cyrilzakka/clinical-trials huggingface dataset:
Pro-self Pain Management in Norway

The main aim of this study is to evaluate whether a patient education programme on cancer pain management compared to standard care decreases pain and increases patients quality of life. The investigators hypothesis is that patients and family caregivers who receive the intervention will have improved outcomes. Patients and family members are seen in their homes by the nurses doing the intervention over 6 weeks. Patients keep a diary of their pain and medication intake.

The undertreatment of cancer pain remains a significant clinical problem. The PRO-SELF Pain Control Program is a 6 week psychoeducational intervention that was shown to improve pain management in oncology outpatients with pain from bone metastasis. However, this promising intervention requires replication in samples of oncology patients with cancer pain outside of the United States.

The purpose of the study was to test the effectiveness of The PRO-SELF Pain Control Program in Norwegian cancer patients and their family caregivers. Only data on patient outcomes will be presented.

The theoretical framework for this study incorporated elements of Orem's self-care theory, as well as the principles of academic detailing and nurse coaching to change patients' self-care behaviors regarding cancer pain management.

Two hundred adult cancer patients with pain from skeletal metastasis and their caregivers participated in this study. Patients were randomized to either the PRO-SELF program or standard care. Patients completed questionnaires about pain, physical functioning, quality of life, anxiety, and depression at the time of enrollment and after 6 weeks. Data on analgesics were collected through chart reviews and patient diaries. Both groups received home visits and telephone calls by an oncology nurse over a period of six weeks. Participants in the intervention group received education about pain management and were coached to improve their pain management behaviors. Two-way repeated measures analyses of variance will be done to determine differences in pain intensity scores and to evaluate the differences over time in the total amount of opioid analgesics taken by the patients.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Radiographic evidence of bone metastasis
* Able to read and write Norwegian
* Average pain intensity of greater than 2.5

Exclusion Criteria:

* Brain metastasis
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

An exploratory study to investigate the effects of RTA 402 on glomerular filtration rate in CKD patients with type 2 diabetes mellitus.

To evaluate the safety of RTA 402.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients with type 2 diabetes mellitus
* Patients whose eGFR levels are eligible for this study
* Patients being treated with stable dose of ACE inhibitors and/or ARB etc.

Exclusion Criteria:

* Patients with Type 1 diabetes
* Patients with known non-diabetic renal disease
* Patients with a history of renal transplantation
* Patients with mean SBP \> 160 mmHg or mean DBP \> 90 mmHg
* Patients with HbA1C \> 10%
* Patients with cardiovascular disease specified in the study protocol
* Patients for whom Inulead® injection is contraindicated etc.
A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to investigate the efficacy and confirm the safety of E0302 in patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of survival rate and functional rating scale.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
2. Patients who are aged 20 years or older at the time of obtaining informed consent.
3. Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
4. Patients who are at stage 1 or 2 of the severity criteria for ALS.
5. Patients within 3-year elapsed time period from disease onset at the start of observation period.
6. Patients who can visit study site for out-patient treatment.

Exclusion Criteria:

1. Patients who underwent tracheostomy.
2. Patients who experienced non-invasive positive pressure ventilation.
3. Patients whose percent-predicted forced vital capacity (%FVC) is \>=60%.
4. Patients with multiple disturbances of conduction detected by nerve conduction test.
5. Patients with neurological symptom(s) due to vitamin B12 deficiency.
6. Patients who initiated newly introduced riluzole therapy after starting the observation period. Or those who received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation.
7. Patients with cognitive impairment.
8. Pregnant women or women with a possibility of becoming pregnant.
9. Patients or their partners who are not willing to use reliable contraception.
10. Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare" (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3).
11. Patients with malignant tumor.
12. Patients who participated in another clinical study within 12 weeks before starting the observation period.
13. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
14. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model

Prospective, non-interventional study carried out after culturing placental trophoblastic tissue ex vivo and infection with Zika and Tonate

The analysis will relate for each virus studied + control + favipiravir to 1 placenta in the 1st trimester and 1 placenta at term.

2 experiments per virus will be planned.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Singleton pregnancy of normal course, at term, birth by caesarean section OR
* Trophoblast from Voluntary Termination of Pregnancy (IVG), after endo-uterine aspiration

Exclusion Criteria:

* Need for pathological, genetic or bacteriological examination of the placenta
* Multiple pregnancy
* HBV+ (Hepatitis B positive), HCV+ (Hepatitis C positive) , known CMV seroconversion during pregnancy (CytoMégaloVirus)
* Immunosuppression (drugs, corticosteroids, etc.)
* Diabetes
* Pre eclampsia
* Intrauterine growth retardation (IUGR),
* Vascular or placental pathology.
* Refusal to participate
* Patient under guardianship / curatorship / security measure
* Patient under AME (state medical aid)
Effects of Allium Hookeri on Blood Glucose

The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.

Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although the antidiabetic activities of Allium hookeri have been documented in animal studies, the improved effects of Allium hookeri on human are not clear. Therefore, in this study, the researchers investigated whether Allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.

Eligibility Criteria:
Inclusion Criteria:

* Fasting glucose 100\~126 mg/dl

Exclusion Criteria:

* Significant variation in weight (more 10%) in the past 3 months
* Treatment by hypoglycemic and hypolipidemic drug therapy within the past three months
* Type 1 diabetes or HbA1c\>9.0%
* Cardiovascular disease
* Hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts
* Pregnancy or breast feeding
Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms

The purpose of this study is to determine if a single dose of pregabalin 300mg in patients receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful differences in measures of "drug liking" and "drug high" as compared to placebo.

Pregabalin is currently being explored as a pharmacotherapy for substance use disorders. Open-labeled, uncontrolled studies indicate modest efficacy of pregabalin in benzodiazepine withdrawal symptom management and as a long-term benzodiazepine dependence treatment. Concurrently, there is increasing information from case reports and adverse drug event registries regarding pregabalin abuse in patients with substance use disorders.

Given that the abuse liability of pregabalin has not been clearly established, nor its effects on benzodiazepine withdrawal symptoms in inpatients, this study is a randomized, double-blind, placebo-controlled, cross-over, abuse liability study of a single dose of pregabalin 300mg, nested within a randomized,double-blind placebo-controlled, feasibility study evaluating pregabalin's effects on withdrawal symptoms in inpatients undergoing medically-assisted withdrawal from benzodiazepine, zopiclone or zolpidem.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Medical Withdrawal Unit at the Centre for Addiction and Mental Health for medically assisted withdrawal from benzodiazepines, zopiclone and/or zolpidem
* Willing and capable to give written informed consent

Exclusion Criteria:

* Patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.
* Pregnant or nursing women
* Renal impairment (creatinine clearance less than 60ml/min)
* History of angioedema, or taking drugs associated with angioedema (e.g., ACE-inhibitors).
* Currently taking pregabalin or gabapentin
* Currently taking thiazolidinedione antidiabetic agents (e.g., rosiglitazone, pioglitazone)
* Previous history of pregabalin or gabapentin abuse
Ultrasound Treatment of Rheumatoid Arthritis

The research objective of the pilot study is to assess early feasibility of safety and efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a blinded and randomized controlled trial. Specific Aims include:

* Measure RA disease activity and functional/biomarker metrics during and after a 2- week course of spleen-directed daily ultrasound treatments (within-arm and between-arm assessments); and
* Monitor adverse events during and after daily ultrasound treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Males and Females aged 18 and over.
2. Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010_revised_criteria_classification_ra.pdf).

   Classification as "definite RA" is based on the confirmed presence of synovitis in at least one joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1).
3. Exhibiting symptoms or signs of inadequate disease control according to one of 2 measures:

   Modified HAQ score of greater than 0.3 and DAS28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease_Activity_Score_-_CRP_(DAS-CRP).
4. Participants should have home access to broadband internet, such that online video conversations can occur with study personnel via study-provided personal digital assistive devices.

Exclusion Criteria:

1. Active bacterial or viral infection.
2. Pregnant women or presence of active malignancy.
3. Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ.
Effect of Anti-inflammatory Diet in Osteoarthritis

In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral radiographic symptomatic KOA
* No changes in therapy during the previous 3 months
* Interested in dietary intervention and able to provide consent and attend follow-up visits

Exclusion Criteria:

* Previous knee surgery
* Severe radiographic disease (KL grade 4)
* Rheumatoid Arthritis
* Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges)
* Use of corticosteroids and/or intra-articular injections during the preceding 3 months
* Use of fish oils and glucosamine
* Participation in a weight loss program in the preceding 6 months
* Recent changes in physical activity levels
* Regular smoking
* Patients with food allergies
* Patient with other medical conditions that will impair the ability to participate in a nutritional study
* Plan to change systemic therapy
* Patients unwilling to change dietary habits
Clinical Trial to Determine the Effectiveness and Safety of Topical Insulin in Dry Eye

This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).

Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Dry eye disease diagnosis
* Treatment with artificial tears or hyaluronic acid gels for at least 3 months
* Signed informed consent by the patient
* Staining equal to or greater than Oxford II

Exclusion Criteria:

* Under 18 years old
* Corneal staining under Oxford II
* Treatment for dry eye disease other than artificial tears or hyaluronic acid gels
* Severe dry eye disease that requires immediate treatment
* Eye surgery in the last 6 months
* Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations
* Contact lenses
* Other treatment besides artificial tears or hyaluronic acid gels
* Visual acuity less than 0.1
* Allergy or intolerance to any of the components included in the study
* Modifications in systemic immunosuppressive treatment
* Pregnancy or lactation
* Women of childbearing age who do not use a highly effective contraceptive method
* History of alcohol or drug abuse
* Participation in another clinical trial in the last 30 days
* Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Mouth Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced mouth cancer.

OBJECTIVES: I. Assess the feasibility of the administration of ethynyluracil concurrently with fluorouracil and radiotherapy in patients with advanced oral cancer. II. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities of this regimen in this patient population.

OUTLINE: This is a dose escalation study of fluorouracil and hydroxyurea. Patients receive oral ethynyluracil every 12 hours on days 1-7 and oral fluorouracil every 12 hours on days 2-6. Radiotherapy to the head and neck is administered twice daily on days 2-6. Treatment continues for 5-7 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities. Once the MTD of fluorouracil is determined, hydroxyurea is added to the treatment regimen. Patients receive fluorouracil and ethynyluracil as per the treatment schedule outlined above. Patients also receive oral hydroxyurea every 12 hours for 11 doses on days 1-6. Radiotherapy is administered as above. Cohorts of 3-6 patients receive escalating doses of hydroxyurea until the MTD is determined. Once the MTD of fluorouracil and hydroxyurea are determined, an additional 10 patients receive Phase II doses of ethynyluracil, fluorouracil and hydroxyurea as per the treatment schedule outlined above. Treatment continues in the absence of unacceptable toxicity. Patients are followed at 4-6 weeks, then every 6 months until death.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced malignant oral or laryngeal neoplasm requiring regional radiotherapy and not amenable to standard therapy Tumor site amenable to radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Expected 2 year survival less than 10% in previously untreated patients Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine clearance at least 50 mL/min Other: No severe infection or medical illness that would preclude study Must be able to swallow and retain oral medications Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Not specified
Conjunctival Allergen Challenge (CAC) Following Allergen Exposure in the Allergen BioCube (ABC)

To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age;
* if female, cannot be pregnant or nursing;
* have a history of ocular and nasal allergy;
* have a positive skin test reaction to ragweed within the past 24 months;
* may/may not have a positive skin test reaction to dust mites within the past 24 months

Exclusion Criteria:

* have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
* have a compromised lung function;
* have any ocular condition that could affect the subject's health or the study parameters;
* have any presence of active ocular or sinus infection;
* have significant nasal conditions;
* have any significant illness that could be expected to interfere with the subject's health or with the study parameters;
* use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period;
* have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH)


Eligibility Criteria:
Inclusion Criteria:

1. Must meet the World Health Organization criteria for heFH
2. Participants must be on a stable statin dose, with or without ezetimibe, for at least 6 weeks before screening
3. Serum LDL-C levels ≥ 100 mg/dL at screening
4. Willing to follow the NCEP ATPIII TLC diet, or an equivalent diet plan, starting at screening and continuing until the last study visit
5. A negative urine/serum pregnancy test at each screening visit and start of the study, for women of childbearing potential

Key Exclusion Criteria:

1. Participants with homozygous FH (clinically or by previous genotyping)
2. Use of a medication (other than a statin or EZE) to alter serum lipids within 42 days (6 weeks) before screening including, but not limited to:

   * Fibrates
   * Niacin (\>500 mg/day)
   * Omega-3 fatty acids (\>1000 mg/day of DHA/EPA)
   * Bile acid resins
3. Use of nutraceuticals or OTC medications that may alter lipid levels that are not stable for at least 6 weeks before screening and are not planned to remain constant throughout the study. Examples include:

   * Omega-3 fatty acids (≤1000 mg/day of DHA/EPA)
   * Niacin (≤500 mg/day)
   * Plant stanols, such as found in Benecol, flax seed oil, psyllium
   * Red yeast rice
4. Disorders known to influence lipid levels, such as nephrotic syndrome, significant liver disease, Cushing's disease, untreated hypothyroidism (patients on stable thyroid replacement for at least 12 weeks before the full screening visit, who are metabolically euthyroid by thyroid-stimulating hormone (TSH) testing are allowed)
5. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before the full screening visit)
6. Fasting serum TG \>350 mg/dL screening
7. LDL apheresis within 12 months before screening
Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions