cyrilzakka/clinical-trials huggingface dataset:
Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings

The goal of this research is to investigate the impact of changing opioid analgesic prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult primary care and emergency department settings. We will change prescribing defaults for select short-acting opioid analgesics including immediate release oxycodone and hydrocodone as well as codeine and tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial of matched pairs of Montefiore Medical Center clinical sites, stratified by specialty and teaching status, we will evaluate the impact of this intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months post-intervention).


Eligibility Criteria:
Clinical Site Inclusion Criteria:

* Primary care clinic (internal medicine, family medicine, or urgent care) or emergency department within Montefiore Medical Center

Patient Inclusion Criteria:

* Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months

Patient Exclusion Criteria:

* Cancer diagnosis code within the past 1 year
Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial

We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery

Spine surgery in paediatrics is frequently associated with substantial blood loss.

Blood product adminestration in children has many complications that are not fully known.

There are many modalities currently available to reduce blood loss in pediatric patients.

Tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss.

To date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-12 years
* Of both sexes
* American society of anesthesiologist (ASA) physical status classification class I
* Undergoing general anesthesia for scoliosis surgery

Exclusion Criteria:

* Parents' refusal of regional block
* Known allergy to tranexamic acid
* Bleeding disorders (INR \>1.4,Platelet count\< 75000)
A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo.

Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.


Eligibility Criteria:
Inclusion Criteria:

* Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
* Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
* Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
* Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
* Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
* If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.

Exclusion Criteria:

* Have dementia or significant other neurological disease that can affect cognition.
* Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
* Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
* Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study.
* Have any contraindications for magnetic resonance imaging (MRI).
* Have a centrally read MRI that does not meets study entry criteria.

Prior or Current Therapies

* Have ever had prior treatment with a passive anti-amyloid immunotherapy.
* Have received active immunization against Aβ in any other study.
Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia

Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant

This clinical trial wants to study the safety, effectiveness and efficacy of NK cells incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.

Eligibility Criteria:
Inclusion Criteria:

1. More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
2. Assessable disease by analytic, molecular or image techniques.
3. Comorbidity Sorror index less than 6.
4. Give informed consent according to the legal requirements.
5. Dispose of a donor without exclusion criteria.

Exclusion Criteria:

1. Positive HIV serology.
2. Patients with an active infection or other underlying serious medical statement.
3. Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study.
4. Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
5. Women who are pregnant or breastfeeding.
Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction

The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859 compared with placebo and an active control (ibuprofen) in subjects with acute dental pain after third molar extraction.


Eligibility Criteria:
Key Inclusion Criteria:

* have 2 or more 3rd molars requiring extraction, including at least 1 partially or completely bone-impacted mandibular molar
* experience moderate to severe pain intensity as measured by the Numeric Pain Rating Scale (NPRS) (score ≥ 5) within 6 hours after surgery
* for male subjects, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive
* for female subjects, be using contraceptives, be postmenopausal, or have undergone hysterectomy or tubal ligation
* be able to take oral study medications

Key Exclusion Criteria:

* have positive results either on the urine screening tests for opiates, tetrahydrocannabinol,cocaine, amphetamines, barbiturates, benzodiazepines, phencyclidine, or propoxyphene or on the alcohol breathalyzer test
* have a history of alcoholism or drug addiction or abuse within 5 years before dosing with study medication
* have a history of chronic use (defined as daily use for \> 2 weeks) of glucocorticoids,nonsteroidal anti-inflammatory drugs, or opiates for any condition within 6 months of study medication administration
* have a known allergy or history of significant reaction to any of the known treatment medications (ADL5859-like compounds or ibuprofen) or rescue pain medication (acetaminophen)
* have significant renal or hepatic disease, as indicated by clinical laboratory assessment
* have a known history of epilepsy or seizure disorder, including history of febrile seizure, or any other medical or psychiatric condition that, in the judgment of the investigator, would put the subject at risk while in the study, could influence the results of the study, or could negatively affect the subject's ability to participate in the study
* have a history or evidence of orthostatic hypotension at screening have a history of significant head trauma (head injury with loss of consciousness)
Prenatal Alcohol Biomarker Study in Uruguay

The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.

The goal of the proposed research study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn children, in a country (Uruguay) where significant alcohol use is common during pregnancy. Maternal alcohol biomarker assays will include ethyl glucuronide (EtG) in hair and nails and PEth in blood obtained at the time of delivery. Newborn umbilical cord and routine 48 hour heel stick blood will be collected to assess newborn PEth levels. Maternal biomarker levels will be compared to patient self-reported alcohol use. This proposed design is a cross-sectional study that will include 1,800 women 18 years and older and their newborns. Women who are admitted to one of two selected public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell and Servicio Medico Integral) for obstetrical care will be recruited to participate in the study. Power estimates suggest that 1,800 maternal/infant pairs will give us sufficient power (\>90%) to estimate the predictive validity of this biomarker as a routine newborn screening test.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for experimental group (n=1,800)
* Pregnant women 18 years and older
* Admitted in active labor as well as their newborn child
* Well enough to participate in the research interview
* Able to provide fingernail, hair, and blood spot samples
* All subjects must have given signed, informed consent prior to registration

Exclusion Criteria:

* Not meeting the appropriate inclusion criteria or providing consent
Effectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study

This protocol (a supplement to 805466) is to test whether our telephone continuing care model can be implemented successfully by "real world" publicly funded programs. Participants will be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The investigators will train city telephone care managers to deliver our telephone continuing care intervention to patients in this program. The investigators will randomize 200 to receive this intervention or usual care and follow them for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* (1) qualify for a DSM-IV diagnosis of cocaine dependence, with cocaine use in the 6 months prior to entrance into the City of Philadelphia Department of Behavioral Health facilities or controlled environment;
* (2) 18 to 75 years of age;
* (3) no current psychotic disorder (as assessed with the psychotic screen from the SCID) or evidence of dementia severe enough to prevent participation in outpatient treatment;
* (4) no acute medical problem requiring immediate inpatient treatment;
* (5) no current participation in methadone or other modes of Drug and Alcohol treatment, other than an Intensive Outpatient Program;
* (6) willingness to be randomized and participate in research.
* (7) Finally, because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least two contacts who can provide locating information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion Criteria:

* Current dependence on opiates is an exclusion as those participants may be better served as part of a methadone program rather than a telephone based therapy protocol. Also, if patients are court-ordered to treatment, or otherwise considered prisoners, they will not be included in the study.
The Letrozole Administration During Luteal Phase

To investigate the effect of letrozole in patients who have high risk of ovarian hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were calculated between letrozole group and supporting treatment group.

1. Object:

   Infertility patients who frozen all embryos due to the risk of OHSS were randomized allocated to letrozole or polygeline injection group. Inclusion criteria meet one of the following conditions: (1) oocyte is more than or equal to 20; (2) human chorionic gonadotropin (hCG) injection on serum estradiol levels greater than or equal to 5000 pmol/L; (3) on the day of oocyte unilateral or bilateral ovarian diameter greater than or equal to 10 cm (4) follicle puncture is larger than or equal to number 20. After the informed consent was signed, letrozole or polygeline injection was randomized allocated after oocyte retrieval. OHSS was determined according to Golan diagnosis standards.
2. Clinical data:

   Including age, infertility duration, body mass index (BMI), basic follicle-stimulating hormone (FSH) and luteinizing hormone (LH), antral follicle number (AFC), Gn dosage, estradiol level on hCG injection day, the number of oocytes, the number of embryos, early onset OHSS incidence, and the existence of ascites.
3. Reproductive hormone levels:

1, 4, 7, days after taken letrozole, and the supernatant was collected for serum reproductive hormone test.

Eligibility Criteria:
Inclusion criteria:

1. oocyte is more than or equal to 20;
2. hCG injection on serum estradiol levels greater than or equal to 5000 pmol/L; 3. on the day of oocyte unilateral or bilateral ovarian diameter greater than or equal to 10 cm;

4. follicle puncture is larger than or equal to number 20.

Exclusion criteria:

Allergic to the letrozole or polygeline.
Skin Microbiome Profile in Hailey-Hailey Disease

"Hailey-Hailey disease is an autosomal dominant disorder caused by a genetic defect in a calcium ATPase (ATP2C1) leading to a defect in keratinocyte adhesion. The characteristic of this disease is the involvement of intertriginous areas of the skin, which are the moist sites including the axillary vault and the inguinal crease. The composition of microbial communities is primarily dependent on the physiology of the skin site and the moist sites have distinct compositions of skin microorganisms. In addition, treatment with doxycycline is often helpful in the management of Hailey-Hailey disease. These findings suggest a role of the skin microbiome in the pathogenesis of Hailey-Hailey disease.

The purpose of this study is to characterize the skin microbiome in patients with Hailey-Hailey disease by the 16S method, to better understand the pathogenesis of the disease and to discover new therapeutic targets in the future.

Investigators will look at patients with Hailey-Hailey disease, and healthy controls.

Investigators will look at skin microbiome (Bacterial diversity and the relative abundance of major bacterial taxa) Investigators will assess this in patients with Hailey-Hailey disease before and after doxycycline and compare them to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

1. Hailey-Hailey disease 1-1. Inclusion Criteria

1. Clinically diagnosed with Hailey-Hailey as confirmed by histopathology and/or genetic analysis.
2. \>19 years old
3. Patients who currently have lesions on the axilla and groin
4. Patietns who signed the consent form and Informed Consent in Human Material Research

2. Normal control 2-1. Inclusion Criteria

1. \>19 years old
2. Persions who signed the consent form and Informed Consent in Human Material Research

Exclusion Criteria:

1-2. Exclusion Criteria

1. Patients who have used systemic steroids or antibiotics within the last 1 month
2. Patients who have used local steroids or antibiotics within the last 2 weeks
3. Patients who have been diagnosed with skin diseases(such as atopic dermatitis) other than Hailey-Hailey disease
4. Patients who are unable to swab or who may have affect a medical condition
5. Patients who have difficulty making clear decisions due to lack of decision-making ability
6. In addition to the above, a person who is considered inappropriate to participate in this study, such as collecting test information, based on the medical judgment of the Principal investigator or Subinvestigator.

2-2. Exclusion Criteria

1. Persions who have skin diseases(such as atopic dermatitis) or diseases affecting the skin microbes
2. Persions who have used systemic steroids or antibiotics within the last 1 month
3. Patients who have used local steroids or antibiotics within the last 2 weeks
4. In addition to the above, a person who is considered inappropriate to participate in this study, such as collecting test information, based on the medical judgment of the Principal investigator or Subinvestigator.
Prevention of Hyperalgesia With Epidural Morphine

American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.

This randomized, double blind, controlled study will perform after obtaining informed consent and ethics approval. American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups with computerized randomization programme. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and N2O-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* Patients who undergoing major abdominal surgery

Exclusion Criteria:

* ASA IV and up
* Coagulopathy
Pain Management of Amputation Wounds With AutoHypnosis

Amputation in vascular surgery mainly concerns the lower limb and is often linked to Obliterative Arterial Disease of the Lower Limbs. It indicates the impossibility or failure of revascularisation after an exhaustive assessment aimed at saving the limb. It is also performed to limit the spread of gangrene, an affection of the limb that can evolve into septicaemia. The principle is to amputate in a healthy and vascularised area to allow good healing of the amputation stump.

Amputations of one, several or all toes, called complete transmetatarsal amputations, may take several months to heal. Amputations require directed healing and, above all, monitoring of the underlying tissues of the amputated area by daily detersions and wiping performed by a nurse at home. The mechanical detersion of the wound necessary for the healing process and cell migration, as well as optimal deep meshing, facilitate the evolution of the healing process.

These treatments often cause pain, despite oral analgesics and local anaesthetics prior to the treatment.

For several years, studies have shown the benefits of hypnosis in modifying the perception of pain, particularly during treatment.

Studies have also shown that self-hypnosis allows a reduction in the intensity of pain.

The clinical experience of the vascular surgery department of the University Hospital of Rennes suggests that patients who use self-hypnosis during the daily dressing of their amputation experience the moment more serenely, increasing their comfort and decreasing their pain and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Naïve to amputation procedures;
* Amputated, within 24 hours prior to inclusion, one, more or all toes
* Pain level on the Numerical Scale ≥ 3 during the first dressing;
* Affiliated to a social security scheme;
* Having signed a free, informed and written consent.

Exclusion Criteria:

* Cognitive impairments that limit understanding of instructions;
* Cultural limitations reducing abstraction skills;
* Previous practice of hypnosis;
* Contraindications to hypnosis: Bipolar disorder or decompensated schizophrenia;
* Chronic non-vascular pain;
* Already in care for painful chronic wounds (ulcer wounds, bedsores...)
* On morphine before surgery;
* Analgesia by perineural catheter;
* Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), nursing woman and minor).
Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin \< 10g/dl) undergoing palliative care chemotherapy.

Patients with non curable solid tumors or lymphoma with anemia (hemoglobin \< 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of non curable cancer or lymphoma
* Receiving a palliative chemotherapy regimen
* Hemoglobin \< 10.0 g/dL
* Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status
* Life expectancy of ≥ 3 months
* Postmenopausal o premenopausal women receiving effective contraceptive method

Exclusion Criteria:

* Active bleeding that may have caused anemia in the prior 30 days.
* Uncontrolled hypertension
* Anemia for another cause other than cancer or chemotherapy
* Untreated iron or folic acid deficiency
* Transfusion in the last 30 days prior to baseline visit
* Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit
* Increased risk of thromboembolic disease
* Radiotherapy in pelvis or spine in the last 60 days
* Myelodysplasic syndrome
* History of congestive heart failure
* Pregnant or lactating
* Patient with known allergy to human albumin or related products