cyrilzakka/clinical-trials huggingface dataset:
Gluten Free Diet in Diminishing Side Effects Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy

This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.

PRIMARY OBJECTIVES:

I. To determine if a gluten free diet (GFD) modulates the rate and severity of bacteremia and gastrointestinal toxicity (measured by total parenteral nutrition \[TPN\] or nothing by mouth \[NPO\] order) in patients undergoing standard acute myeloid leukemia (AML) induction chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the tolerance of, and compliance with, a GFD in patients undergoing standard AML induction chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.

GROUP II: Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen
* No history of celiac disease or non-celiac gluten sensitivity
* No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening
* No documented bacteremia at time of initial screening
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of initial screening

Exclusion Criteria:

* Pregnant women
Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations

The aim of this study is to determine whether the continuous intraarticular infusion of local anesthetics in the postoperative period can improve analgesia and patients satisfaction after knee and shoulder arthroscopy.

We propose to evaluate the long-term efficacy of the continuous intraarticular delivery of local anesthetics via a disposable, self-regulated DonJoy Pain Control infusion pump. Patients will be randomly assigned to receive either an intra-articular infusion of bupivacaine 0.125%, or saline delivered at a rate of 5 ml/hr for 48 hours by a DonJoy® Pain Control infusion pump. Patients will receive a femoral block (FNB) and a sciatic block (SNB) for knee arthroscopy or an interscalene block (INB) for shoulder arthroscopy prior to surgery. After the operation, patients will receive morphine via a Patient Controlled Analgesia (PCA) pump for pain control. The patient will be admitted overnight to a Care Unit, with the PCA discontinued at discharge or 24 hours, whichever is earlier. If clinically indicated, the PCA may be extended at the discretion of the pain team. Upon discharge and during the 48 hour study period the patient will receive oral oxycodone and acetaminophen. The patient and their family will remove the DonJoy® Pain Control infusion pump 48 hours after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 11 and 19 years old.
* Knee and shoulder arthroscopy procedures

Exclusion Criteria:

* Contraindications to Femoral-Interscalene Nerve Block
* Conditions that affect the proper evaluation of pain and side effects.
* Intake of NSAIDs or opioids in the 12 hours prior to the operation
* Allergy to study medications
New Strategies of Genetic Study of Patients With Oculocutaneous Albinism

The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.

The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.

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Eligibility Criteria:
Inclusion Criteria:

-Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes)

Exclusion Criteria:

None
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies

  * Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma
  * Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
* Tumor available for biopsy

Exclusion Criteria:

* History of allergy or severe hypersensitivity to biologic agents
* History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
* Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis
* Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
* Active graft-versus-host disease
Antiviral Activity of AZD7295 in HCV Carriers

PK, safety study of AZD7295 in HCV carriers


Eligibility Criteria:
Inclusion Criteria:

* HCV carrier

Exclusion Criteria:

* concurrent medications
The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients

The investigators are not aware of any study regarding the effect of DASH eating pattern on different cardiovascular risks among type 2 diabetic patients. The investigators assumed that DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Having type 2 diabetes

Exclusion Criteria:

* Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy
Retrospective Multicentre Study on the Impact of Neonatal Screening for Congenital Adrenal Hyperplasia in Italy

Oservational, retrospective, multicenter study focused on neonatal screening for Congenital Adreanl Hyperplasia.

The study refers to neonates who underwent neonatal screening for Congenital Adreanl Hyperplasia between January 2006 and December 2019 at participating centres, but only patients diagnosed with Congenital Adreanl Hyperplasia are enrolled in the study.

The primary aims are: to assess the incidence of classic Congenital Adrenal Hyperplasia in neonates who underwent neonatal screening in the reporting period; to calculate the sensibility of Neonatal Screening for classic Congenital Adrenal Hyperplasia; to calculate the positive predictive rate. The secondary aims are: to describe the biochemical, hormonal, and clinical features of neonates at diagnosis of Congenital Adrenal Hyperplasia; to assess the time required for diagnosis; to calculate the false positive rate; to calculate the diagnostic impact of neonatal screening for Congenital Adrenal Hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* Neonatal who underwent neonatal screening for congenital adrenal hyperplasia between January 2006 and December 2019 at participating centres;
* Patients diagnosed with Congenital Adrenal Hyperplasia;
* Obtaining informed consent.

Exclusion Criteria:

• None.
Nursing Students' Learning About Intimate Partner Violence Against Women With the Screen-based Simulation Method

The aim of this research is to develop training material on intimate partner violence against women for nursing students by using the screen-based simulation method.

Intimate partner violence (ipv) against women is characterized as a global epidemic in health care delivery due to its prevalence, high morbidity, and mortality. One of the first healthcare providers that victims interact with is nurses. Nurses should have sufficient knowledge and skills to fulfill their roles and responsibilities defined in the issue of ipv against women. Educational environments must provide nursing students with the opportunity to be aware of ipv against women and to manage cases. Institutions that add simulation content to their education programs have the potential to become the gold standard when preparing nursing students for case management of ipv against women. Screen-based simulations (SBSs) use available digital technology to represent patients, populations, or other healthcare encounters on a computer screen or a mobile tablet, smartphone, or other screen-based devices. Simulations using screens have advantages over mannequin-based simulations-the software is infinitely replicable, the simulation programs can be portable, they can be accessed asynchronously without a live instructor present, and the software can be distributed to many devices, and the programming can track massive amounts of usage data. The aim of this research is to develop training material on intimate partner violence against women for nursing students by using the screen-based simulation method. The sample group of the research in a quasi-experimental design in a single-group pre-test-post-test order will consist of fourth-year students from a university's faculty of nursing. Power analysis was made for the sample size, and it was planned to include 50 students in the sample group. In the research, training will be given to the sample group on ipv against women through screen-based simulation. The research outputs will be measured by Health Workers' Attitudes and Practices on Intimate Partner Violence Against Women Scale, Simulation Design Scale and Debriefing Experience Scale.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being a 4th-year student in the nursing department

Exclusion Criteria:

* Having worked as a nurse before
* To have taken an elective course on violence against women in undergraduate education
* To be married
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients

This study will examine whether fasting and non-fasting lipid measures can provide similar clinical information in order to guide lipid management by primary physicians. It will compare fasting vs. non-fasting lipid measurements in patients with and without diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Park Nicollet Health Services patients due for routine lipid measures

Exclusion Criteria:

* Unwilling or unable to provide consent
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.

In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.

About 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. After the treatment, the miscarriage rates in the groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with threated miscarriage in the first trimester.

Exclusion Criteria:

* - pregnant women with abortus incipiens.
Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF

It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

The investigators hope to enroll 25 patients with cystic fibrosis (with daily sputum production) in this study. It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CF established by standard criteria (sweat chloride \> 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
2. Age older than 8 years.
3. Known to consistently produce sputum.
4. Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
5. FEV1 \> 30%-predicted, and with stable lung function

Exclusion Criteria:

1. Hospitalization for CF pulmonary complications in the 1 months preceding enrollment.
2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chronic chest pain.
4. Participation in another interventional clinical trial in the previous 30 days.
Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

Spleen could have been surgically removed for trauma, cancer, auto-immune disease, or to perform a diagnosis. Spleen could be non-functional due to radiotherapy or splenic artery embolism. These patients are at risks of infectious diseases due to encapsulated bacteria, cancer, and thromboembolism disease. The purpose of this study is to assess complications occurring in French patients without spleen and to implement new diagnostic tools for follow-up.

Asplenia can be congenital or acquired. Acquired asplenia can be due to diagnostic or therapeutic surgery, splenic artery embolization, or radiotherapy. Incidence of splenectomized patients was estimated between 10 and 15/100 000 persons in 2003. More recent data suggested a decrease in splenectomy due to increase of splenic artery embolization. From 212 to 2016, about 4000 splenectomy had still been performed.

Three different risks are known for asplenic patients: infectious, neoplastic, and thromboembolic. Prevalence rate of infectious complications in splenectomized patients was 3.2% with a mortality rate of 1.4%. A US cohort study including 8149 splenectomized veterans have shown that the risk of cancer was increased, so did the risk of thromboembolic disease, on a 27-year period of follow-up. Pathophysiology of these risks are not well known.

There are very few tools to assess splenic function: Howell-Jolly bodies in red blood cells, scintigraphy. These tools lack sensitivity and are not correlated with complications in asplenic patients.

To better understand how splenic function and how immunity evolves during time in asplenic patients, a longitudinal follow-up could be useful. There may be some differences between splenectomized patients, those who benefited from splenic artery embolization, and those who received radiotherapy. Infectious risk may be different between these three groups. Implementing new tools assessing residual splenic function could improve management of these patients. A prospective follow-up aims at accurately estimate the incidence rate of infectious and non-infectious complications in this population.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 year-old
* With asplenia due to splenectomy, splenic artery embolization or radiotherapy

Exclusion Criteria:

* Genetic asplenia including sick cell disease
Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review

Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in patients with Alagille Syndrome. The study will also assess the effect of these stenoses on the right ventricle. The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.

The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. We also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well. For the third aim, we hope to learn about the different blood vessel abnormalities in the brain, and which abnormalities are most likely to lead to stroke.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alagille Syndrome

Exclusion Criteria:

* None
Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm

Searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. Impact on the incidence of complications and recovery are evaluated at 1 month.

Blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma ACTH at 8 am and thyroid hormones (T3, free T4 , and TSH). Dynamic test ACTH stimulation (test Synacthene) with renewal of serum cortisol to H + 1 (60min). Evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. GOS to 1 month.

Searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. Impact on the incidence of complications and recovery are evaluated at 1 month.

Blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma ACTH at 8 am and thyroid hormones (T3, free T4 , and TSH). Dynamic test ACTH stimulation (test Synacthene) with renewal of serum cortisol to H + 1 (60min). Evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. GOS to 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (Glasgow coma scale \>=9)

Exclusion Criteria:

* Pituitary failure
* Patient with corticosteroids drugs or antithyroid drugs
Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects

We wanted to test the shortterm effects of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Both men and women
* Age: Between 20-50
* BMI\<30

Exclusion Criteria:

* Cl. signs or history of disease of heart, lungs, kidneys or endocrine organs.
* Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose)
* Albuminuria or glucosuria
* Cancer
* Art. hypertension
* Alcohol abuse
* Med. treatment, except oral contraceptives
* Pregnancy or breast feeding
* Blood donation less than 1 month before study
Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement

This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors.

This single-centered randomized clinical trial evaluated the effects of micro-osteoperforations in the retraction of maxillary incisors in patients who required the extraction of the first premolars to correct malocclusion. The canine retraction was performed in a previous step. The possible effects of micro-osteoperforantions in the following parameters were evaluated in the upper arch: anteroposterior incisors and first molars displacement, space closure, inclination and length of central incisors.

Eligibility Criteria:
Inclusion Criteria:

* both male and female subjects
* 16 or more years old
* orthodontic need of upper incisors extractions
* presence of all upper permanent teeth with exception of the third molars.

Exclusion Criteria:

* diseases and medications that were likely to affect bone biology
* pregnancy
* poor oral hygiene
* previous orthodontic treatment
* evidence of bone loss
* active periodontal disease
* smoking
* syndromes or cleft patients
* severe crowding or Class II malocclusion (Pg-Nper \> 18 mm, ANB \> 7º, SN-GoGn \> 38º e overjet \> 10 mm).
Glutaminergic Agents for Cocaine Abuse - 5

The purpose of this study is to evaluate glutaminergic agents for cocaine abuse.


Eligibility Criteria:
Please contact site for information.
Continuous NMB in PCAS

The main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (older than 19)
2. OHCA with sustained ROSC
3. Comatose (i.e., not following commands) following ROSC
4. Undergoing targeted temperature management (TTM)
5. Time of enrollment ≤ 6hrs from ROSC

Exclusion Criteria:

1. Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC \> 3)
2. Traumatic etiology for cardiac arrest
3. Protected population (pregnant, prisoner)