cyrilzakka/clinical-trials huggingface dataset:
Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program

The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.


Eligibility Criteria:
Inclusion Criteria:

* Currently experiencing a major depressive episode, which requires the initiation of antidepressant drug treatment or a change in current antidepressant drug treatment
* At least 18 years of age

Exclusion Criteria:

* History or presence of bipolar disorder
* Current treatment with venlafaxine
Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study

To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy

Prospective controlled study in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal with no cardiovascular comorbidities

Exclusion Criteria:

* endometrial cancer cases, patients who received pre-operative hormonal preparations, previously resected cases and cases done using bipolar diathermy.
Study on Infectious Mononucleosis in Munich

This observational clinical study aims at the identification of novel biomarkers and causative factors of complicated and/or protracted Epstein-Barr virus-associated infectious mononucleosis (IM).

Clinical, biochemical, and routine virological data were collected from 200 patients with IM, novel analytical tools were implemented, and immunological and virological experimental data were generated using blood samples and mouthwashes. Patients have been investigated within four weeks after the onset of symptoms as well as one month and six months thereafter.

EBV-associated diseases are a severe and global health problem, and novel tools and targets for a better pathogenetic understanding, diagnosis, treatment, and prevention are clearly needed. Here we propose to use several novel experimental approaches to investigate immunological, virological, biochemical, and clinical features in an observational study on Munich IM patients.

This study aims at identifying biomarkers and causative factors of protracted and/or complicated IM to facilitate the development of novel approaches to early diagnosis, therapy, and prevention of severe, life-threatening, and chronic EBV-associated diseases, including post-viral syndromes.

Two hundred patients with IM onset within the last four weeks were recruited from Munich health care institutions and were re-investigated at one and six months after the onset of symptoms. A novel diagnostic scoring system was developed to indicate the severity, complexity, and protraction of symptoms.

Investigated clinical parameters, including reported symptoms and physical signs of IM, as well as candidate risk factors in the medical history of patients and family members. Peripheral blood was analysed by established and novel analytical assays to determine the immunological and virological phenotypes of IM, and viral load was determined in mouthwashes.

Eligibility Criteria:
Inclusion Criteria:

* IM onset within the last four weeks
* with at least one of four typical clinical findings (tonsillopharyngitis, fever, lymphadenopathy, fatigue) - virological findings indicating primary EBV infection (EBV-specific antibodies, EBV DNA).

Exclusion Criteria:

* Pregnancy
* transfusion
* and/or transplantation during the last year
* and/or no informed consent.
Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations

This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.

This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.A total of 7000 medical personnel will be involved in this study: 3500 will use SA58 Nasal Spray in the drug group, and 3500 not use SA58 Nasal Spray in the blank control group. The medication is self-administered intranasally 1\~2 times per day with an interval of 6 hours for about 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot;
* Subjects were 18 years of age and older and in good health;
* Subjects volunteered to use COVID-19 neutralizing antibody nasal spray.

Exclusion Criteria:

* Previous history of severe allergies or sensitivity to inhaled allergens;
* Women were pregnant or breastfeeding;
* Subjects were unable to cooperate with nasal spray inhalation;
* Other conditions for which medication was not appropriate.
BACK MASSAGE APPLIED CLIMACTERIC WOMEN MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT

The purpose of this study is to determine the effect of back massage applied by partners on menopausal complaints, sleep quality, and marital adjustment of women in climacteric period.

Climacterium is a life period in which women move from the reproductive age to the period when their reproductive ability is lost due to the decrease in ovarian functions. The most common climacteric disorder is vasomotor changes. The most common problem seen in menopausal period after vasomotor complaints is insomnia.

Sleep disorders seen in climacteric period negatively affect the quality of life and psychosocial health of woman. In their study, Jean-Louis et al., expressed that women in menopausal period spent approximately 10% of their daily sleep time by sleeping outside the bed during the day. 61% of menopausal women woke up at least once a week and several times from the night's sleep. In their study, Anttalainen et al., determined that women in postmenopausal period had more sleep problems compared to women in premenopausal period. In addition to physical changes due to hormonal changes in climacterium, mental problems such as nervousness, anxiety and depression developing in women may negatively affect the relationships in family environment especially the communication with the spouse. Besides, it is thought that an incompatible marriage can increase menopausal complaints. In the studies investigating the relationship between menopausal complaints and marital adjustment, women with compatible marital life were found to experience less menopausal complaints. Due to the negative effects of physician-controlled hormone replacement treatment administered to reduce menopausal symptoms, demand for non-pharmacological interventions has increased and women have started to accept that therapeutic massage is safe and contributes to health. It is stated that women experience insomnia, a symptom of menopause, and tend to choose especially body therapies from alternative therapies in the first place. Massage is widely accepted as a treatment tool. Although the menopausal period is physiological, it is a period that must be addressed specifically by healthcare professionals since it is accompanied by pathological events causing distress in life and impairing the quality of life.

