cyrilzakka/clinical-trials huggingface dataset:
A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)

This is a prospective, multicentre observational follow-up study of PegIFN treatment unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will join this study after finished following clinical trail about A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B(OSST trail),A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B (COST study), Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients(Endeavor study),A Prospective Clinical Trial in Chronic Hepatitis B Patients Nucleotide Analogues Experienced (Anchor A Study),Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients (NPGV study).We plan to compare the HBsAg negative rate and maintenance rate,the occurrence of liver cirrhosis and the occurrence rate of hepatocellular carcinoma(HCC) related to hepatitis B virus(HBV) within five years between interferon group (including interferon alone or interferon combined with other drugs) and nucleoside analogues.Patients were divided into two groups based on whether they received interferon or not.

Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor NPGV studies, were included in the observational study after they finished. The patients entered the following two observation groups based on previous studies: Group A: formerly interferon group (including interferon alone or interferon combined with other drugs); Group B: formerly nucleoside analogue treatment group. Each group was followed for five years.All patients were followed up for physical examination (vital signs, whole body examination) and laboratory assessment (HBsAg quantification, HBeAg quantification, HBV DNA, HBV immunology marker, blood routine, blood biochemistry, alpha fetoprotein, Fibroscan, liver Doppler) in every six month.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients from 18 to 65 years of age;
2. Have finished the OSST,COST,Endeavor, Anchor,NPGV studies;
3. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria:

1. patients have not participated in the OSST,Cost,Endeavor,Anchor or NPGV study ;
2. unable or unwilling to provide informed consent or follow the research requirements
Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus

Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.

Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (\<34 weeks, \<37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetics who are at or less than 16 weeks in their pregnancy
* 18 years of age or more
* Voluntary participation

Exclusion Criteria:

* \<18 years of age
* Not Type I diabetic
Functional Changes of Urogenital System After Holmium Laser Prostatectomy

Holmium laser prostatectomy will enhance voiding function.

Holmium laser prostatectomy will enhance sleep quality.

Holmium laser prostatectomy will enhance renal function.

Holmium laser prostatectomy will enhance erectile function.

Holmium laser prostatectomy will enhance the health-related quality of life.

Check urodynamic parameters for voiding function evaluation Check low urinary tract symptoms (IPSS: international prostate symptom score) for voiding function evaluation Check Pittsburgh Sleep Quality Index for sleep quality evaluation Check estimated glomerular filtration rate and urine protein/creatinine ratio for renal function evaluation Check International Index of Erectile Function score (IIEF-5) for erectile function evaluation Check nocturnal penile tumescence parameters for erectile function evaluation Check 36-Item Short- Form Health Survey (SF-36) for evaluation of the health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Prostate size over 30 cc by transrectal ultrasonography
* prostate-specific antigen level less than 10 ng/ml
* International prostate symptom score more than 7
* At least one of followings: Bladder outlet obstruction index \> 40, maximal flow rate \< 10 cc/sec, postvoid residual urine \>100cc or schäfer grade II or more

Exclusion Criteria:

* Patients who do not want surgery
* Evidence of prostate cancer or bladder cancer during evaluation or treatment
* All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
* Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
* History of pelvic radiation therapy
* Poorly controlled diabetes mellitus or hypertension
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.


Eligibility Criteria:
Key Inclusion Criteria:

* newly diagnosed glioblastoma
* World Health Organization (WHO) performance status less than or equal to (\<=2)
* stable or decreasing corticosteroid dose within 5 days prior to randomization

Key Exclusion Criteria:

* evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain
* any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas
* any prior radiotherapy to brain
* clinically significant cardiovascular disease
* history of greater than or equal to (\>=) grade 2 hemoptysis within 1 month prior to randomization
* previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
2. Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 pounds).
3. Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
4. Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.

All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.

Exclusion Criteria:

1. Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
2. Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
3. History of relevant orthostatic hypotension, fainting spells or blackouts.
4. Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin
Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work

The study is an initial investigation of the feasibility of applying Bayesian sequential analyses to individual participant single-case data for rapid detection of whether or not the individual is benefitting from a low-intensity computerized cognitive training intervention for depression. Patients waiting for, or in follow-up from, outpatient psychological therapy will complete first a two-week period of daily symptom monitoring, followed by two different two-week cognitive training interventions. Data collected will be used to assess feasibility of a future formal case series using Bayesian sequential analyses to determine switching of interventions, and inform the analysis parameters for such a future study.


Eligibility Criteria:
Inclusion Criteria:

* Patient registered at the Ruhr University of Bochum Outpatient Psychotherapy Center ("Zentrum für Psychotherapie", ZPT) in an appropriate phase of treatment (on waiting list/ in follow-up), or from 26/10/22 having had a first consultation ("Beratungsgespräch")
* Aged 18 years or above
* Owning a technical device (e.g. a laptop, computer) that is compatible with the computerized training
* Scoring ≥ 6 on the QIDS (indicating at least mild levels of depressive symptoms)
* Willing and able to complete all study procedures

Exclusion Criteria:

* Existence of a condition or circumstances that would interfere with completion of the study procedures (e.g. severe visual impairment, neurological problem, acute psychosis, or substance withdrawal symptoms)
* Acute crisis with high levels of suicidal ideations or high levels of self-harm, identified either through therapist's assessment or score \>1 on item 12 of the QIDS
Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study

The investigators propose a pilot study to determine if autologous platelet-rich plasma (PRP) improves ovarian reserves and In-vitro fertilisation (IVF) outcomes in women with diminished ovarian reserve / premature ovarian insufficiency.

Ovarian aging is a principal limiting factor for success in both spontaneous and assisted reproductive techniques (ART) conceptions. This results in diminished ovarian reserve (DOR) and premature ovarian insufficiency (POI), accounting for \~10% of IVF patients in Singapore and worldwide. Existing solutions include nutritional supplementations, high dose gonadotrophin usage, and experimental in-vitro activation with limited effectiveness, while donor oocyte programs or adoption do not provide a genetically related offspring. The substantial clinical burden and lack of effective treatments underscore the highly unmet need in this group of women.

Intraovarian autologous platelet-rich plasma (PRP) infusion was recently introduced in the context of addressing ovarian insufficiency, with several studies showing an increase in ovarian function and promising ART outcomes. Possible mechanism includes anti-inflammatory and mitogenic potentials in this growth factor rich fraction contributing towards tissues regeneration. Through being involved in the cell regeneration cycle, autologous PRP potentially gives women with POI/DOR a hope in achieving a healthy genetically related offspring. It however, still remains an experimental technique as there are very few small studies published till date, with no locally published data on its use.

The investigators propose a pilot study in KK Women's and Children's Hospital IVF (KKIVF) Centre to establish technical expertise, and to evaluate response to PRP to power a randomized controlled trial eventually. Primary outcomes are Anti-Mullerian Hormone (AMH), D2/3 Antral Follicle Count (AFC) and number of oocytes collected at stimulation. The secondary outcome will be clinical pregnancy and live birth rates. Thirty women with DOR/POI will be recruited over a 1 year period. The investigators hypothesize that PRP increases the overall pregnancy and live birth rates in these women.

Eligibility Criteria:
Inclusion criteria

* Diminished ovarian reserves AND/OR;
* Anti-Mullerian Hormone (AMH) 0.2-0.5ng/ml or
* At least 2 Follicle Stimulating Hormone (FSH) readings of \>25 (mIU/L) or
* AFC \< 5
* Poor Ovarian Response of \<4 oocytes retrieved at a prior IVF stimulation cycle with gonadotrophin doses of 450u per day

Exclusion criteria

* Amenorrhea of \> 1 years
* Medical conditions - Diabetes Mellitus, Hypertension, Collagen vascular diseases, Thyroid disease
* Patients presenting with anemia and thrombophilic disorders
* Inability to be monitored for at least 1 year at the treating centre
* Lack of suitable sperm for Intracytoplasmic Sperm Injection (ICSI) (eg. Azoospermia)
Cultural Adaptation of Drug Treatment for DJJ Youth

This project aims to improve the understanding of the impact of Ethnic and Racial Discrimination (ERD) on adolescent alcohol and other drug use (AOD) within the Black Justice-Involved Youth (JIY) population. Individual interviews with Black JIY and focus groups with parents and guardians of Black JIY and community members who support change and reform in the justice community for Black JIY will be conducted.

Black JIY are overrepresented in the criminal justice system due to institutional racism and discrimination. The General Strain Theory posits that high levels of ethnic and racial discrimination (ERD), paired with elevated levels of witnessing or experiencing police brutality, places Black JIY at unique risk of increased alcohol and other drug use (AOD) as a means of coping with stressful events. Black JIY report engaging in comorbid alcohol and cannabis use to achieve temporary respite from discrimination-induced stress. While JIY engage in higher rates of comorbid alcohol and cannabis use compared to non-justice-involved youth, overall, Black JIY are less likely to be diverted to substance use treatment programs, less likely to engage in care after being released on probation, less likely to benefit from substance use treatment in terms of reduced risk of recidivism, and are more adversely affected by early onset of AOD activity than White JIY. To date, no known adolescent substance use treatment directly addresses ERD, the increased risk of AOD due to ERD, or explicitly presents tools on how to appropriately respond to AOD and discrimination distress among Black JIY. To address this problem, the investigator's research program aspires to improve the understanding of the impact of ERD on adolescent AOD within the Black JIY population. Individual interviews with Black JIY and focus groups with guardians of Black JIY and community members will be conducted. Data will be used to culturally adapt an adolescent substance use intervention. The culturally adapted intervention will then be piloted with 30 Black JIY.

Eligibility Criteria:
For Focus Groups and Interviews:

Black JIY Participants:

Inclusion Criteria:

• Between the ages of 12-17, 2) identify as Black or African American, and 3) on community probation.

Exclusion Criteria:

• Will be excluded if they do not have parental consent to participate.

For Focus Groups and Interviews:

Adult Participants

Inclusion Criteria:

* A guardian of JIY
* An advocate (someone who supports change and reform in the justice community) for Black JIY.

Exclusion Criteria:

• Will be excluded if they do not provide consent to participate.

For pilot feasibility study:

Black JIY Participants:

Inclusion Criteria:

* Between the ages of 12 and 17
* Identify as Black or African American
* Be on community probation
* Meet criteria for alcohol, cannabis, or other drug misuse as defined by the DSM 5
* Be experiencing at least 1 problem related to AOD;
* The frequency of AOD must be weekly use over a 3-month period

Exclusion Criteria:

* Will be excluded if they do not have parental consent to participate
* Parole violation
Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.


Eligibility Criteria:
Key Inclusion Criteria:

* HCV-infected patients living in Mexico
* Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician

Key Exclusion Criteria:

* Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
* Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country prior to their SVR12 visit)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

The primary purpose of this study is to investigate the effect of lidocaine patch on the shoulder pain score after end of surgery.

The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* Infection, trauma, or bleeding on shoulder
* Allergy to lidocaine
* Chronic pain
* Renal dysfunction
* Liver dysfunction
* Seizure
* History of shoulder surgery
Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure

To date no specific treatment has been proven to be effective for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that contains antibodies to SARS-Cov-2 might be effective against the progression of infection. Promising results have been shown by preliminary data from China cases. The investigators planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best evidence based therapy approved for treatment of COVID patients by regional Health system emergency committee.

500-700 ml of Plasma will be collected by apheresis from COVID recovered donors showing the presence of neutralizing antibodies to SARS-Cov-2 (anti-SARS-Cov-2). All plasma will be screened for transmissible diseases according to italian law (Hepatitis B Virus,Hepatitis C Virus, Human Immunodeficiency Virus 1-2, Syphilis) plus adjunctive screening for Hepatitis A Virus and Hepatitis E Virus-RNA and Parvovirus B19-DNA as requested from Italian National Blood Authority. Apheresis will be divided in two/three units (170-300 ml each), virus inactivated with Riboflavin and ultraviolet light illumination technology and immediately frozen and stored separately from other plasma bags.

Enrolled patients will be stratified according to severity of respiratory failure and randomized in three arms: 1) Standard Therapy Protocol (STP), 2) Standard Therapy Protocol + 170-350 ml standard Plasma (SP) on day 1-3-5 after randomization, 3) Standard Therapy Protocol + 170-350 ml COVID-19 Convalescent Plasma on day 1-3-5 after randomization.

The three therapeutic units of COVID-19 Convalescent plasma will be chosen in order to minimize variations among patients in the total amount of infused SARS-Cov-2 antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-Cov-2 diagnosis by RT-PCR on nasopharyngeal swab or on bronchoalveolar lavage
* Respiratory failure onset or progression within 5 days
* Signed Informed Consent

Exclusion Criteria:

* Pregnancy
* Previous severe reactions to plasma transfusion
* Unavailability of blood group compatible COVID-19 convalescent plasma
The Adherence to Oral Anticoagulant in Chinese Patients With NVAF

Investigate the compliance of oral anticoagulants in Chinese NVAF patients and find out the causes, so as to provide basis for formulating effective measures to improve the compliance of oral anticoagulants.

1. The general information about these patients was recorded such as gender, age, smoking history, drinking history, heart failure, hypertension, diabetes, coronary heart disease, stroke history, TIA history, peripheral vascular disease, etc. CHA2DS2-VASc score and HAS-BLED score were recorded.
2. Medication information and follow-up information was collected.For the patients included in the study, the medication records of oral anticoagulants (outpatient, emergency, hospitalization), adverse reactions, anticoagulant use history, drug withdrawal or dressing change, disease changes, etc. within three years were recorded by referring to the patient's medical records.

Eligibility Criteria:
Inclusion Criteria:

NVAF; CHA2DS2-VASc≥2（femal≥3）; After starting the medication, the duration of continuous medication was more than 3 months

Exclusion Criteria:

The patients had the records of anticoagulants in other hospitals; Patients lost to follow-up; Patients who do not need long-term anticoagulants after successful radiofrequency ablation or left atrial appendage occlusion. The follow-up time was 3 years or the following conditions occurred: the patient's condition changed and no longer used oral anticoagulants or died, the follow-up was stopped.