cyrilzakka/clinical-trials huggingface dataset:
Adaptive Radiation Therapy for Head & Neck Cancer Patients

The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.

The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.

Eligibility Criteria:
Inclusion Criteria:

* Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
* Patients should meet at least one of the following criteria:

  1. Locally advanced cancer (T3-T4 and/or N2-N3)
  2. Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem
  3. Significant expected weight loss.

Exclusion Criteria:

* Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
* Poor renal function (inability to undergo a CT with IV contrast)
* Previous radiation therapy to the head and neck.
* Inability to tolerate prolonged immobilization.
* Children and women who are pregnant or decline to use contraception.
Rosuvastatin in Visceral Adiposity

The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.

The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.

Eligibility Criteria:
Inclusion Criteria:

* Male patients between 40 and 65 years of age.
* Abdominal obesity
* Dyslipidemia
* Written informed consent.

Exclusion Criteria:

* Uncontrolled hypertension
* Diabetes mellitus
* Severe liver disease
* Severely reduced renal function
* Uncontrolled endocrine disorders
* History of or ongoing malignant disease
* Patients with known myopathic disease
* Recent alcohol or drug abuse
* Weight loss or weight gain during the three months prior to screening.
* Ongoing treatment with statins
* Ongoing treatment with calcineurin-inhibitors
* Ongoing treatment with anti-inflammatory drugs
* Received an investigational drug within 30 days prior to screening.
* Strong clinical indication for statin treatment
* In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation.
* For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.
Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

To determine the quality of life following the radical excision of recto-vaginal endometriosis.

Patients undergoing surgery for severe endometriosis with bowel involvement were asked to complete pre-operative and post operative questionnaires at 2, 6 and 12 months, then 5, 10, 15, 20 and 25 years post operatively.

Quality of life measured using the EHP-30 and EQ-5D questionnaires. Bowel symptoms were measured using GIQLI. Dysmenorrhoea, dyspareunia, dyschezia and chronic pain were measured using a visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing planned surgery for severe endometriosis with bowel involvement.

Exclusion Criteria:

* Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.
Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female participants who are between 18 and 49 years of age (inclusive). Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit. Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive). Exercise regularly as per physical activity guidelines for Americans \[structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)\] and willing to maintain the same level of physical activity throughout the study period. Can maintain their exercise status at the beginning of the study throughout the study period. Can achieve a peak VO2 at screening that is at least 60% of their age and gender matched normative value per American College of Sports Medicine recommendations. Have normal or acceptable to the investigator vital signs (BP and HR) at screening. Individuals with childbearing potential: Agree to have urine pregnancy test performed on each trial day. Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion Criteria:

* Female participants who are lactating, pregnant or planning to become pregnant during the study. Carry a diagnosis of diabetes. Weigh less than or equal to 80 pounds at any visits. Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1). Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible. Consume more than two standard alcoholic drinks per day. Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study. Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume. Smoking tobacco products.
Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars

Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.

In plastic and reconstructive surgery, treatment of burn scars is still challenging, because excessive and hypertrophic scarring can occur. Burn garments are usually used to reduce such scarring. However, measure are taken manually by a measuring tape using interpolation. Therefore, compression garments produced on base of 3D surface imaging using a scanning system are compared to compression garments based on manually measurements regarding correct fitting, wearing comfort, suitability for daily use and scar properties.

Eligibility Criteria:
Inclusion Criteria:

* Burn scars on an arm after IIa-III. burn (1-30% surface area)
* Indication for burn garments
* Experience in using burn garments

Exclusion Criteria:

* Consume of pain killer
* Medication with cortisone or immun suppressive therapy
* Psychiatric disease
Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study

ECHAS One will test the use of a smartphone app to assist patients to decide if it is necessary to call for emergency care with symptoms that could represent a heart attack or stroke.

The ECHAS One Study will be conducted in 200 patients who have already called for emergency care for a heart or stroke, and have been evaluated. The endpoint of the study will be a decision if the initial call was an appropriate call for emergency care. The sensitivity of the app for detecting appropriate calls will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Presented to ED via emergency medical services (EMS) for "Stroke alert" symptoms, including:

Slurred speech Asymmetric weakness or numbness Balance problems Vision changes Headache

And/or "MI alert" symptoms including:

Chest discomfort Chest pressure or pain Palpitations Shortness of breath Lightheadedness or presyncope Syncope Age ≥ 18 years Able to provide informed consent

Exclusion Criteria:

* Non-English speaking
* Moderate or greater dementia
* Severe visual impairment
* Inability to use smartphone (for physical, cognitive, or other reasons)
* Unable to consent for study
Fat Induced Insulin Resistance and Atherosclerosis

The overall objective of the current proposal is to strengthen the putative link between FFA induced insulin resistance and atherosclerotic vascular disease (ASVD). To this end, the investigators will test the following hypotheses: 1) that FFA induced activation of protein kinase C βII (PKC β II) and δ and other serine kinases such as IκB kinase (IKK) in human muscle is associated with a decrease in insulin stimulated tyrosine phosphorylation of the insulin receptor substrate-1 (IRS-1) and of IRS-1 associated phosphatidylinositol 3 (PI3) kinase; 2) that these changes precede the development of insulin resistance; 3) that the decrease in IκB-α results in activation of nuclear factor κB (NFκB) and the expression of adhesion molecules and cytokines; 4) that PKC and IKK are involved in producing insulin resistance and activation of the IκB/ NFκB pathway and lastly 5) that the same mechanisms operative in healthy volunteers are also operative in patients with T2DM.The investigators will test these hypotheses in normal (current) and diabetic volunteers (previously completed) . Euglycemic-hyperinsulinemic clamps will be performed with and without co-infusion of lipid plus heparin (to raise FFAs) and by obtaining serial muscle and fat biopsies and blood samples will be obtained for measurement of substrates, hormones, enzymes and metabolites.

All subjects will be admitted to the GCRC in the afternoon before the tests (Day 1) and will undergo a thorough physical examination. Routine admission lab tests (including a 2-h 75g OGTT) and body composition measurements will be obtained. A standardized dinner will be served at \~ 6PM. The next (Day 2) after an overnight fast, IV lines will be placed (arms will be wrapped with a heating blanket and kept at 70ºF to arterialize venous blood).

The following studies will be performed.

Thirty-two healthy volunteers will undergo euglycemic - hyperinsulinemic clamping without radioactive isotopes and with (n=16) and without (n=16) lipid/heparin co-infusion for 8 hours.

Serial (at 0, 1, 2 and 4 h) muscle and fat biopsies and serial blood samples (q' 1 h) will be obtained. The following measurements will be obtained in muscle biopsies and T-cell extracts: PKC-βI and II and PKC-δ, IKK, IκB-α, NFκB, IRS-1 tyrosine phosphorylation, IRS-1 associated PI3- kinase, ICAM, VCAM and e-selectin mRNAs.

Eligibility Criteria:
Inclusion Criteria:

* The investigators plan to study 32 healthy normal subjects.
* These volunteers will be male and female, between the ages of 30 and 75 years and of all races.
* None of these volunteers will have a family history of diabetes or any other endocrine disorder and none will be taking any medications.

Exclusion Criteria:

* Patients with chronic health problems including cardiovascular, pulmonary, hematologic (\*Hb\< 9 g/dl), renal (serum creatinine \> 1.8 mg/dl), hepatic disease, AIDS or other chronic infectious disease will be excluded.
* Pregnant women will be excluded. Non-pregnant women will be studied during the follicular phase of their menstrual cycle. If needed, a pregnancy test will be performed to exclude pregnancy.
The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer

The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.

We aimed that to correlate both primary lesion 18F-fluorodeoxyglucose (FDG) maximum standardized uptake value (SUVmax) and diffusion-weighted imaging (DWI) apparent diffusion coefficient (ADC) with clinicopathological prognostic factors and compare the prognostic value of these indexes in breast cancer in this study. The evaluated and compared parameters are SUVmax and ADC according to age, tumour size, lymph node metastasis, receptor status, histologic grade, modified Nottingham prognostic index.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of breast cancer for which surgical intervention is planned

Exclusion Criteria:

* patients received neoadjuvant chemotherapy
* before breast surgery
Bioequivalence Study of Minocycline 100mg Tablets Under Fasting Conditions

The purpose of this study was to determine the bioequivalence of Minocycline formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of Ranbaxy pharmaceuticals inc with Minocin 100mg capsules of in healthy, adult, human, subjects under fasting conditions.

