cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions.

This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.

The protocol posting has been updated with regards to the enrolment of subjects and outcome measures following Protocol amendment 2, 22 August 2011.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
* Written informed consent obtained from parent(s) or from the guardian(s) of the subject.

Exclusion Criteria:

* Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use during the study period. If a child belongs to a high risk group for pneumococcal infections for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
* Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Known severe hypersensitivity to any component of the study vaccines, including neomycin.
* Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia

This study is a multicenter clinical research and focuses on the exploring of optimal diagnosis and treatment strategies of MDD based on anhedonia.

Major depressive disorder (MDD) is a heterogeneious psychiatric disorder with complex etiology and pathogenesis. The lack of objective criteria for diagnosis and the use of trial-and-error treatment strategy are the current challenge. Anhedonia is the core symptom of MDD and the aberrant reward system and abnormal inflammatory immune may be the pathological mechanisms. Previous evidence suggests anhedonia cannot be improved quickly and efficiently by taking the first-line antidepressants. This study focuses on exploring the optimal diagnosis and treatment strategy for MDD patients with anhedonia. Based on the hypothesis of inflammatory-immune system，neurotransmitter abnormalities and aberrant reward system, this study aims to evaluate the efficacy and safety of the combinations of escitalopram and aripiprazole and/or omega-3 polyunsaturated fatty acids for MDD patients with anhedonia with a factorial design. Moreover, the multidimensional data including the clinicopathological features, neuroimaging data (MRI) and inflammatory cytokines will be used to establish the model of diagnosis and treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
2. Age: 18-55 (including 18 and 55)
3. HAMD-17≥18
4. DARS ≤ 28
5. Do not receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months.
6. Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol.

Exclusion Criteria:

1. Patients who are diagnosed with major somatic diseases;
2. Patients who meet DSM-5 diagnostic criteria for other mental disorders: Personality disorder, mental retardation; drug and/or alcohol dependence;
3. Patients with severe suicidal tendencies or suicidal behavior;
4. Pregnant or lactating women;
5. Patients with MRI contraindications;
6. Patients who are regarded as unsuitable by investigators for this clinical trial.
A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m\^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
* Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
* Measurable disease, as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Active hepatitis B or hepatitis C
* Prior treatment with docetaxel
* Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Impact of Corona Vaccination on AMH- Anti Mullerian Hormone

Since December 2020 Nationwide anti-COVID-19 vaccination began in Israel using the Pfizer - BioNtech vaccine (BNT162b2 mRNA). The vaccination campaign has been associated with concerns regarding potential detrimental effects on future fertility. The aim of the study is to determine the impact of COVID-19 vaccination on n AMH- Anti Mullerian Hormone which express ovarin function.

disease and/or immunization on human follicular function, by comparing follicular steroidogenesis, response to the LH/hCG trigger, and oocyte quality biomarker (HSPG2), in the aspirated follicular fluid of patients undergoing ovum pick-up.

Our assumption is that there is no effect of the vaccination on the AMH level. We plan to recruit 90 patients who are divided to three groups First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. Second group patients who were infected by Covid-19 ant therefor were not vaccinated to compare the AMH level before and after the infectious. The third group patients who were not infected and not vaccinated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-44

Exclusion Criteria:

Age over 45
Cytosorb Therapy in Cardiac Surgery

Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.


Eligibility Criteria:
Inclusion Criteria:

* patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit

Exclusion Criteria:

* denial of consent for data use
Impact of Air Pollution on the Course of Inflammatory Rheumatism

The objective of this study is to see if there is a link between air pollution and inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis)

To do this, the investigators are going to follow a cohort of about 200-400 patients for 6 months by means of a self-questionnaire, which the investigators ask the patient to fill in once a week on a fixed day, and opposite the corresponding week to put the letter corresponding to the question concerning the activity of your disease: 3 possible answers: A: no flare-up, B: short flare-up of 1 to 3 days, C: persistent flare-up of more than 3 days

Then the investigators will collect the questionnaire at the end of these 6 months and at each visit to the consultation or day hospital (on average every 4 to 6 weeks), and they will look to see if any relapses have occurred. At the same time the investigators will calculate the disease activity score (DAS or BASDAI) to have an objective score. Then in parallel they will look at the level of exposure to air pollution according to the place of residence and work of each patient.

