cyrilzakka/clinical-trials huggingface dataset:
Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors

This is a dose-finding study; therefore, there is no hypothesis testing


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are appropriate;
* Patients \>18 years of age;
* Good performance status;
* Adequate bone marrow and organ function

Exclusion Criteria:

* Previous treatment with any other compound that targets CD40
* Current or planned concurrent treatment with any anticancer agent;
* Patients who have received bone marrow transplant;
* History of autoimmune disorder
* History (within the previous year) of heart failure or heart attack
* Cancer-associated coagulation disorders
Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome

The question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered.

Bladder training includes as resources the educational program, lifestyle modifications, as a strategy to suppress urgency and as programmed urges to improve the control of urgency and incontinence; increase bladder capacity, and thus prolong the intervals between such as urination; giving the patient a confidence in the bladder control. Already, a justification for the use of TMAP is a contraction of the pelvic floor muscles (MAP) inhibits detrusor contraction, improving the symptoms of detrusor overactivity.

Eligibility Criteria:
Inclusion Criteria:

* Women with IUU and / or IUM with a predominance of urinary urgency, capable of contracting MAPs adequately, and who agree to participate in the study, signing the Informed Consent Form.

Exclusion Criteria:

* Women with a diagnosis of glaucoma, myasthenia gravis, urinary tract obstruction, neurological and chronic-degenerative diseases, decompensated diabetic patients and patients with complete denervation of the pelvic floor, pregnancy, abnormal genital bleeding, impairment of cognition, inability to fill in the diary voiding, genital dystopias beyond the vaginal introitus and urethral sphincter defect. Patients may not be in use or have used anticholinergics, tricyclic antidepressants or local hormone therapy within the six months prior to the study.
Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function

The aim of the present study is to determine the effect of non-nutritive sweeteners on intestinal barrier function and inflammatory markers in healthy subjects in comparison to mono- and disaccharides.

In the intervention study normal weight participants will receive beverages sweetened with non-nutritive sweeteners, mono- and disaccharides for a defined number of days. Before and after intervention parameters of intestinal barrier function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* No known history of metabolic diseases/disorders
* BMI \<25 kg/m2

Exclusion Criteria:

* Food allergies or intolerances (esp. fructose intolerance and malabsorption)
* Chronic disease of the gastrointestinal tract
* Renal insufficiency
* Taking drugs affecting lipid or glucose metabolism
Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control

The aim of this work was to:

1. Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns.
2. Determine the prevalence of congenital heart diseases or any cardiac abnormalities in infants born to diabetic mother in relation to the glycemic control of their mothers


Eligibility Criteria:
Inclusion Criteria:

* Infant of diabetic mother (IDM) (pregestational and gestational diabetes) born in Alexandria University Children 's Hospital (AUCH) whatever their weight or their gestational age

Exclusion Criteria:

* Neonates aged more 7 days.
* Patient born outside the tertiary center of Alexandria University Children 's Hospital.
Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy

The use of robotic rehabilitation, a treatment method for improving the motor functions of the upper extremities, is gradually increasing in children with cerebral palsy.

The aim of this study is to investigate the effect of robot-assisted rehabilitation for the upper extremity on upper extremity functions, manual skills and quality of life in patients with unilateral or bilateral/triplegic spastic cerebral palsy and also to compare the effect of robot-assisted upper extremity rehabilitation compared to traditional rehabilitation methods.

In this study, it was planned to include 42 patients diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy, aged 5-15 years, who were treated in the Pediatric Rehabilitation Service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and met the inclusion criteria.

Participants will be divided into two groups as study and control groups. In addition to the conventional rehabilitation program, the study group will be included in the robot-assisted upper extremity rehabilitation program, while the control group will be included in the conventional rehabilitation program only.

Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment. Assessments will be made before initiating treatment, at the end of treatment, and 3 months after initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy
* Be between the ages of 5-15
* Levels I, II and III according to the Manual Ability Classification System (MACS)
* Have sufficient cognitive level, such as the ability to understand and follow simple instructions, and to perform desired tasks
* The upper extremity dimensions are suitable for the robot
* Parents and patients aged ≥ 9 years have agreed to participate in the study

Exclusion Criteria:

* Injection of antispasticity drugs (eg Botox) into upper extremity muscles and/or upper extremity orthopedic surgery in the last 6 months
* Having musculoskeletal disorders and peripheral nervous system disorders that impair the ability to use the upper extremity robotic system
* Having severe muscle spasticity and/or contracture
* Having uncontrolled seizures and/or presence of visually induced seizures
* Having severe learning difficulties, behavioral problems, skin lesions, visual and/or hearing difficulties that may affect function and participation
Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis

Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years;
2. Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field;
3. EDSS score of 3-6 (including 3 and 6);
4. EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3；
5. Evidence of current disease activity;
6. If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ;
7. No evidence of hepatic inflammation or fibrosis;

Exclusion Criteria:

1. Patients with evidence of myelodysplasia or other non-autoimmune cytopenia;
2. Patients having received a cytotoxic agent within one month of enrolling in this study;
3. Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.);
4. Patients having received a cytotoxic agent within one month of enrolling in this study;
5. Patients with a malignant tumor currently or within the last 5 years;
6. Patients with cardiac, renal, pulmonary, hepatic or other organ impairment;
7. Patients whose life expectancy is severely limited by another conditions;
8. Pregnancy or risk of pregnancy;
9. Patients unable to give written informed consent in accordance with research ethics board guidelines.
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants

The primary purpose of Part A of this study is to compare, in a single dose and multiple doses the safety, tolerability, and pharmacokinetics (PK) profile administered in Japanese and Caucasian participants and of Part B of the study is to assess the food effect of a single dose of INS1007 administered in Japanese and Caucasian participants.


Eligibility Criteria:
Inclusion Criteria:

* For Japanese participants: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant must have all four grandparents born in Japan). Participants must have lived less than 10 years outside of Japan.
* For Caucasian participants: Participants must be of Caucasian descent, as evidenced by verbal confirmation that all four grandparents are Caucasian.
* Healthy, based on pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations) by the PI or designee.

Exclusion Criteria:

* Have clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the PI or designee.
* Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to Screening. Examples may include, but are not limited to, infections requiring intravenous (IV) antibiotics, hospitalization, or prolonged (\>14 day) anti-infective treatment.
* Have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or non-prescription drugs or food.
* Have a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antigen or antibody at the Screening Visit.
FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy

Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema.

To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine (\[18F\]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years or older
* Histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma
* Patients must have undergone surgery with macroscopic complete resection or incomplete resection with residual disease less than 5 cm on MRI
* An MRI or a scan 48h after surgery should be available
* WHO ≤ 2
* Indication for adjuvant radiotherapy
* Surgery must have been performed 45 days before the start of radiotherapy.
* Ability to understand and to give consent

Exclusion Criteria:

* Age \< 18 Years.
* Prior radiation therapy to the brain
* Any usual formal indication against MRI (claustrophobia, metallic objects or implanted medical devices in body: pacemaker, clips, prostheses ...)
* Allergic reaction to FET
* Pregnant women or nursing mothers
* Refusal to use effective contraception at study entry and throughout the study if patient is of childbearing age.
ICF in Takayasu Arteritis

The aim was to analyze the problem in patients with Takayasu Arteritis based on the International Classification of Functioning, Disability and Health.The sample of our study will consist of individuals between the ages of 18-65 who have been diagnosed with Takayasu Arteritis by rheumatologists and are followed by Pamukkale University Rheumatology Clinic.


Eligibility Criteria:
Inclusion Criteria:-Being between the ages of 18-65

* Volunteering to participate in the study
* Being diagnosed with Takayasu Arteritis by a rheumatologist

Exclusion Criteria:- Having another disease that affects your physical condition

* Having cognitive impairment that makes it difficult to cooperate
* Being pregnant
* Having a neurological disease
* Having had any surgery in the last year
* Having another concurrent rheumatic disease
Diaphragmatic Doming vs Breathing Exercises on Ventilatory Function & Core Endurance in Chronic Neck Pain

The purpose of the study is to investigate if there is any difference between effect of diaphragmatic doming versus breathing exercises on ventilatory function and core endurance in patients with chronic neck pain

Patients with chronic neck pain will be participated in this comparative study.

