cyrilzakka/clinical-trials huggingface dataset:
Non-syndromic Inherited Anomalies of Mineralized Tooth Tissues: a Whole Exome Study to Identify New Pathogenic Variants

ExoDent specifically aims to discover new genes and new mutations causing isolated amelogenesis imperfecta (AI) and dentinogenesis imperfecta (DI) and other dentin anomalies. The key point for clinicians is to distinguish between non syndromic and syndromic disorders in order to improve patients guidance and counseling. To do so, two targeted NGS panel have been designed, one searching for isolated AI and the other for DI. After 18 months, some families remain without any positive results. ExoDent project proposes those negative patients a Whole Exome Sequencing (WES) approach to deeper explore their genetic background.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of amelogenesis imperfecta or dentinogenesis imerfecta or other dentin anomaly with no other signs or symptoms ( familial or isolated)
* negative results after targeted NGS strategy for molecular diagnosis

Exclusion Criteria:

* absence of positive clinical diagnosis
* Diagnosis of syndromic disease
A Nurse Led Patient Management Programme to Improve Outcomes in Gout

This study evaluates the addition of a structured nurse led patient management programme to standard of care in gout patients. Half of the patient will receive the nurse led programme in addition to standard of care and the other half will receive standard of care only.

There is evidence from other chronic diseases that nurse led care in addition to standard of care ameliorates outcomes.

In gout the primary target is the serum uric acid level (SUA). We intend to demonstrate the superiority of a structured nurse led patient management programme over standard of care in a randomized controlled study.

The primary endpoint is the percentage of patients reaching the target SUA level at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of gout according to aspiration of Monosodium urate (MSU) crystals or positive dual energy computer tomography (DECT) or American college of rheumatology (ACR) criteria 2015 fulfilled (1)
* written informed consent
* age \>=18 years
* ability and willingness to follow a fixed outpatient programme as judged by the investigator
* indication for urate-lowering therapy (ULT)
* In case of established disease and intercritical gout a SUA level over 360 umol per liter is mandatory.

Exclusion Criteria:

* informed consent not obtained
* age \<18 years
* inability or unwillingness to follow a fixed outpatient programme as judged by the investigator
* no definite diagnosis of Gout
* no indication for ULT or contraindications against ULT
* in case of established disease and intercritical gout a SUA level \<360 umol per liter is an exclusion criterion
* Pregnant or breastfeeding women can´t participate.
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. The investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes.

The investigators will collect insulin dosing via pump records, blood glucose meter, continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100 children with diabetes. The investigators hypothesize that with the collection and analysis of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with diabetes the investigators can identify glucose patterns and predictors of acute events.

The 100 children will be randomized to either conventional therapy (data upload group) or intensive remote therapy (weekly review group). Conventional therapy will consist of routine quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated by the family, between study visits. Intensive remote therapy will consist of routine quarterly visits to the clinic along with weekly remote review of insulin and blood glucose data by the research staff, and additional communication with the family, initiated by the diabetes staff as needed, between visits. The investigators hypothesize that with weekly, manual review of real-time insulin, glucose, and activity data in children with diabetes, and recommended regimen changes based on the data, the investigators will be able to lower HbA1c values in children in the weekly review group as compared to children in the data upload group.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes, using an insulin pump (Medtronic, Omnipod, Animas)
2. Duration of diabetes \>1 year
3. Age: 8-17 years of age, inclusive.
4. Hemoglobin A1c 8.0-10.0% at baseline visit, inclusive.
5. Seen in the McNeely Diabetes Clinic within the past 6 months.
6. The family/child is testing blood glucose at least 4 times a day.
7. The family has a smart phone and service.

Exclusion Criteria:

1. The child is not using insulin for management of diabetes.
2. The child uses multiple daily injections of insulin.
3. The child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis
4. The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
5. Diagnosis of a mental health disorder.
6. Parent/child does not speak English as the device software is only available in English.
Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia

The aim of this study is to evaluate the feasibility and efficacy of transcranial alternating current stimulation (tACS) as an add-on treatment for auditory hallucinations in refractory schizophrenia. Meanwhile, we aim to evaluate the effect of tACS on cognitive function of schizophrenia patients. we hypothesize tACS would improve refractory auditory hallucination symptoms in schizophrenia by regulating the gamma frequency band of temporal lobe。

This is a randomized, double-blind, sham-controlled study to detect the effect of tACS for treatment of refractory auditory hallucinations in schizophrenia. 50 participants were randomly assigned 1:1 to tACS group or sham-control group. For both active and sham group, daily tACS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, active participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe, while controls received sham stimulations with the same protocol. Scale assessments are performed at baseline, week 2, week 4 and week 6. Collection of blood took place at baseline, week 4 and week 6.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible participants aged 18-70 with DSM-5-defined schizophrenia or schizophrenia-like disorder.
2. Duration of illness \> 12 weeks.
3. Being clinically stable and on an adequate therapeutic dose of antipsychotics for at least 8 weeks prior to enrolment.
4. Junior high school education or above
5. After treatment with ≥ 2 different antipsychotics (greater than the equivalent dose of chlorpromazine 600mg), the curative effect was poor (CGI ≥ 4 points or the PANSS score reduction rate since this treatment was less than 20%)
6. Agreement to participate in the study and provide the written informed consent.

