cyrilzakka/clinical-trials huggingface dataset:
A Study of a New Drug Treatment for Acne

A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
* If female of childbearing potential, must take a pregnancy test and have a negative result
* Females of childbearing potential must also agree to use an adequate method of birth control, which would include:

  * systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
  * Condom with spermicide
  * IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods

Exclusion Criteria:

* Known sensitivity to any of the ingredients in the study medication
* More than 3 nodulocystic acne lesions
* Use of acne treatments, therapies or medications within protocol-specified timeframes
* Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
* Excessive facial hair that may interfere with application of the medication and/or evaluations
Spinal Cord Analysis in Multiple Sclerosis

Research project in which patients with Multiple Sclerosis (MS) are examined clinically and with magnetic resonance imaging (MRI). To evaluate spinal cord (SC) grey and white matter changes (incl. lesions) using fast, high-resolution MRI sequences with high contrast between SC and cerebrospinal fluid (CSF) as well as high contrast within the SC (grey-white matter contrast).

The Swiss Multiple Sclerosis Cohort (SMSC-Study) aims to better evaluate specific Multiple Sclerosis (MS) phenotypes through the systematic and standardised documentation and acquisition of clinical course and paraclinical tests such as magnetic resonance imaging (MRI), blood and cerebrospinal fluid (CSF) specimens.

Determination of the relative contribution of SC metrics (cervical cord volume, cervical grey matter (GM) cord volume, cervical white matter (WM) cord volume, SC lesion load) to disability in MS.

Eligibility Criteria:
Inclusion criteria

* Diagnosis of multiple sclerosis
* Steroid free period: \> 4 weeks
* healthy controls without any history of severe neurological, internistic or psychiatric disease

Exclusion Criteria for all participants:

* History of severe (other) neurological, internistic or psychiatric disease
* MRI related exclusion criteria:

  1. Paramagnetic and/or superparamagnetic foreign objects in the body
  2. Pacemaker
  3. Claustrophobia
  4. Pregnancy, lactation
Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the clinical outcome of patients Methods.We recruited children who undergone diagnostic colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and patch test for common foods, and symptoms scoring at baseline and follow up have been performed by blinded clinicians. Chi-square test for trend was used to compare the frequency of symptoms score improvement (\>1 point) among groups. The association of baseline features of patients with the clinical response was estimated by frequency analysis.

Lymphoid nodular hyperplasia (LNH) of the lower gastrointestinal tract is a common finding in pediatric colonoscopies, whose clinical significance is not yet been clearly established. Although initially considered to be a normal, age-related variant, some authors recently suggested to regard LNH as a marker of food allergy (FA).

Eligibility Criteria:
Inclusion Criteria:

1. isolated finding of LNH\[18\], defined as the demonstration of a significant cluster of lymphoid nodules (\>10/visible field) by endoscopy and lymphoid follicle hyperplasia by hystology;
2. negative results of preliminary evaluation

Exclusion Criteria:

1. diagnosis of concomitant inflammatory, rheumatic or infectious disease, and
2. the assumption of any dietetic or therapy since the clinical onset.
Asthma Control Study

The "Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores" Study is a 16 week, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Tueo Health program on asthma control as indicated by change in baseline and study end (week 16) score on the Childhood Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17 years) in children with uncontrolled asthma as the primary study objective.


Eligibility Criteria:
Inclusion Criteria:

* Parent has a child who is \> 6 and \< 17.5 years old
* Parent reports child has a diagnosis of asthma
* Child takes daily asthma controller medication
* Child has used rescue inhaler (e.g.albuterol, ProAir, etc) or nebulizer at least 2 times per week in the past 4 weeks
* Child sleeps on a toddler, single, or double bed by themselves
* Child will live in the same home for the majority of the next 16 weeks
* Parent is \> 18 years old

Exclusion Criteria:

