cyrilzakka/clinical-trials huggingface dataset:
Multisensory Stimulation in Infants for Eye Examination

This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns.

It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.

Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.

Eligibility Criteria:
Inclusion Criteria:

* According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of \< 1500 g.
* Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity.

Exclusion Criteria:

* Newborns who need CPR during the examination.
* Newborns experience apnea during the examination.
Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing

Rotator cuff injury patients treated with ERAS were included. The control group was given routine nursing. The observation group was given the Internet plus nursing home rehabilitation mode.

Relying on mobile app and wechat, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.


Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff injury
* ERAS surgery treatment
* Full thickness tear of rotator cuff, The range of tear is 1cm-3cm

Exclusion Criteria:

* Surgery not applicable
* Combined with other injuries, malignant tumor, disabilities, mental illness, critically ill patients, pregnant women, illiteracy, minors, cognitive impairment
Effects of Storage on Lactate in Blood Samples

The purpose of this study is to determine whether laboratory storage of samples affects the amount of lactate over 3 years.

Lactate is a natural substance normally present in the body. Lactate levels can go up for many different reasons, including treatment with nucleotide reverse transcriptase inhibitor drugs. This study will help researchers know if stored blood samples can be used to test lactate levels.

Lactic acidosis syndrome is a complication of therapy with nucleoside reverse transcriptase inhibitor (NRTI) drugs. Measurement of lactate levels is important in clinical trials of antiretroviral treatments. The preferred collection method for determining plasma lactate is with NaF/KOx tubes, while a number of ACTG studies have stored blood in ethylenediaminetetraacetic acid (EDTA) tubes. This study will analyze lactate in samples collected and stored in NaF/KOx and EDTA tubes to investigate the reliability of lactate concentrations over time.

Pre- and post-exercise blood samples are drawn from participants into NaF/KOx and EDTA tubes and a portion is tested for lactate levels immediately. The remaining portions are frozen and tested at 1, 3, 6, 12, 18, 24, and 36 months.

Eligibility Criteria:
Inclusion Criteria

Participants may be eligible for this study if they:

* Are at least 18 years old.
* Have sufficient forearm veins.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have a physical disability that prevents forearm exercise.
* Have any known medical reason, such as anemia, for not having 82 ml of blood drawn.
Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment

The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.

Primary objective The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.

Secondary objective The main secondary objective of this study is to evaluate confounding factors associated with retention rate of topiramate compared with other anticonvulsants.

1. Baseline characteristics

   * Seizure Type
   * Gender
   * Age of onset
2. Treatment regimen

   * Number of concomitant medication
   * Type of drug combination
   * Final target dose
   * Titration speed

Other secondary objectives

The other secondary objectives of this study are to compare followings by each medication:

* Rate of seizure reduction (≥75%, ≥50%)
* Rate of seizure freedom

Eligibility Criteria:
Inclusion Criteria:

* Subjects who began their treatment with topiramate, levetiracetam or oxcarbazepine as mono or add-on therapy with conventional drugs.
* Subjects who are with partial or generalized epilepsy

Exclusion Criteria:

* Subjects who administered combination therapy in topiramate, levetiracetam or oxcarbazepine
* Subjects who have past experience of surgery for epilepsy treatment
* Subjects who were not followed up for at least 1 year
A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma

The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. After the standard 1st line chemotherapy with doxorubicin, the only a few treatment option is available. Recently, pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated and moderately effective. Based on the background, investigators planned to conduct the phase II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue sarcomas.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide
2. Measurable or evaluable disease (RECIST 1.1.)
3. Age ≥19 years
4. ECOG performance status of 0-2
5. Adequate laboratory findings

   * Absolute neutrophil count (ANC) ≥ 1500 /µL
   * Platelet count ≥ 75,000/ µL
   * Serum creatinine \< 1.5 x upper limit of normal (ULN)
   * AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal (ULN)
   * Total bilirubin \<1.5 x upper limit of normal (ULN)
6. more than 3 months of expected survival
7. Provision of written informed consent prior to any study procedure

Exclusion Criteria:

1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study'
2. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
3. Resectable lung metastases
4. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
5. Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
6. Uncontrolled medical conditions
Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Age of 19 or above
* Inadequately controlled Essential hypertension at Screening

  1. Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1

     * Mean sitDBP ≥ 95mmHg on target arm
  2. Taking antihypertensive drug but not controlled

     * Mean sitDBP ≥ 90mmHg on target arm
* Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy

  * Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
* Ability to provide written informed consent

Exclusion Criteria:

* The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
* Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
* Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* Patient with congestive heart failure(NYHA class III, IV)
* Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
* History of stroke, cerebral hemorrhage within 6 months
* Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c \> 8.5%
* History of severe or malignant retinopathy
* AST/ALT \> UNL\*3, Serum creatinine \> UNL\*1.5, K \> 5.5mEq/L
* Patient with acute or chronic inflammatory(treatment required) status
* Patient who need to take antihypertensive drug besides Investigational products
* Patient must be treated with medications prohibited for concomitant use during the study period
* History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
* Hypersensitive to Candesartan/Amlodipine
* Patient who are dependent on drugs or alcohol within 6 months
* History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
* Patients treated with other investigational product within 30 days at first time taking the investigational product
* Women with pregnant, breast-feeding
* History of malignant tumor within 5 years
* Not eligible to participate for the study at the discretion of investigator
Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Non-suspected lung cancer group (600 cases)

  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung nodule lesion in the chest (based on local CT result);
  4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
* Suspected lung cancer group (600 cases)

  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung cancer lesion in the chest (based on local CT result);
  4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.

