cyrilzakka/clinical-trials huggingface dataset:
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed non-small cell lung cancer;
* Initial diagnosis of intracranial oligometastases (no treatment after brain metastases) was defined as brain parenchymal metastases confirmed by MRI, the number of intracranial parenchymal metastases was less than 5, and the lesions were 3mm away from the optic nerve and brainstem; There must be at least one measurable lesion with a diameter of 5mm or more in the brain.
* EGFR sensitivity mutation (exon19del or exon21 L858R);
* Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past;
* Age 18-75;

Inclusion criteria:

* A history (past or concurrent) of malignancies in other sites, excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
* The subjects had received brain radiotherapy before enrollment;
* Patients whose lung lesions were surgically evaluated as resectable were not included if there was no metastasis in other parts of the body;
* Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment;
* Prior patients with interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease with idiopathic pulmonary fibrosis found on CT scan at baseline;
* Pregnant and lactating patients;
* MRI contraindicated patients;
* Patients who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery that interferes with absorption, or have active digestive tract ulcers;
* The researchers judged that brain radiotherapy could not be received because of other head and facial diseases;
* Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease).
Resistance Exercise and Protein During Weight Loss

The purpose of this study is to determine if post-exercise protein supplementation can rescue the anabolic response of muscle and bone to resistance exercise during caloric restriction.

1. Preliminary Testing Prior to the study start, participants will be weighed and body composition will be determined using bioimpedance analysis. Then participants will undergo a 5RM barbell back squat exercise testing procedure.
2. Randomization

   Participants will proceed through each of the following conditions lasting 3 days:

   CON: Participants will be in energy balance and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise.

   CR+C: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise.

   CR+P: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g whey protein post-exercise.
3. Diet Prescription Dietary energy intake will be controlled using clinical products, maltodextrin and whey protein isolate to meet target energy intakes. Participants will receive calcium and Vitamin D supplementation throughout the study.
4. Exercise Prescription Participants will perform one bout of 5 sets of 5 repetitions of barbell back squat exercise on the morning of Day 3 each condition. Additional exercise and intense physical activity will be prohibited.
5. Assessments Body weight and composition (DXA + BIA), fasting blood draws for assessment of metabolic and anabolic hormones and questionnaires will be conducted before and after each condition. A 24-hour serial blood draw procedure will be conducted following each workout session on each Day 3.
6. Washout Once a participant completes a study condition, participants will continue to take daily body weights at home for up to one week. Then participants will be required to wait one more week before completing their next condition during which they will resume regular diet and physical activity.

Eligibility Criteria:
Baseline Inclusion Criteria:

* Weigh at least 110 lbs
* Weight-Stable (2.5 kg) within the past six months
* Height-Stable (\< 0.25 inches) within the past year
* 3 years of resistance training experience

Tested Inclusion Criteria:

- \<20% body fat (men) or \<30% body fat (women)

Exclusion Criteria:

* Lactose intolerant
* Pregnancy
* Taking interfering medications such as steroids, thyroid or growth hormones
Establishment of Reproductive Cohort and Prediction Model of Genetic Counseling for Mitochondrial Genetic Diseases

The goal of this observational study is to provide a reference for clinicians to conduct genetic counseling and carry out preimplantation genetic testing of mitochondrial patients. The main questions it aims to answer are:

* The relationship between mitochondrial mutation load and clinical symptom
* The symptomatic threshold of common mitochondrial DNA mutations
* The distribution of mitochondrial mutation load in offspring and genetic rule of mitochondrial DNA mutation
* The minimum number of eggs taken by preimplantation genetic testing in mitochondrial mutation carriers Biological samples such as blood, urine, oral epithelial cells, nails, some granulosa cells, trophoderm cells, embryo culture fluid, embryo biopsy fluid, and embryo trophoblast cells of the participants will be collected and the mutation loads of them will be measured. The clinical symptoms and mutation load of the participants will be followed up once a year.

