cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy of Kalinox® 170 Bar in Adult Oncology

In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 year
* OMS between 0 to 3
* Patient who has to undergo an invasive gesture or a painful care
* Absence of contra-indication to the administration of the product

Exclusion Criteria:

* Patient already included in another incompatible study with this protocol
* Patient incapable of self-assessment by the EVA
* Confusional syndrome
* OMS \> 3
* Patient already included in this protocol
* Exclusion criteria linked to the product
Effects of Vitamin A and Carotenoids on Iron Absorption

The objective of this study is to investigate the effect of vitamin A and carotenoids on iron absorption in healthy subjects with low and normal vitamin A status. Vitamin A and carotenoids have been reported to enhance the nonheme iron absorption, but the results from human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have consistently reported an increase in iron absorption, whereas stable and radio isotopes studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A status of the subjects may be a possible explanation for the contradictory findings. In this study, iron absorption will be measured from an iron-fortified maize bread meal with or without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope techniques in Venezuelan women with a range of vitamin A status.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-52 years old
* Body weight ≤ 70 kg
* Body mass index (BMI), 18.5-30 kg/m2
* Adequate vitamin A status (SR ≥ 0.7 μmol/L, n=20)
* Inadequate vitamin A status (SR \< 0.7 μmol/L, n=20)
* No major medical illnesses (no known infection, gastrointestinal or metabolic disorders)

Exclusion Criteria:

* Pregnancy or lactation
* Regular intake of medication (except oral contraceptives)
* Blood donation or significant blood loss (accident, surgery) over the past 4 months
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* Former participation in a study involving administration of iron stable isotopes
Observational Study of Patients With Mucopolysaccharidosis (MPS) VI Who Previously Participated in ASB-00-02

There is limited information on the long-term effects of treating patients with MPS VI with Naglazyme® and limited data on the natural history of treated and untreated MPS VI patients. The Re-survey Study ASB-00-03 will assist in understanding the effects of long-term Naglazyme treatment and the natural history of the MPS VI patient population.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written, signed informed consent, or in the case of patients under the age of 16 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Previously participated in Survey Study ASB-00-02, and met the criteria of a MPS VI diagnosis.
* Willing to perform all study assessments and procedures as physically possible.

Exclusion Criteria:

* Concurrent disease or condition that would interfere with study participation or safety.
* Any condition that, in the view of the Investigator would place the patient at high risk of not completing the study.
* Concurrent enrollment and randomization into a clinical study of MPS VI treatment. Patients enrolled in the BioMarin MPS VI Clinical Surveillance Program may be enrolled in the Re-survey Study ASB-00-03.
Comparison of the Analgesic Efficacy of Chest Wall Blocks in Coronary Artery Bypass Surgery

In this study, the analgesic effects of the Transverse Thoracic Muscle Plane Block and deep Serratus Anterior Plane versus deep and superficial Serratus Anterior Plane applications, which will be performed under ultrasound guidance in patients undergoing coronary artery bypass surgery with sternotomy, will be compared and evaluated.

Postoperative pain is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If effective respiratory function cannot be maintained in patients with high pain levels, atelectasis, cardiac ischemia, and arrhythmias may be observed. This prolongs the hospital discharge time of patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Moreover, if postoperative acute pain is not adequately treated, chronic pain may develop after surgery, preventing patients from regaining their normal activities for a long time. In addition to medications, various neuroaxial and peripheral nerve blocks can be used in cardiac surgery. The use of intraoperative heparin limits the application of neuroaxial anesthesia (thoracic epidural and intrathecal opioids) and paravertebral block due to potential complications. Nevertheless, studies have shown their benefits in reducing cardiac and pulmonary complications. Recently, fascial plane nerve blocks, which are alternatives to these methods, have gained more popularity in cardiovascular surgery. These blocks include pectoral nerve blocks, serratus anterior plane block (SAPB), erector spinae plane block (ESPB), transverse thoracic plane blocks (TTMP), pecto-intercostal fascial blocks (PIF), and intercostal nerve blocks. The inability to effectively prevent postoperative pain in cardiac surgery has led not only to the exploration of new block applications but also to the combination of these blocks.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80
* Patients with ASA score I-II-III
* Patients with a body mass index (BMI) between 18-35
* Patients undergoing sternotomy in the operating room

