cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Dance Intervention for Children With Cerebral Palsy

Children with cerebral palsy (CP) have motor impairments that make it challenging for them to participate in standard physical activity (PA) programs. There is a need to evaluate adapted PA programs for this population. Dance can promote coordination, posture, muscle strength, motor learning, and executive functioning. This pilot study evaluated the feasibility and the effects of a new therapeutic ballet intervention specifically designed for children with CP on physiological and executive functions outcomes.

8 children with CP (9-14y/o; 75% female) participated in a six-week therapeutic ballet program. Participants had body composition (DXA), muscle strength (hand-grip dynamometer), habitual physical activity, gait and selective motor control functions, and executive function tasks before and after the intervention. Follow-up assessments of habitual physical activity, gait and executive functions were completed four to five week post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy spastic diplegia and/or hemiplegia
* Absence of health problems that would preclude participation in exercise
* Male or female age 9 - 15 years inclusive at the time of consent
* Minimum level of intellectual functioning (e.g., as determined by an IQ score of 80 or above or other education placement and testing indicating sufficient understanding)
* Ability to complete study measures at the assessment
* Ability to participate in dance classes conducted in English
* Interest in learning ballet
* Intact vision
* Intact hearing
* Able to ambulate independently in the community with or without a device
* Intact proprioception in lower extremities
* Able to complete assessment measures and consents in English
* Referral from the child's pediatrician or other physician indicating that the child is physically able to participate in an exercise intervention

Exclusion Criteria:

* Children with a current diagnosis of severe Major Depressive Disorder
* Generalized Anxiety Disorder
* Epilepsy
* Autism
* Other major medical conditions that prohibit full participation and children with severe developmental disorders (e.g., mental retardation, severe autism) or with physical impairments that prohibit full participation were excluded from the study.
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.

Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.

Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.

The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* All patients undergoing endoscopic treatment of pancreatic fluid collections

Exclusion Criteria:

* Age \< 18 years
* Patients who did not receive endoscopic treatment of pancreatic fluid collections
A Phase 1 Study of TT-00920 in Healthy Subjects

This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.

This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10 randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and a single dose on day 7. The study will consist of a Screening Period, an In-house Period and a Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained
* Age ≥ 18.0 years and ≤ 55.0 years, male or female
* BMI between 18.0 and 30.0 kg/m2, inclusive, and male weighs at least 50.0 kg and female weighs at least 45.0 kg

Exclusion Criteria:

* Known hypersensitivity or allergy to lactose
* Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
* Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
* Subject with a history of severe visual diseases; or visual changes
* Subject is unable to complete this study for other reasons
Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.

Eligibility Criteria:
Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must:

* Be able to give written informed consent.
* Males and females aged \>18 and \<75
* Have IBS as defined by the Rome IV criteria

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria:

* pregnant or having a follow-up of less than 6 months;
* unable to give informed consent;
* suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
* unable to undergo endoscopy.
Childhood Uveitis Initial Management and One-year Outcomes

The investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end of the first year.

The investigators therefore propose to run a high quality surveillance study, together with the British Ophthalmological Surveillance Unit (BOSU) at the Royal College of Ophthalmologists and with the Scottish Ophthalmological Surveillance Unit (SOSU). BOSU and SOSU operate a monthly reporting card scheme. All UK consultant ophthalmologists and associate specialists receive a monthly 'report card' with a list of conditions being surveyed. Reporting clinicians will tick a box if they have seen a case of childhood uveitis in the preceding month, and return the card to BOSU/SOSU, who will inform us, the study investigators.

Following reporting of a new case, the investigators will directly contact reporting clinicians and send them a clinical proforma to collect clinical details about the case. At 12 months, a follow up questionnaire will be sent. The investigators will use only information available from patient case notes, with no direct patient contact. The investigators principal aim is to determine incidence of childhood uveitis in the UK. Secondary aims are to identify presentation patterns, referral pathways, associated medical conditions, management, and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.

Exclusion Criteria:

* In England/Wales/Northern Ireland, children who are known to have pre existing juvenile idiopathic arthritis (joint inflammation) will be excluded. No exclusions will apply to the Scotland cohort.
Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

Following arthroscopic shoulder surgery a small but significant number of people suffer severe postoperative pain.

This study aims to predict which patients are at risk of developing severe post operative pain so that they may be targeted with a more aggressive post operative pain regimen.

Patients presenting for elective (day case) arthroscopic shoulder surgery for either Arthroscopic Subacromial Decompression (ASD Group) or Rotator Cuff Repair (RCR Group) are recruited. Using a Cefar PainMatcher, a pain and sensory threshold assessment tool, consenting patients will have their preoperative pain thresholds recorded. The patients will then have a standard anaesthetic administered with TIVA (propofol/remifentanil) and either a subacromial injection (ASD Group) or interscalene block (RCR Group). Four days following surgery a telephone questionnaire will be completed by the patients recording their worst pain score since surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)

Exclusion Criteria:

* Unable to give informed consent
* Allergy to remifentanil, propofol or levobupivacaine.
* Absence of contralateral arm (thumb/fingers)
* Documented sensory abnormality (e.g. peripheral neuropathy)
* Those not consenting to subacromial injection or interscalene block intraopertively (part of routine management after surgery).
* Psychiatric disease (documented history in Hospital notes or GP referral summary)
* Drug or alcohol misuse (suspicion of or documented)
* No telephone or unable to communicate in English (no interpreter service available)
Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue

This study adopted a randomized controlled design, 2-arm trial cross-over study. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-09). Patients were recruited from the hematology oncology department of Taichung Tzu Chi general hospital. After random assignment to 2 groups, patients in the RS and SR groups will receive real and shame laser acupuncture. Before laser acupuncture, one week later, we will evaluate the patient-reported cancer-related fatigue index and other co-morbid symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 to 85 years old
* Patients who signed the informed consent form
* Patients who have been given a diagnosis of cancer
* Able to communicate verbally and completely fill the questionnaires

Exclusion Criteria:

* Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires
A RCT Study of ERAS in Infants With Choledochal Cyst

Recently, with reference to the successful experience of accelerated rehabilitation surgery in the field of adult surgery, the investigators have conducted studies on ERAS in pediatric and even infant cholangiectasia surgery to discuss its feasibility and safety. The results showed that some items of ERAS could be safely applied in perioperative management of CBD, and could reduce traumatic stress and promote postoperative recovery. Therefore, the investigators assumed that the ERAS protocols could be safely applied in the treatment of CBD in children and even infants, reducing traumatic stress in children with CBD, promoting postoperative rehabilitation, reducing complications and hospitalization time, reducing hospitalization costs, and saving medical resources.

1. Optimize preoperative, intraoperative and postoperative perioperative management by learning from the successful experience of accelerated rehabilitation surgery model in other fields.

   For example: necessary and sufficient preoperative education of children and guardians; short fasting before surgery; oral carbohydrate at 2h before surgery; breast feeding at 4h before surgery (formula feeding at 6h before surgery); improved intestinal preparation; irregular placement of nasogastric tube; the use of general anesthesia plus epidural or sacral block anesthesia during surgery; attention to the whole process of heat preservation; strict control of infusion volume; and selection of minimally invasive hands Methods of operation; early postoperative activity, multi-mode analgesia, etc.
2. According to the pathophysiological characteristics of infants with cholangiectasia, several aspects were studied: minimally invasive surgery；promote gastrointestinal motor function recovery；develop principles and plans for early postoperative feeding；Rational placement of abdominal drainage tube; precise choice of anesthesia method, etc.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 0-12 months
* According to the clinical manifestations and preoperative imaging examination, the children admitted to hospital were diagnosed with choledochal cyst
* The legal guardian of the child signs the Informed Consent

Exclusion Criteria:

* Have potentially life-threatening diseases of various organ systems
* Preoperatively associated with other diseases that interfere with the treatment process of the child
* Caroli's disease was diagnosed
* Any other condition that the investigator deems unsuitable for participation in the trial
Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis

Neonatal septicemia remains one of the main causes of neonatal morbidity and mortality . Sepsis which is caused by a dysregulated host response to an infectious trigger leading to a life threatening organ dysfunction was declared by the World Health Organization (WHO) on May 2017 as a global health priority that requires resolution for its prevention , dignosis , and management (Monneret et al., 2019). Despite the advances in perinatal and neonatal sepsis remains high and the outcome is still sever (Chirio et al.,2011) .

HLA-DR is on the surface of monocyte \\ macrophages , dendritic cells, and B cells and plays a crucial role in adaptive immune response , More than 30 years ago , researches proved an association between the low level of HLA-DR and the development of sepsis (Cheadle at al .,1991) . A decreased expression of mHLA-DR molecules has been associated with immunoparalysis , which is an inflammatory immune responce that occurs in sepsis .(Pradhan et al.,2016).


Eligibility Criteria:
Inclusion Criteria:

* Neonates of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis , e.g., prolonged labor , premature rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and neonates with sepsis-related clinical signs: temperature instability, apnea , need for supplemental oxygen ,bradycardia , tachycardia , hypotension , hypoperfusion , feeding intolerance and abdominal distension ,

Exclusion Criteria:

* are the adminstration of antibiotic therapy prior to admission , birth asphyxia , laboratory finding suggestive of inborn error of metabolism , and congenital anomalies including congenital heart diseases .
Feasibility of Use of BariCare App in Pre-bariatric Surgery.

This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.


Eligibility Criteria:
Inclusion Criteria:

1. Patients, who upon completion of an evaluation by Endocrinology, are considered appropriate to pursue a primary, laparoscopic bariatric surgery.
2. Patients who are 18 years of age or greater.
3. Patients who own a smartphone.

Exclusion Criteria:

1. Patients with a history of a prior bariatric surgery.
2. Patients with active psychiatric disorder(s).
3. Patients with active tobacco use.
4. Patients with active substance use (alcohol, illicit drugs, etc.)
Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients

Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema

Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. Those patients who had glaucoma history or IOP above 21 mm of Hg, Phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-VEGF injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with center involving diabetic macular edema on optical coherence tomography

Exclusion Criteria:

* Raised intraocular pressure
* History of glaucoma
* Corneal opacity
* Vitreous hemorrhage
* Proliferative diabetic retinopathy
* Anti-VEGF injections in last 3 months
* History of pan-retinal photocoagulation
* Contraindications for anti-VEGF
Eniluracil Hand Foot Syndrome

A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).

Primary Objectives

1. To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
2. To assess any eniluracil dose response relationship in prevention of HFS.
3. To evaluate any potential toxicity of eniluracil ointment.

Eligibility Criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in this study ONLY if ALL of the following criteria apply:

1. Signed written informed consent.
2. Male or female, at least 18 years of age.
3. Histologically or cytologically confirmed diagnosis of breast or colon cancer.
4. Radiologically documented measurable disease
5. Planned to receive capecitabine at 1000-1250 mg/m2 PO twice daily and has experienced grade 1 or greater HFS on a previous cycle of capecitabine.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at study entry.
7. Adequate liver function with SGOT and SGPT \< 2.5 times upper limits of normal.
8. Adequate bone marrow function evidence by WBC \> 2500/mm3, PMN \>2000/mm3 and platelet count \> 100,000/mm3.
9. Adequate renal function with serum creatinine \< 1.7 mg/dl.
10. Recovery from relevant toxicity before study entry.
11. Negative serum or urine pregnancy test within 7 days before study entry for women of childbearing potential. Effective contraception throughout the course of the study for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:

1. Known DPD deficiency
2. Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
3. History of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for \>28 days.
4. Stroke, major surgery, or other major tissue injury within 30 days before study entry.
5. Myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ECG abnormalities.
6. No concurrent or planned use of topical pharmaceuticals to the hands or feet other than Aquaphor®.
7. No concurrent or planned use of cytotoxic drugs (other than capecitabine).
8. No other dermatologic condition that may complicate evaluation of the study.
9. Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic.
10. Breast feeding or lactating.
11. Unable to return at the regular required intervals for reassessment or study drug administration.
12. Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian.
13. Allergy to lanolin