cyrilzakka/clinical-trials huggingface dataset:
Validation of WatchBP Office Ankle-brachial Index (ABI) Function

Measurement of the ankle-brachial index (ABI) with the oscillometric device WatchBP Office will be assessed compared to the reference method (Doppler).

Ninety three adult subjects assessed for hypertension, treated or untreated, with complete study data were included. Data on the presence of cardiovascular (CV) disease and classical CV risk factors were recorded.

All the ABI measurements of each individual participant will be performed by the same observer in a randomized order (concerning Doppler and WatchBP)

All study measurements were performed under standardized conditions in a quiet examination room with 10 min rest in the supine position before measurements. Ankle-brachial index (ABI) was measured manually by Doppler and automatically by the oscillometric device in randomized order by a single investigator. Manual Doppler ABI was measured according to the American Heart Association guidelines using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe. Systolic blood pressure was defined with a standard mercury sphygmomanometer by the first Doppler flow signal while deflating the cuff from a suprasystolic level in brachial, dorsalis pedis and posterior tibial arteries. Systolic pressure was determined sequentially for brachial, dorsalis pedis and posterior tibial arteries for each side and ABI was calculated for each leg by dividing the highest ankle pressure to the highest arm pressure. Automated ABI measurement was performed using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland). This device allows automated simultaneous both arms or arm and leg blood pressure measurements and thereby the calculation of ABI. The ABI results are displayed on the device screen.

The study protocol included three steps: (i) an introductory familiarization automated ABI measurement, (ii) three simultaneous oscillometric both arms blood pressure measurements; in case of a consistent inter-arm difference ≥12 mmHg, the arm with the higher blood pressure was selected for the subsequent oscillometric ABI measurements (otherwise the right arm was used) and (iii) Doppler and automated ABI measurement in randomized order; Doppler ABI was measured once, whereas automated ABI calculation included triplicate simultaneous arm-leg measurements performed for each side. The occurrence of five sequential oscillometric errors was defined as a failure of the oscillometric device to measure ABI.

Eligibility Criteria:
Inclusion Criteria:

* Treated or untreated subjects assessed for hypertension

Exclusion Criteria:

* Atrial fibrillation
* Incompressible ankle arteries
Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days

The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must have pin-holed Snellen visual acuity equal to or better than 20/40, in both eyes
* Must be in good health (no current or past relevant medical/ocular history) based on the judgment of the Investigator
* Must be willing to discontinue contact lens wear for the duration of the study

Exclusion Criteria:

* Known hypersensitivity to fourth generation fluoroquinolone (SS734) or to any of the ingredients in the study medication Investigator determines could interfere with the study
* History of extended or continuous wear contact lens use other than silicone hydrogels
* History of intraocular surgery
* Any topical ophthalmic medication, including tear substitutes, that cannot be discontinued during the study
* Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
AESCULAP® Plasmafit® Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene

Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads

Osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. Surgical treatment usually include installation of implants. Every year new types of implants were fabricated from the new material. The effectiveness of this new devices need carefully independent assess in clinic.

Eligibility Criteria:
Inclusion Criteria:

* All patients who needs total knee replacement surgery
* Informed consent from the patients.

Exclusion Criteria:

-
Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).

This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Same as parent trial (NCT02905864)

Exclusion Criteria:

* Same as parent trial (NCT02905864)
SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment

The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Have KS.
* Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten better or could not tolerate treatment therapy.
* Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related edema (swelling) without sores, or KS-related edema of the arms and legs.
* Agree to use an effective method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant or breast-feeding.
* Are allergic to Cremophor.
Involvement of the Translation Initiation Factors in Resolution of Inflammation in the Elderly Population

Aging cause specific changes in the immune system. Processes like "immunoessence" and "inflammaging" offend the functioning of the immune cells and expose the elderly patient to infections that can lead to morbidity and death.

Protein translation regulation offers a strategic advantage to the immune cells, because it enables rapid activation or termination of synthesis of specific proteins, required for inflammation or its resolution. Translation initiation depends on recruitment of eukaryotic initiation factor "eIF4F" complex.

The aim of the current study is to investigate the involvement of the translation initiation factors (eIF4E and eIF4G) in the process of recovery from acute infection in elderly patient admitted to the internal department with an acute infection.

1. Blood samples of elderly patients diagnosed with acute infection (fever and leukocytosis) will be collected twice - at admittance to Meir hospital and after recovery (24-48 hours without fever and leukocytosis). evidence of infection (chest x ray, urine and blood samples) will be collected. participants will be divided to two age groups: 65-80 yrs and very old patient \>85 yrs, and will be compared to younger patients aged 50-65.
2. Peripheral blood samples will be separated to subpopulations of lymphocytes, monocytes and polymorphonuclears, and protein will be extracted.
3. protein lysates will be separated by SDS-PAGE electrophoresis and immunoblotted for phosphorylated and total eIF4E and eIF4G; their regulators: Mnk 1/2, 4EBP1, mTOR and targets: cyclin D1, c-Myc, survivin, BCL2, VEGFA, etc.
4. Paired samples (within each age group) will be analyzed and correlated with clinical response of the patients. The source of the infection will also be considered.
5. Comparison between age groups at admittance and upon recovery will be made (Unpaired).

Eligibility Criteria:
Inclusion Criteria:

* patient aged 50 y and more with:
* fever \>38c that started in the 48 hours prior to admission
* leukocytosis \>10.0 K/microLiter
* suspected source of infection by symptoms, lab results or imaging
* treatment with antibiotics started in the last 24 hours or is about to be started

Exclusion Criteria:

* patients who cannot sign the informed concent ( dementia)
* patients with active malignancy
* patients who are under chemotherapy
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients

The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.


Eligibility Criteria:
Inclusion Criteria:

* Female 18 years of age or older
* Diagnosis of unilateral breast cancer-related lymphedema
* Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
* ≥ 5% volume difference between affected and unaffected arm as verified via perometry
* Willing and able to give informed consent
* Willing and able to comply with the study protocol requirements and all study-related visit requirements

Exclusion Criteria:

* In-home use of PCD within previous 3 months
* Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
* Mastectomy or lymph node removal on side without lymphedema
* Bilateral lymphedema
* Heart failure (acute pulmonary edema, decompensated acute heart failure)
* Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
* Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
* Active cancer (cancer that is currently under treatment, but not yet in remission)
* Poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
* BMI \>50
* Any circumstance where increased lymphatic or venous return is undesirable
* Currently pregnant or trying to become pregnant
* Allergy to iodine
Comparative Effect of Training on Postpartum Depression

New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness.

This study will be a randomized clinical trial. It divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. Data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. In this study Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) will be used as subjective measurements.

New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Postpartum depression typically begins within the first two to three days after delivery and may last for up to several weeks or months. Activity and mobility are an integral part of human life that is manifested in a special way in each period. Postpartum life has caused lack of movement, the risk factor of depression and difficulty in maternal life. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness. A logical approach to treatment, therefore, would be to improve postpartum life. Flexibility exercises are not just for gymnasts, but rather for everyone. Along with the better range of motion, it decreases risks of injuries, increases blood supply and nutrients to joints, reduces muscular tension and help to improve quality of life.

This study will be a randomized clinical trial. Subjects meeting the predetermined inclusion and exclusion criteria will divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. After informed consents were obtained, data will collect. After taking written consent from participants who meet the inclusion criteria, data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. Pre-treatment assessment and Post treatment reading will be done using Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) as subjective measurements. Recorded values will be analyzed for any change using SPSs version 25.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 40
* 6 weeks to 8 months postpartum females
* primiparous or multiparous postnatal wome

Exclusion Criteria:

* Family history of depression
* Hospitalization for a psychiatric disorder in the past 6 months; and currently receiving antidepressant medication or psychotherapy for depression.
* Pregnant women
* Women with psychiatric diagnoses other than depression
Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure

The purpose of this project is to study the effects of air pollution toxicants on pregnant mothers' immune health during and after pregnancy.

Using already collected samples, this study proposes to evaluate changes in immune function in response to air pollution with the use of innovative technologies, to identify the drivers of immune dysfunction and potential modifiable factors, and to determine how these immune findings are associated with pollution exposure and outcomes of disease.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women: at 18-25 weeks gestation at time of eligibility screening and baseline visit

Exclusion Criteria:

* Having smoked more than 50 cigarettes during pregnancy
* A history of autoimmune diseases, HIV or cancer
Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony

The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.


