cyrilzakka/clinical-trials huggingface dataset:
A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy

This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of participates will receive Keluo Xin capsules while other one third will receive placebo.

This study composes two parts. The first is a 24-week period during which subjects receive designed treatment regimen; after that, subjects will be informed again for the next 24-week regimen (extention phase) and can choose whether or not to participate in the treatment (with the same regimen in the first period) voluntarily.

Eligibility Criteria:
Inclusion Criteria:

* 18 years to 70 years;
* Patients diagnosed with type 2 diabetes mellitus;
* Patients diagnosed with nonproliferative diabetic retinopathy;
* Patients diagnosed with traditional Chinese medicine syndrome(TCM) differentiation of both Qi and Yin deficiency with blood Stasis;
* HbA1c≤8.0%;

Exclusion Criteria:

* Study eye been received panretinal photocoagulation;
* Study eye with neovascular elsewhere or neovascular of the disc, or neovascularization of iris;
* Prior panretinal photocoagulation in the study eye within 6 months;
* Uncontrolled blood pressure;
* Subjects who develop chronic diarrhoea;
* Any history of acute diabetic complications;
* Any history of allergy to components of Keluo Xin capsule;
* Pregnant or breast-feeding women.
Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity. The device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old

Exclusion Criteria:

* any current traumatic lower or upper extremity injury
* unwilling or unable to provide written informed consent
* history of any anatomy-altering injury or procedure to the upper or lower extremity
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy, postmenopausal women who seek treatment for hot flashes.
2. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
3. Patients must be experiencing at least 7 moderate to severe hot flashes per day.
4. Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling.

Other inclusions apply.

Exclusion Criteria:

1. Patients with hypersensitivity to gabapentin.
2. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
3. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.

Other exclusions apply.
Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive)
* Diagnosed with atopic dermatitis
* Suffering from chronic pruritus with pruritus being actively present

Exclusion Criteria:

* Chronic pruritus due to condition other than atopic dermatitis (AD)
* Participation in a previous tradipitant (LY686017 or VLY-686) trial
* Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
* Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion

This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion


Eligibility Criteria:
Inclusion Criteria:

* All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.
* Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included

Exclusion Criteria:

* Patients with a follow-up period of fewer than 12 months.
* Patients with very severe UCE and required posterior lamellar grafts.
* Patients with etiology other than trachoma.
* Patients with dysplastic lashes without entropion were excluded
A Myth Orthopaedic Implant Pain in Cold Weather

In daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature is examined, there is only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

Fractures and degenerative joint diseases are common medical problems that many people experience throughout their lives. Orthopaedic implants are widely manufactured and used worldwide to replace a degenerated joint or to reduce a fractured bone and promote healing (1). In a 1988 incidence study, it was estimated that 4.9 million people in the USA had fixation material (2). Today, this rate is thought to increase much more due to increasing population, developing and increasing number of motorised vehicles and increasing surgical indications. Although the removal of these implants is a very controversial issue in the literature, most surgeons do not recommend routine removal of implants unless there are complications (3). In a study, it was reported that the reasons for implant removal were osteomyelitis and persistent pain in only 28% of patients, but the reason for removal was 'patient request' in 72% of patients who had implants removed (4).

In daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature was examined, there was only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma.

Exclusion Criteria:

* Patients \<18 years of age
* Patients with incomplete fracture union
* Patients with joint prosthesis (knee, hip, shoulder prosthesis, etc.)
* Patients with complications in the operated extremity (implant infection, implant failure, etc.)
* Acute or chronic infection (bacterial or viral infection) of any body site
* Patients diagnosed with neuropathy (diabetic, alcoholism, autoimmune, nutritional deficiency, infectious)
ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination

Primary Objective:

To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M

Secondary Objectives:

1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy
2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level

The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.

Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes mellitus patients
* Patients with HbA1c \>or= 7.0% and \< 10.0%
* Patients not currently treated with any oral antidiabetic drugs (OADs)

Exclusion criteria:

* Participation in other investigational Clinical Trial
* Current temporary insulin treatment: gestational diabetes, pancreas cancer, surgery etc.
* Women who are pregnant and lactating
* Type 1 diabetes mellitus patients
* Treatment with antihypertensive Angiotensin-Converting Enzyme (ACE)-Inhibitors and/or Angiotensin II Receptor Blocker (ARB) or has just stopped treatment for less than two months
* Treatment with lipid lowering agent statins or has just stopped treatment for less than two months
* Known hypersensitive to any of the excipients of Amaryl-M, sulphonylureas, sulfonamides or biguanide
* Patients with active smoking or history of smoking cessation less than 2 months
* Patients with history of severe hepatic dysfunction
* Patients with serum creatinine \>or= 1.5 mg/dL (male) and \>or= 1.4 mg/dL (female)
* Patients with congestive heart failure requiring pharmacologic treatment
* Treatment with antifungal agent especially Miconazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sinus Balloon Dilation in Pediatric Patients

Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.


Eligibility Criteria:
Inclusion Criteria:

Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.

Exclusion Criteria:

History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

Increases in life expectancy in almost all childhood-onset chronic conditions (COCC) has brought unique challenges for adolescents and young adults (AYA) who struggle to deal with the associated disease burden, manage therapies, and thrive as they develop independent self-management skills, and become active and engaged patients. The challenges that influence the lives of AYAs are largely adaptive, such as making lifestyle modifications, adhering to complex medication regimens, and learning to navigate the adult health system. Adding to this complexity is the need for AYAs to progressively take over greater self-management responsibilities from parents. Promoting activated self-management is critically important given that this shift in health care management from parents and health care providers to the AYA is identified as key to successful adult outcomes. Peer support interventions are well-suited to address challenges theorized as critical to AYAs given the importance of peer relationships during this time. The investigators propose a mixed-methods, five-year randomized controlled trial, that will include 225 AYAs (16-22 years) with COCCs, to test the Peer i-Coaching for Activated Self-Management Optimization (PICASO) versus an attention control group. This novel, mobile health intervention utilizes an established telephone/text based secure interface to allow AYAs access knowledge, experience, and instrumental/emotional support from a trained peer coach (18-26 years), who has already developed independence and is an active self-manager. The investigators will determine the efficacy of PICASO on self-management, patient activation, transition readiness, health-related quality, and emotional health of life across 12 months. The investigators will explore whether age, sex, race/ethnicity, chronic condition, and/or disease severity moderate the trajectory of PICASO effects on self-management, patient activation, coping, emotional health and health-related quality of life. Lastly, the investigators will explore mechanisms of the PICASO impact by describing AYA experiences with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* AYA 16 to 22 years
* Childhood onset chronic condition from 1 of 3 condition categories
* Read and speaks English
* Access to internet via computer or Smart Phone
* Access to telephone (Smart Phone not required as text feature can be accessed via internet)

Exclusion Criteria:

* Diagnosed cognitive dysfunction
* Need for English translator
Avascular Necrosis (AVN) Long-Term Follow-up

Long-term follow-up of IDE patients for publication

This device (Hedrocel AVN Intervention Implant) was approved via 510(k) on April 15, 2005. One site was left open to follow patients to 5 year follow-up for publication of device survivorship.

Eligibility Criteria:
Inclusion Criteria:

* Patient qualifies for core decompression based on physical exam
* No history of core decompression
* Patient is willing and able to provide written informed consent

Exclusion Criteria:

* Patient has been diagnosed as Stage 0, III, IV, V or VI using the Steinberg/UPenn staging system.
* Patient's BMI is \>40
* Patient is mentally compromised
* Patient has neurological condition in ipsilateral or contralateral limb, which affect lower limb function
* The patient has had a proximal femoral osteotomy or internal fixation in the affected hip.
* The patient has undergone previous treatment for AVN
* Previous hip conditions
* Patient's bone stock is insufficient
* Patient has diagnosed systemic disease
* Patient is a pregnant female
* Patient is unable or unwilling to attend postop follow-up visits
* Patient has received investigational drug within the previous 6 months or an investigational device within the last 12 months
* Patient has an active or latent infection
* Patient has metal sensitivity
* Patient is a prisoner
Investigating the Role of Ginger Tea ORAC Value in Hypertension Management

The purpose of this study is to evaluate the antihypertensive effects of ginger tea. By examining its impact on blood pressure levels, this research aims to determine whether ginger tea can be an effective, natural adjunct to conventional hypertension treatments.

This investigation will provide insights into its potential role in reducing the burden of hypertension and improving cardiovascular health

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 30-65 years
* Diagnosed with stage 1 or stage 2 hypertension
* Not currently taking antihypertensive medication
* Willing to provide informed consent and adhere to study protocols.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Participants on antioxidant supplements or other herbal teas.
"The MaP Study": Mapping the Patient Journey in MMA and PA

Longitudinal, exploratory, natural history study of patients with MMA due to mut deficiency and PA to characterize the changes in blood disease biomarkers over time and the frequency and severity of clinical events related to their disease.


Eligibility Criteria:
Inclusion Criteria:

MMA Only • Patient has a confirmed diagnosis of isolated MMA due to MUT deficiency (mut0 or mut-) based on the following criteria:

* Elevated plasma/serum/DBS or urine methylmalonic acid levels
* Presence of normal serum/plasma vitamin B12 and plasma homocysteine levels
* Confirmed by molecular genetic testing. Genetic testing can be performed after the administration of informed consent if not available, however, molecular genetic results must be confirmed before the second study visit

PA Only

• Patient has a confirmed diagnosis of isolated PA based on the following criteria:

* Elevated plasma/DBS/urine 2-MC and/or 3-HP
* Elevated plasma/serum/DBS propionylcarnitine (C3)
* Confirmed by genetic testing for mutations of the PCCA or PCCB genes. Genetic testing can be performed after the administration of informed consent if not available, however, molecular genetic results must be confirmed before the second study visit

Both MMA and PA

* Patient (and/or legally authorized representative as applicable to local regulations) is willing and able to comply with study-related assessments and activities
* Patient or legally authorized representative is willing and able to provide informed consent and/or assent as mandated by local regulation

Exclusion Criteria:

* Estimated GFR \<30 mL/min/1.73m2 based on age appropriate equations or patients who undergo chronic dialysis
* The patient is pregnant or lactating at the time of screening. (Note: Patients who become pregnant during the study may remain in the study) MMA Only
* Patients diagnosed with isolated MMA cblA, cblB, or cblD enzymatic subtypes or methylmalonyl-CoA epimerase deficiency or combined MMA with homocystinuria PA Only
* Patient has a confirmed diagnosis of multiple carboxylase deficiency
Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease

While the efficacy of aspirin for the secondary prevention of cardiovascular disease is evident, the effect of aspirin for primary prevention is unclear. The use of aspirin reduces cardiovascular mortality and myocardial infarction but increases side effects such as bleeding. Therefore, the use of aspirin for primary prevention in people without cardiovascular disease should be determined by individual risk and clinical benefit. The European guidelines have been changed to not recommend aspirin use in people without cardiovascular disease, but there are still people taking aspirin for primary prevention. The purpose of this study is to investigate the effect of aspirin withdrawal on cardiovascular events in patients without cardiovascular disease.

This is a single center, prospective, randomized clinical study evaluating the safety and efficacy of withdrawal of aspirin among patients with moderate or high cardiovascular risk.

Patients taking aspirin will be randomly assigned to a group that maintains taking aspirin and a group that discontinues to take aspirin by 1:1 manner. The follow-up duration is five years and clinical outcomes will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19-80 years old
* Subjects who are taking for more than 12 months
* Subjects with moderate or high cardiovascular risk based on cardiovascular risk classification of 2015 Korea Society of Lipidology And Atherosclerosis guideline or 2004 American Heart Association guideline: 1) moderate risk: people with ≥2 major risk factors, 2) high risk: people with carotid atherosclerosis, abdominal aortic aneurysm, or diabetes, who is taking statin
* Subjects who voluntarily participate in the study and sign informed consent form

Exclusion Criteria:

* Subjects with a history of major cardiovascular disease confirmed by medical history and medical history; myocardial infarction, angina pectoris, coronary angioplasty, coronary artery bypass surgery, peripheral vascular disease, ischemic stroke, transient ischemic attack
* Subjects has any contraindication to use of aspirin or hypersensitivity to aspirin
* Subjects with atrial fibrillation
* Subjects who are taking anti-platelet agents other than aspirin or anticoagulants
* Subjects who have been diagnosed with cancer within the last 5 years
* Pregnant women or those who have pregnancy plan after enrolling in this study
To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics.

The VERTIGO study is likely to help determine characteristics of different types of vertigo in patients presenting in the Ear Nose \& Throat (ENT) clinics with complaints of dizziness. Moreover, it will also help to develop an understanding about the current management practices of this condition at local level.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age and older
* Patients with vestibular vertigo of known or unknown origin
* Patients who are willing and able to provide written informed consent

Exclusion Criteria:

* Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment
* Patient with psychiatric disorders, significant neurological disorder or spinal cord damage that would make the evaluation difficult for the investigator
* Patients who are not willing to give informed consent
* Patients with a known history of hypersensitivity to betahistine
* Patients with a history of pheochromocytoma