cyrilzakka/clinical-trials huggingface dataset:
Therapist-dependent Dose of Spinal TENS

The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is not consensus regarding the effectiveness dose of TENS

Twenty healthy volunteers will divide into two groups: Therapist 1 and Therapist 2. Both therapist will apply spinal TENS and sham stimulation for 40min in random order to each subject, at an intensity to produce a "strong but comfortable sensation".

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 60 years old

Exclusion Criteria:

* Musculoskeletal pathology of the lower limbs
* History of neuromuscular disease
* Unable to tolerate electrical current
* Allergy to the electrode material
* Pacemaker or any implanted device
* Epilepsy
* Neurotrauma
* Recent surgical procedures
* Pain affecting the lower limbs or lower back
* Diabetes
* Pregnancy
* Cancer
Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases

The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0 to 30 years
* Written informed consent from patient and/or parents or guardian
* Patients with Karnofsky Index \> 60%
* Malignant disease:

  * acute lymphoblastic leukemia
  * acute myeloid leukemia
  * myelodysplastic syndrome
  * chronic myeloid leukemia according to the standard indications
  * solid tumors (e.g. neuroblastoma recurrence, soft-tissue sarcoma, Ewing's sarcoma, osteosarcoma, hepatoblastoma)

    . Non malignant disease:
  * acquired anemias (e.g. severe aplastic anemia, particularly severe Evans syndrome)
  * congenital anemias (e.g. thalassemia and sickle cell anemia)
* Women reliable contraception method when appropriate

Exclusion Criteria:

* Participation in other clinical trials
* Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
* Pregnant or nursing women
* Patients who underwent a stem cell transplantation in the last 250 days
* Patients with kidney, heart or liver insufficiency
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
* A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/ LAR of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
* History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
* Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrollment.
* Documented human immunodeficiency virus (HIV) positive subject.
* Any contraindications as stated in the Summary of Product Characteristics.
* Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce relapse in such cases. Patients will be randomized to receive the adjuvant combination therapy or no therapy. All patients will be monitored closely for signs of relapse and treated appropriately with conventional salvage therapy.


Eligibility Criteria:
Inclusion Criteria:

* Radical prostatectomy for prostate cancer within last 2 months.
* Post-operative Kattan nomogram predicts \>25% risk of PSA relapse by 5 years.
* 6-week post-operative serum PSA\<0.2ng/mL.
* Low levels of circulating prostate cancer cells in the blood, detected by PCR amplification of PSA mRNA 6 weeks post-prostatectomy.

Exclusion Criteria:

* Pre-operative serum PSA level \>20ng/ml.
* Clinical evidence of metastases by 6-week post-operative visit.
* Prior treatment with either ADT or bisphosphonate therapy.
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)

Other protocol defined inclusion / exclusion criteria may apply.
Osteoporosis Prevention With Low Dose Alendronate

The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.


Eligibility Criteria:
Inclusion Criteria:

* 45 to 60 year-old women
* Menopausal since at least 6 months
* Baseline lumbar BMD from -1 till -2.5

Exclusion Criteria:

* Bone disease other than osteopenia
* Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
* Former or current treatment with any bisphosphonate or bone forming agents
* Chronic use of oral or iv corticosteroids
* Any diagnosis of malignancy less than 12 months
The Prevelence of IVS 1-6 (T-C) [HBB:c.92 +6 T-C] Gene Mutation in Suspected Cases of β Thalassemia in Assiut University Hospitals

1. - To design an amplification-refractory mutation system (ARMS) for the DNA diagnosis of the IVS I-6 (T\>C) mutation.
2. - To detect the prevelence of the mutation among Assiut University Hospital patients.
3. - Phenotype/genotype correlation of the mutation.

• The β-thalassaemias result from 300 gene mutations ( https://globin.bx.psu.edu ).

All of the mutations are regionally specific and the spectrum of mutations has now been determined for most at-risk populations(Old JM, 2007).

* The strategy for identifying β-thalassaemia mutations is usually based on the knowledge of the common and rare mutations in the ethnic group of the individual being screened.(Old JM, 2007) .
* In Mediterranean it represnts 8-15%
* In Africa it represnts 3.5%
* In Egyptians it represnts 13.6% ( https://globin.bx.psu.edu ).
* The β globin gene mutation IVS I-6(T\>C) is the First most common β globin gene mutation among Egyptians
* (36.3%) according to ( Somaia El-Gawhary et al 2007 )
* (27.66%) ( Ammar D. Elmezayen et al 2015 )
* and the second most common mutation
* (40%) according to ( El-shanshory M et al 2014)
* (21.25%) ( Elhalfawy et al 2017) The molecular characterization of the globin gene mutation is necessary for definite diagnosis, genetic counseling, and to offer prenatal diagnosis. The amplification-refractory mutation system (ARMS) is a simple method for detecting any mutation involving single base changes or small deletions.
* the DNA is analysed after amplification by PCR for Detection of point mutation IVS I-6(T\>C) by Using primer pairs that only amplify individual alleles \[ARMS\] .

Eligibility Criteria:
Inclusion Criteria:

* : β thalassemia (suspected \& clinically diagnosed cases).

Exclusion Criteria:

* : Iron deficiency anaemia, anaemia of chronic disease, types of haemolytic anaemias other than thalassemia, other types of thalassemia and Hb variants
Ventilatory Weaning Guided by a New Index

Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value.

Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value. Our study aimed to evaluate the performance of a new ventilatory weaning index, the timed inspiratory effort index (TIE index), as a weaning predictor in comparison with the traditionally used spontaneous breathing test (SBT). The study is a randomized controlled trial of a cohort of mechanically ventilated patients over 24 hours admitted to the ICU of Hospital e Clínica São Gonçalo (HCSG), located in the city of São Gonçalo, State of Rio de Janeiro, Brazil. The TIE index is calculated as the ratio of the maximum inspiratory pressure developed in the last 30 seconds of a 60 second period of unidirectional airway occlusion by the time required to reach this value.

Eligibility Criteria:
Inclusion and exclusion criteria

Our study included patients over 18 years old, under mechanical ventilation, who remained for more than 24 hours of invasive ventilatory assistance and who were able to start the process of weaning. Exclusion criteria comprised tracheostomy, chronic neurological disorders, low level of alertness, and chronic immune suppression states, including positive serology for HIV.
The Application of Neck Ultrasound in the Assessment of Peripherally Inserted Central Catheter (PICC) Tip Position

Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip malposition. This study was designed to evaluate whether the addition of ultrasound (US) inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant position facilitating catheter reposition prior to completion of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years old) ordered for a peripherally inserted central catheter insertion

Exclusion Criteria:

* patients unable to provide informed consent
* previous peripheral inserted central catheter placement at the institution
Project on TDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals

This project aims to explore key brain functional and biochemical indicators associated with impaired advanced social cognition through an integrated approach encompassing unconscious control, conscious control, cognitive flexibility, problem-solving, and social interaction domains. By incorporating multimodal measures spanning physiological, neural, cognitive, psychological, and behavioral dimensions, we will develop a comprehensive intervention protocol combining course-based brain stimulation and cognitive training. The study will employ a multi-timepoint, multi-level assessment framework to track the enhancement of higher cognitive functions and brain functional recovery in individuals undergoing drug rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* age between 30 and 60 years;
* fulfilling the diagnostic criteria for severe substance use disorder as specified in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders.
* a history of heroin use exceeding ten years, with a daily average intake of at least 0.1 grams.
* abstinence duration of eight months or less, with a positive result of a urine test before entering the rehabilitation center.
* no history of neuromodulation treatments such as tDCS within the past six months.

Exclusion Criteria:

* a history of alcohol dependence, neurological disorders, or other complex psychiatric conditions.
* the presence of intracranial metallic implants or elevated intracranial pressure.
* a history of epilepsy or recent electroencephalogram evidence of epileptiform activity.
* the use of implanted electronic devices, such as pacemakers;.
* scalp hyperalgesia or a tendency toward bleeding.
* severe cardiac conditions.
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)

This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol and nicotine dependence.
* Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
* Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
* Motivated to quit smoking.
* Willing and able to participate in the 12 week outpatient treatment.
* Acceptable health.
* Able to provide a collateral informant.
* Willing to be followed for 6 months after treatment ends.
* Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.

Exclusion Criteria:

* Current diagnosis of dependence on other substances except nicotine and alcohol.
* Having moderately severe or severe alcohol withdrawal symptoms.
* Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
* History of opioid abuse.
* Recent use of cocaine.
* Not desiring to quit smoking.
* Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.
* History of psychosis.
* Current suicidality, homicidally or psychiatric symptoms requiring other medications.
* Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.
* Current treatment with psychotropic medications.
* Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.
Trends of Cancer Incidence and Mortality in Russia

The study aims to assess the dynamics of incidence and mortality for all major groups of cancers for which the national data is available for the longest possible time series. The data obtained from publicly available sources are used.


Eligibility Criteria:
Non applicable
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.

72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation.

Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period.

The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator.

The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.

Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have an ileostomy or colostomy
* Have had their ostomy for at least 3 months
* Must use 1 piece open or closed ostomy products during the test period
* Currently using a 1 piece. flat product
* Must be able to use custom cut product
* Have intact peristomal skin
* Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
* Are evaluated to be suitable for a soft convex product

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Participating in other interventional clinical investigations or have previously participated in this investigation
The Impact of Parent Training on the Child's Health Services

The purpose of the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program.

Pediatric health services utilization (pHSU) by children with mental health conditions demonstrated dramatic increases between 2006 and 2011. These national trends reflecting large increases in pHSU for mental health conditions were seen across multiple developmental levels. Health services costs for children with mental health conditions are estimated to be twice those for the average child. The Incredible Years® Parent Program (IY) has a strong evidence-base supporting its effectiveness in reducing early onset conduct problems. The overall objective of this stage 3 (T3) translational research proposal is to conduct a pilot study of 45 pediatrician-referred parents who participate in IY and examine the impact of IY on pHSU of their children. Pediatric HSU outcome measures include: all-cause ED visits; in-patient hospitalizations and length of stay; authorizations for specialist referrals; primary and acute care visits; and ED visits for mental health conditions. The investigator's central hypothesis is that children ages 3 to 6 years with behavior concerns whose parents are referred by their pediatricians for participation in IY will have decreased mean annual all-cause pHSU and decreased ED visits for mental health conditions in the 12 months following IY, compared to the 24 months prior to IY participation. This is important to demonstrate because significant financial barriers exist to integrating effective family focused prevention services like IY into pediatric primary care settings. Demonstration of reduced pHSU is one way to address these translational barriers. Results of this pilot study are expected to provide preliminary data on pre- and post-intervention effect sizes; these data will be used to demonstrate the feasibility of collecting data using existing sources of pHSU to design a more fully powered multi-site trial with a robust comparator group.

Eligibility Criteria:
Inclusion Criteria:

* Children receiving primary care at CHLA AltaMed with parent-reported behavioral concerns whose parents are referred by their pediatricians for participation in the Incredible Years Parenting Program.
* Continuous enrollment in AltaMed Medicaid funded health services during the 24 months prior to participation in IY and 12 months following participation in IY with lapses in coverage of no more than 90 days in length.
* Parents are English or Spanish-speaking or willing to use interpretation if they speak another language.

Exclusion Criteria:

* Private (commercial non-Medicaid) insurance coverage for greater than 90 days during the 24 months prior to participation in IY and 12 months following participation in IY.