cyrilzakka/clinical-trials huggingface dataset:
The Sensitivity of Traditional Chinese Medical Diagnostic Tools for Diabetic Retinopathy Diabetic retinopathy-a Pilot Study

Diabetic retinopathy (DR) is the leading cause of impaired visual function and blindness in adults. The fundus photographs were examined to detect DR. The DR severity was graded non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scales. The pathogenesis of DR is complex and not fully understood, and platelet aggregation, microvascular damage, microvascular enlargement, leakage, hemorrhage, or obstruction, resulting in retinal hypoxia and retinal neovascularization. Traditional Chinese medicine (TCM) diagnostic tools are non-invasive and convenient. This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR. Furtherly we would evaluate the sensitivity and specificity of TCM diagnostic tools.

This study is a prospective cross-sectional study. We enroll participants form the department of Chinese medicine, China Medical University Hospital. In total, 100 participants , composed of 50 of type 2 diabetes and 50 of diabetic retinopathy, whom previously had a retinal examination. We apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis in DR.

This study aims to identify the clinical symptoms of DR with TCM diagnostic tools and investigate the pattern difference and treatment for DR. Furtherly, we could design a clinical trial with improving blood circulation to treat or prevent DR, and improve the health status and quality of life in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 DM group were diagnosed with DM based on criteria recommended by the American Diabetes Association and required to have a fasting plasma glucose of ≥7mmol/L or an HbA1c of ≥6.5%, as measured on 2 separate occasions.

Exclusion Criteria:

* cancer, active liver disease, current pregnancy, active infection, and cerebrovascular disease
The Effect of a 2000-m Ergometer Test on Training Status Indicators and the Muscle Adaptation in Rowers

Intense physical exercise can lead to micro-damage to tissues and activation of inflammatory processes, the body's natural response to exercise-related metabolic stress. Monitoring inflammation and fatigue will enable the observation of athletes in terms of post-exercise regeneration and muscle adaptation to physical effort. The obtained results will allow for estimating the level of fatigue, minimizing the risk of injury, and will show the rate of post-exercise regeneration or its absence.

The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. The study will be held on three dates related to the specifics of the athletes' training cycle, i.e. in the preparatory period (March), the competition period (June), and the detraining period (November). The participants will perform an intensive exercise test on a rowing ergometer (manufacturer: Concept II, USA), covering a distance of 2,000 meters in the shortest possible time. The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. Each time, before starting the exercise test, a non-invasive anthropometric analysis will be performed using the TANITA MC-780MA body composition analyzer (tanita Japan), to determine the body composition: percentage of body fat, body fat mass, lean tissue mass, muscle mass, body water and body mass index (BMI). On the three indicated dates, before and after the stress test, capillary blood (ear lobe) from the cubital vein will be collected from the participants. Using immunoenzymatic ELISA tests, the following will be determined: EPO (erythropoietin), VEGF (vascular endothelial growth factor), CRP (C-reactive protein), glycogen, hypoxanthine (Hx). Glucose level will be determined using an Accu-Chek Active glucometer (Roche, Germany).

Eligibility Criteria:
Inclusion Criteria:

* members of the Polish Youth Rowing Team - competitors officially called up to the Polish national rowing team,
* no musculoskeletal injuries that would prevent them from performing the exercise test,
* written consent of the competitor to participate in the study.

Exclusion Criteria:

* anti-inflammatory drugs, other supplements in the last 3 months before starting the study,
* failure to complete the test,
* current injury, post-traumatic condition, illness,
* lack of informed consent of the athlete.
Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure. In addition safety and effects on renal function and biomarkers will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Male and female heart failure patients with body weight \<160 kg, on standard therapy including a stable dose of furosemide 40-240 mg/day orally (p.o). or equivalent dose of loop diuretics, reduced systolic function (LVEF ≤ 45% measured within the past 6 months), BNP ≥ 100 pg/mL or NT-pro-BNP of ≥ 400 pg/mLNYHA Class II or III, and worsening symptoms, e.g. fatigue, dyspnea, breathlessness within 3 months
* Mild to moderate renal impairment

Exclusion criteria:

* Systolic blood pressure (SBP) \< 110 mm Hg at the time of randomization
* Administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization
* Current use of non-steroidal antiinflammatory drugs (NSAIDs)
* Current or planned (through the completion of study drug infusion) treatment with any i.v. therapies, including vasodilators (including nesiritide), positive inotropic agents, vasopressors, levosimendan, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device).
* Clinically significant hepatic impairment defined as hepatic encephalopathy of any degree or total bilirubin \> 50 μmol/l (3 mg/dl) or, if patient is not on warfarin therapy, INR \> 2.0 (or Prothrombin Time \> 2 \* ULN)

Other protocol-defined inclusion/exclusion criteria may apply.
Ointment to Prevent Scar After Thyroidectomy

The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy.

Participants will be asked to apply ointment on their scar for 12 weeks.

to evaluate the efficacy

-investigator check POSAS and VSS

Eligibility Criteria:
Inclusion Criteria:

* Patient who got thyroidectomy due to Thyroid cancer
* has scar longer than 3 cm

Exclusion Criteria:

* have history about Keloid or Hypertrophic scar
* have infection on surgical site
Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours

The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Exclusion Criteria:

* Prior treatment with a VEGF inhibitor
* Poorly controlled hypertension
A Study to Identify Barriers to Cellular Therapies for People with Plasma Cell Disorders

This is an observational study that will include both participants with relapsed/refractory Multiple Myeloma and their doctors. The purpose of this study is to gather information about the use of hematopoietic cell transplantation/HCT and B-cell maturation antigen /BCMS targeted chimeric antigen receptor/CAR autologous T-cell therapy.


Eligibility Criteria:
Inclusion Criteria:

Patient

* Diagnosis of Multiple Myeloma after January 1, 2017.
* Karnofsky Performance Status \> 70%
* ≥ 2 lines of prior therapy
* Anticipated to start new a line of therapy for RRMM within the next 12 months
* Age 18-80 years of age.
* English or Spanish speaking.
* Willing to provide informed consent
* Willing to perform study procedures.

Physician Investigator

* Be a Co-Investigator
* Agree to comply with study procedures

Exclusion Criteria:

Patient

* Active CNS disease
* Patients who already have a definitive plan are to be excluded
Premom: Pregnancy Remote Monitoring

Multiple cardiovascular adaptations happen during pregnancy. When gestational hypertensive disorders (GHD) occurs, these adaptations are abnormal. Approximately 5 - 8 % of all pregnant women develop GHD.

GHD is an pregnancy complication which is characterized by an elevated blood pressure (≥ 140/90 mm Hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks of pregnancy. When this remains uncured, GHD can have severe complications for both mother and child. For this reason, a close follow-up of women with a high risk for developing this condition is recommended. This to detect and threat GHD early.

Patients can be included when they are at least 10 weeks pregnant. Every pregnant women receives two devices to control daily here parameters in her home environment: a blood pressure monitor and an activity tracker. The women will be asked to perform two blood pressure measurements a day and to wear the activity tracker day and night. This data will be send by Bluetooth and Wi-Fi to the investigator in the hospital. Also will the women be asked to measure once a week her weight and send this to the hospital.

Name of the device Measurement Protocol Blood pressure monitor Blood pressure, heart rate Twice a day (morning and evening) Activity tracker Activity- and sleep pattern Day and night Weight scale (not remote) Weight Once a week (morning)

The investigator controls daily the incoming measurements and consults the responsible gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. Depending on the decisions of the gyneacologist, following actions can be performed:

* Further observations
* Extra monitor
* Adjustments to the medication scheme
* Performing an 24 hours urine collection
* Admission to the prenatal observation ward When results are missing, the investigator contacts the women to ask of this measurement is due to personal or technical causes.

The purpose of this study part is to detect early signs of PE.

When patients gave birth, the data about the delivery (duration of labour, complications, mode of delivery, date of delivery, complications, parameters of the mother, specialties) and the neonate (gestational age, date and hour of birth, Apgar score, birth weight, length, complications and admission to the neonatal intensive care) will be collected. These data will be compared to the data of women who were admitted to the hospital for GHD, but who doesn't receive remote monitoring devices.


Eligibility Criteria:
Inclusion Criteria:

* \> 10 weeks of gestation, in the possession of a Smartphone

Exclusion Criteria:

* congenital malformations of the fetus
Influence of Vessel Wall Calcification on Early Stent Strut Healing

To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)

To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcificatition by opticaL COHERENCE TOMOGRAPHY.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all the following conditions will be included:

* Patients aged ≥ 18 years old and;
* Patients with clinical indication for stent implantation and;
* Patients with OCT evaluation that shows the presence of calcified tissue underlying the lumen surface, fulfilling the definition of superficial calcium (The distance from the abluminal point of the calcium to the luminal surface is less than 500 μm, in a perpendicular axis to the vessel luminal surface. When referred to the stent struts it will be assumed that such distance of less than 500 μm will be measured between the centre of the abluminal surface of the strut and the abluminal point of the calcium, in the same perpendicular axis).and;
* Patients with good quality baseline OCT evaluation as judged by the investigators and;
* Patients who have been briefed on the study characteristics and have given their prior written informed consent.

Exclusion Criteria:

* Patients who meet, at least, 1 of the following conditions will be excluded:
* Patients with current ST-elevation Myocardial Infarction (STEMI).
* Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.
* Patients with contraindication for the 1-month follow-up angiography and OCT:

  * Glomerular Filtration Rate (GFR)\< 30 ml/min/1.72m2
  * Contrast allergy
  * Baseline post-stent control OCT failure, due to tortuosity or any other reason.
* Patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team.
The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression

The research to be conducted within the scope of the project will be randomized controlled, and the population of the research will be primiparous pregnant women reached through social media. Primiparous pregnant women in the 32nd - 40th weeks of pregnancy will be included in the study, and the sample size is determined by using the G\*Power (3.1.9.2) program, considering a margin of error of 0.05 and data loss, with a power of 95% and a medium effect size; 27 people should be included in the experimental (baby massage) group and 27 people in the control group. In determining the groups, participants will be assigned to experimental and control groups using the "Randomizer.org" program. Pregnant women included in the research will be informed about the study and will be presented with an "Informed Consent Form" and "Voluntary Consent Form". Baby massage training will be given to the experimental group, and a reminder training will be given 2 weeks later. "Personal Information Form", "Prenatal Attachment Inventory" and "Beck Depression Inventory" will be applied to both groups at the beginning of the study, and postpartum 30-42 weeks. and 60-72. "Maternal Attachment Scale" and "Edinburg Postpartum Depression Scale" will be administered between days.


Eligibility Criteria:
Inclusion Criteria:

Being between the ages of 18-35, Being primiparous and having a singleton pregnancy,

* No high-risk pregnancy,
* Being in the 32nd to 40th week of pregnancy,
* Being literate and knowing and understanding Turkish,
* Pregnant women who have internet access and knowledge of internet usage.

Exclusion Criteria:

* ● Presence of chronic disease,

  * Pregnancy with congenital malformation,
  * Unwanted pregnancy,
  * Having attended a pregnancy school,
  * Women who become pregnant as a result of assisted reproductive technology,
  * Those with hearing and vision problems,
  * Having a known serious psychiatric disease diagnosis.
Development of Functional Spatial Hearing in Reverberation

The goal of the clinical trial study (Phase 0) is to map out the developmental trajectory of functional spatial hearing abilities in reverberant environments for children with normal hearing between the ages of 6 and 18 years, and to understand the inter-relationships between the three perceptual abilities: auditory object size formation, spatial acuity, and spatial unmasking during typical development. Children are asked to perform psychoacoustic tasks when the auditory stimuli are processed to present in virtual acoustic environments (1) with no reverberation and (2) with one of the two levels of reverberation that emulate everyday indoor environments. The intervention of this clinical study is in the random assignment of one of the two reverberant environments. Researchers will compare these children with a group of normal-hearing adults to anchor matured performances.


Eligibility Criteria:
Inclusion Criteria:

* All individuals within age limits who are typically developing with normal hearing who pass 25 dB HL from 250 Hz to 8000 Hz.

Exclusion Criteria:

* Individuals who fail hearing screen as described above.
* Individuals who have a diagnosed intellectual developmental disability
Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.

The primary purpose of the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins.

So far the assessment of the development potential of the single embryo has been limited by the vulnerability of the embryos when exposed to fluctuations in temperature and CO2 levels.

Thus embryos can only be allowed to leave incubators for a very limited time period.

However, with the development of time-lapse systems for clinical use it is possible to make continuous time-lapse recordings of embryos while they are in a safe incubator environment.

The embryos are not compromised, but the entire embryonic development can still be seen, and will subsequently provide new and essential information on the competence of the single embryo.

Based on the above it is expected that the probability of selecting the most viable and competent embryo is increased, which, in turn, will increase the success rate for couples seeking infertility treatment.

Eligibility Criteria:
Inclusion Criteria:

Participants(heterosexuals, lesbian couples and single women) must sign a document of informed consent

* Female age 21-45 years(both inclusive)
* Patients for IVF treatment
* Regular menstrual cycle 21-35 days(both inclusive)
* Normal FSH levels(1-15 IU/L)
* BMI between 18-32(both inclusive)
* Patients must be able to read and understand patient information in national language

Exclusion Criteria:

PCO

- Endometriosis as primary diagnosis
Phenotypic Clinical, and Genetic Characteristics of Patients With Nontuberculosis Mycobacteria

The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics of Korean Nontuberculosis Mycobacteria (NTM) patients.

To elucidate phenotypic, clinical, and genetic characteristics of Korean NTM patients.

Especially, to compare body mass index, positive rate of IGRA, and CFTR mutation with general Korean population.

Eligibility Criteria:
Inclusion Criteria:

* Persons met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007

Exclusion Criteria:

* Already on treatment for NTM lung disease
* Appropriate exclusion of other lung diagnosis
Validation of the 3D-CAM to Detect Postoperative Delirium

The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined Delirium. The primary objective of this study is to translate the 3D-CAM into the German language, as well as to validate its use to detect postoperative delirium in the recovery room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders).

Approximately 200 patients will be enrolled in the study. They will followed up until the third postoperative day.

Calculation and analysis of demographic and perioperative influencing factors on postoperative delirium according to routine parameters (age, sex, body height, body weight, diagnosis, physical status according to the American Society of Anaesthesiologists (ASA PS), duration of surgery, Physiological and Operative Severity Score (POSSUM), type of anesthesia, medication against pain and delirium) will be performed.

Eligibility Criteria:
Inclusion criteria:

* Male and female patients with age ≥ 18 years
* Admission to recovery room (RR) or post anaesthesia care unit (PACU) following elective general anaesthesia and scheduled
* Inpatient treatment not less than 24 hours.

Exclusion criteria:

* Patients with psychiatric diseases and mental retardation
* Analphabetism
* Anacusis or Hypoacusis with hearing aid device,
* Amaurosis
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* Patients with unability speaking German or English language
* Participation in other clinical studies during the study period
* Coworker in the study site
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study

The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years suggest in both animal and human studies that erythropoietin (Epo) may have significant neuroprotective effects. Given the historical safe medical profile of Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase II study of high-dose Epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.

Eligible extremely premature infants will be enrolled in this double-blind, placebo-controlled randomized trial from the neonatal intensive care unit at Morristown Memorial Hospital (Morristown, New Jersey). Subjects will be enrolled within the first 24 hours of life and randomly assigned to receive Epo or saline vehicle placebo.

Standard NICU care will be provided to all subjects. Serial exams, CBC-d, reticulocyte counts, serum Epo levels, serial HUS, and head MRI will be collected at established time points during the study period. At 18 to 22 months corrected age, subjects will undergo a neurodevelopmental evaluation assessing for cerebral palsy, Bayley Scores of Infant Development-II (BSID-II) Mental Development Index (MDI), BSID-II Psychomotor Development Index (PDI), bilateral hearing aid use, and visual impairment.

Eligibility Criteria:
Inclusion Criteria:

* 500 to 1250 grams at birth
* Less than 32 weeks gestation at birth
* Less than 24 hours of life at time of enrollment

Exclusion Criteria:

* Congenital anomalies (chromosomal, CNS, cardiac, GI, pulmonary)
* Seizures within first 24 hours of life
* Severe neutropenia (ANC \< 500 cells/microL) within first 24 hours of life
* Polycythemia (Hct \> 65%) within first 24 hours of life
* Thrombocytopenia (platelets \< 50K cells/microL) within first 24 hours of life
* Hypertension (SBP \> 100mmHg) without vasopressor support within first 24 hours of life