cyrilzakka/clinical-trials huggingface dataset:
Molar Incisor Hypomineralization and Hypomineralized Second Primary Molars

Molar and Incisor Hypomineralization (MIH) is a qualitative developmental defect of the dental enamel with a multifactorial aetiology defined in 2001 as an "hypomineralization of systemic origin affecting one or more permanent molars, usually first permanent molars (FPMs) with or without the involvement of one or more affected permanent incisors". Due to its porous structure with an altered prism organization and an increased content of proteins, the hypomineralized enamel has reduced mechanical properties and a lower refractive index in comparison to the sound enamel. MIH is associated to a large number of objective and subjective problems as an altered aesthetics, an increased risk of plaque accumulation, caries and/or post-eruptive breakdown, reduced retention rates of adhesive materials, hypersensitivity and difficulty in anesthetizing the affected teeth that make its management a challenging condition. MIH is a very widespread pathology with a worldwide prevalence ranging from 2.8 to 44% and a global average prevalence of 13.1% with significant geographical differences. In 2015, the number of global prevalent cases was estimated at 878 million people with a percentage of needing-care cases of 27.4% (in mean 240 million prevalent cases). In Europe, MIH prevalence rates between 3.6 to 25%. Regarding Italy, a limited number of prevalence studies are available. Recently, literature reports that the presence of MIH-like lesions in primary dentition, especially on second primary molars, may be a predictive factor for developing MIH in permanent dentition. However, the absence of this defect called Hypomineralized Second Primary Molars (HSPM) does not rule out MIH development. The early diagnosis of HSPM is very useful to early diagnose MIH and reduce its care burden. The reported HSPM global prevalence rate ranges from 0 to 21.8% with a global average about 7.88%. MIH and HSPM are both very widespread pathologies affecting an increasing number of children worldwide and represent a significant problem in pediatric dentistry. The aim of this study is to estimate the prevalence of MIH in Italian (Trieste), Spanish (Huesca, Zaragoza) and Turkish (Istanbul) children. The hypothesis is that the estimated prevalence of MIH may be in line with that reported in literature and that the presence of HSPM in primary dentition may be associated with MIH development in permanent dentition.


Eligibility Criteria:
Inclusion Criteria:

* Age: 6-16 years;
* Signature of the informed consent to the study by patients' parents or by their legal guardians

Exclusion Criteria:

* Fluorosis, white spots, amelogenesis imperfecta, hypoplasia or other dental enamel defects in differential diagnosis with MIH and HSPM;
* Patients not sufficiently cooperative;
* Children with orthodontic devices hiding the teeth to consider
The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility

In the management and remediation of students with specific performance deficits in speech-in-noise intelligibility, most often, a "triad" approach for treatment is used, which includes direct therapy, compensatory strategies, and environmental modifications.

The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM System, can improve specific performance deficits in speech-in-noise intelligibility. Participants will complete a test battery related to auditory processing, as well as some psychological tests and questionnaires. One group of participants with specific performance deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a second group will not. The effect of this treatment on auditory performance, school performance and satisfaction, attention and verbal learning and memory, self concept, behavior and listening effort following 26 weeks of hearing aid use will be compared across the groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of specific performance deficits in speech-in-noise intelligibility based on two or more standardized tests of auditory processing in noise including retests.
* Students in the 1st to 4th class of primary school

Exclusion Criteria:

* Hearing loss, defined as:

  * Air conduction pure tone thresholds (250-8000 Hz) exceeding 20 dBHL
  * Air-bone gaps, even in the presence of normal sensitivity, exceeding 10 dBHL
  * Abnormal tympanogram
* History or diagnosis of behavioral and/or emotional disorders meeting ICD-GM-criteria (including attention deficit/hyperactivity disorders (AD-/HD)
* Non-German speaking
* Cognitively impaired children (IQ \< 85)
* Children currently using psychoactive medication
* Students with special education
Use of Lipogems for Knee Osteoarthritis

Lipogems system consist in the use of a monouse kit for liposuction, processing and administration of adipose tissue. The use of the final product (microfragmented adipose tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical improvement

The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous tissue for the treatment of the knee osteoarthritis (OA).

