cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS) showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. However, TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.

Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected responses and frequent relapses. The corner-stones in treatment of FNRFI are education, positive motivation, and toilet training. Preparation of children and their parents for a long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal is to have regular bowel movements and normal continence and this can be achieved by teaching the child the importance of regular toilet use and avoid urges.

Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI. However, there are sufficient studies evaluating the long term effect of TPNS and this has motivated the authors to conduct of this study The aim of this study is to evaluate the Long term outcome and quality of life in children with Functional non-retentive fecal incontinence and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from (6-14 years) with FNRFI with normal bowel habits
* Children with normal defecation frequency and normal stool consistency
* Children with incontinence score ranging from 8-22 according to Vaizey score

Exclusion Criteria:

* Children who have traumatic sphincter injury.
* Children who have Fecal impaction
* Children who have Spinal diseases causing incontinence
* Children who have Anorectal malformation
* Children who were not cooperative
Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure

This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.

A randomized, placebo-controlled, double-blind study of HemaMax to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single 12 μg subcutaneous dose of HemaMax on 60 healthy subjects for 28 days after HemaMax administration.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects, who have signed the informed consent form must meet all of the following criteria

  1. 18 to 45 years of age
  2. Body mass index (BMI) \> 19 and \< 0 kg/m2
  3. Normal ECG, vital signs and laboratory test results
  4. Use of effective birth control method and abstinence from sex
  5. Negative pregnancy test and drug screen

Exclusion Criteria:

* Subjects with any of the following characteristics will be considered ineligible:

  1. History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
  2. Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
  3. Current drug or alcohol addiction
  4. History of clinically significant allergy of any kind
  5. Prior use of IL-12 or HemaMax
  6. Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months
A Prospective Study of Factors Related to Exacerbation and Mortality of Non-cystic Fibrosis Bronchiectasis in Hong Kong

Bronchiectasis is associated with repeated exacerbations which occurs at rates of 1.5-6.5 per patients per year, and are associated with an increased risk of admission and readmission to hospital, and high health care costs. In a local study carried out more than 10 years ago, idiopathic disease dominates and patients with bronchiectasis are mainly female with high hospitalization and mortality rates; 21.9 cases per 100,000 and 2.7 cases per 100,000 respectively. Moreover, exacerbation characterized by increases in symptoms requiring antibiotic treatment is associated with disease progression and significant mortality. Updated prevalence of this disease with the characteristics of etiology, clinical presentation and outcomes are needed to guide further management plan.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older
2. Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy)
3. Diagnosis of bronchiectasis defined by high-resolution computed tomography scan

Exclusion Criteria:

1. History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis
2. Those who are unable to give consent
Cross-sectional Survey of Zhejiang ECMO Application

Extracorporeal lung oxygenation (ECMO) was first used in neonates in the 1970s and is now widely used to treat adult patients with intractable shock and respiratory failure who have failed various types of conventional life support. According to the Extracorporeal Life Support Organization (ELSO), a total of 61,193 adult patients worldwide received ECMO in 2019. According to the Extracorporeal Life Support Organization (ELSO), a total of 61,193 adult patients were treated with ECMO worldwide in 2019, including 25,631 VV-ECOM, 12,836 VA, and 5086 ECPR. The number of ECMO cases and hospitals in Zhejiang province are increasing year by year, and they play an irreplaceable role in various critical care resuscitation, especially in response to public emergencies, but there is a lack of precise data on the current status of ECMO implementation. This study aims to investigate the implementation of ECMO, problems and needs of hospitals at all levels in Zhejiang Province, and provide reference for further improving the capacity and quality of ECMO application in the province.

This is a multicenter cross-sectional survey study ,was conducted jointly by the Zhejiang Emergency Medicine Quality Control Center, the Zhejiang Medical Emergency Medicine Branch and the Zhejiang Physicians Association Emergency Physicians Branch. The survey covers the general situation and ECMO implementation in general public hospitals at the county and district level in Zhejiang Province, including people's hospitals, Chinese medicine hospitals and above.

Eligibility Criteria:
Inclusion Criteria:

* All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province

Exclusion Criteria:

* Hospitals that explicitly do not wish to participate
Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD

Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (ADHD).

The investigators administered a randomized controlled trial (RCT) through random assignment of ADHD subjects in to three different groups to compare the effects of CACR, immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* age between 7 and 12
* IQ \> 85

Exclusion Criteria:

* sever co-morbid disorder
* seizure
* IQ \< 85
* disability
* sever medical condition
Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS)

Paraneoplastic neurological syndromes (PNS) are immune-mediated complications of cancer that can affect any part of the central or peripheral nervous system.

PNS occurs at the intersection between immune system and the tumor, where a combination of genetical and environmental factors may play a role.

Mechanisms leading to immune tolerance breakdown and autoimmunity in PNS remain largely unknown, and this reflects in an unsatisfactory repertoire of treatments available. Moreover, a better understanding of the biological mechanisms underlying PNS would allow a more precise identification of the modalities that permit PNS patients to have a better oncological prognosis than cancer patient without PNS, with obvious repercussions in clinical oncology.

To this effect, an extremely innovative approach involves directly exploring the tumoral tissue of patients suffering from specific PNS via genomic and transcriptomic analysis.

The study team hypothesizes that antigen ectopic expression by tumour cells may contribute to the generation of PNS.

In the present study, the investigators will analyze the salient features of tumors associated with PNS, namely the histological and immune cells infiltrate characteristics, their transcriptomic profile, and mutational status of involved antigens.


Eligibility Criteria:
Inclusion Criteria:

* presence of well characterized antibodies in serum or cerebrospinal fluid;
* histologically proven cancer with available tumour sample;
* Paraneoplastic neurological syndrome (PNS) diagnosis according to the international guidelines;
* Age: at least 18 years old.

Exclusion Criteria:

* Absence of complete clinicopathological data
Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes

The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy (MST) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.

The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC.

The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of \>8% and an average HbA1c of \>8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* insulin dependent Type 1 or Type 2 diabetes
* diagnosed with diabetes ≥ 1 year
* current HbA1c ≥ 8%
* average HbA1c ≥ 8% over the past year
* aged 10 -17
* patient of Children's Hospital of Michigan Diabetes Clinic
* lives within 30 miles of Children's Hospital of Michigan

Exclusion Criteria:

* moderate to severe mental retardation (unable to complete study measures)
* psychosis or current suicidal intent
* any medical diagnosis that alters standard diabetes care
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty

The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (TJA). Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and analyze the cost benefit of each.


Eligibility Criteria:
Inclusion Criteria:

* Those identified at pre-operative testing to have an elevated BMI (\> 35)

Exclusion Criteria:

* Active infection
* previous scar or wound healing complication
* post traumatic degenerative joint disease (DJD) with hardware
* revision surgery
* inflammatory arthritis
* anticoagulation outside of the standard of care.
Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy

The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Abdominal hysterectomy
* ASA class I or II

Exclusion Criteria:

* psychiatric disorders
* ASA III and IV
* Chronic inflammatory disorders
* Pregnancy
* Local anesthetics allergy
* Coagulation disorders
* patients receiving anticoagulants
Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study

Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain.

The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.

The use of methylxanthines as therapy for apnea of prematurity may be a double-edged sword. Although widely-used, and efficacious for treatment of apnea of prematurity, long-term drug effects have not been rigorously studied. Neonatal methylxanthine therapy may have long-term impacts on sleep organization and ventilatory control. The CAP trial, funded by the Canadian Institutes of Health Research, was initiated due to the paucity of well-controlled data on the long-term effects of methylxanthines in preterm infants. The initial CAP trial was a multicenter, randomized, placebo-controlled trial of caffeine vs placebo as treatment for apnea of prematurity with follow-up to a corrected age of 18 months. 2,006 infants were enrolled. The CAP trial found that methylxanthines reduced the rates of bronchopulmonary dysplasia (BPD) and cerebral palsy (CP), and did not affect mortality. However, concerns remain regarding long-term sequelae of methylxanthine use. The Canadian Institutes of Health Research have therefore funded further follow-up of the entire CAP trial cohort to age 5 years, corrected for prematurity. The key objectives of this study are to examine the impact of methylxanthines on neurocognition and behavior. This ongoing parent study provides an opportunity to determine potential long-term effects of methylxanthines on sleep disorders, and to correlate these findings with daytime functioning. Our overall hypothesis is that methylxanthine use in preterm infants, while beneficial in the short term, results in longstanding abnormalities in the regulation of sleep, and breathing during sleep.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 5-7 years who are enrolled in the CAP trial.
* Parental/guardian permission (informed consent) and if appropriate, child assent.
Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants

The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.

All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for a standard total knee replacement
* Patient who are scheduled for patient-specific total knee replacement (iTotal)
* Patient age \> 18 years

Exclusion Criteria:

* Patients who do not receive a total knee replacement
* Unwilling or unable to comply with study requirements
Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

The aim of the study is to investigate postoperative pain relief for patients undergoing surgical treatment of proximal femoral fracture using intrathecal administration of morphine.

In this study, the investigators will compare the efficiency of intrathecal morphine administration with the standard of care (parenteral application of analgesics) for pain relief in patients after proximal femoral fracture surgery. The secondary outcome measure will be to determine the frequency of adverse effects of intrathecally administered morphine. The study will be monocentric, randomized, and single-blinded. A total of 50 patients are expected to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* 60 to 90 years of age
* surgical treatment of proximal femur fracture
* The American Society of Anesthesiologists (ASA) classification I to III
* spinal anesthesia used for the operation

Exclusion Criteria:

* general anesthesia used for the operation
* allergy to opioids
* high risk of respiratory depression
PAPSY - Memory in Psychiatry

Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales).

The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis
* Age\>=45
* Permanent residency in the geographical area of the Czech Republic

Exclusion Criteria:

* Diagnosis of mental retardation (F70-F79) according to ICD-10
* Refusal to sign the informed consent and consent with GDPR
* Uncorrected visual impairment
* Uncorrected auditory impairment
* Inability to participate in the project
Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19

180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours.

At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Negative PCR testing through throat swabs
* Signing Conscious Consent

Exclusion Criteria:

* History of ocular complications and visual disturbances
* Sensitivity to plant compounds in the product
Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus

systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations.

Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria.

SLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti_double stranded DNA (dsDNA) antibodies.

Anti_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis.

So the aim of the work is to determine the relationship between Anti_KU antibodies and SLE manifestations.


Eligibility Criteria:
Inclusion Criteria:

* all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.

Exclusion Criteria:

* any patient with any collagen disease other than SLE