Exclusion Criteria:

* Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
* Already treated by chemotherapy or surgery
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 90 years
* NIHSS of 4 to 30
* Diagnosis of AIS within 24 hours after stroke symptoms onset

Exclusion Criteria:

* Treatement with approved drug during the current AIS
* Pre-stroke disability
* Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
* Suspected subarachnoid hemorrhage
* Seizure
* Uncontrolled hypertension
* INR \>1.7 and/or abnormal aPTT or platelet count \<100,000/mm3
* Blood glucose concentration \<50 mg/dL or \>400 mg/dL
* Lactating or pregnant subjects or those planning to become pregnant during the study
* Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
* AIS, myocardial infarction, serious head trauma or major surgery within 90 days
* Bleeding event within 21 days
* Puncture of noncompressible vessels within 7 days
* Severe hepatic, renal, and/or infectious disease
Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.

Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal.

This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters.

All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster.

The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subject referred for clinical colon/panenteric examination
* Subject received an explanation about the nature of the study and agreed to provide written informed consent

Exclusion Criteria:

* Subject with dysphagia or any swallowing disorder
* Subject with a prior stomach, small bowel, or colonic resection
* Subject with severe renal insufficiency
* Subject with any allergy or other known contraindication to the medications used in the study
* Women who are either pregnant or nursing
* Subject suffers from life threatening conditions
CAES for Internal Hemorrhoids and Rectal Prolapse

Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.

CAES is an innovative endoscopic sclerotherapy procedure which is different from traditional method. Firstly, the cap added to the front of colonoscope can fully expose the operating field. Secondly, before or during the opportunity of CAES, endoscopist can perform endoscopic differentiation diagnosis (such as tumors, inflammatory bowel disease and others induced hematochezia), endoscopic therapy within lower-gut based on the same colon preparation, thus saving patients' medical cost, physical and mental pain. The last but not least, specially designed length of endoscopic injection needle (eg.10-20 mm) was used in CAES could be helpful for accurately controlling the injection angle, direction, depth under direct vision and to avoid iatrogenic injury due to ectopic injection.The core value of CAES for internal hemorrhoids and rectal prolapse is to provide precise therapy, reduce the iatrogenic injuries, avoid pain during and after therapy. Our pilot studies demonstrated that CAES based on long injection needle is an effective, safe, convenient operation technique. 100% of participants underwent CAES showed sustained clinical efficacy within the 3-month follow-up, with no severe or obvious complications related to CAES. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse need to be confirmed by further large sample real world studies.

Eligibility Criteria:
Inclusion Criteria:

1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
2. Patients with bowel preparation.

Exclusion Criteria:

1. History of anoscopic/endoscopic sclerotherapy.
2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
4. Inflammatory bowel disease.
5. Full-thickness rectal prolapse through the anus.
6. Acute diarrhea in the past 24 hours.
7. Hypertensive with uncontrolled blood pressure.
8. Cerebrovascular accident.
9. Blood coagulation dysfunction.
10. Pregnant women.
11. Mental disorders.
12. Decompensated cirrhosis.
the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
* 2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
* 3. Subjects aged between 18 and 45 (both inclusive) years old.
* 4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
* 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* 1. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
* 2. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
* 3. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
* 4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
* 5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
* 6. Positive results from urine drug screen test.
* 7. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test.
* 8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
* 9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
* 10. Subjects who plan to receive or have had organ transplants.
* 11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
* 12. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
* 13. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases

Despite advances in effective psoriatic disease treatment, the disease still has a serious impact on mental health and well-being of millions of patients. Up to 20.7% of patients report poor mental health, compared to 7.1% of the general population. Mental health treatment involves a combination of medication and talk therapy to address such issues. However, there is increasing evidence that optimizing behaviors such as sleep, physical activity, stress, and nutrition are critical components in improving mental health too. Numerous online health programs have evolved to help patients optimize such behaviors but very little exists for patients with psoriatic diseases. The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost, high-touch, personalized intervention that patients can access 24/7. In conjunction with traditional clinical care, the goal of this program is to leverage the convenience, affordability, scalability and effectiveness of an online eCoaching program to improve key physical behaviors, thereby reducing the mental health burden experienced by psoriatic disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient of Cleveland Clinic
* Adults (=18 years of age)
* Diagnosis of psoriasis or psoriatic arthritis by a board certified physician.
* PHQ9 score between 5 and 20
* Computer and internet access
* A valid email address
* Able to speak \& read English
* Able to understand \& sign informed consent

Exclusion Criteria:

* PHQ9 score \> 20
* History of major depressive disorder
* Currently receiving psychotherapy for major depressive disorder (MDD), anxiety or psychotic disorder
* On a wait-list for psychotherapeutic treatment
* Received treatment for a severe psychiatric illness in the previous 6 months
* Demonstrate a notable suicidal risk at study visit