cyrilzakka/clinical-trials huggingface dataset:
Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL®

The objective of this study is to collect outcome information on patients requiring Total Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK® Endo-Model® SL® under routine conditions.

Post Market Clinical Follow-ups (PMCF) through observational investigations are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine condition. Against this background a prospective multi-center study with the LINK® Endo-Model® SL® will be conducted.

Eligibility Criteria:
Inclusion criteria

* Implantation of the LINK® Endo-Model® SL®.
* Between 18 and 78 years of age.
* Patient has signed the Informed Consent. The indications and contraindications for the implantation of the LINK® Endo-Model® SL® listed in the product catalogue and chapter 2.5 and 2.6 \[of the protocol\] are applicable and have to be considered / fulfilled

Exclusion criteria

* Body Mass Index (BMI) \> 40 kg/m2
* Poor general state of health with a foreseeable life expectancy of less than 5 years
* Knee replacement on the contralateral side within the last year and with a KSS fuctional score \< 70 points
* Comorbidities and known medical circumstances which forseeable affect the clinical functional results after implantation (e.g. neurological or musculoskeletal impairments)
* Revision in floride septic environment
* Female patient who is pregnant
* Prisoner
* Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule
Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight

RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life.

PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in helping women with stage I, stage II, or stage III breast cancer in complete remission lose weight.

OBJECTIVES:

* Determine the ability to recruit survivors of estrogen receptor/progesterone receptor (ER/PR)-negative stage I-III breast cancer to participate in a 3-month, soy-based, meal-replacement (Almased®) weight loss intervention.
* Assess the patient's ability to adhere to this intervention protocol.
* Measure changes in anthropometrics (body weight, bioelectrical impedance, waist circumference) and biomarkers (serum levels of glucose, insulin, highly specific C-reactive protein, insulin-like growth factor, insulin-like growth factor binding protein-3, lipids).
* Measure changes in health-related quality of life.

OUTLINE: This is a prospective, longitudinal, pilot study.

Patients undergo goal-oriented, cognitive-behavioral therapy comprising group counseling weekly for 3 weeks and individual counseling once a month. Weight loss interventions include behavioral techniques, dietary modification (using a portion-controlled diet and soy-based meal-replacement \[Almased®\] once or twice daily), physical activity (≥ 15 minutes per day, 6 days a week), and social support. Weight loss is monitored weekly and patients complete daily logs of dietary intake and physical activity. Therapy continues for 12 weeks.

Health-related quality of life is assessed at baseline and then weekly for 12 weeks.

Patients undergo blood draws at baseline and at 12 weeks for analysis of C-reactive protein, glucose, insulin, insulin-like growth factor (ILGF), and ILGF-binding protein-3.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Previously diagnosed stage I-III breast cancer currently in complete remission
* Completed treatment for breast cancer ≥ 6 months ago

  * Free of disease at last clinic visit
* Body mass index ≥ 27
* Hormone receptor status

  * Estrogen receptor (ER)/progesterone receptor (PR) negative

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* No history of soy allergies
* No uncontrolled blood pressure
* No uncontrolled hyperthyroidism or hypothyroidism
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No diabetes mellitus (type 1 or 2)
* No medical, psychiatric, or behavioral factors that would preclude study participation
* No definite plans to move out of the area during the study period

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent medications for weight loss
* No concurrent treatment for ER/PR-negative disease
S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).


Eligibility Criteria:
Inclusion Criteria:

* Patients who voluntarily provide written informed consent prior to entering into this study
* Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
* Patients who underwent radical resection with wide lymph node dissection
* TNM stage (6th AJCC) of IIIB or IV on post-operative staging
* Patients who can be randomized within 6 weeks after surgery

Exclusion Criteria:

* Aged \< 20 years or ≥ 76 years
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Patients who underwent surgery for neoplasm in stomach in the past
* History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
* Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
* Residual cancer on post-operative staging (R1 and R2 resection)
* Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
* Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
* Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
* Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
* History of hypersensitivity to the investigational products (S1 and Oxaliplatin)
Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"

The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.