The hypothesis is that air pollution has an influence on the activity of inflammatory rheumatism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with RA according to ACR/EULAR 2010 criteria, or spondyloarthritis according to ASAS criteria.
* Patients older than 18 years of age
* Patients with RA or spondyloarthritis considered stable (no change in background or biological therapy for at least 3 months) and in low activity (SAR 28 CRP \< 3.2 for RA and BASDAI \< 4 for 3 months).
* Patient treated with biological therapy

Exclusion Criteria:

* Patient with no fixed abode
* Patient planning to move within 6 months.
* Patient unable to read or understand the non-opposition notice.
The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability

Due to an early brain injury occurring in antenatal or postnatal, cerebral palsy (CP) causes alteration in motor function with posture and gait disorders. It is commonly observed motor performance degradation during adulthood, and the underlying pathophysiology remains poorly known.

One of the hypotheses to explain the decline in walking capacities in adults with CP is their greater fatigability, that could be related to energy overconsumption (due to the specific biomechanical constraints of their walking pattern) and/or the occurrence of early sarcopenia affecting the compensatory muscle mechanisms commonly seen in children to compensate for architectural disorders and posture alterations. To optimize prevention and/or therapy in these patients, it is crucial to better understand the aetiology of fatigability and its role in the decline in walking performance.

Eligibility Criteria:
Inclusion Criteria:

Common for CP and healthy volunteers:

* Capable of walking for six minutes without stopping
* Capable of consenting to the tests

Specific for the CP group

* GMFCS I or II at age 18
* Spastic diplegic cerebral palsy

Exclusion Criteria:

* Counter-indications to the test procedures
* Mental retardation or intelligence quotient (IQ) below 80
* Accompanying diseases not allowing for the test setup
* Major surgeries altering performance in the last six months
* Injection of botulin altering maximal force production in the last three months
* Refusing to sign the consent form
Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D\&C) in the management of first trimester missed abortion.

A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D\&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP).

Exclusion Criteria:

* women who electively choose to terminate pregnancy
* women who took medical treatment for missed abortion prior to recruitment
* women with known uterine abnormality
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group, placebo-controlled, prospective study to investigate the renoprotective effect of DPP4 inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will take study drugs for 8 days starting from one day before cisplatin treatment. Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days after cisplatin treatment.

This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* cancer patients treated with intravenous cisplatin
* written consent

Exclusion Criteria:

* Diabetes mellitus
* Chronic kidney disease stage IV-V (eGFR \< 30ml/min/1.73m2)
* History of transplantation
* History of acute kidney injury before randomization
* Use of other nephrotoxic agents such as non steroidal anti-inflammatory drugs, aminoglycosides, colistin, vancomycin
* Receiving contrast media during last 72 hours
* Liver disease (bilirubin \> 2 mg/dl, transaminase levels \>2.5 times the upper limit normal)
* Active infection
* Patients with high risks of dehydration owing to poor oral intake
* High blood pressure (\> 180/110 mmHg despite antihypertensive medications)
* Hypersensitivity to Gemigliptin or its excipients
* Low compliance to Gemigliptin treatment
On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients

Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their long-term outcomes and survival. Currently, no effective cardiovascular preventative care is provided for this pediatric population, in part, due to the fact that clinic-based programs are not easily accessible to children and their families. However, tele-health has been show to improve medical outcomes by making care more accessible to these patients. This study aims to meet the urgent need for an effective and sustainable delivery of preventative care to pediatric heart transplant patients using a diet and exercise intervention program delivered live over the internet direct to these patients' homes.


