cyrilzakka/clinical-trials huggingface dataset:
Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration

This study will investigate the efficacy of three diode laser wavelengths 445 nm, 660 nm, 970 nm when applied just before placement of composite restoration on reducing postoperative sensitivity from Non-carious cervical lesions (NCCLs) with class V cavity preparation.

In this randomized clinical trial, patients with NCCLs will be included (four teeth in each participant). After class V cavity preparation in the NCCLs, the teeth will be randomly assigned into four groups according to diode laser irradiation wavelength Group 1 (placebo) laser simulation and Group 2 (445 nm) diode laser wavelength, Group 3 (660 nm) diode laser wavelength, and Group 4 (970 nm) diode laser wavelength. Following laser irradiation, the universal self-etch adhesive will be applied and all the cavities will be restored with the same resin composite. Tooth sensitivity to a cold stimulus will be recorded using a visual analogue scale (VAS) before treatment and on follow-up days 1, 14 followed by 1, 3, and 6 month after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. NCCLs on the Buccal Surface of Teeth, Maxilla, or Mandible.
2. Preoperative VAS Score \> 2.
3. Good Oral Hygiene. Score (0-1.2).
4. Teeth Must be Vital.

Exclusion Criteria:

1. Teeth with a History of Trauma, Dental caries, Defective Restoration, Pulpitis, Occlusal Restoration.
2. Teeth with Periodontal Disease or History of Surgical Procedure.
3. Use of Desensitizing Toothpaste or Solutions in the Past 3 Month.
4. Patients Taking Analgesics within 72 h Before Sensitivity Testing.
5. Patients with Known Allergic Reactions Against Any Material to be Used.
6. Patients with a History of Psychological Diseases and those Taking Antipsychotic Medications.
7. Pregnancy or Nursing.
8. Unwillingness of the Patient to the Treatment Procedure.
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years at enrollment.
* Greater than or equal to 5% blasts in the bone marrow.
* Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
* Negative pregnancy test in women of childbearing potential.

Exclusion Criteria

* Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
* Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.
Engagement of Patients With Advanced Cancer

The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.

VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed stage III or IV cancer
* Recurrent disease (any stage)
* Ability to consent to study

Exclusion Criteria:

* Patients who are unable to consent to study procedures
Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma

The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is a second-generation platinum compound that is more active against squamous cell carcinoma of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.


Eligibility Criteria:
Inclusion Criteria:

1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
2. IIIB-no radiotherapy indication /IV phased by ASLC 2009 TNM criteria.
3. at least one measurable tumor based on RECIST ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
4. male or female, age≥18 or ≤75 years old
5. ECOG PS: 0 or 1
6. estimated time of survival: ≥12 weeks
7. suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
8. suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
9. suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
10. no history of chemotherapy
11. at the enrollment, the past operation has been over 4 weeks and the subject recovered.
12. for the female subject with the intact uterus, if amenorrhea is less than 24 months, pregnancy test must be negative within 28 days of enrollment. If pregnancy test has been past 7 days at the time of initial chemotherapy, urine pregnancy test must be done.
13. the authorized ICF must be signed

Exclusion Criteria:

1. having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded.
2. having the evidence of CNS metastasis, no matter if treated; if being suspicious of CNS metastasis, CNS MRI or enhanced CT scan must be done within 28 days of enrollment.
3. AST and /or ALT\>2.5×normal ULN, and ALP\>5×normal ULN.
4. radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field)
5. chemotherapy in the past (excluding bisphosphonates )
6. having the other uncontrolled diseases.
7. the female in pregnancy or feeding.
8. the subjects with the productivity capacity, but refusal to use the effective contraception measure.
9. participating in other clinical trial and at the time of treatment period.
10. allergy to the tested drugs
11. having the other uncontrolled diseases
12. BMT had been done.
Study of SPG601 in Adult Men With Fragile X Syndrome

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.

This study is a Phase 2 randomized, double blind, placebo-controlled, cross over, single dose of SPG601 and matching Placebo in patients with Fragile X syndrome.

This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo. Participants will receive a dose of either SPG601 or placebo at first visit, and will cross over to receive the other product at the second visit.

Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 18 to 45 years
* Diagnosis of Fragile X as confirmed with genetic testing
* Patient must have caregiver
* Must be in good health with no significant medical history
* Clinical laboratory values within normal range or \< 1.2 times ULN
* Contraceptive use by men or women consistent with local regulations
* Able and willing to provide written informed consent
* Stable dosing of psychotropic drugs for at least 4 weeks

Exclusion Criteria:

* Any physical or psychological condition that prohibits study completion
* Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months.
* Auditory or visual impairments that can not be corrected
* History of suicidal behavior or suicidal ideation
* Screening vital signs that are abnormal per protocol specification
* ECG that are clinically significant abnormal
* History of substance abuse or dependence within 6 months
* Other investigational products within 30 days
Deep rTMS and Varenicline for Smoking Cessation

The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.

This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for 4 weeks (5 sessions/week). All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study are:

1. To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment.
2. To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity.
3. To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up.

Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. This will be confirmed using plasma cotinine levels. All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS), and Tiffany Questionnaire of Smoking Urges (T-QSU).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65;
* Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
* Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
* Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
* Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.

Exclusion Criteria:

* Reported smoking abstinence in the 3 months preceding screening visit;
* Current use of other smoking cessation aids;
* Allergy and/or contraindication to varenicline or rTMS;
* Pregnancy, trying to become pregnant or breastfeeding;
* Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
* Current or historical evidence of suicidal behavior;
* Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.);
* Current, personal history or family history of seizures;
* Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score \<24;
* Concomitant use of medication that lowers seizure threshold
Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?

It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.

The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age \< 30 weeks (maternal dates or early fetal ultrasound);
2. Tolerating an enteral intake of ≥100 mL/kg/d for ≥ 24h;
3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥150 mL/kg/d) has been achieved;
4. Written informed consent has been obtained from the infant's legal representative.
5. Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
6. Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.

Exclusion Criteria:

1. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
2. Babies with enterostoma or short gut syndrome;
3. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
4. Fluid restriction \<140 mL/kg/d for ≥ 3 consecutive days;
5. Sepsis - all infants with gram-negative sepsis will be removed from the study;
6. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
7. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen \>10 mmol/L and creatinine of 130mmol/L
8. Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;
9. Probability of transfer to another neonatal intensive care unit or level II nursery outside the McMaster Children's Hospital, as discussed with the most responsible physician (MRP)
A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent in minimising internal adhesion formation in the neck after thyroid surgery and therefore reduce swallowing discomfort experienced by patients after surgery.

Thyroid surgery not only constitutes one of the main pillars in the treatment of thyroid cancers, but is also employed in the management of symptomatic goitres. Occasionally, it is mandated in patients with thyrotoxicosis refractory to medical therapy. While thyroid surgery can be performed with low risks such that patients rarely have to stay beyond three days in hospital, the track record of thyroid surgery is somewhat blemished by the unfortunate side effects associated with the neck scarring after thyroid surgery. Not uncommonly, patients experience discomfort in the neck region after thyroid surgery; in the extreme of cases, patients may even complain of a lifelong pulling sensation in the neck area during eating.

The anti-adhesive properties of Seprafilm are well established in animal studies and affirmed by clinical observations in abdominal surgeries that utilize this material. Thus, Seprafilm is routinely used in instances when a surgeon foresees a need to perform abdominal surgery on the same patient in future, or during the fashioning of a temporary stoma. The safety profile of Seprafilm in thyroidectomy has also been shown by a recent study conducted by a group of clinicians in Seoul.

We postulate that the application of Seprafilm to the surgical wound towards the end of a thyroidectomy significantly reduces internal adhesion formation in the neck region. By achieving this objective, we hope to improve patients' satisfaction with thyroid surgery in terms of ease of swallowing after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-75
* Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled by medication.
* Undergoing total thyroidectomy

Exclusion Criteria:

* Previous neck surgery
* Previous neck radiotherapy
* Patients with a known history of keloids
* Patients with a known history of motility disorders in the upper gastrointestinal tract and preexisting swallowing difficulty.
* Patients with metastatic disease; patients with disease that would require postop radiation therapy, radionuclide iodine therapy and any adjuvant therapies.
* Patients with advanced disease that would require radical or modified neck dissection
* Patients with lobe larger than 10 cm, or nodule larger than 8 cm which require extensive dissection that may confound the study
* Patients with connective tissue diseases and chronic diseases on long-term medications that may interfere with wound healings such as steroids
Revatio Special Investigation for Long-term Use in Pediatric Patients

Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice

The objective of this study is to obtain the information on dosage and administration, safety, and efficacy of Revatio when it is administered for a long period of time (1 year) under the actual use after the approval of the dosage and administration in pediatric patients (aged 1 year or older, weighed 8 kg or more) .

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients.

Exclusion Criteria:

* None.
Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

The purpose of this retrospective registry is to collect data about patients with acute HIT II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid, Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily routine in this indication in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
* Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux

Exclusion Criteria:

-
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

* Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis.
* Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables.
* Evaluate correlation between articular and enthesis ultrasound exam in this study.
* Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.


Eligibility Criteria:
Inclusion Criteria:

* Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009)
* Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease,
* 18 - 65 years old

Exclusion Criteria:

* Fibromyalgia
* Corticosteroid injection in the last 3 months
* Previous surgery in joint or enthesis of study
* Peripheric neuropathy
* Diabetes mellitus
* Hypothyroidism
* Peripheric venous insufficiency (with edema or ocre dermatitis)
Protein Source on Plasma Amino Acid Concentrations

This study will determine the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults. Each participant will receive all four treatments.

The 2015-2020 Dietary Guidelines for Americans stipulates how much Protein Foods should be consumed per day and per week as part of a Healthy U.S.-Style Eating Pattern. The predominant protein sources include lean meats, poultry, and eggs, however, nuts, seeds, and soy products are also included. Ounce-equivalents (oz-eq) are used as a standard unit of measure to compare animal to non-animal protein sources. One oz-eq of lean meat (1 oz) is equal to 0.5 oz of nuts (1 oz-eq), 0.25 cups (1 oz-eq) of beans, and one whole egg (1 oz-eq). One limitation of this unit of measure is that the protein quantity and quality of the foods are not considered. For example, 1 oz-eq of pork loin contains \~7 g of dietary protein whereas 1 oz-eq of almonds contains 3 g of protein. Consequently, consuming an oz-eq portion of protein foods from different sources could have different effects on the anabolic response to feeding. The purpose of this study is to assess the effect of consuming ounce equivalent portions of fresh pork versus nuts, beans, and eggs on essential amino acid substrate availability for protein anabolism. While it would seem intuitive that this research would show that higher protein intakes from pork and egg will lead to higher plasma essential amino acid responses, this research is paramount to addressing the shortcoming of using oz-eq to achieve the Dietary Guidelines for Americans recommendations for Protein Foods. This research will serve as an important resource for future Dietary Guidelines Advisory Committees to reevaluate the appropriateness of equating animal- and plant-based Protein Foods on the current ounce-equivalent basis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 25-39
* BMI 25-35 kg∙m-2
* Weight stable (± 4.5 kg) 3 months pre-study
* Not acutely ill
* Not diabetic
* Not pregnant or lactating
* Not currently (or within 3 months pre-study) following a vigorous exercise regimen
* Non-smoking
* Willing to consume study foods and travel to testing facilities.