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* Patients with an ASA score of IV or higher
* Patients with advanced comorbidities
* Patients with a history of bleeding diathesis
* Patients using medications that cause bleeding disorders
* Patients with infections in the area where the block will be performed
* Patients with a body mass index (BMI) below 18 or above 35
R-CHOP + GM-CSF for Previously Untreated LCL in Elderly

Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease
* Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP.

Exclusion Criteria:

* Pregnant
* Hepatitis B Surface Antigen positive
* Have known CNS disease or HIV infection
* Have NY Classification III or IV disease.
Urinary Proteomics in Predicting Heart Transplantation Outcomes

uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft performance is recipients of heart transplants

The proof of concept underlying uPROPHET rests on the EPLORE findings that capillary electrophoresis coupled with high-resolution mass-spectroscopy reproducibly identified unique urinary proteomic (UP) signatures associated with subclinical left ventricular dysfunction, renal impairment and adverse cardiovascular outcomes. Consensus criteria currently applied for the selection of patients for heart transplantation (HTx) leave an inconvenient margin of uncertainty, because of the unpredictable course of the disease and the shortage of donor hearts. Furthermore, monitoring graft function and adjusting immunosuppression remain major challenges after HTx. Endomyocardial biopsies, up to 20 in the first year after HTx, are the standard approach to detect graft rejection, but require an invasive risk-carrying procedure. uPROPHET aims to develop UP profiling: (1) as a prognostic tool helpful in selecting terminally ill heart failure patients for HTx with the greatest probability of survival while adding a maximum of high-quality years to life; and (2) as an instrument to monitor graft performance and immune system activity and to manage immunosuppression. The new UP classifiers will be initially validated by demonstrating analogy between the proteomic profiles in urine and tissue samples of explanted hearts.

Eligibility Criteria:
Inclusion Criteria:

* End-stage heart failure resistant to treatment

Exclusion Criteria:

* According to guidelines (J Heart Lung Transplant 2010;29:717-27 and J Heart Lung Transplant 2016; 35: http://dx.doi.org/10.1016/j.healun.2015.10.023).
Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Children with esophageal atresia who undergo surgical repair are at risk for anastomotic stricture following surgery. Esophageal stricture can be treated with serial endoscopic dilation but may ultimately need surgical resection if the stricture proves refractory to therapy. Several risk factors have been reported for development of recalcitrant stricture, but to date, no studies have specifically examined the relationship between anastomotic thickness and echotexture at time of initial postoperative endoscopy and treatment outcomes. Other risk factors that have been implicated in the development of recalcitrant stricture include gastroesophageal reflux disease, anastomotic leak, long-gap esophageal atresia, and gestational age. Moreover, it is poorly understood how esophageal layers alter and progress with repeated therapeutic dilation. The investigator hypothesize that the initial thickness and echotexture will help determine therapeutic outcome. It will also help us understand the progression of esophageal echotexture following therapeutic dilation.


Eligibility Criteria:
Inclusion Criteria:

- Patients ages 0-21 years old at time of evaluation with a suspected diagnosis of esophageal stricture secondary to esophageal atresia (with or without Tracheoesophageal fistula) post surgical repair

Exclusion Criteria:

* Patients with pre-diagnosis of eosinophilic esophagitis
* Patients with pre-diagnosis of congenital esophageal stricture
* Patients diagnosed with esophageal stricture secondary to caustic ingestion
* Patient is diagnosed with an esophageal perforation at time of endoscopy
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant and an estimated gestational age from week 13 to 18 at visit 1
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\*10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
* Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
* For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:

* Currently pregnant with multiple gestations (twins or more)
* History of severe preeclampsia in a previous pregnancy
* History of myocardial infarction, unstable ischemic heart disease, or stroke
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone
* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Non-small Cell Lung Cancer and Quality of Life

The principal objective is to study clinical observations, symptoms and quality of life of non-small-cell lung cancer (NSCLC) patients undergoing specific non-operative treatment for cancer, including chemotherapy and radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with verified NSCLC
* after the NSCLC diagnosis has been confirmed prior to first chemotherapy or radiotherapy
* Finnish speaking patients
* aged 18 years or more
* Written informed consent has to be signed

Exclusion Criteria:

* Patients not consenting to participate in the study
* patients not able to communicate sufficiently
* cancer type is other than non-small-cell lung cancer
A Study of CDX-0159 in Patients With Prurigo Nodularis

The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. Patients will receive one dose of CDX-0159 (barzolvolimab) or placebo.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females, 18 - 75 years old.
2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:

   1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
   2. An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).
3. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
5. Willing to apply a topical moisturizer (emollient) twice daily throughout the study.
6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
7. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.

Key Exclusion Criteria:

1. PN due to neuropathy, psychiatric disorders or medications.
2. Unilateral lesions of prurigo (eg, only one arm affected)
3. Active unstable pruritic skin conditions in addition to PN.
4. Women who are pregnant or nursing.
5. Known hepatitis B or hepatitis C infection or active COVID-19 infection
6. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
7. History of anaphylaxis.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.

Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.


Eligibility Criteria:
Inclusion Criteria:

* Women aged greater than 18 years.
* Postmenopausal subjects
* Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)

Exclusion Criteria:

* Extensive visceral disease
* Subjects with bone as the only site of disease
* Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion
LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.

Following angiography, patients with significant diameter stenosis \> 50% and lesion length (\> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 20 years
* Significant native coronary artery stenosis (\> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
* Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, zotarolimus, or everolimus
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
* Acute ST-segment-elevation MI or cardiogenic shock
* Terminal illness with life expectancy \< 1 year
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
* In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment) However, non-target vessel In-stent restenosis is permitted
* Patients with EF \< 30%
* Serum creatinine level \>=2.0mg/dL or dependence on dialysis
* Patients with left main stem stenosis (\> 50% visual estimate)
Effects of Exenatide on Hypothalamic Obesity

The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.

Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the glucagon-like peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite.

Eligibility Criteria:
Inclusion Criteria:

* \>/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
* 10-21 years old
* Age-and sex-adjusted BMI \>/=95%
* Parent sign consent and patient sign assent

Exclusion Criteria:

* \< 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
* Pregnant or breastfeeding, or those women who plan to get pregnant
* Renal impairment
* Gastroparesis
* Pancreatitis
* Diabetes
* \<1 month post initiation of Metformin treatment
* Prescription or over-the-counter weight loss medications within 3 months of screening
* Are actively participating in, or have participated in a formal weight loss program within the last 3 months
* Have had bariatric surgery
The 3q29 Deletion and 3q29 Duplication: Architecture of Behavioral Phenotypes

The 3q29 deletion syndrome is caused by a deletion of a small part of human chromosome 3, and the duplication syndrome is caused by a duplication of this same small region. The purpose of this study is to understand the medical and behavioral consequences of these syndromes.

People with 3q29 deletion syndrome are missing a small part of a region on human chromosome 3, and people with 3q29 duplication syndrome have an extra part of their chromosome 3. Sometimes babies are born with a deletion or duplication of part of human chromosome 3, even though their parents have an intact chromosome 3. This is called de novo (or new) abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of 3q29 deletion or 3q29 duplication
* Consent from parents or guardians or an adult with 3q29 deletion or 3q29 duplication that does not require a legal guardian or an adult who is the healthy sibling of an individual with 3q29 deletion or 3q29 duplication or a healthy age-matched control

Exclusion Criteria:

* Clinically significant medical disease that would prohibit participation in the study procedures