cyrilzakka/clinical-trials huggingface dataset:
US Development and Evaluation Study of a Patch-Based PSG System

The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.

The diagnostic gold standard to detect a sleep disorder in the presence of a comorbidity is attended, inpatient, polysomnography (PSG)1. Currently, these tests are limited to the in-patient setting in the sleep laboratory, which requires a large number of personnel, and the PSG studies are time-consuming and expensive to conduct. PSG studies are also burdensome for patients, as they require each patient to sleep at the hospital for at least one night while wearing multiple electrodes and other physiological monitoring equipment attached to the head, face, torso, and legs, which makes sleeping difficult and limits movement. A portable PSG device that does not incorporate traditional leads and electrodes would facilitate sleep studies and allow such studies to be done in other locations and be performed more quickly and easily. Studies outside the hospital setting using an optimized, portable PSG device would be easier for sleep technicians to set up and allow each patient to sleep more comfortably.

Onera STS is a wearable system for measuring physiological signals during a PSG study that was designed to overcome the limitations described above that are associated with attended, inpatient PSG. The Onera STS performs electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), and electrocardiography (ECG) and also measures respiratory signals, nasal pressure, oxygen saturation, activity, body position, and snoring loudness via four sensor patches applied to the forehead, upper chest, abdomen, and lower leg. These sensor patches eliminate the need for individual leads and separate electrodes. When used in an in-patient setting, setup time can be reduced compared to the classical PSG setup. The Onera STS system is FDA approved (510k) for the purpose of monitoring physiological parameters intended to provide information which is used to take decisions on the diagnosis of sleep disorders.

The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Referral for a suspected sleep disorder requiring a sleep diagnostic study

Exclusion Criteria:

* Inability to provide informed consent
* History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
* Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
* Has an implanted cardiac stimulator or diaphragmatic pacer
* Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
* Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device
Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)

The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* CD20+ follicular B-cell non-hodgkin's lymphoma with at least 1 site of measurable disease.
* Previous treatment with 1 to 4 prior chemotherapy regimens
* ECOG performance status of greater than or equal to 2
* Life expectancy of greater than 18 weeks
* Meet safety lab requirements and organ function tests

Exclusion Criteria:

* Prior treatment with rituximab or IL-2
* Prior radioimmunotherapy including Zevalin or Bexxar
* 5 or more prior chemotherapy regimens
* Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection.
* History of allogenic bone marrow transplant
* Female subjects that are pregnant or breast feeding
* Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment
Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia

fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection.

Objective of the study: The purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation.

Materials and Methods: The study will be a double-blind randomized controlled clinical trial, with a parallel design. A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankel behavioral rating scale. Written consent will be obtained from the legal guardian. Participants will be randomly allocated into two groups according to the type of needle bevel that will be used. Group I (test group) will receive inferior alveolar nerve block (IANB) using a double scalpel blade bevel needle, while group II (control group) will receive IANB using a standard blade bevel needle. All the procedures will be videotaped. Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory, Eye, and Motor (SEM) scale. After the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children with ASA I, II Classification.
* Children with no learning disabilities.
* Positive or definitely positive behavior according to the Frankl Scale.
* Patient requiring local anesthetic injection IANB for dental treatment.
* Written consent of the legal guardian.

Exclusion Criteria:

* Medically compromised patient.
* Children with emergency treatment needs, such as abscess, cellulitis and space infection.
* Hypersensitivity to local anesthetic drugs
Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study

The aim is to conduct a single centre retrospective study of all patients with stage IV melanoma that underwent surgery for metastases at Sahlgrenska University Hospital between 2010-01-01 and 2018-12-31. Pre- and postoperative data will be collected from digital medical records, the Swedish Cancer Registry, the Swedish Cause of Death Register as well as from the national Swedish cancer patient database (INCA). If needed, patient records will be collected from other hospitals. Results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period.

The aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage IV metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy verified stage IV malignant melanoma, stage M1c.
* Having undergone surgery with metastasectomy of melanoma tumors.

Exclusion Criteria:

* retroperitoneal tumors
Muscle Insulin Resistance in Aging (Mirage)

The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.

Study Objectives:

1. To determine the effects of diet-induced weight loss with and without the addition of exercise on mitochondrial biogenesis and energetic capacity, cellular redox state and insulin resistance.
2. To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
3. To determine the effects of diet-induced weight loss with and without exercise on skeletal muscle proteins mediating a program of autophagy and either loss or maintenance of muscle mass.

Eligibility Criteria:
Inclusion Criteria:

* 65-80 years of age
* Stable weight (No Gain/Loss of \>10 lbs in 6 months)
* Sedentary (≤ 1 continuous exercise/week)
* Non-smoker
* BMI ≥ 30 kg/m2
* Resting Blood Pressure ≤ 150 millimeters of mercury systolic and ≤ 95 millimeters of mercury diastolic
* Note from Primary care physician/Cardiologist for exercise clearance if positive stress test symptoms were observed from exercise test
* Must be willing to washout for 14 days from all diabetes medication and independent in self blood glucose monitoring during the washout periods (those with diabetes only)

Exclusion Criteria:

* Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
* Peripheral Vascular Disease
* Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
* Clinically diminished pulse
* Presence of bruits in lower extremities
* Previous history of pulmonary emboli
* Peripheral Neuropathy
Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer

This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.


Eligibility Criteria:
Inclusion Criteria:

-Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France

NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC

Exclusion Criteria:

* Primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
* Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy
* Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled
* Pregnant women and participants under guardianship
Concomitant CC and E2 Versus CC Alone in Ovulation Induction

The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.

Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women with eugonadotrophic anovulation/oligoovulation.
* Unexplained infertility.

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2.
* Presence of any infertility factor other than anovulation/oligoovulation.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Metabolic or hormonal abnormalities.
Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup

This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in combination with the optimys short stem. Wear rate and migration is assessed with roentgen stereophotogrammetric analysis (RSA) measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient.
* Patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or 56mm)
* Patients between the ages of 50 and 75 inclusive
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

* Patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head
* Patients that offer no guarantee for regular follow-up controls
* Patients that have a revision surgery
* Patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis
* Patients that had a previous osteotomy of the femur or pelvis
* Pregnant women or those seeking to become pregnant
* Patients with a history of active infection
Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry

This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). The analysis was performed in two databases, IBM® MarketScan® database: Commercial Claims and Encounters (CCAE) and Medicare Supplemental Beneficiaries (MDCR) from 01 January 2010 to 30 June 2021 and BADBIR from 01 January 2016 to 01 September 2021.


Eligibility Criteria:
MarketScan® secukinumab cohort:

Inclusion criteria:

* Included patients with at least 1 secukinumab claim between 01 January 2015 and 30 June 2020 (index date is the first secukinumab claim)
* Included patients age ≥18 years as of the year of index date
* Included patients with at least 1 non-ruleout psoriasis diagnosis during 2 years of pre-index period
* Included patients with continuous medical/pharmacy coverage in the 2-year pre-index period
* Included patients with continuous medical/pharmacy coverage in the 1-year post-index period

Exclusion criteria:

* Excluded patients with any psoriatic arthritis diagnosis during 2 years to 5 years pre-index period, as well as on the index date
* Excluded patients with any biologics/apremilast including secukinumab claim during the 2-year pre-index (excluding index date)
* Excluded patients received other non-secukinumab biologics/apremilast during 6 months post index date period (including index date) (This criterion is only applicable for the secukinumab cohort)

BADBIR cohort:

Inclusion criteria:

* Included non-switched patients with secukinumab treatment on or after the enrollment between 01 January 2017 to 01 September 2020

  * Non-switched patients are those who did not use other biologics/apremilast treatments on the enrollment date
  * Index date will be the date of the first secukinumab treatment date
* Included patients with age ≥ 18 on the index date
* Included patients with psoriasis diagnosis in the pre-index period and index date
* Included patients with ≥ 1 year follow-up period

  * Follow-up period is the gap between patient's last visit date and index date

Exclusion criteria:

* Excluded patients with psoriatic arthritis (PsA) prior to and on index date
* Excluded patients with any biologics/apremilast including secukinumab in the baseline period
Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis

Since the beginning of COVID-19 pandemic, a safe and effective vaccine against infection and development of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is needed control of the wide spread of COVID-19 and reduce death rates throughout the world. Many clinical trials investigated the immunogenicity of different proposed vaccine including the first distributed vaccine; the ChAdOx1 nCoV-19 vaccine and there is a need to analyze the results of published clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Participant who received 2 doses of ChAdOx1 nCoV-19 vaccine

Exclusion Criteria:

* non vaccinated person
Music Therapy for Pain Modification in Pediatric Palliative Care

The purpose of this within-subjects randomized controlled trial is to determine whether two music therapy interventions are efficacious in reducing pain symptoms, in order to improve the quality of care for children in pediatric hospice. The investigators hypothesize that both music therapy interventions, live guitar and vocal intervention and vibroacoustic intervention, will reduce behavioural pain scores and that behavioural pain scores will correlate with physiological outcome measures.

Effective pain management in pediatric palliative care is a quality of life issue for patients, families and professionals. Current research supports the use of music therapy to assist with pain management in pediatric medical settings. However, little research has been done to explore the use of music therapy for reducing pain in children with life-limiting neurological impairments or metabolic conditions.

As the first known project to examine the effects of music therapy on pain symptoms with children who have life-limiting neurological impairments or metabolic disorders, this study will expand the evidence-base for practice with this population. It is imperative that an evidence base for music therapy in this area be established, so that the most effective interventions can be provided to these vulnerable children.

Eligibility Criteria:
Inclusion Criteria:

* Children, ages 1-19, who have been diagnosed with life-limiting neurological impairments and metabolic conditions
* Cognitive functioning level of one year or less will be enrolled in the study
* Receiving respite or symptom management care at the time of admission to the Canuck Place Children's Hospice
* Guardians must be able to provide written consent in English; interpreters will be available if a guardian needs clarification on specific points.

Exclusion Criteria:

* Children who are actively dying (i.e. admitted for end-of-life care or determined by physicians to require immediate end-of-life care)
* Any history of adverse responses to live or recorded music or to vibroacoustic stimulation
* Severe to profound hearing impairment will be excluded.
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients

Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer
* Hormone receptor-positive status
* More than 6 histologically examined lymph nodes
* Laboratory parameters

  1. hematopoiesis: \> 3500/µl leukocytes, \> 100,000/µl thrombocytes
  2. renal function: creatinin \< 1.5mg %
  3. hepatic function: GOT \</= 2.5 x UNL
  4. bilirubin: \< 1.5mg %
  5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
  6. blood coagulation: PZ \> 60%
* Concluded healing process following surgery
* \</= 4 weeks interval since surgery
* Informed consent

Exclusion Criteria:

* T4 carcinoma; inflammatory breast cancer, carcinoma in situ
* Simultaneous or sequential bilateral breast cancer
* Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment
* Male patients
* Pregnancy or lactation
* Lacking compliance or understanding of the disease
* General contraindication against cytostatic treatment
* Serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up
* Second carcinoma or status post second carcinoma (except for curatively treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
Changes in Different Fat Compartments and Their Effect on Particular Manifestations of Metabolic Syndrome After Bariatric Procedures.

The metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern It has been shown that weight loss after bariatric surgery is followed by metabolic improvements.

The amount of fat lost from each site may be independently regulated. Very scant information is found in the literature regarding the relative changes in different fat body compartments, and their effect on the improvement of the metabolic profile.

In this study we define the absolute and relative changes in the different adipose tissue compartment after weight loss surgery

The metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern.

The amount of fat lost from each site may be independently regulated. Very scant information is found in the literature regarding the relative changes in different fat body compartments.

Rapid and preferential reduction of visceral fat mass could occur in morbid obese with visceral obesity. It has been previously shown, and it was also partially confirmed in this study, that a reduction in visceral fat was associated with metabolic improvements that included improved glucose tolerance and reduced plasma insulin and lipid levels.

This again suggests a threshold of proportional visceral fat loss, above which there is an improvement in insulin sensitivity and other component of metabolic syndrom.

We will quantify the different fat compartments changes after bariatric surgery by means of CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity,
* Metabolic syndrome

Exclusion Criteria:

* Previous abdominoplasty surgery,
* Previous major abdominal surgey