cyrilzakka/clinical-trials huggingface dataset:
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
* Subject is non-lactating and is either:
* Not of childbearing potential
* Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
* Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

* Subject is pregnant or breastfeeding
* Any subject whom the investigators deem unable to complete any/all research related tasks
* Subjects who are cognitively impaired (by history)
* Subject requires antipsychotic medications
* Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery
* Subject has known allergy to dexmedetomidine
* Subjects with impaired renal or hepatic function
* Subjects with advanced heart block
* Subjects with severe ventricular dysfunction
Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers

This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke.

The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS) will improve the diagnostic accuracy of emergency medical dispatchers for stroke.


Eligibility Criteria:
Inclusion Criteria:

1. All 911 calls transferred by local Public Service Answering Points (PSAPs) to the County Communication center of Santa Clara County where the emergency medical dispatchers complete the interrogation using MPDS protocols.
2. All 911 calls received directly at the County Communication center of Santa Clara County where emergency medical dispatchers complete the interrogation using the MPDS protocols.
3. All 911 calls received from subjects (patient) aged \> 18 years or second party calls (by-stander or family who are in close proximity to the patient and can administer the tool) by subjects \> 18 years of age.

Exclusion Criteria:

1. All calls that require immediate response (ECHO level determinant for life threatening conditions) and emergency medical dispatchers cannot complete Card 28
2. Calls answered by emergency medical dispatchers who have not completed training on the use of Cincinnati Stroke Scale.
3. Calls originating from the cities of Palo Alto, Mountain View, Sunnyvale, Santa Clara, and San Jose that are not interrogated by the County Communication Center for Santa Clara County.
4. 911 calls with no available outcomes in the final discharge database.

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RISE - Reduce Sitting Time Among Breast Cancer Survivors

This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.

Many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. This is known as accelerated aging. One way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. Another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. Long periods of sitting are related to many physical and health problems. Cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. This study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivors (stages I-IV) at least 1 year post active treatment (e.g., chemotherapy, radiotherapy)
* Breast cancer was treated with chemotherapy, radiation, immunotherapy, and/or endocrine therapy
* self-report difficulties with physical function
* self-report low levels of moderate to vigorous physical activity
* self-report high levels of sitting time

Exclusion Criteria:

* medical condition that interferes with ability to safely stand or stay balanced
* other cancer diagnoses that occurred after their breast cancer diagnosis
* Stage IV breast cancer with brain metastases or less than 12 months life-expectancy
* unable to commit to a 3-month study
Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)

Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.

The study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. Half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin D supplementation (Vigantol oil) over a period of one year, and half to placebo.

Participants will be followed for one year.

Eligibility Criteria:
Inclusion Criteria:

* Permanent resident or member of staff at sheltered accommodation unit
* If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
* Able to give written informed consent to participate
* Age ≥ 16 years on day of first dose of IMP

Exclusion Criteria:

* Current diagnosis of asthma or chronic obstructive pulmonary disease
* Chronic upper or lower respiratory infection or other condition causing chronic cough
* Condition requiring treatment with vitamin D at a dose of \> 10 micrograms vitamin D/day
* Episode of upper or lower respiratory tract infection up to 28 days before first dose of IMP
* Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission at time of recruitment
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
* Taking oral preparation containing \> 10 micrograms vitamin D/day up to 2 months before first dose of IMP
* Using topical vitamin D analogue
* Treatment with any investigational medical product or device up to 4 months before first dose of IMP
* Breastfeeding, pregnant or planning a pregnancy
* Baseline corrected serum calcium \> 2.65 mmol/L
* Baseline serum creatinine \> 125 micromol/L
* Inability to complete symptom diary with / without assistance
* Cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations
Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching

The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by autologous blood patch injection (ABPI).

Pneumothorax is the most common complication of percutaneous lung biopsies. Reducing this risk is a goal of those who perform these procedures, particularly a reduction in large pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (Clayton et al. 2016). Recently, autologous blood patch injection (ABPI) inside the biopsy track has been suggested as an effective mean of sealing the punctured lung thus halting air loss and consequently pneumothorax (Graffy et al. 2017).

The aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by ABPI.

In particular, the main objectives are to compare:

1. incidence of immediate pneumothorax
2. incidence of late pneumothorax (2 hrs)
3. incidence of chest tube placement
4. duration of the procedure

Eligibility Criteria:
All patients scheduled for lung biopsy will be asked to join this study. After signing the informed consent the subject will be randomized for ABPI vs CNB approach.

Inclusion criteria:

1) patients with pulmonary nodule requiring CT-guided lung biopsy.

Exclusion criteria:

1. unfit for lung biopsy (INR \>1.5, PLT \<50.000, single lung);
2. unavailable venous access.
Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients

The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.

Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group.

The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Chronic kidney disease stage 3-4 (eGFR 15-59 mL/min/1.73m2 body surface area, calculated using the MDRD Study equation GFR calculator)
* Hypovitaminosis D (serum 25OHD \< 31 ng/mL)
* Secondary hyperparathyroidism (Intact PTH \> 70 pg/mL for stage 3, and iPTH \> 110 pg/mL for stage 4)

Exclusion Criteria:

* Initiation of vitamin D therapy between the time of the lab draw used for screening and the screening process
* History of liver failure
* History of intestinal malabsorption or chronic diarrhea
* Serum calcium level greater than 10.2 mg/dL
* Treatment with an activated vitamin D formulation (calcitriol, doxercalciferol or paricalcitol) within the past 6 months
* Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
* Primary hyperparathyroidism, active of a prior history of such
* Active malignancy excluding basal cell or localized squamous cell skin cancer
* Subject is pregnant (e.g. positive HCG test) or breast-feeding
* Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the treatment phase of the study
* Serum phosphorus level greater than 4.5 or treatment with an oral phosphate binder within the past 6 months
* Treatment with cinacalcet or other calcimimetic within the past 6 months
* Anticipated dialysis within 6 months after randomization
* Inability to swallow tablets
* Known sensitivity, intolerance, or other adverse response to the study drugs which would prevent compliance with study medication
* Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
* Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
* Current treatment with vitamin D 50,000 IU
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice

This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and pre-treated patients switching from nevirapine immediate release or other anti-retroviral therapy (ART) will be included in the study. The decision to initiate treatment with nevirapine extended release is independent of this study and is based entirely on individual patient need and the judgement of the treating physician. The aim of the study is to assess the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1 infected patients in routine clinical practice. It is planned to document five visits for each patient over a twenty four week observational period.

Study Design:

non-interventional uncontrolled observational study

Eligibility Criteria:
Inclusion criteria:

1. HIV-1 infected male and female 18 years and above;
2. anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART.

Exclusion criteria:

Consistent with the current VIRAMUNE prolonged release SPC.
Analgesic Mechanisms of Percutaneous Electrolysis

Percutaneous electrolysis is based on the application of a galvanic current through an acupuncture needle. The underlying mechanisms that explain the efficacy of this technique are not completely well understood. The objective is to delve into the neurophysiological analgesic effects of percutaneous electrolysis. Participants will be assigned to one of three intervention groups. The analgesic effects of the technique will be evaluated by means of variables related to endogenous pain modulation.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects
* Signature of the informed consent

Exclusion Criteria:

* Fear of needles
* Any pathology or process that causes pain
* Neurological, rheumatologic, cardiovascular or metabolic diseases
* Cutaneous alterations and cognitive or sensitivity disorders
* Pregnancy
* Recent intake of alcohol or caffeine
* Vigorous physical activity on the day of testing
e-GAB: Electronic Geriatric Assessment Bundle: Development of an Arabic Self-administered Android CGA Application

The aim of this study is to design and assess the accuracy of administering the electronic Geriatric Assessment Bundle (e-GAB) compared to geriatrician performed comprehensive geriatric assessment (CGA) in a group of Egyptian elderly. The development of an Arabic software platform for CGA can improve the clinical practice by providing a valid user friendly tool to collect and analyze data for geriatric patients attending non- Geriatric health care service.

Modern geriatric care is based primarily on the concept of multidisciplinary approach of elderly care. This could be achieved by integrating CGA in different disciplines dealing with the older patient. CGA is different from that of the standard medical evaluation; it is a systematic evaluation of frail older adults. It uses combinations of validated geriatric tools to formulate an inventory of health problems, and develop an individualized geriatric intervention plan.

The software platform for CGA has been widely used in western countries; however, tools that can fit patients with different backgrounds should be implemented..

From the initial pool of 3 potential subtests, four experienced geriatricians developed a bundle of 15 subtests, to evaluate cognition, mood, vision, hearing, urinary continence, nutrition, functional capacity, fall risk and balance impairment, frailty, polypharmacy, sleep, pain, home safety, and social problems. Moreover, a rapid survey of medical and surgical conditions was obtained.

Initial evaluation of these subsets compared to the reference standard CGA was done. Each patient completed the bundle then underwent CGA by an experienced geriatrician blinded to the result of e-GAB

Eligibility Criteria:
Inclusion Criteria:

* 60 years or above
* community dwelling
* can read and write
* can use the android application

Exclusion Criteria:

* any patient refused to participate
Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

This study will investigate the effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types.

In the present study, we propose to examine some promotion factors and mitigation strategies and how they impact tobacco product legal and illegal purchases. Specifically, we have developed an Illegal Experimental Tobacco Marketplace (iETM). The iETM permits us to identify the number, type, and characteristics of tobacco users who would seek illegal tobacco products and the conditions that would induce them to seek that option. The critical questions we seek to answer are whether changes in product standards and availability will engender illegal tobacco purchasing as a function of tobacco user type (e.g., exclusive combustible product users, and dual cigarette/NVP users). Understanding the user types and the relevant conditions will inform greater tailoring of policy to diminish consumer interest in an illegal market.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Be at least 21 years of age or older
* Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
* Stable tobacco use patterns for at least two months

For exclusive cigarette smokers:

* Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month).
* For dual cigarette/NVP users:
* Smoke at least 10 cigarettes daily and use NVPs at least 3 times in a week (report use of closed nicotine salt system)

Exclusion criteria:

* Have plans to move out of the area
* Have a serious or unstable physical or mental health condition
* Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
* Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study
* Being pregnant or lactating
Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander

The objective of this study will be to assess and compare between sub-periosteal self- inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge augmentation and periosteal releasing incision using autogenous onlay block bone graft.

The assessment and comparison will be based on:

1. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar

   ridge augmentation.
2. Quantity of the soft tissue obtained after soft tissue expansion.

* Sixteen patients will be selected from the outpatient clinic of the department of, Oral medicine Periodontology, and oral diagnosis, Faculty of Dentistry, Ain Shams University.
* Three surgeries will be carried out for group I patient; the first is placement of soft tissue expander, the second surgery is bone grafting and placement of collagen membrane for ridge augmentation while the third (re-entry surgery) is implant placement in a routine fashion.

two surgeries will be carried out for group II patient; the first is surgery is bone grafting for ridge augmentation while the second (re-entry surgery) is implant placement in a routine fashion.

-Measurements and evaluation of edentulous ridge will be done by CBCT

Eligibility Criteria:
Inclusion Criteria:

* All patients should have partially edentulous ridge (missing upper one or two neighboring anterior teeth or premolars) of the maxilla. The edentulous area should require horizontal bone augmentation procedures owing to lack of sufficient residual bone.
* All patients should not have any particular medical history (medically free) according to Burket health medical history questionnaire (Glick et al.2008).
* All patients should not have any known contraindication to oral surgery.

Exclusion Criteria:

* Smokers will be excluded from our study.
* Patients with poor oral hygiene or not willing to perform oral hygiene measures.
* Patients who showed residual infections in the edentulous area or apparent infection in a neighboring tooth.
* Patients with systemic diseases such as diabetes mellitus and hemorrhagic disorders, patients receiving intravenous bisphosphonate therapy or systemic corticosteroid treatment.
* Patients with occlusal discrepancies will be excluded.
* Vulnerable groups (as pregnant and lactating females, and decisionaly impaired individuals) will be excluded from the study.
Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction

This study aims to evaluate the analgesic efficacy of single dose of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use in comparison to two different doses of an oral paracetamol form controlled versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged from 18 years of age
* Patients scheduled to undergo the removal of one third soft-tissue impacted or not-impacted mandibular molar (associated or not to an ipsilateral erupted maxillary molar) under short-acting local anaesthetic preoperatively;
* Patients weighing \> 50 kg;

Additional inclusion criteria

* Patients experiencing a moderate pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 40 mm and ≤ 60 mm;
* Third mandibular molar extraction completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth).

Exclusion Criteria:

* Patient who undergoes an extraction of contralateral molar in the same procedure or a bony-impacted molar;
* Patients treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within the 3 days prior to the day of randomization (or within 5 times the elimination half-life whichever the longest);
* Patient who received other analgesic than short-acting preoperative or intraoperative local anaesthetic agents within 12 hours before the start of the surgery or peri-operatively until randomization;
* Patients with any known hypersensitivity to paracetamol, ibuprofen or ingredients contained in IMPs and Non-Investigational Medicinal Product (NIMP);
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"

The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.


Eligibility Criteria:
Inclusion Criteria:

1. Are willing and able to provide written informed consent.
2. Are males or females 18 to 80 year of age, inclusive.
3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
4. Confirmation of infection with P. aeruginosa at screening

Exclusion Criteria:

1. Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
2. Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
3. Have a diagnosis of cystic fibrosis..
4. Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:

   * Azithromycin
   * Hypertonic saline
   * Bronchodilator medications
   * Oral corticosteroid.
5. Have received an investigational drug or device within 28 days prior to Visit 1.
6. Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.