cyrilzakka/clinical-trials huggingface dataset:
Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. Changes in cardiac function, morphology and clinical outcomes were followed up and compared.


Eligibility Criteria:
Inclusion Criteria:

* Dilated cardiomyopathy
* Presence of anti-β1-adrenergic receptor
* Age 18-75 years
* LVEF ≤ 40% determined by echocardiography (according to assessment of the local investigators)
* NYHA class II-IV
* Symptoms of heart failure ≥ 6 months
* Treatment with guideline-directed medical therapy (GDMT) for ≥6 months and stable dose of ACEI/ARB/ARNI/β-blocker/SGLT2i/MRA/sGCa for ≥1 month (excluding diuretics)
* Hemodynamically stable
* Informed consent

Exclusion Criteria:

* ICD implantation \< 1 month or CRT/D implantation \< 6 months
* Heart failure caused by other heart diseases
* End-stage heart failure, inability to discontinue intravenously positive inotropic or vasoactive drugs
* Expected survival \< 1 year
* Hemoglobin \< 90g/L
* Any disease requiring immunosuppressive drugs
* Commodities with other acute or severe illnesses, such as infections, severe hepatic or renal dysfunction, hematological diseases, malignant tumors, cachexia, autoimmune diseases, etc.
* Previous treatment with immunoadsorption therapy or intravenous immunoglobulin therapy
* Contraindications to extracorporeal circulation therapy, such as mental illness or consciousness disorders, shock, severe bleeding or bleeding tendency, coagulation dysfunction, multiple organ failure, etc.
* Pregnancy/lactation
* Any other conditions that the researcher deems may increase the risk to the subject or interfere with the clinical trial and outcome assessment (such as excessive anxiety, alcohol or drug abuse, or cognitive impairment, etc.)
Life Quality and Mental State in Patients With Breast Cancer

Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer


Eligibility Criteria:
Inclusion Criteria:

* diagnosed breast cancer
* current usual care treatment
* willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group
* informed consent

Exclusion Criteria:

* complementary treatment at the Hospital Meran in the last 6 months
* no German or Italian language ability
* participation in other study
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function

A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Normal Hepatic Function:

  * Weighs at least 45 kg
  * Body mass index between 18 and 40 kg/m2 inclusive
  * Must have normal hepatic function
* Hepatic Impaired Subjects:

  * Weighs at least 45 kg
  * Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method
  * Body mass index between 18 and 40 kg/m2 inclusive

Exclusion Criteria:

* Subjects with Normal Hepatic Function:

  * Smokes more than 10 cigarettes per day
  * Known to be HIV positive or has HIV antibodies
  * Has clinically significant history or presence of illness, malignancy, or immunodeficiency
  * Is Hepatitis A, B, or C positive
  * Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
  * History of substance abuse within 6 months prior to screening
* Hepatic Impaired Subjects:

  * Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis
  * Is hypovolemic or has evidence of orthostatic hypotension
  * Smokes more than 10 cigarettes per day
  * Known to be HIV positive or has HIV antibodies
  * Has clinically significant history or presence of illness, malignancy, or immunodeficiency
  * Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment
  * Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
  * History of substance abuse within 6 months prior to screening
Hematological Manifestations in Systemic Lupus Erythematosus Patients

The goal of this observational study is to evaluate hematological abnormalities among patients with systemic lupus erythematosus (SLE) admitted to a tertiary care center in Nepal. The main question it aims to answer is:

- What are the types and frequencies of hematological abnormalities seen in hospitalized SLE patients in Nepal?

The study retrospectively reviews medical records of SLE patients admitted between April 2018 and March 2023 to collect data on hematologic parameters, demographic profiles, clinical manifestations.


Eligibility Criteria:
Inclusion Criteria:

* All the patient diagnosed with systemic lupus erythematosus based on 2019 European League of Associations for Rheumatology and American College of Rheumatology (2019 EULAR/ACR) criteria.

Exclusion Criteria:

* Underlying hematological diseases or conditions: Patients who had hematological disease (e.g. hemophilia, leukemia, lymphoma) or conditions that could independently affect hematological parameters.
* Incomplete records
Identification of Graphic Markers of Neurocognitive Disorders (MG)

The diagnosis of neurocognitive disorders such as early Alzheimer's disease (AD) or primary progressive aphasia (PPA) is particularly difficult and constantly evolving, often leading to diagnostic erraticity. However, several studies have shown that graphic parameters are affected in people with moderate to severe Alzheimer's disease. The use of new technologies in the study and analysis of the abilities of people with neurodegenerative diseases is increasingly recommended. The use of a digital tablet with a stylus makes it possible to objectivize the kinematic parameters of writing (pressure, inclination, speed, jerk, time of writing task) and thus would allow a low-cost diffusion of this technology in particular by including it in already existing screening batteries.

The overall objective of the project is to characterize and compare the graphical markers of a writing task, either language-based (writing words, non-words, sentences) or non-language-based (drawing shapes), in patients with PPA, early-stage Alzheimer's disease (i.e., at the stage of minor neurocognitive disorders and major neurocognitive disorders at the beginning of the disease), and in people with no cognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

* = \> 50 years old

For control group :

* not have a diagnosis of minor or major neurocognitive disorder.

For AD :

* Have mild stage Alzheimer's disease: 1/ Be diagnosed according to ICD-10 criteria for the following conditions: Alzheimer's disease and 2/ Have an MMSE score between 20 and 27, corresponding to a major TNC of mild stage or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously done MMSE is 3 months.

For PPA :

* Have Primary Progressive Aphasia according to the Gorno-Tempini criteria (Gorno-Tempini et al., 2011) and have an MMSE score between 20 and 27, corresponding to major mild TNC or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously made MMSE is 3 months.

Exclusion Criteria:

* Presence of pathologies of the dominant upper limb(s) (left, right or ambidextrous lateralization) disabling such as osteoarthritis, finger amputation, etc.
* History of stroke.
* Illiterate person.
* Participate in a concurrent experimental clinical study, to avoid interference with our study.
* Not understand oral and written French. The speakers are French-speaking and the language task is performed in French.
Lifetime Incidence and Socio-economic Implications of Mental Illness

The purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the Danish population and to estimate the influence on socio-economic functioning.

The purpose of the present study is to estimate the lifetime incidence of any mental disorder in a nationwide population-based register linkage study for the Danish population in total and according to gender and to estimate the influence on socio-economic functioning. The investigaters hypothesised that the lifetime incidence of any mental disorder is substantially higher than hitherto believed.

Eligibility Criteria:
Inclusion Criteria:

* The study was based on a randomly selected 1,500,000 sample of all persons who were registered in Statistics Denmark on the 1st of January 1995.

Exclusion Criteria:

* None
Effects of Al-Lisaan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters

The study plans to find the efficacy of a digital application/software, Al-lisan that adult stutters can be used for assessment and management of their stuttering. The Software has been developed with the help of a software engineer. After the current trends employed by Speech language pathologists explored through qualitative study design, the manual which is under development process through a focused group in which assessment and treatment options of the software were finalized. The next step will include the reliability and validity of the software for assessment and management of adult stutters followed by finding the efficacy of the software. As this Application will be in Urdu language it will assist less literate and those living in peripheries to assess or provide self-treatment options to the persons who stutter. It will allow adults for self-assessment and treatment options in Urdu language.

The term stuttering refers to the dis-fluent pattern of speech. In adult stuttering it's a learned pattern of dis-fluent production that may become the part of their speech permanently. It affects 1% of the worldwide population. There are many therapeutic techniques to treat the stuttering in adults. Self-help therapy is common to use. Besides the personalized treatment of self-help therapy by adult stutters, there are many digital applications available and used by many adult stutters worldwide. Few are StammerApp, Stamurai and SMAAT. The objective of the study is to develop a digital application/software that adult stutters can be used for assessment and management of their stuttering. This study being a part of PhD project, started in March 2020 and until now, the current trends employed by Speech language pathologists have been explored through qualitative study design. The manual was developed through a focused group in which assessment and treatment options of the software were finalized. The Software has been developed with the help of a software engineer. The objective of this study is to find the effects of Al-lisan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters. For this step we are applying for the grant. As this Application will be in Urdu language it will assist less literate and those living in peripheries to assess or provide self-treatment options to the persons who stutter. It will allow adults for self-assessment and treatment options in Urdu language.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will be Stutters who are above the age of 19 and who have not taken regular therapy from last one year

Exclusion Criteria:

Adults with neurogenic stuttering or any other organic cause will be excluded
Expression and the Clinical Significance of Neutrophil PD-L1 During Sepsis

Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.


Eligibility Criteria:
Inclusion Criteria:

* patients with severe sepsis
* patients with sepsis after PCNL for infectious kidney stone
* patients with pancreatic cancer
* healthy volunteers

Exclusion Criteria:

* patients with immunodeficient diseases
* patients who accept glucocorticoid or immunosuppressant
* patients with an age older than 18 years
* patients providing the informed consent
Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

The purpose of this study is to help overweight or obese children to maintain or reduce their body mass index (BMI) through the home-based parent training program the investigators developed called DRIVE. The investigators hypothesize that children from families that receive the DRIVE program will show greater maintenance or improvement in their BMIs than families who do not receive DRIVE.

The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program with 15 sessions focused on improve family nutrition and physical activity and promoting positive parent-child interactions. The aim of this study is to pilot-test the development of a childhood obesity program that includes parenting and health information. Participants in this study will be recruited through community organizations based upon their obesity health risk. Only families whose children's BMI percentile is greater than or equal to 75 will be eligible to participate in this study These participants will be randomly assigned to either the control group, in which participants will receive health information via mail only, or the experimental group that will participate in 15 DRIVE sessions focusing on parent-child interactions, health and nutrition, and physical activity. Both groups will complete a baseline assessment, mid-point assessment, and post assessment in their home, which will measure parent and child height, weight, and waist circumference; parent attitudes towards health and nutrition; and parent and child food consumption and physical activity levels. Results from this study will provide information regarding the feasibility of implementing the DRIVE curriculum as well as its impact on parent and child body mass indexes, and parents' knowledge, and attitudes related to nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Child age 2-6 years old with a BMI percentile greater than or equal to 75
* Fluent in English
* Parent has primary custody of the primary child participant in the study

Exclusion Criteria:

* Pregnant or currently breastfeeding (parent)
* Planning to get pregnant while enrolled in the study (parent)
* Have BMI greater than 45 (parent)
* Chronic disease that affects body weight, appetite, or metabolism (for example, diabetes- type I or type II) (child)
* Have HIV or AIDS (child)
* Use prescription or over-the-counter medications or herbal products that affect appetite, body weight, or metabolism (child)
* Plan to move out of the Atlanta/Baton Rouge area for the duration of enrollment (approximately 5 months) (family)
* Plan to be out of the Atlanta/Baton Rouge area for more than 2 weeks for the duration of enrollment (approximately 5 months) (family)
Pranayama and Diaphragmatic Breathing Exercise Applied to Female Patients With Fibromyalgia

Female patients diagnosed with fibromyalgia were divided into pranayama breathing exercise, diaphragm breathing exercise and control groups. The sleep quality, pain and fatigue levels of the patients in the intervention group were determined before and after the breathing exercise.

Aim: This study was conducted to determine the effect of pranayama and diaphragm breathing exercises applied to female patients diagnosed with fibromyalgia on sleep quality, pain and fatigue levels.

Material and Method: This study, designed as a randomized controlled and experimental study, was conducted between November 2022 and June 2023. The data of the study consisted of 100 female patients diagnosed with fibromyalgia: 32 in the pranayama group, 33 in the diaphragm breathing exercise group and 35 in the control group. As data collection tools; Patient Information Form, Visual Analog Scale, Fatigue Severity Scale and Pittsburgh Sleep Quality Scale were used. During the study, the control group received routine treatment, while the two groups in the intervention group received the following training given by the researcher; They were asked to do pranayama and diaphragm breathing exercise 3 sets a day (morning-afternoon-evening), 7 days a week for 6 weeks. At the end of this process, sleep quality, pain and fatigue levels of three groups were evaluated again.

