cyrilzakka/clinical-trials huggingface dataset:
Improving Hypertension Medication Adherence for Older Adults

This randomized controlled trial will assess the efficacy and scalability of a blood pressure technology system intervention. The investigators will enroll 224 older adults with hypertension to identify those who are nonadherent for one hypertension medication. The participants will be randomized to one of two groups (112 per group) to use the blood pressure system for 6-months. Both groups receive information about high blood pressure and medications. One group will also receive strategies that can be used to take medications and manage blood pressure. Both groups will complete a mid-assessment at 3-months and a post-assessment at 6-months.


Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older
* self-manage at least one hypertension medication
* able to read and speak English
* willing to participate in the study for six months
* currently have and use an Apple iPhone
* have hypertension medication adherence ≤ 90% in the last 2 weeks of the 4-week baseline monitoring period using an AARDEX MEMS® cap

Exclusion Criteria:

* have inadequate visual acuity (worse than 20/50 corrected near vision on Snellen test)
* experience severe depression (\> 11 on Geriatric Depression Scale Short Form, GDS-15)
* are at risk for cognitive impairment (\< 23 on Montreal Cognitive Assessment, MoCA)
* been instructed by their healthcare provider to withhold their blood pressure medication
REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation

To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.

This is a multi-center, single arm prospective trial to evaluate whether reduced elective nodal dose (30.6 Gy) reduces toxicity as defined by the CTCAE Toxicity Index compared to historic patients treated with standard nodal dose on NRG/RTOG0529 and patient reported GI toxicity using the validated PRO-CTCAE scale for diarrhea compared to historic patients treated on UC-GI-1601.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Patients must have stage T1-4N+M0 or T3/T4N0M0 locally advanced anal cancer as evidenced by a PET scan AND either a CT with contrast of the abdomen/pelvis or an MRI with contrast of the pelvis. All imaging must be from within 60 days prior to registration.

   1. Note: Patients with T2N0 disease will be allowed if the primary tumor is \>4 cm. Patients with Stage I-T1N0M0 or Stage II-T2N0M0 (tumor ≤ 4cm) will be ineligible for participation.
   2. Patients with perianal cancer that is HPV associated (P16+) will be eligible if the tumor extends to the anal verge and the CTV will include the mesorectal, internal/external iliac, and inguinal lymph nodes.
   3. Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible.
3. ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A).
4. Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator.
5. Creatinine Clearance must be \> 30 ml/min.
6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Any prior pelvic radiation.
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
3. Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine.

   a. Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
4. Pregnant or breastfeeding women are excluded from this study.
5. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.
6. Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.
AZD1981 Midazolam CYP4503A Induction Study

The primary objective of the study is to investigate if the exposure of midazolam is clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme induction of CYP3A.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion

This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

* Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10.
* Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed.
* Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery.
* Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old at time of surgery.
* Male or female patients undergoing total knee replacement under either general or neuraxial anesthesia (spinal or epidural). Intraoperative, patients will receive spinal anesthetics with 15 mg bupivacaine and 25mcg of fentanyl intrathecally.

Exclusion Criteria:

* Current or recent drug abuse (within past 6 months).
* Pregnancy.
* Patient refuses regional analgesia.
Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.

Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) \[1\]. However, the incidence of atrial fibrillation (AF) recurrence remains high \[2\], mostly due to pulmonary vein (PV) reconnection \[1\], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines \[3\].

Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions \[4\].

Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) \[1\]. However, the incidence of atrial fibrillation (AF) recurrence remains high \[2\], mostly due to pulmonary vein (PV) reconnection \[1\], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines \[3\].

Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions \[4\].

The high-power short duration (HPSD) RF application applies to all RF energies delivered at more than 40 W \[5\]. Higher the power more is the resistive heating causing wider tissue injury \[5\]. The lesion size with HPSD is larger in width but lesser in depth compared to lower powers with longer duration \[5\]. In contrast, RF applications of lower power and longer duration result in larger dissipation of RF energies deep into the tissues due to conductive heating causing tissue destruction at greater depths \[6\]. Hence, there is a risk of collateral tissue damage \[5\].

HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage as the lesions are smaller in depth. However, Maintaining a high power for a constant duration in the absence of a guide may not be the right strategy \[5\].

Unipolar waveform modification by complete elimination of the negative component may serve as a guide for HPSD ablation \[5\].

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation

Exclusion Criteria:

* Age\< 18 or \> 80 years old,
* Atrium (LA) diameter \> 50 mm,
* The presence of a mechanical mitral valve prosthesis,
* Left ventricular ejection fraction \< 40%,
* Abnormal thyroid function,
* Contraindication to anticoagulant therapy,
* Current malignancy,
* Prior catheter or surgical AF ablation.
Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia.

Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected.

Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested.

Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability.

Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.


Eligibility Criteria:
Inclusion Criteria:

* Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic
* Age: upper to 18 years
* Weight: upper to 50 kg

Exclusion Criteria:

* Cutaneous infection in the point of draining
* Clinical Disorder(Confusion) of the coagulation
* Retreat(Withdrawal) of the consent in the course of protocol
* Unwanted Effect engraves(burns) requiring the stop(ruling) of the treatment(processing)
Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.


Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
* Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion Criteria:

* Evidence of active systemic or localized major infection at the time of initial sirolimus administration
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
* Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections

This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients.

A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively.

A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. For the infectious and non-infectious disease groups, additional inclusion criteria have to be met. These will include:

In the Infectious disease group:

* Peak fever \>37.5°C (99.5°F)
* Clinical suspicion of an acute infectious disease
* Symptoms duration ≤ 12 days

In the Non-infectious disease control group:

- A non-infectious disease or healthy individuals

Exclusion Criteria:

Patients who will meet one or more of the following criteria will be excluded from the study:

* Evidence of another episode of acute infectious disease in the last two weeks
* Diagnosed congenital immune deficiency (CID)
* Current treatment with immunosuppressive therapy such as: Active chemotherapy,Post-transplant drugs,High dose steroids (\>1 mg/kg/day prednisone or equivalent).
* Active radiotherapy
* Immune-modulating/suppressive drugs including monoclonal antibodies, intravenous immunoglobulin (IVIG), cyclosporine, and anti-TNF agents
* Current treatment with immune stimulants such as: Interleukin (IL)-2, Granulocyte-Monocytes/Granulocyte colony-stimulating factor (GM/G-CSF),Interferon.
* An active hematological malignancy
* A diagnosis of myelodysplastic syndrome or myeloproliferative disease
* A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block

The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III physical status
* Surgery of distal arm, forearm or hand

Exclusion Criteria:

* Skin infection near block injection site
* Allergy to local anesthetics
* Peripheral neuropathy upper limb
* INR of more than 1.4
* Thrombocytopenia
* Opioid dependency
* Chronic pain syndrome
* Lack of orientation to person, place and time
* Patient refusal
Open Label Study Telmisartan and Amlodipine in Hypertension

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.


Eligibility Criteria:
Inclusion Criteria:

1. patients aged at least 18 years
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria:

1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
3. discontinuation from the preceding trial because of any adverse event or any other reason
4. known or suspected secondary hypertension
5. mean seated Systolic Blood Pressure =\> 180 mmHg and/or mean seated Diastolic Blood Pressure =\> 120 mmHg at any visit
Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?

Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.

The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate.

The investigators are planning a non-inferiority design.

The current study will test the following null hypothesis:

In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up.

The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* AO/OTA class A- and C-fractures
* Age \> 65 years
* Unacceptable primary reduction or redislocation \< 20 days post-injury with at least one of the following findings:
* dorsal angulation \> 10 degrees
* radial shortening \> 3 mm
* intraarticular step-off \> 2 mm
* Ability to sign an informed consent
* Acute fracture, inclusion within 20 days from injury.
* Ability to reconstruct the articular surface with a volar locking plate

Exclusion Criteria:

* Volar angulated fractures and AO type B
* Associated diseases contraindicating surgery
* Mental impairment, nursery home patient
* Earlier wrist injury
* Pathological fractures
* Open fractures (\>Gustilo-Anderson I) or damaged soft tissue
* Drug abuse
* Concomitant injuries that might affect outcome
* Congenital anomaly of affected extremity
* Median nerve compression that requires acute operation
* Foreign language
* Tourists
400mcg Sublingual Misoprostol as First Line Treatment

Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.


Eligibility Criteria:
Inclusion Criteria:

* uterine size less than 12 weeks lmp
* open cervical os
* current or past vaginal bleeding
* willing to provide contact information for follow-up
* over 18 or with guardian consent

Exclusion Criteria:

* suspicion of ectopic pregnancy
* intrauterine device in place
* bad general health (infection, anemia, shoc)
Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients

Assessing the immune activation in MS patients deficient in Vitamin D and whether Vitamin D supplementation reverse the immune activation

Evaluating whether Vitamin D deficiency result in lower cognitive performance in MS patients and the effect of Vitamin D supplementation on reversing the cognitive impairment?

We will compare the immune responses in patients with Vitamin D deficiency (serum level \<20ng/ml) to those of patients with normal Vitamin D (serum level \>35 ng/ml). We will focus on proliferation and cytokine production to myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) peptides and on the percentage of Th1 (IFN gamma producing cells) and Th17 (IL-17 producing cells) during in vitro polarization assays. Our hypothesis is that patients with low Vitamin D have increase proliferation to MBP and MOG and increased production of pro-inflammatory cytokines (IFN gamma and IL-17) and that Vitamin D supplementation will decrease this pro-inflammatory profile.

We will measure cognitive performance in patients with Vitamin D deficiency (serum level \<20ng/ml) compared to those of patients with normal Vitamin D (serum level \>35 ng/ml) after adjusting for educational levels and disease duration. We hypothesize that low Vitamin D has a negative effect on cognitive performance and that Vitamin D supplementation will improve cognitive function.

Eligibility Criteria:
Inclusion Criteria:

1. Definite diagnosis of Multiple Sclerosis following the revised McDonald MS diagnostic criteria
2. Male and Female Aged 18 and above
3. On interferon-β treatment (Rebif®, Avonex®, or Betaseron®)
4. No signs of active inflammation or attack or new lesions on MRI

Exclusion Criteria:

1. Treatment with immune modulating/ suppressive drugs other than IFN-b within 6 weeks prior to enrolment
2. Pregnancy
3. Hypercalcemia
4. eglomerular filtration rate\<60
5. History of primary hyperparathyroidism, hypercalcemia, renal dysfunction, cardiac disease, malignancy, or granulomatous disease
6. The occurrence of an exacerbation (defined as an episode of neurologic dysfunction lasting at least 24 hours) within 4 weeks of enrollment
7. History of dementia or related disorders
8. History of traumatic brain injury
9. Diagnosis of epilepsy or history of seizure
10. Diagnosis of psychiatric disease, substance abuse/dependence, alcohol abuse/dependence
11. Currently, on any of the following medications Lithium, or Thiazide diuretics
The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates

This study will determine whether the use of low oxygen tension during "in vitro" embryo culture may increase the pregnancy rates in women undergoing egg donation.

As far as oxygen (O2) tension is concerned, both oocytes and embryos from different mammalian species included the human are normally surrounded by values which are much less than half of atmospheric O2, ranging from high (8.7% O2) in the rabbit oviduct, rabbit and hamster uterus, to as low as 11 mm Hg (1.5% O2) in the monkey uterus. Even in the preovulatory follicle, oocytes are bathed within follicular fluids containing oxygen that range from \> 1 to 5.5 % The aim of this study was to evaluate the impact the effect of low oxygen tension after day-3 embryo transfer in our egg donation programme on pregnancy and implantation rates.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 25-45 years of age;
* In good mental and physical health;
* First or second of egg-recipient treatment;
* Embryo transfer on Day 3.
* One to three embryos will be transferred.
* BMI between 18-25 kg/m2.

Exclusion Criteria:

* Uterine pathology or hydrosalpinx
* Recurrent miscarriage
* No chronic illnesses