cyrilzakka/clinical-trials huggingface dataset:
Monitoring of Donor-specific Antibodies After Treatment with Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation

Single-arm, prospective observational study

This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

Eligibility Criteria:
Inclusion Criteria:

* all patients after lung transplantation with detection of donor-specific antibodies

Exclusion Criteria:

* none
Prevalence of Cachexia in Patients Undergoing Chemotherapy

Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing chemotherapy. The purpose of this study is to assess prevalence of cachexia and low nutritional intake and the impact on quality of life, fatigue and mortality in patients undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and chemotherapy, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing chemotherapy at least in the second cycle.
* Patients who have signed a written Informed Consent.

Exclusion Criteria:

* Patients with implanted pacemaker or defibrillator.
Functional Electrical Stimulation for Hemiplegic Cerebral Palsy

The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.

The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemiplegic Cerebral Palsy
* Gross Motor Function Classification System (GMFCS) I or II
* Age 6-17 years inclusive
* Demonstrate foot drop during gait without wearing ankle foot orthosis
* Tolerance to neuroprosthesis stimulation
* Physician referral to participate in intervention
* Passive dorsiflexion to at least neutral with knee extended
* Available to travel to and from study visits
* Ability to follow instructions and cooperate with study protocol
* Caregiver reads and understands English

  * Exclusion criteria:
* Any metal implants containing electrical circuitry
* Continuous regular use of neuroprosthesis stimulation previous to study enrollment
* Previous orthopaedic procedure involving tibialis anterior muscle at any time
* Previous orthopaedic procedure to affected limb in the last year
* Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study
* Any condition that PI feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)
Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina

This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with MVA

Considering the reduced CFR and increased platelet aggregability in patients with MVA, together with the augmented effect on adenosine-mediated coronary blood flow and potent antiplatelet effect of ticagrelor, we speculate that ticagrelor can promisingly ameliorate the coronary microvascular function in patients with MVA.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study subjects should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged 18-80 years
3. A diagnosis of stable primary MVA based on the presence of

   * a history of typical effort angina,
   * exercise-induced ST-segment depression\>1 mm,
   * normal or near-normal (coronary artery stenosis\<50%) coronary angiography,
   * absence vasospastic angina
   * a coronary flow reserve (CFR) \<2.5 in the left anterior descending coronary artery as assessed by coronary blood flow (CBF) response to adenosine at transthoracic Doppler echocardiography
   * suboptimal control of symptoms on conventional anti-ischemic therapy, as indicated by the occurrence of \>1 episode per week of angina

Exclusion Criteria:

ubjects should not enter the study if any of the following exclusion criteria are fulfilled:

1. concomitance with any of the cardiac condition below

   * significant （\>50%）coronary plaque disease
   * coronary artery spasm at angiography or other evidence of vasospastic angina
   * valvular or other structural heart disease
   * uncontrolled hypertension
   * abnormal echocardiographic examination including left ventricular hypertrophy
2. no previous consumption of the ticagrelor
3. no apparent contraindications to ticagrelor administration.

   * History of Intracranial Hemorrhage
   * Active Bleeding
   * Severe Hepatic Impairment: AST and ALT are greater than 3 times of the upper limit. Bilirubin is greater than the upper limit.
   * hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product
   * severe COPD or asthma
Discerning Pseudoprogression vs True Tumor Growth in GBMs

One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard noninvasive tool for distinguishing between pseudoprogression and progressive disease. Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits measurement of hemodynamic imaging variables. Previous literature reports attempted to use some or all of these metrics to assess their utility in distinguishing PsP from true cancer progression. These studies showed mixed results, likely due to a number of factors, including poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and varied analysis methodologies. The investigators aim to address these issues in this study.

See BRIEF SUMMARY section

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older.
* Participants must be able to read and comprehend the English language.
* In agreement with the care providing physician, participants must be willing to have surgery to remove possible brain tumor.
* Participants must have a MRI scan within 24 hours after the tumor is removed (if a tumor is confirmed).
* Participants must have the tumor analyzed by the laboratory and pathology departments and receive the diagnosis of glioblastoma.
* Participants must be willing to follow the Stupp treatment protocol (this treatment plan and its' procedures are considered the standard for treating glioblastoma). (The Stupp protocol is the name of the radiation and chemotherapy plan that has been found to help in many cases of glioblastoma.)
* Participants must be willing to follow any additional study procedures (including having all follow-up MRIs performed at St. Vincent 86th St).