Main purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).

Secondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at 6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs (pre-intervention versus 6±1 months). Evaluation "quality-adjusted life years" (QUALY) in relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months).

The study is an interventional, prospective, randomized, controlled trial. Controls: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).

Surgical technique: patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.

Eligibility Criteria:
Inclusion Criteria:

* patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,
* age between 45 and 75,
* pain ≥ 6 VAS scale,
* no ligamentous instability,axial deviation less than 10°
* BMI between 18 and 30,
* International Normalized Ratio (INR) \< 1.5

Exclusion Criteria:

* previous traumatic lesion (tibial fracture, osteothomy) of the knee
* osteonecrosis
* meniscal surgery in the previous 6 weeks
* chemiotherapy, radioteherapy
* diabetes
* alchoolism, psichiatric disease,drug addiction
* coagulation disorders
* pregnancy
MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has had a history of migraine with or without aura
* Patient is able to complete study questionnaire(s) and paper diary

Exclusion Criteria:

* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
* Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
* Patient was older than 50 years of age at migraine onset
* History of gastric or small intestinal surgery or has a disease that causes malabsorption
* Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
* Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
* Currently participating in a study with MK-0974 or MK-3207
Additional Effects of Scapular Stabilization Exercise With Exergaming Training in Stroke Patients

The World Health Organization has termed stroke to be a clinical syndrome, of presumed vascular origin, typified by rapidly developing signs of focal or global disturbance of cerebral functions and the leading cause of death worldwide in 2016 making it a major non-contagious cause of death. This study would be beneficial in a way that it will give a valuable input and will contribute for the knowledge of interventions for stroke with an emphasis on upper extremity function among health care practitioners for their goal of promoting health, prevention of diseases and improving quality of life.

Exergaming can contribute to improvement of the function of UE motor and AROM in chronic stroke patients, additional studies with a large number of subjects with long follow-up periods are required to determine their effectiveness neurorehabilitation stimulation . The exergaming protocol presented in this study represents success a tool for UE functional aspects in patients with chronic stroke. It has shown improvement in gripping strength, handicrafts and UE's operational recovery. Movement control and the position of scapula determine an optimal upper limb function. Paresis leading to scapular disorientation ultimately exaggerates motor impairment in upper extremities. Recent literature has emphasized on the need to design an upper extremity protocol including scapular stabilization exercises in order to increase muscular strength and decrease scapular dyskinesis .The results of a study showed that scapular stability exercises had an impact on hand function and the ability to move hemiplegic patients after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Stroke patients with an initial onset of 6 months or above.
* Those who had 30-65 points by Fugl-Meyer Assessment of upper extremity
* Those who had minimum score 24 on mini mental state examination
* Those who have the ability to execute at least 20' of active shoulder flexion and abduction against gravity those who could understand and follow instructions provided by the investigator
* Those who are medically stable enough to participate in active rehab
* Those who have no problems with auditory or visual functioning.
* Modified Ashworth Scale (MAS) 1-3

Exclusion Criteria:

* Orthopaedic or mental health problems
* Those who have difficulty to stay in a sitting position
* Severe conditions such as uncontrolled blood pressure or angina
* History of epilepsy
* The refusal to play a video game.
Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
* Patients must have received prior PD-1/PD-L1 inhibitor therapy
* Patients with the presence of at least one measurable lesion.
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
* Documented left ventricular ejection fraction (LVEF) ≥ 50% - 6 month prior to drug administration.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Known history or evidence of brain metastases.
* Require any antineoplastic therapy.
* History of prior treatment with anti-LAG3.
* Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
* Had any investigational cytotoxic drug within 4 weeks prior to study treatment.
* Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
* Major surgery
* Hypersensitivity reaction to any monoclonal antibody.
* Has an active known or suspected autoimmune disease.
* Has a diagnosis of immunodeficiency.
* Prior tissue or organ allograft or allogeneic bone marrow transplantation.
* Requires daily supplemental oxygen
* History of interstitial lung disease.
* Significant heart disease
* History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
* Infection with HIV or hepatitis B or C at screening.
* Has an active infection.
* Unable to have blood drawn.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
* Woman who are pregnant or breastfeeding.
Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer

The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years old
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent

Exclusion Criteria:

1. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
6. History of other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within the past 6 months
9. History of cerebrovascular accident within the past 6 months
10. History of continuous systematic administration of corticosteroids within 1 month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1\<50% of the predicted values
Study of LY2409021 in Participants With Type 1 Diabetes

This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.


Eligibility Criteria:
Inclusion Criteria:

* Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
* Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
* Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m\^2)
* Have given written informed consent approved by Lilly

Exclusion Criteria:

* Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
* Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
* Are pregnant or intend to become pregnant during the course of the study
* Women who are breastfeeding
* Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
* Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter \[mmol/L\])
* Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase \[ALT\] or aspartate transaminase \[AST\] greater than 2 times the upper limit of normal at screening)
* Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine \>2.0 mg/dL (177 micromoles per liter \[μmol/L\])
* Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment
* Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Rehabilitation Trajectories

The main aim of this multicentre cohort study is to provide evidence that can be used to improve continuity and quality in rehabilitation practice and rehabilitation processes across health care levels for patients with rheumatic and musculoskeletal diseases (RMDs).

There is an urgent need to develop rehabilitation trajectories that ensure coordination and communication between health care levels, support of self-management and self-monitoring, and follow-up tailored to patients' needs. Such trajectories should be based on evidence from current practice. The "Rehabilitation trajectories" project will systematically explore and describe current practice of planned and implemented follow-up and self-management strategies in primary health care during the first year after rehabilitation for patients with musculoskeletal diseases. Further, a newly developed core set of PROMs designed for evaluation of rehabilitation in RMDs and a self-monitoring web-based system will be tested for feasibility. Knowledge of patients' experiences and use of this self-monitoring system as a self-management and communication tool is needed in order to improve and integrate such e-technology in future care.

The Rehabilitation Trajectory study is a multi-centre study, led by the National Unit on Rehabilitation in Rheumatology and including participants at four rheumatology hospital departments and five specialized rehabilitation institutions. Participants will thus be included from all four health regions in Norway.

The study has five points of assessment. In an electronic portal, delivered by CheckWare, patients will log in with their Bank ID and complete the core set of PROMs at admission, discharge, and 4, 8 and 12 months following discharge.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to rehabilitation at one of the nine participating rehabilitation centres with one of the following groups of diagnosis: Inflammatory rheumatic disease, Osteoarthritis, Low back pain, Neck/shoulder pain, Generalized pain syndromes (including fibromyalgia), Osteoporosis, Connective tissue diseases (SLE, Lupus, Myositis etc.), Fractures with need of rehabilitation, or Rehabilitation after orthopaedic surgery. Good proficiency in oral and written Norwegian language. Access to internet and BankID.

Exclusion Criteria:

* Cognitive impairment or severe mental illness.
Single Escalating Dose Study Of HSK7653 In Healthy Subjects

To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and Age ≤60 years
* BMI ≥18 and BMI ≤ 25 kg/m2 (Body Mass Index)
* Able to understand the procedures of the study, provide written informed consent, and be willing to comply with the protocol of the study

Exclusion Criteria:

* Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening
* Evidence or history of clinically significant renal, gastrointestinal (including pancreatitis), hepatic disease at the time of screening
* Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV)
* Treatment with an investigational drug within 3 months
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after the last dose
ESWT as a Treatment for Chronic NHO in TBI Patients

Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients

Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.

PROTOCOL SYNOPSIS Title Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients.

The investigators primary objective is to determine whether Extracorporeal Shock Wave Therapy (ESWT) is effective in reducing pain and improving function in people with traumatic brain injury who have heterotopic ossification around the hip or knee.

The investigators hypothesize that four applications of ESWT to the affected hip or knee joint in the patient group will demonstrate a positive physiological effect and this will lead to a reduction in pain and improved function.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year.
* Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information.

Exclusion Criteria:

* Pregnancy.
* Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures
* Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan