cyrilzakka/clinical-trials huggingface dataset:
Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment

The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.

This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.

Eligibility Criteria:
Inclusion Criteria:

* 18 year old ≤ Male or female \< 75 year old
* Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
* Patients who understand the study conditions
* Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud

Exclusion Criteria:

* Patients with known allergy or hypersensitivity reaction to the Investigational products
* Patients who use the Investigational products
* Patients who undergone H.pylori eradication
* Patients with abnormal laboratory results, as specified below:

Total bilirubin, creatinine \> 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen \> 2 x upper limit of normal

* Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products
* Pregnant women and lactating women
* Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)
* Patients with uncontrolled Diabetes mellitus
* Patients with uncontrolled Hypertension
* Patients with Alcoholics
* Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)
* Patients who had undergone a esophageal or gastric surgery
* Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
* Patients who had participated in other investigational study within 30 days before the study entry (Day 1)
* Patients who, in the investigator's opinion, are not suitable for the study for any other reason
A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
* a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
* No evidence of active or latent tuberculosis

Exclusion Criteria:

* Non-plaque or drug induced forms of psoriasis
* cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
* any uncontrolled significant medical condition
The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity

The purpose of this study is to assess whether the diuretic drug spironolactone can prevent chronic damage to transplanted kidneys caused by the medication that prevents rejection.

Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of being involved in the processes leading to chronic rejection of transplanted kidneys. Hence, by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function in transplant patients.

AIM: The purpose of this study is to assess whether spironolactone can prevent the formation of fibrosis in transplanted kidneys.

BACKGROUND: Calcineurin inhibitors (CNI) are one of the cornerstones of immunosuppressive therapy after kidney transplantation. The introduction of CNI has caused a significant decrease in acute rejections. However, CNI also have known side effects. These include the formation of tubulointerstitial fibrosis in the transplanted kidney, contributing over time to impaired kidney function and reduced graft survival.

The mineralocorticoid aldosterone may be involved in the development of renal fibrosis. Recent observations suggest that aldosterone plays a central role in the pathogenesis of CNI nephrotoxicity and that the mineralocorticoid-receptor-blocker spironolactone could be a useful agent to prevent it.

METHODS: This study is a randomized, placebo-controlled, double-blind study in which 170 renal transplant patients will be recruited from two nephrological departments in Southern Denmark. Patients will be randomized to three years of treatment with either spironolactone or placebo added to the standard immunosuppressive treatment. Renal graft biopsies, various molecular tests of tissue, blood and urine, chrome-EDTA clearance, 24-hour bloodpressure measurement and blood samples will be performed at inclusion, after 1 year, 2 years and upon completion.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Proteinuria \< 3 g/24 hours
3. Creatinine clearance ≥ 30 mL/min
4. S-Potassium \< 5,5 mmol/L
5. Negative pregnancy test at the inclusion and anticonception

Exclusion Criteria:

1. Intolerance to spironolactone
2. Creatinine clearance \< 30 ml/min
3. S-Potassium ≥ 5,5 mmol/L
4. Resin or digoxine treatment
5. Pregnancy or planned pregnancy
6. Relevant organic, systemic or mental illness
7. Anticipation of lack of compliance or understanding the study
Observational Study to Assess the Quality of Life in Nephropathic Cystinosis Patients

Most of the real world evidence data related to efficacy of cysteamine therapy is retrospective. This study is a ambispective study to investigate the impact of cystine depletion therapy on the quality of life of patients and their parents.


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of nephropathic cystinosis
* Undergoing cystine depletion therapy with oral cysteamine
* Signature of informed concent.
Drug Use Investigation of COMIRNATY Intramuscular Injection

Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.

The healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected.

If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed.

If booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and COVID-19 will be continuously obtained after booster vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.

Exclusion Criteria:

* No exclusion criteria.
Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.

The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in patients with colorectal liver metastases (CLM) is object of debate. We build a study, using the propensity score matched analysis, to compare the short- and long-term outcome of the tow groups of patients.

The aim of this study is to investigate the outcome of patients with colorectal liver metastases (CLM) undergoing multiple minor hepatectomies (MMH) instead of major hepatectomies (MH). Indeed, the performance of MMH versus MH in patients with CLM is object of debate. For this purpose, the databases at two independent institutions were retrospectively reviewed. To control for confounding variable distributions, a propensity score-matched analysis 1:1 was performed, and the nearest neighbor-matching method with caliper distance of 0.01 was used. Among 554 patients, 110 patients undergoing MMH and 110 undergoing MH were matched. They were similar in baseline characteristics, comorbidities, features of the primary tumors, and CLM. Primary outcomes were short- and long-term outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLM

Exclusion Criteria:

* Uncertain diagnosis
* Lost at follow-up
Is Osteoporosis Education Effective in Parkinsonian Patients

The effects of osteoporosis (OP) education on OP patients and the normal population studied and described in numerous studies. But the effects of OP education on Parkinsonian patients have not been sufficiently elucidated.

