cyrilzakka/clinical-trials huggingface dataset:
Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

To evaluate the effectiveness and safety of tenofovir for different treatment duration in preventing HBV relapse in patients with malignancies after receiving chemotherapy and off-treatment of chemotherapy.

This study aims to evaluate the effectiveness and safety of tenofovir in preventing HBV relapse in HBV carriers with malignant tumor following chemotherapy. Approximately 100 patients who are planned to receive chemotherapy for malignant tumor will be invited to participate in this trail. A 1 or less 1-week tenofovir prophylaxis treatment should be administered by all subjects prior to the chemotherapy and eligible subjects will be randomly assigned to extend 24-week prophylaxis group A or 48-week prophylaxis group B in a 1:1 ratio at the end of the chemotherapy. The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively. The relapse episode will be followed until 24 weeks after the end of prophylaxis therapy. Data collection will take place at screening, every cyclic visit of chemotherapy, at the end of chemotherapy, and the following prophylaxis period, then every 4 weeks during the follow-up period. Patients in both groups will be treated with tenofovir or other antiviral agent according to investigator judgement when HBV relapse after discontinuation of tenofovir therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 to 70 years of age
2. Patients with histologically proven malignant tumor planned to receive chemotherapy after enrollment
3. Hepatitis B virus (HBV) carriers who fulfill one of the following criteria:

   seropositive of HBsAg, or HBsAg negative, but Anti-HBc positive with HBV DNA detectable defined as HBV DNA \> 20 IU/mL (by Roche Taqman real time assay).
4. Patients with ALT ≤ 2 x ULN (upper limit of normal)
5. Normal Cr mg/dL or eGFR \> 80 mL/min
6. Life expectancy \> 1 year
7. Willing and able to provide written informed consent

Exclusion Criteria:

1. Females who are pregnant/nursing or with intention to be pregnant within the study period
2. Documented hepatitis C virus (HCV) co-infection
3. Patients with other current major systemic disease such as active infection, significant cardiac disease, poor control diabetes mellitus, osteopenia or osteoporosis that the investigators consider to be significant risk
4. Current use of any hepatitis B prophylaxis medication
5. Decompensated liver cirrhosis
6. Current or previous use of any chemotherapy
7. Use of any investigational product medicine within 1 month prior to the initiation of study treatment
Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Abdominal Surgery

This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with shorter hospital stay after surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients requiring elective or semi-elective major abdominal surgery will be assessed for eligibility.

Exclusion Criteria:

* Age under 18 years old,
* Coagulopathy,
* Significant renal/hepatic dysfunction (creatine \>50% or liver enzymes \> 50% of normal values),
* Congestive heart failure,
* Cardiac arrhythmias producing irregular rhythms, and
* Patient choice.
Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

The purpose of this study is to explore the effects of Vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and MET-TKI.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years, female or male
2. Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
3. c-MET overexpression diagnosed by IHC
4. KPS ≥60
5. Adequate hematological, renal, and hepatic function.

   All patients should meet the following criteria:
   1. absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
   2. serum creatinine clearance ≥80 mL/min
   3. total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
   4. aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT \< 2.5 × ULN
6. The patient and his/her family members were informed and provided signed and informed consent

Exclusion Criteria:

1. Any previous postoperative treatment except for concurrent chemoradiotherapy;
2. Individuals unable to undergo cranial MRI examination;
3. Active hemorrhage detected by cranial CT or MRI scan before enrollment;
4. Uncontrolled hypertension;
5. Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
6. Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA \>1000IU/ml;
7. Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
8. Pregnant or lactating women;
9. Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
10. Individuals deemed unsuitable for participation in this clinical trial by the investigator.
Targeting the Sensory Disturbance in Autism Spectrum Disorder

This study aims to establish a cognitive-behavior therapy (CBT) based virtual exposure (VR) exposure program to train ASD adults coping with everyday sensory scenarios. Through the practice and training, the ASD participants may learn the strategy to deal with the common sensory scenarios and master the anxiety around the exposure. The anticipatory anxiety and the maladaptive behaviors may be decreased along with the process of desensitization, while the functional impairment related to sensory sensitivity can partly be recovered.


Eligibility Criteria:
Inclusion Criteria:

* young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5;
* has sensory and social problems as reported by the participant and the caregiver;
* is motivated to participate in the treatment;
* is fluent in Chinese;
* has a full-scale IQ \> 70 on WAIS-IV;
* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

Exclusion Criteria:

* A history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases;
* visual impairment and/or hearing impairment that would preclude participation in the CBT-based VR exposure program
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix

The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated cervix cancer
* FIGO stage IB2, II, IIIB, IVA
* Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation

Exclusion Criteria:

* Hemoglobin level above 125g/L
* Lower one-third vaginal involvement
* Para-aortic lymphadenopathy
Longitudinal Investigation of Cancer-related Fatigue

In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and extensively surveyed over five years on factors that are associated with fatigue.

