cyrilzakka/clinical-trials huggingface dataset:
Interaction Study of Timolol Eye Drops and Paroxetine Capsules

The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma levels of timolol and its main metabolites after topical application of ophthalmic timolol products.

This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy male volunteers aged 18 - 40 years will be enrolled.

Placebo or paroxetine will be given for three days after which 1 drop of timolol product will be administered once in both eyes.

The duration of the paroxetine or placebo treatment period will be 3 days. There will be four different treatment periods. A washout between the study periods will be at least 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* male
* 18 - 40 years of age
* be in good general health
* be willing to follow instructions
* provide a written informed consent
* have a BMI of 18.5 - 26
* have systolic blood pressure at least 105 mmHg
* have haemoglobin at least 135 g/l.

Exclusion Criteria:

* known hypersensitivity to timolol, paroxetine or any component of the study medications
* any contraindications to timolol treatment including asthma and obstructive lung disease
* any contraindications to paroxetine treatment
* have heart rate 50/min or less in rest
* any regular medication
* allergy requiring antihistamine or ocular or nasal treatment
* clinically significant abnormalities (from normal limits) in laboratory values: basic blood count, creatinine, ALAT, AFOS, gamma-GT, K, Na
* clinically significant EKG abnormalities assessed by the investigator
* blood donation within the last 60 days (the required time period between two donations for men given by RedCross Finland).
* participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 60 days
Physical Workload Identify in Chest Compression Position Using Surface Electromyogram

The chest compression depth decreases over time after starting continuous chest compression due to the rescuers' fatigue.

The investigators hypothesized that the frequency parameters from surface electromyogram from each muscle during chest compression may reflect the muscle fatigue of the rescuers.

Then investigators can identify which of the body are mainly used and get tired by continuous chest compression using surface electromyogram.


Eligibility Criteria:
Inclusion Criteria:

* doctors with American Heart Association Basic Life Support (AHA BLS) provider certification
* healthy, experienced health-care providers

Exclusion Criteria:

* physical pain (ex. low back, wrist)
* heart disease
Role of Serum ADAM 17 (A Disintegrin And Metalloprotease 17) and Caspase 3 in Patients With Chronic Kidney Disease

1. To evaluate clinical utility of Serum ADAM 17 (A disintegrin and metalloprotease 17) and Caspase 3 measurement in chronic kidney disease patients
2. Study relationship of serum ADAM 17 and Caspase 3 to stages of chronic kidney disease
3. Compare serum ADAM 17 and Caspase 3 levels in Diabetic Chronic kidney disease patients and Non Diabetic Chronic kidney disease patients

Kidney diseases represent a global public health problem ,It is estimated that 10-15% of the population is affected by Chronic kidney disease.(1) Chronic kidney disease (CKD) is defined by persistent urine and structural abnormalities or impaired excretory renal function ( an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2, persisting for three months or more suggestive of a loss of functional nephrons) (2) the most common contributing factors to CKD include genetic abnormalities and ageing, while the most common underlying diseases associated with CKD are diabetes and hypertension However, CKD can be also due to infectious diseases, autoimmune diseases (such as lupus), and medications (3) A disintegrin and metalloproteinase (ADAM) 17, also known as tumour necrosis factor α-converting enzyme (TACE), is a metalloproteinase that releases the ectodomains of most growth factors, cytokines, receptors and enzymes and has been associated with the presence of chronic kidney disease (5) Clinical and experimental studies have shown that ADAM17 is involved in chronic kidney disease (CKD) with a proinflammatory and profibrotic role, suggesting that it could be an important mediator of CKD progression. ADAM17 inhibition attenuates fibrosis and inflammation, suggesting that its inhibition may be a possible new valuable therapeutic tool in fibrotic kidney disease treatment(6) Caspases (cysteine aspartases, cysteine-aspartic proteases) are protease enzymes which play a role in apoptotic pathway. Their name derives from their specific cysteine protease activity . Most cells have caspases in an inactive proenzyme form, which is activated and induces other pro-caspases, thus initiating a protease cascade. This process is able to amplify the apoptotic signaling pathway and to induce rapid cell death, ,Caspase-3 plays a dominant role in apoptosis, involved in the pathogenesis and progression of chronic kidney disease (CKD).(7)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic kidney disease
2. Patients with different contributing factors e.g Diabetis mellitus, Hypertension ,autoimmune diseases.

Exclusion Criteria:

1. Patients with pulmonary oedema or hepatic disease .
2. Patients with known any organ malignancy.
Topical Ruxolitinib Lichen Planus

To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.

This is a single center, exploratory, open-label, single-arm design study of 12 patients. Treatment naïve and treatment refractory patients with LP will be treated with INCB018424 PHOSPHATE CREAM. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. The study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). The screening and washout period will allow for treatment naïve/ new diagnosis LP to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. The total duration of the study will be 13-16 weeks.

Eligibility Criteria:
Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator.

Subjects must give written, signed, and dated informed consent before any study related activity is performed.

