cyrilzakka/clinical-trials huggingface dataset:
Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method

The JADE wRAP™, a wrist worn cuff to measure blood pressure and its supporting software platform is currently at the final alpha prototype stage of development and is not intended for sale.

There are minimal risks with using the JADE wRAP™ device; however, the likelihood of these risks has been reduced through design limitations on electrical power delivered to the device and of the pressure delivered to the cuff portion. Patients should experience little to no discomfort from the inflation of the JADE wRAP™ cuff.

The purpose of this study is to validate the JADE wRAP™ in adult patients (≥18 years of age) according to American National Standard, ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.

The study is intended to be a simple validation of blood pressure parameters only (Systolic and Diastolic). This study is not intended to yield any other special information.

OBJECTIVES

1) To validate the JADE wRAP™ for systolic and diastolic blood pressures compared to the reference standard mercury sphygmomanometer.

The data collected from this study is for internal purposes only and should assist in further developing the device and supporting platform to a beta stage.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years of age
2. Male or Female
3. Must provide written informed consent prior to the performance of any study-related procedures.

Exclusion Criteria:

1. Subjects who in the opinion of the study staff are too agitated, distressed or who are otherwise unable to cooperate with study procedures
2. Subjects with bigeminy, trigeminy, isolated ventricular premature beat (VPD) or atrial fibrillation or any other condition, in the opinion of the study staff that can result in a significantly irregular heath rhythm.
3. Subjects with signs or recent history of inflammation or infection of the wrists or at the reference clinical test site.
Preventing Overweight in USAF Personnel: Minimal Contact Program

The prevalence of overweight in the United States Air Force (USAF) is about 22%. The objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW) and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as compared to UC.

The objective of this study is to compare the relative effectiveness of two approaches to weight management, using a controlled comparison experiment. The two approaches are: Minimal Contact Behavior Therapy Plus Usual Care (MCBT+UC) which includes an orientation meeting, provision of a self-help book, use of an interactive weight management web site for 6 months, and 2 brief motivational interviewing telephone follow-ups, plus usual care;and Usual Care (UC) which includes and orientation meeting and usual care (consisting of required USAF annual physical and fitness exam, participation in any mandatory weight loss or fitness programs, and the requirement to stay below a Maximum Allowable Weight \[MAW\], with penalties or separation as potential contingencies for failure to remain below MAW). The primary outcome is weight loss.Additional outcomes include body mass index, percent body fat, and waist circumference.

Eligibility Criteria:
Inclusion Criteria:

* Within 5 pounds below or equal to their MAW or above MAW according to USAF Weight and height tables
* Access to personal computer with Internet access
* Plan to remain in the local area for one year
* Male or female between the ages 18-55 years

Exclusion Criteria:

* Pregnant, planning to become pregnant or becomes pregnant
* Weight loss of more than 10 pounds in the past 3 months
* No prescription or nonprescription weight-loss medication for at least 6 months prior to screening
* On any medical profile. Specific exclusion includes history of myocardial infarction, stroke, or cancer in the past 5 years, diabetes, angina, and orthopedic or joint problems that would prohibit exercise.
Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole

The clinical symptoms of non transfusion dependent non severe aplastic anemia (NSAA) are often lighter than that of severe aplastic anemia. Clinical observation is often used and the treatment should be given according to the follow-up results of peripheral blood routine and the survival condition of the patients. In recent years, a number of studies at home or abroad have tended to intervene earlier. The risk of observation and waiting for disease progression is higher. Early immunosuppression should be considered. For the treatment of non transfusion dependent non severe aplastic anemia, the commonly used treatment regimen is androgen combined with CSA. But the investigators find that Levamisole hydrochloride (LMS) as a commonly used immunomodulatory drugs may be helpful to improving immune disorder symptoms in NSAA patients. Therefore,the investigators are conducting a prospective, randomized controlled study to compare the rate, side effects and long-term survival in non transfusion dependent patients with NSAA between the androgen+CSA group and the androgen+CSA+LMS group.


