cyrilzakka/clinical-trials huggingface dataset:
Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity

The purpose of this study is to assess the effect of IV clonidine administration on lower limb spinal motoneuron excitability during standardized total intravenous anesthesia (propofol and remifentanil).

According to the literature data, intraoperative administration of clonidine reduces the need for morphine per and postoperative and thus reduces the side effects associated related to their administration.

Nevertheless, on the basis of current knowledge, clonidine may disrupt some electrophysiological measures required for the intraoperative monitoring of surgeries with a high risk of neurological complications.

For such surgery, anaesthesiologists are led to inject clonidine after surgery, at a time when the electrophysiological measures are no longer needed, which limits the benefit in terms of intraoperative morphine savings.

Whith this study, investigators would like to investigate if an early administration of clonidine in patients aged 6 to 16 years undergoing ear surgery disturbs excitability of the spinal motor neuron.

The choice of the study population is justified by the fact that the ear surgery does not require electrophysiological monitoring and it is carried out under conditions similar to that of anesthesia of scoliosis corrective surgery for which electrophysiological measurements are essential for the prevention of neurological complications.

Observations will allow investigators to determine therefore whether early administration of clonidine is possible at high risk of neurological complications surgeries for which electrophysiological monitoring is essential.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 6 to 18 years at time of hospital admission
2. Planned hospital admission for tympanoplasty
3. Informed Consent signed by both parents

Exclusion Criteria:

1. Known hypersensitivity to clonidine or to any component of the Catapressan
2. Patient treated with alpha2 agonists
3. Surgical emergency
4. Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
5. Abnormal heart rhythms
6. Neuromuscular disease
7. Renal impairment
8. Patient treated with methylphenidate
9. Pregnant or breastfeeding woman
Evaluation of Kidney Disease in Liver Transplant Recipients

A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates would be useful for monitoring of kidney damage. Particularly, the ability to predict irreversibility of such renal damage or progressive nature of renal disease in LT candidates would be of importance to determine the need for dual kidney-liver transplantation (KLT) versus LT alone. We will correlate kidney histology with cytokine/chemokine profile expression in the urine as a potentially useful noninvasive diagnostic tool.


Eligibility Criteria:
Inclusion Criteria:

* Subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes.

Exclusion Criteria:

* Contraindication to kidney biopsy
* Inability to give informed consent
Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia

To determine the effects of WB-EMS application on balance, pain, muscle strength, muscle endurance, flexibility, muscle shortening and quality of life in individuals with Lumbar Disc Hernia and compare it with individuals who have not received this training.

Lumbar disc hernia (LDH); It is one of the common spinal problems that occur in the form of low back pain and radiculopathy that spreads to the lower extremities. The prevalence of lumbar disc herniation reported in individuals with low back pain; It ranges from 0% to 47%. It has been reported that the highest prevalence of LDH is in adults between the ages of 30-50. Disc herniation at the L4-5 and L5 - S1 spinal levels is more common in adults over the age of 55. The most important complaint in LDH is pain, and patients often complain of a blunt pain in the lumbar region. Weakness in the muscles surrounding the vertebra can cause balance and walking problems. For Lumbar Disc Hernia, sedentary life, gender, high body mass index, occupation, smoking, psychosocial factors and people exposed to vibration for a long time are among the risk factors. Lack of time is reported to be the biggest obstacle to exercising. In addition, kinesiophobia, that is the fear of pain due to movement, is very common in this group. Physical activity and exercise are arguably the most comprehensive therapeutic agent for a long-term and fundamentally established society. There is a consensus on the review of the current literature that it positively affects the risk of exercise disease, but not all, risk factors, diseases, and disability between middle and advanced age. Whole Body Electromyostimulation (WB-EMS), a technology that addresses nine (main) muscle groups, may be a good option. Given the low training intensity of 1-2 sessions per week for 20 sessions, it may be of interest to people who are close to traditional exercise programs, with low volunteer intensity and a high degree of oversight and individualization of existing WB-EMS settings.

