cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy Toxicity Reduction Via Urea Cycle Support

Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels.

We, the researchers at Vanderbilt University, propose to perform a randomized, prospective, double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid intermediate, or placebo beginning before conditioning therapy and continuing until 21 days after BMT. All patients will be followed for 100 days after study enrollment with intensive data collection.


Eligibility Criteria:
Inclusion Criteria:

* We propose to study 144 patients undergoing allogeneic bone marrow transplantation or peripheral blood stem cell transplant over a 4 year period.
* Patients of either sex and of any race or ethnic origin, older than age greater than or equal to13, and admitted to the Myelosuppression Unit (MSU) of Vanderbilt University Hospital or the VA Hospital to undergo bone marrow transplantation will be recruited for this study.

Exclusion Criteria:

* Patients will be excluded if pregnant (unlikely) or if informed consent cannot be obtained.
* Because of the intrinsic toxicity of the treatment regimens, BMT is not usually offered to patients with severe underlying derangements in organ function. Nevertheless, other exclusions that will prevent entry of patients into the study include advanced renal or hepatic failure (serum creatinine \> 6mg/dl, serum bilirubin \>3.5 mg/dl), moribund patients, and patients whose primary physician is not committed to full support of the patient (i.e. "Do Not Resuscitate").
* Other exclusions will include patients enrolled in another experimental (interventional) protocol aimed at reducing transplant related complications during BMT, patients testing positive for HIV, those who have had previous BMT, and patients actively bleeding at the time of initiation of induction therapy. We will not exclude patients undergoing newer regimens of cytotoxic chemotherapy.
Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study

There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high.

The prevalence of coronary heart disease in patient with diabetes varies according to the patient's age, the duration of the diabetes, the coexistence of other heart disease risk factors, but also the type of diagnostic used to detect it. In addition, clinical symptoms are often lacking in diabetic patients.

The latest recommendations from the European Society of Cardiology in 2018 propose a graduation of cardiovascular risk into 3 categories according to the presence of cardiovascular disease, other target organ damage, the duration of diabetes and the coexistence of other heart disease risk factors.

The use of imaging can be considered to refine the cardiovascular risk stratification , such as detection of carotid plaque (class IIa), coronary artery calcium score (class IIb) or even the coronary scanner or ischemia tests (class IIb ). In a much more pragmatic and operational way, the French Society of Cardiology and the Francophone Society of Diabetology very recently published a consensus document, proposing a cardiovascular risk stratification based on clinical elements, the existence of other cardiovascular risk factors and target organ damage risk factors, and the use of the coronary artery calcium score to stratify in particular patients qualified as high risk.

Eligibility Criteria:
Inclusion Criteria:

* Coronary asymptomatic patient
* Patient with type 2 diabetes and aged 50 to 70 or - Patient with type 2 diabetes for more than 10 years and aged 18 to 50 or - Patient with type 1 diabetes for more than 20 years and aged \> 35
* Coronary artery calcium score evaluation planned

Exclusion Criteria:

* Patients who already have a clinical history of coronary disease
* Patients with other peripheral arterial disease
* Patients with clinical suspicion of coronary artery disease
* Patients with progressive cancer
* Patients with serious chronic conditions with an estimated life expectancy \< 3 years.
* Pregnant, lactating, or pre-menopausal women without a recent negative pregnancy test available.
* Patients under guardianship or curator or placed under justice safeguard
* Patients who do not benefit from the social security scheme, or any equivalent scheme
* Patients refusing or being linguistically or psychologically unable to sign the informed consent form

Participation in another biomedical research protocol is permitted
Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterized by the appearance of lesions, characterized by heterogeneity in its pathological, clinical and radiological presentation. It has a significant socioeconomic impact, affecting interpersonal relationships and causing a significant reduction in quality of life.

Patients with MS suffer from a series of symptoms (ocular, spasticity, cerebellar, sensory, fatigue, depression) that may be independent of the course of the disease and their management significantly influences quality of life and also requires multidisciplinary therapeutic measures.

Physiotherapy and occupational therapy techniques are essential to reduce spasticity and prevent complications derived from it. Amongst physiotherapy techniques, we can find minimally invasive techniques such as dry needling which uses a fine filiform needle to penetrate the skin and mechanically break the myofascial trigger points, charactewrized by abnomral/pathological electrical activity. There have been previous studies with dry needling in stroke patients which have shown improvements in gait, but its effectiveness in other populations such as multiple sclerosis is still unclear.

In addition, dry needling has proven to be a cost-effective treatment for spasticity in patients with chronic and subacute stroke and could be an alternative to other pharmacological treatments, although more studies are necessary to compare both the effectiveness and the cost-effectiveness .

Recent studies carried out in patients with multiple sclerosis suggest that dry needling can improve mobility and gait speed. The main objective of the study is to analyze the effect of the application of a single session of dry needling in the lower limbs on the gait of patients with multiple sclerosis.

A prospective randomized parallel group clinical trial with blinded outcome assessment will be conducted. Participants will be recruited from the Hospital Universitario de Canarias.


Eligibility Criteria:
Inclusion Criteria:

1. Having been diagnosed with Multiple Sclerosis in a period of more than two years before the study starts
2. Participate voluntarily and sign the informed consent.
3. Suffering from some type of hypertonia or spasticity in MMII that makes walking difficult, measured with Expanded Disability Status Scale\>2 (Pyramidal section \>2)
4. Age from 18 to 60 years old.
5. Not having phobia of needles.

Exclusion Criteria:

1. Not signing the informed consent.
2. Having a phobia of needles.
3. Presenting an outbreak at the start of the study or having presented any outbreak up to two months before the start of the study.
A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.

The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer, age 18-56 years
* BMI between 18-34 kg/m2,and body weight not less than 50.0kg.

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female in- or out-patients at least 18 years of age
* Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment
* Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol
* Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 \& 2
* Patients must be considered reliable

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
* Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV
* Documented history of intolerance to olanzapine or Lithium Carbonate
* Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2
Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults

A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, aged from 18 to 49 years old. Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
2. Provided legal identification for the sake of recruitment.
3. Subjects are able to understand and sign informed consents.

Exclusion Criteria:

1. Histroy of Hand-foot-mouth Disease
2. Women of lactation, pregnancy or about to be pregnant in 60 days
3. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
5. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
6. Epilepsy, seizures or convulsions history, or family history of mental illness
7. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
8. History of asthma, angioedema, diabetes or malignancy
9. History of thyroidectomy or thyroid disease that required medication within the past 12 months
10. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
11. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
12. Acute illness or acute exacerbation of chronic disease within the past 7 days
13. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
14. History of any blood products within 3 months
15. Administration of any live attenuated vaccine within 28 days
16. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
17. Axillary temperature \> 37.0 centigrade before vaccination
18. Abnormal laboratory parameters before vaccination
19. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1)

The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic knee OA with VAS \>50mm
* Knee OA Kellgren-Lawrence grade II to III
* Chondromalacia grade I to III
* Stable joint

Exclusion Criteria:

* Bilateral symptomatic knee OA
* Local infection
* Neoplasia
* Joint replacement
* Recent use of local steroids
* BMI \> 30
Percutaneous Removal and Margin Ablation for Breast Cancer

We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).

Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 90 years of age
* Non-pregnant, not breastfeeding
* Pre-study documentation of:
* Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration
* Uni-centricity, unilateral cancer by radiology (mammogram and MRI)
* Location of abnormality \> 1 cm from the skin
* Ductal Carcinoma, Invasive (Grade I-III) or In-Situ
* No palpable axillary or supraclavicular lymph nodes
* Good general health
* Zubrod Performance Status of 0, 1, or 2
* If prior non-breast malignancy, must have 5 year disease-free survival
* No prior chemotherapy
* Hormonal therapy must be stopped
* Therapy with tamoxifen must have been of 14 days or less duration

Exclusion Criteria:

* Subjects less than 18 years of age or greater than 90 years of age
* Pregnant or breastfeeding
* Male
* Prior Breast Biopsy affected breast
* Breast implants
* Multicentric disease, bilateral disease
* Residual disease after IVEB of \> 1cm on MRI
* Lesions \> 1.5 cm in diameter
* Lesions \< 1 cm from skin surface
* Previous radiation therapy to the breast
Biomarkers in Parkinsonian Syndromes

This is a prospective observational study to identify biomarkers in parkinson syndromes. Patients with parkinsonian syndromes at the early stages of disease will be recruited and will be followed up until their established clinical diagnosis or for at least 5 years. In this population, imaging and wet biomarkers as well as clinical data will b systematically collected.


Eligibility Criteria:
IΙnclusion Criteria:

* Written informed consent, including consent to monitoring
* Patients with Parkinsonism and disease duration \< 2 years
* Patients with Parkinsonism and disease duration \> 2 years
* Healthy individuals without any neurological disease

Exclusion Criteria:

* Drug-induced parkinsonism (eg, neuroleptics, lithium, valproic acid, metoclopramide).
* Metabolic conditions related parkinsonism (eg, Wilson's disease, hypoparathyroidism).
* Structural lesions on brain magnetic resonance imaging (MRI) that explain the symptoms, such as normal pressure hydrocephalus, moderate to severe chronic vascular encephalopathy, cerebral infarction, neoplasm
* Other serious diseases that indicate a life expectancy of \<5 years.
* Active participation in other interventional clinical studies
Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone

Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be monitored.

* Selection of the patients who meet the inclusion and non inclusion criteria.
* Detailed explanations about the study to the patients.
* Signature of the informed consent by the patients.
* Randomisation of the patients by drawing lots into two groups; group AB who will receive treatment A during 14 days (period 1) then treatment B during 14 days (period 2) and group BA who will receive treatment B during 14 days (period 1) then treatment A during 14 days (period 2).
* Each patient will receive a daily follow-up sheet, a quality of life questionnaire, a glucometer with test strips and the treatment in different bottles for each period of the study.
* The daily follow-up sheet concerns habits during Ramadan (eating, sleeping), the occurrence of complications and blood glucose monitoring. Daily blood glucose monitoring is requested at midday, before dinner and if a malaise occurs. A detailed questionnaire on abnormal symptoms that might occur during fasting have to be fulfilled for each malaise.
* Quality of life will be evaluated using AddiQol questionnaire translated in Tunisian dialect. Patients have to complete the questionnaire before the fasting month and at the end of each period of treatment.
* Treatment is presented in the form of capsules with the same colour and size. Patients have to take one capsule at dinner and one capsule at pre-dawn meal. Patients will receive either hydrocortisone 15mg at pre-dawn meal and 5mg at dinner (sunset) (treatment A) or prednisolone 5mg at pre-dawn meal and a placebo (starch) at dinner (treatment B).
* During the study, patients will be in regular phone contact with a responsible of the study for any information or problem.
* At the end of the study, the completed follow-up sheets and questionnaires will be picked up.

Eligibility Criteria:
Inclusion Criteria:

* Known corticotrope deficiency treated by 20mg hydrocortisone per day.
* Age: 18-70 years
* patients who are willing to fast Ramadan 2018 and who voluntary accept to participate in the study.

Non inclusion criteria:

Patients with either diabetes mellitus, hypertension, diabetes insipidus, severe organ damage (renal, cardiac, pulmonary, hepatic), neoplasia, psychiatric disease, epilepsy or pregnant or breast-feeding women.

Exclusion Criteria:

The occurrence of any of the non inclusion criteria during the study. The occurrence of a severe malaise.
Testing Ultraprocessed Food Labels in Chile

The goal of this experiment is to examine the effects of a warning label signaling that a product is ultraprocessed among a sample of Chilean parents. The main questions this experiment aims to answer are:

Do ultraprocessed warning labels on their own impact product purchase intentions?

Do ultraprocessed warning labels impact product purchase intentions in the presence of nutrient warning labels?

Do ultraprocessed warning labels help more consumers identify ultraprocessed foods?

Participants will be randomly assigned to a control arm or an ultraprocessed warning label arm. In both arms, products will carry nutrient warning labels, which are Chile's current policy. Participants will see three similar products, all of which will be ultraprocessed: one not high in any nutrients of concern, one high in sodium, and one high in sodium and saturated fat. For each product, participants will rate their purchase intentions and indicate whether they believe the product to be ultraprocessed. Researchers will compare results across arms.

Participants will complete an online randomized experiment programmed in Qualtrics. After providing informed consent, participants will be randomly assigned to one of two arms: control (i.e., no ultraprocessed warning label) arm or ultraprocessed warning label arm. In both arms, products will carry nutrient warning labels, which are Chile's current policy.

In random order, participants will see three similar mock bags of potato chips. All products seen will be ultraprocessed, and thus carry an ultraprocessed warning label in the ultraprocessed warning label arm. Additionally, one of the products will not be high in any nutrients of concern, one product will be high in sodium, and one product will be high in sodium and saturated fat. For each product, participants will rate their purchase intentions, perceived healthfulness, and indicate whether they believe the product to be ultraprocessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Parent or guardian of child between 2-14 years old who has never been diagnosed with diabetes, high blood sugar, pre-diabetes or insulin resistance
* Residing in Chile

Exclusion Criteria:

* Less than 18 years old
* Not parent or guardian of child between 2-14 years old who has never been diagnosed with diabetes, high blood sugar, pre-diabetes or insulin resistance
* Not residing in Chile
A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery

The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery


Eligibility Criteria:
Inclusion criteria:

* Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period
* New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surgery
* Body mass index of less than or equal to 40 kg/m2 and weight of \>55 kg
* Patients scheduled to undergo an isolated (bypass grafting only without valve replacement, significant aortic reconstruction, or ventriculoplasty) primary CABG surgery via median sternotomy, using cardiopulmonary bypass

Exclusion criteria:

* Patient has undergone or is going to have emergency coronary artery bypass graft surgery or surgery without cardiopulmonary bypass procedure
* Symptomatic peripheral vascular disease
* Heart attack within 48 hours of surgery