The drug being tested in this study is called Glatiramer acetate is being tested to treat people who have Multiple sclerosis. This study will look at the safety and efficacy of Glatiramer acetate in patients with multiple sclerosis in the routine clinical setting.

The study will enroll approximately 1000 patients.

• Glatiramer acetate subcutaneous injection syringe

This multi-center trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

- All patients treated with Copaxone from the first day of market launch of the product

Exclusion Criteria:

-None
Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

The purpose of this study is to see whether transcutaneous electrical nerve stimulation (or TENS) reduces pain during an endometrial biopsy. A TENS unit is an over-the-counter, FDA approved device that sends low-level electrical impulses through the skin to reduce the amount of discomfort experienced during procedures. A TENS unit is very low-risk and used in a lot of ways, including for chronic pain, after surgery, and during labor. Since there is no standard way of managing discomfort during an endometrial biopsy, the investigators think that TENS might be helpful.

Participating in the study may require some additional time in clinic to answer research-related questions. Subjects will be asked to answer demographic questions (which will be combined anonymously) before and after the procedure, as well as rate subject's pain at different time points during the procedure.

The biggest benefit in participating is that subject's discomfort might be lower during and after the procedure. Subjects may not benefit from participating in this study. There is a small risk of a skin reaction from wearing the TENS pads.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* undergoing an outpatient endometrial biopsy
* Duke gynecological oncology clinics and general gynecology clinic

Exclusion Criteria:

* age younger than 18 years
* unable to follow study instructions and/or independently adjust TENS settings
* cutaneous damage at the TENS application site
* pacemaker or automatic implanted cardiac defibrillator
* inability to understand or declines to sign the informed consent form
* previous personal experience using a TENS unit
* pregnant women (will be excluded as part of standard of care for endometrial evaluation)
Men in Maternity Health (MiM) in Myanmar

World Health Organization integrated husband involvement into reproductive health programs to carry out safe motherhood successfully and therefore it has been encouraged as a new strategy to improve maternal health since 2000. In Myanmar, maternal health intervention and education programs for safe motherhood are progressing but maternal mortality is still high. Even though sufficient evidences prove that husband can influence maternal health care service utilization during pregnancy and there by positively impact obstetric emergency, few interventions have focused on husband directly to involve and also effectiveness of husband involvement intervention on birth preparedness and complication readiness for safe motherhood are still limited in Myanmar. Therefore, the objective of this study is to explore the effectiveness of the men in maternity health (MiM) intervention on male involvement in maternal health care, including its impact on knowledge about maternal health related issues, attitudes towards maternal health care and birth preparedness and complication readiness (BPCR) practices and improving institutional delivery rates for safe motherhood.


Eligibility Criteria:
Inclusion criteria:

For Men in Maternity health (MiM) Intervention; male partners who

* Aged ≥ 18 years
* Partners' pregnancies are ≤16 weeks gestational age
* Partners are pregnant for the first time (Gravida 1)
* Currently live with their female partners
* Have been living in the study area for at least 1 year

For quantitative and qualitative assessment:

* Male partners who participated in the MiM intervention and their female partners
* Maternal health stakeholders who oversee MiM implementation and maternal health care providers in the intervention township

Exclusion criteria:

For Men in Maternity Health (MiM) Intervention, male partners who

* Are severely ill and cannot communicate
* Do not give consent

For quantitative and qualitative assessment:

* Feel uncomfortable to participate in this study
* Do not give consent
* Are severely ill and cannot communicate
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean

To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
* Those who have been Helicobacter pylori positive
* Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Those who have anatomical disability in insertion and maintenance of pH meter catheter
Detection of Early Airway Obstruction in Patients with COPD Using RCexp

We hypothesize that Cexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.

Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease worldwide, leading to significant morbidity, mortality, and high treatment costs. In 2020, the global prevalence of COPD was estimated to be 10.6%, affecting around 480 million people. The diagnosis of COPD in suspected patients is typically confirmed through routine spirometry, a simple noninvasive test that assesses the degree of airway obstruction. However, research has revealed that extensive small airway disease exists in COPD before it can be detected using traditional spirometric measures, such as forced expiratory volume in the first second (FEV1) and the ratio of FEV1 to forced expiratory capacity (FEV1/FVC). Efforts are underway to find new parameters to improve early detection of airway obstruction in patients with COPD. The expiratory time constant (RCexp) is a promising variable studied in critical care medicine and may also prove useful in pulmonology. Data from ventilated COPD patients demonstrate that prolonged RCexp was present in all patients with COPD. The FEV1/FVC ratio is currently the gold standard for diagnosing COPD, but it only yields a single calculated value. In contrast, RCexp may offer more precision as it reflects exhalation dynamics at multiple time points during exhalation. If there is a prolongation of subsequent RCexp towards the end of exhalation, it could indicate the presence of obstruction. We hypothesize that RCexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.

Eligibility Criteria:
Inclusion Criteria: all patients eligible for routine spirometry if indicated as per the standard of care -

Exclusion Criteria: known pulmonary disease, post thoracic surgery

-
Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.

The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their association with bone and cardiovascular parameters in patients with Polycystic Ovary Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism

Exclusion Criteria:

* acute infectious disease, a thyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorder; history of cardiovascular disease or pulmonary embolism; a family history of coronary artery disease; smoking history; hypertension; diabetes mellitus; use of oral contraceptives, anti-androgens and drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs.

any medication known to affect hormonal or metabolic parameters.
NLCR in Prediction of the Grade of Lung Tumor.

The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the routine preoperative blood test may predict lung tumors' grading.

Lung cancer remains as one of the leading causes of death among oncology patients. Close connection between inflammation and pathogenesis of some neoplasms was determined in a number of studies. Some studies show promise that ratio of neutrophil to lymphocyte count (NLCR) may be recognized as a prognostic marker for several carcinomas: renal, lung and colorectal. The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the routine preoperative blood test may predict lung tumors' grading. During routine preoperative blood tests complete blood count is done and NLCR, WBC, neutrophil and lymphocyte count is noted. After the thoracic surgery intervention and histopathological examination grading of lung tumor is noted.

Eligibility Criteria:
Inclusion Criteria:

* consecutive thoracic surgery patients with lung cancer grading confirmed by histopathology postoperatively
* preoperative routine complete blood count analysis

Exclusion Criteria:

* infectious disease
* pregnancy
* autoimmunologic disease
* other known conditions or treatments that may influence the blood count (seropositivity for HIV, chemotherapy, and corticotherapy)
HaemoCerTM Application in Breast Cancer Surgery

HaemoCer is a hemostatic agent to control bleedings during surgical procedures by accelerating natural hemostasis and is frequently applied during breast conserving surgery in women with breast cancer. There is however no adequate data available on the efficacy of HaemoCer regarding seroma formation or drainage output. The objective of this study is to investigate whether the intraoperative application of haemostatic powder (HaemoCer) in breast-conserving surgery in breast cancer patients reduces the postoperative drainage output and number of days until drain removal (number of hospitalization days).


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer undergoing breast-conserving surgery
* No previous breast-conserving surgery on the same site
* ≥ 18 years age
* no current pregnancy
* Informed consent

Exclusion Criteria:

Patients with previous breast-conserving surgery on the same site

-
Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the effect of a commercial dietary fiber supplement on patients with type 2 diabetes mellitus, in the way of glucose control, insulin action in the body, and the gut microbiota (bacteria) abundance.

Fiber supplements such as psyllium are known to be beneficial to glycemic control in patients with type 2 diabetes mellitus (T2DM). Gut microbiota has a role in regulating host energy metabolism and systemic inflammation by several pathways such as short-chain fatty acid production, fasting-induced adipose factor expression, endocannabinoid system, and gut epithelial permeability. As dietary components can influence the composition of the microbiota, we hypothesized that fiber supplements could modify gut microbiota and consequently affect glycemic control and inflammatory condition in patients with T2DM.

