cyrilzakka/clinical-trials huggingface dataset:
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.

Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods for non-focused cognitive remediation are available to the pediatric field. The aims of this feasibility trial are the description, implementation, and test of an intensive program specific to the training and re-adaptation of memory function in children (IM-FTP). Method: Eleven children and adolescents with ABI (mean age at injury=12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient received a psychometric evaluation and a brain functional MRI at enrollment and at discharge. Ten pediatric controls with ABI (mean age at injury=13.8 years) were clinically assessed, and rehabilitated through a standard program.


Eligibility Criteria:
Inclusion Criteria:

* i) age at first assessment between 6 and 18 years;
* ii) time between injury and first assessment \<3 months;
* iii) documented evidence of a severe ABI of traumatic or non-traumatic (i.e. anoxic, vascular or infectious) etiology, as indicated by a Glasgow Coma Scale (GCS, \[26\]), score ≤8 at insult;
* iv) presence of severe memory impairment, as assessed at first evaluation;
* v) sufficient attentive skills for attending a simple task and understanding simple commands/directions, and sufficient verbal comprehension for executing simple procedures/exercises;
* vi) absence of congenital pathology or disability previous to the injury;
* vii) medical records sufficiently detailed to determine the injury severity and neurological findings;
* viii) absence of severe motor or sensitive deficits.

Exclusion Criteria:

* none
Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

The main objective of this study was to determine if the dural puncture epidural (DPE) anesthesia provides superior analgesia and better patient satisfaction when compared to traditional spinal anesthesia for rigid cystoscopy.

Most urologic surgeries are performed in a narrow and limited space with the minimally invasive technique or cystoscope, and most patients undergoing urologic surgeries are elderly individuals with other diseases.

Cystoscopic evaluation of the lower urinary tract is a vital part of an office-based urologic practice. However, regular surveillance cystoscopy is a significant source of morbidity for patients, and therefore attempts have been made to minimize discomfort secondary to this procedure.

Spinal anesthesia is popular for endoscopic urological surgery because of early recognition of symptoms caused by overhydration, transurethral resection of prostate (TURP) syndrome and bladder perforation.

The dural puncture epidural (DPE) technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural (EPL) technique without the side effects observed with the CSE technique.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Both sex.
* American Society of Anesthesiology (ASA) physical status I, II, III.
* Admitted for elective rigid cystoscopy.

Exclusion Criteria:

* Refusal of patients.
* Body Mass Index (BMI) \> 35.
* Patients who have history of substance abuse.
* Patients with difficult communication.
* Contraindication to neuraxial anesthesia (e.g.; infection near the site of injection, coagulopathy or bleeding disorder).
* Patients with history of allergy to local anesthetics.
Exactech Shoulder Post Market Clinical Follow-up Study

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
* Patient is skeletelly mature
* Patient is expected to survive at least 2 years beyond surgery
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Medial humeral bone loss resulting in compromised humeral stem fixation
* Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
* Neuromuscular disorders that do not allow control of the joint
* Significant injury to the brachial plexus
* Non-functional deltoid muscles
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient is contraindicated for the surgery
* Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)
* Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)
* Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)
* Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)
SpineTRACK Registry - Spinal Outcomes Registry

The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies. As an observational database, there are no initial driving hypotheses, but rather data will be mined to answer unforeseen questions, but which may include broad topics such as comparative effectiveness between and among various surgical treatment options, and/or outcomes in various subgroups of patients such as defined by demographics, comorbidities, indications and symptoms, treatment variables, and/or outcome variables.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for spinal surgery
Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions:

1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
3. What are each treatment approach's financial costs?

Researchers will compare the following to groups:

Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation.

and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy.

Participants are going to:

1. Get the usual chemotherapy (taxanes and/or anthracyclines).
2. Receive radiation therapy for three to four weeks.
3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed invasive breast cancer
2. Stage IIB-III invasive breast cancer (AJCC 8th edition)
3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
4. Patients fit to receive adjuvant chemotherapy and radiotherapy
5. Age \> 18 years

Exclusion Criteria:

1. Hypersensitivity to taxanes
2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
3. Unable or unwilling for regular follow up
4. Bilateral tumour needed RT to both sides
5. Patients planned for RT to oligometastatic sites
6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints).
7. Pregnant patient
Washed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis

This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following inclusion criteria to enter the study:

  1. Clinically diagnosed with gastroptosis;
  2. Meets the diagnostic criteria for malnutrition (fulfilling any one of the following two criteria):

     * Weight loss (weight loss \>5% within the last 6 months or \>10% over more than 6 months);

       * Low BMI (BMI \<18.5 kg/m² for individuals \<70 years old; BMI \<20 kg/m² for individuals ≥70 years old);
  3. Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years;
  4. Willing to voluntarily sign a written informed consent form and agrees to follow medical advice for regular follow-up examinations and monitoring after the completion of treatment.

Exclusion Criteria:

* Subjects meeting any of the following exclusion criteria must be excluded from the study:

  1. Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning;
  2. Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition;
  3. Anticipated survival time \<3 months;
  4. Clinically significant cardiovascular diseases, including heart failure (NYHA Class III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, history of myocardial infarction, hemodynamic instability at enrollment, unstable vital signs, or anticipated risk events during treatment;
  5. Poor pulmonary function deemed by investigators to impact study treatment (e.g., acute exacerbation of COPD or requirement for long-term oral/intravenous corticosteroids \[excluding inhaled corticosteroids\]);
  6. Active severe clinical infections (\> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections;
  7. Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement;
  8. Use of medications affecting or modulating gut microbiota within the past 48 hours;
  9. Lack of legal capacity or restricted legal capacity;
  10. Hematologic disorders unsuitable for blood draw examinations;
  11. Other severe medical conditions deemed by investigators to preclude patient enrollment.
Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped

Brief summary: In order to get a better clinical plan for brain protection during perioperative anesthesia for high-risk patients - carotid intima stripped. We observing the hemodynamic changes of sevoflurane post-treatment in carotid intima stripped, the comparison of postoperative cognitive function and postoperative radiographic changes.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists（ASA）：II-III
* Aged between 40 and 80 years
* Patients scheduled for surgery of Carotid stenosis under general anaesthesia

Exclusion Criteria:

* Has a history of mental illness can't cooperate,
* Serious heart block or cardiac decompensation or severe sinus slow (HR \< 50 times/min),
* The abnormal nerve monitoring in operation, MMES preoperative score \< 20 points,
* Any rescue unexpected occurred during the operation
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent

The objectives of this trial are:

1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers
2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.

The first in human study is intended to evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects
2. Healthy subjects aged 18 to 55 years inclusive
3. Suitable veins for phlebotomy, cannulation, or repeated venipuncture
4. Have a body mass index between 18 and 32 kg/m\^2 (inclusive); weigh at least 55 kg.
5. Appropriately completed written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening
2. Vital sign abnormalities at screening or admission
3. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator
4. Positive pregnancy test at screening or admission
5. History of alcohol abuse
6. History of drug abuse
7. Use of nicotine-containing products within 12 months of study start
8. Use of medication except topical products without significant systemic absorption
9. Known allergies to any component of RVP-001
10. Subjects who have received any investigational product (IP) in a clinical research study within 5 IP half-lives or 30 days prior to first dose.
11. Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.
12. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
Voiding Class Study for Symptom Reduction and Quality of Life in Children With LUTS

Lower urinary tract dysfunction (LUTD) is a common pathology within children and shows a wide spectrum of lower urinary tract symptoms (LUTS). These symptoms have a significant impact on a child's well-being. For the treatment of LUTS in children urotherapy, a non-medicamentous form of therapy, is implemented as standard therapy. It can be described as a bladder re-education and rehabilitation programme where the participants are informed on the anatomy and physiology of the normal and pathological urinary system. Urotherapy has been offered as individual therapy for a long time but is now also offered as group therapy (the voiding school). This is, as compared to the individual therapy, more cost-effective and gives the participants the feeling not to be alone in the situation. The effectiveness of the individual therapy for children with LUTD has already been determined, however little research has been done on the effectiveness of urotherapy in group (the voiding class). The present study wants to investigate the effect of the group therapy on the symptoms and quality of life of children with LUTD.

The current study is a prospective cohort-study in which information of the impact of the voiding class on the symptoms and well-being of the children is obtained through two questionnaires, respectively the Vancouver Symptom Score for Dysfunctional Elimination Syndrome (VSSDES) and the Paediatric Incontinence Questionnaire (PinQ). Participants of this study are as well asked to complete drinking and voiding charts and nocturnal diaries. These questionnaires and documents are filled in before and after the voiding class. The collected data will be further analysed statistically trough Statistical Package for the Social Sciences (SPPS), to determine significant improvements in symptoms and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* children (5-12 years old)
* children with LUTS
* children who follow voiding school, with or without previously failed training

Exclusion Criteria:

* children \>12 years ol and \<5 years old
* children who suffer from solely faecal problems without lower urinary tract symptoms
* children who are currently following a different kind of therapy concerning the LUTS, than VC
* children with neurological disorders or anatomical variations of the bladder
* children who underwent surgical intervention of the bladder
TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.

Portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding. However, the safety of transjugular intrahepatic portosystemic shunt remains uncertain in patients with portal vein thrombosis.

Eligibility Criteria:
Inclusion criteria

1. liver cirrhosis (histological or clinical);
2. Significant variceal bleeding \>5 days and ≤ 42 days
3. Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
4. Portal vein thrombosis occlusion\>=25% of the vessel lumen;
5. Presence of ascites
6. Child-Pugh score 8-12 at inclusion
7. Age 18 to 70 years

Exclusion criteria

1. Bleeding from isolated gastric or ectopic varices
2. Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
3. Contraindications to TIPS : extensive potral vein thrombosis, fibrotic cord replacing original main portal vein; bilirubin\>3.5 mg/dL, plasma creatinine\>2.1 mg/dL, Child-Pugh score \>=13points
4. A history of significant heart failure (New York Heart Association class III and IV)
5. Overt hepatic encephalopathy,
6. Prehepatic portal hypertension
7. Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
8. Uncontrolled infection and sepsis
9. Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
10. Pregnancy or lactation
Joint Injections for Osteoarthritic Knee Pain

The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (OA).

OA is a common, debilitating condition for which there is no cure and no known cause. Prolotherapy (PrT) is an injection-based therapy for chronic musculoskeletal pain in which an irritant solution is injected at painful ligaments and tendons to produce stronger connective tissue and decrease pain. Although limited studies suggest PrT is effective may be effective for low back pain, its use has not been rigorously studied in human clinical trials for osteoarthritis.

Participants in this study will be randomly assigned to receive one of three treatments: standard PrT, injections with a saline placebo, or a pamphlet with recommendations for home knee physical therapy. Injections will be given at Weeks 1, 5, and 9; injection group subjects will have the option to receive an additional 2 sets of injections. All participants will be assessed for a total of 1 year. A set of disease-specific and general quality-of-life questionnaires will be used to assess participants' outcomes . A randomized subset of participants (N=38)will receive magnetic resonance imaging (MRI)of the knee at baseline and 52 weeks. At study completion, participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost. Data will be collected for this group (minus MRI) and will be analyzed separately. Enrollment is limited to residents of Southern Wisconsin.

Eligibility Criteria:
Inclusion Criteria:

* Pain from knee osteoarthritis that has impacted life for 3 months to 10 years
* X-ray results indicating knee osteoarthritis

Exclusion Criteria:

* Knee osteoarthritis surgical candidate
* History of total knee joint repair
* Prior use of PrT
* Prior fracture of the knee joint
* Joint injection of steroids or other drugs within the past 3 months
* Rheumatoid or inflammatory arthritis
* Chronic use of narcotic medication
* Other chronic pain diagnoses
* diabetes mellitus
* Body mass index (BMI) greater than 45
* Unresolved litigation
* Pregnancy
* Co-morbidity that may interfere with the study