cyrilzakka/clinical-trials huggingface dataset:
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept® (donepezil hydrochloride) tablet by PK modeling.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male volunteers, 18-55 years of age, inclusive at the time of informed consent.
* Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and weight at least 55 kg and above.
* Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
* Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 60-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
* Clinical laboratory values within the clinical site's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".

Exclusion Criteria:

* Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
* Known history or presence of seizure or convulsion, unless determined as not clinically significant by the PI/Sub-Investigator.
* Known history or presence of peptic ulcer or gastrointestinal bleeding within 3 months prior to study drug administration, unless determined as not clinically significant by the PI/Sub-Investigator.
* Known risk of developing ulcers (for example, if you are taking non-steroidal anti-inflammatory drugs \[NSAIDS\] or high doses of acetylsalicylic acid \[ASA\] \[Aspirin®\]), unless determined as not clinically significant by the PI/Sub-Investigator.
* Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug experienced within 7 days prior to study drug administration, as determined by the PI/Sub-Investigator.
* Presence of any clinically significant illness within 30 days prior to dosing, as determined by the PI/Sub-Investigator
* Presence of any clinically significant illness within 30 days prior to dosing, as determined by the PI/Sub-Investigator.
A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration

The purpose of this study is to evaluate safety and tolerability after administration of KHK4951 in healthy volunteers and patients with wet age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria: Healthy Volunteers

* Voluntary written informed consent to participate in the study
* Japanese or white men 20 to \< 50 years at the time of informed consent
* BMI 18.5 to \< 30.0 at screening
* Intraocular pressure (study eye) 10.0 mm Hg to 21.0 mm Hg
* Monocular or binocular visual acuity (corrected visual acuity if correction is required) ≥ 1.0 at screening

Inclusion Criteria: Patients

* Voluntary written informed consent to participate in the study
* Age ≥ 50 years at the time of informed consent
* AMD-associated by active subfoveal CNV lesions in the study eye or juxtafoveal CNV lesions with CNV-associated findings in the fovea in the study eye
* CST ≥ 300 μm in the study eye at screening, as measured by OCT
* BCVA score ≥ 23 letters in the study eye at screening and enrollment, as measured by the ETDRS visual acuity chart
* BCVA score ≥ 58 letters in the non-study eye at screening, as measured by the ETDRS visual acuity chart
* In subjects with prior treatment of the study eye with anti-vascular endothelial growth factor (anti-VEGF) drugs such as Beovu, Eylea, Lucentis, Avastin, or Macugen, presence of response to the anti-VEGF drug(s) as judged by the investigator or subinvestigator based OCT, FA, visual acuity, or other assessment results

Exclusion Criteria: Healthy Volunteers

* Current illness requiring treatment
* History of ophthalmologic laser surgery, ophthalmologic surgery, nasolacrimal duct surgery, orany eyelid surgery affecting flow in the nasolacrimal duct
* History of or current circulatory disease (e.g., cerebrovascular or cardiovascular disease)
* History of or current dry eye
* Abnormal findings on OCT at screening or enrollment examination

Exclusion Criteria: Patients

* Clinical findings or a history of conditions other than wAMD affecting the retina and choroid (e.g., diabetic retinopathy, diabetic macular edema, myopic CNV, retinal vein occlusion, or premacular membrane) in either of the eyes
* Any of the following diseases in the study eye:

  * Glaucoma
  * Ischemic optic neuropathy
  * Retinitis pigmentosa
* Current or history of vitreous hemorrhage or macular hole in the study eye
* Any abnormality in the anterior segment of the eye or vitreous body that may affect fundus observation by OCT, color fundus photography, or fluorescein angiography
Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children

Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future.

Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.

Site of study:

This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals.

b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6-18 years old.
* Sex: both sexes.
* Physical status: American Society Of Anesthesiologist 1\& II.
* Body Mass Index \>5 th and \< the 85th percentile for age.
* Type of operations: elective intracranial surgeries under general anesthesia.
* Duration of operation \< 3 hours.
* Written informed consent from the parent of child

Exclusion Criteria:

* Altered mental state
* Unsuitability for extubation.
* Patients on beta blocker, alpha 2 agonist.
* Patients on pain killer or with known history of allergy to study drugs.
* Hepatic, renal, Cardiovascular and respiratory disease.
* The patient has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools

The purpose of this study is to determine the effects of a commercial hand washing promotion program on hygiene knowledge, attitudes, and practices, and on health outcomes such as reported infectious illnesses and school absences.

Diarrheal and respiratory diseases cause 3.8 million deaths annually among children in the developing world. Reduced rates of these diseases have been measured during intensive, home-based handwashing interventions. We evaluated a school-based handwashing program for 1st grade students to determine whether a more scalable intervention could also reduce illness rates, and impact hygiene knowledge and attitudes.

Thirty schools from each of 3 counties in Fujian Province, China, were randomized to one of the following groups: a) control; b) standard intervention, which included a handwashing program (1 hour of hygiene instruction and 1 soap sample kit per pupil); or c) expanded intervention, which included the handwashing program, soap for school sinks and 1 peer hygiene monitor per class. Teachers collected illness symptom information from students weekly and recorded student absences daily between January and April, 2005. Mean illness and absence rates were calculated for each school. Students were given a knowledge, attitudes, and practices questionnaire before the intervention and again 5 months later.

Eligibility Criteria:
Inclusion Criteria:

* school has running water

Exclusion Criteria:

* school has not previously received commercial handwashing promotion program
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder

This is a prospective, single-center, placebo-controlled, non-comparative, phase II study to evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears.

The study including its financial support was approved by the medical director of the General Accident Insurance Institution (AUVA) , Dr. Roland Frank.

Hypothesis to prove: Adjuvant intravenous therapy with zoledronic acid does improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.,


Eligibility Criteria:
Inclusion Criteria

* Age between 50 and 70 years
* Magnetic resonance imaging verified rotator cuff tear (within 6 month prior to surgery)
* Rupture size with a maximum diameter of 3 cm
* Willingness to participate in the study
* Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperativel

Exclusion Criteria:

* Patients younger than 50 or older than 70 years of age
* Pregnancy
* Known allergy to zoledronic acid or other components of the medicinal product
* Previous fracture of the affected shoulder
* Previous surgery of the affected shoulder
* Previous or existing bacterial infection of the affected shoulder
* Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear)
* Isolated subscapularis tendon tear
* Presence of glenohumeral osteoarthritis (Hamada type 3 or higher)
* Diabetes mellitus (fasting glucose ≥ 126 mg/dl, HbA1C ≥ ZORRO Version Draft1.0/09.05.2022 Page 6 of 42 6.5%)
* Malignant tumor disease
* Pathological dental status
* Known disease that interferes with bone metabolism
* Concomitant diseases that do not permit general anesthesia
* Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)
* Epilepsy
* Claustrophobia
* Chronic alcohol abuse
* Drug abuse
Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma

Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1\*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.


Eligibility Criteria:
Inclusion Criteria:

* Brain-damaged patients in coma (trauma or anoxic origin).
* Male and female, ranging in age from 18 to 75 years.

Exclusion Criteria:

* Withdrawal of consent from the patients (or the persons having legal responsibility for them).
* Sedation or general anaesthesia during assessement period (\< 24 hours).
* MRI contraindications
A Clinical Trial to Investigate the Efficacy of a Supplement to Improve and Maintain Cognitive Function and Memory

This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years
* Regular experience of symptoms related to cognitive decline (e.g., forgetfulness, lack of focus, brain fog)
* Generally healthy without uncontrolled chronic diseases
* Willingness to avoid certain medications and supplements during the study

Exclusion Criteria:

* Any medical condition or treatment impacting cognitive ability Mental health or neurological disorders
* Severe allergies, particularly to soy or other product ingredients
* Taking blood thinning medication
* Recent or planned surgeries
* Major illness in the past three months
The Effect of Erector Spina Plan Block Application Time on Postoperative Anxiety

we aimed to compare the effect of preoperative awake or post-induction erector spina plane block on patient anxiety and recovery quality in patients who will undergo elective lumbar disc hernioplasty.

Postoperative recovery quality can be tested with the Quality of Recovery-40 (QoR-40) questionnaire. Preoperative anxiety can be detected through structured and standardized screening with the State-Trait Anxiety Inventory (STAI) I and II. In our study, 108 patients between the ages of 18-70 who were planned for lumbar disc hernioplasty will be included. Preoperative Quality of Recovery-40 (QoR40), STAI I and II scores (anxiety questionnaire) will be administered to each patient.The patients will be divided into two groups as preoperative ve intraoperative group. Erector spina plane block will be applied to preoperative group patients in the preoperative period. In the intraoperative group, erector spina plane block will be applied after anesthesia induction. The STAI and Quality of Recovery-40 (QoR40) questionnaire will be repeated postoperatively, the Numerical Rating Scale (NRS) and postoperative patient satisfaction will be measured.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* American Society of Anesthesiologists score I-II-III
* Patients who can read and write
* Can speak Turkish language clearly

Exclusion Criteria:

* Visual and hearing impaired
* Those with dementia
* Known serious heart, kidney and liver diseases
* Life-threatening hematological diseases
* Central and peripheral neurological diseases
* Psychiatric disorders
* History of allergy to amide type local anesthetics
* Infection in the block area
* Bleeding diathesis
* Morbidly obese (patients with BMI 40 and above)
* A history of narcotic drug use within 24 hours before the operation
* Those with narcotic substance and alcohol addiction related to chronic pain
* Patients who refused to participate in the study
Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients

1. Assess the impact of midodrine administration on weaning of IV vasopressors
2. Assess the cost effectiveness of using midodrine in critically ill patients

A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows

1. Group 1(n=30):will receive IV vasopressor infusion only
2. Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18-80)years
2. Hypotensive (systolic blood pressure\<90mm Hg)and require IV vasopressor for more than 24 hours
3. Require IV vasopressor at rate \< 8mcg/min and unable to wean for \>24 hours

Exclusion Criteria:

1. Severe organic heart disease (ejection fraction \<30 percent due to higher risk of arrythmia)
2. Bradycardia (HR\<50 b/m)due to higher likelihood of symptomatic bradycardia
3. Chronic kidney disease (serum creatinine \>2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
4. Thyrotoxicosis
5. Known allergy to midodrine
Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.

Approximately 200 patients will be included in the study and randomized to either condition.

The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBS given by physician
* At screening fulfilling Rome III-criteria for IBS

Exclusion Criteria:

* Severe depression
* Suicidal ideation
* Presence of unexplained IBS alarm symptoms
Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block

This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.

Thoracic paravertebral block (TPVB) application has also been used in recent years due to the lower incidence of side effects. The erector spinae plane block (ESPB)has been used as a part of multimodal analgesia in recent years. In ESPB is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle . ESPB creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves . Midtransverse process to pleura (MTP) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura. Due to fenestrations present in the superior costotransverse ligament (SCTL), the drug reaches the paravertebral space

Eligibility Criteria:
Inclusion Criteria:

* lung cancer patients for thoracotomy surgeries.
* Physical status American Society of Anesthesiologists (ASA )II, III.
* Age ≥ 18 and ≤ 65 Years.
* Body mass index (BMI): \&gt; 20 kg/m2 and \&lt; 35 kg/m2

Exclusion Criteria:

* Patient refusal
* physical status ASA IV,
* Age \&lt;18 years or \&gt;65 years
* BMI \&lt; 20 kg/m2 and \&gt;35 kg/m2
* Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
* History of psychological disorders and/or chronic pain.
* Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy.
* Severe respiratory, cardiac, hepatic or renal disease.
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.

The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.

After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.

The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
* Disease duration of at least 6 months
* Must be treated with Methotrexate for at least 24 weeks
* At least 6 swollen joints and 6 tender joints
* Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
* Women of childbearing age and all males must use acceptable method of birth control

Exclusion Criteria:

* Tuberculosis
* Malignancies
* Abnormal electrocardiograms as described in the protocol
* Current infection or recurrent infections or immunodeficiency
* Liver diseases and abnormalities in liver function tests as described in the protocol
* Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
* History of demyelization diseases
* Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol