cyrilzakka/clinical-trials huggingface dataset:
Gait Perturbations to Improve Balance Post-stroke

Individuals with stroke have balance and gait deficits. Gait training does improve balance and gait abilities, but adding perturbations may have increase these effects. The objective was to compare the effect gait training with and without perturbations on balance and gait abilities in individuals with hemiparesis due to stroke at a chronic stage.


Eligibility Criteria:
Inclusion Criteria:

* able to walk at a comfortable speed less than 1.0 m/s
* have reduced dynamic balance capacities (as evaluated by the mini-BESTest; score below the 95% confidence interval of the mean score of the corresponding age group of normative data)
* with or without a history of fall
* be able to walk on a treadmill, without external support, such as handrails or walking aid, for at least 1 minute

Exclusion Criteria:

* hemineglect (more than 6 omissions on the bell cancellation test),
* cognitive impairment (Mini-Mental State Examination score under 24/30)
* uncorrected visual deficit or pathologies other than stroke which can affect their gait or balance
Attain Stability™ Quad Clinical Study

The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).

The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, investigational Device Exemption (IDE), interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary efficacy endpoints.

All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).

Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines)
* Patient (or legally authorized representative) has signed and dated the study-specific Informed Consent Form
* Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
* Patient is expected to remain available for follow-up visits

Exclusion Criteria:

* Patient has had a previous unsuccessful LV lead implant attempt
* Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial)
* Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead
* Patient has known coronary venous vasculature that is inadequate for lead placement
* Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
* Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 90 days
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Patient has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
* Patient is contraindicated for \<1mg dexamethasone acetate
* Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Patient has a terminal illness and is not expected to survive more than six months
* Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
* Patient is unable to tolerate an urgent thoracotomy
Tempus Priority Study: A Pan-tumor Observational Study

Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers cancer research.

The Study will collect combined clinical and molecular health information for cancer patients in the United States from multiple academic medical centers and community oncology practices. Participants who agree to join the Study will have their molecular profiling results, associated clinical health information, and longitudinal outcomes health information collected by the participating Institution for submission to Tempus. The specific goal of the Study is to create an outcomes-based dataset for future research to improve cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Solid or hematologic malignancy.
2. Willing and able to provide informed consent where required.
3. Has received or will receive genomic profiling.

Exclusion Criteria:

1. Individuals without the capacity to consent.
2. Prisoners at the time of enrollment.
Developmental Hip Dysplasia by Ultrasonographic Screening of Asymptomatic Infants at Assiut University Hospital

Developmental dysplasia of the hip (DDH), formerly known as congenital dislocation of the hip, comprises a spectrum of abnormalities that include abnormal acetabular shape (dysplasia) and malposition of the femoral head.

The origin and pathogenesis of DDH are multifactorial. Abnormal laxity of the ligaments and hip capsule is seen in patients with DDH. The maternal hormone relaxin may also be a factor. Extreme hip flexion with knee extension, as in the breech position, tends to promote femoral head dislocation and leads to the shortening and contracture of the iliopsoas muscle.

It was previously reported that DDH was the underlying aetiology in about 25 % of the performed hip replacements under the age of 40 years and the initial diagnosis age ranged from 0 to 39 years, with a mean of 8 years in these patients.

The main purpose of a newborn hip screening program is to detect DDH as early as possible, so that early treatment can be given and the need for surgical treatment as well as the development of residual hip dysplasia can be avoided.

Ultrasonography offers distinct advantages compared with other imaging techniques: unlike plain radiography, it can distinguish the cartilaginous components of the acetabulum and the femoral head from other soft tissue structures, real-time US permits multiplanar examinations that can early determine the position of the femoral head in respect to the acetabulum; thus it provides the same type of information that can be obtained with arthrography, computerized tomography, or magnetic resonance imaging, but at lower cost, although ultrasonography is more expensive than plain radiography, it doesn't require sedation and doesn't involve ionizing radiation, unlike other techniques and it allows observation of changes in hip position with movement.

Eligibility Criteria:
Inclusion Criteria:

* All infants under the age of 6 months attending Pediatric Orthopedic outpatient clinics at Assiut university hospital in the period between 1st of January 2017 to 30th of December 2017.

Exclusion Criteria:

* Age older than 6 months
* Having any hip joint complaints
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection

The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 60 years of age
* No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
* Subject's liver disease is stable with ALT values \< 5 X ULN
* Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening
* Documented HCV Genotype 1 chronic hepatitis C.
* Judged to be in good health on the basis of medical history and physical examination
* All other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities.
* Be treatment-naïve or experienced.
* For female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control.
* Sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period
* Female subjects of childbearing potential must have a negative serum ß-HCG pregnancy test at screening and a negative urine pregnancy test on Day 1 before the first dose of study drugs.
* Agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial.

