cyrilzakka/clinical-trials huggingface dataset:
Closure of Implant Emergence Profile

In the case of unitary edentulousness, a dental implant is a prosthetic device fixed in the bone which makes it possible to receive a fixed dental prosthesis (crown). Peri-implant soft tissues (gums) play an essential role in the integration of the crown. Indeed, the implant gingival emergence profile provides an aesthetic integration mimicking that of a natural tooth. This implant emergence profile (EIP) is modeled during the surgical and / or prosthetic phases.

The problem comes from the labile character of the EIP (Emergence Implant Profile). If the literature evokes this problem, the instability of the volume of the EIP during the impression phases has never been measured. Moreover, the three-dimensional behavior of the EIP over time (kinetic) during the acquisition phases is not known.

Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues

Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues.

The main objective is to study the effect of removal of a healing abutment on the closure of the EIP volume at 5 minutes.

This non-interventional study is a prospectively recruited research of the participants and a cross-sectional measure of the judgment criteria (during a single visit). The study is mono-centric, it will take place in the odontology department of Toulouse Hospital.

The question is to know if the decrease in the volume of the PEI is significant during the preparatory phase of the implant impression where the PEI is no longer supported by the healing screw over a period of 5 minutes.

Optical impressions are designed to record adjacent implant site teeth and peri-implant soft tissue PEI using a Optical Camera. The optical camera works like a camera and does not come into contact with the patient's mucous membranes or teeth. The images obtained are saved in STL format on an anonymized file.

Eligibility Criteria:
Inclusion Criteria:

* Patient from the Department of Dentistry who has received an implant in the maxillary or mandible, anterior sector or 1st premolar, and presents himself for the prosthetic stages of the implant treatment (realization of the crown of use),
* Patient affiliated with Social Security,
* Patient having given no objection to his participation in this study
* Good written and oral comprehension of French

Exclusion Criteria:

* Patient who has received an implant intended to receive a removable prosthesis.
* Patient under court bail, tutelage
Study of Nutrition and Activity in Kids

While a substantial body of research suggests that RRV is related to obesity, there is very little research on factors that contribute to the RRV of food, particularly how patterns of eating can increase or decrease the motivation to eat specific foods. Previous work has demonstrated that a subset of individuals with obesity show increases in RRV of food after repeated consumption of large portions of high energy density (HED) snack foods, which has been conceptualized as sensitization. Preliminary data suggest that sensitization of the RRV of HED food is a predictor of weight gain over time. However, more work needs to be done to address this relationship using a planned, prospective study design, using adolescent research subjects, and examining potential moderators of this relationship.

The purpose of this study is to identify risk and protective factors to excess zBMI change in adolescents over time. Aim 1 was to measure the relative reinforcing value (RRV) of a preferred HED and low energy density (LED) snack food before and after 2-weeks of daily exposure. Aim 2 was to assess the RRV of exercise and sedentary activity. Hypotheses include 1) sensitization to HED food will be associated with greater zBMI at the time of testing as well as greater zBMI change over time 2) sensitization to LED food will be associated with lower zBMI at the time of testing in adolescents and less zBMI change over time. 3) Greater RRV of exercise will be protective against zBMI increases over time.


Eligibility Criteria:
Inclusion Criteria:

* between 12-14yoa (male and female)
* zBMI: -1.5 to +2.0 (\*determined by Height/weight measurement at Visit 1)
* neutral or higher liking of the study foods
* Willingness to complete 9 study visits over 2 years.

Exclusion Criteria:

* -metabolic or endocrine disorder
* use of medications known to effect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)
* Unwilling to complete the study visits
* allergy to study foods
* dislike of study foods (\*determined via Preference for Study foods forms at Visit 1)
* parent report that child reads below 4th grade reading level
* parent report that child cannot complete light physical activity without assistance
* No English Speaking parent or legal guardian (therefore cannot provide consent in English nor answer questionnaires for this study) \* all other exclusion criteria are assessed from Survey monkey screening in advance of the first appointment vis parental report. At the first appointment the child is directly asses for height, weight, and The linking of study foods.
Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen.

PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.

OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the administration of a course of adjuvant tamoxifen or ablation of ovarian function results in prolongation of time to recurrence or death in patients under 50 years of age with operable carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual functioning in these patients.

OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are randomized following primary therapy, which, in addition to surgery, may include local irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen. The first group receives no further therapy. Then second group receives tamoxifen daily for at least 2 years. The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually.

PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence alone of secondary mass allowed unless considered unequivocal evidence of metastasis No primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No bilateral tumors Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status Performance status: Not specified Life expectancy: No limits on life expectancy due to intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000 Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney function required Other: Fit for surgery No prior treatment for other malignancies except: Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking patients eligible for quality-of-life assessments

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least 6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not specified Surgery: Not specified
Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

* Prospective randomized comparative study
* Patients with cataract and:

primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)

* Phacotrabeculectomy augmented with OLO or MMC
* Follow-up - 12 months

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

Exclusion Criteria:

* Difficulty in reading or speaking Polish
* Previous ocular surgery
* Pregnant and breastfeeding women
* Angle closure glaucoma
* Secondary glaucoma except pseudoexfoliation glaucoma
* Ocular diseases with excessive scarring
* Allergy to collagen or Mitomycin C
The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion

The purpose of this study is to investigate the prevalence of sleep disturbances in children with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion (TTI) on sleep disturbances.

Comparison of sleep disturbances will be between infants with Chronic Otitis Media with Effusion (COME) who will be referred for tympanostomy tube insertion (TTI) (study group) and healthy infants that were recruited from the community well-baby clinics (control group).

To evaluate sleep patterns, parents of the study group will complete two validated sleep questionnaires assessing the infant's typical sleep patterns based on parental reports. A week before TTI and 1 week to 1 month after the surgery, sleep will be evaluate by actigraph for a week long.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6-36 months
* Referred for tympanostomy tube insertion as a treatment for COME.

Exclusion Criteria:

* Snoring and sleep disordered breathing (SDB)
* Chronic medical condition
* referred for TTI and adenoidectomy/tonsillectomy
Hypophosphatemia as a Predictor in Surgical Resuscitation Sepsis

Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.


Eligibility Criteria:
Inclusion Criteria:

* Adults

Exclusion Criteria:

* Less than 18 years old
* Infected at admission
Exercise and Cardiovascular Control During Upright Tilt in Older Adults With Type 2 Diabetes

Older persons with diabetes have a harder time maintaining blood pressure when standing up. When blood pressure drops when standing up, fainting may occur. This study will see how regular exercise can improve the ability of the body to keep blood pressure up when standing. We want to see how this improvement varies with different types of exercise. The types of exercise that we will be studying are aerobic (running or cycling on a stationary bike) and strength training (weight lifting).

1. PURPOSE: Older adults with diabetes faint frequently, due to an impairment in the cardiovascular control mechanisms (arterial baroreceptor function, autonomic nervous system function and cerebral autoregulation) that prevent syncope. The purpose of this study is to examine the ability of different intensities of aerobic exercise to reverse these impairments.
2. HYPOTHESES: a) Aerobic or strength training will improve the compensatory cardiovascular responses that prevent syncope in older adults with Type 2 diabetes. Aerobic training will:

   * increase arterial baroreflex sensitivity
   * increase heart rate variability (marker of autonomic nervous system function)
   * decrease cerebrovascular resistance
   * improve cerebral autoregulation during upright tilt. b) There will be relationship between the improvement in compensatory cardiovascular responses and aerobic or strength training.

     c) The majority of the benefits of aerobic or strength exercise on the above parameters will with which training, allowing for the design of more practicable training prescriptions than that used in a research setting.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 5 years treated with diet alone or oral agents Nonsmoker for at least 5 years Subjects must be sedentary BMI between 24 and 35 All subjects will have a fasting glucose of \<12 mM and a hemoglobin A1c \< 8.5% All subjects must have developed hypertension CDA guidelines (systolic greater than 130 or diastolic greater than 80)

Exclusion Criteria:

* Abnormalities on complete blood count, electrolytes or creatinine, on resting ECG, treadmill exercise stress test Significant pulmonary, exercise-limiting orthopedic or neurological impairment Evidence of valvular disease, exercise-induced syncope, angina, arrhythmias or peripheral vascular disease Poor blood pressure control as defined as systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg Total cholesterol/HDL cholesterol greater than or equal to 5.0 or LDL cholesterol greater than or equal to 4.21 mmol/L Peripheral neuropathy severe enough to cause discomfort (for safety reasons) Significant orthostatic hypotension defined as a drop in systolic blood pressure greater than 30 mmHg during one of five consecutive arterial blood pressure readings immediately after changing position from lying to standing for safety.

Overt diabetic nephropathy excluding subjects with a urine albumin to creatinine ratio of greater than 2.0 in men or 2.8 in women Diabetic retinopathy
Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture

Elastic tapes, named "kinesiotapes" have a limited, but proven influence on pain reduction, improvement in muscular strength and joint function. It can be hypothetised that by using kinesiotape techniques on damaged chest wall (due to mostly rib fracture) we can improve not only analgesia, but also improve lung function tests and speed recovery.

Chest wall injury changes the function of chest wall muscles and other structures, which in turn influences respiratory function and cause significant pain.

Elastic tapes, named "kinesiotapes" have a limited, but proven influence on pain reduction, improvement in muscular strength and joint function. It can be hypothetised that by using kinesiotape techniques on damaged chest wall (due to mostly rib fracture) we can improve not only analgesia, but also improve lung function tests and speed recovery.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral chest wall injury with multiple rib fracture (\< 5 ribs)
* Signed informed consent

Exclusion Criteria:

* Minors
* Pregnant women
* Contraindications of using kinesiotapes
* Contraindications to perform spirometry (lung function tests)
* Inability to cooperate
* Chest drains
* Pneumothorax
D-0316 First Time in Patients Ascending Dose Study

This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
* Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
* Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
* Confirmation that the tumour harbours an EGFR T790M mutation.
* No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
* Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria:

* Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.
* Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.

Other protocol defined inclusion/exclusion criteria could apply
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food

To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease).
* Use of tobacco or nicotine containing products within 3 months of screening.
* A positive urine drug screen.
Collection of Biological Specimens and Associated Health Information

The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease.


Eligibility Criteria:
Inclusion Criteria:

* Are patients of participating study site clinics/clinical groups
* Are adults (aged 18 or older)
* Have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy
* Participants may have other active diagnoses with confirmatory clinical results

Exclusion Criteria:

* Individuals who lack the capacity to provide informed consent
* Individuals known to be prisoners at time of biological specimen collection
Effect of a Pilot Group Hand-washing Program on Handwashing Behaviors Among Elementary School Children in Assam

The United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under their Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities, practices and institutionalize WASH in school settings. Under the WinS program, UNICEF piloted a group hand washing program in 100 elementary schools. Multiple past studies have shown that handwashing is an effective intervention to reduce diarrheal diseases and respiratory tract infections, but the evidence on the interventions or programs that can achieve this behavior change is mixed and limited in case of school setting. The main objective of Daily Handwashing for an Ailment-free Life (DHaAL) program was to institutionalize handwashing with soap before consuming mid-day meals and after using toilets among elementary school students. DHaAL is implemented on the Mid-day Meal platform where free meals are given to all students attending government schools.

In addition to the standard DHaAL intervention, several pilot phase schools also received an additional program for a holistic and participatory development of school systems for health, nutrition, learning outcomes and wellbeing of children called Child Friendly School System (CFSS). Although CFSS is not a WASH intervention it can develop systems and processes and offer longer support from and implementing agencies which help DHaAL Intervention also.

This evaluation study seeks to answer whether DHaAL improved handwashing practice before the mid-day meals in rural lower primary schools as a primary research question. The intermediate outputs and secondary outcomes evaluated in this study include functionality of handwashing infrastructure at school, handwashing practice after toilet use, and availability of and use of handwashing facilities at homes (indirect effect). The evaluation study has other supplemental operations research objectives to help improve the program in future.


Eligibility Criteria:
Inclusion Criteria:

* Should be present in the school on the day of interview/survey

Exclusion Criteria:

* None
The Measurement of Empathy and Its Efficacy in Psychotherapy

The purpose of the research is to: 1) to test whether psychotherapy including immediate feedback of empathy data is more efficacious than therapy without such an exchange of data, 2) to measure the degree of accuracy of therapist's empathy and its relationship to the patient's estimate of the therapist's empathy.

Objective: To develop and evaluate a feedback method for measuring and increasing therapists' empathic accuracy and reducing empathic errors in psychotherapy. Method: Sixteen (16) patient-therapist pairs were randomly assigned to intervention and control groups. All patients rated their own functioning using the GAF (Global Assessment of Functioning) and predicted the accuracy with which their therapists would estimate their ratings. Therapists rated the patient's GAF, predicted the patients' ratings of their own GAFs, and rated their confidence in their own predictions. In the intervention condition, therapist and patients discussed the previous session's ratings for a few minutes of the therapy session. Results: Intervention therapists showed greater empathic accuracy relative to controls on our empathy measure (t(14) = 2.69, p \< .01) and increased empathy over time on the Barrett-Lenard Empathy subscale (t(32) = 3.21, p \< .01). We also found significant effects on errors related to perceived accuracy of therapist empathy. Patients in the control group were found to perceive their therapists to be either more or less accurate than was actually the case (over/under-idealization), but such biases were not as strong in the intervention group. Similarly, therapists in the control group were likely to over-estimate their own accuracy (over-confidence) to a greater extent than intervention therapists. Affective responses to the instrument were positive overall and did not differ by condition. Conclusion: Empathy feedback and feedback concerning degrees of patient idealization and therapist confidence may be effective in improving functioning as well as in increasing empathic accuracy in psychotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient psychotherapy at University of Illinois at Chicago
* Age 18-65

Exclusion Criteria:

* Psychosis
* Suicidality
* Organic Brain Disorder