cyrilzakka/clinical-trials huggingface dataset:
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer

Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will evaluate the safety and efficacy of TLBZT based herbal therapy in combination with chemotherapy in patients with metastatic colorectal cancer.

A phase I/II, multicentric,randomized, controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum with non-resectable metastatic disease;
* Ages between 18 and 70 years;
* Measurable lesion;
* Karnofsky Performance Status ≥ 60%;
* Estimated life expectancy of at least 6 months;
* Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥90g/L, N \> 1.5×10\^9/L, platelet≥ 100×10\^9/L, normal liver and kidney function;
* Informed consent from the patient.

Exclusion Criteria:

* Symptomatic brain metastasis;
* Adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
* Serious disease of heart, liver, kidney with severe dysfunction;
* Serious complications, such as gastrointestinal tract obstruction and hemorrhage;
* Pregnancy or breast-feeding women;
* Mental or cognitive disorders;
* Be participating other drug trials;
* Who are allergic to the study drug.
Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture

Interferential current is a form of electrotherapy that is obtained by placing two different plates that produce medium frequency waveform current, resulting in a low frequency interferential waveform in deeper tissues. It was shown interferential current electrotherapy is beneficial for reduction of traumatic edema in tissues and pain control.

Patients with conservatively managed distal radius fractures were recruited after casts are shed, and were treated with one session(30 minutes) of different protocols of interferential current electrotherapy. Before and after therapy, they were evaluated with volumetry, hand grip strength and visual analogue scale for pain.


Eligibility Criteria:
Inclusion Criteria:

* Conservatively managed distal radius fractures

Exclusion Criteria:

* Secondary conditions associated with edema(renal failure, congestive heart failure etc)
* Complex regional pain syndrome
* Compartment syndrome
* Contraindications for electrotherapy(cardiac pacemaker, thrombosis, pregnancy etc)
* Mental state unfit for electrotherapy
* Having treated with electrotherapy before
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting

A randomized single-blind interventional trial to test the effectiveness of an electronic medical record-based best practice alert recommending evidence-based medical therapies versus usual care in inpatient adult patients presenting with heart failure with reduced ejection fraction.

Heart failure (HF) is the major cause of healthcare expenditure, morbidity, and mortality in the United States. HF is the primary diagnosis for hospital discharge in \~1 million and a secondary diagnosis in \~2 million hospitalizations annually in the US. In fact, inpatient admissions account for more than half of HF healthcare expenditure. However, data from several registries over the last three decades has failed to see use of these evidence- based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field. It remains unclear as to why many patients with HF reduced ejection fraction (HFrEF) are not on evidence-based therapies especially post hospital discharge and why the percentages are consistent across national registries over time. Whether the gap between clinical trial use and real-world practice is due to a lack of knowledge or providers making individualized decisions about their patients is unclear. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.

The goal of this trial is to determine the effectiveness of a BPA alert system that informs providers about evidence-based medical therapy for the treatment of HFrEF versus usual care (no alert) in the inpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years admitted to a hospital within the Yale New Haven Hospital system (either Yale New Haven Hospital, St. Raphael's Campus, Greenwich Hospital, or Bridgeport Hospital).
* Have HFrEF defined as:

  1. NT-pro-BNP \>500 pg/ml within 24 hours of admission
  2. On IV loop diuretic within 24 hours of admission
  3. Left ventricular ejection fraction ≤40% (most recent)

Exclusion Criteria:

* Patients within 48 hours of admission
* Patients in the intensive care unit
* Patients on hospice service
* Patients receiving intravenous milrinone
* Patient on NPO (nothing by mouth) order
* Patients on all evidence based medical therapy for HFrEF (on all 4 classes of evidence based medical therapy: beta-blockers, ACEi/ARB/ARNI, MRA, SGLT2i)
* Opted out of medical record research
How Common Are Sleep Disorders and Problems With Emergence From Anesthesia in Surgical Patients

Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem in pre-school children, with estimates of the incidence ranging from 10-70% of children in this age group. These children are agitated, seemingly unaware of their surroundings, and typically do not respond to parents or caregivers. They are therefore at risk for self-inflicted traumatic injury and complications secondary to disruptions of intravenous lines, surgical incisions, or drains. Children with ED typically require more resources in the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED would allow for better allocation of resources in the post-anesthetic care unit (PACU).

The peak incidence of ED in children occurs in the same age range at which the peak incidence of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable physical events or experiences that occur during entry into sleep, within sleep or during arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.

The purpose of this pilot study is to determine the incidence of ED and PS in our population, in order to determine the number of patients necessary to enroll in a larger study to either confirm or reject the hypothesis that ED and PS are correlated.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients age 1-6 (inclusive) scheduled for elective ENT or urologic surgery
2. ASA I or II
3. Presence of a caregiver who is familiar with the child's sleep history

Exclusion Criteria:

1. Autism
2. Severe developmental delay
3. Children receiving clonidine
4. Medication for seizures
5. Children who have received ED treatment prior to a diagnosis of ED (clonidine, dexmedetomidine, or propofol)
The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial

The objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.

Gingival recession constitute a functional and aesthetic problem that affects much of the population. One of the possible causes refers to a traumatic brushing. Individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. These lesions have been considered subrogated outcomes of gingival recession noninfectious. The literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion.

This is the first clinical trial to evaluate the gingival fissures according to the type of brush used.

Eligibility Criteria:
Inclusion Criteria:

* good/ excellent health;
* idade de 14 a 20 anos;
* at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding;
* absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas.

Exclusion Criteria:

* were unable to provide consent or comply with the sudy protocol;
* smokers;
* pregnant women;
* persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries;
* need of antibiotic prophylaxis associated with dental procedures.
Determine the Point of View of Society Society to Natural Orifice Surgeon

200 participants' perception and acceptability of natural hole surgeon

100 participants health personnel 100 participants population two group's perception and acceptability of natural orifice surgeon

Eligibility Criteria:
Inclusion Criteria:

* all female (health personnel and population)

Exclusion Criteria:

* none
Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects

This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.

A randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic and prehypertensive subjects. Over a 12 week test period, the red ginseng group (n=31) consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31) consumed the same product without red ginseng. Fasting plasma metabolomes were profiled using UPLC-LTQ-Orbitrap mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study.

Exclusion Criteria:

* exclusion criteria included previous diagnosed clinical hypertension
* self-reported use of antihypertensive medication
* abnormal liver or renal function
* history of cardiovascular disease
* kidney disease
* cancer
* thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment
* we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.
Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients

This study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients

Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days thumb ECG at the same time. The detection rates of the two methods will be compared

Eligibility Criteria:
Inclusion Criteria:

* stroke or TIA within the last 3 months verified by a CT or a MR scan or unequivocal symptoms and old infarcts visualised on CT or MR
* age 65 or above
* patients able to handle the thumb-ECG
* written informed consent

Exclusion Criteria:

* earlier diagnose of atrial fibrillation
* pacemaker or ICD device
* stroke induced by trauma, infection or surgery procedure
* carotid stenosis of more than 60%
A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery

The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. The main question it aims to answer is:

* Does RMC-035 protect the function of kidneys after surgery?
* Is RMC-035 safe?

Researchers will compare RMC-035 in high dose, RMC-035 in low dose and placebo to see if

* Kidney function better for participants treated with any of the RMC-035 doses?
* What medical problems do participants have when receiving RMC-035?

Participants will

* Receive 3 doses of RMC-035 or placebo: at the beginning of surgery, end of surgery and 24h after surgery
* Have extra checkups and tests during their hospital stay
* Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* eGFR ≥30 ml/min/1.73m2
* Scheduled for non-emergent surgery of any of the following types, with use of cardiopulmonary bypass (CPB): coronary artery bypass grafting (CABG), valve surgery, ascending aorta aneurysm surgery
* Risk factors for acute kidney injury are present
* Participant capable of providing written informed consent
* Participant agrees to study restrictions such as not to take part in another interventional study, use contraception and not donate ova or sperm

Exclusion Criteria:

* Any medical condition that makes the participant unsuitable
* Scheduled for emergent surgeries
* Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries
* Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation
* Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices such as intraaortic balloon pumping (IABP) within 24 hours prior to surgery
* Requires any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support.
* Diagnosed with AKI prior to surgery
* Requires cardiopulmonary resuscitation prior to surgery
* Ongoing sepsis or an untreated diagnosed clinically significant infection
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3.0 times the upper limit of normal (ULN).
* Total bilirubin ≥2.0 time ULN
* History of solid organ transplantation
* History of renal replacement therapy
* Severe allergic asthma
* Chronic immunosuppressive treatment that may have an impact on kidney function
* Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
* Current enrolment or past recent participation in any other clinical study involving an investigational study treatment
* Previously treatment of RMC-035
* Sensitivity to any of the study interventions, or components thereof
Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure

This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.


Eligibility Criteria:
Inclusion Criteria:

* admitted in the PICU of Grenoble-Alps University Hospital
* for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs

Exclusion Criteria:

* already followed-up by a pediatric pulmonologist
* with congenital disease
* with long term ventilation
* still admitted at 3 months
Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy

The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.

Depression is associated with increased risk of cardiovascular disease, in which one possible mechanism is systemic inflammation. Further, patients at high risk of cardiovascular disease, rosuvastatin decreases the risk, especially among patients with increased inflammation. This is a proof-of-concept study to investigate whether the antiinflammatory effect of rosuvastatin is similar in depressive as in patients with cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Persisting self-reported depressive symptoms \> 5 weeks
* Indications of aortic atherosclerosis on PET/CT

Exclusion Criteria:

* Clinical indication of statin use.
* Contraindication of statins, or of PET/CT and MRI.
* Established cardiovascular disease.
* Bipolar disorder og comorbid psychosis.
Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who voluntarily participate and sign the informed consent form;
2. Healthy male/female volunteers aged 18 to 45 years;
3. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 \~ 26.0 kg/m2, inclusive;
4. Able to comply with the lifestyle restrictions.

Exclusion Criteria:

1. Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
2. Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
3. Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
4. Subject has a history of self-mutilation; or at risk of suicide;
5. Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
6. Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
7. Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
8. Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
9. Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
10. Subject has a history of substance abuse within 1 year or a positive urine drug screen;
11. Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
12. Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia;
13. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
14. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
15. Subject who has participated in other clinical trials within 3 months before administration;
16. Subject has used blood products or being blood donor or blood loss within 3 months;
17. Pregnant, lactating women, or positive pregnancy test;
18. Subject who refusal to contraception, or plan to donate sperm or ovums;
19. Other conditions which would make participation in the study unsuitable.
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.

Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine/naloxone. The proposed study compares buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine/naloxone in the care of prescription opioid dependent patients in primary care.

Eligibility Criteria:
Inclusion Criteria:

* opioid dependence

Exclusion Criteria:

* current dependence on alcohol, cocaine, benzodiazepines or sedatives
* current suicide or homicide risk
* current psychotic disorder or untreated major depression
* inability to read or understand English
* life-threatening or unstable medical problems
A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects

The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male Caucasian subjects aged 18 to 55
* A body weight of ≥60 kg

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
* Clinically relevant abnormal medical history, physical findings or laboratory values