cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
* Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 NIA-AA criteria.
* Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
* Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion Criteria:

* Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
* Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
* Participants must not have certain safety concerns, including certain laboratory test irregularities.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Asymptomatic Leishmania Infection in HIV Patients

To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV co-infected individuals in East-Africa (Ethiopia).


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* without a history of VL in the last 5 years
* stable residents of a VL-endemic area
* willing to participate and giving free informed consent

Exclusion Criteria:

* younger than 18 years
Study on Tear Proteins in Diabetic Retinopathy of Type 2 Diabetics

Diabetes mellitus is becoming a global epidemic. There is a need to devise a non invasive method for detection of diabetes and its related complication. Tear proteins are easy to collect causing no harm to a patient and different studies indicate that tear proteins of diabetic patients are significantly different from non diabetic population. This difference in the composition of tear proteins become more pronounced with advancement of diabetic retinopathy.

Diabetes mellitus causes a significant alteration in tear proteins. If we analyze tear proteins by means of electrophoresis, HPLC, and mass spectroscopy.

We can find different type of tear proteins in different grades of diabetic retinopathy these biomarkers can help in mass screening , diagnosis and management of diabetic population.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients with type 2 diabetes
* age above 30
* willing to participate

Exclusion Criteria:

* ocular surface disorders.
* collagen vascular diseases
* Limbal hyperemia
* previous ocular surgery
* creatinine level above 1.0
* liver diseases
Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.


Eligibility Criteria:
Inclusion Criteria:

1. Women diagnosed with benign ovarian cysts requiring surgical management.
2. Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
3. Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
4. Women aged between 18 and 40 years old.
5. It was diagnosed by ultrasound as unilateral or bilateral benign ovarian cysts with a maximum diameter of 4-8cm. The nature of the cysts is ultimately confirmed by postoperative pathological examination.
6. Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.
7. Patients with no history of endocrine disorders such as hyperprolactinemia, hypothyroidism, or hyperthyroidism, and no history of endocrine therapy within 6 months before laparoscopic ovarian cystectomy.

Exclusion Criteria:

1. Polycystic ovary syndrome.
2. Pregnancy or lactation period.
3. Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
4. Women who have undergone two or more pelvic or abdominal surgeries.
5. Evidence of premature ovarian failure or premature menopause, such as AMH\<1ng/ml.
6. Conversion to open surgery.
7. Women who refuse to sign informed consent or are unable to attend follow-up regularly.
8. Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids

This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.

Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.

Eligibility Criteria:
Inclusion Criteria:

* Adults, minimum age of 18
* Native English speakers
* Ability to complete questionnaires and laboratory assessments
* Symmetric, mild to moderately-severe sensorineural hearing loss
* Informed consent completed with signature

Exclusion Criteria:

* Inability to visit the Starkey Headquarters building for testing
* Central or middle ear hearing problems
* Medical contraindications to wearing hearing aids
* Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet the study population criteria

Exclusion Criteria:

* Subjects with a history of hypersensitivity to the ingredients of zanamivir
Partners at Meals - Respite Care and Home (PAM)

The goal of this study was to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Using a train-the-trainer program built on the Partners at Meals model, volunteers in respite centers partner worked with caregivers and developed a mealtime plan that builds on the strengths of the person with dementia (PWD), and developed a supportive environment for change. A tele-health component was involved in the communication between the respite center volunteers/staff and families. Recruitment was limited to people attending the particular respite centers. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC were the sites of this project.

The goal of this study was to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provided a social model of care for people with dementia living in the community and support for their caregivers. Largely staffed by long-time volunteers, these centers support caregivers' ability to maintain their loved one in the home. Traditionally, support for social activities and mealtime offered by the RCCs cannot be extended to home. In this project, we used a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.

The primary unit of analysis was PWD and their caregiver (CG) outcomes which included: a) PWD weight; b) dysfunctional behaviors at meals; c) quality of life (QOL) of both persons with dementia and their caregivers; and, d) CG self efficacy of managing meals at home.

Eligibility Criteria:
Inclusion Criteria:

* Persons with Dementia (PWD): aged ≥ 60 years; attending a participating respite care center (RCC) at least once/week; living with or within the same property as caregiver (CG); diagnosis of Alzheimer's disease or related dementia with mild to moderate stage as demonstrated by the Functional Assessment Staging Scale (FAST) of 5 or greater and a MMSE of 12 or above; absence of wasting disorders (e.g., HIV/AIDS, heart or renal failure or COPD, end-stage cancer); some supervision required or dysfunctional behavior present (e.g., redirection)
* Caregiver (CG): lives with or on same property as the PWD; provides 4 hours or more of care/day; assists with ADLs including meals
* Volunteer: present at the RCC at least weekly (at least 4 hours/week); identify as comfortable in the teacher/coach role, and demonstrate ability to use televideo and photograph.

Exclusion Criteria:

* Persons with Dementia (PWD): not receiving enteral feeding or active treatment by a speech pathologist/therapist; not diagnosed with dysphagia as identified by caregiver or on RCC Intake Sheet. Those enrolled in or qualifying for hospice will not be included.
* Caregiver (CG): paid for services as caregiver; unable to speak or read English
* Volunteer: unable to read and speak English
Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:

* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?
* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?

Participants will:

* Continue to receive the best available therapy for ALL in Western Europe.
* Have blood samples taken from their central line to measure dexamethasone levels.
* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.
* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of acute lymphoblastic leukaemia
* Age 1-17.9 years

Exclusion Criteria:

* Down syndrome
The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients

In the CDs rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and prevented by altering dietary Cu content suggesting a chronic and acute role for Cu. These abnormalities become apparent when the CDs rats are exposed to high sucrose low copper diet, triggering a vicious sequence of events: exocrine damage, recruitment of macrophages expressing IL-1beta leading to oxidative stress and even more reduction in the activity of Cu-dependent enzymes (chronic effect). When Cu levels are re-established (acute effect) they may prevent the inhibitory effect of IL-1beta on insulin release and may restore the activity of enzymes inhibited by IL-1beta. In this study we will identify humans with marginal Cu status that may benefit from copper supplementation to normalize their GSIS. These patients will be given a daily Cu supplement (3mg/d), or placebo for a period of 6 months. GSIS, pancreatic dysfunction and biomarkers of marginal Cu status will be measured in different blood components before and every 4 weeks during treatments or placebo.


Eligibility Criteria:
Inclusion Criteria:

* diabetic subjects with BMI \< 33
* HbA1C \< 8
* plasma copper levels of \< 90 ul/dl

Exclusion Criteria:

* patients with bad physical conditions
Effects of Green Tea on Cardiometabolic Outcomes

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Green tea may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Between 18 \& 65 years
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to quercetin
* Habitual consumption of quercetin
* Not regularly taking medication or antioxidant supplements
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath.

In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza.

MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis.

If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021.

Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.

Eligibility Criteria:
Inclusion Criteria:

* suspected Influenza infection

Exclusion Criteria:

* later than 48h after admission and detection of Influenza infection
* later than 32 days after admission and detection of SARS-CoV-2- infection
* no written consent
Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men

Lifestyle and environmental factors can disrupt development and testicular function. In France, cannabis is the most widely used illicit substance and about 8% of adults between 18 and 64 years smoke cannabis at least once a year, and mostly men under 45 years. Endocannabinoids are lipid mediators that share some effects with the active ingredients of cannabis. Cannabis and endocannabinoids act via two types of endogenous receptors which were detected at different levels of the reproductive system and are involved in the central and local regulation of the gonad. Cannabis use may alter the normal regulation of the endocannabinoid system. In males, the regulation of the endocannabinoid system is critical for Sertoli and Leydig cells functions, germ cell differentiation, maturation of sperm nucleus and sperm quality. The cannabis can have a negative impact on sperm parameters, capacitation and acrosome reaction. Cannabinoids may decrease testosterone synthesis and induce apoptosis of Sertoli cells. Studies on the effect of cannabinoids on male fertility are scarce or nonexistent in infertile men because of ethical considerations and bias due to consumption often underreported. Investigators hypothesized that cannabis use may alter sperm nuclear quality. Investigators want to explore this hypothesis conducting a multicentric prospective study exposed/non-exposed in infertile men who are consulting for Medically Assisted Reproductive Technologies (ART). To reach this study, it is planned to include a total of 200 subjects taking into account any exclusions.


Eligibility Criteria:
Inclusion Criteria:

* Male Patient,
* Patient age ≥ 18 years,
* Infertile patient with isolated teratozoospermia or associated with asthenozoospermia and / or oligozoospermia and / or necrozoospermia, defined according to WHO recommendations (WHO guidelines, 2010) and the David amended classification (Auger et al, 2001) for teratozoospermia
* Patient with normal constitutional karyotype (46, XY).
* Smoking tobacco,
* Drinking ≤ 20 g (2 units) / day,
* Patient exposed : Cannabis user for over 3 months and consuming at least weekly (≥ 1 / week) \[questionnaire and positive blood detection of Delta-9-Tetrahydrocannabinol (THC) and / or its derivatives (11-hydroxy-THC and 11-nor-9-carboxy-THC)\].
* Unexposed : No cannabis user (questionnaire and negative blood detection of Delta-9-THC and its derivatives) matched for age (+/- 2.5 years) with exposed patients included,

Exclusion Criteria:

* Patient age \> 60 years
* Patient with azoospermia
* Patient previously exposed to gonadotoxic treatment (chemotherapy, radiotherapy, androgen therapy and other gonadotoxic treatments),
* Patient with professional toxic exposure,
* Patient consuming other recreational drugs,
* Patient with severely impaired sperm parameters and sperm counts \<1 million,
The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles.

This study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.


Eligibility Criteria:
Inclusion Criteria:

* Asymptotic peripheral arterial disease (Ankle-brachial index \< 0.9), intermittent claudication (Ankle-brachial index 0.4 - 0.9), or critical limb ischemia (Ankle-brachial index \< 0.4)

Exclusion Criteria:

* Diagnosed with intermittent claudication secondary to vascular insufficiency
* Warfarin or heparin usage
* Underwent a vascular intervention in the last 6 months
* Active cancer, renal- or liver disease
Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.

Eligible patients are included according to a standard 3+3 design.

Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.

The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven non small cell lung cancer
2. Inoperable tage IIIA or IIIB non small cell lung cancer
3. Age ≥ 18 years
4. PerfLife expectancy ≥6 months
5. Hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
6. Hepatic function: Bilirubin within normal limits et AST and ALT ≤ 2 times the upper limit of normal (ULN).
7. Renal function: Creatinine ≤ 1.5 times ULN.
8. Absence of cardiac insufficiency, absence of unstable angina, absence of arrythmia
9. Patient has health insurance coverage.
10. Signed informed consent.

Exclusion Criteria:

1. Patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
2. Uncontrolled hypertension
3. Uncontrolled bleeding within the last 3 months.
4. Patients under anti-coagulation with anti-vitamin K or therapeutic dose heparin ; low-molecular heparins for prophylaxis are permitted and are not considered an exclusion criterion.
5. Presence of cerebral metastases.
6. Participation in a clinical trial within the last 8 weeks.
7. Any other specific concomitant anti-tumor treatment (such as chemotherapy, radiotherapy ...).
8. Patients with a history of myocardial infarction or a cerebral vascular accident within the last 12 months.
9. Continued use of aspirin (\>325mg/day)
10. Major surgery whiting the last 28 days or planned.
11. Major non-healing wound, ulcer
12. Pregnant or breastfeeding women cannot participate in this trial. Women of reproductive potential must have a negative pregnancy test (blood) within 72 hours before the start of treatment.
13. Men and women of reproductive potential must use an efficient contraceptive method when entering the trial and until one months after the end of treatment.
14. History of a thrombo-embolic or hemorrhagic event.
15. Patients put under tutelage.
16. Patients not able to follow the procedures visits, exams foreseen by the trial.
17. Any other severe medical or psychiatric condition or biological anomaly - acute or chronic - that, in the investigator's opinion - may render the inclusion of the patient inappropriate.
Follow-up of Critical COVID-19 Patients

The study will follow COVID-19 patients who required intensive care after 3-6 months and one year after discharge from the ICU with functional level as well as organ function to assess recovery after COVID-19. Blood and urine will be collected for biobanking.

The study will follow COVID-19 patients who required intensive care at Uppsala University Hospital and were included in the Uppsala COVID-19 biobank. The patients will be contacted after three to six months for a first follow-up with assessment of functional level in activities of daily life, psychiatric symptoms, neurological symptoms and working capacity as well as specific organ functions. The organ functions will include circulation, respiration, coagulation, immune function and kidney function. In addition, blood and urine will be collected for biobanking.

Eligibility Criteria:
Inclusion Criteria:

* PCR-verified Covid-19
* Treated in ICU

Exclusion Criteria:

* Pregnant of breastfeeding