cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON

Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.

Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:

* Group I (Control group): 20 teeth will be treated with ICON.
* Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.

Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.

Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 20-40 years of age.
* Each patient has 4 or more WSLs.
* Mild and moderate WSLs according to Gorelick's scale.
* Good oral hygiene and willing patients who can attend the study visits.
* a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion Criteria:

* Active carious lesions.
* Facial surface restorations.
* Intrinsic and extrinsic stains.
* Patients who have a significant medical history or if they smoke.
* Criteria for discontinuation; Mortality and acquiring severe debilitating disease
Comparison of Two Protocols for Deflation of Radial Band Following Coronary Procedures Via the Radial Artery

Coronary angiography is now mainly performed via the radial route rather than the femoral route. At the end of the procedure, the sheath is removed and a band is inflated to obtain hemostasis. The air in the band is then deflated at regular intervals. Currently there are different protocols for deflation of the band, but none of these have been studied with regards to patient comfort and time of deflation, and potential complications such as bleeding. Here in this study the investigators wish to compare two such protocols of band deflation and assess the levels of patient comfort and time to discharge with two widely used protocols.

Coronary angiography is a procedure by which the anatomy of the coronary arteries are studied. It can be done either via the radial artery approach or the femoral artery approach. Currently most centers use the radial artery approach due to the lower risk of access site bleeding as compared to the femoral artery approach. In addition, the radial approach allows earlier patient mobilisation after the procedure.

Once the sheath, through which the procedure is done, is removed, a special air filled band is used to compress the artery to prevent bleeding. This involves filling the band with around 18 ml of air and then releasing the air at periodic intervals. There are however no set protocols for the removal of air and literature often suggests varying protocols. However what the protocols try to achieve is proper hemostasis, with low incidence of radial artery occlusion. In addition to these, patient comfort and safety along with staff ease of use is important. Some protocols involve frequent deflations which might be more tedious for the nurses, but more comfortable for patients whilst others might be easier for the staff (due to longer intervals), but more uncomfortable for the patients. However, there are no studies that actually compare these protocols

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing coronary procedures via the radial route

Exclusion Criteria:

* Those below the age of 18 and those unable to give consent
A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis

This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis

In addition to the data collected in this study, historical data from 43 patients treated with placebo from the multicenter trial of sirolimus in LAM (MILES) study (NCT00414648) were down weighted to an effective sample size of 18 for comparison of FEV1 and FVC endpoints. Reference to the publication of the MILES study has been provided under "Result Publication".

Eligibility Criteria:
Inclusion Criteria:

* Female aged \>/= 18 years with a diagnosis of LAM
* Pulmonary function abnormalities as follows:
* FEV1 of ≤ 80% of the predicted value following administration of a standard dose of a short acting β2-agonist (\*200 µg Salbutamol, measured between 10 and 15 minutes of inhalation) OR
* FEV1 \< 90% of the predicted value of bronchodilator following administration of a standard dose of a short acting β2-agonist (\*200 µg Salbutamol, measured between 10 and 15 minutes of inhalation) and DLco (uncorrected) \<80% predicted.
* Female patients including those of childbearing potential will be included in this study.
* Negative pregnancy test at screening and baseline

Exclusion Criteria:

* FEV1\<50% of predicted post-bronchodilator.
* Change in FVC (ml) \> ± 15% of screening value at baseline visit (not less than 14d after screening visit).
* Use of any medicine containing estrogen in the 4 months prior to the screening visit and for the duration of the study
* Significant hematologic, renal, hepatic laboratory abnormality or amylase \> 1.5x the upper limit of the normal range at the screening or baseline visits
* Fasting blood glucose \> 126mg/dl or random blood glucose \>200mg/dl at screening and/or baseline
* Recent surgery (involving entry into a body cavity or requiring sutures) within 2 months of the screening visit or any evidence of unhealed surgical wound.
* Uncontrolled hyperlipidemia (defined as persistent elevation of total cholesterol or triglycerides \>6.5nM/L) or a history of clinical atherosclerotic disease including heart attack, angina, peripheral vascular disease or stroke.
* Previous organ transplantation
* Inability to give informed consent
* Inability to perform pulmonary function or 6 minute walk tests and imaging assessments

Other protocol-defined inclusion/exclusion criteria may apply
Study of Robot-assisted Arm Therapy for Acute Stroke Patients

The purpose of this study is to compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements with help from the device.

HYPOTHESES

* Motor function will be significantly greater for the patients in the robotic training group as measured by standard clinical evaluations.
* Functional independence gains will be similar for both groups because the robotic therapy is not task-specific for activities of daily living (ADL).
* Robotic training will reduce pain and spasticity more effectively than conventional therapy alone, due to increased number of movements performed during the robotic training.
* Muscle activation patterns for patients receiving robotic training will show decreased agonist/antagonist co-contraction and less erratic muscle activation.
* Robotic training patients will demonstrate significantly greater ROM, movement accuracy and higher movement speed during exercises performed as part of robotic training. For robotic exercises performed only as part of the robotic assessment, these improvements will be significantly less than those for practiced movements.

Eligibility Criteria:
Inclusion criteria Right hemisphere, unilateral ischemic stroke with onset of less than 15 days that results in arm weakness Right-handed 65-84 years of age Manual Muscle Test score of at least 2/5 Must be able to follow 2-3 step commands Head, neck, and trunk control to maintain an upright posture for a minimum of 45 minutes Some synergistic movement at shoulder Active shoulder flexion and/or abduction greater then 30 degrees Active elbow flexion of 45 degrees or more

Exclusion criteria

* Previous stroke history
* Hemorrhagic stroke, cerebellar stroke, or subarachnoid hemorrhage
* Contractures in the involved upper extremity at the shoulder, elbow, or wrist
* Moderate to severe tone in the involved upper extremity
* Flaccid involved upper extremity
* Full, active isolated movement of the involved upper extremity
* Corrected visual acuity worse than 20/50 for distance
* Cognitive or other deficits that would negatively affect their ability to follow directions or track visual targets
* Unstable cardiovascular orthopedic or neurological conditions that would preclude exercise in short-duration, high work-load trials
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth

The construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. The closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician. Plastic materials have also changed. In addition, the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology. In some cases, modular constructions were introduced with respect to the customized one. All this has changed the classic corsets over time, even without changing their name / type, and according to the hypothesis that their effectiveness remained at least the same, if not even improved.

There are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations.

The purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic adolescent scoliosis and/or dorsal hyperkyphosis,
* age under 16 years at the start of observation,
* brace prescription for more than 18 hours/day,
* availability of radiographs of the entire spine while standing and in brace radiographs at 1 month or out of brace at 5 ± 2 months at the end growth after 48 hours without brace and at 1 year.
* availability of compliance data
* Risser between 0 and 4 at first assessment

Exclusion Criteria:

* All secondary causes of scoliosis
* history of spinal fusion surgery
* lack of one of the radiographic examinations required by the protocol
Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping

Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts.

Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine

Eligibility Criteria:
Inclusion Criteria:

1. Each child has bilateral vital cavitated carious lesions in primary molars.
2. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
3. Patient and parent cooperation.
4. Accessible isolation for the operated tooth with rubber dam.
5. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
6. Availability of remaining dentin thickness over the pulp.
7. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

Exclusion Criteria:

1. Spontaneous pain, or persistent swelling or fistula.
2. Pain with percussion, presence of abscess and pathological mobility.
3. Uncooperative patient.
4. Progression of caries lesion to pulp and pulp exposure.
5. Presence of periapical lesion as abscess, cyst or granuloma.
6. Unhealthy bony tissues.
Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Preterm labor
* GA24-34wk
* Intact membranes

Exclusion Criteria:

* Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress
* Placenta previa
* medical and obstetric complications
* allergy to dydrogesterone
Cross-disciplinary HIV Integrated Mental Health Support Intervention

The proposed project seeks to develop and test an intervention to improve engagement in HIV and mental health care for young Black gay, bisexual and other men who have sex with men (YB-GBMSM) in Ryan White clinics.

Young Black gay, bisexual and other men who have sex with men (YB-GBMSM) are disproportionately impacted by HIV, with suboptimal rates of engagement across the HIV Continuum of Care (HIV-CoC). Mental health (MH) comorbidities contribute to poor HIV care engagement for many YB-GBMSM; however, effective treatment for these conditions is hindered by barriers including logistical challenges, medical mistrust, and MH stigma.

The Ryan White Care act supports integration of HIV and MH services; however, preliminary studies demonstrate low rates of MH referrals and MH care engagement among YB-GBMSM living with HIV, even in these ostensibly integrated care settings. The objective of this study is to develop and implement CHIMES (Cross-disciplinary HIV Integrated with Mental Health Support), a clinic- and provider-level intervention to improve HIV-MH care integration and MH care engagement among YB-GBMSM attending Ryan White clinics.

The rationale for this study is that efforts to improve integration of services, particularly if they are culturally tailored, are likely to increase MH and HIV care engagement for YB-GBMSM. The proposed study will pursue two specific aims: (1) to develop the CHIMES intervention; and (2) to conduct a hybrid type 2 implementation-effectiveness pilot trial of CHIMES in two Health Resources and Services Administration (HRSA)/Ryan White-funded clinics in Atlanta, Georgia - a city in the heart of the Southern HIV epidemic.

For the first aim, the researchers will work collaboratively with provider and patient stakeholders, adapt existing evidence-based interventions, and build on formative data to refine intervention content, informed by the Capability- Opportunity-Motivation-Behavior (COM-B) Model. For the second aim, the researchers will implement CHIMES in the two clinic settings and conduct a mixed-methods assessment in which continuous data collection informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework will be used to evaluate effectiveness and implementation processes.

The effectiveness of the CHIMES intervention will be measured by change in HIV and MH care engagement before, during, and after CHIMES implementation. The researchers will abstract clinic-level aggregate data to characterize change in HIV-CoC and MH care engagement outcomes for YB-GBMSM.

Eligibility Criteria:
Inclusion Criteria:

* young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV
* patient at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic

Exclusion Criteria:

* none
Health Effects of Recreational Soccer in Type 2 Diabetic Men

The present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans, echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12 and 24 weeks, respectively.

The study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed
* 35-60 years old men

Exclusion Criteria:

* Smoker
* Ischaemic heart Disease
* Congestive heart failure
* Joint or limp pains to an extent where recreational soccer can not be performed.
* Apoplexia.
* Anticoagulant therapy (aspirin accepted)
Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants

This trial studies the effects of a dietary intervention based on the Alternative Healthy Eating Index (AHEI) on inflammatory markers and breast density in healthy participants. The AHEI is a quantifiable measure of diet quality designed to target food and macronutrient sources that are associated with chronic disease risk. Adherence to the AHEI may be associated with a reduction in inflammatory biomarkers and sex steroid hormone levels compared to other dietary patterns/scores.

OUTLINE:

DIETARY INTERVENTION: Participants receive dietary counseling with a dietitian in person or via telephone to support adherence to a diet based on the AHEI guidelines once weekly for up to 12 weeks.

DUAL X-RAY ABSORPTIOMETRY (DXA) ONLY STUDY: Participants undergo DXA scan for breast density measurement at baseline and at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women will be eligible if they are nulliparous, aged 18-30, and score below 75 on the AHEI. Study eligibility will be assessed via online screening questionnaire and online Food Frequency Questionnaire (FFQ). These criteria were chosen because of our focus on the years before first birth as a critical period for establishing breast cancer risk
* Participants must be able to come to two clinic visits, complete questionnaires in English, and will be required to discontinue all vitamins and nutritional supplements during the study period
* DXA ONLY PILOT STUDY: Participants must be able to come to one visit in the Prevention Center where they will receive the consent form and undergo the DXA scan. No intervention will occur and there will be no follow-up assessments or measurements beyond the DXA scan

Exclusion Criteria:

* Women will be ineligible if they are postmenopausal, pregnant, taking hormone therapy (e.g., oral contraceptives), or have chronic illnesses that are known to affect gastrointestinal absorption of nutrients
* Women who obtain a score of \>= 75 on the AHEI are also ineligible
* DXA ONLY PILOT STUDY: Women who are pregnant
Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).


Eligibility Criteria:
Inclusion Criteria:

* If of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study
* Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH)
* Have been treated with an optimal dose of statin for at least 6 weeks

Exclusion Criteria:

* Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of screening or expect to undergo treatment with LDL apheresis during the course of the study
* Homozygous familial hypercholesterolemia
* Severe chronic heart failure
* Uncontrolled hypertension
* Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), unstable angina, or stroke within 3 months
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Active or chronic hepatobiliary, hepatic, or gall bladder disease
* Pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication
* History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
* Human immunodeficiency virus (HIV) positive
* History of malignancy ≤5 years
* Donated blood products or has had phlebotomy of \>300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study
* Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment \<3 weeks prior
* Consumes more than 2 alcoholic drinks per day
* Currently participating or has participated in a study with an investigational compound or device within 3 months
* Receiving treatment with systemic corticosteroids or taking systemic anabolic agents
PET CT Re-Planning NSCLC (4DCT-PET)

This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or more than 18 years old
* Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
* Chemo-RT patients of any stage of NSCLC
* Patients with a measurable tumor on CT scan.
* Patients who are able to lie supine for two consecutive 25 minutes sessions.

Exclusion Criteria:

* Trimodality patients who will have surgery within 2 months post RT
* Previous radiotherapy to intended treatment volumes.
* Patients with recurrent disease
* Active malignancy other than lung cancer
* Pregnancy
* Failure to provide written informed consent