Eligibility Criteria:
Inclusion Criteria:

* Bulging or protruding disc herniation between L1-S1 levels diagnosed by the attending physician
* Without a neurological sign
* Not attending physiotherapy and rehabilitation session in the last 6 months
* No regular exercise habits
* No previous WB-EMS experience

Exclusion Criteria:

* Use of muscle relaxants
* Pain medication use
* Pacemaker
* Implants
* Having a history of cancer
Wound Healing Abnormalities in Major Abdominal Surgery

This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Male or female
* Informed consent
* Major abdominal surgery

Exclusion Criteria:

* Pre-existing coagulation abnormalities
* Pre-existing severe renal or liver failure
* Chemo- or radiochemotherapy
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.

Eligibility Criteria:
Inclusion Criteria:

1. Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
2. Chronic HCV infection.
3. Participants must be non-cirrhotic.
4. Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
5. Participants must meet specific human leukocyte antigen (HLA) allele requirements.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
5. History of solid organ transplant.
6. Screening laboratory analysis that shows abnormal results.
Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients

In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made based on clinical findings and physical examinations. Then, the cross-sectional areas of the participants' median nerves from different levels were measured. Meidolateral and anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated. The obtained data were compared between RA with CTS, RA without CTS and healthy control.


Eligibility Criteria:
Inclusion Criteria:

* RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria
* healthy controls (HC) with no history of rheumatic diseases and CTS.
* Individuals aged 18-65 years.

Exclusion Criteria:

* thoese with hypothyroidism,
* gout,
* diabetes mellitus,
* history of CTS surgery,
* upper extremity plexopathy,
* polinöropathy,
* uncontrollable fibromyalgia,
* steroid injection for CTS
* For the HC group, those with phalen or tinnel detected in at least one wrist and those with bifid median nerve detected during US evaluation were not included in the study.
Treatment Targets in Spanish and English Bilingual Speech Intervention

The goal of this clinical trial is to learn which speech treatment targets result in the greatest amount of speech learning in Spanish-English bilingual children with speech sound disorders. The main questions it aims to answer are:

* Does linguistic complexity of the treatment target increase the amount of generalized learning within the treated language?
* Does linguistic complexity of the treatment target increase the amount of generalized speech across languages?

Researchers will compare intervention effects across treatment provided in English and Spanish to see if the effect differs according to the language of intervention.

Participants will:

* Attend between 12 and 18 45-minute speech intervention sessions in Spanish or English for up to 6 weeks
* Attend assessment visits before and after intervention
* Attend follow-up assessment visits 1 month and 2 months after intervention

This study is a single-subject experimental design with staggered multiple baselines examining speech intervention for Spanish-English bilingual children with speech sound disorders. The study includes two arms based on the language of intervention (Spanish or English). Within each arm are two conditions that manipulate the linguistic complexity of the speech treatment target (simple consonant singleton or complex consonant cluster). Participants will be pseudo-randomly assigned to these arms and conditions.

The primary outcome is system-wide generalization; specifically, a) within-language and b) across-language generalization to untreated sounds. Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech probes in English and Spanish. The entire generalization probe is administered at each assessment visit (Pre, Post, and 1- and 2-Month Follow-Ups), and shorter subset probes targeting only monitored sounds are administered during Baselines and weekly during Treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be regularly exposed to English for at least 3 months in one of the following ways: a) an English-speaking caregiver or sibling who interacts with the child on a daily basis in English, b) attendance at an English-speaking daycare, preschool, or elementary school.
* Caregivers will have reported concern with their child's speech development and/or reduced intelligibility on the Intelligibility in Context Scale in Spanish or English.
* Participants will present with 5 or more consonants or clusters missing from their phonetic inventories in each language to confirm presence of a speech sound disorder and sufficient gaps in phonological knowledge to warrant treatment.

Exclusion Criteria:

* Participants receiving speech or language treatment elsewhere during their participation in this project.
Long-term Safety in Atrial Fibrillation Patients

The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).


Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
* completing treatment with study drug in D1250C00008.

Exclusion Criteria:

* Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
* Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment
* Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
* Conditions associated with increased risk of major bleeding.
Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry

GET PrEPD-Psychiatry is a mixed-methods, developmental study to adapt a shared decision making (SDM) intervention to be specific for psychiatry decisions (Aim 1, previously completed), evaluate its feasibility and acceptability (Aim 2), and examine potential mechanisms of change and preliminary outcomes (Aim 3) of this innovative intervention to increase SDM and self-management for adults with serious mental illness (SMI). In line with National Institute of Mental Health (NIMH) priorities, we are examining whether GET PrEPD-Psychiatry engages the target mechanisms that putatively underlie the intervention (i.e., patient activation and communication self-efficacy; Aim 3). Aim 1 used approximately 200 deidentified transcripts from our prior study of SDM in psychiatry to cull language used in decision-making. These conversations were then used to program the Virtual Provider to represent common interactions and decisions in psychiatric visits. Iterative testing of the use of the Virtual Provider has been completed and feedback was obtained from our psychiatry consultants to refine the program. For Aim 2, we will recruit up to 40 patients to participate in GET PrEPD-Psychiatry (4 weekly goal setting/coaching sessions, coupled with Virtual Provider training and practice). We will assess participant satisfaction and utility ratings, as well as track their use (frequency and time-on-task) of the Virtual Provider program. For Aim 3, we will follow enrolled patient participants, interviewing them at baseline and approximately 3 months later. We hypothesize that participants will have significantly 1) improved mechanisms of change, demonstrated by increases in self-reported activation and communication self-efficacy, 2) improved SDM, and 3) improved self-management and recovery attitudes. The Narrative Evaluation of Intervention Interview (NEII), completed at approximately 3 months, will be used as a qualitative interview guide to understand the acceptability and impact of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Current patient at the participating mental health center
* English speaking
* Willingness to participate in weekly coaching sessions, engage in practice with the Virtual Provider program

Exclusion Criteria:

* Under 18 years of age
* No reasonable access to use of internet on a computer
* Inability or unwillingness to use a computer (necessary for Virtual Provider Program practice)
* Never or rarely uses a computer or similar device (based on self-report)
* Very or somewhat uncomfortable using a computer or similar device (based on self-report)
A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma

This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375 mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle of treatment. The anticipated time on study treatment is up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years of age
* CD20+ low-grade (indolent) lymphoma of follicular and marginal zone type, small lymphocytic lymphoma without a B-CLL phenotype, or indolent lymphoma not otherwise specified
* Stage II (with bulky disease), III, or IV lymphoma
* No previous chemotherapy or a maximum of 6 months chlorambucil or cyclophosphamide
* Indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression \>6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or decreased hemoglobin or platelets due to lymphoma, general symptoms (weight loss, night sweats or fever)
* WHO performance status 0-2

Exclusion Criteria:

* Prior treatment with rituximab or an interferon
* B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or central nervous system lymphoma
* Indolent lymphoma transformed into aggressive lymphoma
* Indolent lymphoma with bulky tumor requiring urgent therapy
* Prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or curative surgery \>5 years ago
* Positive for HIV infection
* Uncontrolled asthma or allergy requiring corticosteroids
Characterization of Local Vascular Effects of LNMMA

Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human hand veins.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* any relevant disease
Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children

The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.


Eligibility Criteria:
Inclusion Criteria:

* Age group: 10-12 years old
* Presence of at least 20 dental elements
* Do not use orthodontic fixed appliances
* Simplified Oral Hygiene Index (S-OHI) is greater than 2
* Levels of Microbiological Streptococcus mutans in saliva high (\> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)
* Susceptibility to form biofilm and gingival inflammation
* Absence of systemic disease
* Not be under the use of antiseptic mouthwash in the last 3 months

Exclusion Criteria:

-
Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study

Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one.

Furthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.


Eligibility Criteria:
Inclusion criteria

* Patients undergoing adjuvant radiotherapy for breast cancer
* Able to understand and sign informed consent

Exclusion criteria

* Patients with inadequate linguistic abilities and inability to express informed consent
* Patients denying informed consent
* Patients receiving palliative treatments
* Patients affected by major psychiatric disorders
Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery

Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.

The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.

Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.

Group A:

Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)

Group B:

MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours.

Outcome measures: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection) within 30 days of the procedure (decrease 3% in the rate) Secondary measures: Anastomotic leaks, other surgical and non-surgical compliactions, hospital length of stay, readmission rate, patients' preparation tolerance, preparation regimens side-effects, time to beginning of adjuvant treatment for colorectal cancer.

Sample Size: It is estimated that 105 patients per treatment arm are needed.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled colorectal cancer surgery

Exclusion Criteria:

* Emergency surgery
* Obstructive and perforated cancer
* Intolerance to bowel preparation regimen
* Allergies to orally administered antibiotics