* Child's asthma has been controlled over the past 4 weeks
* Child has any of the following conditions: sleep apnea, congenital heart disease, cardiac arrhythmias, or any other heart abnormalities, neurologic conditions including seizures, cerebral palsy, muscular dystrophy, genetic conditions or developmental disorders, autism, other major medical condition
* Child is currently pregnant
* Child was born premature (earlier than 36 weeks)
* Parent is not fluent in English
* No in-home WiFi
* Parent does not use an Android phone as their primary phone
* In a household with an existing enrolled participant in the study, even for a different child (e.g. only one child in a household may have questions reported back to the researchers by their parent)
* Lives in Hawaii or Alaska
Identifying Expression Markers of Cumulus Cells to Identify Oocyte Developmental Potential Through a Maturation Analysis

The aim of the study is to analyze the expression of genes and microRNAs potentially involved in oocyte competence in follicles of different sizes (\<17mm and ≥17mm) at the time of oocyte pick-up.

In ART, one of the major obstacles encountered in some patients is the wide variation in the follicular size at the oocyte pick-up day and consequently, the number of available mature oocytes and the number of competent embryos for implantation. The follicular size at the day of oocyte pick-up reflects the synchronicity of the individual follicular responsiveness to FSH.

For successful preimplantation development of an embryo, the oocyte must contain all necessary maternal factors. Two of these factors are specific mRNA transcripts (GDF9, PTX3, HAS2, PTGS2, TNFAIP6) and microRNA (miR-224).

For each Cumulus Oocyte Complex, the evaluation of embryo development and morphokinetics will be correlated with the expression and implantation data to identify a quantitative biomarker to predict the embryo with the highest chance of implantation in patients.

Experimental Design:

1. - Collection of Cumulus Oocyte Complex (COC) from patients
2. - Separation of oocytes according to the size of the follicule they have been retrieved from (\<17mm; ≥17mm)
3. - Isolation of mRNA from both groups of cumulus cells
4. - Expression studies, qRT-PCR (GDF9, PTX3, HAS2, PTGS2, TNFAIP6)
5. - Analysis of miR-224, a negative regulator of cumulus expansion via PTX3
6. - Time-lapse culture \& evaluation of morphokinetics

Eligibility Criteria:
Inclusion Criteria:

* No more than 2 previous treatment cycles
* No history of recurrent spontaneous abortions
* Age ≤ 39 years
* BMI \< 30 kg / m2
* ≥ 8 cumulus-oocyte-complexes (COC) retrieved
* human Chorionic Gonadotrophin (hCG) triggering

Exclusion Criteria:

* Preimplantaion Genetic Diagnosis (PGD) or Preimplantation Genetics Screening (PGS) indication
* Maximum number of 24 COC during pickup
* Failure to culture until Day 5
* Polycystic ovary syndrome
* Severe endometrial factor that can influence implantation
* Uterine malformation or congenital anomaly
* Severe male factor (Azoospermia)
The Prone Position in Covid-19 Affected Patients

The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.

BACKGROUND:

It has been shown that the prone position (PP) during mechanical ventilation (VM) in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality.

The reduced mortality, however, is not only caused by an increase in oxygen, but also by the ability of the PP to reduce the damage associated with mechanical ventilation (VILI).

Studies show that the benefits of PP are also present in non-intubated patients; the PP prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).

Moreover, a reduction in the need for intubation and therefore hospitalization in the ICU would be particularly useful in a context of great health emergency with limited resources.

The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.

STUDY DESIGN:

This is a monocentric study that will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen support or CPAP.

Sample size (n. Patients): 56

The duration of enrollment is estimated in 1 month. Patients will be monitored until discharged from the hospital. The overall duration of the study is estimated to be 1 year (including enrollment, follow up and data analysis).

The patient will be enrolled in the study when consent is obtained. The following data will be collected:

* Patient registration
* Demographic and anthropometric data
* Comorbidity and lifestyle habits
* Hospitalization data
* Blood chemistry tests
* Ventilation parameters

After 10 minutes and at the end of pronation, the feasibility of pronation and ventilation parameters will also be assessed.

