cyrilzakka/clinical-trials huggingface dataset:
Elmex Gel Efficacy in Preventing White Spot Lesions

the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.

314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months.

tooth brushing with product (test product or control) once per week during the entire study.

4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study.

toothbrush and a sandglass will be provided every 6 weeks

Eligibility Criteria:
Inclusion Criteria:

* treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
* written declaration of informed consent

Exclusion Criteria:

* known allergy to components of test products
* handicapped patients who have difficulties brushing their teeth
* pathological desquamation changes
* known pregnancy, breast feeding
* eating disorders
* disease that effect dental hard tissue
* participation in another clinical trial either currently or within the lase 30 days
Association of Inpatient Blood Pressure Levels With In-hospital Adverse Events(APPLE Study)

The purpose of the study is to investigate the association between inpatient blood pressure levels and in-hosopital adverse outcomes.

Study population includes subjects who are hospitalized due to illness, of any race or ethnicity, any of age.The primary outcome is all-cause mortality occured in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient with all age or race;
* Have blood pressure data.

Exclusion Criteria:

* Non-patients；
* Death outside the hospital；
* Missing blood pressure data.
Organochlorine Pesticide Exposure in Residents Near Lake Apopka

In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane, toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests and to improve crop harvests. For most of those years, the farmworkers were exposed to the pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these organochlorine pesticides (OCPs) are readily taken up into the body and not readily eliminated. Therefore, they can be detected in exposed individuals for many years after the exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems in sensitive individuals. For example, exposure to some OCPs has been associated with development of Parkinsonism. Exposure to other OCPs has been associated with development of lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may have mixed interactions with steroid receptors.

In this research study the investigators aim is to test the blood from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.

In this research study, a onetime blood test will be collected from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.

The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) which has monitored the pesticide exposure (with the exception of toxaphene) of people older than 8 years, so there is information on the range of concentrations of these chemicals in the blood of Americans. This data will be use as the control group for comparison with the values found for OCP concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Persons who worked on farms near lake Apopka, Florida up to 1998.
* Preference will be given to those who worked on the farms for over 10 years.

Exclusion Criteria:

* Persons who did not work on farms near Lake Apopka, Florida up to 1998.
The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) After Ileostomy Reversal

Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study


Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing ileostomy repair at multicenter

Exclusion Criteria:

* Active bacterial infection needing antibiotics before surgery
* parastomal infection before surgery
* uncontrolled diabetes mellitus
* Emergency repair of stoma (ex. stoma prolapse, high output stoma etc...)
* Inflammatory bowel disease
The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients

Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.

The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.

This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.

0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for laparoscopic cholecystectomy.

Exclusion Criteria:

* pregnant or breast feeding patients
* smokers
* patients with history of chronic opioid abuse
* hypersensitivity to 5-HT3 receptor antagonists or analgesics
* those who were antiemetic or opioid treatment within 24 hours prior to surgery
A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Men 18 years \& older
* Confirmed diagnosis of prostate cancer with bone metastases

Exclusion Criteria:

* No more than 2 prior chemotherapy regimens
* No radiation, chemotherapy or bisphosphonates in the past 4 weeks
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male or female at the age of 18-65 (inclusive) at the time of informed consent
* Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
* Diagnosis of type 2 diabetes mellitus for over 3 months
* Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.

Exclusion Criteria:

* History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
* Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
* Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
* Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
* Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test


Eligibility Criteria:
Inclusion Criteria:

* Patients seeking treatment of a pectus excavatum
* Haller index \> 3.2
* Desire for treatment
* age between 15 and 40 years old

Exclusion Criteria:

* Cognitive impairment
* Pregnancy
* Contraindication to exercise stress test or general anesthesia
* Coagulation disorders
A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831

The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period

The study includes an open-label sub-study prior to the main study

Eligibility Criteria:
Inclusion Criteria:

* NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
* Elevated serum ALT levels

Exclusion Criteria:

* Hepatic cirrhosis
* Other known cause of liver disease
* Uncontrolled diabetes mellitis type 2, i.e. HbA1c \> 8.5%
* Positive history of tuberculosis or a positive PPD skin test which is not explained by previous BCG vaccination
* History of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than 30 g/day (3 units) for males
* Subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-HIV drugs, tamoxifen)
Prevention of Acute Kidney Injury in Patients With NSTEMI

A randomized, double-blind, placebo-controlled, multi-center, phase 2 clinical study in patients with NSTEMI undergoing urgent coronary angiography. Approximately 220 patients with CKD and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI).

Approximately 220 patients with chronic kidney disease (CKD) and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI) will be screened for the study. Only patients with acute NSTEMI presumed to be a spontaneous myocardial infarction, related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection (i.e. type 1) are eligible. Written informed consent will be obtained before urgent coronary angiography. Patients with NSTEMI will typically undergo coronary angiography within 72 hours after admission and/or diagnosis of NSTEMI. It is estimated that 70% of these patients will have PCI. Randomization will continue until the 160th patient has had a PCI.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent as documented by a signature and date of the patient
2. Age 18-85 years
3. Acute NSTEMI as anticipated to be type 1 (expert opinion by the cardiologist before coronary angiography) and scheduled for urgent coronary angiography
4. Documented kidney disease existing for ≥3 months OR Two estimated glomerular filtration rate (eGFR) measurements of \<60ml/min/1.73m2 as calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) study equation and at least 6 hours apart OR eGFR of \<50 mL/min//1.73m2 as calculated by using the CKD-EPI study equation at presentation
5. At least one of the following risk factors for AKI: diabetes mellitus, age \>60 years, established cardiovascular disease, heart failure with reduced ejection fraction, anemia

Exclusion Criteria:

1. Contraindications to the class of drugs under study (C1 esterase inhibitors), e.g. known hypersensitivity or allergy to class of drugs or the IMP
2. History or suspicion of allergy to rabbits
3. Women who are pregnant or breast feeding
4. ST elevation myocardial infarction or unstable angina
5. Cardiogenic shock requiring mechanical support
6. Non-cardiac comorbidity with expected survival \<6 months
7. Acute urinary tract infection (e.g. cystitis, pyelonephritis).
8. Liver cirrhosis (any Child-Pugh score)
9. Dialysis or eGFR \<20 and \>59mL/min/1.73 m2 at baseline (d0)
10. Incapacity or inability to provide informed consent
11. Participation in another study with investigational drug within 30 days preceding, and during the present study
12. Previous enrolment into the current study
IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.

This is a double-blind randomized, parallel group, placebo-controlled dose escalation study (2 cohorts) in patients with sickle cell disease (SCD) and vaso-occlusive crisis (VOC) who are at-risk for development of acute chest syndrome (ACS) based on the combination of VOC, fever (T ≥38.0ºC), and a serum sPLA2 concentration ≥50 ng/mL.

The first group of patients will be randomized 2:1 to receive low dose A-001 or placebo as a 48-hour continuous infusion. Pharmacokinetic and clinical data from this group will undergo review by the Independent Data Monitoring Committee (IDMC). If there is no significant toxicity associated with A-001, then an additional group of patients will be enrolled and randomized 2:1 to high dose A-001 versus placebo as a 48-hour continuous infusion.

Eligibility Criteria:
Patients are eligible for inclusion if they meet the following criteria:

* Sickle cell variant (Hb SS, Hb SC, sickle β°-thalassemia, sickle β+-thalassemia)
* Pain consistent with vaso-occlusive crisis
* Elevated serum sPLA2 level (measured on-site)
* Fever
* Age ≥5 years (through adult)

Patients must NOT meet any of the following exclusion criteria:

* New lung infiltrate by chest radiography
* Pregnancy or breastfeeding
* Significant renal dysfunction
* Significant hepatic dysfunction
* Acute neurologic dysfunction
* Any medical condition for which transfusion may be needed imminently, and/or hemoglobin \<5 g/dL
* Red blood cell transfusion within 30 days of entry into the study
High Threshold Peanut Challenge Study

This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.

The primary objective of the study is to identify and characterize a sub-population of high-threshold peanut allergic individuals and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (NCT01750879).

Clinical Objective:

To evaluate the clinical status of peanut-sensitized individuals previously passing a DBPCFC to 443 mg as being either: non-allergic, stably high-threshold allergic or more clinically reactive on repeat exposure.

Eligibility Criteria:
Inclusion Criteria:

* Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-004.
* Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
* Willingness to sign consent (or for parent/guardian to sign consent).
* Willingness to sign the assent form, if consent provided by parent/guardian.

Exclusion Criteria:

* History of severe anaphylaxis
* Severe or Moderate asthma
* Poorly controlled asthma
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
* Inability to cooperate with and/or perform oral food challenge procedures
* Primary Immune Deficiency
* Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
* Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
* Use within the past 6 months of other systemic immunomodulatory treatments
* Clinical signs or symptoms of anemia
* Hematocrit \<0.36 for adult females or \<0.38 for adult males
* Hematocrit \<0.34 for children 7-18 years of age
* Weight \<23 kg
NKG2D CAR-NK & Ovarian Cancer

This trial will explore the maximum tolerated dose （MTD）of NKG2D CAR-NK cells in the treatment of platinum-resistant, relapsed epithelial ovarian cancer in a dose-escalation manner, and observe the clinical safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older
2. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer
3. Documented platinum resistant epithelial ovarian cancer with at least 1 measurable lesion
4. ECOG performance status of 0-2
5. Adequate organ function defined as: ANC≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5×ULN, AST≤2.5×ULN, ALT≤2.5×ULN, Cr≤1.5×ULN
6. Negative urine or serum pregnancy test within 7 days prior to treatment for women of childbearing age
7. Life expectancy ≥ 12 weeks from the time of enrollment
8. All patients must have the ability to understand and willingness to sign a written informed consent form (ICF).

Exclusion Criteria:

1. Patients with history of other active malignancy within 1 year prior to enrollment;
2. Patients with central nervous system (CNS) metastases. History of any CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema;
3. Patients with ongoing uncontrolled serious infection, clinically significant cardiac disease (i.e., symptomatic congestive heart failure, myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, uncontrolled cardiac arrhythmia), poorly controlled pulmonary disease (no clinically significant pleural effusion), or psychiatric illness/social situations that would limit compliance with study requirements within 12 months prior to enrollment;
4. Patients with immunologic deficiency or autoimmune diseases;
5. Known human immunodeficiency virus (HIV) seropositivity or active hepatitis B or C infection. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative assay;
6. Patients who are breastfeeding or pregnant;
7. Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study;
8. Patients participated in another investigation treatment study 4 weeks prior to enrollment.
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease

The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.

The purpose of the study is to investigate the effect of lesion characteristics in ExAblate Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim thalamic nucleus. Clinical measures will be used to study patients suffering from medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.

This study is designed as a prospective, observational, and clinical study. Assessments will be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL) improvements, assessment of adverse events, and correlations of these measures with the size and shape of the lesion and the surrounding edema .

Eligibility Criteria:
Inclusion Criteria:

* Men and women, between 18 and 80 years.
* Patients who underwent the MRgFUS procedure.
* Patients who are able and willing to give consent and able to attend all study visits and Radiologic follow-up examination by MRI.
* A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination preformed by a movement disorders neurologist.
* ET patients: tremor severity score of greater than or equal to 2 in the treated hand/arm as measured by postural or action item on the Clinical Rating Scale for Tremor (CRST).
* PD patients: tremor severity score of equal or greater than 3 on either item 20 or item 21 of motor part in the Unified PD Rating Scale (UPDRS).
* Substantial disability in the performance of at least two daily activities from the disability subsection of the scales UPDRS for PD patients or CRST for ET patients.
* The patient must have a history of an unsatisfactory response to medical management. All patients will need to have tried and failed at least one drug. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy.
* Stable doses of all medications for 30 days prior to study entry.

Exclusion Criteria:

* Patients which have not completed the MRgFUS procedure.
* Patients which were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.