cyrilzakka/clinical-trials huggingface dataset:
Minocycline Treatment in Retinitis Pigmentosa

The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d), administered for 6 months, for the treatment of patients with retinitis pigments(RP).

Retinitis Pigmentosa (RP)is a sort of inherited blinding disorders and no effective or safe treatment are widely applied for it. The worldwide prevalence of RP is estimated to be 1/5000. RP is characterized by degeneration of peripheral rod photoreceptor(PR) and associated retinal pigment epithelium(RPE) cells. Nyctalopia and visual field constriction are common symptoms. Cone degeneration and associated loss of central vision are typically followed later.

Minocycline, a secord-generation, semi-synthetic tetracycline antibiotic, is a highly lipophilic molecule and can easily pass through the blood-brain barrier. Several animal experiments and clinical trials have reported that minocycline exert anti-apoptotic, anti-inflammatory and antioxidant effects in treating neurodegenerative diseases.

We propose to test the effect and safety of oral minocycline for retinitis pigmentosa.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Retinitis Pigmentosa: nyctalopia, visual field constriction and loss of central vision; degeneration of peripheral rod photoreceptor and retinal pigment epithelium cells.
* Age from 18 to 60 years old.
* BCVA \>20/100(0.2) at least in one eye.
* Full-field cone electroretinogram amplitude to 30-Hz flashes \>0uV at least in one eye.
* Written informed consent is provided.

Exclusion Criteria:

* Glucocortticoids or tetracycline were used within 3 months.
* Vitamin A, DHA and other neurotrophic drugs were used within 3 months.
* Other ocular diseases or fundus diseases except cataract: glaucoma, diabetic retinopathy, retinal detachment.
* Tetracycline or minocycline allergy or intolerance.
* Renal or hepatic insufficiency.
* History of thyroid neoplasm.
* History of idiopathic intracranial hypertension.
* Pregnant or lactating females.
Intranasal Glutathione in Parkinson's Disease

Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I single ascending dose escalation study.

Individuals will be randomized to one of three treatment (100 mg GSH/ ml, 200 mg GSH/ ml, or placebo) arms in a double-blind fashion. All study medication will be administered 1 ml three times daily for three months, with a one-month wash out.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's Disease made by neurologist within previous 10 years
2. Modified Hoehn and Yahr Stage \<3
3. Age \>20
4. Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16
5. Subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.
6. Dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment.
7. Diet, exercise and supplementation must be kept constant throughout participation in study
8. Ability to read and speak English

Exclusion Criteria:

1. Dementia as evidenced by Montreal Cognitive Assessment (MoCA) \<24
2. Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)
3. Epilepsy
4. History of stroke, CVA
5. Elevated levels of ALT, AST, BUN or creatinine
6. Chronic sinusitis as defined by SNOT-20 score \>1.0 on items 1-10.
7. Presence of other serious illness
8. History of brain surgery
9. History of structural brain damage
10. History of intranasal telangiectasia
11. Supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period.
12. Pregnant or at risk of becoming pregnant.
A Cross-sectional Study of the Oral Health of Elderly Inpatients in Acute and Subacute Hospitals in Northumberland and North Tyneside

To provide a point-in-time measurement of the oral health of elderly inpatients across the trust (elderly defined here as over 70 years). This will provide information about the number of teeth, need for restorative and periodontal treatment, and extractions, the health of the oral mucosa, quality of any dentures and hygiene of the teeth and dentures.

Such information will allow identification of any problems with oral health in this hospital population, thereby allowing development of strategies and protocols for managing these problems. There have been a number of studies examining these variables in elderly residents in care homes and a few in long term hospital settings (over 1 year admission), but only one in the UK previously in acute hospitals. Therefore the published literature is sparse, and requires further data collection. The oral health of the elderly, but particularly the institutionalized, is increasingly recognised for its important relationships with general health, wellbeing and quality of life. This study will provide useful information to address these concerns.

Eligibility Criteria:
Inclusion Criteria:

* age 70 or over and admitted to geriatric ward within the study area, able to consent

Exclusion Criteria:

* unable to consent, aged under 70
Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.

The incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. Behaviors with verbal agression and, less frequently, physical agressions, are described.

These behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression.

It is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. Such questionnaires are very rare, and none have been validated in French.

The objective of this study is to develop a questionnaire in French that aims to assess anger, hostility and aggression after acquired brain injury. The psychometric qualities of this questionnaire will be evaluated using the Rasch probabilistic model.

The development of such a tool will be of major interest for clinical practice and future clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Patients of the CHU Brugmann Hospital
* Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year).

Exclusion Criteria:

* Pregnant or lactating women
* Presence or antecedents of psychiatric disease
* Degenerative pathology (ex: Parkinson...)
* Antecedents of other neurologic pathologies before the acquired lesion
* Oral or written comprehension dysfunctions.
Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.

You will be asked to undergo a face to face interview. During the interview, you will be asked questions about your values and feelings about your health status. You will be shown a "feeling thermometer" and asked to rate how your health condition makes you feel. You will also be asked to rate how some of the risks of treatment of cervix cancer make you feel. You will be shown a "chance board" and asked to consider some of the possible outcomes of the disease and possible risks associated with the treatment of cervix cancer. You will be asked to consider the likelihood of achieving certain outcomes and of developing certain side effects due to the disease and/or treatment. The interview will take place in a private room in the clinic and should take around 20 minutes to complete.

This is an investigational study. As many as 96 women will participate in this study. Up to 48 women who are at high risk of developing cervix cancer and up to 48 women who have been diagnosed with cervix cancer will participate. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Women who are at least 18 years of age.
2. Women who speak English
3. Women presenting to the Colposcopy Clinic in the Gynecologic Oncology Clinic at M.D. Anderson Cancer Center OR women with an established diagnosis of either Stage IA2 or IB1 cervix cancer treated with radical hysterectomy 3-24 months prior to presenting to the Gynecologic Oncology

Exclusion Criteria:

1. Women who are not 18 years of age.
2. Women who are non-English speakers.
3. Women with a diagnosis of any type of cancer other than cervical cancer.
4. Women who are currently pregnant.
A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes

The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Type 2 Diabetes (T2DM).
* Participants who are insulin naive or receiving basal insulin \[NPH (neutral protamine Hagedorn) once or twice daily, once-daily insulin glargine U100 or U300, once-daily insulin degludec, or insulin detemir once or twice daily\] for fewer than 5 years prior to screening.
* Have glycated hemoglobin (HbA1c) of ≥7.0 percent (%) to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or Sodium-Glucose Transport Protein 2 inhibitors who require washout.
* Have a body mass index between 27 and 40 kilograms per meter square.
* Male or female participants who are willing to comply with the contraception requirements consistent with local regulations.
* Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol.

Exclusion Criteria:

* Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study.
* Have a specific type of diabetes other than T2DM.
* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
* Participants with a history of kidney complications.
Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure

The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events.

The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Aim: Prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.

Eligibility Criteria:
Inclusion Criteria:

* Respiratory Failure Requiring Intubation

Exclusion Criteria:

* Pregnancy
* Patients intubated during code blue clinical scenarios
* Requiring surgical airway
* Failed intubations
* MAP less than 65 or Systolic Blood Pressure (SBP) less than 90mmHg pre-intubation
* Systolic blood pressure greater than 150mmHg
* Prisoners
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer

Current therapies for Stage III or IV Ovarian Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage III or IV Ovarian Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or IV Ovarian Cancer.

Stage III or IV Ovarian Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage III or IV Ovarian Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage III or IV Ovarian Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage III or IV epithelial or germ cell ovarian cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
* Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure

Renal:

* Creatinine no greater than 2.5 mg/mL
* No renal insufficiency
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No uncontrolled hypertension
* No history of congestive heart failure
* No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study participation
* No active infection
* No concurrent serious systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

* Concurrent corticosteroids allowed (e.g., dexamethasone or methylprednisone)

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplaston therapy
* No other concurrent antineoplastic agents
Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis

The hypothesis being tested is that inhibition of the enzyme known as elastase in the airways of patients with cystic fibrosis will help decrease the number of bacteria. Alpha1 antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by aerosol therapy twice in 1 day and sputum will be collected to measure the density of bacteria

Cystic fibrosis is usually characterized by chronic bacterial infections of the airways. Neutrophils release the enzyme elastase in the airways and this enzyme can prevent the ingestion and killing of bacteria by the airway phagocytic cells. The hypothesis being tested is that inhibition of elastase in the airways will help neutrophils decrease the number of bacteria. Each subject with cystic fibrosis will first undergo aerosol therapy with a sterile saline solution and sputum will be collected 2, 4 and 6 hours after the aerosol therapy to measure the density of bacteria. Subsequently, alpha1 antitrypsin, an elastase inhibitor, will be given to the same patients by aerosol therapy twice in 1 day and sputum will be collected at 2, 4 and 6 hours after treatment to measure the density of bacteria. The results will be compared to those obtained after after aerosol therapy with saline solution.

Study phase II

Study type Interventional

Study design Purpose - treatment Allocation - nonrandomized trial Masking - open Control - active Assignment - cross-over Endpoint - efficacy

Primary Outcome Measure Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Age 14 years and older
* Women must have a negative pregnancy test and used effective contraception
* Must be able to produce sputum
* Sputum culture positive for Pseudomonas aeruginosa

Exclusion Criteria:

-
ODM-207 in Patients With Advance Solid Tumours

This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
* Life expectancy \>12 weeks
* Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
* ECOG performance status of 0 to 1

Exclusion Criteria:

* History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
* Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
* History of or current leptomeningeal or brain metastasis or spinal cord compression.
Cultural Differences in Treatment Preferences and Perceptions of Acne

This study will use a survey to examine relationships between culture, race, and ethnicity with treatment preferences and perceptions for acne vulgaris.

The purpose of this study is to determine how explanatory models, perceptions, and treatment preferences of acne vulgaris vary across different cultures and racial and ethnic backgrounds. This study will also use Willingness to Pay to investigate differences in treatment valuation. Clarifying these differences will better inform patient counseling and treatment adherence by improving the quality of shared decision making.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have acne vulgaris, be at least 18 years of age, and must be able to complete a survey published in English.

Exclusion Criteria:

-
Nudges for Statin Prescribing in Primary Care

The objective of the study is to evaluate the effect of nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet national guidelines.

Cardiovascular disease (CVD) is the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing the risk of CVD-related events and mortality, but statins are often not prescribed for patients that meet evidence-based guidelines. In this study, the investigators will evaluate nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet the United States Preventive Task Force guidelines, patients with clinical atherosclerotic cardiovascular disease (ASCVD) condition, and patients with a history of familial hyperlipidemia. In partnership with the health system, this will be conducted as a 4-arm factorial, cluster randomized trial to evaluate the effect of the interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Have new or return visit with a primary care provider at one of the study practices at the University of Pennsylvania Health System
2. Either have an ASCVD condition, history of familial hyperlipidemia, or meet United State Preventive Task Force Guidelines for Statin Therapy which includes age 40-75 years, at least 1 cardiovascular risk factor (e.g. dyslipidemia, diabetes, hypertension, smoking), 10-year ASVCD risk score ≥ 10%

Exclusion Criteria:

1. Already prescribed a statin
2. Allergy to statins
3. Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
4. Adverse reaction to statins including statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
5. Pregnant
6. Currently breastfeeding
7. on hospice or at the end-of-life
8. On a PCSK9 Inhibitor medication

Clinicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin medication.
Gastrointestinal Manifestations Among Patients With COVID19

many patients with confirmed infection with COVID-19 suffer from different symptoms and signs of gastrointestinal symptoms

many patients with COVID1-9 infection experienced many intestinal symptoms mainly abdominal pain, vomiting, and diarrhea. This study aimed to assess the frequency of GIT manifestations among patients with COVID-19 and its impact on the outcome

Eligibility Criteria:
Inclusion Criteria:

* all patients with COVID19

Exclusion Criteria:

* patient refusal to participate in the study
Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD

To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as much as possible will improve prognosis in CHD patients compared with a strategy reflecting current best clinical practice with simvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Previous myocardial infarction

Exclusion Criteria:

* Women who are breast feeding or are pregnant