cyrilzakka/clinical-trials huggingface dataset:
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).


Eligibility Criteria:
Inclusion Criteria:

* Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;
* Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;
* Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;

Exclusion Criteria:

* Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance
* Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;
* Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents

To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents and young adults with NSSI (12 in each group: high, low, and placebo).

This study is a double-blind, placebo controlled, 4-week course of two-tiered N-acetylcysteine (NAC) dosing focused on identifying the optimal dose to achieve meaningful change in measurable biomarkers (glutathione and glutamate).

This design will allow us to confirm acute biological changes, select the optimal dose for achieving biological effects, and examine dose/concentration-response relationships with respect to biological markers and pharmacokinetics.

Brief schedule of activities: Subjects will be recruited through community and clinical settings and screened over the phone. There will be a total of 4 in-person visits and two sets of on-line study activities.

Eligible participants will be assigned to one of 3 groups (double-blinded): a low-dose NAC group (3600 mg/day), a high-dose NAC group (5400mg/day), and placebo (PBO). The study intervention period is 4 weeks. Total participation is up to 8 weeks, depending on the length of time between Day 0 and Day 1.

The investigators will recruit 36 adolescents and young adults aged 16-24 years. There will be 12 participants in each group (PBO, 3600mg/day, 5400mg/day). The investigators will use a minimization procedure to ensure that the participants in these 3 groups will have similar age, clinical severity and medication status.

Eligibility Criteria:
Inclusion Criteria:

* Current frequency of at least one NSSI episode in the past 2 months
* ≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)
* Psychotropic medications are dose-stable for 1 month
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted devices)
* Any current serious medical illness as defined by medical history
* Current Substance Use Disorder (except Tobacco Use Disorder)
* Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder)
* Neurodevelopmental disorder such as mental retardation or autism
* Changes in psychotropic medications in past 1 month
* Taken NAC or glutathione on a regular basis in the past 6 months
* Currently pregnant, planning to become pregnant, currently breastfeeding, or unwillingness to use contraception throughout the study.
* Allergy/sensitivity to N-acetylcysteine.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth

The aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS) criteria.

A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. The restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. The results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p\< 0.05).

The aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS) criteria.

Fifty-four patients having Class I and II restorations/caries were included in the study. A total of 256 restorations were made with EquiaFil (GC Corp, Japan) and Riva SC (SDI, Australia). Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. After cavity preparations, the teeth were randomly restored with one glass ionomer cement and coated with Equia Coat or Fuji Varnish. The restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. Two evaluators checked color-match, marginal discoloration, marginal adaptation, caries formation, anatomical form, postoperative sensitivity and retention rate and photographs were taken at each recalls. The results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p\< 0.05).

The 18-month results were presented at the CED IADR congress iheld in Barcelona in 2010 (Turkun LS, \& Kanic O ,Clinical evaluation of new glass ionomer coating combined systems for 18-months Journal of Dental Research 89 (Special Issue B) Abstract #402.) Gurgan S et al. also mentioned our 18-month results in their published manuscript ( Gurgan S,Kutuk ZB, Ergin E, Oztas ZZ \& Cakir FY (2015) Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system Operative Dentistry 40(2) 134-143).

Eligibility Criteria:
Inclusion Criteria:

1. having good oral hygiene;
2. need for at least two or more posterior restorations in contact with neighbouring tooth and in occlusion with antagonist teeth;
3. teeth planned to be restore should be vital and symptomless;
4. the cavity isthmus size should be more than 1/3 of the intercuspal distance.

Exclusion Criteria:

1. absence of adjacent and antagonist teeth;
2. teeth with periodontal problems;
3. teeth with preoperative pain or pulpal inflammations;
4. teeth formerly subjected to direct pulp capping;
5. patients having severe systemic diseases, allergies or adverse medical history.
A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession

Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.

