cyrilzakka/clinical-trials huggingface dataset:
Significance of Benign Lymph Node Enlargement in Colorectal Cancer

The objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node （BLNE） enlargement in patients with colorectal cancer. The main questions it aims to answer are:

Do patients with benign mesenteric lymph node enlargement have a better prognosis? What are the clinical characteristics of benign mesenteric lymph node enlargement? As part of routine medical care for colorectal cancer, we will follow up with all participants over the course of the study.

From January 2015 to June 2023, 2,270 patients with colorectal cancer received surgical treatment at Peking University Third Hospital. The clinical data of these patients were recorded retrospectively and the eligible patients were divided into two groups. According to the 9th edition of the TNM staging System published by the AJCC, the BLNE group included the mesenteric BLNE group, while the non-benign lymph node enlargement (NBLNE) group was the control group. Inclusion criteria were :1) No regional lymph node metastasis or distant metastasis; 2) Stage I and II patients with AJCC staging system; 3) Radical CRC resection reached R0 status, no positive lymph nodes; Colonoscopy confirmed a single malignant lesion. Exclusion criteria :1) emergency surgery or preoperative complications such as intestinal obstruction and perforation; 2) Positron emission tomography (PET-CT) suspected distant metastasis; 3) Preoperative neoadjuvant therapy; 4) Hereditary colorectal cancer such as familial adenomatous polyposis; Microsatellite instability (MSI) was confirmed by pathology. In early colorectal cancer, MSI-H status is associated with a favorable prognosis and enhanced anti-tumor immune response. Therefore, we excluded these patients to avoid their influence on prognosis. 6) Lack of imaging data; 7) Loss of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* no regional lymph node metastasis or distant metastasis;
* stage I and II patients in the AJCC staging system;
* radical CRC resection achieving R0 status with no positive lymph nodes;
* a single malignant lesion confirmed via colonoscopy

Exclusion Criteria:

* underwent emergency surgery or had preoperative complications such as intestinal obstruction or perforation;
* had suspected distant metastasis on positron emission tomography (PET-CT);
* received preoperative neoadjuvant therapy;
* had hereditary CRC such as familial adenomatous polyposis;
* had microsatellite instability (MSI) confirmed by pathology.
* lacked imaging data;
* were lost to follow-up.
Using an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study

A one-arm feasibility study was conducted to test if violinists would accept to play with an identified ergonomic chinrest (EC) with the brand name Kréddle every day for two weeks. Every day the participants had to divide their total playing time equally between EC+ (ergonomic chinrest with shoulder rest) and EC- (ergonomic chinrest without shoulder rest) each day.

This study is testing the feasibility (usability and acceptability) of a two-week familiarization period where violinists usually playing with a shoulder rest had to play their violin with an ergonomic chinrest (EC) with (EC+) and without a shoulder rest (EC-).

Primary outcomes were compliance, adherence, usability and acceptability of the familiarization period.

Prior the familiarization period each violinist received the chinrest (Kréddle) and a shoulder rest (Kun Super rest violin 4/4) and had to follow instructions given through three introduction videos.

The included violinists received a web questionnaire (QA) before and after the familiarization period. This period is unsupervised with the EC (ergonomic chinrest). Every day each violinist should equally divide their total playing time between playing without shoulder rest (EC-) and the other half with the shoulder rest (EC+) with the EC. A diary was answered each day containing different questions in regard to playing hours and usability.

The reporting in this study adheres to the CONSORT 2010 extension for pilot and feasibility trials.

When this study was initiated, we aimed at a sample size of 10-12 as a rule of thumb for a pilot/feasibility study. However, due to the corona pandemic and the many national restrictions including keeping distance, seeing only a few people, getting tested for the virus and staying at home, if possible, this number could not be reached. Even though the study was planned to include more participants the result from this small study is pointing in one direction, which is supported in a previous study as well.

Eligibility Criteria:
Inclusion Criteria:

* Writing and speaking Danish or English fluently. Participants had to be trained violinists who could play the protocol classical repertoire and without a permanent employment contract in a Danish symphony orchestra.

Exclusion Criteria:

* Trauma on the upper cervical spine or upper extremities within the previous year, previous or planned shoulder/neck operation, life-threatening health disorders, pacemaker or severe eczema on neck and upper extremities.
Comparison of Two Types of Biopsy in Patients With Breast Lesions

RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions that cannot be felt upon examination.

OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods in these patients. III. Demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients. IV. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two diagnostic arms. Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram. Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis OR Nonpalpable breast lesion that is not amenable to core needle biopsy or advanced breast biopsy instrumentation (ABBI) excision Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Not specified
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer

Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy. we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is widely used in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified superficial transitional cell carcinoma of the bladder.
* patients with primary or recurrent intermediate risk superficial bladder cancer after TUR. Patients with primary tumor with stage TaG1 with multiple lesions (\>3) or lesions bigger than 3 cm or patients with TaG2-3 or T1G1-2.
* Patients must not be pre-treated with any intravesical immunotherapy (BCG) or chemotherapy.
* Male or female, age greater than 18.