The purpose of this study is to determine the effect of back massage applied by partners on menopausal complaints, sleep quality, and marital adjustment of women in climacteric period.

Eligibility Criteria:
Inclusion Criteria:

* women aged between 40-65 years,
* women who have 5 or more points from Pittsburgh Sleep Quality Index (PSQI),
* women who do not use hormone therapy or who stopped hormone therapy at least one year ago.

Exclusion Criteria:

* women who had sleep problems before climacteric period,
* women who had uncontrolled chronic disease,
* women receiving psychiatric treatment and/or using sleeping pills,
* women with open wounds on their back were excluded from the study group.
Assessing AI for Detecting Lung Nodules and Cancer: Pre- and Post-Deployment Study

The study evaluates the impact of qXR-LN compared to standard radiologist-only interpretations before and after AI deployment. The goal is to compare how well lung nodules and cancers are detected in two time periods: before and after the implementation of the AI tool in routine clinical practice. The study aims to determine whether the AI system can help radiologists identify more actionable lung nodules and diagnose lung cancer earlier, ultimately improving patient outcomes.

No changes will be made to patients' standard care, and all treatment decisions will be based on the clinical judgment of physicians. The study includes patients over 35 years old who undergo chest X-rays for various medical reasons, excluding those with known lung cancer.

This study evaluates the clinical impact of the FDA-cleared artificial intelligence (AI) tool, qXR-LN, for detecting lung nodules and diagnosing lung cancer using chest X-rays (CXR). The study employs an ambispective observational cohort design with two cohorts: pre-deployment (before AI implementation) and post-deployment (after AI implementation).

The primary objective is to assess differences in lung nodule detection rates and the percentage of lung cancers diagnosed through the nodule pathway between the two cohorts. Secondary objectives include evaluating whether the AI tool aids in detecting more early-stage lung cancers and identifying reasons for patients dropping out of the nodule clinic pathway.

In the post-deployment cohort, qXR-LN integrates seamlessly with the hospital's existing systems to provide real-time AI findings on radiologists' workstations. Radiologists can accept or reject AI suggestions, ensuring that the final decisions remain under human supervision. Data from both cohorts, including patient demographics, nodule detection rates, cancer diagnoses, and treatment outcomes, will be collected and analyzed.

The study excludes patients under 35 years old and those with known lung cancer at the time of imaging. Ethical considerations include obtaining waivers of consent where applicable and ensuring minimal risk to participants. The findings of this study aim to inform clinical practices and enhance the use of AI tools in lung cancer screening and diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥35 years at the time of chest X-ray acquisition
* Chest X-ray must be obtained as part of routine care (e.g., ordered for respiratory complaints, screening, or other clinical indications)
* Chest X-ray performed using CR/DR/DX imaging modality
* Examination described as "Chest"
* View: PA or AP
* Patient positioned as Erect or Supine
* Image available in valid DICOM format with proper DICOM prefix values (including "DICM" in the header)

Exclusion Criteria:

* Patients aged \<35 years at the time of chest X-ray
* Patients with known lung cancer at the time of chest X-ray acquisition
* Lateral views or any imaging modality other than CR/DR/DX
* Imaging or anatomy not specified as Chest (e.g., different body parts or modalities)
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. This project aims to test in a pragmatic clinic-randomized controlled trial two electronic health record-based behavioral economic nudges to help clinicians reduce high-risk polypharmacy among their older adult patients and in the subgroup with dementia or cognitive impairment.

The main questions this trial aims to answer are:

Aim 1: To evaluate the effects of an EHR-based commitment nudge, a justification nudge, and the combination of both nudges on a composite measure of high-risk polypharmacy via a pragmatic randomized controlled trial. The investigators will use cluster randomization in which primary care clinics are randomized to receive 0, 1, or 2 nudges using a factorial design. The nudges will run for 18 months, followed by 12 months of observation to assess persistence of effects.

Aim 2: To qualitatively and quantitatively assess clinician experiences with the EHR-based nudges, including their acceptability and effects on workflow. At the conclusion of the intervention period, the investigators will perform semi-structured interviews and field a clinician survey.


Eligibility Criteria:
Inclusion Criteria:

* Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics

Exclusion Criteria:

* None
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
* Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.

Exclusion Criteria:

* No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
* Subjects with a total IgE at screening of \>2,000 kU/L
* Previous reaction to omalizumab
* Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy

The study is focused on the possible improving effect of N-acetylcysteine on nephropathy of type-2 diabetic patients.

Study design: Prospective clinical based study. The aim of this work is to study the effect of N-acetylcysteine (NAC) on proteinuria and on the serum level of lipoprotein a (LPa) in diabetes induced nephropathy in type-2 diabetic patients.

This study will be carried on 60 participants with Type 2 Diabetes with age over 20 years.

Participants will be classified into two groups:

1. Group I (Interventional): treated with (NAC) dose of 1200 mg/day for two months in conjunction with conventional treatment.
2. Group II (Non-interventional): control group receive conventional treatment.

All patients will undergo the following:

1. Full medical history will be taken.
2. Laboratory investigations as follows:

Blood samples will be collected for analysis after overnight fasting at the beginning and after 2 months of the study for determination of:

1. Total cholesterol (T-chol).
2. Plasma triglycerides (TG).
3. High density lipoprotein cholesterol (HDL-C).
4. Low density lipoprotein cholesterol (LDL-C).
5. Fasting blood sugar.
6. Blood urea nitrogen (BUN).
7. Serum creatinine (SCr).
8. Urine analysis.
9. Glycated hemoglobin (HbA1c).
10. Lipoprotein (a). In addition, blood pressure will be measured for 24 hr.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of Diabetes Mellitus.
2. Age over 20 years.
3. Patients with proteinuria ≥ 30 mg /dl.

Exclusion Criteria:

1. Patients on lipid lowering medications.
2. Cigarette smokers.
3. Presence of liver and heart diseases.
Glaucoma Biomarkers

Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.


Eligibility Criteria:
Inclusion Criteria:

* Either gender.
* Any self-declared ethnoracial category.
* Greater than or equal to 40 years.
* Healthy eyes with the crystalline lens, without glaucoma (cup:disc ratio \< 0.8 both eyes; asymmetry of cup:disc ratio between eyes \< 0.2).
* Open angles.
* Ability to cooperate for aqueous humor dynamic studies.
* Nonprescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study.
* Contact lenses removed prior to topical fluorescein instillation, and not used until the end of each fluorophotometry session.
* Able to participate on site over the multi-visit study period.

Exclusion Criteria:

* Women who are pregnant due to IOP changes.
* Any form of glaucoma, including extremely narrow angle with complete or partial closure.
* Current use of any glaucoma medication, either topically or orally.
* Chronic or recurrent inflammatory eye disease.
* Ocular trauma within the past 6 months.
* Ocular infection or ocular inflammation in the past 3 months.
* Clinically significant retinal disease.
* Any abnormality preventing reliable fluorophotometry of either eye, such as corneal scarring or severe dry eye that results in punctate fluorescein staining of the cornea.
* Intraocular surgery within 6 months.
* Serious hypersensitivity to any components of the study medications or risk from treatment with glaucoma medications, such as severe asthma or emphysema.
* Subjects must be on a stable regimen for at least 30 days prior to the Visit 1 regarding a chronic systemic medication that may affect IOP (i.e., sympathomimetic agents, beta-blockers, alpha-adrenergic agonists, alpha-adrenergic blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.). Any change of such medication during the study period will result in exclusion.
* Use of any glucocorticoid by any route. Subject must be washed out of the glucocorticoid for at least 2 weeks before study entry.
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).


Eligibility Criteria:
Inclusion criteria:

* Participant has a diagnosis of essential hypertension.
* Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
* Participant has a mean trough SiDBP of \>=90mmHg and \< 110mmHg.
* Participant has a mean trough SiSBP of \>=140mmHg and \< 200mmHg.
* Participant has no clinically significant abnormality at screening visit.

Exclusion criteria:

* Participant is currently taking \> 2 antihypertensive medications.
* Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).
* Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.
* Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.
* Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Thoracoscopic Talc Pleurodesis Versus Bleomycin -Tranxemic Acid Mixture Injection in Chest Tube in Malignant Pleural Effusion

Comparing Two Methods to Treat Fluid Build-up in Chest for Cancer Patients:Talc Powder Surgery versus Chest Tube Medicine.

Closure of the space where the effusion is recurrently accumulated through talc poudrage in thoracoscopy or bleomycin - tranxemic acid solution injection in chest tube.

Eligibility Criteria:
Inclusion Criteria:

- 1. Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.

2. Fit patients for the procedure selected.

Exclusion Criteria:

1. Inability to provide informed consent for the procedure.
2. Hemodynamically unstable patients.
3. Bleeding diathesis.
4. Uncontrolled cough.
5. Hypoxic index less than 300.
6. Endobronchial obstruction.
7. Pleural thickening with trapped lung.
ADIPOA - Clinical Study

Primary:

To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

Secondary:

To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).


Eligibility Criteria:
Inclusion Criteria:

* OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.

Exclusion Criteria:

* Any disease or medication affecting the bone or cartilage metabolism, including corticoids.