cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.


Eligibility Criteria:
Inclusion Criteria:

* Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg)
* Morning screening serum testosterone concentration \<300 ng/dL

Exclusion Criteria:

* American Urological Association (AUA) Symptom Score ≥15 or significant prostatic symptoms
* History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof
* Screening serum prostate-specific antigen (PSA) level \>4 ng/mL or hyperplasia of the prostate (size \>75 cm3 as measured by transrectal ultrasonography)
* Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]) exceeding 1.5 times upper limit of normal
* History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident
* Severe acne
* Hypertension (systolic blood pressure \>160 mm Hg and diastolic blood pressure \>95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator
* Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is \>9%
* Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug)
* Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone \[DHEA\]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug)
* Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug
* History of sleep apnea Insulin-dependent diabetes mellitus
* Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)
Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin

This study will assess and compare the efficacy and safety of valsartan and the combination of valsartan and simvastatin in patients with high blood pressure and high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at least 50 years of age
* Mild to moderate essential systolic hypertension (grades 1 and 2 WHO classification) defined as MSSBP ≥ 150 mmHg and \<180mmHg
* Simultaneous primary hypercholesterolemia or mixed dislipidemia (Fredrickson Types IIa and IIb) defined by LDL-C level ≥ 130 mg/dL and \<190 mg/dL and triglyceride levels ≤ 400 mg/dL despite dietary therapy
* Off medication at randomization

Exclusion Criteria:

* Severe hypertension (grade 3 WHO classification
* ≥ 180 mm Hg systolic or ≥ 110 mm Hg (diastolic)
* secondary form of hypertension
* known Keith-Wagener Grade III or IV hypertensive retinopathy
* history of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months
* transient ischemic cerebral attack during the preceding 6 months
* dyslipidemia secondary to other causes
* Type 1 diabetes mellitus
* Type 2 diabetes mellitus with poor glucose control
* history of systemic inflammatory diseases
* serum CK more than twice ULN
* sodium depletion
* malignancy in preceding 5 years history of heart failure
* myocardial infarction within the preceding 12 months
* second or third degree heart block
* concomitant refractory angina pectoris
* symptomatic arrhythmia
* valvular heart disease
* Any condition/surgery that may alter absorption, distribution, metabolism, excretion of any drug (e.g. history of major gastrointestinal tract surgery, inflammatory bowel syndrome, pancreatic dysfunction, impaired renal or liver function)
Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)

The aim of this study is to develop a blood test to determine which patients are at risk for pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The long-term goal of this project is to decrease deaths from colon cancer by using a blood test to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.

Telomeres are the repetitive DNA sequences that cap both ends of chromosomes. Shortening of peripheral blood lymphocyte (PBL) telomeres has been associated with renal and other cancers. The investigators' preliminary data shows an association between shorter PBL telomere length and ACPs.

I. Specific Aims

1. Develop a DNA and data repository from individuals with advanced colon polyps (ACPs) and controls
2. Confirm that individuals 50 to 60 years of age with ACPs tend to have shorter peripheral blood lymphocyte (PBL) telomeres than those without ACPs
3. Identify a potential optimal PBL telomere length cut-off to differentiate between individuals with ACPs and those without for evaluation in a larger scale study

The over reaching long term goal is to decrease disease and death from colorectal cancer (CRC) using a biomarker strategy to target colonoscopy to those at higher risk.

Eligibility Criteria:
Inclusion Criteria:

Advanced Colon Polyp Group (ACP):

* Must be 50 to 60 years of age with an advanced colon polyp (ACP: advanced colon polyps are those larger than 10 mm, or a colon polyp with high grade dysplasia, or a colon polyp with villous features.

Control Group (Controls):

* Must be 50 to 60 years of age and have had a negative screening colonoscopy.
* Controls will also have no history of adenomatous colorectal neoplasia.

Exclusion Criteria:

* Subjects under 50 years of age
* Subjects over 60 years of age
* Subjects with colon polyps less than 10 mm in size
Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression

Online self-help is an innovative way of providing self-help. The investigators want to study the effect of an interactive online self-help-program (Deprexis) in the treatment of severe depressive symptoms. Participants will be randomised to either twelve weeks of online-self help or a waiting-list control. Symptoms of depression and other aspects will be assessed over a six months period. The investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65, ability to read German, willingness to participate in a telephone diagnostic interview, achieving a score of at least 15 on the PHQ-9 in an initial screening, and providing written informed consent

Exclusion Criteria:

* Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)
A Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-38518168 After a Single Oral Dose in Healthy Male Participants.

The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C JNJ-38518168.

This is an open-label (all people know the identity of the intervention), single-center, single-arm (single group), and single-dose study. This study will include a screening period of 21 days prior to study medication administration. Six men will be enrolled and admitted to the clinical study unit on the morning of Day -1. On Day 1, participants will receive a single oral solution dose containing 30 mg of 14C JNJ-38518168 given as an oral solution. The participants will be confined to the clinical study unit for at least 360 hours after dosing ie, Day -1 through Day 14 and they will be discharged on Day 15; however, participants who, by Day 15, do not meet the discharge criteria will extend their residency in the study unit for up to Day 21. They will return to the study center 7 to 10 days after discharge for the final safety follow-up. The study will include the following safety evaluations: adverse event, vital sign, 12-lead electrocardiography, physical examination, and clinical laboratory test. For each participant the total duration in the study is approximately 6 weeks (including screening and safety follow-up) or 7 weeks for participants who extend the residence up to Day 21.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male participants with a body mass index 18 to 30 kg/m2 (inclusive) and a body weight not less than 50 kg
* Must use adequate contraception and not donate sperm during study and for 90 days after receiving the study medication
* Non-smoker and blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Have a 12-lead ECG consistent with normal cardiac conduction and function at screening

Exclusion Criteria:

* Exposure to radiation for professional or medical reasons in the past 12 months
* Recent changes in bowel habits (frequency, consistency, and amount) and irregular defecation pattern (less than one defecation per day)
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease and coagulation disorders
* History of malignancy within 5 years before screening
* Has received a Bacille Calmette-Guérin vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks prior to the first administration of study agent
A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
* Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
* Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
* Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
* Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically relevant abnormal findings
* Current smokers
* Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
* Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study
Genetic Risk Factors of the Sneddon Syndrome

Sneddon syndrome (SS) is a rare disorder with an incidence of about 4/million/year that affects mainly young and predominantly female adults. It is characterized by recurrent strokes and livedo reticularis, a purple reticular patterning of the skin. A genetic predisposition to this disease, for which there is still no single therapy, is being discussed. Our group recently identified a homozygous nonsense mutation within epidermal growth factor repeat (EGFr) 19 of NOTCH3 in two siblings of a consanguineous family with Sneddon syndrome and pediatric stroke. In an attempt to find other possible contributing genes in Sneddon syndrome patients with adult-onset stroke, we also searched for loss-of-function variants in genes downstream of NOTCH3. In doing so, we found 2 patients carrying heterozygous loss-of-function variants in the PALLD and ANGPTL4 genes. Our results suggest that a bi-allelic loss-of-function mutation in NOTCH3 is a cause of familial Sneddon syndrome with pediatric stroke and that impaired NOTCH3 signaling is an underlying disease mechanism in general. In addition, we have identified several other promising variants that are either located in genes associated with NOTCH3 signaling or play a role in vascular function and stroke.

Based on these results, we now want to investigate whether these aforementioned variants are detectable in a larger number of patients and additionally analyze whether other genetic variants also play a role in disease pathogenesis. The goal of our project is to identify risk variants for Sneddon syndrome by whole exome sequencing and subsequent conventional sequencing....

The detection of a risk gene would be a helpful tool for the diagnosis of Sneddon syndrome and a possible basis for new therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18years old.
* Affected subjects must have been clinically diagnosed with Sneddon Syndrome. When analyzing families with Sneddon syndrome, healthy family members and participants with only symptoms of the skin will be included if consent is obtained.Frau Elli Greisenegger
* Unaffected subjects or subjects with symptoms restricted to the skin must have at least one family member with the clinical diagnosis Sneddon syndrome participating in the study.
* Subjects must be able to communicate well with the investigator, to understand the requirements of the study, as well as to understand and sign thewritten informed consent(= informed consent approved by thelocalethics committee).

Exclusion Criteria:

- Subjects who are unable to communicate well with the investigator, to understand the requirements of the study, as well as to understand and sign the written informed consent, are not eligible for inclusion in this study.
Black and African Americans Connections to Parkinson's Disease (BLAAC PD)

BLAAC PD is a research study to understand what Parkinson's disease looks like for Black and African American communities.

BLAAC PD is happening at research centers around the United States. The study is part of the Global Parkinson's Genetics Program (GP2). GP2 is a research project working to transform understanding of the genetics of Parkinson's disease and make that knowledge globally relevant.

Research studies have found connections between genes and Parkinson's disease (PD). But those results have mostly come from studies with non-Black or African American volunteers. BLAAC PD aims to learn more about gene changes that may cause Parkinson's in Black and African American people. Study volunteers at sites across the United States will attend one visit and will give either a blood or saliva sample, complete a smell test, and may be asked to complete a physical exam. This new data could lead to future Parkinson's tests and treatments for Black and African American people and it may help better understand disease in other groups, too.

This pioneering initiative will fill a gap of knowledge about PD in Black and African American people.

Eligibility Criteria:
Inclusion Criteria for Control Participants:

* Ability to provide informed consent
* Age 18 years or older
* Self-identify as Black or African American

Exclusion Criteria for Control Participants:

* Diagnosis of Parkinson's Disease and/or neurological condition
* Familial history of PD and/or neurodegenerative or psychiatric conditions
* Unknown family history of PD and/or neurodegenerative or psychiatric conditions
* Any conditions that, in the investigator's opinion, preclude the individual's ability to carry out study activities
* If submitting a saliva sample, nothing by mouth (food, drink, gum, tobacco, or smoking) for 30 minutes prior to sample collection

Inclusion Criteria for Participants with a Diagnosis of PD:

* Ability to provide informed consent
* Age 18 years or older
* Self-identify as Black or African American
* Meet the Movement Disorder Society's clinical diagnostic criteria for Parkinson's disease

Exclusion Criteria for Participants with a Diagnosis of PD:

- If submitting a saliva sample, nothing by mouth (food, drink, gum, tobacco, or smoking) for 30 minutes prior to sample collection
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.

It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
3. The subject requires one level lumbar fusion (L-3 to S-1).
4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria:

1. The subject has active spinal and/or systemic infection.
2. The subject is morbidly obese.
3. The subject has a known sensitivity to any component of the OP-1 Putty.
4. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
NESBID: Neuro-Stimulation of the Brain in Depression

In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients.

In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment.

The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.


Eligibility Criteria:
Inclusion Criteria:

* Currently suffering from an MDE with a score on the Montgomery-Åsberg Depression Rating Scale (MADRS) greater than 34 (signifying severe depression)
* Have ultra treatment resistant MDD (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ECT, or failure to remit with ketamine)

Exclusion Criteria:

* Have been diagnosed with psychosis, an addiction disorder (other than nicotine), borderline personality disorder, or antisocial personality disorder, as these conditions could interfere with adherence to the study protocol
* Are currently using a herbal compound or known NMDA-modulating agent, as these substances could interfere with the induction of LTP and thereby limit the effectiveness of tDCS
* Are pregnant, as tDCS has not been adequately studied in this population
* Have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tDCS cannot be assured given these comorbidities
Application of Mechanical Cardiopulmonary Resuscitation Devices and Their Value in Out-of-hospital Cardiac Arrest: A Retrospective Analysis of the German Resuscitation Registry

The aim of this study was to analyse a large CPR database, the German Resuscitation Registry, to evaluate potential benefits of mechanical CPR devices over manual CPR in adult cardiac arrest victims. The primary endpoint considered is ROSC.

In a retrospective analysis of the German Resuscitation Registry between 2007-2014, investigators examined the outcome after using mechanical CPR on return of spontaneous circulation (ROSC) in adults with out-of-hospital cardiac arrest (OHCA). Investigators compared mechanical CPR (Intervention group) to manual CPR (control group). According to preclinical risk factors, investigators calculated the predicted ROSC-after-cardiac-arrest (RACA) score for each group, and compared it to the rate of ROSC observed. Using multivariate analysis, investigators adjusted the influence of the devices' application on ROSC for epidemiological factors and therapeutic measures.

Eligibility Criteria:
Inclusion Criteria:

* out of hospital cardiac arrest
* during time prod from January 2007 until December 2014
* CPR attempted

Exclusion Criteria:

* Investigators excluded cases in which CPR was continued for less than five minutes, or duration of CPR was missing, as the outcome in this early period is not affected by the CPR mode.
* Children aged less than 18 years and patients of unknown age were also excluded as the devices are not approved for resuscitation on children.
* An active compression-decompression (ACD) is a hand-held suction device, to compress and actively decompress the chest after each compression.
* Investigators also excluded cases where ACD CPR was used, because it constitutes a different technology.
* Cases due to trauma were excluded as application of mechanical CPR devices may be limited due in traumatic events.
* Cases where data on ROSC and/or CPR mode was missing were also excluded.