cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of Thoracolumbar Spinal Fusion Graft

This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years old or older
* Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support
* Failed at least 6 weeks of conservative care
* ODI v2.1 score \> 30%
* No contraindication to BMAC (as per manufacturer)
* Signed consent form

Exclusion Criteria:

* Spondylolisthesis grade ≥ 3
* Pagets disease, osteomalacia, or any metabolic bone disease
* Use of medications that interfere with bone healing (chronic steroids)
* Patient unlikely to comply with post-op schedule with physician
* Recent history of chemical dependency
* Participation in other investigational device trial(s) within past 30 days
* Active malignancy
* Pregnancy or planning to become pregnant
* Direct involvement in execution of this protocol
A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA

The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.

Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.


Eligibility Criteria:
Inclusion Criteria:

* PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes，
* Hemoglobin A1c (HbA1c) ≤10%
* Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months)
* Did not undergo retintis photocoagulation (PRP)
* Vitreous hemorrhage disease course within six months

Exclusion Criteria:

* Patients who have had previous vitreoretinal surgery
* Intravitreal drug injection within 3 months
* Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole
* Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy
* B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin)
* Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function
Mechanical Coring to Achieve Directional Skin Tightening

The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, male or female subjects between 30 and 70 years of age.
2. Able to read, understand, and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
5. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.

Exclusion Criteria:

1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
2. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area.
3. History of keloid formation
4. Active smoker or having quit smoking in the last 3 months.
5. Active, chronic, or recurrent infection
6. Compromised immune and/or healing system (e.g. diabetes)
7. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
8. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.
9. Pregnant or breastfeeding
10. Any indication that may cause excessive bleeding, e.g., anticoagulants.
11. Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
12. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
13. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device
14. Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.
Motor Control Exercise in Osteoporotic Women

The objective of this study was to explore the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fractures.

Osteoporosis is a common metabolic bone disease that usually affects the aging population. It is an important public health problem, due to its association with vertebral and nonvertebral fractures leading to increased morbidity. Vertebral fractures are accompanied by kyphosis, reduced pulmonary function, loss of height, and are often associated with elevated pain while they may also lead to subsequent vertebral fractures. Osteoporotic individuals exhibit kyphosis in the erect standing position, which, in turn, is compensated by the deformation of other parts of the body. Improvement of postural alignment may lead to less stress on the spine, facilitate posture and proper body mechanics and may improve balance. The aim of the present study was to assess the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fracture against the results of a control group that received the basic therapies for osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal osteoporosis
* Osteoporotic vertebral fractures
* Pain
* Under medical osteoporotic treatment

Exclusion Criteria:

* osteoporosis other than primary postmenopausal
* vertebral collapse with neurological deficits
* more than 5 fractured vertebrae
* major respiratory conditions
* receiving pain reducing agents, teriparatide or calcitonin
Improving Appetite Regulation in Patients With Obesity

Over 70% of U.S. adults have overweight or obesity. Currently, the most efficacious behavioral intervention for obesity is standard behavioral treatment (SBT), often composed of group sessions, calorie goals, and physical activity goals. With this approach, participants often lose 8-10% of the person's baseline weight, and also decrease risk for cardiovascular disease. Long-term weight loss, however, is limited; many participants return to baseline weight within five years following treatment. One reason SBT may not create long-term weight loss may be due to treatment components that teach participants to rely on external methods for changing eating decisions (e.g., counting calories, restricting certain foods), rather than internal cues of hunger and satiety. Because individuals with obesity report significant challenges with adhering to these cues, augmenting behavioral interventions with appetite self-regulation training may be a solution. Thus, the investigator propose to examine the feasibility and acceptability of a 6-month remotely-delivered appetite regulation + lifestyle modification intervention to treat obesity.

Aim 1. Using a single-arm design, the investigator will examine the feasibility and acceptability of a 6-month, remotely-delivered, appetite self-regulation intervention for weight loss maintenance.

Aim 2. Examine the preliminary efficacy of the intervention on weight maintenance at 4 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age,
* BMI ≥ 25-45 kg/m\^2,
* have and regularly use a smartphone,
* weight loss of 5% or more within the last 2 years
* complete the screening questionnaire

Exclusion Criteria:

* have no internet access,
* report a medical condition that could jeopardize the person's safety in a weight control program with diet and exercise guidelines
* are currently pregnant
* are in substance use treatment
* are involved in another weight reduction program
* have received prior or planned bariatric surgery
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.

PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer or DCIS who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES: I. To assess whether other intermediate molecular markers including estrogen receptor alpha (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.ARM II: Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Women at high risk for breast cancer, defined as any of the following groups:
* Five year Gail risk \> 1.7%
* Known BRCA1/BRCA2 mutation carrier
* Family history consistent with hereditary breast cancer
* Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS)
* History of invasive breast cancer or ductal carcinoma in situ (DCIS) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor
* Signed Informed Consent

Exclusion Criteria:

* Metastatic breast cancer
* Undergoing treatment (chemotherapy, radiation, or SERMs)
* Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
* Regular soy consumers (i.e., \< once per week of soy food, soy supplements or other products)
* Known food allergies such as to soy or nuts
* Not willing to avoid soy foods/supplements during study period
* Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
* Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
* Active participant in other ongoing trials
Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth.

The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich.

Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person.

