cyrilzakka/clinical-trials huggingface dataset:
Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer

This study will take disease-free survival time and recurrence and metastasis rate as the main evaluation indexes, to evaluate the clinical efficacy of strengthening the spleen and reducing phlegm method in patients with stage II high-risk and stage III colorectal cancer

The study enrolled 350 patients with stage II high-risk and stage III colorectal cancer who underwent adjuvant chemotherapy (based on a 5-fluorouracil（5-FU） regimen for at least 3 months) and patients who received chemotherapy for less than 3 months. The study will use a large sample, multicenter, randomized, double-blind study. The experimental group was given oral Jianpi Huatan dispensing granule, once a day in the morning and evening, 1 course per 1 month, a total of 3 courses; the control group of oral Chinese medicine formula low dose control granules (including the test group dose 1 /10), 1 time each morning and evening, 1 course per month, for a total of 3 courses.

The patients were followed up once a month during the treatment period and once every 3-6 months after the end of treatment until the patient relapsed, died or the study was over.Some patients in the study will be tested for circulating tumor cells.

Main outcome measures is Disease-free survival time（DFS）and Metastasis recurrence rate in 1 year；Secondary outcome measures：Quality of life score: applied quality of life scale.Metastasis recurrence rate in 2、3years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria；
2. Radical resection of colorectal cancer was performed and adjuvant chemotherapy (based on 5-FU regimens for at least 3 months) was completed within 3 months of the end of chemotherapy；
3. Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage；
4. Age 18-80 years, sex unlimited；
5. No recurrence or metastasis by imaging or doctor's clinical judgement；
6. Signed informed consent； Note \* According to National Comprehensive Cancer Network(NCCN )clinical guidelines: Phase II:T3-4N0M0; High-risk Phase II is defined as follows:：a.T4;b. Less than 12 lymph nodes were detected；c. preoperative intestinal obstruction, perforation of tumor site；d. poor histological differentiation (except highly unstable microsatellite)；e. neurological invasion and vascular tumor thrombus； f. positive or unknown margin, and insufficient margin safety distance. Phase III：T1-4N1-2M0.

Exclusion criteria:

1. History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix；
2. Combined with severe heart, liver and kidney disease；
3. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia;
4. The researchers determine that they were not suitable for the study.
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age;
* Evidence of at least one donor-specific antibody (DSA);
* Recipient of a kidney transplant;
* Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;
* Acute AMR.

Exclusion Criteria:

* Recipient of an en bloc kidney transplant;
* Current active hepatitis C virus (HCV) infection;
* Active bacterial or fungal infection;
* Ongoing dialysis \>2 weeks;
* Known congenital bleeding or coagulopathy disorder;
* Current cancer or a history of cancer;
* Female subjects who are pregnant or breast feeding;
* Male or female subjects who are unwilling to use contraception or who are not surgically sterile.
Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants

The purpose of this study is to compare the effects of two different anti-HIV drug regimens on HIV transmission risk behavior among SMART study participants.

It is important to consider the role that HIV infected individuals play in ongoing HIV transmission. Different anti-HIV treatment regimens may lead to variations in HIV transmission risk behavior among HIV infected individuals. HIV infected people with viral loads of less than 1,000 copies/ml are less likely to transmit HIV through heterosexual sex. However, condom use sometimes decreases after individuals start combination antiretroviral therapy (ART); also, some studies have shown an increased rate in acquiring sexually transmitted infections (STIs) following initiation of ART, and those on ART may transmit a drug-resistant strain of HIV. In the SMART study, participants were randomly assigned to one of two treatment groups:

* Group 1 participants will follow a drug conservation (DC) regimen in which ART will be stopped or deferred until CD4 cell count drops below 250 cells/mm3, will be initiated until CD4 cell count is at least 350 cells/mm3, and then will be followed by episodic ART based on CD4 cell count.
* Group 2 participants will follow a viral suppression (VS) regimen in which ART is continued to keep viral loads as low as possible, regardless of CD4 cell count.

The purpose of this study is to compare how the DC and VS regimens affect HIV transmission risk behavior among SMART study participants.

At baseline, participants will complete a questionnaire about their sexual behavior during the previous 2 months. They will also undergo urine and blood collection for STI testing. These same procedures will occur at Months 4 and 12, then every year thereafter for the first 4 years that a participant is in the parent study. Participants and their physicians will be notified of STI testing results so that patients can be referred to appropriate care.

Eligibility Criteria:
Inclusion Criteria:

* Coenrollment in the SMART study
* Parent or guardian willing to provide informed consent, if applicable
Efficacy of Racecadotril in Acute Watery Diarrhea in Children

The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.

Background: Treatment of acute diarrhea is based on the following various oral rehydration management guidelines. Lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children.

Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea.

Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients: One group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.

Eligibility Criteria:
Inclusion Criteria:

* Acute watery diarrhea

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Systemic infections
* Coinfections
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

Eligibility Criteria:
Inclusion Criteria:

* De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate
* The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of \>= 50% and \< 100% with a TIMI flow of \>= 1
* Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done \>= 90 days prior to the index procedure or if planned to be done \> 9 months after the index procedure

Exclusion Criteria:

* De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) \< 9 months prior to index procedure
* Target lesion(s) restenotic from previous intervention
* Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy
* Target vessel(s) contains visible thrombus
* Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
* Patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
The Effect of Myofascial Induction and Therapeutic Pain Education in Chronic Low Back Pain

The aim of this study was to investigate the effects of therapeutic pain education and myofascial induction therapy on pain and function in patients with chronic low back pain. In the literature, studies on myofascial induction therapy in patients with chronic low back pain are very limited and there is no study comparing therapeutic pain training.

Lumbar pain has become a major health problem which is growing and is very common in all societies and negatively affects the full well-being of the individual. It has been reported that 80% of the population experienced low back pain at any time in their lives. The prolongation of this painful process affects the physical, mental and psychological state of the patient and limits its daily functions. The acute or chronic pain determines the nature and duration of pain. Low back pain lasting 12 weeks or more is defined as chronic. In chronic diseases, lumbar pain, which is the first one, restricts the daily activities of the person due to current chronic pain or deterioration of functional status and causes loss of labor force.

Myofascial induction therapy is a therapy concept focused on optimizing function and balance within the fascial system. The approach aims at global recovery, local correction and painless body use.

Superficial procedures are directed to surface and / or local restrictions that can be directly detected by palpation. Deep myofascial induction therapy is a method that eliminates the limitations of the myofascial system and the three-dimensional pressures.

Therapeutic pain education is a training intervention that aims to reduce pain and disability by helping patients better understand the biological processes that support pain states. The neurobiology of pain and pain processed by the nervous system is explained to the patient in detail. Changes the patient's olab viewpoint to pain. For example, the patient believes that the cause of pain is caused by tissue damage. The patient who receives pain education understands that the cause of pain is the hypersensitive central nervous system. As a result, the patient's fear avoidance behavior decreases and he starts to move more easily. Because the sensitivity of the central nervous system will be alleviated, the perceived pain will decrease.

Eligibility Criteria:
Inclusion Criteria:

* Between 25-65 years old
* Low back pain for at least 12 weeks
* Physical therapy in the last 1 month
* There is no other disease that may cause low back pain.

Exclusion Criteria:

* Stem pressure associated with pain
* Having severe discopathy
* Available compression fracture
* To have rheumatic or inflammatory disease that may cause back pain.
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients

The goal of this study will be to determine if a lower than normal blood pressure during surgery for bleeding in the abdomen or chest will result in decreased bleeding and decreased chance of death.

For the proposed study, all trauma patients undergoing laparotomy or thoracotomy for trauma that had a systolic blood pressure \< 90 mmHg prior to going to the operating room will be randomized to one of two groups. The randomization will take place at the operating room door. The first group will have a target minimum mean arterial pressure of 50 mm Hg (LMAP) and the second group will have a target minimum mean arterial pressure of 65 mmHg (HMAP). Before the operating room and in all other aspects of their care the patients will be treated as per standard of care. Patients will then be followed to determine if there is a difference in 30 day survival between the two groups. Secondary outcome measures will be Sequential Organ Failure Assessment (SOFA) score, APACHE II, ARDS, ICU length of stay, myocardial ischemia, stroke, acidosis, coagulopathy by conventional labs and thromboelastogram, estimated blood loss, transfusion requirements, Glasgow Outcome Score, the presence of leukocyte apoptosis, the serum level of the pro-inflammatory cytokines, IL-6 and G-CSF, and the rate of infectious complications (VAP, UTI, Wound infections). Blood samples (20 ml each) will be taken at three time points: prior to randomization, immediately after the end of resuscitation protocol, and 24 hrs after randomization. Blood will be examined for the presence of leukocyte apoptosis and levels of IL-6 and G-CSF.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients seen in the Ben Taub emergency center that have suffered a trauma, have a systolic blood pressure less than 90mm Hg, and are going to the operating room for a laparotomy or thoracotomy

Exclusion Criteria:

* Known or suspected head injury
* Age \> 45 years old, \<= 12 years old
* Incarcerated individuals
* Pregnant women
* Patients with an advanced directive that refuse resuscitation
* Patients with "opt-out" bracelets that signify their refusal of participation in the project
Neodymiun:Yttrium Aluminum Garnet Laser in Caries Prevention of Primary Teeth: One-year Follow-up

The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without fluoride, in prevention of occlusal caries in the primary dentition.

The aim of this controlled clinical study was to evaluate the Neodymiun:yttrium aluminum garnet laser, with or without fluoride, in prevention of occlusal caries in the primary dentition. High caries risk children (7.6±1.4 years) were selected for this study and received the following treatments: G1-1st molar was negative control, and the 2nd molar received a resin sealant; G2-1st molar was negative control, and the 2nd molar received laser irradiation (100 milliJoule, 5 Hertz - 0.5 Watts); G3-1st molar received only fluoride gel and the 2nd molar received fluoride gel + laser irradiation; G4-1st molar received only fluoride varnish and the 2nd molar received fluoride varnish + laser irradiation. Patients were followed up to 12 months to evaluate the formation of white-spot lesions and/or caries cavities by three calibrated observers.

Eligibility Criteria:
Inclusion Criteria:

* subject age of 7 to 8 years, high caries risk (evaluated by oral hygiene, dietary habits and fluoride exposure, according to Kidd 2011), with the first permanent molars without caries cavities, restorations, enamel defects, morphological anomalies and/or signals of fluorosis. Subjects had to be willing to comply with all study procedures and protocols. They had to be residents of Ribeirão Preto or other nearby local communities with the same water fluoridation pattern (to eliminate water fluoridation as a potential con- founding variable). Subjects had to be healthy and the parents or the child legal guardian need to be willing to sign the "Authorization and informed consent for research" form. There were no gender restrictions.

Exclusion Criteria:

* suffering from systemic diseases, had a significant past or medical history with conditions that may affect oral health (i.e., diabetes, HIV, heart conditions that require antibiotic prophylaxis), were taking medications that may affect the oral flora or salivary flow (e.g., antibiotic use in the past three months, drugs associated with dry mouth / xerostomia), had in-office fluoride treatment within the last three months prior to being enrolled in the study, or were not willing to stop the use of any mouth rinse during the duration of the study.
The Effect of Exercise Therapy in Painful Shoulder Disorders

20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.

20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Exercises will be applied 3 days a week for 4 weeks, 45-55 minutes by a physiotherapist within the framework of shoulder rehabilitation. In addition, balance exercises will not be given. Balance measurements will be made by the Biodex Balance System, which provides objective data.

Eligibility Criteria:
Inclusion Criteria:

* Having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon,
* Pain severity felt by the patient above-8 according to the Visual Analogue Scale divided into 10 equal intervals,
* Patients who were recommended conservative treatment

Exclusion Criteria:

* Any previous surgical operation,
* Skeletal system fractures or dislocations,
* Other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy
Manual Lymphatic Drainage Versus Standard Treatment for the Prevention of Breast Cancer-related Lymphoedema in Patients Who Undergo Axillary Node Clearance

Axillary lymph nodes are the main site of metastasis in breast cancer. If positive axillary lymph nodes are present, an axillary lymph node dissection (ALND) is usually performed. This procedure improves disease-free survival but comes with the risk of lymphoedema as a result of disrupted lymphatic channels. Breast cancer-related lymphoedema (BCRL) is associated with considerable morbidity, which is why proven measures to reduce its incidence would improve patient outcomes. We aimed to investigate whether a regime of manual lymphatic drainage and exercise, supervised by a manual lymphatic drainage therapist compared to standard care would reduce the incidence of breast cancer-related lymphoedema in patients undergoing ALND.

Eligible patients were those in whom a primary operable breast cancer is diagnosed and in whom surgery is planned to include ALND. Patients with recurrent carcinoma, previous axillary surgery/radiotherapy or any previous arm/axillary pathology leading to arm volume changes will be excluded. Eligible participants will be identified at the breast multidisciplinary meeting and will be informed of the study and given a written information sheet. Patients who choose to participate will be asked to fill in a written consent form. Patients allocated to the decongestive lymphatic therapy group will undergo intervention for a total period of 3 months. This will consist of 2 visits to a qualified practitioner in Dr Vodder manual lymphatic drainage therapist, one at the start of the 3-month period and again 6 weeks later. Patients in both groups will also be instructed to perform self-MLD on a daily basis and will be taught a series of exercises to be performed on a daily basis. Compression hosiery will be fitted to be worn during the exercises.

Eligibility Criteria:
Inclusion criteria:

* Patients with a new diagnosis of primary operable breast cancer
* Surgery will involve axillary lymph node clearance

Exclusion criteria:

* Patients with recurrent breast cancer
* Patients with previous axillary surgery
* Patients with previous axillary radiotheraphy
* Patients with previous arm/axillary pathology leading to arm volume changes
Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project

The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.

This pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and health care providers throughout North America.

Participants in the first two cohorts are recruited concurrently from callers to OTIS centers, from health care providers and through direct to consumer marketing efforts. The source of historical controls is archived data on pregnancies that have been followed through the California Teratogen Information Service's Clinical Research Program located at the University of California San Diego.

Eligibility Criteria:
Cohort 1 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in the US or Canada who have had any exposure to etanercept for treatment of Rheumatoid Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or Psoriasis (PsO) at any time during the first trimester of pregnancy which is defined as the period between first day of the last menstrual period (i.e., within two weeks of conception) up to and including the 12th week after the first day of the last menstrual period (LMP) - Eligible subjects must have documentation of an exposure to etanercept during the first trimester of pregnancy.

Cohort 2 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in the US or Canada who have not taken etanercept or any TNF antagonist for treatment of RA, JRA, AS, PsoA or PsO at any time in the current pregnancy or within two months prior to the first day of the last menstrual period (LMP).

Cohort 3 Inclusion Criteria: Eligible subjects will be pregnant women who were residing in the US or Canada who had not been diagnosed with RA, JRA, AS, PsoA or PsO and had not been exposed to a known human teratogen during the index pregnancy.