cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients

The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.

This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old(male or female)
* Patients who are planning to receive a kidney from a deceased or a living non-related/related donor
* Agreement with written informed consent

Exclusion Criteria:

* Previously received organs other than kidneys or who are planed to be transplanted simultaneously
* Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient
* Receive a kidney from a related donor who showed HLA-0 mismatch (identical)
* Undergo desensitization therapy with high sensitization
* Diagnosed with cancer in the last five years \[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.\]
* Patients or donors who have positive HIV test result
* Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
* Severe systemic infection requiring treatment
* Prior to the kidney transplantation

  * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
  * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/mm\^3
* Pregnant women or nursing mothers
* Fertile women who not practice contraception with appropriate methods
* Participated in other trial within 4 weeks
* In investigator's judgment
DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for endometrial screening. Four hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 7150 patients.


Eligibility Criteria:
Inclusion Criteria:

* With uerine and uterine cervix intact
* Aged 18 years or older
* With accessible histological results of endometrium
* Signed an approved informed consents
* With accessible cervical cytology before harvesting endometrial histology

Exclusion Criteria:

* Not meeting all of the inclusion criteria
The Utility of Circulating Tumor Cells as Confirmation of Pathologic Diagnosis in Patients With Suspected Early Stage Non-small Cell Lung Cancer

The primary objective of this study is to determine whether circulating tumor cells (CTCs) can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage I) non-small cell lung cancer (NSCLC). Patients scheduled to undergo surgical intervention will have blood samples obtained to test for CTCs. Presence of CTCs will be compared to final pathologic diagnosis based on surgical specimens to assess the sensitivity of using CTCs alone to make a definitive diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of stage I NSCLC a. Only patients with a pathologically confirmed NSCLC will be retained for data analysis b. Should pathologic diagnosis reveal a more advanced stage, these subjects will remain in the study
2. 18 years of age
3. Ability to read and sign informed consent
4. Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

1. Prior cancer diagnosis, excluding previously treated non-melanoma skin cancer
2. Prior or ongoing treatment of the clinically diagnosed cancer
Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women

The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.5 - 29.9 kg/m2
* Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score \> 25 points)
* MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)
* PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties
* Given written informed consent

Exclusion Criteria:

* History of dietary supplement use 4 weeks before the study commences
* Pregnancy (or planning pregnancy)
* Abnormal values for lab clinical chemistry (\> 2 SD)
* Unwillingness to return for follow-up analysis
* Participation in other clinical trials
The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia

This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.


Eligibility Criteria:
Inclusion Criteria:

* Active motion in upper extremity
* Brunnstrom's Scale above 3

Exclusion Criteria:

* Unstable medical conditions
* Cognitive problems
A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects

The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.


Eligibility Criteria:
Main Inclusion Criteria:

* Healthy males and non-pregnant, non-lactating healthy females aged 18 to 55 years inclusive at time of signing informed consent with a body weight ≥55 kg.
* Body mass index (BMI) 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.

Main Exclusion Criteria:

* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
* Subjects with a history of fainting, dizziness, bradycardia or hypotension as considered clinically significant by the investigator
* Subject has a medical condition that may adversely affect taste or smell activity
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum

Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion

Aims, purpose, or objectives:

1. Observe changes in bowel pattern based on gum-chewing
2. Examine bowel function after anterior lumbar interbody fusion
3. Measure length of time to return of bowel function after anterior lumbar interbody fusion
4. Compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care
5. Measure the hospital length of stay amongst study groups
6. Measure post-operative pain amongst study groups

Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):

One or two level anterior lumbar interbody fusions are designed to correct lumbar spondylosis and spondylolisthesis, which can cause debilitating back and leg pain. This surgery involves an anterior approach, which often requires displacement of bowel for the length of the surgery. Patients frequently have a slow return of bowel function secondary to anesthetic time, opioid use, and primarily due to the bowel displacement intraoperatively. Because this is a one or two level surgery, many patients would benefit from same-day discharge but often remain inpatient several days due to slow return of bowel function.

Gum chewing has been shown to decrease the time for return to bowel function (RBF) in colorectal and gynecology patients postoperatively.

Gum chewing and RBF has been studied in the spine population for posterior operations but not anterior spine surgery. This study aims to identify whether chewing gum has an impact on patient's report of pain, RBF, length of stay, and subjective report of satisfaction post-operatively. This could be an outpatient operation; however, pain and RBF often prevent patients from discharging home the same day of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing one or two level anterior lumbar interbody fusion
2. Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication

Exclusion Criteria:

1. Previous bowel surgery
2. Diagnosis of an inflammatory bowel disease
3. Allergy to xylitol
4. Pregnancy

Some participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. They will not be excluded, but the investigators will include this group in a different data subset.
The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.

The main focus of the study is the assessment of hormonal function in the course of COVID-19 infection with special regard for trends predicting clinical events defined as primary endpoints of the study.


Eligibility Criteria:
Inclusion Criteria:

* PCR-confirmed COVID-19 infection
* volunteers consenting to participate

Exclusion Criteria:

* no consent
Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing

The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.

The goal of this study is to develop and refine I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), an electronic health record-integrated mobile health (mHealth) application designed to support advanced cancer patients and care teams in pain management.

The research study procedures include screening for eligibility, surveys, and interviews. It is expected that up to 73 participants will take part in this research study. Activities 1-3 are non-interventional and will be used to collect data for application development.

Activity 4: This activity will be interventional and will be added with a future amendment.

Eligibility Criteria:
Inclusion Criteria for Participants (Activities 1a, 2a, 3a):

* Age ≥ 21 years
* Current or previous diagnosis of advanced cancer
* Current or previous experience with cancer pain

Exclusion Criteria for Participants (Activities 1a, 2a, 3a):

* Inability to understand, speak, or read English
* Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection.

Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.


Eligibility Criteria:
Inclusion Criteria:

1. Mucinous cystic neoplasm defined by cyst fluid analysis \[23, 28\]:

   * CEA \> 192ng/mL
   * Amylase \< 800 IU/L
   * Cytology negative for malignant cells
   * No communication of cyst with pancreatic duct on 2 imaging studies (EUS, CT, MRCP, or ERCP)
2. Cyst size \> 15mm but \<50mm
3. 3 or fewer cyst compartments
4. Age ≥18 and ≤ 85

Exclusion Criteria:

1. Inability to safely undergo EUS examination with standard conscious sedation
2. Inability for safe FNA needle insertion into the cyst (eg: intervening vessel)
3. Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia)
4. Coagulopathy (INR\>1.5 or platelets\<50)
5. Active pancreatitis or pancreatic infection
6. Active sepsis/bacteremia
7. Inability to provide informed consent
8. Pregnancy
9. Breastfeeding women
Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection.

This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.

Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than 18 years old
* Written informed consent is obtained
* Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy
* Meniscal pathology is confirmed through MRI and arthroscopically
* Subject agrees to all follow-up evaluations
* Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views

Exclusion Criteria:

* Any subject lacking decisional capability
* Unwillingness to participate in the necessary follow-up
* Subject is pregnant or may become pregnant
* History of diabetes mellitus
* History of rheumatoid arthritis or other autoimmune disorder
* History of solid organ or hematologic transplantation
* Diagnosis of a non-basal cell malignancy within the preceding 5 years
* Infection requiring antibiotic treatment within the preceding 3 months
* Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views
* Prior surgery on the index meniscus
* Concomitant surgery such as ligament surgery or cartilage repair or restoration
* Infection
* Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks
SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)

The purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive acute ischemic stroke/TIA patients with NVAF

Exclusion Criteria:

1. Rheumatic mitral valve disease
2. A history of prosthetic valve replacement or mitral valve surgical repair
3. Active infective endocarditis
4. Patient, family member or legally responsible person does not have given informed consent
5. Inappropriate patient's conditions for study enrollment in the opinion of the investigator
Dual Channel Rehabilitation Technology Promotes Rapid Recovery of Upper Limbs After Stroke

The injury and remodeling mechanism about upper extremity motor network after stroke is not clear. There are few studies on the motor network covering cortex, white matter and blood perfusion at the time. Some studies have shown that metal imagery activates the cortex through active mental simulation. Our previous study has shown that passive application of transcranial direct current stimulation causes subthreshold polarization and promotes the effective integration of residual brain high-level network. This study proposes a hypothesis: transcranial Direct Current Stimulation + Motor Imagery combines active and passive neuromodulation techniques to produce dual channel effect, which can synergistically excite motor cortex, remodel the motor network and optimize cerebral perfusion. The research contents include clarify the effect of transcranial Direct Current Stimulation + Motor Imagery neuromodulation therapy through comprehensive randomized controlled trial study; present the process of brain injury and secondary neural plasticity through the motor network construction, functional connectivity strength and cerebral perfusion with Blood Oxygen Level Dependent, Diffusion Tensor Imaging and Arterial Spin Labeling multimodal magnetic resonance technology; calculate the correlation between motor score and brain functional network, extract the key nodes that can promote the motor network remodeling. The research results are expected to provide preliminary theoretical foundations for further research on the injury and remodeling mechanism about upper extremity motor network after stroke.


Eligibility Criteria:
Inclusion Criteria:

* First stroke with upper limb motor dysfunction
* No rapid natural recovery in the last week
* Greater than 1 month since stroke onset
* Pass the motor imagery test

Exclusion Criteria:

* Severe cognitive disorder
* Severe spasm or joint contracture
* Mental implants in vivo
* Do not sign the informed consent
Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. The purpose of this study is to provide data about multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects also data of non-affected relatives is collected (second cohort). the questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request.

Specific aspects include potential consequences from iron deficiency, efficacy and safety of self-packing, effect of female sex hormones, mortality, effects on the immune system.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of Hereditary Haemorrhagic Telangiectasia

Exclusion Criteria:

* unable to provide informed consent
Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia

Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining Normothermia During the Peri-operative Period

Subjects will be randomized into two groups. The first group will have the standard warming devices currently used which consists of a forced air warming device. This will be applied in the form of a gown in the pre-operative area. The device is called the Bair Paws. (Subjects will either continue with this or have a separate forced air warming device applied in the operating room called a Bair Hugger.) This device is non experimental and is FDA approved and used within the hospital to keep patients warm. They will then have their temperature taken and documented by the staff at various prescribed times.

The second group will receive the warming devices being studied which consist of a jacket, pants, gloves and socks with integrated air-activated chemical heat packs. The garment is applied at least twenty minutes prior to surgery. The same warming device will be maintained in place throughout the surgery and the period of post-anesthesia.

Intraoperative period: The participants temperature will be monitored and documented at prescribed times.

Postoperative period: The participants will have temperature monitored in the post anesthesia care area. Your part in this study will last until you are admitted to your room after surgery or you change into your own clothes prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

Male Female ASA physical status classification system Class I ASA physical status classification system Class II Age 18-80

Exclusion Criteria:

ASA physical status classification system Class III -VI Body Mass Index greater than 37.0