The tunnel technique is an approach that optimizes esthetics and predictability because of its ability to avoid releasing critical papillae and maintaining a high level of vascularity at the surgical site to support the grafts. The tunnel technique has a minimally invasive nature since the interdental papillae are left intact and vertical incisions are not performed which results in better esthetics. This technique entailed the placement of a connective tissue graft in the tunnel. Complete graft coverage is not mandatory as long as the graft dimensions are sufficient to ensure its survival. Avoiding detachment of the highly fragile interdental soft tissue can minimize the risk of losing papilla height in critical esthetic areas, avoid scar formation, maximize the papillary and lateral blood supply to the underlying graft and better stabilize the graft for optimal wound healing Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years old.
2. The presence of Miller's class I gingival recession (25).
3. Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
4. Absence of a history of periodontal surgery at the involved sites in the last 12 months.
5. History of compliance with oral hygiene instructions and periodontal recall.
6. Sufficient palatal donor tissue thickness (\> 2mm).
7. Clearly identifiable cemento-enamel-junction (CEJ)

Exclusion Criteria:

1. Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc (26).
2. Pregnant and lactating women
3. Current use of any form of tobacco.
Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells

Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic defaults. The cartilage has no intrinsic ability to repair resulting at long term in function loss in the joints. Currently available treatments are not satisfactory in the long term, the use of mesenchymal stem cells appears to be promising due to their ability to multipotency and immunomodulation properties. This project aims to determine the most appropriate source for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in patients with osteoarthritis. These cells will be tested for different chondrogenic markers. The success of this project will consider the implementation of a strategy for regenerative medicine in bone and joint diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Patients with knee osteoarthritis
* Patients requiring total knee arthroplasty
* Patients who signed the consent form

Exclusion Criteria:

* Patients aged less than 18 years
* Major Patients under guardianship
* Pregnant woman
* Infectious pathology or progressive tumor
* Refusal to participate in the study
* State of immunosuppression
* Congenital or acquired malformation resulting in a deformation of the knee
A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.

There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for young children with cancer, with resultant increased risk of morbidity, mortality and inferior outcome. Of the anti-cancer agents used frequently in infants and young children, the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used for the treatment of several childhood cancers since the 1960s. Despite its longstanding and widespread use in pediatric oncology, there is virtually no pharmacokinetic information from which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists will continue to administer the durg despite the gap in knowledge.

Eligibility Criteria:
Inclusion Criteria:

* 6 months - 18 years
* Due to receive actinomycin-D as a component of cancer treatment
* Central venous catheter (e.g. Port-a Cath, Broviac)
* Informed consent of parent or legal guardian and patient assent when appropriate

Exclusion Criteria:

* Serious illness other than the primary diagnosis of cancer
* Weight \< 5 kilograms
* Previous participation in CHP-810
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal

Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes in eating and activity behaviors and weight status, particularly for children who enhance their sleep the most. Enhancing sleep may be particularly important for racial minority children and those from lower socioeconomic backgrounds given their increased risk for short sleep, obesity and CV risk factors. In this study two active obesity preventive interventions will be evaluated: a) enhancing sleep alone (Optimize Sleep \[OS\]), and b) enhancing sleep along with eating and activity behaviors that have demonstrated efficacy for obesity prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred four children 6-11 years old who are primarily African American/black, primarily from low socioeconomic backgrounds, and who sleep \< 9.5 hours/night into a 12-month study will be enrolled. Children will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all children will attend an 8-session treatment; monthly phone contacts will occur during maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Caregiver-reported child age of 6-11 years
2. \< 9.5 Hours time-in-bed for sleep most days/week
3. BMI for age and gender \> 25th percentile (but no greater than 100% overweight)
4. Understanding of and ability to complete protocol
5. Self-reported caregiver age of 18 years and primary caregiver at bedtimes/wake times
6. Likes food used in the eating regulation paradigms
7. Willingness to be randomized to either treatment condition.

Exclusion Criteria:

1. Diagnosable sleep disorder
2. Medication use or diagnosis of medical or psychiatric condition that may impact sleep/weight status
3. Current or planned treatment for weight control
4. Allergies or dietary restrictions that would prevent consumption of foods used in the study
Enhanced Recovery After Spine Surgery

Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.


Eligibility Criteria:
Inclusion Criteria:

* Any patient presenting for 1 or 2 level posterior lumbar fusion.

Exclusion Criteria:

* Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate).
* Kidney disease: GFR \<60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012).
* Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy.
* Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease).
* Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol.
* Patients whose primary or preferred language is not English.
Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma

Oral squamous cell carcinoma is the most common malignant tumor of the oral and maxillofacial region. Currently, surgery is the main method of comprehensive treatment. TPF (paclitaxel, cisplatin, and fluorouracil) chemotherapy regimen is one of the important methods for the treatment of oral squamous cell carcinoma. Adjuvant chemotherapy before and after surgery can significantly improve the therapeutic effect of oral cancer patients. Oral mucositis (OM) is a common side effect during chemotherapy, which seriously affects the quality of life of chemotherapy patients and may lead to the termination of chemotherapy. Prevention and treatment of oral mucositis is still an urgent clinical problem. Investigators' previous studies have found that vitamin D can significantly inhibit the proliferation, migration, invasion and metastasis of oral squamous cell carcinoma cells, and vitamin D can protect normal oral mucosal tissue by inhibiting pyroptosis caused by platinum-based chemotherapy drugs. Based on the previous basic research, this project intends to conduct a single-center, prospective, clinical randomized controlled study on the clinical efficacy of vitamin D in reducing oral mucosal inflammation in patients with oral squamous cell carcinoma undergoing TPF chemotherapy, in order to provide evidence-based medical evidence for the clinical use of vitamin D in reducing oral mucosal inflammation in patients with oral cancer chemotherapy. The results of this study are expected to serve as guidelines to guide clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 20-70 years
2. Patients with pathologically diagnosed oral squamous cell carcinoma who need TPF-based chemotherapy regimens, and whose expected survival time is greater than 6 months
3. Patients whose serum 25-hydroxyvitamin D level was vitamin D deficiency (\<30nmol/L) and adequate (30-50nmol/L) before chemotherapy
4. Patients and their families agree to participate in this trial and sign an informed consent form
5. No cognitive impairment

Exclusion Criteria:

1. People with oral ulcers or other oral mucosal diseases (such as: oral mucosal pemphigus, etc.) at the beginning of the study
2. Patients who are allergic to alfacalcidol drops
3. Patients with severe cardiac insufficiency, liver and kidney insufficiency, and systemic infectious diseases
4. Pregnant women (judged by HCG test) and lactating patients
5. Participating in other clinical trials during the study
6. Those who do not understand or cooperate with clinical trials
7. Patients with hypervitaminosis D, hypercalcemia, hyperphosphatemia and renal rickets
A Study Regarding Tissue Response During and After Treatment for Anal Cancer

The aim of this study is to improve the understanding for the tumour biology in relation to treatment response in patients with anal cancer by examining:

* The tumour microenvironment
* The localisation of and cellular interactions between the tumour and immune cells
* The gene and protein expression by cells present in the tumour and surrounding tissue.

All adult patients with anal cancer presenting within the Sahlgrenska University Hospital catchment area or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. The patients that are newly diagnosed or that have a suspected recurrence will be offered to enter the study with biopsies as well as blood samples during the diagnostic examination that is performed under anaesthesia. Biopsies will then be taken during follow-up exams if applicable. Biopsies will also be taken during surgery if that is scheduled and in cases where surgery is not necessary biopsies will be taken if the patient undergoes examinations under anaesthesia after treatment cessation.

If it is not possible to take biopsies prior treatment blood samples will still be drawn.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or recurrent anal cancer

Exclusion Criteria:

* No diagnosis of anal cancer, contraindication to biopsies and blood samples
Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Services

Main aims of this project are

* To assess the baseline status-quo of transition and "fitness for transfer" in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related quality of life (HrQoL), and self-efficacy in adolescnets with inborn errors of metabolism. Biochemical or physical parameters as appropriate for the respective diseases from 12 months before are documented.
* To provide targeted, structured intervention modules (using available and, if necessary, adapted materials).
* To measure the effects of these interventions on information about adult services short-term (within a month) and to re-assess all other baseline status-quo parameters long-term (6 and 12 months later). Psychological assessments will be complemented by biochemical or physical parameters as appropriate for the respective diseases and indicative for transition success.


Eligibility Criteria:
Inclusion Criteria:Patients

* with an inborn error of metabolism in the care of a specialized metabolic care unit
* requiring specialized adult metabolic care
* at least 14 years old
* with a disease for which at least one biochemical and / or physical parameter disease marker is well established .

Exclusion Criteria:

Patients -

* with insufficient knowledge of the German
* with cognitive impairment to a degree that consent, and participation would be impossible
* in an end-of-life situation
* with a disease for which no biochemical and / or physical parameter disease marker is well established