cyrilzakka/clinical-trials huggingface dataset:
Tachycardia as an Indication for Prophylactic Phenylephrine Injection in Caesarean Section Under Spinal Anesthesia; an Observational Study

The value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section.

This observational study will take place at Ain Shams University Maternity hospitals, Cairo, Egypt. All patients will sign written informed consent before inclusion.

Sample size:

Using PASS 15 program for sample size calculation, setting confidence level at 95% and margin of error at 0.05, it is estimated that sample size of 80 women will be needed to detect an expected incidence rate of hypotension after phenylephrine administration of 30% "Hasanin et al., 2019"

Inclusion criteria:

ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.

Exclusion criteria:

Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI \& patients with cardiovascular diseases For all pregnant females including whose in the study group, preoperative labs will be done including ( CBC, INR, Liver function \& Kidney function) , oral and written informed consents will be taken from the patients with explanation of the spinal anesthesia and expected complications.

In OR wide pore IV access and preload started with crystalloids, full standard monitoring, spinal anesthesia will be performed by the expert anesthetist. The pregnant female will be in the sitting position and complete sterilization of her back, local anesthesia by 5 ml lidocaine 1% then the spinal needle (Pencil point 27 G) introduced between L4-5 and injection of (50 µg fentanyl + bupivacaine 0.5%) in total volume between 1.8 - 2.3 according to patient's height.

Then patient will lie supine with head elevated 30 degrees by a bellow and start recording the data just after spinal anesthesia.

Phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline.

Then blood pressure \& HR will be recorded after the administration of phenylephrine and every 5 minutes.

Any further doses given will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.

Exclusion Criteria:

* Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI patients with cardiovascular diseases
Exparel v Dexamethasone in RCR

Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.


Eligibility Criteria:
Inclusion Criteria:

* Participants having a primary rotator cuff repair
* Age 18 and older
* English speaking
* Ability to complete surveys by phone or in person
* Ability to provide informed consent

Exclusion Criteria:

* Revision rotator cuff repair (RCR) cases
* Participants having an open RCR
* Allergies and/or medical contra-indications to study medications
* Non-English speakers
* Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
* Rotator cuff repair needing Graft Augmentation
* Known alcohol or narcotic abuse history
* Existing contract with a pain specialist due to underlying preoperative pain syndrome
* Preoperative opioid use within the 3 months prior to surgery
Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF

Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection

Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.

Eligibility Criteria:
Inclusion Criteria

* Having anti-VGEF intravitreal injection scheduled
* Informed consent signed

Exclusion Criteria

* Under 45 years
* Opacity that prevents ophthalmological evaluation and fixation
* Patients with severe dry eye
* Patients with signs of infection on the ocular surface
* Allergy to iodine
* Pregnancy
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk


Eligibility Criteria:
Inclusion Criteria:

* New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
* Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date

Exclusion Criteria:

* Less than one year of medical history information prior to the date of combined treatment initiation (index date)
* Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
* Asthma diagnosis within one year prior to the index date
Home-Based Asthma Support and Education for Adults

This study tests the hypothesis that community health workers providing home visits to provide education and support for self-management of asthma, assessment of the home for environmental triggers, resources for asthma control, and assistance in effective communication with medical providers over the course of one year would reduce asthma morbidity, asthma-related urgent health care use and exposure to indoor asthma triggers among low income adults with not well controlled asthma.

We used a randomized controlled parallel group design to compare the intervention to a usual-care control group. We attempted to evaluate the effectiveness of the intervention in the "real world," rather than its ideal efficacy.

The CHWs used protocols that specified education content, participant skill development and participant and CHW actions. The CHWs modified their approach to meet the priorities of participants using motivational interviewing techniques. They addressed asthma patho-physiology, reliever and controller medication use, self-monitoring, use of an asthma action plan, environmental assessment, trigger avoidance, effective use of the health care system, successful communication with health care providers, and weight control (obesity is associated with increased asthma symptoms). Participants also received low-literacy educational materials, in English or Spanish. The education concepts and environmental assessment activities were based on our prior healthy homes work modified for adults.

Eligibility Criteria:
Inclusion Criteria:

* residence of King County Washington
* household income below the 250% of the 2007 federal poverty level
* had "not well controlled asthma" or "very poorly controlled asthma"

Exclusion Criteria:

* speak a language other than English or Spanish
* no permanent housing
Feasability of Collaborative Care in the Secondary Prevention of Coronary Heart Disease

The main focus of the pilot study is to evaluate the feasability and effectiveness of a collaborative care intervention for patients suffering from a coronary heart disease (CHD) with insufficient controlled health related risk factors in their lifestyle. The design of the study is a wait list control design. 30 patients will receive treatment immediately after submission, the other 30 after 6 months. An interdisciplinary team, including a care manager for each patient, will offer an individualized treatment plan, based on shared decision making for each patient to reduce risk factors and improve quality of life.

The following assumptions will be evaluated:

1. The collaborative care concept is feasable in the context of the german health care system and leads to greater patient satisfaction
2. The team-based intervention leads to a decrease of cardiovascular risk factors of patients in the intervention group compared to participants in the waitlist condition
3. The collaborative care intervention leads to an improvement of quality of life as well as mental well being of participants in the intervention group compared to participants of the waitlist condition

Eligibility Criteria:
Inclusion Criteria:

* both sexes
* coronary heart disease (angiographically oder clinically approved)
* sufficient knowledge of the german language
* at least one not sufficient controlled risk factor : Diabetes mellitus (HbA1c\>7,5%), smoking, lack of physical activity (less than 60 minutes of light physical exercise per week), heightened stress level (PSS-4 \>5), arterial hypertension (blood pressure despite medication repeatedly heightened \>140/90 or in a 24-hour measurement \>135/85 mmHg), hypercholesteremia (LDL \>130 mg/dl)
* written informed consent to participate

Exclusion Criteria:

* no existence of an medically approved coronary heart disease
* insufficient knowledge of the german language and ulterior disabilities to complete the questionnaires or to understand the education about the Intervention
* existence of a psychosis
* drug dependency (except tobacco)
* dementia
* severe episode of Depression
* current suicidal tendency
* cardiac insufficiency NYHA 4
* missing informed consent
* malign tumor (unless curative treated and without relapse)
* acute coronary syndrome or cardiosurgery within the last 3 months
Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia

Prospective, before and after study in 5 Intensive Care Units (ICUs) of a university hospital.

The before period (control phase, 6 months): standard oral care 3 times a day in every consecutive intubated patients in the participating ICUs The interphase period (1 month): formal training of all the nurses, physicians and residents on the use of toothbrushing during oral care The after period: (study phase, 6 months): standard oral care with tooth brushing 3 times a day in every consecutive intubated patients in the participating ICUs

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Intubated mechanically ventilated ICU patient
* Platelets count \>50G/L

Exclusion Criteria:

* Edentulous patients
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma

The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Previously participated in protocol 005/05 (NCT00769704) and:

   1. received the maximum number of talimogene laherparepvec treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or
   2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05. New injectable lesions must have appeared within ≤ 12 months from the End of Treatment visit on the 005/05 study.
2. In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted \[e.g., those patients who do not have clinically relevant progressive disease (PDr)\].
3. Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1.
4. For patients randomized to talimogene laherparepvec only: Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.

Exclusion Criteria:

1. Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity related to talimogene laherparepvec of any organ system (with the exception of injection site reactions, fever and vomiting).
2. History of Grade 3 fatigue lasting \> 1 week while on talimogene laherparepvec treatment.
3. History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.
4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other talimogene laherparepvec related non-hematological toxicities while on talimogene laherparepvec treatment that required a dose delay or discontinuation of talimogene laherparepvec therapy.
5. PDr while participating in study 005/05
6. Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
7. At the discretion of the investigator, patient was withdrawn from the 005/05 trial.
Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

1. To evaluate histopathological findings of products of conception in both sporadic and recurrent miscarriage.
2. To determine the prevalence of chronic histiocytic intervillositis in both sporadic and recurrent miscarriage.

Early miscarriage is a term used to describe the loss of pregnancy within the first 12 weeks of gestation .This diagnosis concerns 10-15% of all pregnancies and is made based on additional tests such as serial determinations of chorionic gonadotropin concentration and imaging examinations ultrasonography. Depending on the clinical presentation and results of ultrasonography, miscarriages can be divided into complete spontaneous miscarriage, and incomplete miscarriage, when the width of the echo of residual tissues in the uterine cavity exceeds 10 mm on ultrasonography and is accompanied by the presence of clinical symptoms such as vaginal bleeding and abdominal pain .The other type of miscarriage is defined as retained products of conception (RPOC) and refers to the state when the gestational sac contains the embryo with crown-rump length (CRL) of \> 7 mm but embryonic cardiac activity is invisible. Empty gestational sac is diagnosed when the gestational sac with a diameter of \> 25 mm and without an embryo is visible in the uterine cavity on ultrasonography .

Histopathological examination of products of conception is an integral and a routine component of the management of patients with early pregnancy failure . Two important primary reasons for such an examination are to confirm the presence of an intrauterine gestation and to exclude gestational trophoblastic disease in the form of partial or complete hydatidiform mole .

Eligibility Criteria:
Inclusion Criteria:

* all pregnants with clinical symptoms and signs of abortion
* fit for medical induction of abortion
* fit for surgical procedure

Exclusion Criteria:

* threatened abortion
* complete abortion
* unfit participants for medical abortion
* unfit participants for surgical procedure
Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients

The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition.

From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient.

Testicular cancer constitutes 1% to 1.5% of male tumors, 5% of urological tumors. In the Western society to which we belong, the incidence is between 3 and 6 new cases per 100,000 inhabitants per year. In particular, this incidence has recorded continuous growth over the last thirty years. Different histologies of this disease are known, with a clear prevalence of germ cell tumors (90-95%).

From these general epidemiological coordinates it can be deduced that this pathology could affects a young segment of the population; It must be underlined that a pathology is peculiar due to the impact it has on the affected individual, who must be treated not only from an oncological point of view but also with regards to the sexual, reproductive and psychological-relational aspects. Such complexity requires a systematic and detailed approach to examine all aspects.

The creation of this database let to have a follow up above all an extension over time that is not present in the literature, especially towards the functional aspects of this condition.

The database will represent a resource for future research.

Eligibility Criteria:
Inclusion Criteria:

* subjects suffering from suspected neoplastic testicular pathology candidates for testicle removal surgery
* patients suffering from neoplastic testicular pathology requiring removal of the retroperitoneal lymph nodes
* subjects \> 18 years old
* subjects with at least elementary education
* signature of informed consent

Exclusion Criteria:

* subjects \< 18 years
* presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery

Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.

Laparoscopic adrenalectomy is today considered the gold standard of treatment for adrenal tumors. This technique was described for the first time by Gagner in 1992 and in the past years several studies have shown the advantages of laparoscopic approach with decrease of the perioperative morbidity, lower complication rates, less operative blood loss, less postoperative pain and shorter hospital stay compared with open adrenalectomy. Laparoscopic surgery is more difficult to learn and requires different psychomotor skills than open laparotomy. In fact, the surgeons have to work in a three-dimensional space, but are guided by two-dimensional images. The development of high definition cameras does not eliminate the major limitation of two-dimensional (2D) laparoscopy: lack of depth perception and lose of spatial orientation with potential increasing the strain for the surgeon, the risk of errors and the operative time. Three-dimensional (3D) HD laparoscopy was developed as an alternative to conventional 2D laparoscopy.

In literature there are still few clinical studies on use of 3D in laparoscopic adrenalectomies with different results.

For these reasons the investigators propose an international multicenter study to compare 3D laparoscopic adrenalectomy with standard laparoscopic adrenalectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients competent to give consent
* aged between 18 and 85 years
* functioning and not functioning benign adrenal lesions,
* adrenal malignancies candidate to laparoscopic adrenal surgery.

Exclusion Criteria:

* open adrenal surgery
* preoperative signs of local periadrenal invasiveness
Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female Subjects

The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
* Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
* Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults

The purpose of this study is to assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults.

Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Eligibility Criteria:
Inclusion Criteria:

* Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.
* Ability to provide informed consent
* Baseline brachial flow-mediated dilation (FMD) \< 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
* Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
* Willing to accept random assignment to condition

Exclusion Criteria:

* Current smoking
* Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
* Body mass index (BMI) \>40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
* Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions \[multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging\]), except hypertension and hyperlipidemia
* Regular vigorous aerobic/endurance exercise (\>3 vigorous bouts/week).
* Not weight stable in the prior 3 months (\>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function.
* Current treatment or recent cessation (\< 3 mo) of hormone replacement therapy
* Moderate or severe peripheral artery disease (ankle-brachial index \<0.7).
* A graded exercise test will be performed by all subjects, if there is physician concern or an adverse event, the subject will not participate in a maximal oxygen consumption (VO2max) test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association).
* Thyroid disease that is not controlled by medications or \<3 month's use of a particular medication and/or dosage (uncontrolled thyroid diseases are associated with alterations in vascular function).