cyrilzakka/clinical-trials huggingface dataset:
Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia.

The therapeutic options, aside from treating the underlying disease, depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable number of patients which do not sufficiently respond, making additional therapy necessary.

Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH.

The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the serum sodium levels of patients with SIADH.


Eligibility Criteria:
Inclusion Criteria:

- Hyponatremia \<130mmol/l due to SIADH

Exclusion Criteria:

* any Treatment for SIADH during \>48h before study start
* severe illness with ICU-Admission
* Treatment with 3% sodium Chloride (NaCl) solution
* uncontrolled hypothyroidism
* uncontrolled adrenal insufficiency
* severe renal impairment (GFR \<30ml/min), end stage renal disease
* severe hepatic impairment (Child-Pugh class C)
* systolic blood pressure \<90mmHg
* Diabetes mellitus type 1
* acute myocardial infarction or chronic venous insufficiency (CVI)
* Treatment with SGLT2 Inhibitor, Lithium Chloride or Urea
* recurrent urinary-/genital tract infections
* contraindication for lowering blood pressure
* severe immunosuppression
* pregnancy or breastfeeding
* palliative care
The Effect of OSA on Pregnancy and Fetal Outcomes

This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
* Pregnant women who are willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
* Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
* Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
* Pregnant women who refuse to participate in the study or are unable to provide informed consent.
Video Game-based Exercise for Persons With Parkinson's Disease

This study assessed the effects of interactive video game-based exercise (IVGB) on balance in persons with Parkinson's disease . Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A underwent IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then received IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.

The experiments were conducted as a prospective, randomized, single blinded, crossover, 12-week trial. The group A undergoes the IVGB training in the initial 6 weeks (intervention phase), follows by suspended from exercise in the subsequent 6 weeks (control phase). The group B does not received treatment in the first 6 weeks (control phase), and then performs IVGB training in the following 6 weeks (intervention phase). For all participants, The 36-Item Short-Form Health Survey (SF-36), Modified Falls Efficacy Scale (MFES), Berg Balance Scale (BBS), Multidirectional reach test (MDRT) and Maximum step length (MSL) test were assessed at weeks 0, 6, and 12 of the experiment.

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of idiopathic Parkinson's Disease
* independent community ambulatory individuals
* capable of giving informed and written consent (Mini-Mental Status Examination (MMSE)\>23)

Exclusion Criteria:

* the other neurological conditions such as dementia, and stroke, or if they have arthritis, vision impairment,
* cardiovascular disease that impair walking, or diabetic and uremic individuals, or if they were unable to walk without assistance.
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes

This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
2. Subjects who have signed the informed consent;
3. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
4. Subjects who agree to participate in the study;
5. Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
6. Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
3. Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
4. Subjects with history of leukemia, dementia or multiple sclerosis.
Sleep Disorders in Children With ADHD

ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness.

In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances).

Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented.

The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.


Eligibility Criteria:
Inclusion Criteria:

- We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10

Exclusion Criteria:

mental retardation -
Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients

The study will prospectively determine the clinical utility of non-pathogen specific cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of immunosuppression. The investigators will use the results of the assay to predict whether patients develop opportunistic infections and predict organ rejection.

Solid organ transplant (SOT) recipients undergo life-long immunosuppression to prevent allograft rejection. However, this also puts patients at significant risk for opportunistic infection. The degree of immunosuppression varies for each individual and is likely influenced by a combination of clinical factors such as antirejection medication, comorbidities, patient age as well as the state of patient immune system. Thus far, there have been no standardized methods to quantify the degree of global immunosuppression. A new blood test (Quantiferon-Monitor) has been recently developed that might help predict the level of immune suppression. The purpose of this study is to determine whether this new test will help determine a person's level of immune suppression after organ transplant. This will be done by trying to relate the level of immunity with the development of infection or rejection. If the test for immunosuppression is helpful, it may help us to better take into account the differences in patients when designing therapy. Ultimately, it may help develop better ways for preventing infections and transplant rejections.

Eligibility Criteria:
Inclusion Criteria:

* Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol.

Exclusion Criteria:

* None
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand

The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.

Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior effects associated with study participation are assessed.

Eligibility Criteria:
Inclusion Criteria

Volunteers may be eligible for this study if they:

* Are 20 to 60 years old.
* Are HIV-negative.
* Have used intravenous drugs in the previous 12 months.
* Are available and commit to 3 years of follow-up.
* Have a Thai National ID or its equivalent such as government official ID or state enterprise ID.
* Are able to understand the study and pass a test showing they understand it, and give written informed consent.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

* Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study.
* Are HIV-positive.
* Have ever received an experimental HIV-1 vaccine.
* Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation).
* Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection.
* Have received immunoglobulins for a long time.
* Have received non-licensed, research agents within 4 weeks of the first study injection.
* Expect to miss study visits or plan to move within 36 months.
* Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period.
* Are women who have sex with men and do not plan to use effective birth control.
Helping Olfaction and Nutrition On Renal Replacement

This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.

Malnutrition and cachexia are prevalent in end stage renal disease (ESRD) patients and are associated with increased morbidity and mortality. Food aversion is a major contributor to anorexia and malnutrition in ESRD and it also impacts the quality of life. Olfactory dysfunction has been shown to contribute to food aversion in ESRD patients. Since up to 80% of a meal's flavor is attributed to olfactory input, loss or alteration of smell leads to loss or alteration of taste in ESRD patients and at present there are no effective therapies to treat smell and/or taste disorders in ESRD patients.

In patients with other causes of olfactory dysfunction such as congenital hyposmia and traumatic brain injury, intranasal theophylline has been shown to be effective in improving olfactory defects via increasing nasal mucus levels of cAMP and cGMP, second messengers critical for optimal smell sensation. However, the efficacy of nasal theophylline to improve olfaction in ESRD patients has not been investigated and the effects of nasal theophylline treatment on the nutritional parameters are unknown in ESRD patients.

Aim: To examine the efficacy and safety of nasal theophylline treatment to improve olfaction and nutrition in ESRD patients

Hypothesis: Nasal theophylline treatment improves olfaction and nutrition in ESRD patients with olfactory defects by via increasing intracellular cAMP and cGMP levels.

A previous pilot clinical trial demonstrated that intranasal theophylline is safe and effective in improving olfactory deficits in congenital hyposmia and traumatic brain injury, however, it has not been examined in ESRD patients. The investigators will conduct a pilot single arm open-label clinical trial (n=20) of 6 weeks duration to examine the efficacy and safety of nasal theophylline in hemodialysis-dependent ESRD patients with olfactory defects. The investigators will examine whether nasal theophylline improves olfaction and nutritional status in trial participants.

Eligibility Criteria:
Inclusion Criteria:

* ESRD requiring chronic outpatient hemodialysis
* Able to provide written consent
* Defects in smell identification and/or smell threshold detection as measured by "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and Smell Threshold Test

Exclusion Criteria:

* Prior allergic reaction to theophylline
* Patients currently treated with theophylline for clinical indication
* Pregnancy or lactation
* ESRD patients on peritoneal dialysis
* Patients hospitalized at the time of study enrollment
Dietary Intake and Vitamin D Level in Adult Women

Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia. Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are thought to be at greater risk for vitamin D deficiency because of their darker skin type and the likelihood of reduced ultraviolet exposure . The present study entitled, "Dietary Intake and Vitamin D Level in adult Women," was formulated as there is paucity of data on the etiologic importance of dietary intake in Vitamin D level on blood on women. The major objective of the proposed study is to assess the effect of dietary intake of nutrients and level of vitamin D in women .

For this study, the investigators enrolled 168 women 35-55 years old to evaluate Vitamin D status and to determined whether status was correlated with Vitamin D deficiency.

All women completed a self-administered questionnaire about personal socio-demographic characteristics; They all had anthropometric measurements of body mass index and waist circumference. A 24-hour dietary recall was administered to all women.

The proximate analysis of 25 types of food was conducted according to the American Association of Organic Chemists (AOAC) methods. The following parameters were measured: serum calcium. Vitamin D, levels of parathyroid hormone.

Eligibility Criteria:
Inclusion Criteria:

* Women 35- 55 years old,
* Women who spoke Arabic language fluently, and
* Women who were willing to fill a 24-hour questionnaire and provide a serum sample for measurements.

Exclusion Criteria:

* Women \< 35 years old or \> 55 years old.
Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies

Fibrosarcoma is a malignant tumor originating from mesenchymal tissues and consists of fibroblasts with various types of collagen production. It represents 10% of musculoskeletal sarcomas and less than 5% of all primary bone tumors. It affects middle-aged patients with the most common location in the femur and 70% long tubular bones. Studies reported that fibrosarcoma patients tend to develop a subsequent primary malignancy, the analysis showed a higher risk of SPMs even a decade following the initial diagnosis of fibrosarcoma.

SPMs affect the long-term survival of patients with soft tissue tumors, and since there are no available studies analyzing the risk of second primary malignancies in different types of fibrosarcomas, especially the infantile and adult-type. Therefore, the purpose of this study was to assess the risk of second primary malignancies following primary fibrosarcoma diagnosis for a better understanding of the nature of this rare neoplasm. The investigators used the Surveillance, Epidemiology and End Results (SEER) database to extract the data and calculate the standardized incidence ratio as Observed/Expected and the Excess risk for second primary malignancies with 95% Confidence Interval. Significance was achieved at 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with fibrosarcoma from 2000 to 2021.
* Sequence 0 or 1.
* Histological types:

Infantile fibrosarcoma, Fibromyxosarcoma, Periosteal fibrosarcoma, Facial fibrosarcoma, Dermatofibrosarcoma, Central odontogenic fibrosarcoma, Ameloblastic fibrosarcoma

Exclusion Criteria:

* Patients with unknown histology type
Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the two pilot communities and will complete three 90-minute workshop sessions over a 6 week period.

The pilot study will use mixed methods to compare pre- and post-workshop data about urinary and bowel incontinence symptoms and care-seeking from workshop participants as well as information about workshop acceptability from workshop participants and community partners. The study is expected to last 6 months from initial IRB approval through data analysis and workshop revision. This research will provide preliminary data for a larger test of this workshop in four diverse Wisconsin Communities, followed by a randomized, controlled trial and subsequent dissemination research study.

Eligibility Criteria:
Inclusion Criteria:

* qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria:

* receiving new treatment for qualifying symptoms in 3 months prior to enrollment
A Comparative Study of Different Traditional and Bioactive Indirect Pulp Capping Materials

The protection of the dentin-pulp complex consists of the application of one or more layers of specific material between the restorative material and dental tissue to avoid additional challenge to the pulp tissue caused by operative procedures, toxicity of restorative materials and bacteria penetration due to microleakage. Protection of the dentinpulp complex has also the function to recover pulp vitality.The materials that can be used for this purpose are varnishes,calcium hydroxide (CH)-based products, glass ionomer cements (GICs) and adhesive systems.The biological compatibility together with the sealing capabilities of dental materials is of paramount importance to avoid or limit pulp tissue irritation and dentinal hypersensitivity.

Pulp plays an important role in the formation and nutrition of dentin as well as in the innervation and defense of the teeth. The primary pulp function is dentin formation, which begins in the moment that the peripheric mesenchimal cells differentiate into odontoblasts and starts the deposition of collagen matrix, in a sequence of deposition/mineralization that ends with the complete tooth formation. Even after the initial formation, pulp continues to physiologically produce dentin due to the tooth aging. Reparative dentin may also be produced in response to physical and/or chemical injuries. Odontoblasts maintain their processes inside the newly formed tissue, thus creating real channels that are responsible for dentin nutrition. changes in the flow of the fluid in the dentinal tubules can trigger pain receptors present on nerve endings in the pulpal aspect to fire nerve impulses, thereby causing pain . This hydrodynamic flow can be increased by changes in temperature, humidity, air pressure and osmotic pressure, or forces acting on the tooth. Hot or cold foods and drinks, and physical pressure are typical triggers in people with dentin hypersensitivity.

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age ranges from 20-50 years old with vital first permanent molar tooth on testing by vitality test, such as thermal or electrical pulp tester.
2. Class I or II cavities.
3. Deep carious lesions.
4. Absence of clinical signs or symptoms suggesting non-vital tooth such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
5. Sufficient tooth structure for restoration.
6. Healthy patients with good general health.
7. Patients are cooperative and motivated.

Exclusion Criteria:

1. Patient with systemic diseases such as uncontrolled diabetic, cardiovascular diseases, or patient received chemotherapy or radiotherapy.
2. History of spontaneous, unprovoked toothache or mobility, (grade I, II and III).
3. Sensitivity to percussion, external or internal root resorption, periapical lesions or presence of a fistulae.
4. Pregnant females.
5. Drug abuser patients.
6. Previously restored teeth.
Reducing AIDS Stigma Among Health Professionals in India

This Randomized Controlled Trial has been designed to test the efficacy of a behavioral intervention to reduce HIV-related stigma among nursing students and ward attendants in 16 sites in South India and 8 sites in North India.

Across the globe, HIV stigma inflicts hardship and suffering on people with HIV and has been found to reduce the likelihood of seeking HIV counseling and testing and PMTCT. Stigma also deters infected individuals from disclosing their status, seeking timely medical treatment for HIV-related problems, reduces ART adherence, and leads to delays in clinic appointments and prescription refills, which can lead to virologic failure and the development and transmission of drug resistance. Medical professionals unfortunately constitute a significant source of stigma for PLHIV.

This study will evaluate the efficacy of a promising intervention designed to reduce HIV stigma among Indian health professionals. The intervention builds on results of our previous research, identifying prevalence and drivers of stigma and discrimination in Indian healthcare settings among PLHIV, health care providers and uninfected patients.

Specifically, the study will:

1. Adapt our pilot-tested 3-session stigma reduction intervention for partial tablet-based delivery to increase its long-term sustainability in health care settings. The two tablet-administered sessions of the intervention use interactive touch screen methodology and video vignettes tailored to situations likely to be encountered by Indian nurses and ward attendants. The third session focuses on skills-building in a group format and is co-facilitated by a PLHIV.
2. Evaluate the efficacy of the intervention in 24 hospitals in North and South India on:

   1. behavioral manifestations of HIV stigma, including endorsement of coercive policies, behavioral intentions to discriminate, and non/stigmatizing provider-patient interactions.
   2. the factors underlying stigma proposed by our conceptual model and targeted in the intervention modules, including fears and misconceptions regarding casual transmission (instrumental stigma), and negative attitudes toward marginalized, vulnerable groups (symbolic stigma).

Eligibility Criteria:
Inclusion Criteria:

For Nursing Students:

1. being enrolled as a 2nd year nursing student in one of the study colleges,
2. being 18 years or older,
3. being able and willing to participate in the intervention and all assessments.

For ward attendants:

1. having worked as ward attendant at one of the study hospitals for at least a year
2. being 18 years or older,
3. being able and willing to participate in the intervention and all assessments.

Exclusion Criteria:

a) Unwilling or unable to participate