Exclusion Criteria:

* Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
* Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol.
* Have a Child-Pugh score \> than 5.
* Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy.
* Have any cause of liver disease other than chronic hepatitis C-infection
* Active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
* Have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months
* Have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia.
* Have a history of psychiatric disorders determined by the investigator to contraindicate therapy.
* Have uncontrolled Type 1 or Type II diabetes.
* Antinuclear antibody titer ≥1:320.
* Coinfection with hepatitis B and/or HIV 1 or HIV 2.
Establishment of 2D and 3D Primary Cell Cultures From Gastric and Gastroesophageal Junction Cancer

In this study, the investigators will establish primary cell cultures from surgically resected gastric and gastroesophageal junction cancer specimen that were collected between 06/2018 and 05/2021.

Gastric cancer is among the leading causes of cancer-related death worldwide. Surgery or radiation monotherapy are applicable as treatment for localized tumors, however, the majority of patients are diagnosed in an advanced disease state requiring systemic therapy Chemotherapies are non-specific, affecting healthy tissues, and the overall response rate in gastric tumors is limited. As such, there is a large unmet medical need for targeted therapies against gastric tumors. Recent advances in the field of onco-immunology unraveled the mechanisms of immune response against cancer, leading to the development of immunotherapeutic strategies such as: immune check point inhibitors (ICIs), and advanced therapy medicinal products (ATMPs), e.g. chimeric antigen receptor (CAR) T cells. ICIs and CAR T cell therapy in particular have evolved as novel therapeutic cornerstones against hematological disease, but their efficacy against solid tumors remains poor. Accordingly, a minority of gastric cancer patients show durable responses to immunotherapies and there is currently no cellular immunotherapy available for gastric cancer. Further, gastric tumors are heterogeneous due to genomic changes, cellular composition, and the microenvironment, conferring a very variable response to immunotherapies. Thus, a personalized approach is needed, in order to understand individual resistance mechanisms and to predict which patients are most suitable for which therapy.

To address this need, test systems resembling patient-specific tumor biology are required. Cell lines lack 3D context and lose their genetic fidelity through passaging. Patient-derived murine xenograft models provide 3D environment and multi-organ context, but the xeno-environment hampers reliability and translatability. The investigators envision patient-derived tumor organoids as a superior model, as they are 3D self-organizing structures which reflect the tumor complexity. In addition, they have the potential to serve as patient avatars and preclinical models to predict the efficacy of therapies.

In this study, the investigators will establish patient-derived organoids and to study individual tumor biology and as testing platforms for (immune-) therapies. The investigators further investigate the individual biology of the patients tumors and healthy tissues to not only understand the heterogeneous mechanisms of gastric cancer but also the heterogeneous mechanisms of healthy gastric tissue in the fields of infectiology and immunology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric or gastroesophageal junction cancer

Exclusion Criteria:

* Age \< 18 years
Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency

The study evaluates the efficacy and safety of \>Your\< Iron Syrup, a novel iron-containing dietary supplement, in the management of dietary iron deficiency in children. The study is a randomized, double-blind, placebo-controlled intervention conducted in 16 research centers in Slovenia, collectively enrolling 92 eligible children. Eligibility of children for participation in the study will be determined by screening for hemoglobin and ferritin (combined with C-reactive protein) levels in a sample of capillary blood. Eligible children will receive basic dietary advice on how to increase the consumption of dietary iron and will be invited to participate in the study. Enrolled children will be randomized to either \>Your\< Iron Syrup arm or to placebo arm in a 3:1 ratio, respectively. Changes in body iron stores (ferritin) and in hematological indices as well as occurence of any adverse events will be monitored after 4 and 12 weeks of once-daily supplementation with either \>Your\< Iron Syrup or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age 9 months to 6 years (inclusive).
* Signed informed consent for screening and for enrollment (parent or legal guardian).
* Iron deficiency with or without mild microcytic anemia not requiring treatment (ferritin ≤20 µg/l and Hb ≥ 100 g/l in a capillary blood sample).

Exclusion Criteria:

* Hb \<100 g/l.
* Anemia due to a cause other than iron deficiency.
* Vegan diet.
* Any known concomitant chronic disease (e. g., chronic inflammation, chronic inflammatory bowel disease, malignancy, kidney and/or liver malfunction, lead poisoning).
* Any known allergies to the components of the investigational product.
* Any known medical, physical, or psychological condition that, in the opinion of the investigator, is incompatible with consumption of the investigational product and/or with the conduct of the study.
* Participation in another clinical study less than 1 month before enrollment or current participation in another clinical study.
* Current consumption of iron-containing medicines or dietary supplements.
Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis

A large number of clinical studies have shown that oral administration, external application or enema of Chinese medicine can promote the recovery of gastrointestinal function and the absorption of pancreatic inflammation. The aims of the study is to explore the application of Dachaihu Decoction Compound (DDC)and Rhubarb Single Medicine (RSM) in the Treatment of Acute Pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old
* Meet the diagnostic criteria of western medicine for acute pancreatitis, within 48 hours of onset
* Consent of the subjects, who sign the informed consent form

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Acute abdomen such as organic intestinal obstruction, gastrointestinal perforation, purulent cholangitis, etc.
* Patients with a history of severe heart, liver, kidney and other important organ diseases
* Patients with mental illness and malignant tumors
* People who have allergies, or are allergic to a certain drug ingredient
Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines

This study explores the routines of registration of surgical site infections (SSI) at different surgical centers in Sweden. It explores the sensitivity and specificity of the registration routines of SSI are at Halmstad County Hospital, Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Surgical Clinics in Sweden that report tho the Swedish national register for Colorectal Cancer.

