cyrilzakka/clinical-trials huggingface dataset:
Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study

In this study the characteristics and alterations of the gut microbiome during neoadjuvant therapy for HER2-positive breast cancer patients are studied, as well as the relation between the gut microbiome and probability of pCR.

Although systemic treatment for early stage HER2-positive breast cancer is becoming increasingly effective, resistance and side effects of current treatment modalities are substantial. There is an urgent need for novel therapies, and in addition, better predictive tools are needed to select the right drug to the right patient. New data suggest that modulation of the microbiome of the gut might provide opportunities to increase anti-tumor efficacy of cancer therapies.

A better understanding of the composition, function and dynamics of the gut microbiome before and during trastuzumab-containing neoadjuvant treatment might help to identify factors that can be influenced during the treatment of patients with primary HER2-positive BC .

This study will prospectively enroll 100 participants with newly diagnosed HER2-positive breast cancer patients undergoing standard of care trastuzumab-containing neoadjuvant treatment and correlate gut microbiome composition with pCR.

Patients will be treated with the standard of care neoadjuvant therapy. Stool and peripheral blood (PB) samples will be collected at time of consent for therapy, mid-treatment, after the completion of neoadjuvant treatment (at the discretion of the medical oncologist). Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible connection with pCR and side effects will be explored.

Eligibility Criteria:
Inclusion Criteria:

1. Female, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
2. Primary tumor greater than (\>) 2 cm in diameter.
3. Age ≥ 18 years and \< 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
6. Availability of tumor tissue specimen after surgery.
7. Histologically proven diagnosis of breast cancer.
8. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
9. Had hormonal receptors (ER and PgR) assessed.
10. Signed informed consent.
11. Able to comply with the protocol.

Exclusion Criteria:

1. prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy
2. Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection
3. Uncontrolled inflammatory bowel disease
4. pregnant
Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer

This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study.

The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.

This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations
* Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable
* Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks
* Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)
* Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC

Exclusion Criteria:

Patients who fulfil any of the following exclusion criteria will not be eligible for the study:

1. Histology of the tumour is considered not to be of primary lung in origin
2. Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -
Injuries in Swedish Youth Athletics. The KLUB-study.

It is well known that participation in sports activities as a youth has several health benefits, but at the same time, studies report that the risk is high to obtain injuries related to participation. There is, however, increasing evidence that many of these injuries can be prevented if necessary measures are taken. Prospective studies are therefore needed to be able to plan and carry out measures to prevent the occurrence of injuries. The overall aim of the project KLUB is to study the prevalence and incidence of injuries among athletics youths aged 12-15 years. A particular focus will be placed on identifying factors associated with injury occurrence.

It is well known that participation in sports activities as a youth has several health benefits, but at the same time, studies report that the risk is high to obtain injuries related to participation. There is, however, increasing evidence that many of these injuries can be prevented if necessary measures are taken. So far, most studies examining sports injuries have been conducted on adult elite and among team sports, for example football, ice hockey and bandy. How injury patterns present in individual sports and among youth is not as well documented. A major problem in athletics is that studies have shown an almost identical prevalence and incidence of injury associated with athletics among both young and adult athletes.

Today there are very few published studies on international incidence of injuries among adolescent athletes in athletics and no describing the incidence in Swedish Athletics. These studies have different study design, definitions of injury and rather small groups of athletes, making it difficult to draw conclusions that can be the basis for prevention programs. What after all can be inferred from these previous studies is that injuries related to overuse seems to be most prevalent. Prospective studies are therefore needed to be able to plan and carry out measures to prevent the occurrence of injuries. We intend to carry out an intervention study among athletics youths aged 12-15 years. Before this is carried out, the investigators need to have adequate knowledge of the study population for the effective implementation of the intervention study.

The overall aim of the project KLUB is to study the prevalence and incidence of injuries among athletics youths aged 12-15 years. A particular focus will be placed on identifying factors associated with injury occurrence. The knowledge obtained will be used to allow for injury prevention in the future.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-15 years
* Regularly participate in organized athletics training

Exclusion Criteria:

-
Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD

Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.

The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.

In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.

interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

Eligibility Criteria:
Inclusion Criteria:

* All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).

Exclusion Criteria:

* Complicated cases with advanced proliferative vitreoretinopathy (PVR).
* Patients with retinal vascular disorders and other macular disorders.
* Combined tractional and rhegmatogenous detachment.
* Previous retinal reattachment surgery or Intravitreal injections.
* Glaucomatous patients.
* Patients with corneal opacity which impairs good visualization.
Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

One important factor determining school performance is the consumption of breakfast. While research has shown that older children perform better in school after consuming breakfast, there are little data for preschool-age children. Consuming breakfasts with different macro- and micronutrient contents may have different effects on performance, which may be associated with variations in satiation and satiety during and after the different breakfasts. In addition, children who consume breakfast have better diet quality than children who skip breakfast.

The investigators will conduct a community based, randomized, crossover trial in 4-5 year old children over 7 weeks to examine the short-term effect of feeding preschoolers three different intervention breakfast types: high protein, high-fiber, or high protein and high fiber compared to a usual breakfast served at the preschool. The investigators expect that the children consuming any of the three experimental breakfasts will consume less overall calories and have better diet quality and memory performance compared to children who have the usual breakfast. The investigators hypothesis is that preschoolers will experience the highest level of satiety as well as highest level of overall diet quality when they consume the combined high-protein and high-fiber based breakfast foods.

