cyrilzakka/clinical-trials huggingface dataset:
Study of Apatinib in Metastatic Esophageal Cancer

The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.

Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to75 years old;
2. Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
3. Failed in first-line chemotherapy or radiotherapy treatment;
4. ECOG PS of 0-1;
5. An expected survival of ≥ 3 months;
6. No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored;
7. Major organ function has to meet the following criteria:

   ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST\<2 × ULN; Plasma Cr\<1.5 × ULN
8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
9. Researchers believe that patients can benefit;

Exclusion Criteria:

1. Pts with other malignant tumor at the same time or in the past.
2. Pregnant or lactating women;
3. Subjects with poor-controlled arterial hypertension (systolic blood pressure\>150 mmHg and diastolic blood pressure\>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)\<50%;
4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months;
6. Associated with CNS (central nervous system) metastases;
7. Abnormal Coagulation, with tendency of bleed;
8. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
9. Anastomotic recurrence;
10. Participated in other clinical trials within 4 weeks;
11. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
12. Other conditions regimented at investigators' discretion.
Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Tendon Injury

The aim of our study is to determine the effect of activity-based intervention on the activity, participation levels and kinesiophobia (fear of movement) of the patients by evaluating the person, environment and activity using the Person-Environment-Occupation model (PEO) in the rehabilitation of hand forearm flexor tendon injuries.

Our study will be carried out on housewives who were operated by Pamukkale University Education, Application and Research Center Directorate Orthopedics and Traumatology and Plastic, Reconstructive and Aesthetic Surgery Services due to flexor tendon injury in the forearm or hand.

Patients will be evaluated at the 7th, 12th and 24th weeks post-operatively, before the start of the post-operative physiotherapy program.

The data obtained from the study will be analyzed with the PASW Statistics 18 Release 18.0.0 program. Whether the data fit the normal distribution will be determined using the Shapiro-Wilk test. If parametric conditions are not met, Wilcoxon Signed Rank Test and Friedman Analysis of Variance will be used for intragroup comparisons, and Mann-Whitney U Test will be used for intergroup comparisons. Statistical significance level will be taken as p\<0.05.

The physiotherapy program will start the post-operative first week for both group. Activity-based therapy group will have activity exercises that is meaningful for the patients, once a week one hour addition to the physiotherapy.

Patients to be included in groups were randomized in a single block order using Random Allocation Software 1.0.0.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-65
* flexor tendon injury
* Primary tendon repair performed
* a woman

Exclusion Criteria:

* Presence of major nerve injury (radial, ulnar, median nerve)
* Presence of concomitant injuries (fracture, joint injury, ligament injury)
* Presence of any previous or ongoing orthopedic, neurological, rheumatological and metabolic disease or disorder in the relevant extremity
The Effect of Vitamin D Supplementation in Type 2 Diabetes

In many observational studies, vitamin D deficiency is related to glucose intolerance and diabetes. But there little randomized, controlled interventional studies that evaluate the effect of vitamin D in type 2 diabetes.

Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2 diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and bone turnover markers.

After informed consent, investigators randomized 180 type 2 diabetes into interventiona group (25-hydroxy vitamin d 2000 IU+ elemental calcium 200mg per day) or placebo group (elemental calcium 200mg per day). The participants should control diabetes by oral medications or lifestyle intervention at the intervention period. Investigators exclude the participants who took vitamin D or calcium or anti-osteoporotic drugs. Investigators also exclude renal insufficiency (Cr\>1.5 in men or Cr\>1.4 in women) or heavy alcoholics.

Investigators followed the participants for 24 weeks. After randomization, investigators checked HbA1c,glucose, calcium, 25-hydroxyvitamin d, AST, ALT,Creatinine, Parathyroid hormone, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, and aortic augmentation index, and precontrast liver computed tomography. Also investigators checked body weight, height, and peripheral blood pressure.

At 12 weeks, investigators checked HbA1c, 25-hydroxy vitamin D, AST, ALT, calcium, and creatinine.

At the end of the study(at 24 weeks), investigators checked HbA1c, glucose, AST, ALT, Creatinine, calcium, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, aortic augmentation index, and precontrast liver computed tomography.

After the study completed, investiators compared the data of interventional groups and placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* TYPE 2 DIABETES MELLITUS PATIENTS WHO CONTROL GLUCOSE BY ORAL ANTIBIABETIC DRUGS OR LIFESTYLE ONLY
* DID NOT CHANGE ANTIDIABETIC DRUG BEFORE THE STUDY FOR 2 MONTHS
* normal physical activity
* 30 to 69 years
* \>=6.5% OR \<8.0% OF HbA1c

Exclusion Criteria:

* Creatinine\>1.5 in men, \>1.4 in women
* heavy alcoholics
* who took calcium or vitamin d or anti-osteoporosis drug within 3 months before the study
To Study the Effects of Host Genetic Factors on Liver Cirrhosis and Hepatocellular Carcinoma (HCC)

The purpose of this study is to identify genetic determinants of susceptibility to liver cirrhosis and hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis and hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) usually occurs in cirrhotic liver. Only 10-30% of HCC occur in non-cirrhotic liver. It has been suggested that etiological factors may differ for HCC which develop in cirrhotic liver: HCC in non-cirrhotic liver might be less often associated with viral infection and chronic alcoholism than HCC in cirrhotic livers. However, in any individual, the factors that determine HCC with or without cirrhosis remain unknown.

Cirrhosis is the end of fibrosis progression. The progress of liver fibrosis is a complex progress involving many cytokines related to activation of the hepatic stellate cells and progressive accumulation of extracellular matrix. The key enzymes responsible for deposition and degradation of all the protein component of extracellular matrix and basement membrane are matrix metalloproteinases.

To assess whether genetic variations in cytokines and matrix metalloproteinases result in diversity of liver cirrhosis and HCC, we conduct a case-control study of single nucleotide polymorphism analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatocellular carcinoma
* restrict the casual agent of liver disease to viral infection

Exclusion criteria:

* the casual aget of liver disease is not viral infection, such as alcohol abuse
Agreement Between Standard and Continuous Wireless Vital Sign Measurements

Patients undergoing major surgery are at risk of postoperative complications. Continuous wireless monitoring outside the post-anesthesia or intensive care units may enable early detection of patient deterioration, but good accuracy of measurements is required.

This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Patients undergoing major surgery are at risk of postoperative complications. Complications may be preceded by abnormal vital signs. Standard monitoring at general wards is intermittent and manual, leaving the patients unobserved for extended periods.

The chance to enhance monitoring has arisen with recent technological advances in the form of small wearable and wireless devices that continuously record vital signs. Wearable devices enable continuous monitoring outside the intensive care unit and post-anesthesia care unit, thus enabling early detection of patient deterioration. However, before implementing such devices in hospital settings, good accuracy, and precision of measurements is required.

This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Eligibility Criteria:
Inclusion Criteria:

* ≥60 years, scheduled for major abdominal cancer surgery with planned PACU admission.

Estimated surgical intervention duration ≥2 hours.

Exclusion Criteria:

* Implanted cardioverter defibrillator or pacemaker, allergy to study devices, severe cognitive impairment assessed by Mini-Mental State Examination ≤24, or inability to cooperate in wearing the wireless monitoring equipment.
Adaptations to Breast Cancer and Exercise

This study aims to investigate the effects of different volumes of combined training on fatigue, neuromuscular variables, morphological, cardiorespiratory capacity, functionality, and quality of life, in breast cancer (BCa) women undergoing primary treatment. Two thirds will be the intervention group that will perform combined training, while the other third will be the control group that will have physiotherapy sessions.

Although chemotherapy and radiation are mainstream treatment modalities, patients will often experience treatment-related side effects such as impairments to the neuromuscular and cardiovascular systems and reduction in quality of life (QoL).To date, numerous positive effects on neuromuscular and aerobic parameters in response to resistance and aerobic training have been reported when both training modalities were simultaneously performed (i.e. combined training - COMB) in BCa patients. However, there is a lack of data regarding the prescription of this modality in BCa patients, as the necessary dose of resistance training for significant improve in fatigue, neuromuscular, and quality of life. In this sense, no previous studies investigate the effect of different volumes of resistance training in BCa patients, providing important informations about the prescription in this clinical population.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnostic at I and II stages;
* Adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed);
* More than 18 years.

Exclusion Criteria:

* Current smoking
* Diabetic neuropathy;
* Hypertension uncontrolled;
* Heart failure;
* Clinical depression;
* Skeletal muscle impairment which not allow physical exercise.
Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury

Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in patients who can benefit from evacuation procedures can lead to worse brain injury, worse outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method for diagnosis of TBI severity in the field. In this study we will examine the feasibility of using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI patients. As control, normal subjects will be tested for pupillary responses using this device.

To examine the feasibility of using the multifocal chromatic pupillometer for monitoring TBI, the pupillary response to multifocal chromatic stimuli will be assessed in 20 healthy subjects and 20 ICP-monitored severe TBI patients.

The portable pupillometer will be tested in 20 healthy volunteers. Their pupillary responses will be measured 3 times/day for 1 week.

Pupillary response of 20 severe TBI patients will be evaluated as detailed below at the following time points:

1. At admittance to ICU, prior to insertion of ICP and CT scan
2. Prior to CT scans that are routinely performed at day 3 and 7 post injury
3. Routinely at the beginning of every medical personnel shift for 7 days (3 times a day).
4. With every change in ICP(more than 5 mmHg for more then 15 min) Data will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects -
* Male or female patients, age between 18 and 70 years, inclusive
* Informed written consent will be obtained from all participants.
* Normal eye examination
* Best-corrected visual acuity (BCVA) of 20/20
* Normal color vision test (Roth-28-hue test)
* Written informed consent to participate in the study,
* TBI-patients:
* Male or female patients, age between 18 and 70 years, inclusive
* Initiation of study before the insertion of the ICP monitor.
* TBI diagnosed by history and clinical examination
* Glasgow Coma Scale (GCS) score between 3 and 8, inclusive
* Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
* Indication for ICP monitoring
* Written informed consent to participate in the study, signed by a family member and independent physician.

Exclusion Criteria:

* Healthy subjects
* History of past or present ocular disease
* Use of any topical or systemic medications that could adversely influence efferent pupil movements
* TBI-patients
* High levels of barbiturate medications as they abolish pupillary responsiveness
* Coma suspected to be primarily due to other causes (e.g. alcohol)
* Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect pupillary response or measurement (such as known retinal dystrophy disease, glaucoma or dense cataract.
Effects of AI Assisted Follow-up Strategy on Secondary Prevention in CABG Patients

The present study is trying to find out whether artificial intelligence assisted follow-up strategy will improve secondary prevention in CABG patients. In addition, we will test whether rural patients may have more benefits under the new follow-up strategy based on the artificial intelligence device compared with urban patients.

There are a large population of coronary heart disease patients in China, which needs more attention to optimize the secondary prevention and improve the prognosis. Secondary prevention has been showing the effects of improving symptoms, preventing disease progression, improving prognosis, and reducing mortality in patients received coronary artery bypass grafting (CABG) surgery. In this study, we are trying to evaluate the effectiveness of artificial intelligence (AI) assisted follow-up strategy on secondary prevention for patients received CABG surgery. And we are trying to find out whether there is difference in secondary prevention of coronary heart disease between urban and rural patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-70, male or female
2. Received isolated CABG procedure due to coronary artery disease
3. Having a smartphone and are willing to cooperate
4. Signing written informed consent

Exclusion Criteria:

1. Patients undergoing CABG + valve replacement surgery
2. Postoperative hospital stays more than 10 days (Due to limited postoperative follow-up time and unstable condition such as incision infection, angina, etc.)
3. Patients with lung, liver, and kidney failure (Due to organ dysfunction which needs more professional health care and not suitable for this trial)
4. Patients with Urinary system diseases (Getting up during sleep, which will interfere with sleep monitoring)
5. Patients mentally or legally disabled
6. Breastfeeding or pregnant women
7. End-stage disease, estimated survival time is less than 3 months
8. Participate in other perioperative intervention studies at the same time
Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women

The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts.

Weight management is a critical issue in developed countries where the prevalence of obesity is increasing. Poor long-term success observed with current weight-control strategies stresses the relevance to explore new weight management approaches. One of these approaches, referred to as Health-At-Every-Size (HAES), is a new weight paradigm that focuses on a healthy lifestyle by promoting overall health benefits of behavioral changes related to dietary habits and physical activity and emphasizes self-acceptance and well-being, independently of body weight status. Studies on the effects of a HAES approach have shown significant improvements in metabolic and psychological variables.

To our knowledge, no study has yet reported the short and long-term impacts of a HAES approach on a cluster of variables (psychological, morphological, metabolic, and nutritional) in women. The aim of this study is to measure the effects of a HAES approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts. In this parallel controlled trial, women will be randomized to one of the 3 treatment conditions: HAES group, Social support group (SS), or Control group. Measurements will be taken in the short term as well as in the long term (up to 1 year post-intervention).

Eligibility Criteria:
Inclusion criteria:

* Healthy premenopausal women from Quebec City metropolitan area
* Age: between 30 to 50 years old
* Stable body weight (+/- 2 kg) for at least 2 months before the beginning of the study
* Overweight or obesity: Body mass index \[BMI\] between 25 and 35 kg/m2
* Preoccupation about weight and eating: showing overconcern with shape and weight, exhibiting restriction over food choices for at least 2 years, and having been unsuccessful in previous attempts to lose weight (for at least the past 2 years)
* Current weight corresponding to maximum weight reached during adult lifetime

Exclusion criteria:

* Women currently dieting to lose weight
* Taking oral contraceptives or postmenopausal status
* Pregnant or lactating women
* Under treatment for coronary heart disease, diabetes, dyslipidemia, hypertension, depression or endocrine disorders (with the exception of stable thyroid disease)
* Women presenting metabolic or important psychological disorders (drug or alcohol abuse, bulimia, ...)
* Women who had already take part to the Health-At-Every-Size (HAES) approach
Comparsion of SPARK and Fundamental Motor Training

It was a Randomized Clinical Trial.Data will be collected from Life care rehabilitation and special child facility.The study was completed within 6 months after approval of synopsis.The

calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's mean and standard deviation (Mean Dynamic Balance) as outcome

measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed Autism and age ranges between 5-12 will be included in the study.Convenient Sampling Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be provided and in group 2 fundamental motor skill training will be provided. To assess the social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills Bruininkse Oseretsky test of motor proficiency (BOTMP) was used.

Autism Spectrum Disorder affects the social communication and fundamental motor skills of children. The current study will evaluate the effects of sports play and active recreation for kids (SPARK) versus fundamental motor skill training on social and motor skills in children with Autism spectrum disorder. It was a Randomized Clinical Trial.Data will be collected from Life care rehabilitation and special child facility.The study was completed within 6 months after approval of synopsis.The

calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's mean and standard deviation (Mean Dynamic Balance) as outcome

measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed Autism and age ranges between 5-12 will be included in the study.Convenient Sampling Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be provided and in group 2 fundamental motor skill training will be provided. To assess the social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills Bruininkse Oseretsky test of motor proficiency (BOTMP) was used. Analysis was carried out on SPSS version 27.

Eligibility Criteria:
Inclusion Criteria:

* Age range 5-9 years (11) • Diagnosed with an Autism Spectrum Disorder (ASD) based on Diagnostic and

Statistical Manual of Mental Disorders,

* Pervasive developmental disorder-not otherwise specified
* Asperger's disorder based on clinical judgment and supported by the Autism Diagnostic Observation Schedule
* Having moderate or greater behavioral problems as measured by a pretreatment score of \>15 on the Aberrant Behavior Checklist-Irritability subscale
* Ability to follow directions and perform requested motor skill proficiency and executive function measures

Exclusion Criteria:

* Participants with diagnosed cognitive impairments

  * Unable to walk independently
  * History of traumatic injury
  * History of previous surgery history
  * Inability to understand the procedure and unwillingness to participate