cyrilzakka/clinical-trials huggingface dataset:
Maternal GDM in Hispanic Youth: Risk for Obesity

Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage. In a subset of this cohort, we will also examine the effects of intrauterine exposure to gestational diabetes on the brain pathways that regulate appetite and body weight in children ages 6 to 15 years old.

Obesity rates have increased dramatically over the last two decades, particularly in children. Obesity is a major risk factor for type 2 diabetes (T2D), and there is a disproportionate prevalence of obesity and T2D in people of Hispanic origin. While a number of factors contribute to the development of obesity and T2D there is compelling evidence suggesting a profound role of the diabetic in utero environment. Epidemiological studies show that exposure to maternal diabetes in utero is associated with a significant risk of developing obesity and diabetes later in life. Provocative studies in animal models suggest that metabolic imprinting resulting from exposure to the altered metabolic milieu of diabetes in pregnancy leads to abnormalities in the development of specific fetal tissues, including the hypothalamus and pancreatic islets. Based on these findings, the goal of this research is to test the hypothesis that exposure to maternal gestational diabetes mellitus in utero results in changes during intrauterine development that mediate increased risk for obesity and diabetes. Through our ongoing studies on the genetics of type 2 diabetes we have access to hundreds of Hispanic offspring of well characterized GDM and control mothers. We are, therefore, in the unique position to perform mechanistic studies examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children and adolescents. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage.

To examine the effects of exposure to GDM on brain pathways involved in the regulation of energy homeostasis, we will perform additional functional magnetic resonance imaging (fMRI) studies in a subset of the larger cohort.

Eligibility Criteria:
Inclusion Criteria:

* Offspring between the ages of 4 and 18 years old who were born to women who participated in the BetaGene Study.

Exclusion Criteria:

* Offspring \< 4 or \> 18 years of age;
* gestation \< 36 weeks at birth;
* significant medical illness and/or current use of medication known to influence glucose tolerance or BMI.
Motivational Interviewing to Acutely Admitted Psychiatric Patients With Comorbid Substance Use

The purpose for this study is to determine whether 2x45 minutes Motivational Interviewing given during hospital stay to acutely admitted psychiatric patients with substance use problems, can reduce substance use after discharge.

The aims of the study are in a randomized controlled trial to compare the effects of 2 x 45 minutes Motivational Interviewing and standard treatment with standard treatment alone.All patients acutely admitted to Østmarka Psychiatric Hospital are evaluated for substance use, and all patients with substance use that give their consent to participate are randomized to Motivational Interviewing and standard treatment or standard treatment alone.

Substance use and function will be followed for two years.Admittances to hospital and contacts with primary health care for five years.

Eligibility Criteria:
Inclusion Criteria:

* substance use
* acutely admitted to psychiatric hospital

Exclusion Criteria:

* dementia
* serious brain damage
* not speaking Norwegian or English
The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy

Worldwide, the rising incidence of obesity has led to the identification of an obesity related syndrome, called metabolic. This syndrome is characterized by central obesity, hypertension, insulin resistance and altered lipid levels.

Taking into consideration the rising incidence of obesity, anesthetists will more frequently encounter patients with metabolic syndrome, in their everyday practice. Moreover, the comorbidities that are related to the metabolic syndrome, increase the risk for perioperative complications. Therefore, strategies that will evaluate and modify the risk will be of great importance in the management of these patients, in order to maximize peri-anaesthetic and surgical safety.

The aim of the study is to assess the incidence of metabolic syndrome and the impact of its presence on the outcome of patients undergoing elective laparotomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.

Exclusion Criteria:

* Endstage neoplasia
* Procedures performed within 1 hour of admission
* Emergency cases
CC-42344 Safety Study in Healthy Participants

CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.

This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts.

Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug.

Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.

Eligibility Criteria:
Inclusion Criteria (main):

* Healthy males or healthy, non-pregnant, non-lactating females
* Body weight of at least 50 kg
* Body mass index between ≥18.0 and ≤32.0 kg/m2
* Good state of health (mentally and physically)
* Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy

Exclusion Criteria (main):

* Have received any investigational drug in a clinical research study within the previous 30 days before screening
* Have received any vaccine within 7 days prior to randomization
* History of any drug or alcohol abuse in the past 2 years
* Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study
* Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator
Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders

The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:

* Does virtual reality have an impact on symptoms of apathy in the elderly?
* Is virtual reality well tolerated by the elderly? Participants will benefit from a 3-session virtual reality headset program with a healthcare professional. They will have one session per week for 3 weeks. They will be observed by another professional, who will complete observation grids on apathy, engagement in activity and tolerance of the virtual reality headset.

There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.

This study is a multicenter interventional exploratory study in two nursing homes and a geriatric long-term care service. Thirty patients will be included. They will be recruited from residents of the long-term care departments of two hospitals, and 4 nursing homes.

A pre- and post-intervention comparison will be made by assessing apathy using the apathy inventory and the neuropsychiatric inventory in the care team version. A comparison of participants' engagement will be carried out through ecological observation of the interventions. This will be objectivized by the Caregiver Interaction Behavior Scale (ECPAI) before the immersion program, and during the first and third virtual reality sessions. An ECPAI scale taken during a conventional animation prior to the program will establish a baseline state for the participant.

The main goal is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders.

Eligibility Criteria:
Inclusion Criteria:

* Persons over 65 years of age
* Persons living in nursing homes or hospitalized in long-term care
* Persons with correct vision or vision corrected by glasses
* People with no hearing problems, or with hearing loss corrected by a hearing aid
* Person with a major neurocognitive disorder
* Person with a Mini Mental State Examination (MMSE) cognitive score \<26
* Individuals with documented apathy

Exclusion Criteria:

* Person with a history of epilepsy
* Persons wearing a pacemaker
* Person with open wounds of the face or skull
* Disabling headache or neck pain
* Person at the immediate end of life or in active palliative care
* Person with a contagious disease
* People who are bedridden or unable to get into a wheelchair
* Persons with severe neurological impairment
* Person with severe behavioral disorders endangering self or staff
* Persons unable to give oral consent
Comparing OutcomeS of Through Knee and Above Knee Amputation

Major lower limb amputation is a life changing surgical procedure to treat complications of diabetes mellitus and peripheral vascular disease. The level of function after amputation is dependent on pre-morbid levels of activity, age, co-morbidities and the level of amputation. The level of amputation performed is determined by level of disease and surgical assessment. Below knee amputation provides the best functional outcomes due to the benefits of keeping the knee intact. When a below knee amputation is not possible, routine practice is to perform an above knee amputation. Greater challenges for rehabilitation present at this level due to the shorter lever. Amputation through the knee is less commonly performed despite its reported benefits which include a long mechanical lever arm, an endbearing stump and greater muscle control.

A recent systematic review recommends further comparison of through knee and above knee amputation. The recommended areas of research are gait biomechanics and quality of life for these patient groups. Therefore, the aim of this research is to compare and contrast the long-term functional mobility and quality of life outcomes of limb wearing through knee and above knee amputees. The study will be split into two workstreams, the first focusing on functional outcomes and the second focusing on quality of life using semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling adults aged 18 or over.
* People who have had either a through-knee or above-knee amputation.
* Unilateral amputees.
* English speaking and cognitively be able to follow instructions and fill out questionnaires independently.

Exclusion Criteria:

* People are unable to provide an informed consent.
* People who have a below-knee amputation.
* Unable to transfer with assistance of one.
* Unable to walk more than 5 metres (ambulatory section workstream 1 only).
* Individuals will be excluded from workstream 2 if they report another health condition with greater impact on their quality of life than their amputation.
Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy

Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.

This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected retrospectively/longitudinally.

The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, defined as a \>2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ \<6 IU/ml) at month 12 of therapy.

All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Chronic hepatitis delta
* Compensated cirrhosis HDV related
* Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022

Exclusion Criteria:

- HDV-related decompensated cirrhosis (CPT ≥7)
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.

This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.

All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.

In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.

Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.

Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.


Eligibility Criteria:
Inclusion Criteria:

Lung cancer patients who answer true to the following statements are eligible to join this clinical study.

* I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
* I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.

Exclusion Criteria:

Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.

* I do not have non small cell lung cancer (NSCLC)
* I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
* I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
* I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
* I have a history of uncontrolled irregular heartbeat
* I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.
Registry for Systemic Eczema Treatments

The Registry for Systemic Eczema Therapies (RESET) registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis (AD) who have used or will initiate any systemic treatment(s) for AD. The goal of the registry is to enable more efficient research recruitment and data collection as well as timely notification to enrollees about newly FDA-approved treatments for AD.

The purpose of the Registry for Systemic Eczema Therapies (RESET) registry is to serve as a database and biospecimen repository of patients with pediatric-onset atopic dermatitis (AD), also known as eczema. This registry seeks to enroll patients with AD who have used or will initiate any systemic treatment(s) for AD. Such a registry will allow investigators to identify patients who are potentially eligible for AD research protocols, including observational studies or clinical trials. The registry will also prospectively collect data that would then serve as a resource for studying a variety of questions surrounding systemic therapy use in patients with AD, for example comparing the effectiveness of treatments or examining treatment effects on patient-reported outcomes. Moreover, the registry would permit safety monitoring of systemic AD medications, as it would include both patients receiving traditional systemic agents with well-known side effect profiles and patients receiving more novel systemic agents with under-characterized side effect profiles. Finally, this registry would allow for the identification of patients with moderate-to-severe AD who may be eligible to receive and benefit from the rapidly expanding number of U.S. Food and Drug Administration (FDA)-approved systemic therapies for AD.

Eligibility Criteria:
Inclusion criteria:

* Age \<26 years old
* Current physician diagnosis of atopic dermatitis
* Provide signed informed consent if ≥ 18 years old
* Provide signed informed consent by parent or legal guardian (if \<18 years old) and informed assent if applicable
* Subject and/or parent/legal guardian is willing to be contacted in the future by study staff
* Seen for clinical care at Johns Hopkins since 1/1/2017
* Previously on, currently on, or planning to initiate (within next 6 months) a systemic AD therapy

Exclusion criteria:

* Age ≥26 years old at the time of registry enrollment
* Does not speak English
* If \<18 years old, has a primary caretaker who does not speak English
* If \<18 years old, parent/legal guardian is unwilling to sign the written informed consent
* Is a foster child
* Has not received clinical care at Johns Hopkins since 1/1/2017
Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer

Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized.

This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques.

The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life.

Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).

In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied.

Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization.

For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period.

A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years.

Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3, pN0-1a, M0
* Age ≥ 60 years
* signed informed consent from the patient

Exclusion Criteria:

* Stage pN1b-PN3, pT4 and / or M1
* incomplete surgical resection
* after mastectomy of the ipsilateral or contralateral breast
* breast reconstruction with implant or expander insert
* bilateral breast cancer
* Lack of compliance or consent
* Indications for irradiation of the axillary, supraclavicular or parasternal lymph nodes