cyrilzakka/clinical-trials huggingface dataset:
Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision

Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.

The studies in the current literature indicated that both techniques of tooth preparation and the materials used are appropriate for the treatment of this condition, but the tendency is to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators will compare the outcomes of direct resin composite and indirect polymer-infiltrated-ceramic-network.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future.
* Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth.
* Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar.

Exclusion Criteria:

* Patients wearing removable partial prosthesis
* Patients presenting skeletal Cl III occlusal Relationship
* Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas.
* Patients with symptomatic temporomandibular joint disorders.
Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical SCI

Purpose: The objective of this study is to assess a newly created decision support intervention (DSI) or decision aid (DA) for people with spinal cord injury (SCI) to learn about and consider upper extremity reconstructive surgery to help them choose a course of treatment that most aligns with their values.

The overarching aim of this project is to define key information about improvement of upper extremity function after SCI (time and extent of recovery, outcome of surgical and non-surgical interventions and the experience thereof) and communicate this information to patients and clinicians to support their treatment decisions.

This particular Aim 3 of the overall project will assess a newly developed DSI/DA tool in a pre-/post- pilot study of people with SCI hoping to restore upper extremity function in cervical SCI. Using information from prior aims of this project, a de novo tool has been created and will be tested. This study will measure participant knowledge of their condition and treatment options, and decisional conflict. Participant feedback, demographics, and health-literacy information will be collected to help improve and refine the DA before it is made widely available to the public.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects (≥18 years to ≤80 years) with mid-cervical level SCI (minimum 6 months and maximum 20 years post-injury).
2. Must have limited use of their hands.
3. Wheelchair dependent for mobility.
4. Ability to read, speak and understand English.

Exclusion Criteria:

1) Previous treatment with nerve or tendon transfer surgery.
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

The primary objective of this study was to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.


Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥18 years old with advanced or metastatic stage solid tumors
2. Eastern Cooperative Oncology Group (ECOG) status ≤ 1
3. Have disease either evaluable (dose-escalation cohort) or measurable (dose-escalation and -expansion cohorts) per RECIST V1.1, except for prostate cancer participants
4. Agree to provide archival tumor tissue
5. Additional inclusion criteria for dose expansion cohorts:

   * Participants with homologous recombination deficiency (HRD+) or known BRCA mutant ovarian cancer Previously received at least one line of platinum-containing therapy in the advanced or metastatic setting and No progression or recurrent disease within 6 months from last platinum-containing regimen.
   * Participants with HRD+ or known BRCA mutant triple-negative breast cancer Up to one prior platinum-containing treatment in any treatment setting and up to 3 prior lines of therapy in the advanced or metastatic setting
   * Participants with HRD+ or known BRCA mutant prostate cancer Chemotherapy-naïve or previously received up to two taxane-based chemotherapy regimens, with documented prostate cancer progression
   * Participants with small cell lung cancer and gastric cancer, previously received ≤ 2 prior lines of therapy
   * Other HRD+ solid tumors of multiple indications

Key Exclusion Criteria: All participants

1. Prior treatment with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
2. Refractory to platinum-based therapy (dose-expansion cohort).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine

The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Participant is aged ≥ 1 year to ≤ 3 years
* Participant without previous history of chickenpox, zoster and epidemic encephalitis B
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Body temperature ≤ 37.5℃

Exclusion Criteria:

* Known allergy to any constituent of the vaccine
* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Failed to the Expanded Programme on Immunization(EPI)
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Plan to receive any vaccine in the 4 weeks following the trial vaccination
* Known bleeding disorder
* Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
* Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
* Participation in any other interventional clinical trial
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer

The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.

The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. female patients, age≥18 year
2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
3. Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization
4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.

Exclusion criteria:

1. Inflammatory breast cancer or Paget's disease
2. Breast deformities and other conditions that impact breast conservation success rate
3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded
4. Pregnancy or lactation
5. Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
6. Patients with stage IV diseases or unresectable lesions in either breast
7. Patients combined with other diseases that may affect survival
8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations
9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
Olmesartan as an add-on to Amlodipine in Hypertension

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone


Eligibility Criteria:
Inclusion Criteria:

* Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
* Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion Criteria:

* Secondary hypertension
* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease

The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with Parkinson's Disease (PD).

Periodical measures of the clinical features with UPDRS will be done at the beginning, each three months until two years. Each group will be compare to evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.
* Informed consent.

Exclusion Criteria:

* Presence of another disease not well controlled.
* Patient with atypical features.
* Patient with advanced Parkinson's disease.
Evaluating a School-based Social and Material Needs Identification System to Prevent Youth Violence Involvement

The goal of this observational study is to evaluate the effects of Pathways to Potential (P2P) on youth violence involvement in Michigan public K-12 students. The main goals of this study are:

* This project will link longitudinal P2P participation data to state administrative records and school disciplinary data to evaluate associations between school P2P participation and youth outcomes-specifically chronic absenteeism, peer aggression expulsions, and child maltreatment rates within a school (Aim 1).
* Given the focus of P2P is to improve the social and structural conditions within a school that contribute to student chronic absenteeism, the team will assess if chronic absenteeism rates mediate the relationships between school P2P participation and youth violence involvement (Aim 2).
* Finally, a survey of success coaches will inform the examination of school and implementation factors that moderate associations between P2P participation and youth violence involvement (Aim 3).

Schools participating in P2P receive Michigan Department of Health and Human Services (MDHHS) caseworkers, called success coaches, in local elementary, middle, and high schools. After identifying a social or material need that is a barrier to school attendance (e.g., transportation barriers, caregiver unemployment), success coaches connect students and families to community resources and public assistance.


Eligibility Criteria:
Administrative Data Inclusion Criteria:

* State of Michigan K-12 public school
* In person instruction
* Open to all students in District/area

Administrative Data Exclusion Criteria:

* Private schools
* Virtual learning
* Needs-specific schools

Survey Inclusion Criteria:

* 18 years of age and older
* Working as a Success Coach inside a Michigan K-12 public school during the data collection period

Survey Exclusion Criteria:

* Former Success Coaches
* Success Coaches not working inside a Michigan K-12 public school during the data collection period
Demineralized Bone Matrix Rotator Cuff Study

Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.

This is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (DBM), or a control group without demineralized bone matrix. Patient outcomes will be collected and compared between the two cohorts up to a five (5) year post-operative period and will include a range of subjective and functional outcomes, along with radiographic imaging.

Eligibility Criteria:
Inclusion Criteria:

* The Subject is between the ages of 40 and 75 years.
* Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
* Two tendon tear or tear size equal to or greater than 3cm
* Amenable to double-row repair
* Primary rotator cuff tears with or without superior labral tear and/or biceps tear)

Exclusion Criteria:

* The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
* The Subject objects to use of allograft
* Irreparable Rotator Cuff Tear
* Complete full thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
* \< 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
* Recurrent shoulder instability
* Intra-articular injections (steroids) within 1 month of surgery
* RCR revisions
* Subject MRI taken more than 12 months prior to surgery
* Pregnant or planning to become pregnant during the study period
* Workman's compensation case
Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial

In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping

Background. Perioperative antibiotic prophylaxis during elective cesarean section at term to reduce postoperative maternal infectious morbidity is generally used but may not be efficient based on the available data. Also, the optimal timing of prophylactic antibiotic administration is unclear.

Methods. The investigators compared the effectiveness of cefazolin, administered before skin incision versus after umbilical cord clamping versus placebo in a three-arm randomized trial. The primary endpoint of the study was postoperative infectious morbidity, defined as wound infection, endometritis, or urinary tract infection. Results: The primary outcome was observed in 18/370 women in group 1 (4.9%) and in 14/371 women in group 2 (3.8%), whereas it was noted in 45/371 women in group 3 (12.1%; p\<0.001 for group 1 vs. group 3; p\<0.001 for group 2 vs. group 3; p\<0.001 for group 1 vs. group 2 vs. group 3). The number needed to treat to avoid one primary outcome was 13. Comparing groups 1 and 2, there was no statistically significant difference regarding the primary outcome (p=0.6).

Conclusions. In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping.

Eligibility Criteria:
Inclusion Criteria:

- Elective cesarean section at term Patientin \>18 years Informed consent NO known allergy to cefazolin NO exposure to any antibiotic agent within 1 week prior to delivery

Exclusion Criteria:

- cesarean section before week 37 cephalosporin allergy age less than 18 years exposure to any antibiotic agent within 1 week prior to delivery
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.

During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.

The extended follow-up period is to collect bone fractures and survival with post-treatment information after Xofigo under the real-world in Japan.

The results of this study (except of extended follow-up period) have to be submitted to the Japanese regulatory authorities as a part of the reexamination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffered from CRPC with bone metastases
* Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice.
* Xofigo treatment naïve

Exclusion Criteria:

* Patients treated Xofigo previously
* Patients participating in an investigational program with interventions outside of routine clinical practice
Effects of a New Dispatcher-Assisted Basic Life Support Training Program

Despite aggressive cardiopulmonary resuscitation (CPR) training, the outcome of cardiac arrest is not good. The problem is method of education. So, the investigators want to add the dispatcher-assisted CPR simulation into conventional CPR training. In this study, the study is aimed to investigate the effect of newer CPR training program.

The training program focuses on working in team with dispatcher, performing all steps from recognizing cardiac arrest to performing CPR, together with the dispatcher. The one hours training session is split into four parts:

1. Video self-instruction manikin practice (30 min), including a brief introduction to automated external defibrillator (AED).
2. Practice in pairs (15 min). Practicing the dispatcher and rescuer role in a simulation to enhance learning.
3. Debriefing. Questions, answers and reflection (15 min).
4. Homework. Leaflet with tasks like learn how to activate the speaker function on your own phone.

The main difference between dispatcher-assisted basic life support (DA-BLS) and traditional BLS training is that DA-BLS provides the scenes and interactive experiences on calling emergency medical service (EMS) and receiving CPR instruction via telephone speaker function, following up the skill training by scenario simulation training.

Eligibility Criteria:
Inclusion Criteria:

* All out-of-hospital cardiac arrest (OHCA) patients with presumed cardiac etiology who are 19 years of age or older and assessed and treated by EMS providers after dispatched by the EMS dispatch center will be included.

Exclusion Criteria:

* We will exclude patients with non-cardiac etiology, prolonged cardiac arrest with a suspected duration more than 30 minutes, cases such as livor mortis or rigor mortis, and decapitated or decomposed body, and patients who have "Do-Not-Resuscitate" card documented by doctor.
PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia following chemotherapy in patients with non-Hodgkin lymphoma.

Neutropenia is a common clinical complication of chemotherapy in cancer patients. It is an important factor that delays the course of standard treatments in patients. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is an effective drug for the treatment of chemotherapy-induced neutropenia. However, for patients with neutropenia, multiple rhG-CSF treatments are usually required. This is likely to extend the antitumor treatment period and increase physical and mental stress in patients. Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is rhG-CSF chemically modified by a single methoxy polyethylene glycol group; it is able to alleviate neutropenia with a single dose. The aim of the present study was to determine the safety and effectiveness of preventive treatment with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) on concurrent chemotherapy-induced neutropenia and to provide a rational basis for its clinical application. Therefore, the investigators designed the multi-center, open-label,randomized controlled clinical study and aimed to compare the efficacy and safety between PEG-rhG-CSF and rhG-CSF in non-Hodgkin lymphoma receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Investigator diagnosis of non-Hodgkin lymphoma(Highly invasive lymphoma/Burkitt lymphoma were excluded)
* Age 18 to 80 years
* ECOG performance status ≤ 2
* receive multi-cycle Chemotherapy naive
* grade 3/4 neutropenia occurred in the patient's first cycle chemotherapy or the risk of neutropenia \>20% without rhG-CSF support
* Expected survival time≥3 months; cNormal bone marrow function(absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 80 × 109/L)
* Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤2.5×upper limit of normal value; serum creatinine≤2×upper limit of normal value;

Exclusion Criteria:

* Patients with severe complications or severe infection;
* Invasion of central nervous system;
* Patients with severe visceral organ dysfunction, heart block, myocardial infarction within 6 months;
* Prior bone marrow stem cell or organ transplantation
* patients with severe allergic constitution, or those who are allergic to Escherichia coli products; 5. Patients participate in other clinical studies within 4 weeks;
* Pregnancy, lactation
* Other patients who are not suitable for the study.