This study will be conducted at Bauer Family Resources in Lafayette as these are the sites of Head Start programs, which are preschools for children from low-income families. Children from families of low income are more likely to have poor diet quality and poor school performance compared to children from families with higher incomes. Therefore, this population is most in need of this type of intervention.


Eligibility Criteria:
Inclusion Criteria:

* 4-5 year old children attending Head Start centers in Lafayette, IN. Males and females of all racial and ethnic background are included.

Exclusion Criteria:

* No digestive disorders, food allergies, or kidney disease. Children cannot be taking medication that would affect appetite.
Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation
* Symptomatic heart failure

Exclusion Criteria:

* Reversible causes of heart failure
* Contraindications to catheter ablation
A Clinical Study of Chinese Domestic Surgical Robot

This is a prospective, multi-center, randomized, single-blind, parallel-controlled clinical trial to evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.

To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.This clinical trial is a prospective, multi-center, randomized, single-blind, parallel-controlled study. The system used in the experimental group is the endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the system used in the control group is the da Vinci endoscopic instrument control system developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. Then they will be randomly assigned to the experimental group or the control group. To evaluate the primary outcome measures and secondary outcome measures and to observe the incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the test product through the comparison of the data obtained from the experimental group and the control group during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old, male or female

2 .American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3

3. BMI 18-30Kg/m2

4. Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and polypoid lesions of gallbladder

5. Subjects or their legal representatives/guardians voluntarily participate in clinical trials and have signed informed consent form

Exclusion Criteria:

1. Participating in any other clinical trial within 30 days before signing the informed consent form
2. Pregnancy or lactation
3. With a history of epilepsy or psychosis
4. With a history of previous operations at related sites
5. Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac function or pulmonary insufficiency that can't tolerate the operation
6. Severe liver and kidney insufficiency such as cirrhosis and renal failure
7. Acute cholecystitis lasting for more than 72 hours, acute cholecystitis with severe complications such as cholecystitis, gangrene, perforation, etc., and gallbladder thickness thicker than 10 mm
8. Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, intrahepatic bile duct stones and obstructive jaundice
9. Gallbladder cancer or protuberant lesions are suspected to be cancerous
10. Severe allergic constitution and suspected or identified addicts to alcohol or drugs
11. Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic diseases
12. Other situations that researchers consider it inappropriate to participate in this clinical trial
Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes

This study is conducted in Asia. The aim of this study is to assess the efficacy of a pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Nulliparity
* Not pregnant at the time of signing informed consent
* Own a smartphone with either Android system version 4.1 and above or iOS system 7.0 and above with internet access

Exclusion Criteria:

* Female subject undergoing treatment for type 1 or 2 diabetes mellitus
* Subjects not residing in the district of Seremban
Measurement Repeatability in Contemporary Aberrometry

Wavefront scans are a common form of diagnostic test applied in preparing patients for laser eye surgery. An optical map of the eye is created by wavefront scanning, and information from these maps is used to program lasers used to correct focusing errors in the eye. Here the investigators are comparing how repeatable measurements are with a new wavefront scanner and one that is already in widespread use.

Aberrometers are used to measure each element of defocus (aberration) in an optical system. In LASIK, information derived from aberrometry (scans performed using aberrometers) is used to program the pattern of laser pulses delivered by an excimer laser in therapeutic reshaping of the cornea to correct defocus. To do this accurately, aberrometry findings need to be repeatable and correspond closely to manifest refraction. Here the investigators compare repeatability of measurements for a new aberrometer (Peramis) versus the aberrometer most widely used in contemporary wavefront guided laser vision correction (iDesign).

The test aberrometer will be:

Peramis (Schwind Eye-tech Solutions, Kleinostheim, Germany).

Control aberrometer will be:

iDesign (AMO, Santa Clara, CA)

Eligibility Criteria:
Inclusion Criteria:

* Myopic LASIK candidates (manifest refraction spherical equivalent range 0 to -10 diopters with up to 6 diopters cylinder) or patients attending corneal service with stage II-III keratoconus or post-keratoplasty

Exclusion Criteria:

* Visually significant co-pathology (CDVA\<6/6) other than irregular astigmatism;
* Patients unable to complete a sequence of 2 good scans (acquisition diameter \>5mm) in one eye within 4 attempts
Stress Echocardiography Study With Regadenoson

Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress
* Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress

Exclusion Criteria:

* Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography
* Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy

RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.

OBJECTIVES:

* Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer.
* Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
* Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
* Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
* Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed localized prostate cancer

  * Stage I or II
* Scheduled prostatectomy between 4-6 weeks after initial biopsy

PATIENT CHARACTERISTICS:

Age:

* 45 to 80

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* No known history of hepatic disease

Renal:

* No known history of renal disease

Other:

* No known history of thyroid disease
* Body mass index no greater than 32
* Omnivorous diet
* No known allergy to study supplements
* No evidence of prostatitis or urinary tract infection
* No other prior malignancy except nonmelanoma skin cancer
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent thyroid hormone replacement medications

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* At least 30 days since prior antibiotics
* At least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day)
* No other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones
* No prior or concurrent therapy for prostate cancer
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations

Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
* T1-2/N1-3M0（except T1N1M0 and single LN\<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
* Age ≥18
* No prior anti-tumor treatment
* Karnofsky Performance Score (KPS)≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* cannot take contrast-MRI imaging
* Pregnant
* Combined with other malignant tumor (except basal cell carcinoma of skin)