cyrilzakka/clinical-trials huggingface dataset:
Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer

This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.

PRIMARY OBJECTIVES:

I. To conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients.

II. To evaluate systemic and intratumoral immunomodulatory effects of probiotics in operable breast and lung cancer patients.

OUTLINE:

Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics orally (PO) once on day 1, and then twice daily (BID) or three times daily (TID) for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery
* Patients must have adequate organ function
* Patients must be willing to provide tissue, blood and stool samples for the research study

Exclusion Criteria:

* Patients must not receive systemic neoadjuvant therapy
* Patients must not have taken any probiotics in the past 30 days prior to the enrollment
* Patients with autoimmune disease, immune deficiency such as human immunodeficiency virus (HIV), irritable bowel, known diverticulosis, and other serious gastrointestinal (GI) conditions at treating physician's discretion will be excluded
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers in the age between 19 and 50 years old.
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

* Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
* Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
* Heavy smoker (\>10 cigarettes/day).
Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage

New androgen pathway targeting agents (ARTA), including Abiraterone acetate, Apalutamide and Enzalutamide, are approved and used in treatment of metastatic hormonal sensitive prostate cancer(mHSPC). However, the development of castration-resistance prostate cancer(CRPC) is only a matter of time. The use of sequential ARTAs in mCRPC showed limited benefit in retrospective series and prospective trials. Therefore this sequence should be avoided because of known cross resistance and the availability of chemotherapy and poly adenosine diphosphate-ribose polymerase(PARP) inhibitors (if a relevant mutation is present).

Recently, a randomized controlled trial(RCT), the ABIDO-SOGUG, indicated that compared with docetaxel, maintaining Abiraterone added to docetaxel in chemotherapy-naive patients who have experienced cancer progression to Abiraterone treatment could not improve radiographic progression-free survival or the other endpoints.However, another RCT, the PRESIDE trial, indicated that in patients who had progressed on Enzalutamide, continued Enzalutamide treatment in combination with docetaxel led to a significant improvement of PFS compared with placebo plus docetaxel.

The aims of this trial is to assess both the efficacy and safety of docetaxel in combination with Enzalutamide as first-line treatment in mCRPC patients progressed on Abiraterone.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma
* mCRPC
* Eastern Cooperative Oncology Group(ECOG) 0-1
* prior Abiraterone treatment

Exclusion Criteria:

* prior Enzalutamide or Docetaxel treatment
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening.
* Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile

Exclusion Criteria:

* Have Type 1 diabetes
* Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin within 8 weeks prior to screening
* After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
* Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
* Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease
* Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening
Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke

Some studies have shown that the end-effector type of hand robotic-assisted therapy (RT) can effectively improve upper extremity (UE) motor function in patients with stroke. However, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the RT in clinical practice. This study aims to develop an end-effector RT treatment protocol and to examine the preliminary effects of the treatment protocol on UE motor function in patients with stroke.

There are two objectives in this case series study. One is combining external scientific evidence with clinical expertise to design a detailed training protocol for RT in patients with different severity of stroke. The other is to examine the effects on UE motor function and explore the client perspective.

The training protocol was developed based on the ACE Star Cycle Knowledge Transformation Model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. Purposive sampling will be used to recruit 35patients with stroke with different severities (Brunnstrom stage of distal part: 10 for stage II\~III /10 for stage IV /15 for stage V\~VI) from a regional hospital in Taiwan. Each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. Motor function evaluations will be administered before and after the intervention. Wilcoxon Signed Rank test will be used to examine the change between the pretest and posttest.

Eligibility Criteria:
Inclusion Criteria:

* (1) Unilateral stroke patients diagnosed by neurologists with stable life conditions
* (2) Twenty years old or older
* (3) Modified Ashworth Scale of proximal UE ≤ 3 (shoulder and elbow), and Modified Ashworth Scale of distal UE ≤ 2 (wrist and fingers)
* (4) UE subscale of Fugl-Meyer Assessment score \< 60
* (5) Cognitive test with the Mini Mental State Examination ≥ 21
* (6) Can provide informed consent

Exclusion Criteria:

* (1) Joint contracture greater than 10° in the paretic wrist or hand
* (2) Absence of proprioception in the wrist and hand
* (3) Other neurological or psychological disorders, e.g. Parkinson's disease
* (4) Receiving Botulinum toxin injections within 3 months
* (5) Enrolling in other rehabilitation experiments or drug studies within 3 months
* (6) unable to operate the AMADEO training system or who may have safety concern
Prospective Post-market Study Examining the Effectiveness of the EcoFit®

The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.

This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a candidate for a total primary hip replacement.
* Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware
* Subject has a BMI of 40.00 kg/m2 or less at the time of enrollment
* Subject is likely to be available for evaluation for the duration of the study
* Subject is able and willing to sign the informed consent and follow study procedures
* Subject is not pregnant

Exclusion Criteria:

* Subject has had a prior hip replacement in the subject hip
* Subject has an active cancer or is a survivor for \<5 years except for squamous cell or basal cell skin cancer
* Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
* Subject is currently a documented substance abuser (alcohol or other addictions)
* Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
* Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
* Subject has a BMI \> 40.00 kg/m2
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
* Subject is pregnant
* Subject has known materials sensitivity (to metals)
Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population

The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.

The overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of L. reuteri on digestive health in an elderly Swedish population, residing in the municipality of Örebro. In addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Informed consent signed by study participant or legal guardian

Exclusion Criteria:

* Known gastrointestinal disease, with strictures, malignance's and ischemia.
* Inflammatory bowel diseases (IBD)
* Participation in other clinical trials in the past three months.
Statin Choice Decision Aid Implementation First Phase

This study is designed to answer a key question in the field of implementation science. Specifically, it seeks to determine if a proposed model for the implementation and scale-up of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the potential of this model, the investigators will conduct a multi-year study comprising 3 phases. This proposal represents the first of these phases.


Eligibility Criteria:
Subjects of the Mayo Clinic Care Network
The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study

This prospective cohort study aims to observe the efficacy and safety of the first-line combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.

1. Establish a clinical database for the advanced gastric cancer patients treated with first-line combined chemotherapy in Tongji hospital.

   1.1.Data including age, gender, smoking state, karnofsky performance score（KPS）, disease history, clinical stage, primary tumor site, metastasis site, surgery, first-line chemotherapy, therapy after failure of first-line treatment, radiotherapy, toxicity, survival time, the time of free of progress, response were collected.

   1.2.The peripheral blood samples were collected for further biomarker reserch.
2. Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer.
3. Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
2. Unresectable locally advanced, or recurrent, or metastasis disease；
3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
4. Life expectancy of at least 3 months;
5. ECOG score 0-2;
6. Voluntarily signed the informed consent.

Exclusion criteria:

1. Previously treated with first-line chemotherapy;
2. First-line chemotherapy with single drug.
A New Therapeutic Approach for Root Coverage

Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession \>4mm. Patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one way analysis of variance for repeated measures. Inter-group analysis will be performed by unpaired t-test for each of evaluation periods.

Both gender patients presenting Miller class I or II recession defects \>4mm were selected. Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or subepithelial connective tissue graft (SCT). Patients were treated in the period of February 2008 and March 2008 and monitored during 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted.

Exclusion Criteria:

* Smokers
* Pregnants
* Use of anti-convulsants, anti-hypertensives, cyclosporine or hormones
* Use of antibiotics for the last 6 months
* Patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)
The Role of Biomarkers in the Occurrence and Development of Asthma

To study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. And to provide supplementary detection means and predictive indicators for the diagnosis of asthma and the severity of asthma.

Recruit 30 children with asthma and 30 healthy children based on the consent of the children and their parents or their guardian. Collect and record general information such as name, age, time of first diagnosis, allergens or triggers, daily dosage and frequency of asthma control drugs, home address and contact information. Collect 5 ml of blood sample for the detect of the biomarkers. Asthma severity was assessed using pulmonary function by spirometry and score of C-CAT. Finally study the correlation between the level of biomarkers and asthma severity and the role of biomarkers in the occurrence and development of asthma.

Eligibility Criteria:
Inclusion Criteria:

* In line with the diagnostic criteria in the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition)
* Age: 4-12 years old for new diagnosis or recurrent episodes
* Typical clinical manifestations and complete clinical data
* Family members or guardians of children with informed research and signed consent
* All healthy control subjects had no history of lung disease, allergic rhinitis or any other atopic disease

Exclusion Criteria:

* Suffering from other respiratory diseases (such as bronchiectasis, allergic rhinitis, respiratory failure, tuberculosis, obstructive airway disease) or other inflammatory diseases.
* Abnormal development of congenital airway and lung tissue
* History of immunosuppressant or glucocorticoid use in the first 4 weeks
* Suffering from other endocrine system and immune system diseases
* Incomplete clinical data or examinations.
Effects of Magnetic Tape on the Autonomic Nervous System

The effect of magnetic tape on pain and autonomic nervous system in subject with lower back pain.

The effects of magnetic nanoparticles in tape applied in the lumbar spine on the autonomic nervous system measured with fully automated pupillometry and on pain in the spine measured with posterior to anterior pressure on the spinous process and the skin pinch test paravertebrally

Eligibility Criteria:
Inclusion Criteria:

* Current lower back pain with NPRS of 5
* Between ages 18-65

Exclusion Criteria:

* No lower back pain or pain \<5 on the NPRS
* Not meeting age limit
* Having condition that prevents the PA procedure
* Conditions of the nervous system and inability keep eyes open
Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.

1. Active Group: ALLO-ASC-SHEET
2. Control Group: Hydrogel SHEET (vehicle control)
3. Study Type: Interventional
4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 18 and 80 years of age.
2. Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
3. Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
4. Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
5. Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
6. Ulcer area blood circulation meets one of the following criteria

   * A. Blood vessels around the ulcer detected by Doppler Test
   * B. range of Ankle Brachial Index(ABI) was \> 0.7 to \< 1.3
   * C. Transcutaneous oxygen pressure, (TcPO2) \> 30 mmHg.
7. Is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Ulcer is of non-diabetic pathophysiology.
2. The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
3. Is Human Immunodeficiency Virus (HIV) positive?
4. Have severe hepatic deficiencies.
5. Have a glycated hemoglobin A1c (HbA1c) level of \> 10%.
6. Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
7. Require intravenous (IV) antibiotics to treat the target wound infection.
8. Have severe renal failure including subject on renal dialysis.
9. Pregnant or breast-feeding.
10. Is unwilling to use an "effective" method of contraception during the study.
11. Have evidence of current infection including pus drainage from the wound site.
12. Have a clinically relevant history of alcohol or drugs abuse.
13. Have postprandial blood sugar \> 350 mg/dl.
14. Is not able to understand the objective of this study or to comply with the study requirements.
15. Is considered by the investigator to have a significant disease which might have impacted the study.
16. Is considered not suitable for the study by investigator.
17. Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
18. Is currently or were enrolled in another clinical study within 60 days of screening.
19. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
20. Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
21. Cannot maintain off-loading process
22. Panel reactive antibody (PRA) levels ≥ 20%
A Cross-sectional Study of COPD and Symptom Variability in MEA Countries

This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.

It will also explore the current practice in management of stable GOLD C and D COPD patients.

1. Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
2. Secondary objectives:

   * To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
   * To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
   * To identify demographic, behavioral and clinical factors associated with symptoms variability.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for inclusion have to fulfill all of the following criteria:

  1. Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
  2. COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC \< 0.7 and an FEV1 \< 50% predicted.

Exclusion Criteria:

Patients are not eligible for inclusion if they meet one of the following criteria:

1. Patient with an ongoing COPD exacerbation\*;
2. Patient who has experienced an exacerbation\* in the previous 3 months;
3. History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
4. Inability to understand the study related questions;
5. Mentally disabled patient or unable to read and write;
6. Pregnant.
7. Current participation in a clinical trial;