Exclusion Criteria:

1. Having unstable medical conditions, current psychiatric comorbidity or active substance use disorder (in exception to caffeine and/or tobacco)
2. Having Serious physical diseases or nervous system diseases;
3. Having any brain device / implant, including cochlear implant and aneurysm clip;
4. Having a history or family history of autoimmune diseases or immune diseases;
5. Pregnancy or breastfeeding at enrollment;
6. Skin lesions on scalp at the area of electrode application.
Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement

The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>18 years of age.
* Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45).
* Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions
* Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.
* Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.
* Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing according to the protocol
* Signed informed consent document before being treated in the study

Exclusion Criteria:

* Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
* Any contraindications for oral surgical procedures
* Current untreated periodontitis or gingivitis
* Probing pocket depth of more than 4 mm at one of the adjacent teeth
* Mucosal diseases (e.g. erosive lichen planus)
* History of local irradiation therapy
* Bone augmentation procedures if the procedure require healing time of more than 12 weeks after implant placement
* Implants in adjacent position to planned implant
* Severe bruxing or clenching habits
* Heavy smokers: Patients who smoke more than 20 cigarettes per day
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation.
* Patients with inadequate oral hygiene or unmotivated for adequate home care

Secondary Exclusion Criteria at Implant Surgery:

* Lack of primary stability of the implant
* Inappropriate implant position to insert implants according to the prosthetic requirements.
* Patients with augmentation procedures requiring more than 12 weeks healing time.
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years;
* Indication for elective left-sided pancreatectomy, either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease);
* Both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team;
* Fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist;
* Written informed consent

Exclusion Criteria:

* Suspected pancreatic ductal adenocarcinoma;
* Tumor or cyst larger than 8 cm;
* Required resection or ablation of organs other than pancreas and spleen;
* Tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava);
* Pregnancy;
* Body mass index \>40 kg/m2;
* Participation in another study with interference of study outcomes
A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease

Based on prior published pilot studies, the investigators have initiated a larger, multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.

Preclinical studies with mouse models of of age-related neurodegeneration led us to develop a Nutriceutical Formulation ("NF") consisting of 6 over-the-counter vitamins and nutriceuticals, that buffers multiple facets of Alzheimer's disease (AD), including (1) reducing presenilin expression, gamma-secretase activity, Abeta generation and tau phosphorylation, (2) buffering homocysteine and Abeta-induced oxidative damage, (3) reducing aggression, (4) increasing acetylcholine production and improving/maintaining cognitive performance.

A 1-year, open-label trial with NF with mild to moderate AD patients demonstrate improvement in cognitive performance (Dementia Rating Scale, Clock-drawing) within 3-6 months. Caregivers reported maintenance of daily performance and improved mood (ADCS-Activities of Daily Living and NeuroPsychiatric Inventory). A placebo-controlled study with moderate to late-stage AD indicates delayed cognitive decline and maintenance of daily activities. No adverse events were reported.

A multi-site trial with \>90 individuals aged 45-73 without dementia indicated that NF statistically improved executive function (Trails B-A) vs. placebo within 3 months, which increased further at 6 months. The placebo group demonstrated identical improvement in a 3-month open-label extension. Following NF withdrawal, participants returned to baseline; statistically-significant improvement was restored once NF was individuals resumed.

We have initiated a larger, multi-site placebo-controlled clinical trial with AD patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
* must be able to swallow pills

Exclusion Criteria:

* known or suspected bipolar disorder
Coconut Oil in Cardiovascular Disease

The purpose of this study is to evaluate the supplementation with extra virgin of coconut oil combined with a nutritional counseling in reducing anthropometry and improves the lipid profile in patients with chronic coronary disease.

The universe of patients with coronary artery disease (CAD) has been increasing steadily worldwide. And associated intimately with certain cardiovascular risk factors such as dyslipidemia , decreased HDL-C , hypertension , diabetes mellitus and obesity. The quality of the fat in the diet influences the incidence of obesity and dyslipidemia. A high intake of saturated fat in different populations is associated with elevated serum cholesterol concentration and cardiovascular mortality. However, studies have shown that extra virgin coconut oil (Cocos nucifera L.) despite being characterized by its high content of saturated fat was not associated with obesity and dyslipidemia in populations that had their high consumption . And this is due to the high proportion of medium chain triglycerides , especially lauric acid in proportions ranging from 45-50 % , and the presence of factors antioxidants like vitamin E and polyphenols. Our hypothesis is that extra virgin coconut oil associated with a nutritional treatment has an effect on weight reduction and control of dyslipidemia contributes to control in secondary prevention in patients with coronary artery disease. All participants will be informed about the research and they must sign a consent form . Volunteers will be divided into two groups : a group receiving dietary treatment for 6 months and the other beyond the dietary treatment during the 6 months starts to receive supplementation with coconut oil extra virgin from 3 months, both groups evaluated monthly . At each visit , weight assessment , compliance with diet and blood pressure measurement is performed. In addition , the blood will also be collected for determination of glucose, insulin, total cholesterol, LDL-cholesterol , HDL-cholesterol, triglycerides , apolipoprotein A and B. The results will be analyzed by the statistical program.It is expected that the results obtained, the extra virgin coconut oil can be used as a coupled secondary prevention in patients with coronary artery disease.Our hypothesis is that extra virgin coconut oil associated with nutritional treatment has an effect on weight reduction and control of dyslipidemia contributes to control in secondary prevention in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

