cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Melatonin Application of Immediate Dental Implant

The presence of periapical pathology, the absence of kera¬tinized tissue and lack of complete soft tissue closure over the extraction socket have been reported a drawbacks of immediate implant placement .

As mentioned before the presence of periapical pathology is one of the limitation of immediate implant placement, melatonin has an action against Gram-positive and Gram-negative microorganisms with a higher efficacy on the latter; it also showed efficacy against different strains of antibiotic-resistant bacteria.

Melatonin was found to be effective in several cases as an anxiolytic and analgesic agent. It also reduce inflammatory pain by blocking the production of nitric oxid Also the lack of complete soft tissue closure over the extraction socket is one of the drawbacks of immediate implant placement; melatonin induces the production of interleukin-1, tumor necrosis factor (TNF)-α and transforming growth factor (TGF). In addition, melatonin is an immunomodulator and a neuroendocrine hormone, and stimulates both monocyte cytokine and fibroblast proliferation, which influence angiogenesis and wound healing..

As the initial implant stability is one of the criteria of implant success, Melatonin was found to increase new cortical bone width and length during the early stages (15 and 30 days), and it also promoted early cell differentiation. Melatonin acted on the bone as a local growth factor .

Melatonin is chemically recognized as N-acetyl-5-methoxytryptamine. It is a compound occurring naturally in plants, microbes and animals. The circulating level of the melatonin hormone in animals shows interesting variations, by entertainment of variable biological functions in a daily cycle "circadian rhythm". Melatonin called hormone of night is secreted by the pineal gland, and its plasma levels concentration are 50 folds higher in night in comparison to daytime. A variety of peripheral cells play a role in production of melatonin such as epithelial cells, bone marrow cells, and lymphocytes. Though melatonin is a hormone, it does not act on a specific organ, it has several functions; stimulation of the synthesis of type I collagen fibers, regulation of the body temperature, sexual development, antioxidant scavenging and detoxifying free radicals thus inhibiting the process of bone resorption through interfering with the function of osteoclasts.

Eligibility Criteria:
Inclusion criteria

1. Age: 18-60.
2. Healthy patients
3. Non Smoker
4. Patients with adequate bone volume for immediate dental implant procedure.
5. Patients with absence of any periapical pathosis.

Exclusion criteria:

1. Heavy smokers.
2. Systemic disease that contraindicates implant placement or surgical procedures.
3. No or poor patient's compliance.
4. Psychological problems.
5. Pathology at the site of intervention.
6. Pregnancy females.
7. Patient refuses to sign the informed consent.
Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)

The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR/MSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.

The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer

CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals.

In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab
* Tumor with microsatellite instability determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) and/or by molecular biology (MSI-H on microsatellite analysis from tumor DNA according to practice routine of the center)

Exclusion Criteria:

* Patients with another concomitant cancer at the time of diagnosis requiring systemic treatment or impacting prognosis according to the medical team.
* Previous treatment with anti-PD1 or anti-PDL1.
* Previous treatment with chemotherapy +/- targeted therapy for MSI/dMMR metastatic colorectal cancer.
* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons).
* Pregnant women
* persons under court protection or under protective supervision (guardianship or curatorship)
* Opposition to participation in the study.
The Effect of Simulation-Based Experience on Nursing Students

This research was planned as a randomized controlled experimental study to determine the effect of simulation training on the acquisition of self-awareness and empathy skills in nursing students.

Simulation is defined as one of the methods that enables students to increase their knowledge and performance in an unreal, safe and risk-free environment and gain experience. Recent research involving the use of simulation in nursing education has mostly focused on the development of cognitive learning and psychomotor skills. However; A limited number of simulation studies have been found that include empirical evaluation of affective learning domains such as affective awareness, self-awareness and empathy. As well as the cognitive and psychomotor domains of nurse educators; It is very important for them to develop strategies to strengthen the affective field. It is predicted that the proportion of the elderly population in our country will increase in the coming years. With the increase in the elderly population, it is likely that there will be changes in the patient profile that nurses who are responsible for 24/7 individual care will encounter. Professional development is required to meet the needs of elderly patients. It is of great importance for nursing students who are still in the education stage to raise this awareness, to increase their self-awareness, to empathize with elderly individuals and to gain these characteristics. In this context, it is aimed to present results on the effects of the simulation scenario designed on the care of elderly individuals and the application of "Geriatric Medication Game" on the self-awareness levels and empathy skills of nursing students. Geriatric Medication Game is an aging simulation game that combines the experiences and challenges of older adults in healthcare and a structured role-playing where students assume the identity of healthcare-seeking seniors. It is designed to influence student attitudes and understanding of older adults and the healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over,
* Studying in the 4th grade,
* Having an AGNO grade point average of 1.80 and above,
* It will consist of students who agree to participate in the research.

Exclusion Criteria:

* Having a health problem that may affect the evaluation of the affective field/receiving treatment,
* Repeating courses due to failure in professional main courses,
* Refusing to participate in the research or giving up during the implementation process,
* Students who graduated from health vocational high school and received associate degree education in the field of health.
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients

The goal of this laboratory research study is to learn if interrupting a patient's letermovir dosing based on their immune system response can help HSC transplant patients avoid post-treatment CMV infections better than taking letermovir every day without interruption.

Primary Objective

•To compare the proportion of CS-CMVi in allo-HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis up to 200 days post transplantation.

Secondary Objectives

* To compare the proportion of CS-CMVi in HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis at 365 days post transplantation.
* To compare the overall use of letermovir in HCT recipients in both arms.
* To compare CMV CMI in HCT recipients in both arms.
* To compare all-cause mortality and nonrelapse mortality between the 2 arms at day +200 and day +365.
* Healthcare expenditures for letermovir use and TCIP for both arms from day +100 to day +200.

Eligibility Criteria:
Inclusion criteria

1. Allogeneic HCT recipients with positive CMV serostatus
2. On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
3. At high risk for CMV reactivation after day +100:

   1. Prior or active graft versus host disease requiring systemic steroids
   2. Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the three specified HLA gene loci (HLA-A, HLA-B, or HLA-DR) and cord donor recipients)
   3. Received T cell depletion or anti thymoglobulin during conditioning
   4. CMV reactivation prior to day 100 post transplant
   5. On steroids at any dose within 2 weeks of enrollment

Exclusion criteria

1. Patients under the age of 18
2. Patients are discharged from our institution and unwilling to come back for follow up
3. Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
4. Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
5. Not able to procure letermovir for extended prophylaxis beyond day +100.
Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer

This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer

OBJECTIVES: I. To determine if Chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. II. To evaluate quality of life following the use of ChronOS as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. OUTLINE: Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion
* Patients may or may not have posterolateral instrumentation

Exclusion Criteria:

* Status-post previous fusion with allogeneic bone graft
Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above

This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score to be used to evaluate fracture healing.

This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. This is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. All these patients had garden type I or II and were mobile before femoral neck fracture were included. In Group-A patients cannulated screw fixation was done using partially threaded screws and in Group-B patients were treated with fully threaded screws were used. Patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score were used to evaluate fracture healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients of garden type I or II fractures.
* All patients to be mobile before femoral neck fracture.

Exclusion Criteria:

* Patients having open fracture.
* Patients with present or past history of chronic kidney disorder.
* Patients presenting with hemorrhage.
* Patient with nervous stroke
* Patients unwilling to be part of this study.
Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

Most suicide attempts are a sign of great distress, often originating from depression; physical and sexual abuse; substance abuse; or family history of suicide, violence, or mental disorder. Risk factors for suicidal behavior are diverse, differing with gender, age, and ethnicity. Since the mid-1980s, the number of reported suicides and suicidal thoughts among young black individuals has increased alarmingly. The higher rates may be caused by high stress living situations attributed to poverty, abuse, discrimination, racism, and difficult family life. Therefore, cultural environments, social situations, and intrapersonal influences are important considerations in developing an effective therapy to prevent suicide. This study will evaluate the effect of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

The participants in this single-blind study will be randomly placed in one of two treatment groups. One group will receive psychoeducational intervention (PEI) and the other will receive enhanced treatment as usual (ETAU). After screening, eligible participants will complete a 2-hour survey about life events, concerns, and feelings with a research team member. One week later, participants will complete a second 1-hour survey. Participants will then be randomly placed in the treatment groups. Participants in both groups will receive treatment at Grady Health System, but those in the PEI group will also attend 10 weekly, 90-minute group sessions. The PEI empowerment group sessions will incorporate cultural, social, and intrapersonal elements. The ETAU group will be given mental health treatment as usual plus an adherence enhancement protocol. Follow-up surveys will occur at Week 10 (after treatment completion) and at Months 6 and 12 post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Identifies as an African-American female
* Abusive relationship within the 12 months prior to study entry
* Suicide attempt within the 12 months prior to study entry
* Seeks services at Grady Health System

Exclusion Criteria:

* Score of less than 22 on Mini Mental Status Exam (MMSE)
* Score of less than 18 on Rapid Estimate of Adult Literacy in Medicine (REALM)
* Acutely psychotic
Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study

After the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. It is known that, across the life course, resistance exercise can be of benefit in increasing muscle mass and function, yet how hard the exercise should be performed has received little attention. Current recommendations are for older people to perform exercise at 70% of the maximum they can lift, quite a high intensity that often puts older people off participating. Recent evidence in younger people has suggested that such intensities are not required.

The investigators aim to determine the feasibility of a study to investigate recruitment and adherence of older people to a study of exercise training at different intensities.

The cohort will comprise two sets of participants: frail older adults and non-frail older adults.

Each participant will receive 8 weeks of twice weekly supervised resistance training. Both the frail and non-frail participants will be randomised into either receiving high load resistance training or low load resistance training. High load resistance training will be delivered at 70% of the participants maximal capacity and low load resistance training will be delivered at 30% of maximal capacity. All resistance training will focus on the lower limb and regardless of intensity each exercise will be done to failure (unable to complete another full repetition).

Eligibility Criteria:
Inclusion Criteria:

Non-frail - Over 65 years of age Frail - Over 65 years of age, Three or more of the following criteria: \>10lbs of weight loss unintentionally in previous year; grip strength in lowest 20% (by sex and BMI); self-reported exhaustion; walking time for 15 feet in slowest 20% (by sex and height); physical activity in the lowest 20%.

Exclusion Criteria:

Non-frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.

Frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.
Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients

The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.

Pain management is of major concern in the postoperative period, mostly based on opioids. In numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. This action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action.

In the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with NaCl.

Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics, mobilisation and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Indication for postoperative pain therapy and admission to ICU
* ASA I-III
* Weight 50-125 kg
* Patients that are willing to participate in the present study

Exclusion Criteria:

* Peridural anesthesia for pain management
* Severe left ventricular function (EF \<30%)
* Severe/exacerbated COPD; Asthma
* ASA IV-V
* Chronic renal insufficiency(Creatinine \> 1,5 mg/dl)
* Ulcera ventriculi
* Known allergy to any of the study agents
* Hb preoperative \<9,5 g/dl
* Alcohol,drug and/or tablet abuse (Opioids, NSAR)
* Emergency operation
* Pregnancy
* Women of childbearing age and without a negative pregnancy test
* Severe liver disease (GOT oder GPT \> 45 U/L)
* Severe neurologica derangements (e.g. M. Parkinson, Multiple Sklerosis)
* History of apoplexia \<6 Monate or residua
* Perioperative myocardial infarction
* Patients that are not able to agree to the present study
* Patients that refuse to participate in the present study
* Patients that are part of any other study