The purpose of this study was to evaluate the effect of OP education on the OP knowledge level and daily life in Parkinsonian patients.

Our hypothesis is; to Parkinsonian patients; there is a statistically significant difference in terms of OP knowledge level and daily life between giving only informative leaflets about OP and also providing structured OP education.

54 participants aged 50 and older with Parkinson's Disease were randomized to the experimental and control groups. While only leaflets were given to the control group, structured OP education was also given to the experimental group. Patients were evaluated with the same structured face-to-face interviews at the entrance and 12 weeks later.

The OP education was performed in groups of 4-5 people by a single physician in the form of verbal expression via slide, with a duration of 20 minutes and in the form of a single session. Our leaflets contained the same information as the OP education program.

Face-to-face interviews include; Revised 2011 Osteoporosis Knowledge Test (rOKT) (0-32 points) for OP knowledge levels; National Osteoporosis Foundation daily calcium intake scale \[NOF, (mg)\], Physical Activity Scale For The Elderly (PASE, 0-763 points), smoking and alcohol use status (Yes/No) and quantities (cigarette pack/per week, alcohol unit/per week), frequency of falls (times/last 1 month) were questioned for effects on daily life.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 50 years or older
2. Being diagnosed with Parkinson's Disease

Exclusion Criteria:

1. Severe physical and cognitive dysability
ODSH + ICE Chemotherapy in Pediatric Solid Tumors

This study will be with pediatric patients who have refractory/recurrent solid tumors. They will receive standard chemotherapy (ICE) and we are investigating if the addition of a new drug, ODSH, will help to increase the time of their platelet recovery after ICE chemotherapy.The purpose of this study is to evaluate the safety and tolerability of ODSH in pediatric patients receiving "ICE" chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or refractory solid tumors. This may include, but is not limited to, osteosarcoma, chondrosarcoma, Ewing's sarcoma, Wilm's Tumor, medulloblastoma, neuroblastoma, hepatoblastoma, rhabdomyosarcoma, retinoblastoma, and primitive neuroectodermal tumors. Histologic proof malignancy must have been available at the time of initial diagnosis.
* Age: 1-21
* Patients must have received standard first-line chemotherapy or other appropriate standard first line therapy for their malignancy.
* Patients must have radiologic or histologic evidence of recurrence
* Patients must have fully recovered from the toxic effects of the prior chemotherapy and must have an ANC \>1000/μL and a platelet count \>100,000/μL
* Performance status \> 60 from Lansky (age 1 to 16) or Karnofsky (age \> 16)
* Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine \< 2.5 x upper normal limit).
* Parent or guardian able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* Patients who, in the investigator's opinion, have extensive bone marrow involvement with tumor
* Presence of significant active infection or uncontrolled bleeding
* Renal insufficiency, which, in the opinion of the investigator, might adversely affect schedule and dose of therapy ICE chemotherapy. patients with creatinine levels ≥2 mg/dl are not eligible
* Pre-existing liver disease , other than liver metastasis
* Use of recreational drugs within the prior month
* Known history of positive hepatitis B surface antigens or HCV antibodies
* Known history of positive test for HIV antibodies
* Patients receiving any form of anticoagulant therapy
* Presence of a known bleeding disorder or coagulation abnormality
* Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry
* Pregnant or breast-feeding patients
* Patient with childbearing potential not using adequate contraception
* Hemorrhage risk that requires maintenance of platelet counts at 50,000 or higher.
* Psychiatric or neurologic conditions that could compromise patient safety or compliance, or interfere with the ability of the patient or family to give proper informed consent.
Staging Procedures to Diagnose Malignant Pleural Mesothelioma

The purpose of this study is to evaluate the accuracy of participants imaging versus staging procedures. The investigators will consent subjects that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo a staging pleuroscopy
* Subject is a surgical candidate
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.

Exclusion Criteria:

* Subject is \<18 years old.
Pharmacogenomics of Methadone in Spine Fusion Surgery

The overall objective is to develop a patient oriented research program to efficiently evaluate the effects of pharmacogenetic variants on the dose-response relationships and safety of opioids and non-opioid analgesics. If an opioid regimen can be created that produces excellent opioid analgesia with minimal toxicity related to supratherapeutic opioid concentrations (i.e., ventilatory depression), other non-opioid analgesics (i.e., gabapentin/pregabalin, ketamine, lidocaine, cyclooxygenase inhibitors, etc.) that may decrease preoperative opioid requirements can be more efficiently and safely evaluated. These interventions may limit the opioid related toxicities related to effect site concentrations that are below those required when opioids are the predominant analgesic, such as opioid related ileus. Methadone's slow elimination clearance and limited pharmacokinetic drug-drug interactions make it an attractive perioperative opioid. The first step towards personalized opioid analgesia is to determine the effect of common pharmacogenetic variants that affect either methadone metabolism (CYP2B6) or opioid elimination.

This study is being done to find the optimal dose of methadone (a long acting pain medication) that decreases the amount of pain that people have after spine surgery. Five different doses of methadone will be compared to each other, while keeping the remainder of the anesthetic routine for surgery. The investigators will determine the analgesic dose-response of methadone. The investigators will also determine the effect of methadone on the incidence of opioid related side effects, the quality of outcome of recovery, and the change in the 3-month opioid use.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I, II, and III
* male and non-pregnant female
* English-speaking
* undergoing elective \< 3 vertebral level lumbar spine fusion (with and without interbody fusion)

Exclusion Criteria:

* Use of more than the equivalent of 20 mg of IV morphine/24 hr in the past 2 weeks
* history of substance abuse at any time in the past
* known QT prolongation
* Non-elective operations (i.e., cancer or trauma)
* severe hepatic impairment (serum albumin \<3.0 g/dL, history of liver disease)
* pregnancy
Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care

In this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center.

This study is a quasi-randomized mixed methods evaluation of the implementation of an innovative collaborative care model to assess whether it is feasible and improves indicators of diabetes and mental health, while exploring themes that will inform redesign of the care model to improve healthcare delivery to young adults with diabetes transitioning to the adult care setting. We will compare primary and secondary outcomes in this model to those in the usual care model for adult diabetes management at MGH Diabetes Center. Those who agree to the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study. The electronic health records (EHRs) of these patients who agree to the research study will also be examined. All patients who successfully complete all 3 survey questionnaires will be eligible for a structured interview portion of the study to explore themes that will inform care model redesign.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* Between ages 18 and 30 years
* Any duration of diabetes
* Must self-manage diabetes
* A new patients at the Massachusetts General Hospital (MGH) Diabetes Center at 50 Staniford Street as of September 1, 2021.
* The patient does not have to be diagnosed with diabetes in youth or have been previously seen at MGH for Children (MGHfC) Pediatric Diabetes Clinic to be included

Exclusion Criteria:

* Patients with gestational diabetes, diabetes during pregnancy, MODY, or other forms of diabetes
* Patients with type 2 diabetes who are on no medications (diet-controlled), or metformin only unless they are within one year of diabetes onset
* Patients with significant cognitive, physical, or mental disability requiring that their diabetes care be managed by another individual (i.e. parent, spouse, guardian, nurse, residential facility) more than 25% of the time
* Non-English speaking
* Patients who are pregnant
Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback (COMPLETE)

I plan to investigate the value of video-based feedback in endoscopic training - specifically, the role of terminal video feedback as compared to usual concurrent feedback on cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills (DOPyS) competency score. I have focused the study on the competency of cold snare polypectomy for subcentimeter polyps. The majority (\>75%) of colon polyps are smaller than one centimeter. Cold snare polypectomy has been shown, and recommended by the American Society for Gastrointestinal Endoscopy (ASGE), to be an effective removal technique. However, its widespread use and moreover, its teaching to trainees is lacking. It takes time and resources to learn and teach endoscopic techniques. Our study will hope to identify a mechanism through video-based feedback that could help to improve the translation of the training of polypectomy skills to its actual performance, and to accelerate the learning curve.


Eligibility Criteria:
Inclusion Criteria:

* Participants: Senior level UCSF gastroenterology trainees (2nd and 3rd year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center (SFVAMC).
* Patients undergoing elective routine colonoscopy procedure.

Exclusion Criteria:

* Participants: Junior level University of California, San Francisco (UCSF) gastroenterology trainees (1st year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center, and senior level trainees who are not rotating at the SFVAMC.
* Patients: Patients undergoing undergoing emergency colonoscopy procedure.
Follow-up of HBsAg Inactive Carriers Study

The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (\< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.


Eligibility Criteria:
Inclusion Criteria:

* HBsAg + since one year or more.

  * HBeAg -, anti-HBe antibodies +
  * HBV-DNA \< 20000 UI/ml on all dosages realized during past year (ultra-sensitive PCR with a detection threshold \< 20 UI/ml), at least 2 dosages during past year.
  * AST and ALT transaminases \< ULN on all dosages realized during past year (at least 3).
  * Age \> 18 and \< 70
  * We will include consecutively all encountered patients (consultation, hospitalization) and diagnosed as HBsAg inactive carriers in each participating center.

Exclusion Criteria:

* anti-VHC antibodies +
* anti-VHD antibodies +
* anti-VIH antibodies +
* genetic hemochromatosis
* liver cirrhosis on liver biopsy or with non-invasive methods (Fibrometer, Fibroscan, Fibrotest, Hepascore ...)
* Past or present treatment against HBV
* Ultrasonic diagnosis of HCC or Portal Hypertension
* non compliant patient whom 5 years follow-up seems uncertain.