cyrilzakka/clinical-trials huggingface dataset:
Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients

In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.

The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated that in clinically node-negative women with T1 or T2 invasive breast cancer, who underwent breast-conserving surgery (BCT) with whole breast irradiation (WBRT), had excellent local control and survival with SLND alone, even if metastases were found in 1 or 2 SLNs. Recently, the long-term follow-up data of the Z0011 study were reported, which demonstrated that the 10-year OS for patients receiving SLND alone was not inferior to that for those receiving ALND.

This breakthrough result of the Z0011 study led to a change in clinical practice regarding the standard management of axillary lymph nodes in patients with breast cancer.

However, these validation data have been generated in Western populations. As the socio-economic profile, life style and culture of Asian are substantially different from those of Western, and genetic backgrounds vary to some extent, it remains unclear whether results similar to those of the Z0011 study could be achieved in a Chinese breast cancer population. In the present study, we prospectively applied the Z0011 eligibility criteria to Chinese patients with clinically node-negative breast cancer undergoing BCT, with planned RT. The purpose of this study is the clinicopathological relevance of the Z0011 findings for Chinese patients with breast cancer, and to verify the feasibility of using the Z0011 criteria to avoid ALND after positive SLN findings.

This is a prospective single-arm study, enrolled patients meeting Z0011 inclusion criteria and providing consent to receive no additional ALND. Overall survival is the primary end point, disease-free survival and occurrence of surgical morbidities a secondary end point.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed invasive breast cancer T1 or T2 tumor 1 or 2 positive sentinel lymph nodes breast-conserving surgery whole-breast RT planned

Exclusion Criteria:

* preoperative therapy 3 or more positive sentinel lymph nodes patients undergoing additional mastectomy due to positive surgical margins
Remote Pregnancy Monitoring to Improve Access

The goal of this clinical trial is to determine the effectiveness of remote nonstress test (NST) compared to in-clinic NSTs in improving fetal testing completion rates. Participants will be randomized to either in-clinic NSTs or use of an FDA-approved remote monitoring belt for their pregnancy monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age between 30 weeks 0 days and 35 weeks 6 days
* Pregnant patients who have clinical indication for fetal surveillance with NSTs (based on UPHS Health System clinical guidelines for antenatal monitoring)
* Able to provide written consent
* English speaking

Exclusion Criteria:

* Multiple gestations
* Maternal pre-gravid BMI greater than 45kg/m2
* Presence of an implanted pacemaker or defibrillator
* Active abdominal skin infection
* A known amniotic fluid index (AFI) less than 5cm or greater than 25cm on the most recent ultrasound (if available) prior to randomization
* Delivery is planned within 2 weeks of potential randomization
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy

Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in preventing organ rejection and maintaining kidney function.

Kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Some patient in this study will also receive two infusions of expanded MSC. This study will evaluate the safety and effectiveness of MSC infusions in patients .

This study will last 2 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and MSC infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, patients will be evaluated. At Months 12 participants will undergo kidney biopsies. Blood collection will occur at regular intervals, Serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.
* Ability to provide written informed consent.
* The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)
* Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).
* Immunosuppressant:CNI and MMF and Sirolimus
* Written informed consent, compliant with local regulations.

Exclusion Criteria:

* Recipients with leucopenia (WBC \< 3000/mm³), thrombocytopenia (Thr \< 100.000/mm³),or hyperlipidemia (Tot Chol \> 300 mg/dl or Triglycerides \> 300 mg/dl).
* Recipients of multiple organs.
* Pregnant women.
* Previous history of malignancy
* Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
* Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
* Inadequate compliance to treatment.
Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Participants will be randomly assigned to either CIMT group or control group. Children of the CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected arm.

Eligibility Criteria:
Inclusion Criteria:

* spastic hemiplegic cerebral palsy patients
* 7\~36 months old

Exclusion Criteria:

* cognitive impairment severe enough to make participation impossible
* uncontrolled epilepsy
* visual or hearing impairment
* musculoskeletal disorders
Effect of C-peptide on Hypoglycemic Counterregulation

Iatrogenic hypoglycemia is the most prominent barrier to the safe, effective management of blood sugar in people with type 1 diabetes due to periodic over-insulinization. During insulin-induced hypoglycemia, glucagon secretion is diminished in type 1 diabetes which, in turn, reduces hepatic glucose production and increases the depth and duration of hypoglycemic episodes. We have observed that the naturally occurring protein C-peptide increases glucagon secretion in dogs during insulin-induced hypoglycemia, which increases hepatic glucose production; the experiments in this application will shed light on the translation of this finding to the human.

Iatrogenic hypoglycemia is recognized as a primary barrier to the safe, effective management of blood glucose in people with type 1 diabetes (T1D). In previous experiments in the dog, we observed that C-peptide infusion augmented glucagon secretion and hepatic glucose production during insulin-induced hypoglycemia. The proposed experiments will determine the translational impact of this finding in patients with and without T1D.

Specific Aim #1 is to determine, in healthy control subjects, the effect of C-peptide co-infusion with insulin on endogenous glucose production (EGP) and counterregulatory hormone levels during hypoglycemia. This will be addressed by studying a single group of healthy subjects two times. In both studies, hypoglycemia will be induced with an intravenous (IV) infusion of insulin. During one study, C-peptide will be infused during the hypoglycemic period, and in the other study, saline will be infused. EGP is our primary variable, with secondary analyses including counterregulatory hormones and metabolic substrates.

Specific Aim #2 is to determine, in T1D patients, the effect of C-peptide co-infusion with insulin on EGP and counterregulatory hormone levels during hypoglycemia. The research plan for this Aim is very similar to that of Aim #1, with the main exception being that we will study T1D patients instead of healthy controls (e.g., two hypoglycemic clamp studies where C-peptide is administered during one study and saline during the other). In addition, the glycemic levels of these T1D patients will be monitored for 10 days prior to this visit to ensure that they do not experience hypoglycemia which could confound the data for the metabolic studies. Similar to Aim #1, EGP is our primary outcome variable, with secondary analyses including hormone and substrate levels.

Eligibility Criteria:
Inclusion Criteria:

* BMI less than 30 kg/m2

Exclusion Criteria:

* pregnant or lactating women cigarette smoking presence of HIV or hepatitis presence of cardiovascular disease presence of microvascular disease
The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease

The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.

The medical treatment of idiopathic Parkinson's disease (IPD) alleviates constipation symptoms due to the restoration of autonomic dysfunction. However, additional laxatives are usually needed in these patients. Other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. Biofeedback therapy (BFT) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. However, researchers have not tried to evaluate its usefulness in constipated IPD patients up to now. The aims of our study are to characterize the nature of constipation in IPD and to evaluate the usefulness of BFT in constipated IPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease

Exclusion Criteria:

* Secondary Parkinson's disease
Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation

Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation

Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction with an observational study to the aim of evaluating the effectiveness and safety of Korean medicine treatment for inpatients

Eligibility Criteria:
Inclusion Criteria:

1. Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
2. Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
3. Patients whose pain intensity of back pain or radiating leg pain is NRS≥5
4. Patients aged 19 to 70
5. Patients who have agreed to participate in the clinical study and given written informed consent
6. Patients admitted to a Korean medicine hospital for treatment

Exclusion Criteria:

1. Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
2. Patients admitted due to pain caused by traffic accidents
3. Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
4. Patients with severe mental illness
5. Patients with difficulty or refusal to give sign written informed consent
6. Patients for whom the researchers judge participation in the clinical study to be difficult
7. Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate

SUMMARY INTRODUCTION: among various treatments for patients with primary snoring, upper airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS), the injection snoreplasty arose as a promising alternative in some selected cases.

OBJECTIVE: to investigate the efficacy and tolerance of injection snoreplasty comparing Ethanol and Ethanolamine Oleate.


Eligibility Criteria:
Inclusion Criteria:

* Snoring
* RDI \< 15 /h

Exclusion Criteria:

* BMI \> 35
A Study of LY2439821 in Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and tolerability of LY2439821 subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis who have completed Study I1F-JE-RHAL (NCT01253265).


Eligibility Criteria:
Inclusion Criteria:

* Participants who have received 7 injections of LY2439821 subcutaneously in the 30-, 80-, or 180-mg dose cohorts, or 11 injections in the 240-mg loading dose/120-mg once-a-week maintenance dose group, and completed the follow-up period (14 weeks) in Study I1F-JE-RHAL ((NCT01253265).
* Ambulatory male or female participants.

  * Male participants: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing.
  * Female participants: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
* Participants who have been treated with methotrexate (MTX) throughout Study I1F-JE-RHAL (NCT01253265). Bucillamine, sulfasalazine and/or hydroxychloroquine are allowed to be administered in addition to MTX. In such a case, the participant needs to have been on a stable dose of the drug(s) throughout Study I1F-JE-RHAL (NCT01253265) and I1F-JE-RHAM.
* Participants who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site.

Exclusion Criteria:

* Participants who have had, during Study I1F-JE-RHAL (NCT01253265), any safety event including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment , that in the opinion of the investigator poses an unacceptable risk to participation in this study.
* Participants who have any of the following abnormalities of clinical laboratory test results by Week 26 of Study I1F-JE-RHAL (NCT01253265):

  * Absolute neutrophil count \<1000 cells/microliters (μL);
  * Lymphocyte count \<500 cells/μL; or
  * White Blood Cells (WBC) count \<2000 cells/μL
Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device

This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals.

The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by multimodal neuroimaging in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Aged 19-39 years
* Informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* High fever patient
* Current and past history of seizure or epilepsy
* Evidence of epilepsy on EEG
* Pregnancy or possibility of pregnancy during period
* Major medical or neurological illnesses
* Evidence of alcohol intake on alcohol breath test
* Contraindications to MRI scans and transcranial magnetic stimulation
* Risk of skin burns
* Use of medications that could have influenced on the study
Anodal Transcranial Direct Current Stimulation on Strength in Subacute Stroke

Loss of strength is a common complication post stroke which leads to loss of balance and walking ability. Variety of interventions are adopted to improve muscle strength after stroke. These include progressive resistance training, specific task training or functional training, functional electrical stimulation and high intensity aerobic exercises

Transcranial direct current stimulation (TDCS) is a relatively new treatment approach for stroke recovery. TDCS is a neuromodulation method which involves application of weak direct current stimulations over the scalp via electrodes. It could induce plasticity via modulation of resting membrane potential and modification of spontaneous discharge rate.

TDCS has been shown to have beneficial effects on mobility, muscle strength, motor learning, lower limb function, balance, gait, functionality and walking ability in post stroke patients. TDCS appears to be a promising intervention for stroke patients however its effects are not significant if used in isolation. Thus, it should be used as an adjunct to some other treatment.

Review of available literature indicates TDCS can be a good option in short and intermediate run but its effects in the long run have not been studied yet. Furthermore, to the best of my knowledge there is little literature available about the long-term effects of TDCS on muscle strength in subacute stage. Therefore, this study is designed to test the long-term effects of TDCS stimulation on subacute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Subacute and first MCA stroke
* Ischemic stroke
* Medium to high fall risk on BBS (BBS score ≤ 40)

Exclusion Criteria:

* Hearing and Visual loss/deficit
* Recurrent CVA
* Neurological condition affecting balance like Multiple Sclerosis, Parkinson disease etc
* Wound at skull
* Presence of shunt and/or metallic implant at cranial region
* Brain tumors
* Musculoskeletal conditions affecting lower limbs
* Cognitively compromised
Immunological Characteristics of Patients With PID and IBD

The investigators wish to characterize alterations in the architecture and function of immune cells in patients with a primary immunodeficiency that also develop inflammatory bowel disease. In addition, The investigators' goal is to characterize the microbiome of these patients, in order to determine whether specific microbial alterations are related to inflammation.

The pathogenesis of inflammatory bowel diseases (IBD), like Crohn's disease and ulcerative colitis is complex and is thought to be related to genetic, environmental and microbial alterations that lead to a hyperactive/dysregulated immune system that mediates tissue damage. In rare cases, IBD can develop in patients with primary immunodeficiencies (PID) who develop severe, atypical or recurrent infections. The bowel disease in these patients can present after they develop infectious complications but also prior to that. The goal of the current study is to characterize immune function in patients with PID and IBD in order to identify alterations in pro-inflammatory and regulatory pathways.

The investigators will obtain blood samples from PID patients with IBD in order to perform deep immune profiling using various techniques such as flow cytometry, ELISA and others. Moreover, the investigators wish to characterize the microbiome of these patients. This multi-disciplinary approach will advance our understanding why specific patients with an immunodeficiency develop an IBD-like phenotype.

Eligibility Criteria:
Inclusion Criteria:

* age \<18 years
* diagnosis of an immunodeficiency
* suspected or confirmed IBD

Exclusion Criteria:

* none
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects who have used bupropion, Zyban, or Wellbutrin previously.
Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)

Viome costumers are consented and recruited for this study and complete the questionnaires upon enrollment. Any participant who previously self reported depression, anxiety, or Irritable Bowel Syndrome (IBS) qualify for this study.

All participants receive Viome's diet, supplement and recommendations.

Participants receive Viome Precision Nutrition Program (VPNP) after completing the health assessment and questionnaire. VPNP consists of diet, supplement and recommendations based on results from their sample results and their self reported questionnaire.

After approximately 5 months, participants were given the same health assessment questionnaire.

The results and data collected before and after the VPNP are analyzed to find correlations and differences between the measurements taken at the beginning of the trial and again approximately 5 months after.

Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 score 5 or above
* GAD-7 score 5 or above
* IBS ROME-IV score 125 or above
* Females and males aged 18 years or older
* Signed and dated informed consent prior to any trial-specific procedures are performed
* Able to speak and read English
* Willing and able to follow the trial instructions
* Viome existing costumer

Exclusion Criteria:

* Unable/unwilling to complete the provided questionnaires