Eligibility Criteria:
Inclusion Criteria:

* Heart transplant \>11 months before baseline visit
* Able to fast overnight
* Cardiac clearance to exercise by the primary cardiologist
* Presence of an adult at home during the exercise training sessions for patients \< 14 years of age

Exclusion Criteria:

* Acute illness
* Latex allergy
* Document transplant rejection \< 3 months
* Re-transplantation or multi-organ transplantation
* Malignancy
Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:

Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
2. Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
3. Measurable or evaluable disease.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).

Exclusion Criteria:

1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
2. Radiotherapy within one week prior to starting study treatment.
3. Other investigational agent(s) within 21 days prior starting to study treatment.
4. Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
5. Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.
Effects of Health Care Provider-mediated, Remote Coaching System Through the PDA-type Glucometer and the Internet on Diabetes Management

The purpose of this study is to investigate the effectiveness of the new diabetes care delivery system applied to preexisting public health care resources through advanced information technologies such as PDA-type glucometer and the Internet on the glycemic control of type 2 diabetes patients lived in isolated rural area.

The investigators conducted a prospective, randomized, controlled trial in patients with type 2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery system, where diabetes center provided specialized management, mediated by nurse of primary health care posts using the Internet and the PDA-type glucometer, while the control group with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured at baseline and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients
* Aged ≥ 40 years
* Baseline HbA1c of 7.0 to 11.0 % who had been already followed up for more than 6 months in the health care post

Exclusion Criteria:

* Participants with diagnosed or suspected disease of the liver, pancreas, endocrine organs, or kidney
* Ischemic heart disease or cerebrovascular disease or a history of such disease
* A creatinine level \> 0.133 mmol/L
* Treatment with an intensified insulin regimens and those unable .
Management of Etonogestrel Subdermal Implant-related Bleeding

This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be conducted within the Mayo Clinic and the Mayo Clinic Health System.

The goal of the research study is to gather information to determine whether Doxycycline is effective for the treatment of unacceptable bleeding associated with the etonogestrel subdermal implant (ESI), as compared to placebo.

ESI is a long-acting reversible contraceptive. Though safety and efficacy have been established world wide, only about 1 % of women have been reported to use this method. Its use is limited by bleeding pattern changes which result in requests for early removal, most commonly within the first 8 months of use.

Women ages 18-51 years, choosing ESI and who meet eligibility criteria, will be offered enrollment in the study at the time of ESI insertion. Every effort will be made to insert Implanon on the same day as consent unless medically contraindicated. Prospective diaries will be completed starting on the date of ESI insertion. All participants will be contacted by study personnel 13 weeks after enrollment and queried as to the presence of unacceptable bleeding. Bleeding concerns will be objectively assessed using a modification of the Pictorial Blood Loss Assessment Chart (PBLAC).

Participants initiating contact with bleeding concerns at any time after 13 weeks post-ESI insertion will be offered treatment randomization at the time of contact. The basis for randomized treatment will be whether the bleeding is considered "unacceptable" to the participant. This is inherently subjective, but constitutes the basis for most removal requests. Participants that report unacceptable bleeding at 13 weeks post-ESI insertion, and those who call with bleeding concerns anytime after 13 weeks post-ESI insertion, will be randomized into one of two groups, Doxycycline or matching placebo.

Participants that do not report unacceptable bleeding will continue to complete diaries and may be eligible for randomized treatment if unacceptable bleeding develops.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, aged 18-51 years
* Expressed desire for compliance-independent contraception
* No current pregnancy or anticipated desire for childbearing within 3 years of study enrollment and Implanon insertion
* Agreement to participate in all study related procedures and evaluations as documented by a signed informed consent

Exclusion Criteria:

* Current or prior use of Implanon
* Current long-term use of Doxycycline for other indications
* Known structural uterine abnormalities such as polyp, submucosal leiomyoma
* Prior permanent sterilization or endometrial ablation
* Pregnancy or desire for childbearing within 3 years
* Contraindications to or intolerance of etonogestrel
* Allergy to or intolerance of Doxycycline
* Inability or unwillingness to complete study related procedures and evaluations