Eligibility Criteria:
Inclusion Criteria:

1. All the patients meet a NSAA diagnostic criteria, and agree the immunosuppressive therapy. Diagnoses reference to The diagnostic and therapeutic criteria for hematologic diseases（Zhang Zhinan 2007）, and The diagnosis and treatment of aplastic anemia（2016 UK guidelines）
2. 18-70years old, male or female
3. Liver and kidney function: the blood bilirubin is less than or equal to 2mg/dL (35 mol/L), AST/ALT in the upper limit of the normal value below 2 times, blood inosine is less than or equal to 177 umol/L.
4. Heart function is normal: EF\>50%.
5. No serious lung infection.
6. All cases had no history of cancer and chemotherapy history, immunology therapy. The control group without hematologic diseases, lupus or other immune disfunctions, allergic disease, Fanconi anemia.
7. Consent signed by patients or their families.

Exclusion Criteria:

1. Congenital hematopoietic failure, Fanconi anemia, or combined with bone marrow hyperplasia, leukemia, multiple myeloma, giant cell anemia, paroxysmal nocturnal hemoglobin or other blood diseases.
2. The HBV DNA copy number is greater than 1000/ml or the serum hepatitis B virus is not clear.
3. Serum bilirubin \> 2mg/dL (35 umol/L); ALT or AST \> 2 times the normal value of the upper limit; alkaline phosphatase \> 3 times the upper limit of the normal value; serum creatinine \> 177 mol/L.
4. HIV positive.
5. Other serious diseases that may limit the patient to participate in the study (e.g., the progressive infection, incontrollable diabetes, severe cardiac insufficiency or angina pectoris, etc.)
6. Conditions are not suitable for immunosuppressive therapy.
7. Pregnant or lactating women.
8. Can not understand or follow the research program.
9. Patients under 16 years of age.
10. Patients with a history of cancer, chemotherapy, or radiation therapy, immune system diseases or allergic diseases.
Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

The purpose this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate.

This study intends to examine how three different OMM techniques, sub-occipital release, rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects will be randomly assigned to one of four cohort groups, receiving either sub-occipital release, rib-raising, stellate ganglion release or all three treatment techniques. A shift towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized questions that become progressively more difficult, and which subjects are asked to answer as quickly and accurately as possible. These stress tests will be induced twice, once without any OMM treatment and a second time with the designated OMM treatment(s). The sympathetic-dependent response to orthostatic change and cognitive challenges will be determined by Fourier analysis of heart rate variability, recorded using an EKG attached to each subject.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Individual capable of giving consent between the ages of 20-50
* Normal blood pressure as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure
* Normal EKG
* Normal Heart Rate

Exclusion Criteria:

* Chronic Cardiovascular Disease (including but not limited to: congestive heart failure, previous myocardial infarction, any cardiomyopathy, any arrhythmia, or previous cardiac surgery)
* Hypertension as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure or hypertensive medications
* Smoking
* Asthma
* Pregnancy
* Diabetes
* Current or recent illness (within the past 7 days)
* Any manipulative therapies within the previous 7 days (including but not limited to: osteopathic manipulative treatment, massage or acupuncture)
* Well conditioned athletes (such as long distance runners)
* Anyone who fails to have an increased heart rate with the passive tilt test (50 degrees head-up)
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.

In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.

Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.


Eligibility Criteria:
Inclusion Criteria:

* known or suspected contrast-enhancing glioma (primary and recurrent)
* location of the tumor permits intended gross-total resection

Exclusion Criteria:

* tumor location prohibits or questions gross-total resection
* contraindications to undergo MRI examinations
The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200

The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.

This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.

Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Appropriate candidate for uncomplicated bilateral LASIK surgery
* Gender: Males and Females.
* Age: 18 or older.
* Refractive error range - SE refractive errors up to 0 to -6D with maximum cylinder up to 3.00D
* Stable refractive error \<0.50D change in preceding year
* Contact lens wear discontinued 3 days prior to pre-op exam and the procedure
* Pachymetry above 490μm with residual greater than 270μm
* Candidates who, as determined by the investigator, can safely undergo LASIK with a 120μm flap
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good general and ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patients with usual relative and absolute contraindications for LASIK surgery (severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
* Pachymetry below 490μm
* Autoimmune or immunodeficiency diseases
* Patients with signs of inability to understand consent for study and procedure planned
* Patients with history of previous ocular surgery

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
A Multicenter Randomized Open-label Study of Chidamide Plus HD-DEX Versus HD-DEX in ITP

