cyrilzakka/clinical-trials huggingface dataset:
Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.

Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold standard of BPM in clinical practice. Due to availability and patient comfort, the number of such BPM is limited. Considering the large number of people using smartphones, app-based measurements and screening procedures have the potential to increase the availability of BPM and improve blood pressure control, but a prerequisite of the use of these alternative BPM methods is accuracy.

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24 hours after calibration will also be tested.

Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the app, leading to 6 possible pairs of comparison. The next day, without another calibration of the app, we will take another 3 pairs of comparison (7 alternating measurements, starting with a conventional measurement). Examinators are blinded for the results of the app measurements. The app automatically sends the data of the BPM to RIVA Digital, where the results measured by the app will be processed. The staff of RIVA Digital are blinded to the conventional BPM results.

Number of Participants: 50 consecutive patients will be included in the study.

Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a 24h-ambulatory blood pressure measurement

Exclusion Criteria:

* age \< 18 years
* impossibility to sign informed consent
* physical restrictions to Blood Pressure Measurement
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States

The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.

Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in first complete remission or first chronic phase; and/or presence of one or more medical conditions that would place the subject at high risk such as heart and kidney disease.
* Subjects with hematologic cancers must have received at least one previous course of chemotherapy or biological therapy. In other words, the subject cannot enroll in this trial for initial treatment of the disease.
* Availability of a healthy related or unrelated volunteer allogeneic donor.

Exclusion Criteria:

* Eligible for another study or standard of care treatment that offers higher probability of cure or long-term control of subject's disease.
* Severe abnormal function of organs such as heart, kidneys, liver.
* Untreated or progressive central nervous system involvement by the disease.
* Subject is pregnant or breast-feeding.
* Performance score is below 50: at the least, requires considerable assistance and frequent medical care.
* Positive for the HIV \[AIDS\] virus
* Life expectancy less than 12 weeks with conventional treatments.
* For subjects capable of having children, refusal to practice birth control while on this study and for at least 12 months after PBSCT or after stopping post-transplant immunosuppressive treatments, whichever occurs later.
Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System

To explore the occurrence of pancreaticobiliary maljunction (PBM) in the Chinese population, the characteristics of various subtypes, and the relationship between PBM and malignant tumors of the biliary system. To explore the general clinical characteristics of patients with mild bile duct dilation but who have not been clinically diagnosed with choledochal cysts, as well as the relationship between these characteristics and malignant tumors of the biliary system. To develop and evaluate a deep learning method for machine learning of Magnetic resonance cholangiopancreatography (MRCP) images, enabling fully automated detection of pancreaticobiliary maljunction.


Eligibility Criteria:
Inclusion Criteria:

Cases that were hospitalized and underwent Magnetic resonance cholangiopancreatography (MRCP) examination at the First Medical Center of Chinese People's Liberation Army General Hospital.

Exclusion Criteria:

1. Patients aged less than 18 years old;
2. Those with unclear diagnosis;
3. Cases with missing or poor-quality imaging data.
Carbetocin Compared To Oxytocin During Cesarean Delivery

As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Normal singleton pregnancy at gestational age of 36 weeks or more.
* Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)
* pregnancy after in vitro fertilization

Exclusion Criteria:

* placenta praevia or invasive placenta.
* pre-eclampsia.
* Bleeding disorder, such as von Willebrand disease type I.
* Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin).
* Any known intolerance to either of the study drugs.
* Prolonged QT-time.
* Other serious cardiac disease.
* Liver or kidney failure.
Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

Primary Objective:

Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.

Secondary Objective:

Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.

Primary Objective:

Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.

Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period

Secondary Objective:

Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.

Measured by Simonson's criteria over 1 year follow up period.

Eligibility Criteria:
Inclusion Criteria

.Children aged 6-9 years old.

.Patients categorized as moderate to high caries risk (deft index \>1) showing more than 1 new carious lesions or restorations in the last 36 months according to "ADA Caries Risk Assessment Form (Age \>6)" .A split mouth study design was followed where all four second molars were selected for intervention in the primary molar group, while all first molars were selected for intervention in the permanent molar group.

.The four molars selected in each patient (primary / permanent) should be fully erupted with no gingival overhangs /operculum and with no history of previous restorations or prior sealants.

.According to International Caries Detection and Assessment System ICDAS grading, molars with (0, 1, 2) scores only were included.

Exclusion Criteria:

.Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries.

.Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded.

.Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits \& fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded.

.Patients \& parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.
An Open-label, Single Dose Pharmacokinetic Study of 14 mg Granisetron Patch in Healthy Subjects

The objective of the study is to characterize the pharmacokinetic profile of granisetron patch after single administration to healthy subjects.

The objective of the study is to characterize the pharmacokinetic profile of granisetron patch after single administration to healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be male at the age of 20-40 years old in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges: Ear body temperature between 35.0-37.5 °C.Systolic blood pressure, 90-140 mm Hg.Diastolic blood pressure, 50-90 mm Hg.Pulse rate, 50-90 bpm.Fasting blood glucose, \< 100 mg/dL.
3. Body weight must be above 50 kg and within -20 to +20% of ideal body weight.
4. Able to sign informed consent prior to study.
5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

1. Use of any prescription medication within 14 days prior to dosing.
2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
3. Significant illness within 2 weeks prior to dosing.
4. Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
5. Donate or loss more than 500 mL of blood within 3 months prior to dosing.
6. Presence of cardiovascular disease.
7. Presence of gastrointestinal disease.
8. Presence of asthma or lung disease.
9. Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an abnormal liver function profile such as GOT, GPT, g-GT, alkaline phosphatase, serum bilirubin, HBsAg, or Anti-HCV.
10. Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
11. Presence of neurological disease.
12. Presence of psychiatrical disease.
13. Subject is known for HIV infected.
14. A known hypersensitivity to granisetron or its analogs.
15. History of drug or alcohol abuse within 12 months prior to dosing.
16. Permanent confinement to an institution.
17. Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.
Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are:

* Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure
* Myometrial niche formation assessed by MRI performed 4 months after the procedure
* Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness
* Post-operative change in hemoglobin
* Time required for hysterotomy closure
* The number of extra sutures required to achieve surgeon-acceptable hemostasis

Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:

1. Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded.
2. Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique.
3. Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique.

Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Singleton gestation
* Nonurgent primary or secondary cesarean delivery at greater than 35w6d
* Body Mass Index (BMI) \<35 kg/m\^2

Exclusion Criteria:

* More than 1 prior cesarean delivery
* Multiple gestation
* Known coagulation disorder or current use of anti-coagulants
* Mullerian anomalies
* Placenta previa
Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes

Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following:

1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care;
2. To show that such an approach can improve quality of life;
3. To establish that the telemedicine can enhance the quality of care; and
4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.

Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's "usual care" supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater
* No better alternative explanation for the parkinsonism
* Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing
* Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine
* Have a local care provider that the study team can contact
* Live at home, in a senior housing complex, or assisted living facility
* Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only)
* Willing and able to provide informed consent
* Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.

Exclusion Criteria:

* Currently hospitalized
* Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse).
* Participation in another telemedicine study.
Visual Function Tests in Age-related Macular Degeneration

The goal of this study is to assess a battery of visual function tests in subjects with non-exudative age-related macular degeneration

Age-related macular degeneration (AMD) is one of the leading causes of visual impairment among elderly populations in developed countries. Majority of AMD patients (80%) suffer from the dry or non-exudative form of the disease. Currently there are no approved treatments for dry AMD. Clinical development of therapeutic agents for dry AMD is limited by slow progressing nature of the disease as well as the lack of sensitive endpoints to assess therapeutic efficacy. Visual acuity, the commonly used functional endpoint, remains minimally affected during early stages of dry AMD. Thus novel visual function endpoints, that can identify functional deficits during early stages of dry AMD prior to development of geographic atrophy, are needed. In the current study a battery of visual function tests will be evaluated in subjects with different stages of dry AMD and normal controls, to assess their sensitivity and feasibility as potential functional endpoints for dry AMD.

Eligibility Criteria:
Inclusion Criteria:

* All Subjects Must:

  1. Be 60 years of age or older;
  2. Provide written informed consent;
  3. Be willing and able to follow all instructions and attend the study visits;
  4. Must be able to perform all study procedures;

     Normal Subjects:
  5. Have BCVA of 20/25 or better in the study eye;
  6. Have no history or clinical evidence of AMD, retinal diseases or any other ocular pathologies in either eye;

     AMD Subjects:
  7. Have BCVA of 20/40 or better in the study eye;
  8. Have a clinical diagnosis of non-exudative AMD in the study eye;

     Exclusion Criteria:

     All subjects must not have any of the below criteria

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  1. Have a diagnosis of wet AMD in the study eye;
  2. Have any other hereditary or acquired retinal diseases in either eye ;
  3. Have glaucoma or other optic nerve diseases in either eye;
  4. Have corneal or other anterior segment diseases in either eye;
  5. Have significant cataract in the study eye;
  6. Have a history of ocular trauma or ocular surgery (other than cataract removal) in the study eye;
  7. Have a history of uncontrolled systemic disease (e.g. poorly controlled hypertension or poorly controlled diabetes);
  8. Have a history of seizures;
  9. On psychotropic medications;
  10. Any other symptoms or conditions that could, in the opinion of the investigator, interfere with study procedures.
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of advanced malignancy:

  * Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas
  * Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia \[AML\] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)
  * Treatment Group C (TGC): Multiple myeloma
* Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion

Key Exclusion Criteria:

* Inadequate hematopoietic, liver, endocrine or renal function
* Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:

  * \< 6 weeks for mitomycin-C or nitrosoureas
  * \< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)
  * \< 28 days for any antibodies or biological therapies
  * \< 5 half-lives for all other anticancer medications, or sponsor approval
* Prior radiotherapy within 2 weeks prior to first dose of study drug
* Untreated brain or central nervous system (CNS) metastases
* Type 1 diabetes or uncontrolled Type 2 diabetes
* Any sign of clinically significant bleeding
KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Strabismus surgery for children is a very common procedure, with a high incidence of emergence delerium in the recovery room. A combination of intravenous ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium in children undergoing adenotonsillectomy. Here, we study its application in strabismus surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

* anything not meeting the above
Lollipop on Gastric Volume

To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.


Eligibility Criteria:
Inclusion Criteria:

* volunteer aged 18 years-45 years old
* volunteer with a body mass index between 18 and 28 kg/m2

Exclusion Criteria:

* those with history of diabetes mellitus
* those with gastric diseases
* those with history of gastro-intestinal surgery
* those with history of smoking
* those with use of gastric mobility medicines
* those with pregnancy or breeding
Oral Cancer Screening in Workplace: a Cross-sectional Study

Employees are to be all screened for oral cancer in work place.


Eligibility Criteria:
Inclusion Criteria:

* adults

Exclusion Criteria:

* refusal to participate