They will be divided into 2 groups:

Group (A) will be consisted of 30 patients who will receive conventional physiotherapy treatment for chronic neck pain plus breathing exercise (diaphragmatic and pursed lip breathing) (Three sessions per week for 6 weeks) Group (B) will be consisted of 30 patients who will receive conventional physiotherapy treatment for chronic neck pain plus Doming of the diaphragm (Three sessions per week for 6 weeks)

Pulmonary functions and neck endurance will be assessed for all patients in both groups before the first session and after the last session

Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic neck pain (for more than 3 months)
* Their age ranged from 20 to 30 years old
* Their body mass index ranged from (18.5 -29.9) kg/m2
* Poor results on the cranio-cervical flexion (CCF) test using a pressure biofeedback instrument.

Exclusion Criteria:

* History of respiratory disease and Clinical signs of a severe cardiac event.
* Severe psychiatric or cognitive impairment
* Tumor and Spinal fractures
* Spinal cord compression that required urgent surgery
* Current or past Smokers
* Obese (BMI \>30) or underweight (BMI ˂18.5)
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)

The objective of PERFECTO is to assess the reendothelialization at 3 months after successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES) by OFDI analysis. Designed as a multicentric, observational and prospective study which will be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Successfully CTO revascularization by PCI with immediate post-PCI OFDI analysis
* 3 months follow-up with OFDI analysis of the recanalized coronary artery
* Aged 18 or over
* Written informed consent

Exclusion Criteria:

* Contraindication or impossibility to realize a safety coronary OFDI (severe tortuosities)
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Pregnancy or women with child-bearing potential
* Bacteriemia or septicemia
* Severe hemodynamic instability
* Severe coagulation disorders
Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects

The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
Prospective Cohort for Early Detection of Liver Cancer

This study aims to recruit 3000 people with liver cirrhosis into a Prospective cohort for early detection of Liver cancer - the Pearl cohort. The study team believe that using a combination of novel tests may improve the detection of early Hepatocellular Carcinoma (HCC).

During a four-year follow-up period, around 100 Pearl patients are expected to be diagnosed with HCC. Blood, urine, clinical and imaging data will be collected over the follow up period. The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of all genders, age \>18 years
2. Participant is willing and able to give informed consent for participation in the study.
3. Evidence of cirrhosis CP A or B (as defined below, cirrhosis ever diagnosed), with an underlying aetiology of at least one of the following: chronic Hepatitis B Virus (HBV) infection, chronic Hepatitis C Virus (HCV) infection, alcoholic liver disease, non-alcoholic fatty liver disease or haemochromatosis

Cirrhosis Diagnosis Definition

1. Histological assessment (Ishak stage 5 or 6) or
2. At least one of the following:

i. Validated non-invasive marker of fibrosis including fibroscan, AST to Platelet Ratio Index (APRI) score \>2 or Enhanced Liver Fibrosis (ELF) score \>10.48 or Fibrotest score \>0.73. Fibroscan readings should be assessed by aetiology as below:

* HBV: \>=10 kPa
* HCV: \>=14.5 kPa
* Alcoholic Liver Disease (ALD): \>=19.5 kPa
* Non-alcoholic fatty liver disease (NAFLD): \>=15 kPa
* Haemochromatosis: \>=12kPa ii. Evidence of varices at endoscopy or imaging in the context of a patent portal vein iii. Definitive radiological evidence of cirrhosis (i.e. nodularity of liver and splenomegaly on Ultrasound/CT)

Exclusion Criteria:

1. Diagnosis of current OR historical hepatocellular carcinoma
2. Liver transplant recipients or patients on active listing for liver transplantation
3. Child-Pugh C cirrhosis
4. In the view of the clinician, if the patient has a co-morbidity likely to lead to death within the following 12 months
5. In the view of the clinician, if the patient was not thought to be suitable for HCC surveillance
The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain

Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular injection pain.The study was designed as a prospective, single-blind, crossover study. The study included 72 volunteer students attending Faculty of Health Sciences, Nursing Department.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18.5 to 29.9kg/m2
* Voluntariness

Exclusion Criteria:

* history of IM injection within 2 weeks
Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.

204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral involvement;
2. Signs and symptoms of degenerative pathology of the knee cartilage;
3. Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
4. Ability and consent of patients to actively participate in clinical follow-up;
5. Signature of informed consent

Exclusion Criteria:

1. Patients undergoing knee surgery within the previous 12 months;
2. Patients with malignant neoplasms;
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with hematologic diseases (coagulopathies);
6. Patients with metabolic disorders of the thyroid gland;
7. Patients abusing alcoholic beverages, drugs or medications
8. Body Mass Index \> 35