The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Pregnant woman at GA 16+0 - 22+6
* Singleton pregnancy
* 18 years or older
* Nulliparous cohort: nulliparous pregnant woman
* Multiparous cohort: multiparous pregnant woman

Exclusion Criteria:

* Lack of informed consent
* Placenta praevia
* Severe vaginal bleeding
* Rupture of membranes before 34 weeks (to be excluded with pH test)
* Visible tissue scarring at the measurement locations\* on cervix
* Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
* Cervical dilation ≥ 3 cm
* Cerclage or pessary in place
* Vaginal or cervical infections (to be excluded with the Amsel criteria)
Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.

Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit site of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers.

Exclusion Criteria:

* History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex
Cortisol Measurement During Intravenous Access With a Medical Clown

The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients needing venous blood sampling or insertion of an intravenous canula
* Normal development according to parents

Exclusion Criteria:

* Critically ill children (e.g. shock, respiratory distress or failure)
* Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
* Known adrenal or pituitary disease
* Children who have received glucocorticoids during the preceeding six weeks
Effects of Rocabado's Approach Versus Kraus Exercise Therapy

TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Temporomandibular joint disorders are a type of craniofacial problems. They affect the temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus therapy on Pain and Disability in patients with temporomandibular dysfunction.

A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using random sampling through opaque sealed enveloped into Group A and Group B. Group A will be treated with Rocabado's approach and Group B will be treated with Kraus exercises. Outcome measures tools will be conducted through NPRS, TMD disability index, Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between the ages of 30 to 60 years
* Patients with jaw pain
* Patients with limited jaw range of motion and associated joint pain
* Patients with TMJ clicking sounds
* Patients with pain upon muscle and joint palpation

Exclusion Criteria:

* Diagnosis of ear, nose, and throat medical pathology underlying the tinnitus;
* Neurological problems that could potentially cause the tinnitus
* Inability to read, understand, and complete the questionnaires or understand and follow commands (e.g., illiteracy, dementia, or blindness)
Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis

Comparison with use of Intravascular Ultrasound (IVUS) analysis of two methods of percutaneous coronary interventions (PCI) with drug eluting stent:

After successful drug eluting stent implantation, patients were randomized into two groups: Group A had no further dilatation, and Group B had additional post-dilatation with a noncompliant balloon. The investigators performed IVUS analysis in groups A and B just before randomization and after post-dilatation in group B.

Stent expansion of DES using current stent deliver systems is frequently suboptimal. Further more smaller minimal stent area (MSA) and stent underexpansion following deployment of DES are strong predictors of stent thrombosis and (TVR) target vessel revascularization. The investigators hypothesize than adjunctive postdilatation with noncompliant balloon can improve DES deployment.

After successful drug eluting stent implantation, patients will be randomized into two groups: Group A with no further dilatation, and Group B with additional post-dilatation with a noncompliant balloon. The investigators will performed IVUS analysis in groups A and B just before randomization and after post-dilatation in group B. Post dilatation will be performed with noncompliant balloon and with a nominal diameter 0.25mm larger than stent balloon.

The primary endpoint is optimum stent deployment. For defining the optimal stent deployment the investigators use the IVUS criteria adopted in the MUSIC study: Complete apposition without underexpansion and with symmetric stent expansion.

Patients are eligible after successful drug-eluting stent implantation in a native coronary artery. Patients with myocardial infarction or acute coronary syndrome will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Successful drug eluting stent implantation in a native coronary artery

Exclusion Criteria:

* Percutaneous coronary intervention (PCI) of Left main coronary artery;
* Myocardial infarction;
* Acute coronary syndrome;
* Emergency PCI;
* PCI for in-stent restenosis;
The Glycemic Effect of Added Sugar on Bake Beans

To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.

There will be a total of 7 test session. Each session will last for 3 hours. At each test session, volunteers will be served with 7 test meals and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerpick. Following the fasting samples, volunteers will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.

Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity
* Age ≥21 and ≤ 60 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure \<140/90 mmHg
* Fasting blood glucose \<6.0 mmol/L
* In general good health

Exclusion Criteria:

* Current Smoker
* have any metabolic diseases (such as diabetes, hypertension etc)
* have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* have intolerances or allergies to any foods
* partake in sports at the competitive and/or endurance levels
* intentionally restrict food intake
Myo-inositol Administration in Gestational Diabetes

Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women affected by gestational diabetes (GDM), but there is no information about the effect on the glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is obviously better than intermittent self monitoring in detecting glucose profile and magnitude and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze the characteristics of glucose variability in GDM women,treated with diet and folic acid alone or with diet, folic acid and myo-inositol supplementation.

Our study is a randomized, prospective, controlled trial, including the first 30 consecutive Caucasian gestational diabetes patients diagnosed,according the International Association of Diabetes and Pregnancy Study Group (IADPSG) panel criteria, from November 2013 in the Department of Obstetric and Gynecology of Messina University (ITALY). After an informed consent they will be randomly assigned to receive (n. 15) diet and folic acid (400 mcg per day) alone or (n. 15) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day)supplementation. The insulin sensitivity index (HOMA-IR) and the glycemic profile will be monitor by CGMS for each patient at GDM diagnosis and after 8 weeks of treatment The pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Gestational diabetes diagnosed within 28 weeks
* Caucasian pregnant women

Exclusion Criteria:

* Non Caucasian pregnant women
* Delivery before 8 weeks of treatment