When appropriate, a legal representative will sign the informed consent according to local laws and regulation

Both men and women must be at least 18 years of age at the time of screening

Subjects must have clinical and histological features of LP

LP must involve between 2 and 20% of the BSA

Subjects must have a minimum of 10 lesions of LP

Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP

Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid
RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX

It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study

For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and RAD001 will be started at one or two dose below the ordinary full dose of each drug as a single agent.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
* No history of chemotherapy or radiation
* Age 18 to 70 years old
* Estimated life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow function (white blood cell counts \>3,000/uL, absolute neutrophil count\>1,500/uL, Platelets\>100,000/uL, Hgb\>8 g/dL)
* Adequate kidney function (creatinine\<1.5 mg/dL)
* Adequate liver function (bilirubin\<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \<3 times the upper normal limit (5 times for patients with liver metastasis))
* Signed written informed consent

Exclusion Criteria:

* Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
* Presence of central nervous system metastasis
* Bowel obstruction
* Evidence of serious gastrointestinal bleeding
* Peripheral neuropathy (NCI CTC AE version 3.0 \> Grade I)
* History of significant neurologic or psychiatric disorders
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions
* Patients with known history of ischemic heart disease and/or with myocardial infarction
* Known allergy to study drugs
* Administration of drugs showing interaction with RAD001
The Association Between Areca-nut Chewing Habit and Metabolic Syndrome

The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS), the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal patients. The current study was designed as a case-control study. Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing are defined as case group. Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing are defined as control group. The participants' age, blood pressures, and smoking habits will be recorded. Body weight, height, waist, and hip circumferences will be measured. Fasting venous blood samples will be obtained to determine hematological parameters \[i.e., serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis factor-alpha, and interleukin-6)\]. Logistic regression analyses are going to perform to examine the relationship between areca nut chewing and MS in this population. If we can make sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can teach people to quit areca nut chewing in order to avoid the possibility of developing metabolic syndrome and cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients proved to be oral and esophageal cancer will be recruited.

Exclusion Criteria:

* Subjects with diabetes mellitus, liver, renal diseases, or undergoing statin therapy.
* Taking antioxidant vitamins supplements.
A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-\[(diphenylmethyl)sulfinyl\]acetamide) is a novel wake- and vigilance-promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 50 years
2. Patient is agreeable to conditions of study and signs consent form
Randomized Controlled Trial of Remote Symptoms Monitoring with Resilience PRO Compared to Care As Usual Only

The goal of this clinical trial is to learn if Resilience PRO, a digital solution performing remote symptoms monitoring, can improve the quality of life of patients with a diagnosis of cancer receiving systemic anticancer treatment.

The main question it aims to answer is:

- Do patients with a diagnosis of cancer receiving systemic anticancer therapy and using Resilience PRO have an improved quality of life? Researchers will compare patients using Resilience PRO plus care as usual to patients receiving care as usual only.

Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Participants both in the control arm and in the intervention arm will further receive care as usual.

Resilience PRO is a digital medical device (dMD CE marked, class IIa) that enables the remote monitoring of patients diagnosed with cancer receiving anticancer systemic therapy. Resilience PRO has been positively evaluated by the French health authorities (HAS, Haute Autorité de Santé) and is registered on the French LATM list (Liste des Activités de Télésurveillance Médicale).

Resilience PRO is a software medical device prescribed by cancer treating physicians to collect electronic patient-reported outcomes (ePRO). The Resilience PRO workflow comprises the following steps:

* Step 1. Collection of ePRO
* Step 2. Intelligent analysis and alerts
* Step 3. Adapted care

Eligibility Criteria:
Inclusion Criteria:

* Age: Adults ≥ 18 years.
* Informed Consent: Patient giving signed informed consent to participate in the RC - 102 clinical study.
* Diagnosis: Patients with cancer at any stage.
* Systemic Treatment
* Remote Monitoring Eligibility: Access to a smartphone
* Language: Ability to understand and communicate in the language(s) in which the trial is conducted.

Exclusion Criteria:

* Age: Patients under 18 years of age.
* Life Expectancy: Patients with a life expectancy of less than 6 months as estimated by the treating physician.
* Concurrent remote monitoring
* HSCT or CAR-T Therapy
* Cognitive Impairment
* Pregnancy or breastfeeding
* Subject under administrative or judicial control
Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes

The aim of this proposed study is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) in children's interstitial lung diseases(chILD) with genetic causes. This study is a randomized controlled clinical trial.

Children Interstitial lung disease (chILD) is a heterogeneous group of rare respiratory disorders of known and unknown etiologies that are mostly chronic and associated with high morbidity and mortality. Genetic factors are important contributors to chILD. Genetic variations have been mainly described in genes encoding (or interacting with) the surfactant proteins (SP): SP-C (SFTPC) and the ATP-binding cassette-family A-member 3 (ABCA3) (ABCA3), and less frequently in the genes encoding NKX homeobox 2 (NKX2)-1 (NKX2-1), SP-B (SFTPB), SP-A (SFTPA) and other genes.

Hydroxychloroquine has been reported to be useful in cases or case series of chILD including those with genetic causes alone or in combination with systemic steroids. However, the efficacy is highly variable and no randomized controlled study has been reported. The study is a randomized controlled investigation aiming to evaluate the efficacy and safety of hydroxychloroquine in chILD with genetic causes.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of chILD with age\<18 years
* Genetically diagnosed (e.g. SFTPC, SFTPB, ABCA3, NKX2-1, CSF2RA, CSF2RB, IARS, MARS, COPA, SLC7A7, LRBA)
* Patients have to be clinically stable with no major changes in their medication in the last 4 weeks
* No HCQ treatment in the last 12 weeks
* Signed and dated informed consent of the subject (if subject has the ability) and the representatives (of underaged children) must be available before start of any specific trial procedures

Exclusion Criteria:

* Acute severe infectious exacerbations
* Known hypersensitivity to HCQ, or other ingredients of the tablets
* Proven retinopathy or maculopathy
* Renal insufficiency at screening, defined as glomerular filtration rate (GFR)\< 40 mL/min/1.73 m2 in patients aged 3 to 8 weeks\< 60 mL/min/1.73 m2 in patients ≥ 8 weeks of age
* Participation in other clinical trials during the present clinical trial
VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)

The objective of this study is to assess the safety of VY-AADC02 in participants with Parkinson's disease (PD) with motor fluctuations.


Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females, 40 to 75 years of age (inclusive)
2. Diagnosis of PD, consistent with United Kingdom Brain Bank Criteria
3. Motor responsiveness to dopaminergic therapy, demonstrated by improvement in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS III score)
4. Disease duration from diagnosis of ≥4 years
5. An average of ≥3 hours of OFF time (that is, periods of insufficient control of motor PD symptoms) per day over 3 consecutive days as confirmed by the PD Diary
6. A stable, optimal regimen of Parkinson's medications including levodopa for at least weeks prior to screening evaluation. Participants must have a minimum duration of levodopa treatment of ≥1 year
7. In the judgment of the Investigator, stable Parkinson's features and symptoms for at least 4 weeks prior to screening evaluation
8. Agrees to defer any elective neurological surgery, including deep brain stimulation or ablation procedure for PD, levodopa or apomorphine infusion, or the addition of new dopaminergic formulations until after the study is completed, if medically appropriate
9. Ability to travel to study visits

Key Exclusion Criteria:

1. Atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins, as determined by the Investigator
2. Montreal Cognitive Assessment (MoCA) score \<26
3. New or unstable psychiatric conditions (psychosis, depression) within 1 year of screening
4. Brain imaging abnormalities in the striatum or other regions that would substantially increase risk of surgery
5. Contraindication to magnetic resonance imaging (MRI) and/or gadolinium-based contrast agents
6. Prior brain surgery, infusion therapies or planned treatments that could complicate the study procedure or negatively impact study evaluations as determined from participant interview, screening MRI, or medical records
7. History of malignancy other than treated carcinoma in situ within 3 years of screening evaluation
8. Prior gene transfer, current treatment with any investigational agent (drug or device) within 2 months of screening evaluation, or participation or plans to participate in another research study
9. Severe, biphasic and/or uncontrolled dyskinesia
10. Disabling or uncontrolled impulse control disorders
Food Effect Study of Codeine Sulfate

The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.
Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)

This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.

This study investigates whether adding digestive pancreatic enzymes to oral nutritional supplements (ONS) can improve nutrient absorption in older adults at risk of malnutrition. While ONS are commonly recommended, their effectiveness is often limited due to age-related declines in exocrine pancreatic function, leading to reduced enzyme secretion. Studies indicate that pancreatic lipase levels decline with age, potentially impairing nutrient digestion and absorption.

The study proposes using pancrelipase (Zenpep®), an FDA-approved pancreatic enzyme replacement therapy, to enhance nutrient bioavailability. The randomized, placebo-controlled trial will assess whether pancrelipase improves postprandial levels of amino acids, fatty acids, and glucose in hospitalized patients at nutritional risk.

The study aims to determine if pancreatic enzyme supplementation can enhance nutrient absorption and provide a novel strategy for managing malnutrition in older adults without diagnosed exocrine pancreatic insufficiency (EPI). If successful, this approach could improve clinical outcomes, reduce healthcare costs, and enhance quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Male or female 70 years of age or older
* Hospitalized at site
* Nutrition Risk Screening 2002 (NRS-2002) ≥ 3
* eGFR ≥ 30 mL/min/1.73 m2 (EPI-CKD) based on medical history (no older than 6 months)
* Ability to eat orally

Exclusion Criteria:

* Patients with acute cardiovascular event ≤ 2 days
* Patients with terminal conditions
* Patients diagnosed with pancreatic exocrine insufficiency (EPI) treated with pancreatic enzyme replacement therapy (PERT)
* Patients having a planned transplant or new-onset dialysis in the next 6 months.
* Patients having a colectomy, resection of the small intestine or cholecystectomy
* Known hypersensitivity to any of the substances or excipients of the ONS or the medicinal product
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HGP1602 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator