cyrilzakka/clinical-trials huggingface dataset:
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

The purpose of this study is to compare the effectiveness of three standard of care outreach approaches (i.e., mailed letter, secure message, and telephone call) on patient adoption of the new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy. The primary study endpoint is the proportion of patients in each outreach arm who adopt the new 10-year colonoscopy surveillance interval.


Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Northern California (KPNC) membership\>12 months
* Primary medical center is either KP San Rafael, KP San Francisco, KP San Leandro, or KP Walnut Creek
* 54-70 years of age at time of 5-year surveillance colonoscopy interval
* A baseline colonoscopy with a finding of 1-2 small tubular adenomas and are due for their 5-year surveillance procedure in 2022
* Average risk for CRC
* A valid mailing address, kp.org account (i.e., KPNC's secure messaging portal), and telephone number at time of study enrollment.

Exclusion Criteria:

* More than 12 months of membership prior to index colonoscopy, and indications that would make an individual above average risk for CRC, such as: adenoma with advanced histology on colonoscopy, adenoma \>10 mm on colonoscopy, family history of CRC, prior history of colonoscopy, prior history of adenomas or colon polyp diagnoses, history of IBD, history of hereditary polyposis syndrome, 3 or more adenomas, adenoma 10 mm in size or greater, adenoma with advanced histology, and any sessile serrated polyp or traditional serrated adenoma
Clinical and Functional Outcome After Lateral Trochlear Lengthening Osteotomy Lateral Trochlear Lengthening Osteotomy

The purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia Dejour type A or B, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.

A short lateral articular trochlea leads to failure in stabilizing the patella close to full Extension of the knee. To address this type of pathology, a trochlear lengthening osteotomy was described. To date only case reports describing the clinical outcome of this new osteotomy exist and information on functional outcome regarding muscle strength and electromyography (EMG) data is lacking. The purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia Dejour type A or B, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.

Eligibility Criteria:
Inclusion Criteria:

* 2 years (as of September 2019) since conducting a lateral trochlear lengthening osteotomy

Exclusion Criteria:

* Inability to provide informed consent
* Neurological disorders potentially affecting lower extremity muscle strength.
* Surgery involving the patellofemoral joint prior to the lateral trochlear lengthening osteotomy
Oral Care With Propolis in Pediatric Oncology Patients

According to the data from the World Health Organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of the most important side effects of both chemotherapy and radiotherapy. This study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple use of chemotherapeutic drugs.

According to the data from the World Health Organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of the most important side effects of both chemotherapy and radiotherapy. This study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple uses of chemotherapeutic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Receiving chemotherapy treatment for lymphoproliferative malignant disease (leukaemia, lymphoma) or other childhood solid tumour (such as central nervous system tumour, neuroblastoma, osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumours)
* Being between the ages of 2-18 (Although there is no harm in using propolis, it is inconvenient for children under the age of 2 to use honey and its by-products due to botulism)
* No development of oral mucositis
* The child who does not smoke

Exclusion Criteria:

* The patient does not receive head and neck RT (increases the incidence of oral mucositis by 40%).
* The patient is allergic to bee products.
* Exclusion Criteria and Practices in this Case:
* Development of an allergic reaction to propolis (Applied oral care protocol is stopped, removed from the sample)
* Starting RT
* The child's need for MV support
Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD

The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and compliance with SensAwake, compared to the same treatment without SensAwake.

Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromising therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.

It is hypothesised that AutoCPAP with SensAwake will improve patient comfort and compliance in the PTSD and OSA patients who are naïve to CPAP therapy.

The investigators will not be blinded to the study. The participants will be blinded to the study.

Eligibility Criteria:
Inclusion Criteria:

Male and female subjects \> 18 years Diagnosed with OSA by a practicing sleep physician, within the last six months Diagnosed with post-traumatic stress disorder as diagnosed by a behavioral health professional, and quantified by McChord PTSD checklist All races and ethnicities will be included Naïve to CPAP therapy (has not used CPAP within the last 5 years)

Exclusion Criteria:

\< 18 years of age if mental status is questionable, the patient will be excluded at the discretion of the consenting provider Unable/unwilling to follow the directions necessary for CPAP use Patients contraindicated for CPAP/AutoCPAP, at the discretion of the consenting provider
Effect E-learning Program About Child Maltreatment

The purpose of this study is to determine whether the e-learning program about the recognition of child maltreatment is effective in nurses on the A\&E department compared to a control group.

Child abuse and neglect represents an international problem with high prevalence and unacceptable levels of morbidity and mortality. Many children are seen each day in the accident and emergency departement of an hospital. Therefore the A\&E departement have an important role in the identification of child maltreatment. The lack of an effective teaching program together with the failures in the child protection process has encouraged the development of a clinical-practice-oriented e-learning program on detecting child maltreatment. We will investigate the effect of this e-learning program.

Eligibility Criteria:
Inclusion Criteria:

* Working at the A\&E department of the UMC-Utrecht.

Exclusion Criteria:

* Absent during one of the two measurement periods.
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR

The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure. The burden of oxidative stress will be determined by the measurement of GPx, superoxide dismutase (SOD) and lipoprotein A (Lp(a)). We hypothesize GPx activity is reduced in participants with severe AS vs control groups and GPx activity is to increase after TAVR is performed.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients with severe AS including participants with low flow, low gradient severe AS and paradoxical severe AS
* Patients meeting criteria for TAVR procedure

Exclusion Criteria:

* Previous aortic valve replacement (surgical or TAVR)
* Participants undergoing chemotherapy
* End stage liver disease/cirrhosis (liver produces GSH)
Brief Treatment for Posttraumatic Stress Disorder

The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.

The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Male and female active duty military personnel who have deployed in support of a post-9/11 conflict seeking treatment for PTSD
* Diagnosis of PTSD
* Ability to speak, read and write English
* Not currently engaged in psychosocial treatment for PTSD
* Individuals taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated.

Exclusion Criteria:

* Current suicide or homicide risk meriting crisis intervention
* Active psychosis
* Moderate to severe brain damage
Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer

The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years;
* histological and/or cytological confirmation of ACC;
* disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy;
* at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）
* ECOG performance status 0-1
* life expectancy of at least 3 months
* satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Alkaline phosphatase（ALP）≤3 UNL(For patients with liver metastasis, the ALP must be ≤5.0 UNL);
* written informed consent

Exclusion Criteria:

* prior exposure to raltitrexed;
* Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (\<=6 months before treatment start),congestive heart failure （New York Heart Association ，NYHA\>= grade 3）,stroke or transient ischemic attack
* Accept kidney dialysis treatment now
* chronic enteropathy on unresolved bowel obstruction;
* previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;
* the UGT1A1 \*28（7/7）\*6（A/A） gene type;
* pregnant or lactated women;
* Unsuitable for the study or other chemotherapy determined by investigator.
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.


Eligibility Criteria:
Inclusion Criteria:

1. A subject's parent/legal representative provides a written consent after being informed about the study objective, methods, effect of the study vaccine, and other relevant information
2. Documented record of the three doses of primary immunization against diphtheria, tetanus, pertussis, and polio either by participating in the previous study, BR-DTPP-CT-301 or by following the national immunization schedule under usual clinical setting (the primary immunization should have been initiated after 6 weeks of age and at minimal interval of 4 weeks)
3. Receipt of a boosting dose against diphtheria, tetanus, and pertussis until 2 years of age; therefore, total of four vaccination records against diphtheria, tetanus, and pertussis and three against polio
4. Healthy male or female children, aged 4 to 6 years on the day of the vaccination

Exclusion Criteria:

1. Children aged 7 years or older
2. Previously received DTaP vaccine five times or more, including the doses received in the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine
3. Previously received IPV vaccine four times or more, including the doses received in the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine
4. The fourth dose of DTaP vaccine was postponed and administered after 4 years of age
5. Acute febrile illness with fever ≥ 38.0°C (tympanic) on the day of the vaccination
6. Moderate to severe systemic acute illness with or without fever
7. History of diphtheria, tetanus, pertussis, or polio (poliomyelitis)
8. Dysfunctional immune system or congenital or acquired immunodeficiency
9. Had encephalopathy of unknown etiology within 7 days following a previous dose of DTaP vaccine
10. Received a vaccine other than the protocol-permitted vaccines within 28 days from the study vaccination day or are planned to receive such a vaccine during the study period
11. Received systemic corticosteroid treatment at immunosuppressive dosage within 28 days from the study vaccination day or are planned to receive such a treatment during the study period (exceptionally, administration of prednisolone ≤ 0.5 mg/kg/day for up to 14 continuous days is allowed)
12. Received immunoglobulins or blood products within 90 days before the study vaccination day or are planned to receive such products during the study period
13. Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigational product or bears such a possibility
14. Currently enrolled in another clinical trial or planned to participate in another clinical trial
15. Any other reasons that preclude the eligibility of the subject, based on investigator's decision
Internal Bracing Following ACL Reconstruction

The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing.

The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

• History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.

Exclusion Criteria:

* Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
* History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.
HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

This study evaluates the association between early trauma, depression and metabolic symptoms.

Early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal axis (HPA-axis) indicated by an increased response to stress, a diminished negative feedback and alterations in expression of glucocorticoid receptors. Patients with a history of childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus type 2 or metabolic syndrome.

The investigators will examine participants with and without early life stress and with and without major depression. The investigators assume that traumatized study participants (1) show an increased endocrine stress reaction to psychosocial stress, (2) display an altered sensitivity of GR, and (3) therefore suffer from an adverse cardiovascular risk profile in comparison to not-traumatized participants.

The investigators study will increase current knowledge on possible sequel of early traumatic stress. The results will lead to a more comprehensive understanding of stress-related eating behaviour and its implications.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MDD and/or experience of early trauma

Exclusion Criteria:

* severe illness,
* control group: no diagnosis of MDD and experience of early trauma
The Role of Cathepsin X in Infection With the Helicobacter Pylori

The immune response to Helicobacter pylori (Hp) importantly determines the pathogenesis of infection as well as the success of antibiotic eradication of the bacteria. The investigators want to demonstrate the importance of cathepsin X (CTSX), a cysteine protease, for the Hp eradication success. The diversity of the innate immune response to H. pylori antigens leading to either successful eradication of the infection or maintenance of chronic inflammation is connected to CTSX. The aim of this study is to determine whether H. pylori suppresses the CTSX expression and cytokine secretion in macrophage cell line THP-1 in the individuals that are not capable of eradicating the infection, opposite to H pylori in patients with successful H pylori eradication . The investigators also investigate the possibility whether strain-dependent differences in H. pylori lipopolysaccharide (LPS) influence the CTSX expression and cytokine secretion.


Eligibility Criteria:
Inclusion Criteria:People with helicobacter gastritis and Helicobacter sensitive to antibiotic therapy but failure of therapy -

Exclusion Criteria:People with helicobacter gastritis who did not eradicate Helicobacter pylori because of primary resistance to antibiotics.

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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects

The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. males or females, aged 18-55;
2. body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and \<90.0 kg; female ≥45.0 kg and \<90.0 kg.

Exclusion Criteria:

1. previous medical history of coagulation or bleeding disorders;
2. known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"

The purpose of this survey is to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on long-term pioglitazone (Actos Tablets) treatment.

This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters, and to analyze the association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an exploratory setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 20000.

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have type 2 diabetes mellitus and have undergone measurements for all of the following parameters to be included in this survey:

Waist circumference, height, body weight, blood pressure, Haemoglobin A1c (HbA1c), fasting triglyceride, High-density Lipoprotein (HDL)-cholesterol

Exclusion Criteria:

* Patients meeting any of the following criteria (1) to (5) will be excluded:

  1. Patients with any contraindications to pioglitazone (Actos Tablets) treatment as specified below:

     Cardiac failure, history of cardiac failure, severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, serious hepatic dysfunction, serious renal dysfunction, severe infection, perioperative state, serious trauma, history of hypersensitivity to any ingredients of pioglitazone (Actos Tablets), pregnancy or possible pregnancy
  2. Patients aged \< 20 or ≥ 75 years
  3. Patients who currently have or have had any of the following: myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease (including left ventricular hypertrophy with cardiac hypofunction\*), atrial fibrillation, atrial flutter, valvular disease, aortic dissection, cerebral infarction, cerebral hemorrhage (including subarachnoid hemorrhage). (\*Reduced cardiac function is roughly defined as having a brain natriuretic peptide \[BNP\] ≥ 40 pg/mL.)
  4. Patients who have taken pioglitazone (Actos Tablets) within 3 months before enrollment in this survey
  5. Patients who have been enrolled in the candesartan cilexetil (Blopress) special drug use surveillance "hypertension: survey on metabolic equivalents (MetS) (Challenge-MetS)" at each medical institution.