A total of 28 non-smoking subjects (16 men and 12 women) were included in this study, of which 28 finished the study according to the protocol,

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between 18 and 45 years of age inclusive.
* Informed o'f the nature of the study and given written informed consent.
* Have a body weight within 15 % of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion Criteria:

* Hypersensitivity to Minocycline (Minocin®), or other antibiotics.
* Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within the 7 days pr/or to study dosing or over-the-counter medication within 3 days of study dosing. This prohibitor\~ does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physic/an2
* Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
* Females of child bearing potential must use a 'medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
* Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection' or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
* Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Intervening With Children/Adolescents With FAS/ARND

Children diagnosed through the FAS DPN clinic (who receive non-study services through the clinic/referrals) will receive baseline assessment. The baseline assessment for the child will include: medical issues (including medication), intellectual assessment, academic achievement, language, social functioning, executive functioning, neurological assessment, perceived self-confidence, and behavioral observation of parent-child interactions (videotaped and coded). For caregivers, baseline assessment will include: demographics, medical histories, educational history, current services, satisfaction with services, knowledge of FAS, stress, parenting competence, and family functioning.

Functional analysis of challenging behaviors will be conducted. Intervention will be an individualized, multimodal, behavioral consultation. The consultation will include: FAS education, emotional/practical support, and teaching child management strategies specific to children with FAS/ARND, advocacy assistance, and school consultation. Specific procedure will be based on previous findings and experience. In particular, specialized "Behavior Support Plans" will be developed for each child with input from parents, teachers, and clinicians.

Team consultations at the child's home during weekly visits. Instruction will include information on FAS, behavioral strategies, and information for advocating with service systems.

Evaluation Plan: Both interventions: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 9-month follow-up (end of school year).

Eligibility Criteria:
Inclusion Criteria:

* children 5 to 12 years of age

Exclusion Criteria:

-
Cone-beam Computed Tomographic (CBCT) and Regenerative Endodontic Treatment.

Dental trauma injuries during childhood may have an adverse impact on oral health throughout life. If trauma injuries causes pulpal necrosis, then the root stop forming. These teeth have consequently a questionable long-term survival.

Dental management of necrotic teeth with aberrant root formation represents a challenging clinical situation. The classical approach for treating these teeth includes apexification. Both apexification with Calcium hydroxide and MTA do not achieve the goals of continued root development or restoration of pulp tissue functionality.

In the last decades, a biological based approach referred as "revascularization", or "regeneration" has emerged as a biological treatment for necrotic pulps with aberrant root development. This treatment aims to regenerate pulp-like tissue within the root canal space after inducing an influx of stem cells from the apical papilla that results in reestablishment of pulp protective functions. There is evidence supporting the regeneration potential of dental tissues after regenerative endodontic treatment. However, root formation in traumatized immature teeth seems variable.

The overall goal of this study is to gain knowledge about the treatment of immature necrotic teeth in young individuals due to dental trauma. The primary goal is to compare volumetric hard tissue formation between the MTA apexification and the regeneration treatment.

A randomized controlled trial, employing 34 young individuals aged 6-18 years, with immature necrotic teeth will be included. The test group will be treated by the regeneration procedure and the control group by the application of an MTA-plug. Clinical and low-dose cone-beam computed tomography scans (preoperatively and at 18-months follow-up) will be retrieved. Clinical data with information about tooth survival, absents of symptoms, resolution of infection and root development will be taken at every session.

Eligibility Criteria:
Inclusion Criteria:

* Immature teeth and confirmed pulp necrosis caused by dental trauma.
* Teeth with apical opening larger that 1mm observed in the initial CBCT.

Exclusion Criteria:

* Extensive loss of coronal tissue that require restoration with a post that will occupy the space required for blood clot formation.
* Patients who had received antibiotic treatment during the previous 3 months.
IN.PACT™ Quality of Life Post-Reimbursement Study

To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

To provide both the French National Authority for Health and the French Economic Committee for Health Products requested information on patient-reported outcomes for the IN.PACT™ Admiral™ Drug-Coated Balloon. Patients will be followed using routine clinical practice and the collection of two validated instruments: EuroQOL EQ-5D Quality of Life questionnaire and the Walking Impairment Questionnaire (WIQ).

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible product
* Patient is consented within the enrollment window of the treatment/therapy received

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)

Note: For this study, de novo patients will be enrolled to assess EQ-5D and WIQ at baseline and follow-up. Patients cannot be treated in the same procedure with a competitor drug-coated (DCB) or drug-eluting (DES) in the vessel segment treated with IN.PACT Admiral.
Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease

All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.

Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.

Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.

Doppler ultrasound will be done at 0, 12 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* All newly diagnosed children with clinical and laboratory hyperthyroidism (high T4 \& low TSH) with positive TRAbs.

Exclusion Criteria:

* Patients receiving radioiodine Patients underwent thyroid surgery History of neck radiation or neck surgery