cyrilzakka/clinical-trials huggingface dataset:
Open Study Assessing the Feasibility of Minocycline in Patients With Unipolar Depression

A single center, open label study assessing the feasibility, safety and therapeutic effect of Minocycline in adult patients with diagnosis of unipolar depression. Up to 30 patients diagnosed with unipolar depression that are in a current depressive episode. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and have HDRS-21≥20. All subjects will continue to take their treatment with antidepressant medications for the duration of the study. All subjects are prescribed minocycline 200 mg/day orally (2X100 mg) for the first 3 days. than, all subjects are prescribed minocycline 400 mg/day orally (2X200 mg) from day 4 until termination visit (day 35). The primary objective of this study is to assess the therapeutic effect of Minocycline in unipolar depression.

The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of Minocycline in unipolar depression.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients and inpatients
2. Men and women 18-68 years of age.
3. Primary DSM-IV diagnosis of Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
4. Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
5. The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
6. Capable and willing to provide informed consent
7. Able to adhere to the treatment schedule.

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Exclusion Criteria:

1. Depression secondary to a general medical condition.
2. History of substance abuse or dependence within the past 6 month (except opioids, nicotine and caffeine).
3. All antidepressant medications, must have been in stable dosage for at least 3 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
4. Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
5. Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
6. Subjects who were taking a known contraindication to minocycline treatment.
7. Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
8. Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
9. Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.(if using oral contraceptives, during the minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding
10. Patients with severe hepatic or renal insufficiency.

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Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer

The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical resection of rectal carcinoma). This study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

A temporary stoma may, in fact, result in reduced quality of life because of feelings of physical and mental restriction, debilitating nuisance, among other problems. Skin irritation, prolapse, and retractionare quite common after ileostomy. A high incidence of parastomal hernia, ileus, and increased salt and fluid loss has been reported, which may also contribute to greater willingness of both the surgeon and patient to close the temporary stoma as soon as possible.

Currently, it remains unclear whether stoma closure should be performed after the end of chemotherapy or during chemotherapy (12 weeks or 24 weeks after radical resection of rectal carcinoma).

The aim of this study is to assess the possible impact of stoma closure timing on postoperative results and to evaluate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

Eligibility Criteria:
Inclusion Criteria:

* sign the informed consent
* postoperative pathology is rectal adenocarcinoma
* primary middle and low rectal cancer patients (tumor distance from the anal margin is less than 10 cm)
* underwent total mesorectal excision for rectal cancer with preventive loop ileostomy

Exclusion Criteria:

* postoperative pathology is not rectal adenocarcinoma (rectal neuroendocrine tumor, lymphoma, etc.)
* postoperative pathologic staging of rectal cancer is I phase, II phase
* underwent total mesorectal excision for rectal cancer without preventive loop ileostomy
* emergency operation for rectal cancer
* disease progression (local recurrence or distant metastasis, etc.)
* anastomotic stenosis
* serious system disease, including heart dysfunction, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases
* participate in other clinical trial
* pregnancy or perinatal woman
* combined with other malignant tumor
* with a history of neurological and psychiatric disorders
* patients with abnormal bone marrow suppression after chemotherapy
Use of a Nurse Pain Educator for Patients With Chronic Pain

This multicenter randomized (block randomization) controlled parallel arm pilot study comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that treat chronic non cancer pain patients with opioid analgesics. Subjects who are either opioid naïve or opioid experienced will be enrolled into the study.

The Nurse Pain Educator arm shall have two phases: a Pre-Teaching Phase and a Teaching/Knowledge Maintenance Phase. During the Pre-Teaching Phase, all subjects who are enrolled will complete different baseline assessments and will be prescribed an opioid. Subjects will then enter the Teaching/Knowledge Maintenance Phase. Subject enrolled into the Nurse Pain Educator arm will be educated on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics. Subjects will meet monthly with the Nurse Educator for up to 5 months for reinforcement of their training and to assess their use of their medication, their quality of life and their physical and mental well-being.

Subjects who are enrolled into the study arm with no Nurse Pain Educator will be monitored every month to assess their use of their medication, their quality of life and their physical and mental well-being. No intervention will be conducted with these subjects beyond that of standard of care at the facility. Subjects will be evaluated monthly but primary differences in outcomes will compare baseline to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read, understand, and provide written informed consent
* Male or Female patients ≥ 18 years of age
* Diagnosed with non-cancer pain for \>3 months
* Ability to meet study requirements (i.e., can attend monthly visits, able to complete questionnaires, etc.)
* Prescribed an oral opioid that will last duration of the study period
* Provide a completed Opioid Patient Prescriber Agreement

Exclusion Criteria:

* Diagnosed with chronic cancer pain
* Personal or family history of alcohol or drug abuse in the past 5 years
* Personal or family history of major mental illness
A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis

The purpose of this study is to compare the number of osteoarthritis patients receiving titrated or increasing doses of tramadol hydrochloride/acetaminophen combination tablet (titration group) who discontinue treatment due to adverse events to the number of patients receiving a non-titrated dose of tramadol/hydrochloride/acetaminophen combination tablet who discontinue treatment due to adverse events.

This is a randomized (study drug assigned by chance), multicenter, double-blind (neither physician nor patient knows the name of the assigned drug), add-on study (NSAIDs or COX-2 medications maintained at pre-study dose.) to investigate the tolerability of titrated doses of tramadol hydrochloride/acetaminophen combination tablet in osteoarthritis patients taking NSAIDS or COX-2 inhibitors (both are drugs used to treat inflammation and pain) compared to non-titrated doses of tramadol hydrochloride/acetaminophen combination tablet. The patients will be randomized into 2 treatment groups. First group (the titration group) receives 1 tablet of tramadol hydrochloride/acetaminophen in the morning, 1 tablet of placebo in the afternoon and evening for 3 days, then 1 tablet of tramadol hydrochloride/acetaminophen in the morning, 1 tablet of placebo in the afternoon and 1 tablet of tramadol hydrochloride/acetaminophen in the evening for 4 days, and the 1 tablet of tramadol hydrochloride/acetaminophen three times daily for next 7 days. The second group (non-titration group) will receive 1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days. The study hypothesis is the first group's discontinuation rate due to adverse events is lower than that of second group. Safety assessments include adverse event, vital sign and clinical lab monitoring. First group will receive 1 tablet of tramadol hydrochloride/acetaminophen and 2 tablets of placebo for 3 days, 2 tablets of tramadol hydrochloride/acetaminophen and 1 tablet of placebo for 4 days, and 3 tablets of tramadol hydrochloride/acetaminophen for 7 days. Second group will receive 3 tablets of tramadol hydrochloride/acetaminophen for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Must have osteoarthritis of the knee for at least one year based on clinical and radiological criteria
* Must have been on a stable daily dose of a NSAID for at least two weeks prior to randomization
* Must have a pain intensity Numeric Rating Scale (NRS) score 4 or more as a average intensity for 48 hours. (On a Numeric Rating Scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)

Exclusion Criteria:

* Have taken tramadol HCL within 14 days prior to randomization
* Have taken acetaminophen within 7 days prior to randomization
* Have received other pain medication (including topical medication and/or anesthetics), sedative hypnotics, or muscle relaxants within a period of less than five half-lives of the given medication prior to randomization
Purine Metabolism Enzyme SNP to Uric Acid Production

Determine whether a relationship exists between polymorphisms of the genes XDH, HPRT1, and PRPS1 and gout, hyperuricemia, or the dose of xanthine oxidase (XO) inhibitors to reach a goal serum uric acid of less than 6 mg/dL. This study is observational in nature as no dose adjustment of XO inhibitors will be made by study investigators.

Background: Our recent gout study demonstrated a relationship between the xanthine oxidase (XO) single nucleotide polymorphism (SNP) 2107A\>G to the dose of allopurinol needed to reach a goal serum uric acid level of 6 mg/dL or less. This study had some limitations but suggests that specific SNPs could be related to dose of allopurinol needed to treat.

Objective: To determine the relationship of multiple purine enzyme SNPs of genes encoding PRPS1, HPRT1, and XO to the dose of xanthine oxidase inhibitor needed to achieve a goal treatment uric acid level of less than 6 mg/dL. Another primary outcome will be to determine relationship of two XO SNPs to hyperuricemia/gout. A secondary outcome will be to determine the frequency of these SNPs tested.

Design: Patients will be consented for enrollment in either the gout/hyperuricemia group or a control group. Control group patients will have neither gout nor hyperuricemia. No patients will be enrolled if they are overproducers of uric acid. It is anticipated that 200 patients will be enrolled in each group for a total of 400 patients over the next 2 years.

Eligibility Criteria:
Inclusion Criteria:

* The study will be open to all adults over age 18 years of age who satisfy at least one of the conditions below:
* Have asymptomatic hyperuricemia (serum uric acid level \> 7.0 mg/dL) on at least 2 separate occasions,
* Clinical diagnosis of gout,
* Have neither asymptomatic hyperuricemia or gout but will serve as part of the control group (approximate age/gender matched control)

Exclusion Criteria:

* To best isolate the relationship between purine enzyme SNPs to hyperuricemia or gout and its treatment, factors which could elevate the serum uric acid level independent of protein function need to be excluded. Specifically, patients who are "overproducers" of serum uric acid will be excluded:
* Have a myeloproliferative disorder (hematologic malignancy such as leukemia or lymphoma)
* Are actively receiving therapy for any neoplasia (aside from non-melanoma skin cacner)
* Have greater than 5% of skin involvement from psoriasis
* Have a known history of xanthinuria
* Consume more than 14 drinks per week of alcoholic beverages

Patients that are pregnant or nursing will not be enrolled. Patients to be enrolled in the control group will also be excluded from enrollment if they have any of the conditions above.
Descriptive Analysis of Real-world Data Collected with ME&MGopen

The ME\&MGopen smartphone application is an investigational software for research purposes only, developed by Ad Scientiam. It features digital tests to assess the respiratory capacity ("My Breathing" Test), dysarthria ("My Voice" Test), ptosis ("My eyelids" test), as well as upper and lower limb muscle function ("My arms" Test and "My legs" Test). The mobile app also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression. The objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, user experience and satisfaction with the application, and safety of use.

The ME\&MGopen smartphone application is an investigational software for research purposes only, developed by Ad Scientiam. It features digital tests to assess the respiratory capacity ("My Breathing" Test), dysarthria ("My Voice" Test), ptosis ("My eyelids" test), as well as upper and lower limb muscle function ("My arms" Test and "My legs" Test). The mobile app also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression.

The objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, user experience and satisfaction with the application, and safety of use.

Analyses will also be performed to identify factors that may influence these parameters and provide levers for understanding and improvement. The existence of a possible learning effect on active testing will also be explored as a data point of interest.

The results will allow researchers to extend their knowledge of gMG from real-life data and of the use of digital tools in a gMG patient population

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 + years old
* Diagnosis of gMG with positive serologic test for anti-AChR autoantibody at screening
* Who has read the information sheet and signed the informed consent form
* Owns a personal smartphone which version is above 14 for IOS and 8 for Android included
* Able to use a smartphone
* Able to perform the ME\&MG tests (based on investigator's judgment)
* Able to read language in which the mobile application is available (English, Spanish, German) and able to understand pictograms

Exclusion Criteria:

* Participating in another ME\&MG trial
* Aged 17 years or younger
* A medical, psychological, or behavioral condition which interferes with compliance
Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers

RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer.

PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.

OBJECTIVES:

* To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).

OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.

Previously collected DNA samples are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. The epidemiological and SNP data contributed to the Central Database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Known positive BRCA1/BRCA2 mutation carrier
* With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199
* Currently enrolled in clinical trial GOG-0199 AND meets the following criteria:

  * Completed baseline questionnaire (BQ-199)
  * Provided information on prior breast cancer history, including date of diagnosis
  * Provided complete data from the DNA analysis on the genetic variants of interest
  * Signed an approved informed consent and authorization permitting release of personal health information
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home

This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.

We will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (DM) disease-management module (known as Cyber-DM) can improve the quality of adult diabetes care. The module will be Web-based, include a graphical HTML "front end" user interface, and will be incorporated into each patient's existing Web-based electronic medical record --the Medical Information Networked Database (MIND) repository at the University of Washington Academic Medical Centers. This Web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers:

1. An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.
2. Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.
3. An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.
4. The ability to download glucometer readings and medication-use information from home directly into the MIND repository.
5. Secure email communication between patients, their primary care physicians, and clinic staff.

A total of 80-85 diabetic patients who are regular utilizers of the UW's General Internal Medicine Clinic and who have home Internet access will be randomized to the experimental and control arms of the trial. Control subjects will receive usual care. We hypothesize that use of Cyber-DM will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. A trial this size would have the statistical power to detect a change in HbA1c of 0.50%. Secure Socket Layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.

Eligibility Criteria:
Inclusion Criteria:

* computer and Internet access at home
* receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt

Exclusion Criteria:

* non-English speaking
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care

A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour changes. In Denmark, the tendency is that nurses in general practice provide a large part of type 2 diabetes care.

Observational studies support Self-determination Theory by finding autonomous motivation and perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes. Hence, research is needed to develop and test interventions that are autonomy supportive.

Aim To develop a training course for practice-nurses in autonomy support in patients with type 2 diabetes, and to evaluate the effect on patient outcomes.

Methods The development of the intervention was based on literature research and expert meetings. The intervention is evaluated in a cluster randomised controlled trial with 40 Danish general practices,

* where nurses, before enrolment in the study, provided consultations to patients with type 2 diabetes,
* and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.

The patients will be followed 15 months from nurse-participation in the course. Data will be obtained from registers and patient-questionnaires. The hypothesis is that patients with type 2 diabetes regardless of education level, age, and gender will benefit from the intervention.


Eligibility Criteria:
Inclusion Criteria:

* The intervention-study comprises 40 general practices were:

  1. more than 50% of the patients with type 2 diabetes, who had participated in diabetes-consultations during the last year from the invitation-date to the project, were seen by a nurse at least once, stated by the practice. The diabetes-consultation should not only include examinations (blood tests and blood pressure measurement), but should also include communication about living with type 2 diabetes ;
  2. enrollment in the project before registration deadline (three weeks after invitation).

Patients with diabetes, alive and affiliated the practices by May 2011, were identified in a a validated diabetes database based on health registers; The national Patient Registry, The national Health Insurance Service registry, the prescription database and the laboratory database in the county.