cyrilzakka/clinical-trials huggingface dataset:
Randomized Control Trial Comparing CMPAT and MAT for Lumbar Puncture

The lumbar puncture (LP) technique is a widely utilized method for diagnosis and treatment purposes. Recently, the paramedian approach technique (PAT) has garnered increasing interest due to its advantages over the midline approach technique (MAT), which has traditionally been used for LP in clinical practice . Utilizing digital virtual human and computer simulation techniques, a new path has been proposed for the computerized modified paramedian approach technique (CMPAT). As such, the objective of the present study is to present a randomized controlled trial (RCT) protocol to investigate and compare the effects of CMPAT versus MAT in patients requiring LP.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years. Indication for LP.（Diagnostic lumbar puncture：Cerebrospinal fluid composition analysis，Cerebrospinal fluid pressure measurement；Cerebrospinal fluid release or lumbar Contiuous drainage of fluid，Intrathecal injection of lumbar cistern, etc.） Informed consent. Sufficient knowledge of the Chinese language to complete forms and follow instructions independently.

Exclusion Criteria:

* Cerebral hernia or high Cerebrospinal fluid pressure that might lead to Cerebral hernia.

Treatment with oral anticoagulant or anti-small plate(3 days or less)or coagulation disorders, various factors leading to a higher risk of bleeding.

Local infection or skin breakdown. Previous surgery on Lumbar spine segments. Pregnancy or lactation Severe somatic or psychiatric illness.（Severe anxiety or depression, etc.） Failure to be followed up as needed or worries about the potential risks of the study.

Failure to provide written informed consent or follow the protocol requirements.

Expected survival time being less than 1 month. Plan to emigrate within 1 month. Other conditions that are unsuitable for clinical research.
Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis

This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological \[CT scan\] or histological evidence of cirrhosis and portal hypertension).
* Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and \<14).
* MELD scores of at least 10 (UNOS Meld calculator).
* Normal AFP Level
* Hb\>10gm/dl.
* Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
* Signed informed consent.

Exclusion Criteria:

* Patients likely to undergo liver transplantation during the duration of the study.
* Presence of advanced hepatic encephalopathy Grades 3 \& 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
* Active variceal bleed.
* Refractory ascites.
* Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
* Platelet count \< 30,000/mm3.
* Serum Sodium \<129mEq/L.
* Serum Creatinine \> 2 mg/dl.
* Hepatocellular carcinoma or other malignancies
* Active infectious disease.
* Presence of severe underlying cardiac, pulmonary or renal disease.
* Excessive alcohol (\>30 gm of alcohol/day) use in the last 3 months before screening.
* Positive HbSAg or antibodies to HIV or HCV.
* Pregnancy or lactation.
* Participation in other clinical trials.
* Unwilling/unable to sign the informed consent.
Evaluating Use of a Farmers Market Incentive Program Among Low-Income Health Center Patients

The purpose of this study is to evaluate the impact of a brief clinic-based educational intervention on utilization of Double Up Food Bucks (DUFB)-a Michigan-wide Supplemental Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center patients at a community health center in Southeast Michigan.

Study participants were provided a 3-5 minute explanation of DUFB, written program materials, and initial $10 market voucher. Participants were surveyed four times over five months, and a subset are also participating in post-intervention focus groups.

Eligibility Criteria:
Inclusion Criteria:

* patient or family member of patient
* at least 18 years of age
* currently SNAP-enrolled
* identifies as one of primary food shoppers for household
* English or Spanish-speaking

Exclusion Criteria:

* under 18
* not currently SNAP-enrolled
* not one of primary food shoppers for household
* unable to complete a telephone survey in English or Spanish
* unable to provide a working telephone number where they could be contacted
Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis

This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema.

Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior)
* ETDRS BCVA score of ≥ 5 letters read in the study eye

Exclusion Criteria:

* Any active ocular disease or infection in the study eye other than uveitis
* Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications.
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease

This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).

The study will be conducted on 120 frail patients with CKD, who will be divided into 2 groups: Group 1, consisting of 60 frail patients, will receive PACE intervention (based on mobile social network support) for 6 months. Group 2, comprising 60 frail patients, will receive usual CKD education and consultation for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CKD stage 1 to 5
* Participants with pre-frail and frail conditions.
* Having access to a mobile phone and is capable of using mobile social network application (Line)

Exclusion Criteria:

* Received renal replacement therapy
* Participants achieved TTM stage 5
Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

* To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE.
* To assess the safety and efficacy of additional therapy with enoxaparin.
* To compare the efficacy and safety of the European and American guideline recommendations.
* To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.

* Although it has been poorly investigated, the risk of VTE among patients with acute primary intracerebral hemorrhage is generally believed to be at least as high as among patients with ischemic stroke.
* The currently available guidelines state that while low doses of subcutaneous heparin or low-molecular-weight heparin may reduce VTE, it is possible that their effect is counterbalanced by an increase in hemorrhagic complications.
* It is still unclear when (if ever) low-molecular-weight-heparin should be safely initiated in ICH patients.

Eligibility Criteria:
Inclusion Criteria:

* acute primary ICH
* \> 17 years
* unable to walk
* admitted within 12 h after onset of ICH
* informed consent obtained

Exclusion Criteria:

* other type of ICH than acute primary intracerebral hemorrhage
* patients who need neurosurgery
* evidence of VTE at screening
* thrombolytic treatment within the preceding week
* major surgery or major trauma within the preceding 3 months
* life expectancy less than 3 months due to comorbid disorders
* confirmed malignant disease (cancer)
* hepatitis and/or liver cirrhosis
* renal failure
* infectious disease (HIV, endocarditis etc.)
* current of previous hematologic disease
* recent active and untreated gastric/duodenal ulcer
* allergy or known hypersensitivity to enoxaparin or heparins
* known hypersensitivity to benzyl alcohol
* women of childbearing age if pregnant
* participation in another study within the preceding 30 days
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.


Eligibility Criteria:
* Inclusion Criteria

  * Age between 20 to 45, healthy male subjects (at screening)
  * BMI between 18 - 27 kg/m2 (at screening)
  * Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
  * FPG 70-125mg/dL glucose level (at screening)
  * Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
* Exclusion Criteria

  * Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
  * Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
  * Subject who had drug hypersensitivity reaction.(gemigliptin, irbesartan, aspirin, antibiotics)
  * Subject who already admitted in other investigator product in 80 days
  * Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)

This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.


Eligibility Criteria:
Inclusion Criteria:

* Weight ≥8 kg
* Diagnosis of PAR and has symptoms of PAR at Visit 1

Exclusion Criteria:

* Past or present medical history of asthma
* Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic, sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergic rhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis)
* Started hyposensitization therapy or non-specific immunotherapy within 6 months prior to Visit 1
* Medical history of inferior concha mucosal resection, submucous resection of inferior turbinates or other surgery aimed at reduction and/or modulation of nasal mucosa (including electrocoagulation, cryoextraction or application of trichloroacetic acid)
* Clinically significant, active disease of the cardiovascular or hematologic systems or uncontrolled hypertension (1 to 5 year olds: \>120/70 mmHg; 6 to 9 year olds: \>130/80 mmHg; 10 to 15 year olds: \>140/85 mmHg)
* Medical history of stunted growth
* Serious drug allergy
* Treated with other clinical study drug within 3 months prior to Visit 1
Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer

The development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon:

* Patients: Exercise interventions may improve patient outcomes, including quality of life and avoidance of skilled nursing facilities.
* Clinicians: Proving the safety and feasibility of targeted interventions in older surgical patients may facilitate the development of clinically relevant preoperative interventions suitable for wider study and implementation.
* Payers: Improved surgical outcomes among high risk surgical patients will be associated with significant cost savings.
* Researchers: Targeted and well controlled studies focusing on improving surgical outcomes through exercise may provide insight into relationships between patient factors, surgical stressors and outcomes. Ultimately, such work may lead to novel clinical approaches to optimize patients for surgery.

The investigators will study the effects of preoperative exercise training on cystectomy patients, specifically targeting increasing functional capacity and muscular strength. Prior to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility, safety, and initial efficacy of preoperative exercise in cystectomy patients must be determined. To address this issue, the investigators will complete a trial of rehabilitation in cystectomy patients at the University of Michigan.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have biopsy-proven bladder cancer.
* Patients age ≥60, diagnosed with bladder cancer with planned cystectomy and urinary diversion, +/- neoadjuvant chemotherapy.
* The patient must be able to communicate and understand/complete forms/instructions, and be able to provide informed written consent prior to enrollment. Patients may have the assistance of an interpreter or surrogate when completing forms/surveys as needed.
* Karnofsky performance status ≥70 with the ability to walk unassisted.
* Sedentary baseline lifestyle, with an average of \<180 minutes/week of moderate-intensity aerobic activity.
* Attending surgeon clearance to undergo a supervised exercise training program.

Exclusion Criteria:

* Contraindication to exercise training, such as skeletal metastases, symptomatic coronary artery disease, severe anemia, or any condition limiting their ability to participate in an exercise training program.
* Patients who require surgery sooner than 28 days from enrollment.
A Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.

The primary endpoint in this study is to investigate if there is a difference in overall survival in patients with locally advanced head and neck cancer, randomized to either radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is performed in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Histologically or cytologically confirmed , previous untreated head and neck squamous cell cancer of the oral cavity, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent
* Tumor stage III and IV , but no evidence of distant metastases beyond the regional nodes in the neck
* WHO/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* The patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab
* The patient must be able to understand the information about the treatment and give a written informed concent to participate in the trial
* Adequate follow-up study must be possible; this will exclude a patient who is uncooperative
* Adequate renal function, creatinine clearance over 50 ml/min/1.73 estimated according to local practice at each study centre

Exclusion Criteria:

* Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years
* Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years
* Two or more synchronous primary head and neck squamous cell cancer at time of diagnosis
* Co-existing disease prejudicing survival (expected survival less than 6 months)
* Absolute neutrophil count less than 1.5 x 109/L
* Platelet count less than 100 x 109/L
* Bilirubin over 1.5 times upper limit of normal
* Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) more than 3 times upper limit of normal
* Pregnancy or lactation
* Allergy to study drug or to the excipients in their formulation
* Neuropathy grade 2 or more according to Common terminology criteria for adverse events (CTCAE) v.4.0
* Hearing loss/tinnitus is a relative exclusion criteria; the responsible physician decides whether the patient may be included in the study
* Severe cardiac illness; myocardial infarction within 6 months prior to randomization, severe congestive heart failure, severe cardiomyopathy, ventricular arrythmia, unstable angina, uncontrolled hypertension
Pharmacokinetic Comparison Of All FK-506 Formulations

The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus.

Eligible patients will be treated with all three formulations in a pre-defined sequence.

The pharmacokinetic parameters T(max), C(max) and AUC(0-24) will be compared between the three formulations Envarsus XR once daily, Astagraf XL once daily and Prograf Twice daily.

Eligibility Criteria:
Inclusion Criteria:

1. Renal transplant recipients, males or females, of 18 years of age or above.
2. Able to participate and willing to give written informed consent and to comply with study visits and restrictions.
3. Able to understand English.
4. Patients having received a primary or secondary renal transplant

Exclusion Criteria:

1. Evidence of acute rejection episode within the past three months prior to screening.
2. Recipients of organ transplants other than kidney.
3. Patients who are known to be HIV positive.
Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery

The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).

Subjects will be randomized according to an adaptive randomization procedure.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following inclusion criteria may be enrolled in the study:

* Male or Female, 18 to 80 years of age, inclusive
* If female, post-menopausal for the past 12 months, surgically sterile (i.e. tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover or sterilized partner
* Subject is scheduled to undergo a partial large bowel resection with primary anastomosis - See Appendix II
* Subject's body weight is ≤100kg
* Subject is scheduled to receive postoperative pain management with i.v. opioids
* Subject is scheduled to have nasogastric tube removed at the end of surgery
* Subject is scheduled to be offered liquids on postoperative day 1
* Subject is scheduled to be encouraged for ambulation on postoperative day 1
* Subject is scheduled to be offered solid food on postoperative day 2

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in the study:

* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450(men)/ \>470(women) milliseconds)
* Subject has history of additional risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of Long QT Syndrome)
* Subject requires use of concomitant medication that prolongs the QT interval - List provided in Study Procedures Manual
* Subject requires use of concomitant medication that is a known to interact with isoenzyme CYP3A4
* Subject has complete bowel obstruction
* Subject is scheduled to receive a thoracic epidural
* Subject is scheduled to receive total colectomy, colostomy, or ileostomy
* Subject is scheduled to receive a lower anterior resection
* Subject is scheduled for laparoscopic procedure
* Subject is scheduled to receive prophylactic antiemetics post surgery; however subjects may receive intraoperatively as part of the anesthesia protocol and postoperative antiemetics for symptomatic treatment
* Subject has significant impairment of liver or renal function (ALT/AST 2 ½ times the upper limit of normal; creatinine clearance \< 50mL/min.)
* Subject has a psychiatric disorder or cognitive impairment that would interfere with participation in the study
* Subject has severe cardiovascular, pulmonary, hematological diseases
* Subject has participated in an investigational study 30 days prior or received TZP-101 90 days prior to the study initiation
* Subject is pregnant (confirmed by quantitative serum pregnancy test) or is breast-feeding
* Subject has a known history of Hep B, Hep C or HIV
* Subject has a known history of drug or alcohol abuse
* Subject has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug