cyrilzakka/clinical-trials huggingface dataset:
Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease

The objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of Korean Red Ginseng (KRG) on fatigue in patients with rheumatic diseases.

Primary objective

: Improvement of fatigue after using KRG in patients with rheumatic diseases according to

Secondary objectives

1. Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI)
2. Improvement of quality of life after using KRG in patients with rheumatic diseases according to EuroQol 5 dimensions questionnaire (EQ-5D)

The study population will be adult patients with rheumatic diseases, especially primary or secondary Sjögren's syndrome who have experienced dryness for more than 3 months. Participants are ramdomly assigned to KRG and placebo group and they are using KRG or placebo for the first 12 weeks. After 12 weeks, the concealment of allocation is lifted and all patients are provided with KRG for next 12 weeks with open-label extension study

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet for Classification Criteria for Sjögren's syndrome
* Patients who have experienced fatigue for over 3 months
* Patients aged ≥ 19 and \<75
* Patients who provide a written consent of participating in this study.

Exclusion Criteria:

* Patients who have experienced hypersensitivity or adverse events to Korean Red ginseng
* Patients who used dietary supplements containing KRG during recent 2 months
* Patients who are pregnant or breast-feeding
* Patients who use oral glucocorticoids or opioids continuously
* Patients who had other comorbidities which could lead to fatigue as symptoms including chronic kidney disease, chronic liver disease, endocrine disoders, malignancy, or depression.
* Patients having fibromyalgia or chronic fatigue syndrome
* Patients who presented abnormal laboratory findings at the time of enrollment White blood cell (WBC) ≤ 3.5 x 10\^9/L or, Hemoglobin (Hb) ≤ 8.5 g/dL or, Platelet (PLT) ≤ 100 x 10\^9/L or, Serum creatinine (Cr) ≥ 2.0 mg/dL or, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥ 2.5 times of upper limits of normal
Omarigliptin in Four Healthy Egyptian Volunteers

The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the four volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from four, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed \& validated) after single oral dose administration of one Marizev® tablet nominally containing 12.5 mg of Omarigliptin (first arm as 4 volunteers). The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines \& the evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Type-2 diabetes
* Hospitalized within 1 week
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

The secondary aims are to:

* validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
* assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
* assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
* evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
* evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
* evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
* establish the minimum sample weight required to achieve a result with the Respirio Flu Test.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥ 1 year;
* Rhinorrhea;
* ≤ 72 hours from onset of Influenza-like illness symptoms;
* Subject (or parent/legal guardian) capable and willing to give informed consent/assent.
* Subject (or parent/legal guardian) able to read and write in English.

Exclusion Criteria:

* Has undergone treatment with antivirals within the previous 7 days;
* Has been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
* Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
* Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
* Has had prior exposure to the Respirio Flu Test;
* Subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.
A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Insulin-naive
* Non-smoker

Exclusion Criteria:

* Significant pulmonary, hepatic or renal disease
* severe congestive heart failure
* active malignancy or malignancy within the last 5 years
* systemic glucocorticoid therapy
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects

The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P glycoprotein (P-gp) (Part 2) and breast cancer resistance protein (BCRP)/organic anion transporting polypeptide (OATP)1B1 (Part 3) inhibition in the fed state in healthy male subjects.

Part 1: The estimated time from screening until the follow-up phone call is approximately 6 weeks per subject.

Part 2: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject.

Part 3: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants aged 18 to 55 years old
* Must agree to use an adequate method of contraception
* Must be able to understand and provide a written informed consent

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
* Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
* Failure to satisfy the investigator of fitness to participate for any other reason.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Is the Normal Looking Bladder Mucosa on WL Cystoscopy During TURBT Really Normal and Can NBI Detect Hidden Tumor

As every urologist does transurethral resection of bladder tumor. So there are instances in which the operating surgeon is not sure whether the normal-looking mucosa or the inflammatory changes are really benign or if we are missing the CIS/bladder cancer.

This is basically the observational study. in which we want to clarify that the normal-looking mucosa on white light cystoscopy is normal in reality or we are missing CIS/bladder tumor.

Eligibility Criteria:
Inclusion Criteria:

any patient with bladder tumor

-

Exclusion Criteria:

* any patient whose age is less than 18 years any patient whose age is more than 75 years
Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France

The primary objective of this study are:

- Describe the characteristics of all patients initiating sodium-glucose co-transporter-2 inhibitors (SGLT2i) and the modalities of prescriptions of these two drugs and the concomitant treatments.

The secondary objectives are:

* Assess the occurrence of atheromatous cardiovascular events (unstable angina, fatal and non-fatal Myocardial infarction (MI), Transient ischemic attack (TIA), fatal and non-fatal stroke), deaths from all causes, hospitalization for heart failure and hospitalization for end-stage renal disease as main and related diagnoses during the exposure to the studied treatment
* Assess the occurrence of the main safety events (ketoacidosis, lower limb amputation and Fournier's gangrene) during the exposure to the studied treatment


Eligibility Criteria:
Inclusion Criteria:

* population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.

Exclusion Criteria:

* None
Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety

This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 6 through 12 years, of any race/ethnicity;
* English- or Spanish-speaking child and parent;
* Have experienced at least one prior dental cleaning;
* If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited).

Exclusion Criteria:

* Dental cleaning within the previous 4 months (i.e., not in need of cleaning);
* Plan to move out of the area within 6 months;
* Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties);
* Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures);
* Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings);
* Presence of orthodontia (braces) or with a plan to get braces in the upcoming 6 months
Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
* Non-smoker, defined as no nicotine consumption for at least one year
* Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

* Previous participation in this trial or other clinical trials within the last 3 months
* Body weight above 87.5 kg
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
* History of alcohol or drug abuse
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease

The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
* Diagnosed with PD within 7 years at the time of initial enrollment (i.e., at time of SAD enrollment for rollover participants), without major motor fluctuations or dyskinesia that may interfere with study treatment and assessments in the opinion of the investigator after consultation with the Sponsor.
* Modified Hoehn and Yahr Stage ≤ 3.

Key Exclusion Criteria:

* Montreal Cognitive Assessment (MoCA) score less than (\<) 23, dementia, or other significant cognitive impairment that, in the opinion of the Investigator, would interfere with study evaluation.
* History of any brain surgery for PD or a history of focused ultrasound treatment at any time; or history of neuromodulation procedures.
* Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year before Screening.
* History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities within 1 year before Screening.
* Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin value greater than or equal to (≥) 8 percent (%) at Screening.
* History or positive test result at Screening for human immunodeficiency virus.
* History or positive test result at Screening for hepatitis C virus antibody.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effectiveness of Virtual Patient Simulation Versus Peer Simulation in Providing Sexual Counseling During Pregnancy

The aim of this study is to compare, in a multidimensional manner, the effectiveness of different educational methods-virtual patient simulation and peer simulation-in improving sexual counseling skills during pregnancy among nursing faculty students.

The study will evaluate three different training methods: virtual patient simulation, peer simulation conducted in a virtual environment, and face-to-face peer simulation. To determine the effectiveness of peer simulation and virtual patient simulation in sexual health counseling, multimodal data collection and analysis methods will be used. These methods will contribute to the development of counseling skills by examining in detail the verbal and non-verbal communication elements exhibited by participants during their interactions with virtual patients and peers. Throughout the research process, students' demographic characteristics, sexual attitudes and beliefs, sexual counseling skills, learning satisfaction and self-confidence levels, opinions on system usability, eye-tracking data, and body movements will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Having the ability to provide care for pregnant women - Providing informed consent to participate in the study

Exclusion Criteria:

* Having suspended enrollment or taken a leave of absence from education.
* Having received formal education aimed at developing sexual counseling skills.
* Wearing glasses (as it may interfere with the use of wearable eye-tracking systems).
The Effect of Preventive Use of Ondansetron in the Cesarean Section Under Spinal Anesthesia

Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population. The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension

Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia, in our Institute over than 90% of the elective cesarean sections are under spinal anesthesia, however this kind of anesthesia frequently associated with, side effects that affect primarily the parturient and the fetal health. The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population . Most authors agree that hypotension presents when the systolic blood pressure decrease under 90 mmHg, or when there is a reduction from baseline of more than 20-30 %. Augmentation of the intravascular volume with crystalloids and vasopressors is the cornerstone of the treatment of spinal anesthesia induced hypotension, the vasopressors usually used are the α and β receptors agonist ephedrine and the selective α agonist phenylephrine that, gain popularity in the last years, because it's more efficacy in maintaining the umbilical cord blood PH and the Apgar score of the neonates. However many studies showed that it was inefficient and no intervention reliably prevents hypotension after spinal anesthesia for cesarean section and, bradycardia can occur from shift in cardiac autonomic balance toward the parasympathetic system from activation of left ventricular mechanoreceptors after sudden decrease in left ventricle volume causing the Bezold Jarish Reflex (BJR). Animal studies suggest that 5-HT( serotonin) may play an important factor associated inducing the BJR and this effect can be blocked at the 5-HT3 receptor using the serotonin inhibitor Ondansetron, commonly used antiemetic . Despite the fact that Ondansetron was evaluated in the management of spinal anesthesia induced hypotension in large heterogeneity and small samples , the need for more investigation in big number of cesarean sections still needed.

The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension and the amount of vasopressor phenylephrine needed to control the hypotension after spinal anesthesia and the possible effect on the umbilical cord blood PH and the Apgar score in one minute after delivery.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesia (ASA) physical status I or II

Exclusion Criteria:

Preeclampsia Cardiovascular disease
Surgery in Context of Terrorist Attack : a Survey of French Surgeons

The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack.

Survey was sent by email to French Surgeons affiliated to French Association of General Surgeons.

First series of questions are relative to age, qualification, usual surgical practice, in order to define different "surgical profiles".

Second series of questions are relative to knowledge in the field of knowledge about trauma and massive casualties surgery.

Third series of questions are relative to the feeling of easiness in case of various situations involving severe trauma and massive casualties.

Results are analyzed in order to assess the need for learning and training in the field of trauma and massive casualties surgery.

Eligibility Criteria:
Inclusion Criteria:

* French Licensed and Resident Surgeons

Exclusion Criteria:

* Medical Doctor, not Resident
A Study To Assess The Safety Of Administering CP-675,206 As A One Hour Infusion In Patients With Surgically Incurable Advanced Melanoma

This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.

This study was prematurely discontinued on April 28, 2008 because a concomitant Phase 3 study met pre-specified futility criteria. The decision to close enrollment early was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed melanoma that is surgically incurable Note: Prior therapies for melanoma, including cancer vaccines, are permitted but are not required. There is no limit to the number of prior regimens for melanoma a patient may have received.
* Evidence of at least one lesion
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* CT scan of the brain with contrast or MRI of the brain within 6 weeks prior to enrollment showing no evidence of active brain metastases. PET scans and PET/CT scans are also acceptable.

Exclusion Criteria:

* Previous treatment with other anti CTLA4 agents (eg, ipilimumab, MDX 010).
* Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP 675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma.
* History of chronic autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, etc.).
* History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT scan only.
* Brain metastases that have not been adequately treated with surgery or stereotactic radiosurgery and have not been stable at least 3 months prior to enrollment.