cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis

The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 44 days for parts A, B, and C, respectively.


Eligibility Criteria:
Inclusion Criteria:

Part A and C:

* Overtly healthy as determined by medical evaluation

  1. To qualify as Japanese for the purpose of this study, the participant must be first generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan
  2. To qualify as Chinese for the purpose of this study, the participant must be, at a minimum, third-generation Chinese, defined as all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
* Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male participants who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in part A and C

Part B:

* Participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the American Academy of Dermatology
* Have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history of intolerance to topical therapy
* Have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive
* Male participants who agree to use highly effective or effective methods of contraception, women not of childbearing potential and women of childbearing potential may participate in part B

Exclusion Criteria:

* Women who are pregnant and/or lactating
* Participants who have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette- Guérin within 35 days of screening
* Have a history or presence of multiple or severe allergies or an anaphylactic reaction to prescription or nonprescription drugs
* Have a known history of diabetes
* Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening
* Have known history of osteoporosis
Occurence of Pain and Use of Analgesic Treatment in Multi-trauma Patients of Intermediate Seveity

To register the perceived pain score during 0-14 days after multitrauma in conscious patients and to register the use (type and dose) of analgesic treatment in the same period.


Eligibility Criteria:
Inclusion Criteria:

* Patient With trauma, ISS \> 8

Exclusion Criteria:

* Unconscious patients at admission
* patients due for major surgery within 3 hrs of admission
* patients primary admitted to other hospitals
* not able to communicate in Norewegian
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.

This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \> or = 18 years of age;
* kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
* functioning graft of \> 6 months and \< 10 years after kidney transplantation, with no signs of acute rejection;
* stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* need for dialysis therapy expected in next 6 months.
Sleep Intervention for Pediatric Epilepsy

The purpose of the study is to develop and evaluate a sleep intervention program for improving sleep and health in youth with epilepsy and their parents.

Sleep problems are more prevalent and serious in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Inadequate sleep has long been recognized as a trigger for seizure and poor sleep habits have been associated with unfavorable outcomes in children with epilepsy. Attention to sleep in children with epilepsy as a result is critically important for seizure control and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1.5 and 6 years with a confirmed diagnosis of epilepsy based on clinical and electro-encephalogram examinations.

Exclusion Criteria:

* Children born before 37 weeks gestation, children with evidence of structural brain damage, or with cerebral palsy or those who are bedridden.
EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers.

Basic science and clinical data suggest that activation of one or more of the brain's arousal pathways is a highly plausible way to induce active emergence from general anesthesia. The investigators have compelling experimental data demonstrating that methylphenidate is highly effective in actively inducing emergence from isoflurane and propofol general anesthesia in rodents. The available literature suggests that IV methylphenidate would be safe to administer to patients recovering from general anesthesia, and that in addition to promoting arousal, it would enhance breathing. Both of these effects would be highly desirable in patients recovering from general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-36 years
2. ASA classification 1 or 2
3. Normal body weight, BMI ≤ 30
4. Non-smoker
5. Right handed
6. No history of taking stimulants

Exclusion Criteria:

* In general, patients will be excluded from the study if the state of their chronic health problems gives them an ASA physical status classification of 3 or beyond.
Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming

Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet feasible method of patient warming.

Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system named "Hot Dog" with an active polymer warming upper-body blanket and a new under-body warming mattress. The polymer-heating devices consist of an electronic regulator and the polymer blankets, which are covered with a washable fabric. Conventional mains power the system. The manufacturer claims, that the new system "Hot Dog" (with combination of under body and upper body warming) is as effective as forced air warming, while not having any disadvantages of the forced air system, like: airborne infection, noise, high power consumption and hard-to-clean hose.

The investigators will compare the new Hot Dog patient warming device combination (under body + upper body) with the established warming system, which blows warm air via a mattress over the body of the patients).


Eligibility Criteria:
Inclusion Criteria:

* The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours.

Exclusion Criteria:

* There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer

To study if Healing Touch is effective during chemotherapy treatment for breast cancer

To study the effectiveness of Healing Touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:- Stage I or II breast cancer

* Post-operative
* Concurrent enrollment on a treatment protocol of 8 weeks of adriamycin + cyclophosphamide given every other week followed by 8 weeks of paclitaxel given every other week
* ECOG Performance Status: 0 to 2
* Speak and read English

Exclusion Criteria:- Previous chemotherapy exposure

- Concomitant energy-work interventions (HT, Reiki, QiGong, acupuncture).
Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery

This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.

Justification:

Moderate-to-high risk cardiovascular surgery is associated with perioperative morbidity and mortality. These patients undergo general anesthesia and often require tight blood pressure control (e.g., using norepinephrine titration) to avoid the complications associated with hypotension and reduced cardiac output. Standard analgesia opioid titration to control nociception (i.e., the patient's unconscious response to noxious stimuli) is based on the anesthesiologist's experience and variations in the patient's heart rate and blood pressure. This causes anesthesiologists to often give too much analgesic, which can lead to inhibition of the sympathetic autonomic nervous system, hypotension, and associated side effects. A recently developed nociception monitor, the PMD-200 (Medasense, Israel), is capable of measuring the patient's level of nociception-antinociception balance and can guide opioid administration. This monitor may allow anesthesiologists to administer only the required amount of opioid, which may lead to better hemodynamic stability and better postoperative outcome.

Objectives:

The goal of this study is to determine if titrating analgesia using the Nol-Index, when compared to standard care, leads to decreased infused remifentanil, decreased norepinephrine, increased cardiac output, more stable blood pressure control, and decreased postoperative complications in moderate-to-high risk patients undergoing cardiac or vascular surgery.

Eligibility Criteria:
Inclusion Criteria:

* moderate-to-high risk cardiac or vascular surgery
* ASA 2-4

Exclusion Criteria:

* chronic arrhythmia (e.g. atrial fibrillation)
* aortic insufficiency
* pacemaker
* implanted defibrillator
* valve surgery
Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection
* ECOG status 0-1
* \>14 and \<56 days since resection

Exclusion Criteria:

* Prior chemotherapy and/or radiation therapy for lung cancer
* Peripheral neuropathy \> grade 1
* Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Medical condition that will not permit treatment or follow up according to the protocol
* Prior treatment with docetaxel or carboplatin
* Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol
* Treatment with other investigational anti-cancer drugs within 30 days of registration
* Pregnant or nursing women
* HIV-positive patients
The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy

Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many functions in the body but it is mostly known for maintaining a circadian rhythm that is governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei in the hypothalamus. Melatonin works by attaching to receptors or nerve endings in the suprachiasmatic nucleus (SCN) in the hypothalamus. It binds to melatonin receptor 1 and melatonin receptor 2, commonly referred to as MT1 and MT2. People can take it as a natural or synthetic supplement to promote restful sleep. Melatonin showed promise for preventing shifts in sleep and wake times in people with jetlag and improving sleep in people with insomnia. It can also be used for headaches, cancer, and Alzheimer's disease.

Melatonin can be used as an analgesic, sedative, and hypnotic drug that can distinguish it as an attractive alternative premedicant

A study that was done before in J Anaesth by Borazan H et al revealed that postoperative pain score in patients undergoing radical prostatectomy who received melatonin one hour before surgery as a premedication was significantly lower than the control group with a significant P-value( less than 0.05).

The entropy is indicated for adult and pediatric patients older than 2 years intraoperatively for monitoring the electric state of the brain. In adult patients, state entropy and response entropy can be used as an aid in monitoring the effects of certain anaesthetic agents which will help the user to titrate the anaesthetic agent according to the individual needs of each patient.

Furthermore, the use of entropy parameters may be associated with a reduction of anaesthetic use and faster emergence of anaesthesia. The entropy measurement is to be used as an adjunct to other physiological parameters.

To the best of investigators knowledge, there is no study that examined the effect of melatonin on inhaled isoflurane requirements intraoperatively. So, in this study, the effect of melatonin will be assessed on intraoperative inhaled isoflurane requirements in patients undergoing open nephrectomy under general anaesthesia by using entropy

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years.
* ASA 1 or 2.
* BMI 25 to 30

Exclusion Criteria:

* Patients with uncontrolled hypertension.
* Patients presenting with (IHD, significant arrhythmias, heart failure).
* Allergy to melatonin.
* History of epileptic seizures, psychoactive medications, neurological disorders or trauma.
Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients

Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls.

The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. The place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent.

In a previous study (MOUVSCO, NTC02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, MD) to allow real-time self-correction of the trunk position.

The aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients.

The hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.

The present study is the first evaluation of the efficacy of the virtual-brace on scoliotic patients.

The efficacy of rehabilitation will be estimate on the correction of the posture of scoliosis patients over 6 months by comparing 2 groups: a control group of patients conventionally treated with a night-time brace (G0 group_conventional) and an experimental group of patients wearing a night-time brace, doing postural rehabilitation exercises with the virtual brace and follow-up visits with a physiotherapist (G1 group_virtual-brace).

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic scoliosis (left lumbar or right thoracic),
* Patients with moderate scoliosis: Cobb angle assessed on the last radiography between 20 ° and 35 °,
* Patients requiring the wearing of a rigid night-time brace,
* Patients having a home computer,
* Patients affiliated to social security or similarly regime,
* Patients who gave their consent to participate in the study,
* Patients whose 2 parents have signed the informed consent

Exclusion Criteria:

* Patients with an unstabilized medical problem,
* Patients with known allergy to elastane,
* Patients with sensitivity to dizziness,
* Patients with pacemaker,
* Patients with implanted cardiac defibrillator,
* Patients with cochlear implant,
* Patients carrying a non-removable metal element,
* Protected patient concerned by articles L1121-5 and L1121-6 of the Public Health Code,
* Patients whose parents are protected by article L1121-8 of the Public Health Code
A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis

This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).

The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Eligibility Criteria:
Key inclusion criteria:

* Male and female patients aged 18 to 55 years.
* Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011).
* A relapsing-remitting course of disease with:

  * at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization ), or
  * a positive Gd-enhancing lesion on brain MRI scan at screening.
* An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
* No evidence of a relapse within 30 days prior to randomization.

Key exclusion criteria:

* A manifestation of another type of MS other than RRMS.
* Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.
* History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome.
* Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
* Women of child-bearing potential and Pregnant or nursing (lactating) women.
* Screening CBC (complete blood count) laboratory values as follows:
* Hemoglobin levels below 10.0 g/dL
* Total leukocyte count less than 3,000 cells/µL
* Neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3
* Platelets less than 100,000/µL
Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients

The aim of this study is to compare the effects of Sustained Natural Apophyseal Glides with and without Pilates on pain, range of motion and disability in patients with lumbar Disc Bulge.

Lumbar disc disease may occur when a disc in the low back area of the spine bulges or herniates between the bony areas of the spine. Lumbar disk disease causes lower back pain and leg pain and weakness that is made worse by movement and activity. Lumbar disc bulge is typically managed through a multidimensional approach that integrates various therapeutic techniques aimed at reducing symptoms and enhancing functional outcomes. The use of SNAGs has been shown to produce positive results such as decreased pain levels and increased mobility in previous studies. Overall physical conditioning can be improved by using a holistic approach that consists of controlled movements combined with breathing techniques and mindfulness. In order to treat lumbar disc bulge patients more effectively, it is important to understand how use and efficacy differ when applying SNAGs alone versus together with Pilates. Delving into how combining SNAGs and Pilates affects lumbar disc bulge patients contributes to an expanding body of proof advocating for a multimodal treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient of both gender under the age of 40-60 year.
* Unilateral radiating pain through the course of sciatic nerve
* a duration of pain of at least 3 months
* Restricted lumbar range of motion.
* Subjects who can understand the instructions and are willing to participate in the study
* Positive slump test with positive pain location and positive pain descriptors.
* Passive Lumbar Extension If the patient experiences severe low back pain or if there is a feeling of heaviness on the lower back or a feeling as though the lower back were about to 'come off' the test is considered positive.
* Straight Leg Raise SLR test positive when it evokes radiating pain along the course of the sciatic nerve and below the knee between 30 and 70 degrees of hip flexion

Exclusion Criteria:

* History of trauma, dislocation and subluxation of lower extremity.
* Rheumatoid Arthritis
* Systemic diseases such as blood coagulation disorders, chronic pain syndrome, cancer, allergies fibromyalgia, systemic lupus erythematous, and psoriatic arthritis.
* Lumbar spine surgery patients.
* Malignancy
* neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia)
* clinical diagnosis of lumbar bilateral radiculopathy or myelopathy
* history of previous physical therapy intervention for the lumbar region in last 6 months