnoid space in TIA and TNA cases with HARM will be analyzed in detail.


Eligibility Criteria:
Inclusion Criteria:

* transient focal neurological symptoms (aphasia, facial paresis, hemiparesis, hemihypaesthesia, double vision, hemianopia, hemiataxia, etc.)
* transient non-focal neurological symptoms (confusion, dizziness, memory deficits, gait insecurity, bilateral weakness, etc.)
* MRI examination possible within 24 hours of symptoms
* able to give informed consent

Exclusion Criteria:

* persistent symptoms
* symptoms lasting more than \> 24 h
* clinical suspicion of other cause of symptoms (seizures, intoxication, hypoglycemia, psychogenic)
* contraindications for MRI (pacemaker, metallic splinter, cochlear implants, etc.)
* unable to give consent
Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study

This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.

This study will evaluate the relation between the detection rate of minimal residual disease(MRD) and recurrence in HER2-positive early breast cancer patients in Asian countries. Blood will be regularly collected to check the presence of ctDNA in HER2-positive breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery. Prognostic data is also collected on the same patients.

MRD is a small number of cancer cells left in the body during or after treatment. These cells have the potential to cause recurrence in cancer patients. MRD detection can help identify patients at increased risk of disease recurrence and guide treatment decisions. However, limited data are available on when ctDNA analysis should be done in the course of treatment, and what is the appropriate analysis method. This study will contribute to determining whether MRD detection using ctDNA is useful to predict the recurrence of HER2-positive early breast cancer patients. If this can be proven, it is expected that detection of MRD can use as a biomarker to assist in the de-/escalation of treatment strategies, therefore allowing to avoid overtreatment in patients at low risk, and to add more intensive treatment in patients at high risk. Moreover, studying with Asian countries, the results will become the basic data for approval of liquid biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 20 years or older at the date of registration.
2. Histological diagnosis of HER2-positive invasive breast carcinoma.
3. Patients scheduled for neoadjuvant chemotherapy followed by surgery.
4. Clinical Stage IIA-IIIC.
5. Known hormone receptor status.
6. Signed informed consent.

Exclusion Criteria:

1. Any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
2. Bilateral synchronous breast cancer.
3. History of breast cancer.
4. Pregnancy at registration.
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
2. Chronic HCV-infection prior to study enrollment.
3. Screening laboratory result indicating HCV genotype 1b-infection.
4. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
5. Per local standard practice, documentation of cirrhosis by one of the following methods:

   * Diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., Metavir Score of \> 3 (including 3/4 or 3 - 4), Ishak score of \> 4 or,
   * FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during the Screening Period.

Exclusion Criteria:

1. HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
2. Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA \> Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
3. Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
4. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
5. Serum Alpha-Fetoprotein (sAFP) \> 100 ng/mL at Screening.
6. Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)
7. Any primary cause of liver disease other than chronic HCV-infection, including but not limited to the following:

   * Hemochromatosis
   * Alpha-1 antitrypsin deficiency
   * Wilson's disease
   * Autoimmune hepatitis
   * Alcoholic liver disease
   * Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy coincident with HCV-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.
8. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital

This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.


Eligibility Criteria:
Inclusion Criteria:

* Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
* Alert: GCS ≥ 14
* Stable:

  * systolic blood pressure ≥ 90 mmHg
  * respiratory frequency 12 - 20 / min
  * adult ≥ 18 years old
* Acute: ≤ 4
* Possible injury to the cervical spine:

  * posterior neck pain following any mechanism
  * no neck pain but visible injury above the clavicles
  * no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury

Exclusion Criteria:

* Acute paralysis (quadriplegia, paraplegia)
* Penetrating trauma to the neck
* Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
* Pregnancy
Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety

The acceptance and commitment therapy (ACT) model theoretically fits with treating appearance-related anxiety in individuals with a visible difference. This study examines the effectiveness of an acceptance-based self-help manual for this population.

Individuals with visible difference commonly experience social anxiety due to appearance-related concerns. There are limited resources to help people with appearance-related distress, so internet-provided self-help interventions may be beneficial. A pilot randomised controlled trial will compare the effectiveness of an acceptance-based self-help intervention to a waitlist control group.

We hypothesise (1) the acceptance-based self-help intervention will significantly increase participants' "psychological flexibility", (2) significantly decrease fear of negative evaluation from others and (3) significantly increase their quality of life, compared to the waitlist control group. Data will be collected at two time points only.

General distress (CORE-10) will be collected pre-intervention only to ensure randomisation has been successful. Should the two groups significantly differ in distress, this will be accounted for in subsequent analyses.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who self-identify as having a visible difference to their appearance (such as, but not restricted to: hair and skin conditions, burns, craniofacial conditions, birthmarks, surgical scarring)
* Must self-define as experiencing concerns about social interaction or a loss of social confidence in relation to their visible difference.
* Must be aged 18 years or over
* Must be fluent in English language
* Must have access to a computer and the internet

Exclusion Criteria:

* Currently receiving any form of psychotherapy
Adductor Canal Block (ACB) vs Femoral Nerve Block (FNB) in Revision Total Knee Arthroplasty

This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. The investigators seek to determine if femoral nerve block (FNB) improves the quality of recovery and improve postoperative analgesia compared with adductor canal block (ACBs) for patients undergoing revision total knee arthroplasty.

This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. A prospective study design will allow both FNBs and ACBs to be accurately assessed in an effective manner without introducing unnecessary confounding factors. Furthermore, randomization and a parallel design with equal allocation ratio will ensure timely enrollment of patients while also minimizing temporal confounders that may occur with institutional changes to clinical care protocols. Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment (FNB or ACB)

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients ages 18-80 scheduled for elective revision TKA.
* American Society of Anesthesiologists (ASA) physical status I -III
* Mentally competent and able to give consent for enrollment in the study.

Exclusion Criteria:

* Patients with any contraindications to regional anesthesia such as infection, nerve injury, anticoagulation.
* Patient refusal.
* Patients with an allergy to local anesthetics or systemic opioids.
Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm).

The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).

The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.


Eligibility Criteria:
Inclusion Criteria:

* Women who delivery vaginally
* Women who experience PPH defined as blood loss ≥700ml
* Women capable of giving consent

Exclusion Criteria:

* Clear contraindication for tranexamic acid such as known allergy or thromboembolic event during pregnancy
* Women delivering via cesarean section
* Provider feels that the woman, at presentation for delivery, is not in a position to give appropriate informed consent
Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD

the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease

Eligibility Criteria:
Inclusion Criteria:

* Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - -
* Patients with comorbidites like hypertension,diabetes,dyslipidemia

Exclusion Criteria:

* Exclusion criteria included the presence of liver disease due to any of the following: viral hepatitis (HBV, HCV)
* acute systemic disease
* cystic fibrosis, coeliac disease
* suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
* metabolic inherited diseases
* autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone).
* Patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition
* protein malnutrition
* previous gastrointestinal surgery
* structural abnormalitiesof the gastrointestinal tract or neurological impairment.
* the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
* probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria.
* Patient with age below 18 or above 60
Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Intralesional Mitomycin-C (MMC) injection has recently been introduced to resolve refractory benign esophageal stricture mostly in children. The investigators aimed to evaluate the clinical efficacy of endoscopic postdilation intralesional injection of MMC in adults with refractory benign esophageal stricture.

The participnts who have refractory benign esophageal stricture even after five or more sessions of bougination are prospectively enrolled. A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) is endoscopically done with a 0.5mL of eight each injection mainly into the tearing esophageal wall, after esophageal bougie dilation is done upto 14mm in diameter. And then, repeated bouginations combined with MMC injection are done with the interval of eight weeks upto 3 times, if dysphagia symptoms recurr with dysphagis score 3 or more. Initial and overall clinical success rates are evaluated with drug and procedure-related complication rates during the follow-up period of at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

* aged more than 29 year and less than 75 year
* refractory benign esophageal stricture who had the symptoms of dysphagia score suggested by Mellow et al greater than 3 (0: able to eat a normal diet, 1: able to eat some solid food, 2: able to eat some semi-solids only, 3: able to swallow liquids only, 4: complete dysphagia)

Exclusion Criteria: Patients who have at least one of following conditions were excluded from our study

* malignant esophageal stricture
* multiple sites of esophageal stricture
* pregnant or breast feeding status
* clinical deterioration not tolerated to endoscopic procedures
* esophageal motility disorders
* esophageal leakage or fistula
* hypersensitivity to mitomycin C
* bleeding tendency due to thrombocytopenia or clotting disorders
Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes

After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. After termination of 21-day program, CGA will be repeated and subjects will get a program of long-term rehabilitation. A phone call in six months and a face-to-face visit in 12 months will be scheduled to follow-up and to evaluate the progress in rehabilitation.

After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. The participation duration will not exceed 13.5 months including the screening period.

The study comprises three periods:

* screening (1-14 days)
* a treatment course of 21 days
* a follow-up period of 12 months On screening visit Study procedures will include
* Informed consent signing
* The Comprehensive Geriatric Assessment (CGA)
* The recommendations on a program of geriatric rehabilitation based on CGA

Visit 2 will be performed at the end of rehabilitation program. It will include:

* The abbreviated CGA
* The evaluation of the results of 21-days geriatric rehabilitation program
* The recommendations on a long-term geriatric rehabilitation

Visit 3 will be scheduled in 3 months after Visit 2 as a phone call. Special questionnaire will be suggested to study subjects. The questionnaire includes questions on implementation of a geriatric rehabilitation program and on quality of life

Visit 4- the last study visit will be performed in 12 months after Visit 2. It will include CGA and study completion procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.
2. One or more indications for geriatric rehabilitation:

   * A discharge after a hospitalization due to an acute illness (excluding stroke and myocardial infarction), trauma, surgery, including planned ones.
   * A condition leading to an acute impairment of functional status (stress, etc.)
   * Newly admitted patients
   * Abnormalities of gait and mobility (R26)

Exclusion Criteria:

1. One or more contraindications to geriatric rehabilitation:

   1. Severe sensory and cognitive impairment hampering rehabilitation
   2. End stage diseases requiring palliative care
   3. End stage frailty (bedridden patients)
2. An acute illness or an exacerbation of a chronic disease during two weeks before the enrollment in the study
3. A contradiction to any component of a rehabilitation program
4. Hearing or visual lost that can influence on study tests results
5. Refuse to participate in the study -
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

The secondary objective is to evaluate the safety and clinical performance of the studied devices.

In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices will be implanted at the discretion of the treating physician.

Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.

The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 90 years old
* Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
* Patient must be available for the appropriate follow-up times for the duration of the study
* Informed consent signed.

Exclusion Criteria:

* Patient less than 18 years old or more than 90 years old.
* Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
* Patient has systemic infection or suspected systemic infection
* Patient has thrombocytopenia (platelet count \< 150000/µl)
* Patient has untreated hyperthyroidism
* Patient has a progressive or untreated malignancy.
* Patient is pregnant or breastfeeding.
* Patient has a life expectancy of less than 1 year.
* Not informed consent signed