Exclusion Criteria:

* Participants are less than 18 years of age.
* Participants have had surgery for your brain tumor and NOT received the diagnosis of glioblastoma
* Participants and care providing physician have decided NOT to follow the Stupp protocol (treatment plan) for glioblastoma treatment. (Deviations or interruptions are allowed if clinically indicated)
* Participants are not having a MRI scan within 24 hours after brain tumor surgery.
* Participants are not willing to follow the study procedures.
Post Marketing Surveillance of Roflumilast in Korea

The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.

The drug being tested in this study is called roflumilast. Roflumilast is used to treat people who have severe chronic obstructive pulmonary disease (COPD) forced expiratory volume in 1 second (FEV1) post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of worsening symptoms. This study will look at side effects and the lung function of people who take roflumilast.

The study will enroll approximately 3000 patients who plan to take roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial will be conducted in Korea.. The administration period of the roflumilast is determined in accordance with actual treatment policy for the subject, Subjects will be evaluated during routine appointments with their healthcare provider.

This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 1 month. Participants will be evaluated during routine appointments with their healthcare provider.

Eligibility Criteria:
Inclusion Criteria:

* 1. Has signed the 'Informed Consent Form' prior to use-result surveillance enrollment.

  2. Has severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of exacerbations.

  3. Plans to take Roflumilast as add on to bronchodilator treatment. 4. Has not participated in the study before.

Exclusion Criteria:

* 1. Is hypersensitive to the principal components and additives of this product .

  2. Suffers from moderate or severe liver diseases (Child-Pugh Class B or C). 3. Suffers from severe immune system disorders (e.g., human immunodeficiency virus (HIV) infection, multiple sclerosis, systemic lupus erythematosus, progressive multifocal leukoencephalopathy etc.).

  4. Suffers from severe acute infectious diseases. 5. Suffers from cancer(excluding basal cell carcinoma). 6. Is administered immunosuppressants (e.g.: Methotrexate, Azathioprine, Infliximab, Etanercept or long-term use of oral Corticosteroids); however short-term use of systemic corticosteroids is excluded.

  7. Suffers from latent infections (e.g., tuberculosis, viral hepatitis, herpes virus infections, herpes zoster and etc.).

  8. Suffers from congestive heart failure (New York Heart Association (NYHA) Class III or IV).

  9. Has a history of depression with suicidal thoughts or behaviors. 10. Has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this drug contains lactose.
The Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study

Executive function is a high-level cognition which plays an important role in our life. Meta-analysis study has demonstrated that acute exercise could improve executive function. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. It is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Therefore, the purposes of present study are: (1) Measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) Measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate.

Executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. Meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. It is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Therefore, the purposes of present study are: (1) Measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) Measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate.

Eligibility Criteria:
Inclusion Criteria:

1. no history of psychiatric or neurological disorders
2. no history of cardiovascular disease
3. normal or corrected to normal vision and normal color perception
4. right handed
5. 18.5 \< BMI \< 27

Exclusion Criteria:

1. Diagnosed with epilepsy
Knowledge , Attitude and Practice (KAP) of Fifth Year Undergraduate Dental Students on Post Exposure Prophylaxis

Considering the increasing number of HIV and HBV cases, the aim of this study is to evaluate the knowledge,Attitude and practice of fifth year undergraduate dental students regarding post-exposure prophylaxis.

needle stick injury is inevitable. Needle stick injury is deﬁned as penetration of a sharp instrument into the body of a healthcare professional, exposing them to high-risk body ﬂuids.

Cutaneous injuries are the most common cause of infection transmission from patient to dentist. The causes of such injuries have been reported as 37% from dental burs , 30% from syringes , 6% from orthodonticwires , 3% from suture needles, 1% from blades and 2% from other sharp instruments .

Since high-risk exposure is unavoidable, dentists should be aware of post-exposure protocols to prevent infection .

Eligibility Criteria:
Inclusion Criteria:

* All Fifth Year dental students in Faculty of Dentistry ,Cairo University at the time of the study

Exclusion Criteria:

* Refusal of participation from the students.
A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients

This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).
* No prior therapy or inadequate response to therapy for hepatitis C.
* Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.

Exclusion Criteria:

* Use of other investigational drugs within at least 30 days of enrollment
* Women of child-bearing potential.

Other protocol-defined inclusion/exclusion criteria apply
Aripiprazole and Effexor XR Drug Interaction Study

The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, ages 18 to 45 (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
* Body Mass Index (BMI) of 18 to 33 kg/m2, inclusive.

Exclusion Criteria:

* Subjects with a decrease in SBP of \>=20 mm Hg and increase in HR of \>=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
* Supine BP of 90/50 mm Hg or lower at screening
* SBP \>=140 mm Hg or DBP \>=90 mm Hg at screening
Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel

Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but also in many other tissues. It is part of balanced anesthesia in general anesthesiology as well as a sedastive agent in intensive care units, but also serves as a third-line agent in many psychiatric diseases including ADHD, schizophrenia and PTSD.

The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The investigators will use a flowcytometric assay to determine activation of thrombozytes when they come into contact with clonidine in vitro as well as Multiplate analyses to determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or arachidonic acid-induced aggregation of thrombozytes.


Eligibility Criteria:
Inclusion Criteria:

* Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel
* Age above 18 years

Exclusion Criteria:

* Additional anticoagulatoric treatment woth another inhibitor of platelet aggregation
* Surgery within the last two weeks
* Patients with long-term mediaction with omeprazole
* Patients under hemodialysis
* Patients with renal insufficiency (creatinine above 1.5mg/dl, urea above 80mg/dl)
* Patients with hepatic dysfunction (GOT above 30U/I, GPT above 30 U/I, GLDH above 10 U/I)
* Age under 18 yeary
* Non-responder to ASS and / or clopidogrel
SGLT2 Inhibitor for Severe Tricuspid Regurgitation

The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.

After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to SGLT2i add-on group or conventional treatment group.

Eligibility Criteria:
Inclusion Criteria:

1. Participant over 20 years of age who understands the research protocol and has written informed consent
2. Participant with severe tricuspid valve regurgitation

   * Vena contracta width \> 0.7cm or effective regurgitant orifice (ERO)≥40mm2 for more than 1 month despite medical treatment
   * Participant with left ventricular ejection fraction ≥ 40%
   * Participant with NYHA class II or more

Exclusion Criteria:

1. Patient with severe mitral valve or aortic valve disease
2. Left ventricular ejection fraction less than 40%\*
3. Patient with severe pulmonary hypertension (TR Vmax \> 4m/s)
4. Patient with acute heart failure or dyspnea of NYHA functional class IV or higher
5. Symptomatic hypotension or systolic blood pressure \< 90 mmHg at screening
6. Patient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism)
7. Patients with renal failure (Estimated GFR \< 30 mL/min/1.73 m2) or on dialysis
8. Patient with Type 1 diabetes
9. If a woman of childbearing potential has not used double contraception
10. Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging
11. Blood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)
12. Life expectancy is less than one year
13. Patient who already take SGLT-2 inhibitor
14. A history of hypersensitivity or allergy to SGLT2 inhibitor
Clinical and Radiographical Analysis of the Distal Radioulnar Joint Following Implantation of a Scheker Total Distal Radioulnar Joint Prosthesis

This project is set to describe by objective measures as the range of motion and weight-bearing ability of the distal radioulnar joint one to five years after primary implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function, especially the pronation and supination. Unlike other ulnar endoprostheses that replace only the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid notch, and is semi-constrained in design.


Eligibility Criteria:
Inclusion Criteria:

* Patient treated with a Scheker total distal radioulnar joint prosthesis and with a follow-up time between 12 and 60 months after primary implantation
* Patient willing and able to give written informed consent to participate in the study

Exclusion criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* Pregnant women
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Technology-Based Breastfeeding Training After Cesarean

Aim: The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and breastfeeding self-efficacy.

Method: The research was designed as a prospective randomized controlled study. In total, 66 women were included in the study, with 31 in the control group and 35 in the intervention group. The intervention group watched a breastfeeding video with VR in the 4th and 24th hours after cesarean. Research data were collected with the sociodemographic information form, LATCH Breastfeeding Charting System and Documentation Tool and the Breastfeeding Self-Efficacy Scale. The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.


Eligibility Criteria:
Inclusion Criteria:

* The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.

Exclusion Criteria:

* Mothers who did not give birth by cesarean section, did not receive breastfeeding counseling during pregnancy, had visual or hearing impairment, or had any neurological disease were not included in the study.