Presenting chronic coronary artery disease (myocardial infarction and/or stable angina

Exclusion Criteria:

angioplasty and/or coronary artery bypass grafting and previous cardiovascular event \<6 months and those who had chronic renal failure with creatinine values\> the 2mg/dl and liver disease.
Teachers and Parents as Partners During Middle School RCT

There are two aims of this study (a) to examine the effect of Teachers and Parents as Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers and facilitators to implementing Teachers and Parents as Partners in middle school for students with behavior concerns.

In the business-as-usual control condition, participants will have access to any services that a school would routinely provide (e.g., develop and implement a behavior support plan) as well as services families can access in the community (e.g., mental health support).

Teachers and Parents as Partners will occur in a series of stages comprised of approximately four structured meetings over approximately 8 weeks. A Teachers and Parents as Partners consultant will meet together with a student's parent(s), teachers, other school personnel (as appropriate), and the student (as appropriate). The Teachers and Parents as Partners team will collaboratively address behavior problem solving objectives. Specific TAPP objectives include: identifying strengths and specific behaviors of concern, specifying alternative prosocial behaviors, creating measurable behavior goals, co-constructing behavior intervention/support plans to address the target concerns, creating sustainable conditions to support plan implementation at home and school, and evaluating the plan to assess progress toward goals.

Eligibility Criteria:
Inclusion Criteria:

* Students will be eligible if they have scores in the "elevated" or "extremely elevated" risk categories on the parent or teacher version of the Behavior Assessment Scale for Children (BASC) 3 Behavioral and Emotional Screening System (BESS). Parents, and primary teachers and school staff associated with an eligible student will be included.

Exclusion Criteria:

* Students who do not meet the inclusion criteria will be excluded from participation, which includes their parent(s), teachers, and other school personnel. Students also may not be eligible if they have mental health concerns or severe behavior problems that may not be appropriate for Teachers and Parents as Partners or a research project (e.g., some internalizing problems, students who pose an risk of harming themselves).
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. Irinotecan will be administered once every 14 days, the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels: 200mg/w, 400mg/w, 600mg/w, weekly. The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks, when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed before performing any of the study's specific procedures.
* ECOG performance status 0-2.
* Age \> 18，both genders.
* Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
* Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
* At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
* Life expectancy more than 3 months.
* K-ras is wild type
* Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
* Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
* Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
* TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN
* No brain metastasis

Exclusion Criteria:

* Previous radiotherapy at lesions within three months
* Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
* Received other anti EGFR monoclonal antibody treatment
* Complete or incomplete intestinal obstruction
* Participation in other interventional clinical trials within 1 month
* Psychiatric disease affected cognitive ability, including brain metastasis
* Peripheral neuropathy lesion is more than I stage.
* History of serious allergic or allergy
* Pregnant or breast-feeding women
* Patients with the history of Serious lung or hear disease
* Other malignant tumor
Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing

This pilot project aims to reduce the prescribing of high-risk medications, such as antipsychotics and benzodiazepines, to hospitalized older adults. To accomplish this, this project consists of two phases. The purpose is to determine whether a novel simulation-based training program reduces prescribing of suboptimal medications for older adults. A 2-arm pilot randomized controlled trial will be conducted to test a simulation-based, principle-driven intervention targeting high-risk prescribing practices versus control.

The overarching goal is to determine whether a newly-designed simulation-based training program for providers based on underlying principles of System 1 and System 2 thinking reduces prescribing of high-risk medications for hospitalized older adults versus control, with the ultimate goal of improving patient safety. Subsequent prescribing for patients cared for by other providers and other adoption and implementation outcomes will be measured to explore the extent to which the intervention could be used at scale.

36 interns practicing on the general medicine inpatient service at Brigham and Women's Hospital will be assigned to the "twilight" team. Interns who consent will be randomized in a 1:1 ratio to one of 2 arms: (a) Arm 1: simulation training and (b) Arm 2: control (online educational training).

Patients who will be included in the analysis will include adults ≥65 years old who are admitted to the BWH/BWFH general medicine service under the care of one of the consenting interns (specifically, with the intern listed as the "Responding Clinician")

Eligibility Criteria:
Residents and interns at Brigham and Women's Hospital will be eligible for this trial if they care for older adults (age 65+) admitted to one of the general medicine wards during an evening shift.