The primary outcome was to assess the effect of fiber on glucose control (by comparing fasting glucose and glycoalbumin), insulin secretion and sensitivity. Secondary outcomes were the changes abundance of microbiota, incretins, and lipopolysaccharide (LPS).

Eligibility Criteria:
Inclusion Criteria (all of the followings):

* Among type 2 diabetic patients who visit Diabetes Center at Samsung Medical Center
* 2 or more of following are required:

  1. use of lipid-lowering drugs and / or triglyceride ≥ 150 mg/dL, high-density lipoprotein \< 40 mg/dL in men and \< 50 mg/dL in women
  2. waist circumference \> 90 cm in men and \> 80 cm in women
  3. antihypertensive medication and / or blood pressure ≥ 130/85 mmHg
* Hemoglobin A1c level 7.0 - 9.0% (6.5 - 9.0% in age 50-60 years old)
* Patients who are treated with combination therapy of sulfonylurea and metformin at least 6 months and in steady-glucose-controlled state.

Exclusion Criteria (at least one of the followings):

* Patients using insulin, alpha-glucosidase inhibitor, meglitinide, thiazolidinedione, or incretin agent (both oral or injectables)
* Recently diagnosed (within 6 months) acute diabetic complication such as diabetic ketoacidosis and hyperosmolar hyperglycemic state
* Clinically significant cardiovascular disease
* Patients treated with oral or intravenous antibiotics last 12 months
* Patients who took fiber supplements last 6 months
* Fasting serum c-peptide level \< 1 ng/mL
* Duration of type 2 diabetes \> 10 years
Educational Program to Increase Colorectal Cancer Screening: a Cluster Trial

* Hypothesis 1. When compared to passive dissemination, active dissemination will result in greater participant enrollment.
* Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics and community sites.
* Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively correlated.

In this study, investigators aim to evaluate 20 community coalitions and 7,200 participants by: testing passive and active approaches to disseminating the Educational Program to Increase Colorectal Cancer Screening (EPICS) to increase screening rates for colorectal cancer; measuring the extent to which EPICS is accepted and the fidelity of implementation in various settings and estimating the potential translatability and public health impact of EPICS. This four-arm cluster randomized trial (five community coalitions plus 1,800 African Americans, 50-74 years of age, who are not current on colorectal cancer (CRC) screening per arm) compares the following implementation strategies: (1) web access to facilitator training materials and toolkits without technical assistance (TA); (2) web access, but with technical assistance (TA); (3) in-person access to facilitator training materials and toolkits without TA and (4) in-person access with TA. Primary outcome measures are the reach (the proportion of representative eligible community coalitions and individuals participating in the trial) and effectiveness (post-intervention changes in CRC screening rates). Secondary outcomes include adoption (percentage of community coalitions implementing the EPICS sessions) and implementation (quality and consistency of the intervention delivery). The extent to which community coalitions continue to implement EPICS post-implementation (maintenance) will also be measured. Cost-effectiveness analysis will be conducted to compare passive to active dissemination costs. Investigators believe that implementing this evidence-based colorectal cancer screening intervention in partnership with community coalitions will result in more rapid adoption than traditional top-down approaches, and that changes in community CRC screening practices are more likely to be sustainable over time. With its national reach, this study has the potential to enhance understanding of barriers and enablers to the uptake of educational programs aimed at eliminating cancer health disparities.

Eligibility Criteria:
Inclusion Criteria:

* African Americans, 50-74 years of age, who are not current on CRC screening, are eligible for study participation

Exclusion Criteria:

* Individuals with a personal history of CRC or inflammatory bowel disease, blindness or severe hearing impairment; dementia; or other condition with life expectancy less than two years, are ineligible for participation