cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.

Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age.
* Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
* Signed informed consent.

Exclusion Criteria:

* Prior surgery or tattoo to the upper or lower lip or lip line.
* Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry.
* A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry.
* Presence of facial hair that may interfere with efficacy evaluations.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
* History of angioedema.
* Previous hypersensitivity to hyaluronic acid or local anesthetics.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
* Cancerous or pre-cancerous lesions in the area to be treated.
* Previous tissue augmenting therapy in the area to be treated with hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months.
* Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated.
* Pregnancy or breast feeding.
* Participation in any other clinical study within 30 days prior to inclusion.
* Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
* Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).
Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women

the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women

Neck and shoulder pain was 73,1%,one fourth of which occurred after birth.the most common area was the superior part of the trapezius.the symptoms of patients are pain, stiffness and limited range of motion (ROM).

Eligibility Criteria:
Inclusion Criteria:

* Multipara two months after labor.
* number of parity not more than 3.
* age range 25_35.BMI less than 35 Kg/m2

Exclusion Criteria:

* Diabetic women
* Women with malignancy
* Neck pain from other conditions such as(spinal
* instability, spinal fracture, spinal cord compression,inflammatory disease, spinal infection, congenital postural deformity
Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure

The purpose of this study is to determine whether direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure.

Coronary artery disease (CAD) remains to be one of the leading causes of mortality and morbidity worldwide. Despite the optimal use of anti-anginal medications and coronary revascularization, a large number of patients with CAD suffer from severe symptoms with disabling angina and heart failure (HF). Experimental and pilot clinical studies provided evidence of the safety and potential efficacy of a strategy of intramyocardial transplantation of autologous bone marrow (BM) cells for neovascularisation of chronically ischemic myocardium. Nevertheless, the possible potent placebo effect on symptoms observed in these pilot studies highlights the need for a randomized, placebo-controlled group to prove the clinical efficacy of cell based angiogenic therapy for treatment of severe CAD.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old
* Canadian cardiovascular (CV) Class II-IV angina and/or NYHA class II-III HF symptoms
* Received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms.
* Not suitable for conventional revascularization by their referring cardiologist.
* LVEF \<40% by echocardiography.
* Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of CAD that is not amenable to standard revascularization procedures.
* creatinine less than 250mmol/L, normal liver function, and normal blood count: WBC, granulocytes; platelet count, Hb.
* Reversible perfusion defect on single photon emission computed tomography (SPECT)
* Able to walk on treadmill
* Hemodynamically stable
* Subject is willing to comply with specified follow-up evaluations.
* All patients give written informed consent.

Exclusion Criteria:

* Atrial fibrillation
* History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation
* Severe valve disease
* Aortic or mitral valve prosthesis
* History of cancer in last 5 years
* Acute or chronic active sepsis, including HIV positive; hepatitis B or C positive
* Left ventricular wall thickness less than 8 mm in the target territory
* Left ventricular thrombus and/or spontaneous echo-contrast in the LV detected by echocardiography or LV aneurysm
* Severe aorto-femoral-iliac disease
* Recent heart attack within the last 30 days
* Hypertrophic or restrictive cardiomyopathy
* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year
Comparison of MET vs Mobilization in Management of Post-partum Backache in Females (NVD) and Cesarean Section Delivery

Effectiveness Comparison of Effects of Muscle Energy Technique (MET) vs Mobilization in Management of Post-partum Backache in Females With Normal Vaginal Delivery (NVD) and Cesarean Section Delivery


Eligibility Criteria:
Inclusion Criteria:

* Subjects with age group 20 to 40 year.
* low back pain and disability after normal vaginal delivery or c-section delivery will be included.

Exclusion Criteria:

* Subjects who had neurological deficit.
* spinal tumors, scoliosis
* underwent spinal surgery
* prolapsed intervertebral disc with or without radiculopathy will be excluded.
Staccato Loxapine Thorough QT/QTc Study

The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.

Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.

Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.

Exclusion Criteria:

* Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
* Subjects who have had an acute illness within the last 5 days of treatment,
* Subjects who are smokers, OR
* Subjects who have an ECG abnormality at baseline.
Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it's still not clear that which therapy can bring better prognosis. Our study sought to investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the Hunan Cancer Hospital.

This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS) would be calculated to balance the baseline characteristics of two arms. Overall survival (OS) was set as the primary endpoint. From July 2019 to October 2022, 106 eligible pts in total were enrolled. According to the treatment received, 72 and 34 pts were respectively allocated into FP cohort and TB cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
2. Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type). Regorafenib was permitted but not required for inclusion.
3. Has measurable or non-measurable disease as defined by RECIST version 1.1
4. Is able to swallow oral tablets.
5. Estimated life expectancy ≥12 weeks.
6. Eastern Cooperative Oncology Group performance status (ECOG PS) less than 2
7. Has adequate organ function.

Exclusion Criteria:

1. Pregnancy, lactating female or possibility of becoming pregnant during the study.
2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
3. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
4. Has severe or uncontrolled active acute or chronic infection.
5. Known carriers of HIV antibodies.
6. Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk

The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women.

Objective: To study the effect of the 'wholegrain concept', i.e. high intake of wheat wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.

Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic syndrome features were prescribed a mild calorie-restricted diet with a deficit of \~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks intervention with RW or WW products providing 2,000kJ/d.

Eligibility Criteria:
Inclusion Criteria:

* BMI 27-37
* Postmenopausal (\>1y) women
* 40-70 years old

Exclusion Criteria:

* Medication (hypertensive treatment not included)
* BP \> 160/100
* Fasting glucose \> 7mM
* Fasting cholesterol \> 6.5mM
* Smoking
* Known chronic illnesses
Alzheimer's Prevention Through Exercise

The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Dementia Rating 0 (nondemented)
* Age 65 or older
* Florbetapir PET evidence of cerebral amyloidosis
* Sedentary or underactive by the Telephone Assessment of Physical Activity
* Stable doses of medications for 30 days.
* Clinician judgment regarding subject's health status and likelihood to successfully complete the 1-year exercise intervention

Exclusion Criteria:

* Clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to standard criteria or significant psychiatric symptoms that could impair the completion of the study
* Clinically-significant systemic illness that may affect safety or completion of the study
* History of clinically-evident stroke
* Clinically-significant infection within the last 30 days
* Active cardiac condition (e.g. angina, myocardial infarction, atrial fibrillation) or pulmonary condition in the past 2 years that, in the investigator's opinion, could pose a safety risk to the participant-unless cleared for exercise by the participant's primary care physician or cardiologist.
* Uncontrolled hypertension within the last 6 months
* History of cancer in the last 5 years (except non-metastatic basal or squamous cell carcinoma)
* History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
* Insulin-dependent diabetes mellitus
* Significant pain or musculoskeletal disorder prohibiting participation in an exercise program
* Unwillingness to undergo or contraindication to brain MRI scan.
* History within the last 5 years of primary or recurrent malignant disease with the exception of resected localized cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma, or prostate cancer.
Translating the ABCS Into HIV Care

The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing CVD morbidity and mortality among PLH.

Our project has two major aims:

Aim 1: To assess the impact of the implementation of an evidence-based, multilevel strategy to reduce cardiovascular vascular disease (CVD) among PLH.

Aim 2: To assess the process of implementation of these strategies using RE-AIM QuEST. Using both quantitative and qualitative methods, we evaluate the process of implementation by assessing Reach, \[Effectiveness addressed in Aim 1\], Adoption, Implementation and Maintenance whilst integrating Qualitative Evaluation for Systematic Translation.

Eligibility Criteria:
Inclusion Criteria:

Sites:

* Serve a cohort of at least 100 HIV patients
* Have an Electronic Health Record (EHR)
* Agree to collaborate on implementing feasible adaptations of intervention strategies

Patients:

* Patient of the site with a diagnosis of HIV
* Age 40-79 years
* ≥5% risk for CVD as calculated using the ASCVD Risk Estimator Plus
* Willing to participate
* No plans to leave the site in the next 12 months
* Proficient in either English or Spanish
* Own a cell phone with texting capabilities

Clinicians:

* Physicians, Physicians Assistants, or Nurse Practitioners who provide direct HIV care to patients
* Work at a participating site
* Willing to implement the project's intervention strategies

Exclusion Criteria:

Patients:

* Currently participating in another CVD trial
* Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA)
* Have had a CVD procedure such as installation of a stent or angioplasty
* Have peripheral vascular disease, intermittent claudication or peripheral arterial disease
* Are pregnant
* Lacks capacity to consent

Clinicians:

• Planning to leave the site within the next 12 months
Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy

The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the disc, and the quality of life questionnaire of all patients were recorded at the beginning of the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four areas, one week and one month after the end of treatment, and all the variables mentioned earlier were evaluated three months after PRP surgery.

This study is single group that the outcomes are compared before and after the intervention


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type 2 with PDR
* Having conscious satisfaction

Exclusion Criteria:

* Patients with a history of other eye diseases
* Patients with a history of previous laser treatment
* Patients with a history of injection of Anti-VGEF
* Patients with Vitreous hemorrhage
* Patients with Macula edema
* Patients with myopia more than -3 diopters or hyperopiamore than +3 diopters
Study of Diclofenac Capsules to Treat Dental Pain

The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female between 18 and 50 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient requires extraction of 2 or more third molars
* Patient must be willing to stay at the study site overnight

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to Screening
Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF

Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. There is no report on whether AASI is associated with left ventricular diastolic dysfunction in patients with HFpEF.

Heart failure with preserved ejection fraction (HFpEF) is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. AASI is especially associated with left ventricular diastolic dysfunction in patients with hypertension. Patients with HFpEF have obvious left ventricular diastolic insufficiency. However, there is still no research investigating the the relationship between AASI and left ventricular diastolic dysfunction in patients with HFpEF.

Eligibility Criteria:
Inclusion Criteria:

Adult aged \>=18years old; Diagnosed with HFpEF.

Exclusion Criteria:

LVEF less than 45% at any time; Severe liver failure; Other causes of shortness of breath, such as severe pulmonary disease or severe Severe valvular disease of the left heart; Chronically bedridden or incapacitated; Age \<18 years old.
Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
* The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
* The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
* There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
* Subaxillary body temperature \<=37.0 C.
* Determine health based on medical history, physical examination, and researcher's judgment.

Exclusion Criteria:

* Have been vaccinated a listed or experimental pneumococcal vaccine.
* History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
* In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
* History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
* Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
* History of pathological jaundice confirmed by diagnosis.
* A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
* Human serum gamma globulin injection after birth.
* There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
* Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
* Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
* Severe asthma.
* Systemic rash, dermatophytes, skin pus or blister.
* Participation in other drug clinical trials.
* Anything that the researcher considers likely to affect the evaluation of the study.