Eligibility Criteria:
Inclusion Criteria:

1. Have an approved indication for a CRT implant
2. Undergoing or previously received the implant of a St. Jude Medical Promote Q 3221-36 CRT-D with a Quartet Model 1458Q LV lead at participating clinical study site
3. Ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations

Exclusion Criteria:

1. Have persistent or permanent atrial fibrillation
2. Have an intrinsic heart rate of \<50 beats per minute
3. Have Cheyne-Stokes breathing
4. Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
5. Have had a recent CVA or TIA within 3 months prior to enrollment
6. Be less than 18 years of age
7. Be pregnant
Periarticular Injection Versus Popliteal Block

This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.

This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.

Eligibility Criteria:
Inclusion Criteria:

* Ankle or hindfoot osteotomy or ankle fracture repair
* Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
* 18-80 years of age
* ASA I-III with medical clearances as needed
* Fluent ub verbal and written English
* Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study
* Willing and able to provide written consent

Exclusion Criteria:

* Diagnosed with chronic pain syndrome
* History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents
* Injury associated with workers' compensation
* Surgery to be performed at a hospital
* Diagnosed with peripheral neuropathy
* Hbg A1C is \> 7 mg/dl in diabetic patients only
* Long term (chronic) preoperative narcotic usage
Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer

The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a Gleason score \> or = to 7 adenocarcinoma of the prostate
* At least 30% of one core involved
* Radical prostatectomy planned
* Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent)
* ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy.

Exclusion Criteria:

* Previous treatment for prostate cancer
* Current use of finasteride or dutasteride
Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury

The aim of this study was to increase and improve the use of affected extremity in obstetric brachial plexus palsy children while restricting the use of less affected arm and the purpose was to improve the function, Range of motion and disability in affected arm of children with brachial plexus injury.


Eligibility Criteria:
Inclusion Criteria:

* 3 to 10 years
* Both genders will be included
* Deficiency of shoulder abduction and external rotation
* Who can follows command

Exclusion Criteria:

* uncontrolled seizures
* Orthopedic and/or neurological surgery.
* A visual impairment interfering with treatment/testing.
* Unable to actively engage in assessment process
Accuracy and Feasibility of Xpert Ultra

Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.


Eligibility Criteria:
Case Detection Group

Inclusion Criteria:

* Age 18 years or above;
* Provision of informed consent;
* Willingness to provide 4 sputum specimens at enrolment;
* Willingness to have a study follow-up visit approximately 42 to 70 days after enrolment
* Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB)

Exclusion Criteria:

* Receipt of any dose of TB treatment within 6 months prior to enrolment
* Participants for whom, at the time of enrolment, the follow-up visit is judged to be poorly feasible (e.g. individuals planning to relocate)

Drug-Resistant TB Group

Inclusion Criteria:

* Age 18 years or above;
* Provision of informed consent;
* Willingness to provide 4 sputum specimens at enrolment;
* Non-converting pulmonary TB cases (category I and category II failures) or multi-drug resistant (MDR) suspect\* (based on World Health Organization definition), i.e. at least one of the following: i) retreatment cases, ii) active TB cases that are MDR-contacts and iii) patients at high risk for MDR-TB as determined by local program (e.g. prisoners)

Exclusion Criteria:

• none
Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia

Determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional)


Eligibility Criteria:
Inclusion Criteria:

* Adults patients,
* With a diagnosis of localized or metastatic cancer,
* During or after their treatment,
* In one of the following three cancer centres: Gustave Roussy (Villejuif), Montpellier Cancer Institute (Montpellier), and Léon Bérard Center (Lyon)
* With a significative score on the self-screening Insomnia Severity Index score (ISI ≥ 8)
* Able to readily read and understand French,
* Able to use informatic tools confidently and with Internet access,
* Who have signed the online consent form,
* Affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

* Patient with a visual, hearing or cognitive disability that is incompatible with the study,
* Simultaneous participation in another study evaluating a treatment of insomnia,
* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Clinical Study Comparing Two Models of a Travoprost Intraocular Implant

Phase III study to compare the safety and efficacy of intraocular implants containing Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT)

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR-063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical Timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma or ocular hypertension
* C/D ratio ≤ 0.8
* Zero to two preoperative ocular hypotensive medications

Exclusion Criteria:

* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma