cyrilzakka/clinical-trials huggingface dataset:
Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery

Erector spinae plane block(ESPB), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. The investigators aim to study efficacy of ESPB for patients who undergone breast cancer surgery and is expected to benefit from opioid-sparing effect of this technique.

This is a retrospective, single-center clinical trial to evaluate analgesic efficacy of Erector spinae plane block (ESPB) after breast cancer surgery. Participant's demographics and medical history, type and extent of surgery, systemic opioid and non-opioid analgesic consumptions, hemodynamic variables and adverse events during and first 24 hours after surgery. After operation, pain scores at first 24 hours, 1., 3., and 6. month will be obtanied from surgical ward and pain clinic registires. patient controlled analgesia device usage history will be obtained from device database at our clinic.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients undergoing breast surgery for breast cancer
* Becoming available of complete records about study data

Exclusion Criteria:

* ASA III-IV patients
* missing records about study data
A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects with an informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol .
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.
Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD

This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections. This will be a pilot trial to assess the feasibility of the IOP program and examine OUD-related outcomes following discharge from the hospital.

The aim is to conduct a single-arm pilot study of 20 participants who are hospitalized for serious injection-related infections to complete the newly tailored program. The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach who will provide support and accountability to the participant. The feasibility of the intervention will be established by evaluating recruitment and the acceptability of the program according to a priori benchmarks. The study team will assess the program's preliminary efficacy by evaluating OUD-related outcomes for up to 28 days after discharge from the hospital. The study will be conducted at Brigham and Women's Hospital (BWH), an urban, 793-bed academic medical center located in Boston, MA, and a major teaching hospital for Harvard Medical School.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults aged 18 and above
* Any DSM-5 substance use disorder
* Can identify at least 2 individuals who can act as points of contact following discharge from the hospital

Exclusion Criteria:

* Psychotic disorder, active suicidality, or homicidally
* Condition likely to be terminal during the study period
* Unable to perform consent due to impaired mental status
Safety of Fondaparinux as Post Partum Thromboprophylaxis

Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis.

The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.

All women were taught the injection technique and counselled regarding the symptoms of bleeding and VTE, prior to discharge. All patients were also advised to wear compression stockings and ensure adequate hydration at home

The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian
* Age 18 and above
* Scores asintermediate risk on 2015 Royal College of Obstetricians \& Gynaecologists (RCOG) VTE risk assessment

Exclusion Criteria:

1. Hypersensitivity to fondaparinux
2. Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease.
3. Weight \< 50 kg
4. Patients with primary postpartum haemorrhage
5. Patients who already on anti - coagulants
6. Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user
7. Uncontrolled hypertension ( blood pressure \> 200 mmHg systolic or \> 120 mmHg diastolic )
White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance

This randomized controlled study was planned to evaluate the effects of listening to white noise and therapeutic touch on physiological parameters, pain and comfort level during the heel blood collection procedure on infants who gave birth at 32 weeks and above and were given to their mothers in Atatürk Training and Research Hospital.

Hypotheses

H1: Newborns who listen to white noise during heel blood collection feel less pain and have a higher comfort level. H2: Newborns who are treated with therapeutic touch during heel blood collection feel less pain and have a higher comfort level. H3: Newborns who listen to white noise and apply therapeutic touch during heel blood collection feel less pain and have a higher comfort level. H4: There is a difference between the pain and comfort levels of newborns in terms of group, group-time and time according to the intervention applied.

Methods

Mothers of newborns whose heel blood will be taken will be informed about the research. The mothers will be informed about the fact that heel blood collection is a routine practice, the data will be recorded by the nurse and 2 observers who take heel blood in the study, and they will also be informed about the white noise and therapeutic touch practices to be listened to, and their written consent will be obtained.

After obtaining informed written consent, it will be determined which group the newborn belongs to by stratified randomization. Stratified randomization was applied according to gender and week of birth.

A standard approach will be applied to all newborns. Standard approach; If the baby is asleep, the heel blood will be taken, he will be woken up, put on a denim bed, his upper extremities will be gently wrapped with a blanket, and the procedure will be performed by the nurse.

Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection; Observational findings including heart rates, SpO2 values, pain and confort scores will be recorded in the data form. No additional care will be given to ensure physiological stability in all groups.

Eligibility Criteria:
Inclusion Criteria:

* Babies who are 32 weeks and older given to their mothers who were born healthy

Exclusion Criteria:

* Newborns 32 weeks and over
* Delivery of the newborn to the mother after birth
* no congenital anomalies or genetic disorders
* The newborn has passed the audiology test
* Obtaining consent form from parent
Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.

Twenty adult pregnant women in good health who are admitted for preterm premature rupture of membranes (24-34 weeks gestational age) will be enrolled in this intensive pharmacokinetic study. Basic information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant, engaged in prenatal care with a medical provider (at least one visit)
2. Estimated gestational age 24-34 weeks
3. Able to provide informed consent
4. English speaking

Exclusion Criteria:

1. Receipt of amoxicillin within the past 7 days. (Routine GBS prophylaxis with ampicillin or other antibiotic and routine surgical prophylaxis prior to cesarean with cephalexin and azithromycin 500 mg IV is allowed).
2. Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics.
3. Known renal impairment (serum creatinine ≥1.2 mg/dL).
4. Active concomitant medications known to interact with amoxicillin: allopurinol, methotrexate, mycophenolate, immune checkpoint inhibitors (ie. pembrolizumab), tetracyclines (ie. doxycycline), vitamin K antagonists (ie. warfarin), aminoglycosides (ie. gentamicin).
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure

We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age admitted to the intensive care unit
* New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease
* ARF will be defined by a sustained (over 24 hours) increase in serum creatinine \> 0.5 mg/dl from baseline
* Patients will be recruited for the study within 3-5 days following establishment of ARF

Exclusion Criteria:

* Institutionalized patient
* Previous kidney transplant
* Pregnancy
* Unable to obtain consent from subject or legally recognized representative
* ARF from urinary tract obstruction or a volume responsive pre-renal state.
* Liver Failure
* Recent cerebrovascular accident (CVA)
* Coagulopathy defined as: Platelets \< 50, PT \> 20, INR \> 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion.
* Life expectancy \< 48 hours
Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure

The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.

Myopia is equivalent to the colloquial term known as near-sightedness. This, in short, means that the image of one's environment is projected in front of the retina (rather than directly on the retina, which is ideal). Of course, glasses can be used to correct the image disparity that is created by being near-sighted (that is why a lot of people need glasses for blurry vision). However, glasses and spectacles and contacts do not correct the underlying problem. Most near-sightedness is due to the eye being "too long" and therefore the image projects in front of the retina. Ideally, if we could prevent the eye from becoming abnormally "long", then we could prevent the progression of near-sightedness. Indeed, a child may only be slightly near-sighted early in life, but as he/she continues to perform activities within an arms length of their environment, they can become progressively near-sighted. Besides spectacle correction, people have tried topical atropine drops (medicated eye drops) and rigid contact lenses (orthokeratology) to attempt to correct near-sightedness. Atropine drops take a lot of cooperation from parent and child. Orthokeratology also requires a lot of cooperation, but also, does not permanently stall myopic progression. The investigators suggest a different means of potentially preventing near-sightedness from getting worse (and thus prevent the eye from getting "too long"). The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism no more than 1.5 D.
* Caretakers who choose to enroll their child in the study must agree to participate in the study on their own will after knowledge of potential alternatives (spectacle correction, orthokeratology, atropine eye drops, etc.) are explained to the patient's caretaker.

Exclusion Criteria:

* Known allergy to riboflavin
* Birth history of premature birth
* Developmental delay or other neurological or mental conditions
* Major systemic health problems
* Significant anisometropia more than 1.5 Diopters
* Any other eye condition which may complicate interpretation of data including: congenital glaucoma, congenital cataract, ectatic corneal condition, amblyopia or strabismus.
Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients

The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age
* Birth at \<28 weeks gestation
* Birth weight \<1000 grams
* Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)
* Cardiac surgery during first 3 months of life
* Severe chronic lung discharge defined as the need for mechanical ventilation at 36 weeks post-menstrual age
* Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at 44 weeks post-menstrual age)

Exclusion Criteria:

* Significant malformations/amputations of the extremities
* Recovering from a surgical procedure within 4 weeks of the assessment
* Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-80 years old
* Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation
* Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram

Exclusion Criteria:

* Insertion of a carotid shunt at the site of an infection
Covid-19 Pandemic and Cerebral Palsy

Investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.

Telemedicine is an application that provides remote healthcare services. Telemedicine method has been reported to be useful in chronic conditions such as cerebral palsy (CP). Patients with CP need regular follow-up, regular physiotherapy, orthosis use, using of antispasmodic drugs, repeated botulinum toxin applications or intrathecal baclofen to reduce spasticity and increase functionality. During the Covid-19 pandemic period, these patients could not come to their controls due to reasons such as difficulty in reaching the doctor, fear of infection transmission, could not continue physiotherapy, repeated botulinum toxin applications could not be performed and necessary operations could not be performed. In this cross sectional study, investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.

Eligibility Criteria:
Inclusion Criteria:

* Patients' ages between 3-18 years
* Caregiver of Patients diagnosed as Cerebral palsy
* Patients with routine follow-ups in our clinic
* Caregivers can be reach by phone

Exclusion Criteria:

* Patients' ages under 3 and over 18 years

  --Caregivers cannot be reach by phone
* Caregivers without quality of life results for the pre-pandemic period
Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are frequently reported as presenting symptoms. These symptoms are in many cases accompanied by nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the irreversible damage to the saliva producing cells, the quantity and quality of saliva reduces. The progressive nature of the syndrome results in a further reduction of salivary flow. Due to hyposalivation the patients suffer from progressive dental decay, dental erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste), inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this can be qualified as a reduction in the quality of life. Until now no effective (palliative) therapy to relieve dry mouth complaints is available. A recent case series study suggests that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline and cortisone and possible strictures are dilated. It is hypothesised that performing a sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and improve the reported mouthfeel score.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosed (by the European League Against Rheumatism guidelines) primary or secondary Syndrome of Sjögren
* Age: \> 18 years and \< 70 years
* A remaining salivary flow

Exclusion Criteria:

* A complete lack of measurable salivary flow, also after stimulation of the glands by taste or chewing
* Acute sialadenitis
* Use of sialogogue medication (i.e. pilocarpine or cevimeline)
* Other severe illnesses or physical conditions that make a treatment under general anesthesia impossible or highly riskful.
A Study of MK-1084 Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)

The purpose of this study is to learn what happens to MK-1084 in a healthy person's body over time and how it is cleared from the body.


Eligibility Criteria:
Inclusion Criteria:

Key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
* Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has a history of cancer.
Treatment of Chronic Hip Pain by Application of Conventional Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturatory Nerve

The estimated prevalence of hip joint pain is 7% in men and 10% in women over the age of 45 years.Although physical therapy and weight loss, use of walking aids (such as walking sticks) and analgesic agents are used as conservative treatment methods, these methods usually provide short-term and partial benefits.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain. In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.

Hip pain is a common medical condition with increasing age.The effectiveness of conservative methods used in hip pain is limited.Since the lifespan of prostheses used in hip surgery is limited, new methods are needed in the treatment of pain.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain.In previous studies with small groups, it was shown that radiofrequency thermocoagulation procedure caused 50% reduction in hip pain between 1-11 months.Hip joint radiofrequency thermocoagulation is a procedure applied in our clinic. In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.

Eligibility Criteria:
Inclusion Criteria:

1. be over 18 years old
2. Written consent has been obtained
3. Those with chronic hip pain for more than 3 weeks

Exclusion Criteria:

1. Major psychiatric illness
2. The patient has lumbar compression pain or referred pain
3. Patients using anticoagulant agents
4. Patients with infection in the area to be treated
5. Those who are allergic to local anesthetics
6. Those who are allergic to betamethasone
7. Pregnancy