Recently, histone deacetylase inhibitors (HDACi) has been used for their anti-inflammatory and immunomodulatory activities. It has been shown that HDACi can alleviate graft-versus-host disease by enhancing the number and function of Foxp3+ Tregs. Our group found that low-dose HDACi alleviated thrombocytopenia in both passive and active murine models of ITP. Furthermore, low-dose HDACi attenuated macrophage phagocytosis of antibody-coated platelets, stimulated production of natural Foxp3+ Tregs, promoted peripheral conversion of T cells into Tregs, and restored Treg suppressive function in vivo and in vitro. The project was undertaking by Qilu Hospital of Shandong University and other 10 well-known hospitals in China. In order to report the efficacy and safety of the low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone in the management of ITP.

Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with low platelet count. Low-dose HDACi alleviated thrombocytopenia in both passive and active murine models of ITP. In this multicentre, open-label, randomized controlled trial, newly diagnosed ITP patients will be enrolled from 11 tertiary medical centres in China. Participants will be randomly assigned into the combination group or the monotherapy group by masked statisticians in a 1:1 ratio. The primary endpoints are sustained response at month 6. The secondary outcomes include initial response, time to response, duration of response, bleeding score, health-related quality of life assessment, and safety issue. This study will compare the efficacy and safety of low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone monotherapy in adults with primary immune thrombocytopenia.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
The Effect of Virtual Reality Glasses on Anxiety Level and Breast Milk Amount

Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application. The study was planned to examine the effect of virtual reality glasses applied to mothers whose babies were in the neonatal intensive care unit, on the level of anxiety and the amount of breast milk.

Although milk is expressed early and frequently, milk volume and milk production may be lower in some mothers in the first few weeks.For this reason, pharmacological and non-pharmacological methods have been focused on to increase prolactin secretion and breast milk production in mothers with premature babies. It is emphasized that practices such as breast massage, hot application, nutrition and fluid consumption of the mother, thinking about her baby or looking at her picture, and psychological relaxation during milk expression with a pump increase the amount of milk. It is thought that the mother's stress and anxiety negatively affect the amount of breast milk in preterm births, and that methods that provide relaxation and relief will contribute to breast milk production by reducing stress and anxiety. Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application.

Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 18-45,
* Those who gave birth at a gestational age of 30 weeks or more,
* whose baby is still in intensive care,
* whose baby has started breastfeeding,
* Giving breast milk to her baby by expressing,
* Not using any medication that will affect milk supply,
* Not diagnosed with a psychiatric disease that will affect breastfeeding in the postpartum period,
* Those who have not had any breast-related surgery before,
* Understands Turkish and can communicate,
* Mothers who sign the Informed Volunteer Consent Form will be included in the research.

Exclusion Criteria:

* Those who are younger than 18 years of age or older than 45 years of age,
* The gestational age is less than 30 weeks,
* whose baby was discharged from intensive care,
* whose baby has not started breastfeeding,
* Those who do not express breast milk to their babies,
* Using medication that will affect milk supply,
* Diagnosed with a psychiatric disease that will affect breastfeeding in the postpartum period,
* Have had any breast-related surgery before,
* Cannot communicate in Turkish,
* Mothers who do not sign the Informed Volunteer Consent Form will not be included in the research.
A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.


Eligibility Criteria:
Inclusion Criteria:

* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.

For Part 2 only:

-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:

* Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
* Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication, topical creams, or food.

Additionally for Part 1, only:

* Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
* History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
* History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
* Evidence of hypertrophic scarring.
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive

In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

OBJECTIVES:

* Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
* Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
* Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5\~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.

Eligibility Criteria:
Inclusion Criteria:

* primary breast cancer
* clinically axilla-positive

Exclusion Criteria:

* enlarged internal mammary nodes by imaging
Effect of Formula on Growth of Infants From Overweight or Obese Mothers

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth


Eligibility Criteria:
Inclusion Criteria:

* healthy newborn infant
* birth weight between 2500g and 4800g
* singleton birth
* mother's BMI before pregnancy was between 26 and 25
* for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
* for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
* having obtained signed informed consent of legal representative

Exclusion Criteria:

* body weight smaller than 5th percentile for that gestational age
* newborn whose mother has diabetes
* newborn whose mother has a drug dependence during pregnancy
* newborn currently participating in another trial