cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Pulse Oximeter With Profound Hypoxia

Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female, between the ages of 18 and 55 years.
* The subject is in good general health with no evidence of any medical problems
* The subject is fluent in both written and spoken English
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* Known history of heart disease, lung disease, kidney or liver disease
* Diagnosis of asthma, sleep apnea, or use of CPAP
* Subject has diabetes
* Subject has a clotting disorder
* The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation
* The subject has any other serious systemic illness
* Th subject is a current smoker
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly
* The subject has a history of fainting or vasovagal response
* The subject has a history of sensitivity to local anesthesia
* The subject has a diagnosis of Raynaud's disease
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test)
* The subject is pregnant, lactating, or trying to get pregnant
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures
* The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study
Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children

The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

Eligibility Criteria:
Inclusion Criteria:

* Child from 3 to 10 years old
* with a vertebral malformation requiring surgery for hemivertebras

Exclusion Criteria:

* Child previously operated on the spine
* Different procedure of a surgical resection of vertebral malformation
* Absence of medical follow-up
* Parents refusal concerning data storage
Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET)

In pregnancies achieved through programmed frozen embryo transfer cycle (PC-FET) and modified natural frozen embryo transfer (mNC-FET), to determine whether there are differences in endothelial and placental function, maternal cardiovascular function, fetal growth and fetal cardiovascular and cerebral programming and to assess whether there is an association between these differences and the plasma concentrations of the main secretion products of the Corpus Luteum (CL) with vasoactive and angiogenic action.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18- 37 years old (both included) at the time of oocyte retrieval and less than 41 years of age at the time of embryo transfer.
* Regular menstrual cycles between 24 and 35 days.
* Availability of cryopreserved blastocysts from own gametes
* Indication for single embryo transfer.
* Patients who will be included in the LUTI study are candidates for either of the two procedures under study, and will have no contraindications for either procedure.

Exclusion Criteria:

* Recurrent pregnancy loss (3 or more).
* Recurrent implantation failure in previous IVF treatments (3 or more unsuccessful embryo transfers). .
* Diagnosis of polycystic ovarian syndrome, diabetes mellitus, chronic arterial hypertension, maternal heart disease and autoimmune diseases (Systemic Lupus Erythematosus (SLE) or Antiphospholipid syndrome (APS)).
* Active treatment with aspirin, heparin or other anticoagulant therapy, antihypertensives or other drugs used to treat circulation or coagulation disorders .
* Indication for PGT (Preimplantation Genetic Testing).
* Multiple pregnancy.
Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube

Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an ICU
* 18 years old or more
* expected to be intubated for more than 48 hours
* less than 24 hours from intubation
* fraction of inspired oxygen set at the ventilator \<80%

Exclusion Criteria:

* Current or past participation in another intervention trial conflicting with the present study
* expected survival less than 24 hours
* Acute severe asthma
* Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO
* Double lumen endotracheal tube in place
* Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation)
* other contraindications posed by staff physicians
taVNS on the Inpatient Psychiatric Unit

This is a research study to find out if mental health symptoms in patients admitted to the Institute of Psychiatry are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will receive ear stimulation during their inpatient treatment at the Institute of Psychiatry. Participants will be randomly assigned to either receive ear stimulation for 1 day (up to 9 treatments over the course of a single day) or 3 days (up to 3 treatments per day), and will have a 50:50 chance of being in either group (like the flip of a coin). Each treatment will last up to 30 minutes and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. In addition, there are several questionnaires that will be completed daily while participants are receiving ear stimulation. Participants in the 1 day stimulation group will also receive 2 days of follow up questionnaires after the initial day of stimulation. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep. The ear stimulation treatments will not interfere with the care subjects are receiving from the medical team. In order to qualify for this study, participants must be actively receiving inpatient care at the MUSC Institute of Psychiatry.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and up
* English speaking
* Admitted to 3 North's inpatient unit in MUSC's Institute of Psychiatry (IOP)
* Have the capacity and ability to provide one's own consent and sign the informed consent document
* Primary depression diagnosis

