cyrilzakka/clinical-trials huggingface dataset:
Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People

This is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. One third of the participants will be given an injection or infusion of placebo (sugar water). All participants will be healthy people.

First in human single dose study. Study terminated 12 October 2011. The ATR-107 Development team reached a recommendation to terminate further development of ATR-107 (PF-05230900). This was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the First-in-Human study in healthy volunteers (B2281001). This recommendation is not based on adverse events observed in study B2281001.

Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential
* Body mass index between 17.5 to 30.5 and body weight \> 50 kg

Exclusion Criteria:

* History of significant medical illness
* Positive urine drug screen or alcohol dependance
* Smoking \> 10 cigarettes per day
A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.

To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy children.

The study was conducted in the objective to compare the safety and reactogenecity of BCG Vaccine of Green Signal Bio pharma Private Limited India(Test) with BCG vaccine of Serum Institute of India(Reference) in 120 healthy children.

The above study was conducted in multi centers(2 centers - Chennai \& Bangalore). The study was conducted as per the protocol approved by DCGI and Madras ethical Committee.

A single dose was administedred to all the subjects and it was inferred that all the 120 subjects vaccinated were safe. Further, the reactogenecity was confirmed after 90th day by PPD administration to all the subjects. Based on the above observations it was well identified that test vaccine can be safely administered to children and it is well tolerated and accepted by the subjects. More over statistically it is inferred that there is no significant variation between the test and reference vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be in the age group of 0 - 14 years of age.
2. Subject's parent should be able to understand and have to sign the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects and risks.
3. Ability to comply with the schedule of treatment and follow-up.
4. Absence of BCG scar
5. Tuberculin negative
6. No evidence of any other infection
7. No evidence of skin disease -

Exclusion Criteria:

History or presence of significant:

Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.

More specifically, history or presence of significant:

Low birth weight babies (\<2.5 Kg),

Malignancy,

Tuberculin positive,

Hodgkin's disease,

Corticosteroid therapy,

Generalised Eczema,

Infective dermatosis,

Hypogammaglobulinemia,

Immunosuppressed,

Above 14 years of age,

On anti-tubercular drugs,

Chest X ray evidence of TB.

-
Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study

The purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called \[11C\] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. This study may help physicians better understand how to treat patients diagnosed with ADHF in the future.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Enrollment in the UAB CMC-ADHF study under the separate UAB approved research protocol (IRB-300000114, PI Rajapreyar)
* Negative urine or serum β-hCG test within 48 hours of \[11C\] acetate administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight exceeding the weight limit of the PET imaging table (500 pounds).
A Study of LY3041658 in Adults With Hidradenitis Suppurativa

The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HS for at least 6 months
* Have HS lesions in at least 2 different anatomic areas
* Have inadequate response or intolerance to a 28 day course of oral antibiotics
* Have a total count of abscesses and inflammatory nodules greater than or equal to 4
* Agree to use a topical antiseptic daily
* Agree to stop using topical antibiotics during the study. In certain cases, oral antibiotics will be allowed

Exclusion Criteria:

* Have more than 20 draining fistulae
* Have received any biologic medication (adalimumab, etc.) for the treatment of HS
* Plan to use oral opioids for HS-related pain during the study
* Uncontrolled depression or suicidal thoughts
Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects

A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at Screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
* Clinically significant history of drug sensitivity or allergy to fluconazole or other azole antifungals
High Pressure Balloon vs Cutting Balloon

Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.

Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.

Data will be collected from standard of care visit, including physician visits and ultrasounds. Follow up will be based on the function of the AV access, dialysis center criteria and/or standard of care ultrasound results: including venous pressure of the AV access, difficult cannulation, urea recirculation, and change in character and sound of the AV access (thrill/bruit), which are standard of care assessment at a dialysis center. All patient data sheets will be kept in a study binder and locked in the research room. Randomization will be performed with a computer program.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age
2. AV fistula or graft
3. Undergoing weekly hemodialysis
4. Patients must agree to the terms of the study and sign an informed Consent

Exclusion Criteria:

1. Pregnant women
Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis

The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).


Eligibility Criteria:
Inclusion Criteria: - Subjects with end stage renal disease (ESRD) on hemodialysis Exclusion Criteria: - Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures
Personalized, Predictive, Precise & Preventive Medicine for Major Depression

Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. In addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural MRI, EEG) are used to assess brain structure and function. In addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). Drug level measurements are also performed.

The goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. These findings could be used to individualize and improve therapy for depressive disorders.


Eligibility Criteria:
Inclusion Criteria:

* MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS) and/or PDD: F34.1
* Symptom severity: Moderate to severe (MADRS ≥ 20).
* First depressive episode before 50 years of age
* Signed informed consent form
* Capacity to consent

Exclusion Criteria:

* Acute Suicidality
* Placement according to state law (e.g. §16/17 Nds. PsychKG)
* The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification
* Concurrent participation in other clinical trials that are not being conducted within the framework of the P4D project
Association of Asprosin in Periodontitis and Acute Coronary Syndrome

Asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose tissue and released during fasting. Appetite, glucose metabolism, insulin resistance, cell apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic ovary syndrome, and cardiovascular diseases. Periodontal tissue may act as a source of endocrine-like inflammatory mediators (such as TNF-α, IL-6 and IL-1) that are important in periodontal inflammation and can affect glucose and lipid metabolism. Production of TNF-α and IL-6 in adipose tissues strengthens the relationship between cardiovascular diseases and periodontitis. Investigators postulated that asprosin may be a candidate for explaining the triangular relationship between cardiovascular and periodontal disease.

Periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria. It is characterized by the formation of an inflammatory response in the supporting bone and connective tissue against microbial dental plaque, and the nature of the resulting inflammatory response determines the course of periodontal disease. Cardiovascular and periodontal diseases are closely related, presenting a triad association. Asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activatesinvestigators the G protein-cAMP-PKA pathway, causing rapid glucose release into the circulation.

Eligibility Criteria:
Inclusion Criteria:

For Healthy group

* All individuals were generally healthy,
* non-smoking For Myocard Infarctus group
* patients with ST elevation of Myocardial Infactus
* patient with less than ten teeth

Exclusion Criteria:

* Smokers or those with diabetes or other inflammatory disease
* Pregnant or breastfeeding women
* None had undergone periodontal therapy and/or antibiotic therapy in the past 6 months.
* None has a contagious disease such as HIV or AIDS
Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.

This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 30 and 35
* Basal Glycemia between 100 and 125 mg/dl

Exclusion Criteria:

* Diabetes diagnosis
* Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc
* Intolerance to inositols, gymnema, alpha-lactalbumin and zinc
Mainz Epilepsy Registry

Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Epileptic or psychogenic seizures

Exclusion Criteria:

* age\<18
* patients who cannot provide informed consent and don't have a legal guardian
Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest

Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the exploration of microvascular function in human. Muscle StO2 is a technique allowing the assessment of microvascular function non-invasively. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.

Out of hospital cardiac arrest is a major health problem accounting for 375000 deaths each year in Europe. Even after return to spontaneous circulation, survival is poor because of complications such as post-anoxic encephalopathy and multi-organ failure. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These conditions are frequently associated with microvascular dysfunction that can be the "motor" of multi-organ failure. Few means allow the exploration of microvascular function in human. Recently, StO2, a non-invasive technique assessing microvascular function has been described. This technique measures the tissular saturation of a muscle using the near-infrared spectroscopy technique. It has been described to be a good prognostic factor during haemorrhagic shock state. Dynamic parameters such as reperfusion slope allow discriminating between survivors and survivors after severe sepsis. This dynamic test assesses the microvasculature recruitment that could be a marker of better prognosis. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest
* Patient aged between 18 and 80 years
* Having a Social Security System

Exclusion Criteria:

* Pregnant women, lack of appropriate consent
Longitudinal Outcomes in Pediatric rTMS and CIT

Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who previously participated in a randomized, controlled trial (RCT) of intensive therapy combined with repetitive Transcranial Magnetic Stimulation (rTMS)

This longitudinal study will evaluate the subjective and behavioral outcomes of a previous randomized controlled study (RCT) rTMS/CIT (Pediatric Hemiparesis: Synergistic Treatment using rTMS and CIT (NIH Grant Number: 1RC1HD063838-01; PI: Dr. James Carey). The previous rTMS/CIT study evaluated the safety and efficacy of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere combined with constraint induced therapy (CIT) to promote recovery of the paretic hand in children and adolescents. CIT has shown improved behavioral outcomes as well as cortical reorganization in representation of the affected limb. The previous RCT was a rTMS-Sham/CIT study design (real rTMS n=10 and sham rTMS n=9).

Our research question, 'What is the medical status and perception of previous participants concerning their involvement in an intensive rTMS/CIT RCT specific to symptom monitoring, the TMS experience, and their current functional status'.

Eligibility Criteria:
Inclusion Criteria:

* Previous participants in a RCT on rTMS/CIT.

Exclusion Criteria:

* Participants who do not wish to participate.
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal

The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.

This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of coronary artery disease (CAD)
* stable angina
* angioplasty
* evidence of \>50% luminal narrowing on coronary angiogram
* acute myocardial infarction
* bypass surgery
* stent placement OR
* two or more CAD risk factors
* systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg)
* high total cholesterol (\>200 mg/dL)
* physician diagnosed diabetes
* body mass index (BMI) \>30
* family history of heart disease in parents or siblings
* 21 years of age or older
* mentally competent to provide informed consent

Exclusion Criteria:

* known history of autoimmune disease
* systemic/chronic disease requiring chemotherapy or long term treatment
Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration

\*Primary: To compare the control group, women in the experimental group will have lower level of labor pain after the intervention of peanut ball usage.

\*Secondary: To compare the control group, women in the experimental group will have higher level of support and control after the intervention of peanut ball usage; To compare the control group, women in the experimental group will have lower level of anxiety after intervention of peanut ball usage; To compare the control group, women in the experimental group will have shorter duration of labor after intervention of peanut ball usage.

We will ask the participants to join this research on the department of obstetric outpatient department, and give the consent form to sign. Then we will allocate the participant into the experiment group or the control group, furthermore, we will give the sheet which includes the information about peanut ball usage, like the destination, method, position, duration, and quick response code of the video.

When they finish the admission process in the delivery room, we will give the peanut ball to the participants who is in the experimental group, and the participants of the control group will receive the routine care of delivery room.

Eligibility Criteria:
Inclusion Criteria:

1. vaginal birth;
2. pregnant women at ≥3 6 weeks of gestation;
3. greater than 20 years old of age;
4. no major obstetric or medical complications;
5. singleton pregnancy;
6. the partner will be accompanied during the labor;
7. cervical dilation is less than 5 cm;
8. able to listen, speak, read and write in Chinese;
9. complete the informed consent form.

Exclusion Criteria:

1. emergency cesarean section;
2. diagnosed with metal disease or drug abuser;
3. complicated with abnormality during labor.
Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

Study design:

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* presence of dyspeptic symptoms, according to Rome IV criteria;
* Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology);
* naive to Helicobacter pylori treatment;
* written informed consent.

Exclusion Criteria:

* previous Helicobacter pylori treatment;
* diagnosis of gastric cancer or other diseases requiring surgery;
* contraindications to upper endoscopy;
* chronic diarrhea;
* known allergy to any drugs used in the intervention and control arm.