Results: It was observed that there was no statistically significant difference between the initial pain and sleep quality total scores of three groups (p\>0.05), there was a significant difference between the groups in terms of pain, fatigue and sleep quality scores after the application (p\<0.05).

Conclusion: As a result, it was determined that breathing exercises reduced the patients' pain and fatigue levels and improved their sleep quality.

Keywords: Pain, diaphragmatic breathing, fibromyalgia, pranayama, sleep quality, fatigue

Eligibility Criteria:
Inclusion Criteria:

•● Being 18 years or older

* Being a female patient who has had pain for at least three months and has been diagnosed with fibromyalgia by a physician according to the ACR 2016 fibromyalgia diagnostic criteria.
* Having a PSQI score of five and above
* Complaint of fatigue and getting a score of 4 or above on the fatigue severity scale
* Pain score of one or above according to VAS
* Having no communication problems and knowing how to read, write and speak Turkish
* Not being pregnant and not breastfeeding

Exclusion Criteria:

* Having a malignancy related to the respiratory system (bronchus or lung)
* Having tuberculosis disease
* Having chest pain
* Having any psychiatric diagnosis during outpatient clinic screenings
* Having a nasal septum derivation or adenoid that will affect the ventilation process
* Having previously practiced/trained in pranayama or diaphragmatic breathing exercises
Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)

Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in every social level and is very prevalent in outpatient and inpatient settings.

A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had beneficial effects abolishing or greatly reducing nightmares that persisted in spite of treatment with conventional PTSD medications. Furthermore, a big number of patients suffering from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep quality improvement. According to clinical and epidemiological data different derivates from the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce distress.

The aim of the proposed study is to broaden the previous observations and to measure the extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients between the 19-60 years of age with a diagnosis of PTSD.
* Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
* Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol .

Exclusion Criteria:

* Those not meeting the inclusion criteria and those not able to give informed consent.
* Women who are currently pregnant or nursing.
* Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
* currently abusing alcohol or drugs;
* currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
* have a known allergy to cannabis-based products.
Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic

Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared.

Renal colic affects over 12% of the global population at some point in their lives, and recurrence rates are 50%. Renal colic affects approximately 1.2 million people annually and is the reason for 1% of emergency department visits and hospital stays. Urinary tract obstruction caused by calculi is the most common cause of renal colic occurrence. The sudden onset of colicky pain that begins in the flank and radiates to the groin is the classic clinical feature of a ureteric colic. Most people agree that this pain is the worst that humans have ever felt. Renal colic pain can be effectively managed with a variety of pharmacologic treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics, antispasmodics, and antidiuretic hormones. However, the best analgesic regimen has not yet been identified. In patients with renal colic, intravenous (IV) injections of analgesics-either opioids or NSAIDs-remain standard clinical procedures for managing pain. While there have been reports of success with IV administration of these medications, side effects and availability are typically problematic, particularly in private clinics or with opioid abuse. Furthermore, because NSAIDs may reduce renal blood flow and obstruct the kidney's autoregulatory response to obstruction, preexisting renal disease may exacerbate renal failure. The majority of doctors are also uncomfortable using these medications because of their side effects, which include hypotension, respiratory depression, dizziness, nausea, vomiting, narcotic dependence, sedation, and lightheadedness. Therefore, it would appear that using alternate treatments to manage renal colic pain is inevitable. In this trial, the investigators will compare the Visual Analogue Scale (VAS) in patients with renal colic after being managed with intracutaneous sterile water injection and intramuscular diclofenac sodium injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 65.
* Patients with renal colic at the emergency department of the 30 June Center for Urology and Nephrology, Ismailia, Egypt.

Exclusion Criteria:

* Cardiovascular diseases.
* Renal, and hepatic dysfunction.
* Hypersensitivity to any of the used drugs.
* Addiction or chronic use of opioids.