cyrilzakka/clinical-trials huggingface dataset:
Improving Medication Adherence in Adolescents Who Had a Liver Transplant

The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).

This is a prospective, multi-center, randomized controlled trial. The study will be conducted in transplant centers in the United States and Canada. Estimated final sample size of 140 after attrition. Pediatric adolescent and young adult (age at enrollment ≥12 and \< 20) transplant recipients will be eligible for participation in the study. Eligible participants will be randomly assigned to intervention or control group. An interim analysis to evaluate efficacy will be performed. Missing data will not be imputed for secondary analyses.

Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥ 12 and \< 20 years of age at enrollment.
* ≥2.5 years after last liver transplantation.
* Guardian's consent, adolescent assent at enrollment.
* The patient is prescribed tacrolimus.
* The patient's MLVI (SD of tacrolimus) was \> 2 when calculated by the site for a period of 2 years prior to the review date

Exclusion Criteria:

* The patient has had transplant of an organ other than liver.
* The patient is currently listed for any organ transplantation.
* The patient is expected to transition to another service (e.g., adult clinic, another
* hospital) during the two years of the study.
* Pregnant patients.
* A temporary exclusion: the patient is not medically stable or was hospitalized for \>48 consecutive hours in the past three months.
* Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.
Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep Treatment

The purpose of this study is to determine the optimum dosage and application method of Glycosides Of Tripterygium Wilfordii Hook(GTW) for Henoch-Schönlein Purpura Nephritis(HSPN) in children, and develop into the normal treatment protocols for Henoch-Schönlein Purpura Nephritis in children.

Based on Chinese Eleventh Five-year Plan for Science and Technology Program, this study follows a large-sample multicenter centerrandom open-label controlled perspective method, enrolls HSPN children with hematuria associated with proteinuria and isolated proteinuria from 2 to 18 years of age, classifys five traditional Chinese medicine patterns of syndrome: wind-heat complicated with blood stasis, blood-heat complicated with blood stasis, yin deficiency complicated with blood stasis, both qi and yin deficiency complicated with blood stasis,damp-heat complicated with blood stasis. For TCM group,according to the severity of HSPN, stepped treatment should be taken. The initial dosage of GTW for severe HSPN is 2mg/kg/d, continued with 1.5mg/kg/d and 1mg/kg/d; The initial dosage of GTW for light HSPN is 1.5mg/kg/d, continued with 1mg/kg/d. On the above base, the comprehensive treatment are taken combined with TCM syndrome differentiation, medicated with Sulfotanshinone Sodium Injection.For controlled group,the treatment for severe HSPN is prednisone combined with heparin plus lotensin and dipyridamole tablets;for light HSPN is heparin plus lotensin and dipyridamole tablets.12 weeks after treatment, the third-party statistics evaluate the efficacy and effect,and a follow-up lasting 36 weeks will go on.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Henoch-Schönlein Purpura Nephritis Disease
* Age form 2-18 years old
* Disease onset within 2 months

Exclusion Criteria:

* Nephritis not causing by HSPN
* Being alergic to the medicine in the treatment
* No compliance
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.

Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(\<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (\< 1 cm)
* Age \> 18 years
* Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
* Child-Push Score: A5-A6
* Estimated life expectancy \> 3 months
* No distant metastasis (M0)
* Blood routine examination: Hb≥80g/L, ANC≥1.0x10\^9/L, PLT≥50x10\^9/L
* Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
* Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
* Voluntary to participate and sign informed consent

Exclusion Criteria:

* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
* Had prior abdominal irradiation
* Had prior liver transplantation
* Had serious myocardial disease or renal failure
* Had moderate or severe ascites with obvious symptoms
* Duration from surgery ≥ 3 months
Study of Aripiprazole in Patients With Acute Bipolar Mania

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
Accuracy of Holladay 2 Formula in the Absence of Lens Thickness

Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.


Eligibility Criteria:
Inclusion Criteria:

* patients with cataract

Exclusion Criteria:

* previous ocular diseases
* previous ocular surgery
Naturally Banded Sleeve Gastrectomy

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study
* previous restrictive bariatric procedure

Exclusion Criteria:

* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy

The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol.

The relationship between HCV and IR is an evolving one. This study will allow a more formal evaluation of this relationship. Four hundred patients will be treated using weight based Peg Intron and Rebetol. Clinical and biochemical data related to IR will be collected to determine if any such factors can predict who will have a sustained virological response. To evaluate patients for insulin resistance, the HOMA score (the product of the fasting insulin level and blood glucose level), waist circumference, and body mass index will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of chronic hepatitis C infection (viremia) by RT-PCR superquantitative
* HCV Genotype 1
* Liver biopsy within 36 months of enrollment consistent with chronic hepatitis
* Compensated liver disease with laboratory parameters at entry visit as follows:

  * Hemoglobin values of \> 12 gm/dL
  * WBC \> 2,500/mm3
  * Neutrophil count \> 1,000/mm3
  * Platelets \> 100,000/mm3
  * Prothrombin time \< 2 seconds prolonged compared to control, or equivalent INR ratio
* Bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as Gilbert's syndrome.
* Albumin \> 3.0 g/dL
* Serum creatinine \< 1.4 mg/dL
* Normal thyroid stimulating hormone (TSH) or thyroid disease clinically controlled
* Antinuclear antibodies (ANA)\< 1:160
* FBS \< 126 mg/dl
* No significant co-existing psychiatric disease
* Free from substance abuse for past 2 years

Exclusion Criteria:

* Previous treatment for HCV.
* Evidence of being HIV positive.
* Hypersensitivity to alpha interferon, Peg Intron or Rebetol.
* Any other causes for chronic liver disease other than chronic hepatitis C besides obesity.
* Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
* Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or hepatic encephalopathy.
* Preexisting medical condition that could interfere with the patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; diabetes mellitus; serious pulmonary disease; immunologically mediated diseases; gout attack within 12 months; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
* Patients with evidence of ischemia on stress testing, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months.
* Patients with a history of organ transplantation will be excluded.
* Patients taking insulin sensitizing drugs.
A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes

There is a gap in the literature about the feasibility and implementation of parent-led support groups for parents who have children or adolescents with eating disorders. In this study, we will be observing the experiences of 40 parents in Ontario who will virtually participate in one of 3 parent-led support groups for parents of children and youth with eating disorders. Parents will be expected to attend the virtual sessions twice a month over the course of six months. We hope to evaluate the acceptability, cost, and parental outcomes of the parent-led support groups via surveys before, during, and after the study, as well as using a post-study interview.


Eligibility Criteria:
Inclusion Criteria:

* have the capacity to write, speak and understand English, in order to participate in the sessions
* have access to the internet/computer to participate in the sessions
* must have a child or adolescent with an eating disorder.

Exclusion Criteria:

* don't have the capacity to write, speak and understand English
* don't have access to the internet/computer
* don't have a child or adolescent with an eating disorder
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)

The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed CTCL; a documented verifiable biopsy report is required.
* Documented clinical Stage IA, IB, or IIA CTCL.
* Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy.
* ECOG performance status of 0-2.

Exclusion Criteria:

* CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL.
* Severe pruritus requiring systemic or topical treatment.
* Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease).
* Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively).
* Any prior history of a hematologic malignancy (other than CTCL).
* History of or current major renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator.
* Evidence of active Hepatitis B or C or HIV.
* Circulating atypical cells \>5%
Postural Training for Standing and Sitting in Men Suffering From Post-prostatectomy Urinary Incontinence

Existing research highlights the difficulty of identifying an optimal rehabilitation technique for improving male urinary continence. However, several authors have demonstrated the benefits of treatment based on improving movement control, often referred to as postural motor contro. The main principles are: respect for the neutral lumbopelvic position, reduction of intra-abdominal constraints and ecology of movement. With the aim of encouraging patient-centred clinical practice, patients are asked to fill in an assessment form on which they note the most disabling gestures with regard to their UI during the initial assessment. In our experience, 'sitting down or getting up from a chair' is the item most frequently and most severely reported. In practical terms, posture and body movements play a vital role in the management of pelvic strain. For example, excessive pressure on the bladder due to poor postural control would increase stress on the bladder. Optimal postural control would have the advantage of reducing and promoting continence mechanisms. If we take the example of the transition from sitting to standing, postural control aims to improve neuromuscular coordination and promote continence.

In the context of health education during the first session, it might be interesting to study the impact of modifying postural control when standing/sitting on urinary incontinence and how patients feel about it.


Eligibility Criteria:
Inclusion Criteria:

* Men over the age of majority.
* Men who had had a prostatectomy within one year of inclusion.
* Positive response to the question 'Do you leak urine when you stand or sit up?
* Patients with a medical prescription for post-prostatectomy urinary incontinence rehabilitation.
* Patients who are able to understand and follow the instructions relating to postural education when standing up or sitting down.
* Patients who have read and understood the information note and who have not objected to participating in the research.
* Patients affiliated to a social security scheme.

Exclusion Criteria:

* Urinary leakage before prostatectomy (diagnosed by a doctor)
* Pad test ≤ 0 grams at the inclusion visit, before showing the postural control technique.
* On anticholinergic treatment initiated less than 3 months ago.
* Impossible to carry out postural control education (spinal surgery, serious neurological or orthopaedic pathology).
* Patients deprived of their liberty by an administrative or judicial decision or protected adults (under guardianship or trusteeship).
* Participation in other interventions: Individuals participating at the same time in other post-prostatectomy rehabilitation programmes or similar clinical studies.
Probiotics and Overreaching Recovery

Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. From a clinical point of view, very intense periods of training are associated with a temporary immunological deficiency which can lead to teh "overreaching syndroms".

During periods of overreaching, nutritional strategies are mainly aimed at ensuring sufficient amounts of energy to support the increase in effort. However less is known about nutritional supplements to attenuated the inflammatory/immunological response to training stress.

Probiotic bacteria are defined as live food ingredients beneficial to the host's health. Numerous health benefits have been attributed to probiotics, including effects on gastrointestinal tract function and disease, immune function, hyperlipidemia, hypertension, and allergic conditions. Studies in the literature on the ergogenic effect of probiotics in athletes are still scarce today. this study aims to explore the potential role of probiotics on performance, recovery from fatigue and immune function during intensive period of training.


Eligibility Criteria:
Inclusion Criteria:

* age 25-55 years
* Body mass index:\> 18 and \<30 kg / m2
* Stable body weight for at least 3 months
* regular practice of physical activity for at least 2 years

Exclusion Criteria:

* Chronic diseases (cardiovascular, hepatic, respiratory, cancer)
* Acute inflammatory states, infections or other pathologies
* Regular use of probiotics
* Use or treatment with steroids (within the previous 3 months)
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)

Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.


Eligibility Criteria:
Inclusion Criteria:

1. No prior treatment for cervical cancer.
2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage
4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
6. Age ≥ 18 years.
7. ECOG (Eastern Cooperative Oncology Group) 0-2.
8. Life expectancy \> 6 months.
9. Patient eligible for standard treatment (according to standards of each center).
10. Patient having health care insurance.
11. Informed and signed consent by patient.

(DICOM = Digital Imaging and Communications in Medicine)

Exclusion Criteria:

1. Patient enrolled in a clinical trial involving an investigative new agent.
2. Co morbidity, preventing patient to tolerate the proposed standard treatment.
3. Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix).
4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 .
5. Patient deprived from ability to decide on her own.
6. Patient unable to have a regular follow up for geographical, social or psychological reasons.
7. Pregnancy or patient old enough to procreate and not using effective contraceptive method.
Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer

Distant metastases is the leading cause of differentiated thyroid cancer-related death. Radioactive iodine (RAI) treatment is the most effective therapy for RAI-avid metastatic differentiated thyroid cancer (DTC). It is well known that the efficacy of RAI therapy is depend on the sodium-iodide symporter protein, which can be synthesized by elevated thyrotropin stimulation. Therefore, thyrotropin stimulation before RAI treatment to ensure sufficient uptake of RAI has been a long-established procedure. According to some observational studies, thyrotropin of 25-30 μIU/mL has been adopted as the standard care protocol. However, whether thyrotropin of 25-30 μIU/mL is enough to stimulate iodine uptake in metastatic lesions remains unknown. In this study, the investigators aim to address the effect of thyrotropin on iodine uptake in metastatic DTC during levothyroxine withdrawal by two times 124I PET/CT scans on different endogenous thyrotropin levels.

It is estimated that 10 patients who met the study criteria will be enrolled. All patients underwent twice 124I PET/CT scans in Beijing Cancer Hospital. The first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, the second 124I PET/CT was prepared with endogenous thyrotropin \>100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent total thyroidectomy.
2. Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.
3. Distant metastases confirmed by CT etc.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Significant hepatic or renal dysfunction;
3. Unable to lie flat, still or tolerate a PET scan.