cyrilzakka/clinical-trials huggingface dataset:
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.

Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. In a recent survey, parents of children receiving chemotherapy in Ontario centres identified nausea as the fourth most prevalent and bothersome treatment-related symptom experienced by their children. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to children.

Eligibility Criteria:
Inclusion Criteria:

* 12-18 years of age;
* able to swallow whole capsules;
* weighing ≥40kg;
* AST, ALT no more than 3 times the upper limit of normal for age and bilirubin concentrations within normal limits;
* receiving 2 consecutive (within 8 weeks) eligible, though not necessarily identical, IV chemotherapy cycles;
* English speaking (nausea assessment tool (PeNAT30) has been validated only in English)
* cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional (to permit self-assessment of nausea severity).

Exclusion Criteria:

* receiving very cisplatin containing chemotherapy (aprepitant capsule administration to these patients is the current standard of care at Sick Kids)
* receiving chemotherapy within 5 days before,during or 5 days after either study cycle that is known or suspected to interact with aprepitant; that is, cyclophosphamide, doxorubicin, daunomycin, etoposide, irinotecan, ifosfamide, imatinib, paclitaxel, topotecan, vinorelbine, vinblastine and vincristine;
* receiving medication known to interact with aprepitant other than dexamethasone (see Appendix I for list of applicable agents and timeframe for exclusion);
* Pregnant or breastfeeding
Nutritional Supplements in Patients with Anorexia Nervosa

Anorexia nervosa causes gastroparesis, constipation, and can lead to elevated liver enzymes. It is often necessary to supplement the diet of patients with nutritional formulas. The ingestion of a peptide formula, with partially hydrolyzed protein and rich in medium chain triglycerides, could favor its digestion and absorption, improving its tolerance and acceptance by the patient, compared to a polymeric formula.

Main objective:

• To compare the digestive tolerance of an oligomeric nutritional supplement with respect to a polymeric nutritional supplement in a group of patients diagnosed with anorexia nervosa under follow-up by the Nutrition Unit.

Secondary Objectives:

* Assess the gastrointestinal tolerance of the oral nutritional supplement on a single occasion with respect to a continuous intake over a period of 4 weeks.
* Evaluate the impact of oral nutritional supplementation on nutritional status over a four-week period.
* Evaluate the impact of oral nutritional supplementation on the functional capacity of the patient in a period of four weeks.
* Evaluate the impact of oral nutritional supplementation on the patient's body composition over a four-week period.
* Evaluate the impact of oral nutritional supplementation on the quality of life of the patient in a period of four weeks.
* Evaluate the impact of oral nutritional supplementation on the depressive and anxious symptoms of the patient in a period of four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, ≥ 12 y ≤ 40 years of age at screening
* Diagnosed of Anorexy nervous according to DSM-5
* Appropiate cultural level \& understanding of the clinical study
* To be in agreement in participate voluntarily in the study and written informed consent must be obtained from the participants.
* Females who are non-pregnant and non-lactating women or women who have given birth at least six weeks before to the screening visit.

Exclusion Criteria:

* Allergy or intolerance to any component of the products under study.
* Participation in a concomitant trial that conflicts with this study
* Doesn't sign the informed consent
A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache

The purpose of this research study is to develop a model to help distinguish patients at high-risk for developing persistent post-traumatic headache from patients who experience headache recovery. Researchers will do this by comparing the brain images, clinical data, and speech of healthy controls to people who have been diagnosed with post-traumatic headache.


Eligibility Criteria:
Inclusion Criteria:

* Post-traumatic headache (PTH) and persistent post-traumatic headache (PPTH) will be diagnosed using the ICHD-3 diagnostic criteria for PTH attributed to mild traumatic brain injury (concussion).
* For patients with PTH, only patients with new onset of PTH without history of PPTH will be included in the study.
* A personal history of prior concussion and history of migraine are allowed according to ICHD-III diagnostic criteria.
* Tension-type headaches on three or fewer days per month is allowed for healthy control subjects.

Exclusion Criteria:

* History of moderate or severe traumatic brain injurie (TBI).
* Prior history of gross anatomical change on imaging.
* Contraindication to MRI, including but not limited to severe claustrophobia and/or presence of ferrous materials in the body.
* Women who are pregnant, or believe that they might be pregnant. Although there are no known contraindications or risks associated with pregnancy and MRI, we will exclude pregnant women or women who believe that there might be a chance that they are pregnant.
* History of concussion or more severe TBI.
* History of migraine or other headaches.
* The diagnosis for PTH and PPTH will be verified by Dr. Schwedt (co-investigator) a board-certified physician in Neurology and Headache Medicine. Presence of concussion will be verified using the Ohio State University TBI Identification Method, a standardized questionnaire assessing the lifetime history of TBI for an individual.
The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs commonly in patients with malignancy. Several studies have suggested that anticoagulant therapy may improve survival in patients with malignancy. The low molecular weight heparins (LMWHs) lend themselves to such studies because of their effects in experimental models of malignancy and the relative ease of administration compared with unfractionated heparin. The purpose of the present RCT was to determine whether addition of LMWH to transarterial chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.