Exclusion Criteria:

* Clinics that dosen´t report.
Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections

Heart rate variability (HRV) is an important indicator of cardiac autonomic function and predictor of cardiac mortality and of all-cause mortality. In this study the investigators examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO) undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).

BoNT/A is a common treatment in patients with NDO. Possible known side effects are urinary retention or increased post void residual. Systemic side effects seems to be rare. However this has not been investigated in detail. Although in very small amounts, BoNT/A can enter the systemic circulation during intradetrusor injections and might cause distant effects on other neuro-muscular systems, i.e. the heart. Aim of this trial is to asses potential systemic adverse effects of BoNT/A on the heart following intradetrusor injections for NDO. Potential effects on the cardiac autonomic function can be detected using HRV analysis. Patients without relevant preexisting disorders of cardiac function and proven NDO are included. During four separate visits, all subjects receive two ECG measurements before (Visit 1 and 2) and two ECG measurements following BoNT/A intradetrusor injections (Visit 3 and 4). We investigate three different groups: 1) patients not receiving BoNT/A intradetrusor injections (= control group), 2) patients receiving intradetrusor injections with 100 units BoNT/A, and 3) patients receiving intradetrusor injections with 300 units BoNT/A.

Eligibility Criteria:
Inclusion Criteria:

* patient with neurogenic detrusor overactivity
* written informed consent
* Medical indication for BoNT/A injections
* able to learn or conduct clean intermittent self-catheterization

Exclusion Criteria:

* No written informed consent
* Pregnancy
* Cancer of infection of the lower urinary tract
* Cardiac pacemaker
* Previous heart attack, angina pectoris
* Medication with effect on HRV
* Previous cardiosurgery
* Cardiac arrhythmia
* Skin disease not allowing application of ECG-electrodes
Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Autoimmune cytopenias are a common entities with good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependant on steroids to maintain an acceptable level of hemoglobin or platelets, and the treatment becomes more difficult increasing the secondary effects. The current study evaluates the safety and efficacy of the combination of low doses of alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for this subset of patients improving the cytopenias without increasing the adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age: \> or = 16 years
* Weight: more than 40 Kg
* Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant
* Idiopathic thrombocytopenic purpura with platelet counts \< 50,000, refractory to treatment, in relapse or steroids dependant

Exclusion Criteria:

* Current viral or bacterial infection.
* Positive serology for HIV, HCV, HBV.
Personalized ViscoElastic Testing-guided Bleeding Management in Liver Surgery, Neurosurgery and Obstetrics

The ClotPro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation. This study aims to assess the agreement of ClotPro 6.0, ROTEM delta, and TEG 6s in three distinct cohorts: i) patients with liver disease undergoing liver surgery, ii) pregnant women undergoing elective cesarean section, and iii) patients undergoing elective intracranial neurosurgery. Further coagulation tests will be performed (standard laboratory coagulation tests, thrombin and plasmin generation tests) in an exploratory fashion to compare them with viscoelastic test results. The obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study.

The primary research question is therefore to compare various parameters of standard ClotPro measurements with corresponding ROTEM delta and TEG 6s parameters.

Additionally, this study aims to close the following clinically important knowledge gaps:

Do VET results mirror measurements obtained by more holistic, in-depth analyses of the hemostatic system that are currently not available in clinical practice, such as TGA-TM and PG?

Which of the three investigated VET devices offers the most rapid availability of diagnostic results?

Do VET results have a predictive ability for the occurrence of perioperative bleeding and/or thromboembolic events?

Do VET results depict sex-specific differences in perioperative coagulation management?

Furthermore, by including a large number of patients from three distinct patient cohorts, this study intends to examine whether cohort-specific reference ranges need to be established for ClotPro. Thereby, this study aims to provide the foundation for an evidence-based ClotPro-guided perioperative coagulation management algorithm, which could upscale current opportunities of personalizing perioperative coagulation management.

Eligibility Criteria:
Inclusion Criteria:

1. Vulnerable patient cohorts

   * Patients undergoing elective liver surgery defined as one of the following invasive procedures:

     * Liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy),
     * Orthotopic liver transplantation,
   * Pregnant women undergoing an elective caesarean section, and
   * Patients undergoing an elective intracranial neurosurgery.
2. Written informed consent

Exclusion Criteria:

none