A total of 600 carriers of disease-causing mitochondrial DNA mutations will be selected as the research objects. The basic information, reproductive history, clinical and genetic diagnosis, and clinical symptoms of the carriers will be investigated by questionnaire. Biological samples such as blood, urine, oral epithelial cells, nails, some granulosa cells, trophoderm cells, embryo culture fluid, embryo biopsy fluid, and embryo trophoblast cells of the participants will be collected and the mutation loads of them will be measured. Placenta and umbilical cord blood samples of some fetuses will be collected after delivery, and the mitochondrial DNA mutation heterogeneity level will be determined. Multiple Logistic regression, Sewell-Wright equation, Kimura equation, binomial distribution model, and machine learning model will be used to establish a prediction model of the incidence probability of mitochondrial diseases and predict the onset threshold of common mitochondrial DNA mutations after standardizing. The distribution model of mitochondrial mutation load in offspring will be established to predict the maternal genetic risk of mitochondrial DNA mutation. A prediction model for egg retrieval will be established to estimate the minimum number of eggs taken by preimplantation genetic testing in mitochondrial mutation carriers. Finally, an online prediction platform for mitochondrial genetic disease genetic counseling will be established to provide standardized standards for mitochondrial disease genetic counseling and PGT.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mitochondrial DNA diseases

Exclusion Criteria:

* none
CMR in T2DM: The NSR Cohort

This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI.

The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI.

Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes.

The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.


Eligibility Criteria:
Inclusion Criteria:

Few and simple, allowing for a broad cohort.

* Male or female fully capable of providing informed consent
* Informed consent
* Age 18-80 (both included)
* T2DM diagnosed at least 3 months prior to inclusion in the study

Exclusion Criteria:
The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients

Extensive studies suggest composition of microbiome of respiratory samples or lung tissues in COPD patients is different from the composition of healthy smokers. Aim of this study is to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to describe difference of composition between COPD patients and healthy smokers.

After the introduction of the Gut-Lung axis theory, extensive studies revealed diversity of microbiomes among healthy smokers and COPD patients form the respiratory samples or lung tissues. In the previous study, distinct difference in composition of microbiome in lung tissue between healthy smokers and COPD patients was reported. This is a cross sectional study to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to compare difference of composition between COPD patients and healthy smokers. This study would help establishing gut-lung axis model in humans.

Eligibility Criteria:
Inclusion Criteria:

* Patients with smoking history at least 10 pack-year
* Patients with persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity ( FEV1/FVC) \<0.7)

Exclusion Criteria:

* Patients with co-existing illness that would interfere with study results (e.g., malignancy, congestive heart failure, cerebrovascular disorders, chronic renal failure, diabetes with severe complications, or uncontrolled hypertension)
* Patients with respiratory disease other than obstructive lung disease (e.g., previous pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis)
* Patients with recent (8 weeks prior to screening) exacerbation or other respiratory illness
A Study to Compare the NexGen LPS and LPS-Flex Knee Implants

The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.

This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

Eligibility Criteria:
Inclusion Criteria:

* Age, 21-80 years
* Sex, Males and females will be included
* BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
* Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
* Patient is willing and able to cooperate in follow-up therapy.
* Patient exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
* Patient has stable and functional collateral ligaments.
* Patient has potential to perform higher than average range of motion activities.
* Operative side range of motion flexion greater than or equal to 90 degrees.
* Severe knee pain and disability due to degenerative joint disease.
* Patient or patient's legal representative has signed the Informed Consent form.

Exclusion Criteria:

* Previous history of infection in the affected joint.
* Previously failed knee endoprosthesis of any kind.
* Charcot joint disease or other severe neurosensory deficits.
* Previous patellectomy.
* Patient is skeletally immature.
* Grossly insufficient femoral or tibial bone stock.
* Patient is pregnant.
* Varus or valgus deformity greater than 20 degrees.
* Fixed flexion deformity greater than 15 degrees.
* Previous high tibial osteotomy.
* Previous femoral osteotomy.
* Patient is a poor compliance risk - currently treated for ethanol or drug abuse, physical or mental handicap, etc.
* Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.
Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome

Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival is a very common problem in hospitalized patients for acute inflammatory diseases and develops within few days from the onset of illness. Deleterious effects of anemia include increased risk of cardiac related morbidity and mortality in critically ill and older patients.

Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron trafficking.

Several studies have been performed on pathophysiology of AI in patients affected by chronic diseases but few explore iron metabolism in humans with acute inflammation.

The aim is to develop effective new strategies to detect and manage AI in the setting of acutely ill patients, based on the understanding of iron balance underlying this disorder.


Eligibility Criteria:
Inclusion Criteria (both):

* serum C-reactive protein level \> 3mg/dL
* creatinine level \< 2mg/dL (clearance \> 30%)

Exclusion Criteria:

* any haematological diseases
* cancer under chemotherapy
* AIDS (or HIV+)
* liver cirrhosis
* genetic hemochromatosis
* immunosuppressive therapy
* blood transfusion in the past 30-days
A Trial of Micronutrients and Adverse Pregnancy Outcomes

The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.

Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.

Eligibility Criteria:
Inclusion Criteria:

* HIV negative
* 12-26 weeks gestational age at screening visit
Improved HRV, Inflammation Markers and Endothelial Function After TAVI

Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* TAVI

Exclusion Criteria:

* stage V chronic kidney disease
* active malignancies
A GBT021601 ADME Microtracer Study in Healthy Volunteers

An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.

This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.
* Body weight ≥ 50 kg at screening
* Females must be nonlactating and nonpregnant (as confirmed by a negative serum pregnancy test at screening and admission for all females), or of nonchildbearing potential (ie, either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal \[defined as at least 12 months no menses, and confirmed by a follicle-stimulating hormone test, at screening\]).
* Creatinine clearance (glomerular filtration rate) as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: ≥90 mL/min, at screening.

Exclusion Criteria:

* History or presence of conditions which, in the opinion of the Investigator, are known to interfere with the ADME of drugs, such as previous surgery on the gastrointestinal tract (including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas). Participants who have a history of appendectomy are eligible for enrollment.
* History of chronic constipation, or recent complaints of an irregular defecation
* Significant and/or acute illness at screening or within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
* Known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Participation in another ADME study with a radiation burden \>0.1 mSv in the period of 1 year prior to screening.
Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain

A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).


Eligibility Criteria:
Inclusion Criteria:

* Sign the study informed consent form;
* To be diagnosed with moderate to severe lumbar sciatic pain (defined as limiting the work activities or the ordinary tasks performance or at the investigator's discretion) within the last 3 days;
* Aged 18 to 75 years old;
* To be able to meet the study procedures

Exclusion Criteria:

o-Diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain;

* Patients with one of the following conditions, as per the investigator's criteria:
* Severe renal failure under hemodialysis, severe liver failure, uncontrolled severe heart failure;
* Severe injuries on gastrointestinal tract;
* Other severe comorbidities;
* Patients taking acetylsalicylic acid or any anti-clotting;
* Female patients who are pregnant, lactating, willing to get pregnant or not willing to use an appropriate contraceptive method during the study period.
The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block

This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.

Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.

Eligibility Criteria:
Inclusion Criteria:

* the patients undergoing unilateral open hernia repair surgery

Exclusion Criteria:

* known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage
Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection

The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older with biopsy-proven breast cancer.
* Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM).
* Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study.
* Intent to continue follow-up for at least 6 months post-operatively.
* Able to give an informed consent to participate in all study's stages.
* Willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery.
* Bilateral axillary dissection patients are eligible to be enrolled for each side.

Exclusion Criteria:

* Previous axillary dissection.
* Lymph node biopsy except for biopsies related to the current cancer event.
* Congenital or acquired arm lymphedema.
* Nephrotic Syndrome
* Anasarca
* Unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.
Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service

0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Eligibility Criteria:
Inclusion Criteria:

Healthy, term infants Informed and written consent obtained from both parents -

Exclusion Criteria:

Sick infants Preterm infants No consent

-
Computer Vision System for the Blind Veteran

This is a feasibility study involving a small number of blind subject to evaluate the effectiveness of using a software and associated hardware components to assist the blind in identifying and locating objects of interests and to assist in way finding tasks. After the system has been successfully tested by the blindfolded engineers, it will be evaluated in a small number of blind subjects.

This is primarily an engineering project to develop computer vision algorithms for an integrated system comprising of a laptop computer, webcam, gps, digital compass, microphone, and stereo earphones. The system will be voice controlled. The algorithm will be trained to identify and located objects and navigationally landmarks in real-time, previously selected by sighted developers. After the system has passed objective engineering milestones, blind subjects will be tested to determine whether the novel system will improve the ability of the blind to travel over a test course in a hospital setting.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and over
* legally blind

Exclusion Criteria:

* decreased hearing
* unable to understand or follow instructions
* inability to walk and stand for 10 minutes