Exclusion Criteria:

* Facial or ear pain or recent ear trauma.
* Metal implant devices in the head, heart or neck.
* History of brain surgery.
* History of myocardial infarction or arrhythmia, bradycardia.
* Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms.
* Active GI symptoms with a history of diabetes mellitus or history of gastroparesis secondary to diabetes mellitus.
* Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
* Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
* Individuals suffering from frequent/severe headaches.
* Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
* Individuals who are catatonic or otherwise unable to participate in the informed consent process.
* Moderate to severe alcohol or substance use disorder.
* Pregnancy
Effect of the Consumption of a Combination of Plant Extracts (BSL_EP026) on Serum Uric Acid.

The objective of this study is to evaluate the effect of the combination of a combination of plant extracts (BSL_EP026) on blood and urine uricemia levels in individuals with levels at the limit of the values considered normal or moderately high.

Hyperuricemia is an abnormally high level of uric acid in the blood, resulted because of an increased production of uric acid, decreased excretion of uric acid, or both. This can cause gout and nephrolithiasis, and it has also been related to metabolic syndrome, diabetes mellitus, cardiovascular disease and chronic kidney disease.

Some plant extracts have diuretic activity that could contribute to improve uric acid excretion. This effect would lead to a decrease in uric acid plasma levels and, secondarily, to an action on its metabolic pathway of endogenous biogeneration.

On the other hand, uric acid has a double reabsorption-elimination step in the renal tubules and the flavonoids of both extracts impede the processes of renal resorption promoting urinary elimination, in addition to increase the pH of the urine (higher than pH 5.8), which favors the non-precipitation or formation of urate stones.

Finally, the routine (present in the used extracts) inhibit the uric acid formation pathway from purines, which would act synergistically.

In this project, the effect of the intake of a combination plant extracts on uricemia levels will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Blood uric acid levels greater than 7 mg/dL in men and 6 mg dL in women.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Having treatment that can affect uric acid levels.
* Use of diuretics.
* Follow a low purine diet.
* Take a food supplement or drug that interferes with uric acid metabolism and renal system function.
* Have an allergy to birch and/or orthosiphon or another component of the test products.
* Low compliance expectation.
Impact of Muscle Fat Accumulation on the Genomic Profile of Skeletal Muscle in Older Adults

Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different testing days for 2.5 hours each day. On one day the subjects participated in blood pressure and body weight measurements as well as a muscle biopsy from the thigh. On the second day the subjects underwent an MRI and MRS scan of the thigh and calf.


Eligibility Criteria:
Inclusion Criteria:

* 60-80 years old, men and women, normal body weight or obese,

Exclusion Criteria:

* Certain medical conditions could have placed them at risk
Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

Nowadays pancreatic cancer is one of the deadliest oncological pathologies today. Even after curative surgery, considered the only effective curative tool, 5-years survival does not exceed 5%. Before surgery, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. However, the evaluation being devoted to the pancreas, this study wishes to extend echoendoscopie to lymph node staging away from the surgical field. The proposed study is based on the hypothesis that the implementation of a simple classification of lymph nodes, based on non-invasive ultrasound criteria, would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

At the same time, the video data obtained will be collected in a computer database in order to create an artificial intelligence lesion detection and qualification tool.

This study plans to recruit 45 adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection (first line and after neoadjuvant treatment) is planned. The main objective is to estimate the sensitivity and specificity of a simple classification "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).

Eligibility Criteria:
Inclusion Criteria:

1. Patient over 18 years old
2. Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
3. Patient with a complete clinical examination performed
4. Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
5. Patient able to receive and understand information relating to the study and give informed written consent
6. Patient affiliated to the French social security system

Exclusion Criteria:

1. Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT \<60%, TCA\> 40 s and platelets \<60,000 / mm3)
2. Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
3. Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary\> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
4. Pregnant or breastfeeding patient
5. Patient in exclusion period (determined by a previous study or in progress)
6. Patient under legal protection
7. Patient under guardianship or trusteeship
PCOS Indirect and Intangible Economic Burden

The primary purpose of the PCOS Indirect and Intangible Economic Buren study is to estimate the economic costs of having PCOS in terms of quality of life and work productivity. The population will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS. This study is a sub-study of The PCOS Challenge Study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PCOS by a health professional, self-diagnosed with PCOS or individuals with PCOS symptoms
* Willing to sign the consent form
* Able to understand the registry surveys or what is being asked

Exclusion Criteria:

* Unable to understand the surveys or what is being asked
* Unwilling to sign the consent form
PSYCHOSOCIAL STIMULATIONS and TREATMENT OUTCOME of SEVERE ACUTE MALNOURISHED CHILDREN

A playroom and a playground are already part of the stabilization unit and are furnished with basic facilities for engaging the SAM children in play-based motor, language, and personal-social activities. The severely acute malnourished children in the intervention group will be sent to a development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational therapist, and a physiotherapist will also be available for sessions.

The World Health Organisation (WHO) also suggests including psychological stimulation in the treatment of severe acute malnutrition. However, there is limited evidence that these interventions are beneficial for SAM children, especially when there are severe food shortages and a lack of a balanced diet.

There is limited available research in Pakistan examining the impact of psychosocial stimulation on severely malnourished children and a significant gap in its implementation. It is obvious that current implementation research is needed to understand how to improve brain development in children with SAM who require inpatient care in a practical and pragmatic approach.

The purpose of this study is to present data on the efficacy of these therapies, which may help shape future SAM treatment plans and policies. Mitigating the physical and mental dimensions of malnourishment can result in more enduring and significant consequences, ultimately enhancing the standard of living for millions of children around the globe.

Eligibility Criteria:
Inclusion Criteria:

* All children aged 6m to 59 months admitted to stabilization centre fulfilling criteria of severe acute malnutrition will be included in study.

Exclusion Criteria:

* Children with chronic diseases like cystic fibrosis, cerebral palsy, celiac disease, chronic kidney disease, chronic liver failure, congenital heart disease, inborn error of metabolism, cleft lip and palate will be excluded from study.
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis

OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.

II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation.

III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism.

Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months.

Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week.

Patients in the third group are treated with growth hormone and calcitriol (same dosages as above).

A control group does not receive any hormonal therapy.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles

--Prior/Concurrent Therapy--

* No concurrent prednisone
* No concurrent cytotoxic agents
* At least 12 months since parathyroidectomy

--Patient Characteristics--

* Other: No documented history of poor compliance with medical treatment regimens
Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.

Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.

Eligibility Criteria:
Inclusion Criteria:

* Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
* Tumor from gallbladder is \<0.5 cm
* not suitable for surgical resection or transplantation,
* have at least one, but less than or equal to 3 tumors,
* of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
* Child-Pugh class A,B
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* American Society of Anaesthesiologists (ASA) score ≤ 3,
* a prothrombin time ratio \> 50%,
* platelet count \> 80x109/L,
* ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* are able to comprehend and willing to sign the written informed consent form (ICF),
* have a life expectancy of at least 3 months.

Exclusion Criteria:

* eligible for surgical treatment or transplantation for HCC,
* Hepatic carcinoma developed on an already transplanted liver,
* cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* any active implanted device (eg Pacemaker),
* women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.

Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.

Eligibility Criteria:
Inclusion Criteria:

* subjects must be at least 18 years of age
* subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
* subjects must understand and sign an informed consent form

Exclusion Criteria:

* none
the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis

the investigators will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis

Iron deficiency is frequently present with chronic inflammatory disease.(1) Iron deficiency anemia results from decreased body's iron content due to blood loss, poor dietary iron intake, malabsorption, or increased iron requirement. Immune activation drives a diversion of iron to storage sites, particularly the mononuclear phagocytes system in liver and spleen leads to poor hemoglobinization and anemia. Iron deficiency and immune activation lead to disturbances of iron homeostasis.(2) this trial will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis

Eligibility Criteria:
Inclusion Criteria:

* children 3-17 years old with chronic tonsillitis

Exclusion Criteria:

* no other causes of Iron Deficiency Anemia