cyrilzakka/clinical-trials huggingface dataset:
Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes

This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with higher daily doses and shorter total treatment time compared to standard fractionation) of the prostate bed with or without the pelvic lymph nodes.

While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.

A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance wil be used.

Eligibility Criteria:
Inclusion Criteria:

* resected prostate carcinoma with histological grading (Gleason Score)
* status post prostatectomy for a pT3 carcinoma and/or R1/2 resection or PSA recurrence after prostatectomy (2 consecutive PSA rises)
* PSA recurrence ≥ 1 ng/ml: CT/PET/MRI imaging excluding pathological lymph nodes
* Karnofksy performance score ≥ 70 %
* age 18 - 80 years
* only arm 2: antihormonal therapy for 2 months prior to radiotherapy and continuation of hormonal suppression after radiotherapy recommended
* written informed consent

Exclusion Criteria:

* patient's refusal
* patient's inabillity to give informed consent
* stage IV (distant metastases)
* lymph node involvement outside the pelvis
* severe wound complications after laparatomy
* only arm 2: severe lymphoedema of the legs, elephantiasis, postthrombotic syndrome
* decompensated pulmonary, cardiovascular, metabolic, hematopoetic, coagulatory or renal comorbidities
* known other malignant disease with distant metastases
* prior pelvic irradiation
* participation in another clinical trial that might compromise the results of the PRIAMOS trial or the other trial
Intraoral Scanning v.s Desktop Scanning

The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.

The use of intra oral scanners (IOS) for rehabilitation of completely edentulous patients is still limited due to the difficulty in scanning large edentulous areas that are smooth and devoid of features. The stitching process can be defective, especially in the palatal area, where, the outmost deviations were reported in the palate when digitizing edentulous jaws with intraoral scanners. The main challenges for a fully digitized complete denture workflow are the digital impression of mobile tissues with functional border molding and the digital registration of the jaw relationship.

Eligibility Criteria:
Inclusion Criteria:

* Patients with well-developed ridge
* Firm healthy mucosa
* Free from any signs of inflammation

Exclusion Criteria:

* Patients having flabby ridge
* Decreased flow of saliva
* Limited mouth opening
Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression

There is a general consensus of efficacy of TMS in treatment of major depression,yet results are not satisfying.A new coil ("H"-coil, recently invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper brain structures than conventional coils.TMS using this coil was named by its developers as "deep TMS" and will hence be refered to by this name.

So far, deep TMS have studied in Israel with promising sucssess in patients with Major depression (An on-going study).A safety study with good results have been recently published.The aim of this study is to reinforce initial results in major depression using deep TMS.

A group of 40 patients with major depression will be randomly assigned to deep TMS with H-1 coil in frequency of 20 HZ or H-2 coil in frequency of 0.1 HZ with 120% of motor threshold to the prefrontal cortex . No change in anti-depressant medication one month prior to study is a prerequisite.Deep TMS will be administered for 4 weeks.During TMS exposure subjects will be exposed to a conversation in which they talk about their depression and their ruminations.Patients will be evaluated using Hamilton Depression Rating Scale (HAM-D24),Hamilton Anxiety Rating Scale (HAM-A),Clinical Global Impression - Improvement(CGI-I) ,Beck Depression Inventory (BDI),Visual Analog Scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Right handed ,18-65 year old male or female subjects
* Diagnosed according to DSM-V-TR as suffering from Major depression using SCID interview
* Score of 22 or more in the Hamilton Depression Rating Scale (HAM-D24)
* The present depressive episode have been treated with at least 2 different anti-depressive drugs at peak doses for at least 6 weeks with not more than a partial response.Augmentation strategies may be included.

Exclusion Criteria:

Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort:

* History of current hypertension
* History of seizure or heat convulsion
* History of epilepsy or seizure in first degree relatives
* History of head injury
* History of any metal in the head (outside the mouth)
* Known history of any metallic particles in the eye
* Implanted cardiac pacemaker or any intra-cardiac lines
* Implanted neuro-stimulators
* Surgical clips or any medical pumps
* History of frequent or severe headaches
* History of migraine
* History of hearing loss
* Known history of cochlear implants
* History of drug abuse or alcoholism
* Pregnancy or not using a reliable method of birth control (non-pregnancy will be proved by beta-HCG test)
* Systemic and metabolic disorders
* Inadequate communication skills or under custodial care.
Effect of Oligofructose on Appetite in Overweight Subjects

This study seeks to look into the effects of oligofructose supplementation on appetite, energy intake, and body weight and body composition in overweight subjects. Compared to a placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby reduce food intake moderately leading to a decrease in body weight.

Appetite regulation plays an important part in energy balance. Suppressing appetite by manipulating the diet is a safe way of reducing energy intake and body weight compared to drug therapy and obesity surgery. How various nutrients affect appetite is not fully understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to differences in physio-chemical properties.

This project will look into how two different NDC affect appetite and energy intake in overweight individuals in a randomised, double-blinded, placebo controlled parallel study. The NDC under investigation are oligofructose and cellulose, both natural compounds of plant origin. The former is broken down (fermented) in the large bowel by friendly bacteria producing various compounds that may affect appetite and the metabolism of the host.

Volunteers will consume one of the two NDC for eight weeks (including a two week run-in period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be conducted before and after the supplementation with NDC (or during the supplementation in the case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite regulating centres will be investigated. Appetite questionnaires and dietary records will completed under free-living conditions at baseline and during the supplementation to explore the effect on subjective appetite feelings and energy intake, respectively.

It is hoped that this project will enhance the understanding of how NDC affect appetite and provide further information on how fermentation of NDC, gut hormone release, body composition, and appetite regulation are linked.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 20-50
* BMI 25-35 kg/m2
* Weight stable for three months prior to enrollment in study (weight change \< 3 kg over a period of three months)
* Habitual dietary fibre ≤ 25g/day (as assessed by 3-day dietary record)
* Non-smokers
* No current or history of endocrine disease, gastrointestinal disease, kidney or liver diseases, cardiovascular disease, pancreatitis, or cancer
* Hydrogen producers

Exclusion Criteria:

* Use of antibiotic less than three months prior to participation in the study
* Participation in other research studies in the previous three months
* Blood donation less than three months before participation in study
* Anaemia
* Hypertension
* Pregnancy or breastfeeding
* Substance abuse
* Vegan diet
* Regular use of prebiotic, probiotic or symbiotic food items/ supplements
* Intense exercise undertaken for more than 5h per week
* Metallic or electronic implants e.g. pacemaker, cochlear ear implants, fixed dental braces
* Claustrophobia
* Depression
The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial

Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis

Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3 per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic and radiographic knee OA

Exclusion Criteria:

* severe patella femoral knee pain that would make cycling difficult
* medical condition which would prohibit an exercise program
Baseline Cohort Malaria Morbidity Study

The BLOOMy study is a longitudinal prospective cohort study of healthy children to assess the incidence of clinical malaria over the main transmission season. Participants will undergo baseline clinical and biological assessments then will receive a curative dose of either artesunate or dihydroartemisinin-piperaquine to clear any existing parasitemia. Clearance of parasites will be confirmed 3 weeks later by Polymerase chain reaction (PCR) and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will be used to ensure that capture of a high proportion of infections in the cohort is achieved.

Blood samples for immunological assessments will be obtained at Day 0 of each positive blood smear episode before treatment and at Weeks 4 post treatment.

Participants will be followed for a minimum of six months throughout the malaria peak transmission season.

The BLOOMy study has two co-Primary objectives:

* To assess the incidence of clinical malaria meeting the primary case definition in children aged 1.5 to 12 years living in the study area over the main transmission season
* To assess the occurrence of reinfection following the radical cure of existing parasitemia.

The secondary objectives are:

* To assess the incidence of clinical malaria meeting various secondary cases definition in children aged 1.5 to 12 years living in the study area over the main transmission season
* To measure the immune responses (humoral and cell-mediated) to a panel of malaria vaccine candidate antigens
* To assess the molecular force of infection
* To pilot and standardize malaria morbidity assessment in three phase 2 malaria vaccine testing sites.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 1.5 to 12 years
* Residence in the study area or surroundings for the period of the study
* Written informed consent from parents/legally acceptable representatives and an assent for children

Exclusion Criteria:

* Complicated symptomatic malaria (defined according to standard World Health Organization criteria)
* Anaemia (Hb\<8g/dL),
* Any (chronic) illness that requires immediate clinical care.
* Family history of sudden death or of congenital or clinical conditions known to prolong QTcB or QTcF interval or e.g. family history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or severe cardiac disease
* Any treatment which can induce a lengthening of QT interval
* Known history of hypersensitivity or allergic reactions to piperaquine or other aminoquinolones
* Receipt of any blood transfusion or immunoglobulins within 3 months
* Known history of hypersensitivity or allergic reactions to artesunate
* Severe malnutrition (weight-for-height being below -3 standard deviation or less than 70% of median of the World Health Organization (WHO) normalized reference values).
* Weight below 5 kg
* Current or previous participation in malaria vaccine trials
* Current active participation in any trial involving administration of investigational drug.
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer

This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with treatment until disease progression. Patients received either FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) chemotherapy with bevacizumab. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. Patients were randomized to receive vismodegib or placebo and were stratified based on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid Tumors (RECIST) measurable disease was present at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologically confirmed metastatic colorectal cancer (CRC)
* Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior to entry of study
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematopoetic capacity
* Adequate hepatic function
* Adequate renal function
* Use of an effective method of barrier contraception (for women of childbearing potential)
* Signed informed consent

Exclusion Criteria:

* Prior chemotherapy for metastatic CRC or adjuvant chemotherapy for CRC within the prior 6 months
* Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
* Major surgical procedure within 4 weeks prior to the first day of treatment in this study (Day 1)
* Pelvic radiation within 2 weeks prior to Day 1
* Wound dehiscence requiring intervention, gastrointestinal perforation, or bowel obstruction
* Pregnancy or lactation
* Uncontrolled medical illnesses including the following: Infection requiring intravenous (IV) antibiotics, congestive heart failure not controlled with medication, hypertension not controlled with medication
* Thromboembolic disease
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies

The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). The technology will be based on bioinformatics (including molecular modelling) and artificial intelligence (including predictive, generative and optimization models). PROJECT TASKS are dedicated to the implementation of individual technological components (including the database necessary for their preparation) and to performing IN VITRO evaluation rounds to optimize the technology.

Integration, within an IN SILICO TECHNOLOGY, of processes which currently require huge amounts of in vitro laboratory experiments that are necessary for bringing new TCR-based cancer immunotherapies into clinical trials:

* finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
* testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
* optimization of pHLA:TCR binding affinity and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of advanced resectable colorectal cancer (Active stage II, III or IV)
* Histopathologically confirmed as adenocarcinoma
* Age 18 or over
* Being able to understand and sign the Informed Consent Form (ICF)
* Qualification for resection within 3 months from W0 or condition after primary tumor resection, not longer than 5 years from surgery

Exclusion Criteria:

* Mucinous colorectal adenocarcinoma
* Canal and anal edge cancer,
* Adenocarcinoma of the appendix,
* Patients treated with neoadjuvant therapy or radiation therapy in the 3 months prior to study enrollment.
* Patients treated with systemic chemotherapy in the 3 months prior to study enrollment.
* Histopathological diagnosis other than adenocarcinoma
* Remission
* History of inflammatory bowel diseases
* Pregnancy
* HIV infection
* Active infection with hepatitis B and C viruses
* Leukocytopenia
Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients

The aim of this study is to evaluate the use of the sagittal abdominal diameter (SAD) as a potential predictor of the skin to epidural space distance (SESD) and to compare its accuracy versus that of the BMI as a previously validated predictor

Adult patients from either sex with BMI from 30-39.9 kg/m², scheduled for lower abdominal operations or surgeries on the lower extremities under epidural anesthesia will be eligible. Pregnant women will be excluded.

The sagittal abdominal diameter (SAD), which is the anteroposterior diameter of the abdomen in the supine position at L4-5 level will be measured in all subjects along with the BMI prior to epidural placement.

The epidural space will be accessed at the L3-L4 or L4-L5 interspace with a 16-G or 18-G Tuohy needle using a loss of resistance to saline technique. The proper placement of the needle in the epidural space will be confirmed by connecting the hub of the epidural needle via a rigid extension tubing to a saline filled pressure transducer to demonstrate the characteristic epidural space pressure wave changes described by Arnuntasupakul and his colleagues (2016), which is a pulsatile waveform synchronized with arterial pulsations.

The distance from skin to epidural space will be marked on the needle with a sterile marker and will be recorded.

An epidural catheter will be passed into the epidural space and the epidural block will be activated in the usual way until adequate sensory and motor block is established in both lower extremities (Bromage score 3-4).

Successful placement of the epidural needle will be considered if the following two criteria are fulfilled: (1) Detection of the characteristic epidural pressure wave form as described above and (2) Establishment of adequate sensory and motor block.

Simple linear regression will be used to deduce an equation relating the skin to epidural space distance to the sagittal abdominal diameter or to the BMI.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* BMI 30 to 39.9
* Either sex
* Elective surgery on lower extremities performed under epidural anesthesia

Exclusion Criteria:

* Pregnant women
* Contraindications to epidural block
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.


Eligibility Criteria:
Inclusion Criteria:

* painful metastatic bone disease from any malignancy

Exclusion Criteria:

* previous RT to same area
* contraindications to RT
Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria.

The timeliness of routine childhood immunization should be an important component in measuring vaccination coverage rates especially in LMIC countries like Nigeria, yet this is overlooked. This study will determine the age- specific immunization timely uptake rates for the various vaccines covered in the routine childhood immunization and seek out factors that affect timely vaccine uptake among Nigerian children.

This study will determine the extent of timely and complete routine childhood vaccination uptake in Nigeria. The investigators will also seek to understand the factors that influence timely/complete uptake and make recommendations. this study will also determine if the present immunization records system in Nigeria is capable of measuring timely immunization uptake.

Eligibility Criteria:
Inclusion Criteria:

* Received all vaccines Available immunization records

Exclusion Criteria:

* Did not receive all vaccines Non- available immunization records
Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.

Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries, this effect achieved due to immune regulation and angiogenesis as well as the neuroprotective effect.

Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP.

This study is prospective, non randomized (open label) with control group.

Eligibility Criteria:
Inclusion Criteria:

- Confirmed diagnosis: Cerebral Palsy.

Exclusion Criteria:

* the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases;
* decompensation of chronic and endocrinological diseases;
* acute respiratory viral and bacterial infections, period less than 1 month after the acute phase.
* HIV infection, hepatitis B and C.
* oncological diseases, chemotherapy in the anamnesis;
* tuberculosis.