Exclusion Criteria:

* Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks.
* Patients who have received previous (BCG) or chemotherapy.
* Patients with evidence of invasive, locally advanced or metastatic bladder cancer (greater than or equal to T2 disease; stage greater than or equal to B1) or patients with upper urinary tract disease.
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair

In this study, a chest muscle sample (biopsy) will be taken and the muscle fibers will be removed from the sample and made into smaller strands or fragments. During this same procedure, those muscle fiber fragments (MFFs) will then be injected directly into the supraspinatus muscle. Once injected, the MFFs will remain in the supraspinatus where Investigators believe the MFF will become part of the participants' existing muscle and provide increased muscle size and strength, improving function (rotator cuff strength and stability).

Muscle fiber fragment (MFF) therapy has shown pre-clinical and clinical promise in the treatment of bladder neck insufficiency/incompetent outlet. Fragmentation of muscle fibers derived from autologous muscle tissue can be injected through a needle into the sphincter region. The injected muscle fibers are able to assemble into long muscle fibers in the direction of host muscle fibers. More importantly, muscle progenitor cells residing on the fragmented muscle fibers survive and integrate into host vasculature and nerve to restore damaged muscle function. Preclinical results indicate that this technology can be used to repair and restore damaged sphincter function in urinary incontinence. The development of an autologous, readily available muscle fiber fragment treatment that may involve less risk and recovery time than those associated with the standard surgical therapies and urethral bulking agents, could alter the treatment paradigm of urinary incontinence. The study team hypothesizes that injected MFFs will incorporate into skeletal muscle and re-assemble along the fiber direction. The Investigators anticipate that the MFFs can safely be injected into the atrophied rotator cuff muscle and will help restore the functional contractile properties of the supraspinatus muscle following rotator cuff repair.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 40 to 80 years
* Unilateral Disease
* \< 1.5cm tear

Exclusion Criteria:

* Diabetes
* Peripheral Neuropathy
* Previous Shoulder Surgery
* Pain Syndrome; cuff arthroplasty
* Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies
* Arthritis of Shoulder
* Unwilling or unable to comply with post-operative instructions or follow-up visits
* Auto Immune Disease
* Complete Subscapularis Tear
* Teres Minor involvement
* History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2
* Pregnancy
* Implanted devices containing ferromagnetic material
* Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator)
* Any other condition which the PI feels would be not in the best interest for the patient or the study
Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to test the following hypothesis:

To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.

Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress. Classical training does not improve these features.

Objectives: To investigate whether electrostimulation program following exacerbation can modify muscle structure and function in COPD patients.

Method: We propose to conduct a controlled and randomized clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 15 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes in muscle structure, muscle oxidative stress and their relationship with quadriceps force and exercise tolerance.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients during or after exacerbation

Exclusion Criteria:

* Comorbidities that could limit exercise training
* Obesity (body mass index \[BMI\] \> 30 kg/m²)
* Neuromuscular disease
* Pacemaker implantation
Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients

This is a prospective single-center study to evaluate a diagnostic method. The main objective of the study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry. The study population are hospitalizing participants aged 75 years and older with an indication to search for sarcopenia.

Sarcopenia is a loss of muscle mass associated with a loss of muscle strength. Sarcopenia is associated with an increase of mortality, risk of falling and hospitalization. The gold standard for assessing loss of muscle mass is X-ray absorptiometry. However, this exam is not systematically performed. The calf circumference (cutoff less than 31 centimeters) is preferentially used. However, this cutoff was defined from a population of women with a mean age of 80 years and a unfrail phenotypic profile that does not allow this result to be applied to elderly hospitalized patients.

The main objective of this study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry.

This is a single-center prospective study to evaluate a diagnostic method. The participants in the study will be hospitalized patients aged 75 years and over, with an indication to search for sarcopenia in the context of screening for protein-energy undernutrition under the recommendations of the French National Authority for Health. Participants will be included after being informed about the protocol and after obtaining their free and informed oral consent. Measurement of calf circumference will be performed before absorptiometry, the results of which will be analyzed in a blinded. The number of subjects to be included with a expected prevalence of 75%, specificity of 95% and an accuracy of 2% is 298 participants according to the literature. A sensitivity and specificity analysis will be performed using the ROC curve. A linear regression analysis will be performed with a significance threshold for the alpha risk of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 75 years
* Hospitalization in a medical department or in the follow-up care or rehabilitation department of the Hospital Center of Orléans
* Presence of an etiological criterion of undernutrition
* Presence of a decrease in muscle strength

Exclusion Criteria:

* Presence of one of two phenotypic criteria for undernutrition other than sarcopenia, which are body mass index less than 22 kilogram per square meter and weight loss (≥ 5 percent over 1 month or ≥ 10 percent over 6 months or ≥10 percent compared with usual weight before the disease).
* Refusal to participate in the study
* Patient under legal protection
* Impossible to perform X-ray absorptiometry (behavioral problems, functional constraints to climb on the DXA machine)
* Person not affiliated to a social security system
Schistosomiasis in Formal and Non-Formal Schools in Uganda: Implications for Control Programmes

Current efforts to control schistosomiasis and soil-transmitted helminthes infections focus on the school-age population, and school-based treatment delivery programs offer a major cost advantages because of the use of the existing school infrastructure and the fact that schoolchildren are accessible through schools. However, in many developing countries, large numbers of school-age children are not in school and this has raised questions about the effectiveness of school-based programs in reaching non-enrolled children. Increasingly, the non-formal education sector is providing a growing solution to the problem of poor enrolment in basic education, especially in sub-Saharan Africa, and has recently been used to deliver praziquantel as part of a national schistosomiasis control program in Uganda. However, it is unclear how effective this program has been in reaching children who attend non-formal schools and whether the program has been reaching children from the poorest households.

This study will compare infection and nutritional status of children enrolled in formal schools and non-formal schools, and non-enrolled children in Nakasongola District in Uganda, and investigate the process and impact of treatment delivered by the national control program. The study will consist of household surveys and cross-sectional parasitological and hematological surveys, with follow-up six months later. The evaluation will take place over the course of a year and will:

* Compare the infection and nutritional status of children enrolled in formal schools and non-formal schools, and non-enrolled children in Nakasongola District, Uganda
* Compare programmatic process indicators, including enrolment rates, attendance rates, access to water and sanitation, treatment coverage in formal and non-formal schools
* Investigate the impact of treatment on intensity of infection and reinfection rates in formal and non-formal schools.

Eligibility Criteria:
Inclusion Criteria:

* School children in grad 1 and 2
The Effects of Dietary Factors on Physiological Subjective Stress Responses

The study aims to investigate the role of dietary factors in chronically stressed subjects. Previous studies have shown that milk proteins, B vitamins and probiotics may influence on subjective well-being in stressed subjects.


Eligibility Criteria:
Inclusion Criteria:

* STAI points 40-65
* BMI 18-30 kg/m2
* healthy

Exclusion Criteria:

* Gastrointestinal disease, diabetes or any other significant major medical morbidity
* milk allergy
* smoking
* excess use of alcohol
* pregnancy and breast feeding
* waist circumference males \>102 cm, females \>88 cm
* no medication or dietary supplements influencing measured responses
Ondansetron for the Treatment of Methamphetamine Dependence - 1

The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

Eligibility Criteria:
Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.
Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold

This study is carried out to explore the short-term and long-term efficacy of the functional collagen scaffold in guiding laryngeal soft tissue regeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-65 years old, male or female
2. Severe unilateral vocal cord injury and poor closure of the glottis
3. Disease course was more than 1 year
4. At least two GRBAS scores reach 2 points or more
5. The subjects have read and fully understood the research notes, signed informed consent

Exclusion Criteria:

1. Over speaking professionals, such as teachers, shop assistants.
2. With vital organ dysfunction, such as heart, lung, liver or kidney.
3. Pregnant or lactating women, or in preconception period.
4. Allergic to various drugs.
5. Difficult to be followed-up or cooperate long-termly.
6. Participated in other clinical trials in the last 3 months.
7. With progressive severe disease.
8. Alcoholics or drug addicts.
9. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers
10. With inevitable circumstances of voice damage.
11. Any other unsuitable conditions for the study.
A Study to Evaluate Effectiveness and Safety of Surgeries in Elderly NSCLC Patients

The trial was designed to compare effectiveness and safety of surgeries in the patients with non-small cell lung cancer

The trial is a multi-centre, real-world, non-interventional, observational study. The Chinese elderly pathologically diagnosed patients with early-stage non-small cell lung cancer enrolled from 2015 to 2017 who received lobectomy or segment/wedge dissection were included and the study data on patient demographic/tumor biological characteristics, and clinical treatments were retrospectively collected to evaluate effectiveness and safety of the surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received surgeries from 2014 to 2017;
* Patients who received lobectomy or segment/wedge dissection;
* Pathologically diagnosed patients with non-small cell lung cancer;
* Patients with age \>=65 years old.

Exclusion Criteria:

* Patients who received neoadjuvant therapy prior to surgery.
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death

1. To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD.
2. To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.

The study was a multicenter, prospective, observational study that prospectively included HCM patients assessed as meeting the ICD implantation indication at Fuwai Hospital and National Collaborative Hospitals from July 1, 2024 to June 30, 2027, for pre-operation screening of S-ICD, and follow-up of patients eventually implanted with S-ICD.

Eligibility Criteria:
Inclusion Criteria:

* HCM patients assessed as meeting the ICD implantation indication

Exclusion Criteria:

* Combined with bradycardia with pacing indications;
* Frequent monomorphic ventricular tachycardia require ATP therapy;
* With indications of CRT;
* Combined with other diseases, life expectancy is less than 1 year.
Olanzapine in the Treatment of Patients With Anorexia Nervosa

The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Eligibility Criteria:
Inclusion Criteria:

* those who meet DSM IV criteria of Anorexia Nervosa- either restricting or binge/purge subtype

Exclusion Criteria:

* patients who are actively self destructive and/or suicidal
* patients whose medical status is seriously compromised
* patients whose eating disorder is superimposed on a major psychiatric disorder such as schizophrenia, major affective disorders, dissociative disorder or an active substance abuse disorder.