The LIFT study aims to comprehensively investigate characteristics, determinants, and long-term course of fatigue. In addition, information shall be gained on the current state of fatigue treatment and care in Germany and on the needs of affected patients.

Data will be collected by mailed or online questionnaires at 6, 9, and 12 months as well as 2, 3, 4 and 5 years post-diagnosis from 2000 cancer patients. Besides questionnaires on socio-demographic, clinical and patient reported outcomes, saliva samples will be collected in order to gain new insights into biological mechanisms. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.

The results of the LIFT study aim to contribute to an improved, evidence-based and individualized treatment to avoid and ease cancer-related fatigue and will further promote patient-oriented offers and treatments.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Diagnosed with a primary tumor of breast, ovarian, or colon cancer
* Time since first diagnosis is 4 - 6 months
* Having received or currently receiving at least one of the following treatments: surgery, chemotherapy, radiotherapy, hormone therapy, or immune therapy.
* Able to understand and follow the study protocol.

Exclusion Criteria:

• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
PIMS-TS in Intensive Care: Retrospective Cohort Trial

Pediatric Multisystem Inflammatory Syndrome Temporally associated with SARS-CoV-2, (PMIS-TS) represents the new unit, partially imitating the previously described Kawasaki disease. Due to variable and frequently incomplete clinical presentation together with variable disease severity, the real incidence in pediatric population remains unclear. Currently, PIMS-TS is defined by persistent fever, elevation of inflammatory markers, organ dysfunction (cardiac, central nervous system, respiratory, coagulation, renal, gastrointestinal), skin lesions (exanthematous), and absence of other possible etiology.

During the world COVID-19 pandemic (2020-2022), pediatric patients with PIMS-TS represented a significant part of pediatric intensive care unit (PICU) load. The initial clinical presentation of patients with PIMS-TS could vary significantly, and also due to progressively evolving recommendations, the diagnostic a therapy could vary regionally and over the time too. The aim of this retrospective cohort trial was to describe the initial clinical presentation, diagnostics, therapy and clinical outcome of pediatric patients admitted during 2020-2022 to the one of the 3 university hospital PICUs.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients with PIMS-TS
* PICU admission

Exclusion Criteria:

* insufficient data
* patients not admitted to PICU
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria for all Participants (Group A, Group B, Group C):

* Body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg.

Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B):

* Participants have moderate HI (Group A), severe HI (Group B) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
* Participants have moderate (Group A) or severe (Group B) HI as defined by National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria.

Inclusion Criteria for a Matched Healthy Participant (Group C):

* Participants must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions as agreed by the investigator and the Sponsor Medical Monitor.
* Participants must be free of any clinically significant disease that would interfere with the study evaluations.

Exclusion Criteria for all Participants (Group A, Group B, and Group C):

* Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
* History of major surgery within 8 weeks before the study intervention administration.
* Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Study of Soft Contact Lens Use With 7 Day Extended Wear

To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.

To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age as of the date of evaluation.
2. Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.
3. Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
4. Be in good general health, based on his/her knowledge.
5. Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
6. Possess wearable and visually functional eyeglasses.

Exclusion Criteria:

1. Previously unsuccessful with contact lens wear.
2. Rigid gas permeable contact lens wear within the past 12 months.
3. Previous refractive surgery; current or previous orthokeratology treatment.
4. Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.
5. Aphakia, keratoconus or an irregular cornea.
6. A known history of corneal hypoesthesia
7. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
8. Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
9. Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

   * History of corneal ulcer, corneal infiltrates or fungal infections.
   * Pterygium, pinguecula or corneal scars within the visual axis
   * Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)
   * Neovascularization or ghost vessels \> 1mm in from the limbus
   * Seborrheic eczema, seborrheic conjunctivitis
   * History of papillary conjunctivitis greater than Grade 2 (Mild)
   * Anterior uveitis or iritis (past or present)
10. Known sensitivity to the care systems used in this study.
11. Poor personal hygiene
12. Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
13. Any active participation in another clinical study within 30 days prior to this study.
14. Subject is a member, relative or household member of the office staff, including the investigator(s).

Subjects must read, indicate understanding of, and sign the Informed Consent Form.
Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients

Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy.

The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.


Eligibility Criteria:
Inclusion Criteria:

* outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD

Exclusion Criteria:

* age \< 18 or \> 70 years
* pregnancy
* breast feeding
* chronic obstructive lung disease (COPD)
* known CO2 retention and refusal to participate in the study
Effect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome

the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant women with PCOS who were treated with LOD.


Eligibility Criteria:
Inclusion Criteria:

* age between 25 and 35
* patients with established PCOS
* history at least one year infertility
* no response to clomiphene citrate for at least three cycles

Exclusion Criteria:

* history of previous IVF/ICSI
* chronic disease such as thyroid disorder and DM
* infertility due to sever male factor
* sever endometriosis
* infertility due to uterine factor such as multiple fibroid
* body mass index \> 30
Healthy Habits, Healthy Girls Preventing Unhealthy Weight Gain

The purpose of this study is to evaluate the impact of a multicomponent school-based intervention based on Bandura's Social Cognitive Theory targeting healthy eating and physical activity for high school adolescent girls from low-income communities in the city of São Paulo, Brazil.

The "Healthy Habits, Healthy Girls" is a 6-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes: (1) enhanced physical education classes (2x/week and delivered by a Physical Education teacher), (2) break/lunch-time physical activity sessions (the participating girls will encourage younger girls to make Physical Activity during break and/or lunch-time. This session will only happen after 3 months of enhanced Physical Education classes, so the girls will be able to pass their knowledge for the others), (3) Nutrition and Physical Activity handbooks with 10 health messages (lessons to be done at home and their family); (4) 4 Parent newsletters; (5) Food and Physical Activity diaries for self-monitoring; (6) text-messages using a group application for more interaction and social support; and (7) 10 weekly Nutrition and Physical Activity key messages (delivered by a Nutrition and Dietetics Bachelor degree and/or Physical Education teacher during break). The intervention will be evaluated using a randomised controlled trial in 10 public schools in the city of São Paulo, Brazil (5 control and 5 intervention) and based on the 10 weekly key messages: (1) eat fruit and vegetables daily; (2) Do Physical Activity respecting your limits; (3) Eat a healthy breakfast every day; (4) Do Physical Activity with your family and friends; (5) Control the portion size you eat during meals - and sit while you are eating; (6) Reduce your sitting time during school break, after the school period and on the weekends; (7) Have less "junk food" for meals/snacks and munch less; (8) Identify the excuses for not practicing PA; (9) Drink water and substitute sodas and artificial juices for water, homemade natural fruit juices and coconut water, and; (10)Make family meals.

Eligibility Criteria:
Inclusion Criteria:

- Adolescent girls from low-income backgrounds enrolled in high schools of the city of São Paulo, Brazil.

Exclusion Criteria:

* Adolescent boys
* Adolescents from middle and high income backgrounds
* Pregnant
Pistachios, Performance, Metabolomics

Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling intensely for 75 kilometers will support substrate utilization during exercise (as determined through metabolomics) and improve performance compared to water only, and attenuate inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.


Eligibility Criteria:
Inclusion Criteria:

* Male endurance cyclists
* Capable of exercising for 2.5 h at a high intensity in the lab
* Ages 18-55
* Agree to train normally and stay weight stable.
* Agree to avoid the use of large dose vitamin/mineral supplements
* Agree to avoid herbs and medications that influence inflammation

Exclusion Criteria:

* Regularly take supplements or medicines known to effect inflammation.
* At moderate or high risk for cardiovascular disease.
* Younger than 18 or older than 55 years of age.
* No history of competing in cycling races.
Deafness and Cognition in Middle-aged Adults

A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.

This case-control study will include 180 middle aged adults (90 cases, 90 healthy controls) matched on sex, age, education level in order to find an association between severe and profound hearing loss and presence of mild cognitive impairment.

90 subjects with severe to profound hearing loss,, with a maximum speech intelligibility of 70% for Fournier's disyllabic words in silence with properly fitted hearing aids could be included. Cognition evaluated on a battery of 5 tests, depression and dependance will be compared to healthy controls with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) The subjects (cases and controls) will be recruited in the ENT consultation from the Cochlear Implant Center (Unité fonctionnelle implants auditifs, Pitié-Salpêtrière Hospital, Head: Dr Isabelle Mosnier)

Eligibility Criteria:
Inclusion Criteria:

* Cases: Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL, current in french
* Controls: normal hearing subjects matched on age, sex and education level

Exclusion Criteria:

* Associated disability that prevents the tests from being performed
* Past and current history of neurological and psychiatric disorders including meningitis
* Psychotropic drug treatment
* Vulnerable subject