100 patients will be randomly assigned to receive either TACE alone or TACE plus LMWH. A block of every 4 participants and a stratified randomization according to portal vein cancer emboli will be used to restrict randomization. LMWH consisted of nadroparin Ca will be given at a dose of 4100 U twice daily during 6 weeks after TACE. The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of LMWH on HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Adults patients with a diagnosis of HCC which is not amenable to surgical resection, liver transplantation or local ablative therapy
2. Without metastasis out of liver
3. Patients must have at least one tumor lesion that meets both of the following criteria:

   1. The lesion can be accurately measured in at least one dimension according to RECIST criteria
   2. The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
4. ECOG performance status (PS) \<2
5. No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
6. Child-Pugh class A or B
7. No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
8. Ability to understand the protocol and to agree to and sign a written informed consent document -

Exclusion Criteria:

1. HBSAg(-)，AFP(-).
2. prothrombin time prolonged more than 4s.
3. blood platelets count less than 50000/L.
4. Renal failure requiring dialysis.
5. Child-Pugh class C hepatic impairment.
6. clinically significant gastrointestinal bleeding within 30 days prior to study entry.
7. History of organ allograft.
8. Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
9. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
10. Pregnant or breast-feeding patients.
ACT for Mental Health in Neurological Disorders

The goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-COVID. These conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. Executive functioning and especially the ability to abstract thinking may be useful for individuals using Acceptance and Commitment Therapy. Therefore, the main questions research questions are:

* Is this intervention effective in improving mental health?
* Do executive functions predict the extent of social participation and mental health at the end of therapy? Participants will take part in 8 weekly group therapy sessions of 100 minutes each.

Mental health issues, especially depression, anxiety, and stress, are common in people with neurological disorders and post-COVID but often neglected and hence, remain untreated. Acceptance and Commitment Therapy (ACT) is a promising approach to assist people in adapting to their conditions by improving "psychological flexibility".

A previous study translated an adapted group psychotherapy manual for stroke survivors into German and demonstrated its feasibility. This pilot study also gave first indications on the manual's efficacy in reducing symptoms of anxiety, depression, and stress. The aim of this study is to investigate the efficacy of this ACT-based group therapy. People with neurological disorders may have impairments in executive functions, which can affect the psychotherapeutic process. Since ACT often uses metaphors and imagery, executive functions, particularly the ability to abstract, could influence the efficacy of the therapy and are therefore being investigated in this study. The program includes 8 weekly sessions with a session length of 100 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Value above a cut-off of the DASS-21 subscales (depression \> 10, anxiety \> 6, and stress \> 10)
* Sufficient cognition and language ability (clinical rating)
* Sufficient therapy motivation (clinical rating)

Exclusion Criteria:

* Behavioral disorders (e.g., high irritability or apathy in clinical rating)
* Other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability)
* Simultaneous psychotherapy or neuropsychological therapy
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

Branches:

* Perimodiolar (PM)
* Lateral wall (PL)

Follow up schedule:

Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)

Eligibility Criteria:
Inclusion Criteria:

Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz

Exclusion Criteria:

Medical or pharmacological comorbid condition that contraindicates cochlear implantation.

Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.

Surgical impossibility to follow the guidelines of the minimally traumatic technique.
(VIII): The Eight Study and Immunologic Response Sub-study

The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.


Eligibility Criteria:
Inclusion Criteria:

* Is 18 years of age or older.
* Is able to speak and read English.
* Plan to receive either the Moderna or Pfizer vaccine (mRNA vaccine).
* No known prior COVID-19 infection.

Exclusion Criteria:

* Known allergy to the adhesive used on the VitalPatch.
Abdominal Plane Blocks (APB) in Chronic Abdominal Pain (CAP)

Background: Chronic Abdominal Pain (CAP) is the sixth most common cause of hospital admission from any cause in women and the tenth most common cause in men. In the UK, it has been estimated that chronic abdominal pain costs the economy in excess of £100 million per annum. The mechanism of CAP is poorly understood. Patients with acute exacerbation of their CAP have multiple hospital admissions, prolonged length of stay and utilise significant health care resources. These patients have undergone multiple investigations with negative results leading to frustration for both the patient and the clinician. Additional testing and investigations increases costs, patient morbidity and comes with added risks. Patients are discharged once the flare up settles. The investigators have shown that treating patients with steroid injection followed by pulsed radio frequency treatment six months later can reduce the length of stay, repeat hospital admission, improve mood and provide durable pain relief in patients with CAP. The steroid is injected into a specific plane in the abdominal wall and is called abdominal plane block (APB). The investigators currently offer ABP treatment as a standard treatment in the management of patients with CAP.

Aim of the study is to evaluate the effectiveness of Abdominal Plane Block (APB) treatment in reducing hospital readmission over 12 months in patients admitted with exacerbation of CAP

Methods: The proposed study is a prospective, observational pilot study that will be conducted at Leicester General Hospital over 36 months. After providing written consent, adult patients admitted to the hospital with acute exacerbation of CAP will receive two sequential APB treatments (steroid injection followed by pulsed radio frequency treatment) six month apart. If the first treatment with steroid does not provide any benefit, the participants will receive a rescue treatment (trigger point injection with steroids). Participants will be asked to complete questionnaires on pain scores, mood and quality of life. Length of hospital stay, number of hospital re-admission following APB treatment as well as any complication from the APB treatment will be recorded. Participation in the study will end at 12 months following the first APB treatment on completion of relevant questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. All patients aged over 18 years.
2. Chronic abdominal pain for above 6 months
3. Moderate to severe pain in the abdomen: Baseline NRS \>4 (worst pain the last 24 hours)

Exclusion Criteria:

1. Lack of consent, including from those patients who lack mental capacity to give informed consent.
2. Patients with known history of drug allergy to depomedrone
3. Patients with infection at injection site at on day of treatment.
C-CAR011 Treatment in Subjects With ALL After HSCT

This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10\^6CAR+T cells/kg

Eligibility Criteria:
Inclusion Criteria:

* Age 15-65 years old, male or female.
* Volunteered to participate in this study and signed informed consent.
* Meet the two populations above.
* Histologically diagnosed as CD19+B-ALL.
* 100% T lymphocytes of donor.
* Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
* Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
* Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
* Expected survival ≧ 3 months.
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* History of allergy to cellular products.
* Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets\<20×109/L.
* The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
* Severe uncontrolled infection (mycotic, bacterial, virus and so on).
* Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
* The subjects were treated CART cells or DLI after HSCT.
* Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
* Any genetically modified T cell therapy.
* History of heavy drinking, drug taking or mental disease.
* Participated in any other clinical trial within one month prior to enrollment.
* Women who are pregnant or lactating or have breeding intent in 6 months.
* The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
Effect of Validated Skills Simulation With the Miya Model

Simulation training with the Miya Model will improve Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons and this phase of the study is designed to test that.

Vaginal Hysterectomy (VH) is the desired hysterectomy technique of The American College of Obstetricians and Gynecologists (ACOG) since it is associated with less morbidity, quicker recovery and lower costs than laparoscopic and abdominal hysterectomy. Despite its well documented advantages, numbers nationwide in the US are declining. Of all minimally invasive hysterectomy procedures, the vaginal approach has been the only one demonstrating a consistent decrease in use from 25% of cases in 1998 to 17% of cases in 2010. A large part of this is due to inadequate training for this technique. There currently is no standardized curriculum for teaching VH, and training varies widely between residency programs. It is widely held that simulation training for surgical procedures improves outcome, but there is a need to validate this for vaginal surgery training.

Eligibility Criteria:
Inclusion Criteria:

* residents at participating Institutions
* residents have performed ten or fewer vaginal hysterectomies

Exclusion Criteria:

* having had prior training dedicated to vaginal hysterectomy
* having performed eleven or more vaginal hysterectomies in the OR
Light Endoscopic Robot Use in Laparoscopic Surgery

Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)

Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic surgery indicated
* Subject with ASA Score 1, 2 or 3
* Subject with health and social protection
* 18 years of age or older
* Written Informed Consent

Exclusion Criteria:

* Subject is pregnant or lactating
* Subject in jail
* Subject hospitalizes without consent
* Protected persons aged 18 years or older
* Subject participated in another study
Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) by the study center.
* Age between 18 and 75 years.
* At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenase (LDH); Baseline EBV-DNA \> 500 copies/mL.
* ECOG performance status of 0 to 3.
* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g/L.
* Adequate organ function: Alanine aminotransferase (ALT) \< 3 × the upper limit of normal (ULN); Total bilirubin (TBil) \< 1.5 × ULN; Serum creatinine \< 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) \> 50%.

Exclusion Criteria:

* Aggressive NK-cell leukemia.
* Central nervous system lymphoma.
* History of any of the following within 6 months: Acute myocardial infarction; Unstable angina; Congestive heart failure; Uncontrolled symptomatic arrhythmia; Complete left bundle branch block; Second- or third-degree atrioventricular block; Long QT syndrome or corrected QT interval (QTc) \> 480 ms.
* Uncontrolled active infection.
* Pregnant or breastfeeding women.