cyrilzakka/clinical-trials huggingface dataset:
Components of Placebo Effects in Sadness

Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). In this study, the investigators examine components of open-label placebos and traditional deceptive placebos in an experimental study investigating sadness.

A growing body of research has indicated that placebos contribute substantially to clinical outcomes. Yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. However, recent research suggests that placebos remain effective even if they openly described as placebos (so-called Open-Label Placebos (OLP)), hence questioning the necessity of deception in clinical trials.

However, comparisons between OLP and deceptive placebos (DP) with regard to their particular mechanisms are lacking. Therefore, the current study aims to identify components of OLP and DP. For this purpose, experimentally induced sadness is examined using a standardized paradigm which has previously been developed by our working group. In particular, healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. Sadness is assessed before and after receiving a nasal spray. Two experimental groups (DP groups) are informed that they would receive an antidepressant nasal spray, another two experimental groups (OLP groups) are informed that they would receive a placebo. In fact, all nasal sprays are active placebos inducing prickling nasal sensations (sesame oil with 0.014% capsaicin). In addition to the factor "Transparency" (DP vs. OLP), the instruction is experimentally varied, with which the substance is administered (scientifically-objective vs. personally-affective), resulting in a 2x2 design. Further, there is an additional fifth group receiving no intervention. The primary outcome is self-rated sadness after taking the nasal spray.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years
* no mental disorder or physical disease
* sufficient German language knowledge

Exclusion Criteria:

* intake of psychopharmacological drugs
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* allergy to capsaicin or sesame
Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects

Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age ≥ 18 and ≤ 45 years
* Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 400 ml within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10\*\*9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or \> 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity
* History of any familial bleeding disorder
* Inability to comply with dietary regimen of study centre
NCF Gene & TNFSF4 in SLE Patients

the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by clinical heterogeneity with variable severity. Among the SLE patients, two may share the same clinical manifestations but have different phenotypes.

This is why studies are searching for the different genes that might be associated with SLE susceptibility.

The Neutrophil cytosolic factor (NCF) Gene provide the instruction for the synthesis of group of proteins that form the NADPH oxidase enzyme complex, that is critical for the induction of reactive oxygen species (ROS) which in turn is important in the regulation of immune system.

While the Tumor necrosis factor superfamily 4 (TNFSF4) encodes the ligand for OX40 (OX40L), which delivers a strong costimulatory signal to activated effector T-cells and enhances both Th1 and Th2 responses when engaged with its receptor. Therefore, increased levels of cell surface OX40L may augment B cell differentiation and proliferation. The consequence of which is that the resulting autoantibodies and immune complexes cause disease pathology in SLE.

So, NCF and TNFSF4 gene polymorphism are supposed to be associated with SLE risk and pathophysiology.

Eligibility Criteria:
Inclusion Criteria:

* SLE patients
* patients older than 18 years old

Exclusion Criteria:

* patients with other connective tissue diseases
* patients older than 70 years old
The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel. Determine the relationship between conducting a GBS test in pregnant women and EOGBSD in Israel.

There have been few studies in recent years, which has prompted us to undertake this study. Our aim was to examine the current colonization rates and attack rates in the Israeli population. Our secondary aim was to evaluate the need to readjust recommendations towards universal screening.

Eligibility Criteria:
Inclusion Criteria:

* All women with term pregnancies from 2015 to 2016 (until 20/9/16) insured by Maccabi Healthcare Services (MHS)

Exclusion Criteria:

* repeat pregnancies occurring in the same woman during the time period
* multiple pregnancies
* gestational age greater than 42 weeks due to probability of data inaccuracy
* women with missing information
Improving Management of Outpatient Actionable Test Results

Clinically significant test results require timely clinician follow-up including the non-urgent clinically significant, or actionable, test results that have received less standardized management and attention. Unfortunately, failure to correctly manage actionable test results is not infrequent and may be associated with important delays in diagnosis and treatment and patient harm. The investigators have designed a safe practice intervention to improve the management of actionable test results for ambulatory patients in a large healthcare system.


Eligibility Criteria:
Inclusion Criteria:

Primary care physicians will be enrolled in the study by virtue of being an actively practicing clinician in an PHS ambulatory practice, and having at least one patient with a diagnostic test included in the PHS CCSTR intervention. The patient population will consist of adult patients \>17 years of age with diagnostic tests in the affiliated ambulatory practices of PHS. Patients will be recruited into the study by a review of electronic medical record data to identify patients with a diagnostic test specified in the PHS CCSTR intervention.

Exclusion Criteria:

Participants who do not meet the inclusion/eligibility requirements will be excluded.
Bisphosphonate Therapy for Osteogenesis Imperfecta

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structural protein of the matrix of tendons, skin, and bones. Affected persons have low bone mineral density (and experience multiple fractures and progressive bony deformity). In its most severe form, the disorder is lethal in infancy. We plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with OI.

Additionally, we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol (too young, history of abdominal pain, etc.) with bisphosphonate. We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen, OR by bone mineral density (BMD) \<2.5 standard deviations (SD) for age plus two of the following:

  * Family history of OI
  * Frequent fractures
  * Blue sclerae
  * Multiple wormian bones on skull x-ray
  * Hearing disturbance
  * Dentinogenesis imperfecta
* Age between 3 and 21 years at the start of the study period.
* Children must be able to swallow whole tablets
* Parents of children must be able to understand protocol and give informed consent.

Exclusion Criteria:

* Therapy with bisphosphonates during the past 12 months.
* Other "non-traditional" therapy for OI in the last 6 months, such as growth hormone or anabolic steroids.
* Other chronic diseases besides OI that interfere with bone morphology or gastrointestinal absorption
Pre-ESRD Syndrome in High Risk African Americans

Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Eligibility Criteria:
Inclusion Criteria: 18-35, healthy volunteers, African American

Exclusion Criteria: Active medical conditions, prescription drug therapy other than birth control
Magnetically Controlled Capsule Endoscopy in Visualization of the UGI and Small Intestine

In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.
3. Able to provide informed consent.

Exclusion Criteria:

1. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
2. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
3. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
4. The patient's basic information in the database is incomplete；
5. Patient fail to be followed up.
Effects of Regular Submaximal Exercise on Asthma Control and Quality of Life in Patients With Persistent Symptoms

The effects of regular exercise on asthma control has not yet been well demonstrated.

The aim of this study is to investigate the impact of submaximal physical exercise on quality of life, on symptomatic control, and on bronchial and systemic inflammatory markers in patients with persistant asthma.

While it is well known that intense physical exercise can generate bronchospasm and limit exercise performance, it recently appeared that regular physical exercise practiced aerobically could improve the clinical status of asthmatic patients.

The investigators are planning a 12-week randomized controlled study to assess the effect of regular aerobic exercise on quality of life, asthma control, bronchial hyperresponsiveness and bronchial and systemic inflammation in patients with persistent asthma

The hypothesis is that regular physical exercise increases control and quality of life and reduces inflammation and bronchial hyperresponsiveness compared to simple physiotherapy sessions.

Eligibility Criteria:
Inclusion Criteria:

* asthmatic patient
* aged 18- 90 years
* ACQ \> 1.5
* stable background treatment comprising at least one inhaled corticosteroid or an anti-leukotriene

Exclusion Criteria:

* IMC \> 35
* severe osteoarthritis of the knees and hips
* unstable angor
* Severe uncontrolled hypertension
Identification of Novel Targetable Kinases in SR-a GvHD

In this study, the investigators aim to identify novel targetable kinases in SR-a GvHD patient samples and investigate their role in different immune cell subtypes.

Corticosteroids are the first-line treatment of a GvHD, however many patients do not respond to corticosteroids. Patients with steroid-refractory a GvHD (SR-a GVHD) have a low 1-year survival rate. In this study, the investigators aim to identify and validate novel targetable kinases in SR-a GvHD patient peripheral blood mononuclear cells (PBMCs) by using a kinase-specific proteomic approach, and thereafter to investigate the role of the identified kinases in different immune cell subtypes by analyzing biopsies taken from SR- a GvHD patients.

Eligibility Criteria:
Inclusion Criteria:

* allo-transplanted
* confirmed diagnosis of a GvHD
* age ≥ 18 years
* peripheral blood samples and biopsies available
* written informed consent
* ability to understand the nature of the study and the study-related procedures and to comply with them

Exclusion Criteria:

* age \< 18 years
* lack of informed consent
* patients that cannot be classified in one of the 2 groups (steroid-refractory, steroid-responsive)
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion

The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.

Malignant pericardial effusions (MPEs), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients, MPE is one of the most unpleasant terminal events. Drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. There is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it is far from clear whether sclerosis really benefits these patients in terminal stages.

Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented lung cancer
* Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology)
* Expected to live 6 weeks or longer
* Sufficient organ function
* Signed informed consent

Exclusion Criteria:

* Myocardial infarction or unstable angina within 3 months
* Constrictive pericarditis
* Active pneumonitis
* Severe infection or disseminated intravascular coagulation (DIC)
* Other severe co-morbidity which could not be relieved with pericardial drainage
* Chemotherapy-naive small cell lung cancer
Neurology Measures in FA Children

The purpose of this study is to identify ways to follow progression of Friedreich's Ataxia (FA) and be able to measure changes over time in children with FA. Participants will have biannual visits to observe how the disease progresses over time and determine the rate of progression.

Funding Source- Food and Drug Administration Office of Orphan Products Development (FDA OOPD).

Investigators seek to identify biological and clinical tests to be used in future clinical trials. The purpose of this research study is to learn more about Friedreich's Ataxia (FA) progression in children. There will be biannual visits which will include a core set of tests and procedures. These include: a collection of medical history, detailed neurological exam, ataxia scales, and health questionnaires. At each visit, blood and cheek swab samples will be obtained to monitor frataxin levels.

A select number of Children's Hospital of Philadelphia (CHOP) participants will have the opportunity to participate in further procedures to better understand how FA affects different tissues. These include a Magnetic Resonance Imaging (MRI) scan and a Motor Evoked Potentials (MEP) procedure.

The MRI scan analyzes how muscle activity is affected in FA. The magnet will be used to capture images of the calf muscle before and after exercising on an ergonomic foot pedal.

The MEP procedure measures how strong the connection is between the brain's motor cortex and a selected body part, specifically the participant's dominant hand.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 2 to 18 years.
2. Genetically confirmed diagnosis of Friedreich's Ataxia (FA) or clinically confirmed diagnosis of FA, pending confirmatory genetic testing through a commercial or research laboratory
3. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1) Inability to complete study evaluations
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

People with allergies frequently complain of a loss or reduction in the sense of smell.

In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 59 years of age.
2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
3. Positive skin or RAST test to allergen.
4. Symptoms of olfactory dysfunction.
5. No significant history of chronic sinusitis.

Exclusion Criteria:

1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
3. Use of any other investigational agent in the last 30 days.
4. Absence of olfactory or nasal symptoms.
5. Use of medications that may affect olfaction.
6. Medical conditions that may affect olfaction.
7. Smoking.
8. URI at the time of screening.
Distal Renal Denervation

Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.

Recent spectacular failure of renal denervation (RDN) therapy in SymplicityHTN-3 trial in fact might be easily predicted from the very beginning. Conventional RDN done as 4-6 point treatments equally distributed within main trunk of renal artery (RA) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. While this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from RA obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). We developed a distal mode of RDN targeting segmental branches of RA and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional RDN in patients with drug-resistant hypertension.

Eligibility Criteria:
Inclusion Criteria:

* systolic BP is equal or greater than 160 mmHg or diastolic BP is equal or greater than 100 mmHg,
* stable (\>3 months) treatment with full doses of at least 3 antihypertensive drugs including a diuretic,
* given written informed consent

Exclusion Criteria:

* secondary hypertension
* 24h-mean systolic BP \<135 mmHg,
* estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2,
* extended disease of renal artery,
* any other clinically important disorders/comorbidities significantly increasing risk of endovascular intervention (investigator's assessment)