cyrilzakka/clinical-trials huggingface dataset:
Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)

The purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life.

Obesity has been recently diagnosed in a younger population and currently in the United States more than two thirds of women of childbearing age are overweight or obese. These women will have children at high risk for developing obesity and Type 2 diabetes (T2DM). There is an acute need for preventing these complications in children so that we can break the cycle of obesity and T2DM. Numerous interventions have attempted but failed to improve outcomes in obese pregnancies by weight loss. Clinicians do not currently have specific recommendation for identifying the obese mothers and risk and for the prevention of infant's complication in healthy obese pregnancies.

The global objective of this study is to identify the relevant maternal phenotype at risk and the mechanism(s) of fetal environment predisposing the offspring for T2DM. This will enhance T2DM early screening and prevention.

The global hypothesis is that dysfunctional adipose tissue secretes angiostatic and pro-inflammatory factors that lead to the formation of a dysfunctional placenta, which through a hypoxic and inflamed environment alters the epigenome to program the fetus for T2DM.

Eligibility Criteria:
Pregnant women Inclusion Criteria:

* Pregnant women undergoing planned cesarean section at 39 weeks of gestation due to: a) elective cesarean section; b) breach presentation c) repeat cesarean section (the rationale for choosing these women is to select only women that have no other risk factors or complications during pregnancy that might affect the outcome)
* Age between 18 and 40 years old
* Pre-pregnancy BMI between 20 and 25 kg/m2 (lean) and \>30 kg/m2 (obese)
* Singleton pregnancies
* Allowing their neonates to participate in the trial

Pregnant women Exclusion Criteria:

* Taking any medication except pre-natal vitamins and medication to treat normal symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia and pain.
* Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
* Pre-eclampsia, eclampsia during this pregnancy
* Liver, kidney, thyroid disease, cancer
* Smoking or using illegal drugs or alcohol during this pregnancy
* Fetal umbilical blood and/or placenta are collected for another reason, i.e. parents decide on cord blood storage

Neonate Inclusion criteria:

- Live neonates born to the study participating mothers

Neonate exclusion criteria:

- Neonate distress as to require admission to the Neonatal Intensive Care Unit.
A First-in-Human Study of CEE321 in Adult Subjects

Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis


Eligibility Criteria:
Key inclusion Criteria for Healthy Subjects (Part A)

* Written informed consent
* Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
* Healthy male and female subjects aged ≥18 and ≤ 65 years
* Able to comply with requirement of domiciliation at the investigational site

Key Exclusion Criteria for Healthy Subjects (Part A)

* Subjects with a history of hypertrophic scars or keloids.
* Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
* Women of childbearing potential defined as all women physiologically capable of becoming pregnant.
* History of drug or alcohol abuse within the 12 months prior to dosing

Key inclusion Criteria for Atopic Dermatitis Subjects (Part B)

* Written informed consent
* Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
* Adult male or female subjects aged ≥18 and ≤ 65 years with confirmed clinical diagnosis of atopic dermatitis (AD)

Key Exclusion Criteria Atopic Dermatitis Subjects (Part B)

* Subjects with a history of hypertrophic scars or keloids.
* Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
* Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
* History of drug or alcohol abuse within the 3 months prior to dosing
* Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity
* Clinical significant medical condition, including psychiatric condition, which in the Investigator's opinion may interfere with safety of subjects, study objectives or adherence to the protocol.
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:

* Smoking history of at least 20 pack-years
* Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria:

1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
3. Patients with concomitant pulmonary disease
4. Patients with a history of asthma
5. Patients with diabetes Type I or uncontrolled diabetes Type II
6. Any patient with lung cancer or a history of lung cancer
7. Patients with a history of certain cardiovascular comorbid conditions
8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)

Other protocol-defined inclusion/exclusion criteria may apply
Imaging Brain Fluids During Breathing

This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation.

Cerebrospinal fluid (CSF) flow is essential for brain health, as it clears waste products from the brain. This study will investigate how breathing affects the flow of CSF around the brain. The investigators will perform high resolution magnetic resonance imaging (MRI) scans in participants who are breathing in specific patterns or performing simple tasks and test the effects on CSF flow. Participants will complete an imaging study visit in which the investigators will image their brain activity while they perform simple tasks, including paced breathing tasks. The participants will be split into two arms: (1) paced breathing (25 participants low resolution, 15 participants high resolution), (2) transcutaneous vagal nerve stimulation (25 participants low resolution, 15 participants high resolution). The MRI scans will take place in the 7 Tesla MRI scanner at Massachusetts General Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18-70 years

Exclusion Criteria:

* No ferrous metal implanted in head or body
* No history of major head trauma
* No neurological or psychiatric disorder
* Not using medication that affects brain function
* No implanted electronic devices (e.g. pacemaker)
* No implant that poses an MR contraindication
* Not pregnant, suspect they are pregnant, or seeking to become pregnant
* Not claustrophobic
* No piercings or jewelry that cannot be removed
* Does not weigh more than 250 pounds
* Normal or contact-corrected normal vision

Exclusion for transcutaneous vagus nerve stimulation (tVNS) arm:

* Conditions of skin or anatomy that affect left auricle or forehead skin and could impact placement of electrodes for tVNS or forehead stimulation
* Diagnosis of significant cardiovascular or cerebrovascular disease \[e.g. congestive heart failure, stroke, cardiac conduction disorders (including: bundle branch block, heart block, long Q-T syndrome), history of asystole or non-sustained ventricular tachycardia.
* Bradycardia (defined as resting heart rate \<50 bpm)
* Hypotension defined as blood pressure \<90/60 mmHg
Targeting Dopamine Therapy in RLS

Neurons in the brain require blood and oxygen for proper function. The term "neurovascular coupling" has been postulated in the 19th century by Roy \& Sherrington referring to increased blood flow to active neurons. The rationale of this research relies on the neurovascular coupling, suggesting that increased blood flow to active regions on the brain should supply not only more blood, but also more of a pharmacological agent present in the blood system at the time. Thus, active regions should be affected by the agent (=drug) to a greater extent.

In the present study we focus on the dopaminergic system, critical in many functions such as cognition, response to stimuli and movement. One of the well-known dopaminergic pathways in the brain is the nigrostriatal pathway, mediating motor function. In this research, we intend to examine the effects of coupling functional activation in this pathway with a dopaminergic agent, Carbidopa/Levodopa, on symptoms of Restless Leg Syndrome (RLS). RLS is characterized by an irresistible urge to move the limbs (i.e. Akathisia), and results most prominently by a significant decrease in the quality of sleep. Our research focuses on this symptom of RLS to examine the effect of coupling brain activation and drug treatment.

The first line of treatment in RLS is dopaminergic drugs. These drugs increase dopamine levels in motor pathways, and our research will aim to couple activation in the nigrostriatal motor pathway with dopaminergic treatment in RLS. Functional activation will be achieved with a simple motor task, known to elicit activation in the nigrostriatal pathway. We hypothesize that the drug will act upon the pre-activated motor system, and that this coupling between brain activation and drug treatment will ameliorate sleep-related symptoms of RLS, compared with treating these symptoms solely with a dopaminergic drug and compared with using a non-motor task.


Eligibility Criteria:
Inclusion Criteria:

RLS diagnosis according the common clinical criteria No known neurological illnesses No known Kidney illnesses No known iron deficiency No history of drug or alcohol use

Exclusion Criteria:

Regular drug treatment Use of a psychotropic substance in the two weeks prior to the study Auditory or Visual impairment Psychiatric history Neurological illness Chronic Kidney illness Obstructive Sleep Apnea (OSA) Dopaminergic drug intolerance or sensitivity Glaucoma Melanoma or Pre-Melanoma (current or previous) Pregnancy
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions

To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Duration of Antibiotic Treatment in Community-acquired Pneumonia

International and national clinical guidelines recommend short antibiotic regimens in patients with non-severe community-acquired pneumonia (CAP) who have reached clinical stability. However, adherence to these recommendations remains unclear. The goals of this quasi-experimental trial are: 1) to assess adherence to clinical guidelines in relation to the duration of antibiotic treatment in patients hospitalized for non-severe CAP who have reached clinical stability; 2) increase adherence to clinical guidelines and reduce the use of antibiotics in patients hospitalized for non-severe CAP who have achieved clinical stability after at least 5 days of antibiotic treatment.

To this end, a multicenter prospective study will be carried out over 2 years and divided into 2 phases: i) during the first year (observational phase), patients with CAP hospitalized in the participating centers will be recorded to assess objective 1; ii) to achieve objective 2, at the beginning of the second year (quasi-experimental trial) the centers will be randomized into 2 groups of hospitals, one of them a control group and the other an intervention group. The intervention will consist in automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years hospitalized for community-acquired pneumonia with a new infiltrate on chest X-ray and/or computerized tomography.
* At least one compatible sign or symptom (fever, cough, expectoration, dyspnea, chest pain or crackles on auscultation)
* Correctly treated with ≥ 3 days of antibiotic

Exclusion Criteria:

* Intensive care unit admission during the first 5 days since hospital admission
* Abscess or necrotizing pneumonia
* Empyema or pleural effusion requiring drainage tube
* Bronchiectasis
* Cystic fibrosis
* Active tuberculosis
* Postobstructive pneumonia
* Suspected bronchial aspiration
* SARS-CoV-2 infection
* Immunosuppression (congenital immunodeficiencies, HIV infection, solid organ transplantation, functional or anatomical asplenia, immunosuppressive treatment, active solid or haematological neoplasia \[active treatment in the last 12 months\], etc.)
* Hospital acquired pneumonia
* Concomitant extrapulmonary infection that requires antibiotic treatment for more than 5 days (eg myocarditis)
* Confirmed diagnosis alternative to pneumonia (eg, lung cancer)
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.

The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal osteoporosis under densitometric criteria of the World Health Organization

Exclusion Criteria:

* secondary osteoporosis
* alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation

This study proposes to use quetiapine as an adjunct treatment to treatment as usual to improve both substance use disorder (SUD) and mood symptoms in youth with SUD and severe mood dysregulation (SMD). This is a randomized, double blind placebo controlled parallel design study. Youth with symptoms of mood dysregulation and active substance use that meets criteria for a SUD will be randomized to adjunct treatment with quetiapine or placebo. The investigators hypothesize that treatment with quetiapine will lead to a reduction in substance use, improvement in mood, and lead to greater engagement in outpatient treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 15 to 24
* Meet DSM-5 criteria for a substance use disorder
* Substance use ≥ 14 days of past 28 days (i.e. use ≥ 50% of days in the past 28 days)
* If subject in restricted setting/care (e.g. inpatient detox unit or residential treatment) for ≤ 2 weeks, then use ≥ 50% of days while outside of restricted setting (e.g. 7 days of substance use out of 14 days in unrestricted setting)
* Subjects need to have been in an unrestricted setting for at least 2 weeks prior to screening
* Meets DSM-5 criteria for bipolar disorder or disruptive mood dysregulation disorder or DSM IV criteria for mood disorder not otherwise specified
* Symptoms of SMD: Youth Self Report (YSR) or Adult Self Report (ASR) AAA ≥180
* Stable to be treated in outpatient level of care

Exclusion Criteria:

* Current methamphetamine use disorder
* Current unstable opioid use disorder (i.e. \< 3 months on medication assisted treatment for an opioid use disorder)
* Pregnant or breastfeeding
* Placement in a restricted setting (e.g. detox or residential treatment) for ≥ 2 weeks out of past 28 days prior to screening visit, or placement in a restricted setting at anytime during study participation
* Unwilling or unable to use effective birth control
* Unwilling or unable to sign release of information for the treatment program providing behavioral treatment
* For participants \>17 years-unable or unwilling to identify emergency contact
Secondary Prevention Treatment in Patients Who Have Suffered a Cardiovascular Event

AstraZeneca was interested in knowing how Cardiologists and Physicians treat patients who have suffered a cardiovascular event.


Eligibility Criteria:
Inclusion Criteria:

* All patients who has experienced cardiovascular events

Exclusion Criteria:

* Patients with no cardiovascular events.
Changes in Body- and Liver-composition During Low Calorie Diet in Morbidly Obese

The purpose of this study is to determine what changes occur in body- and liver-composition during four weeks of low calorie diet in morbidly obese females

Preoperative weight loss prior to laparoscopic gastric bypass is desirable as this reduces liver volume and thus facilitates the visualization of the gastro-esophageal junction. Weight loss is often achieved through low-calorie diet (LCD); however the ideal duration of LCD treatment is unknown.

Morbidly obese female patients awaiting laparoscopic gastric bypass are recruited. They are, as all our patients, treated during four weeks with LCD to achieve a decrease in liver size. During this period they are examined on day 0, 3, 7, 14 and 28 after commencing LCD.

At each evaluation, body composition is assessed through bioelectric impedance analysis (BIA), liver volume and intrahepatic fat through magnetic resonance imaging. A questionnaire regarding quality of life and LCD-related symptoms is administered as well. At surgery two samples of subcutaneous fat and one sample of omental fat is taken.

We do not assign patients to different treatments, instead all are treated similarly according to our routine preoperative regimen.

Eligibility Criteria:
Inclusion Criteria:

* Awaiting laparoscopic gastric bypass
* Residing near Uppsala

Exclusion Criteria:

* Weight above 140 kg
* Metal implants such as pacemaker or intracerebral clips
* Failure to understand or comply with study protocol
HSK7653 in Chinese Patients with Impaired Glucose Tolerance

This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance;
* BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;

Exclusion Criteria:

* History of diabetes mellitus;
* History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
* Current uncontrolled hypertension, serious nephropathy prior to informed consent;
* Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;
* Serious gastrointestinal disease within 2 weeks prior to informed consent;
* Serious infection, trauma, and surgery within 3 months prior to informed consent;
* History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor;
* Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
* Hemoglobin (HGB) \< 10.0 g/dL(100 g/L);
* Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
* Active infectious diseases;
* Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
* Women who are nursing or pregnant, or subjects with birth plans;
* Other protocol-defined inclusion/exclusion criteria.
Prospective Metabolic Surgery in T2DM Chinese Subjects

The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.

The primary objective of this study is to assess the impact of metabolic surgery (Roux-en-Y gastric bypass \[RYGB\] or sleeve gastrectomy \[SG\]) on composite measure of glycemic control at 2 years post surgery in a Type 2 Diabetes Mellitus (T2DM) cohort of subjects.

Eligibility Criteria:
Inclusion Criteria:

1. 20 to 60 years of age (inclusive) on the date the informed consent document (ICD) is signed;
2. A body mass index (BMI) from 28 kg/m2 to 50 kg/m2 ;
3. Previously diagnosed for at least 6 months with T2DM according to World Health Organization (WHO) criteria;
4. C-peptide \> 1 ng/mL (0.3 nmol/L);
5. Able and willing to comply with procedures required by the protocol; and
6. Able to comprehend and sign or, if illiterate, leave their thumb impression on the study ICD.

Exclusion Criteria:

1. History of T2DM for a duration \> 10 years;
2. History of drug and/or alcohol abuse within 2 years of Screening Visit;
3. Any previous major GI surgery (e.g., any GI surgery with a resection, etc.). Previous GI surgery allowed include: appendectomy, gall bladder surgery, liver biopsies, and endoscopic procedures;
4. Scheduled concurrent surgical, non-endoscopy, procedure from Visit 1 through the end of Visit 3;
5. Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant one year or sooner after the surgery;
6. Psychiatric disorders that may affect compliance with the clinical study, including dementia, active psychosis, severe depression, or history of suicide attempts;
7. Any of the following conditions:

   1. Inflammatory diseases of the GI tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
   2. End stage renal disease;
   3. Abnormal results from glutamic acid decarboxylase autoantibodies (GADA) or protein tyrosine phosphatase-like protein (IA-2A) testing; or
   4. Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders;
8. Participation in any other clinical study (not to include registries or survey-only studies) within 30-days or 5 half-lives of an investigational drug (which ever is longer), of Visit 1 (Screening Visit) and for the duration of the study.