STATISTICAL ANALYSIS:

Clinical data relating to enrolled patients will be analysed by means of descriptive statistics on continuous quantitative variables using indicators chosen on the basis of the distributional form. Categorical variables will be described in percentages. Hypotheses on PaO2 / FiO2 performance will be verified through the T test for paired data if the distributional form allows it or alternatively the Wilcoxon test will be used. In this case we will proceed with a recalculation of the power study.

Eligibility Criteria:
Inclusion Criteria:

* Age\> = 18 years old or \<= 75 years old
* Diagnosis of COVID related pneumonia requiring oxygen or CPAP support

Exclusion Criteria:

* pregnant patients
* patients with impaired consciousness and / or uncooperative
* patients with NYHA class\> II
* patients with high proBNP
* patients with COPD
* contraindications evidenced by the physicians
Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy

Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.

The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform.

Primary Objectives:

1. . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
2. To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
3. To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT.

Secondary Objectives:

1. To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
2. To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis

Eligibility Criteria:
Inclusion Criteria:

* Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
* Age \> 18 years
* ECOG performance score \< 3
* English-speaking
* with sufficient vision/hearing or family support
* Coronary artery disease, if cleared by cardiologist
* Subject must have smart phone, computer or tablet.
* Willingness to be randomized

Exclusion Criteria:

* Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).
* Patients with overt evidence of a psychiatric disorder.
* Coronary artery disease, not cleared by cardiologist.
* Contraindication to exercise.
* Chronic fatigue syndrome.
Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) II-III patients.
* Aged 30-50 years.
* The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.

Exclusion Criteria:

* Patients with a known allergy to the study drugs.
* Advanced cardiac, respiratory, renal or hepatic disease.
* Coagulation disorders.
* Infection at or near the site of intrathecal injection.
* Drug or alcohol abuse.
* Psychiatric illnesses that may interfere with perception and assessment of pain.
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA

OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent.

In this study we aim to explore at a primary care level whether the use of benchmarking against a set of guideline-based reference values on a patient basis, may improve quality of patient care, in particular control of diabetes, lipids and blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from diabetes type 2,
* treated or untreated,
* insulin dependent or not insulin dependent Able to read and send SMS (if SMS applicable)

Exclusion Criteria:

* Type 1 diabetes Pregnancy diabetes
* Hospitalization at the moment of enrollment in the study
A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease

The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).

This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.

The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.

Eligibility Criteria:
Inclusion Criteria:

* Mild-to-Moderate Alzheimer's disease
* Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
* MMSE score 10-24 inclusive
* Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD
* Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

* Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days
* Other causes of dementia
* Other primary psychiatric or neurological disorders
* Unstable medical illnesses or significant hepatic or renal disease
bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.

Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Sintilimab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and safe in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of infiltrative HCC.
2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin
3. Age between 18 and 75 years;
4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-2;
8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
9. Prothrombin time ≤18s or international normalized ratio \< 1.7.
10. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. HCC with capsule;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving the main portal vein.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Known history of HIV
7. History of organ allograft
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Ear-Seizure Detection (EarSD) Study

The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.

A wearable seizure detection and prediction device (EarSD) is worn by patients with epileptic seizures. In this study, the goal is to validate the accuracy of a newly developed portable seizure detection device by examining if the Ear-SD device can (1) provide more comfort, (2) be unobtrusive to the subject during daily activities, and (3) be able to provide additional insight on a patients' seizure control.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy.
3. Willing to wear the wearable device.
4. Ability to provide informed consent

Exclusion Criteria:

1. Subjects wearing other ear devices such as hearing aids.
2. Inability or unwillingness to provide informed consent.
3. Irritation of the skin where the device is to be placed.
4. Patients with intracranial electrodes placement.
5. Prisoners
6. Cognitive impaired individuals
7. Pregnant Women
8. Children (Age 0-17)