cyrilzakka/clinical-trials huggingface dataset:
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant

The current prospective clinical study's aim is to determine ABT's SPI implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of SPI implants.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over the age of 18 years who need implantation of 1-4 implants.
2. Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
3. Patients who had provided written informed consent to participate in the study prior to any study procedure.
4. Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.

Exclusion Criteria:

1. Immediate loaded implants.
2. Patient requiring bone augmentation
3. Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
4. Treatment with anticonvulsants drugs.
5. Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
6. Patients with history of alcohol, narcotics or drug abuse.
7. Patients under steroid therapy.
8. Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.

   Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
9. Metabolic bone disorders and/or bone augmentation.
10. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
11. Degenerative diseases.
12. Osteoradionecrosis.
13. Renal failure.
14. Organ transplant recipients.
15. HIV positive.
16. Malignant diseases.
17. Diseases that compromise the immune system.
18. Unbalanced diabetes mellitus. (HbA1c above 6.5)
19. Psychotic diseases.
20. Hypersensitivity to one of the components of the implant in general and titanium in particular.
21. Women who are pregnant or lactating.
22. Lack of patient cooperation.
23. Uncontrolled endocrine diseases.
24. Any systemic condition that is unbalanced and therefore precludes surgical procedures.
25. Parafunctional habits.- e.g Bruxism.
26. Temporomandibular joint disease.
27. Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus ,malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
28. Flapless procedures.

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Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.

Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosed advanced gastric cancer (≥cT3) by endoscopy-biopsy pathology, combined with CT and/or endoscopic ultrasound;
* (2) with both enhanced CT and laparoscopy;
* (3) without typical peritoneal metastasis indications in CT (diffuse omental nodules or omental cake, large amount of ascites, obvious irregular thickening with high peritoneal enhancement);
* (4) without other evidence of distant metastasis, and no stage IV features on CT.

Exclusion Criteria:

* (1) previous abdominal surgery;
* (2) previous abdominal malignancies or inflammatory diseases;
* (3) time intervals between CT and laparoscopy longer than 2 weeks;
* (4) CT image artifacts that undermine peritoneal lesion assessment.
Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study

Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative. (2) Most breast cancer cases can be cured by multimodality treatment, although cure rates vary by clinical stage, subtype and the clinical behavior of cancer which affected by the composition of pro- and anti-tumor immune mediators within the tumor microenvironment. (3, 4) Immune gene signatures in breast tumors -that comprise genes with specialized roles in immune biology- Significantly, have been shown to correlate with patient survival outcomes. (5-8)chemotherapy responsiveness. (7, 9), and more recently, response to immunotherapies.(10-12)One such candidate, the gene encoding Triggering Receptor Expressed on Myeloid Cells (TREM)-1, which emerged as a robust therapy predictive and prognostic marker. TREM1 encodes a type I trans-membrane receptor of the Ig superfamily expressed by effectors of innate immunity including neutrophils, monocytes and macrophages. The TREM-1 receptor is known to augment inflammatory signaling in response to infectious pathogens by promoting release of cytokines that modulate the activation, recruitment and survival of myeloid and lymphoid cells. (13) In this study we hope to gain a better understanding of TREM-1 clinical and molecular relevance in HER2 negative BC either triple negative or hormonal positive which represent significant subset that lack target therapeutic options, evaluating its effect as predictive and prognostic marker and so the potential implications for patient management.

a prospective observational cohort study on the role of TREM-1 as a novel immune biomarker in HER-2 breast cancer it's a molecular and clinical study. our aim is to assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS \& OS and to quantify TREM-1 expression and correlate its level with clinical and pathological response to neo-adjuvant treatment. and evaluate its association with immune cells (eg. monocytes and neutrophils)

Eligibility Criteria:
Inclusion Criteria:

* female patient aged \< 18 yrs. old
* histological proven breast cancer
* HER-2 negative (hormonal positive or triple negative)
* planned to receive neo-adjuvant therapy
* complete clinical, radiological and therapeutic data

Exclusion Criteria:

* metastatic breast cancer
* HER-2 positive
* incomplete clinical, radiological or therapeutic data
Mobile Health Intervention

The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass index decrease at 15 months compared to traditional management in obese adolescents.

Childhood obesity continues to be a key challenge in France. The unit is facing a high demand with limited resources, moreover despite an intensive program of care with a multidisciplinary dedicated team, the impact on weight loss is moderate.

The hypothesis is to ameliorate results by using distance monitoring in maintenance phase.

After a traditional intensive period consisting in a weekly family-based multidisciplinary intervention, patients are randomized in two arms, traditional or distance follow-up.

Traditional follow-up is based on face-to-face multidisciplinary consultations every three months.

The distance monitoring is based on a mobile application dedicated to food behavior change and physical activity, with weekly self-monitoring, goal setting, physical activity and healthy eating support, monthly weight assessment. Pre-programmed feedbacks "motivational strategies" are included.

After one year of follow-up, adolescents are evaluated for weight loss, compliance and quality of life. The two groups will be compared.

The question is can mobile apps help to monitor and promote healthy lifestyle in obese adolescents.

Eligibility Criteria:
Inclusion Criteria:

* 11-17 years old
* Body Mass Index \> 97th percentile using French reference
* Non Syndromic obesity
* Appropriate understanding of the study
* Appropriate understanding of french language, and ability in writing and reading

Exclusion Criteria:

* Mental disability, severe and uncontrolled psychiatric disorders.
* Syndromic obesity, endocrine disorders or drug-induced obesity
* Other therapeutic: bariatric surgery, medications for weight loss
* Enrolment in an other therapeutic study
Veterans Enhanced Recovery Using Integrative Treatments Around Surgery

The study aims to assess the implementation and effectiveness of Integrative Treatments - Music Medicine, Aromatherapy, and Battlefield Acupuncture - in the management of perioperative pain and anxiety, and in the reduction of related pharmacologic treatments.

There is an urgent need for effective, safe, and low-cost nonpharmacologic treatments for postoperative pain. This study aims to:

1. assess the implementation of Music Medicine, Aromatherapy, and Battlefield Acupuncture among patients presenting for procedures at the Durham Veterans Affairs Medical Center; and,
2. compare the effectiveness of these treatments, alone and in combination, versus standard clinical practice not involving any of these treatments.

Patients from the Durham Veterans Affairs Medical Center (Durham VAMC) scheduled to undergo procedures will be eligible to participate in this study. A sample of 400 veterans will be studied. We will offer treatments versus no treatment on alternate months. Recruitment will end when 200 patients have received at least one of these treatments, and 200 patients have received no treatment.

Eligibility Criteria:
Inclusion Criteria:

* Veterans Scheduled to undergo procedures at the Durham VA

Exclusion Criteria:

* Hearing Loss
* Procedures on the Ear
* Risk of Bleeding
* Anosmia
Metabolic Cost of Sandbag Training

This study aims at investigating the metabolic cost of several fundamental exercises with sandbag. Sandbag training has become a popular training modality that is efficiently used to improve cardiovascular status and physical performance. Despite its widespread use and popularity the metabolic cost of exercises using sandbag remains to be elucidated. Therefore, the metabolic cost of various fundamental exercise with sandbag will be determined to aid the planning of exercise training programs.

Ten healthy young adults will be assigned to this study. Participants will initially undergo a baseline assessment of their anthropometrics, body composition (by DXA), resting metabolic rate (RMR), cardiorespiratory fitness (VO2max), muscular strength \[maximal strength (1RM) and muscular endurance\] and functional capacity. After baseline screening, participants will execute in different days (one exercise per day) one set of each of the following 8 exercise: (1) lateral bag drag, (2) dead bag, (3) shoulder to shoulder thruster, (4) sumo DL with pull, (5) front lunge, (6) single leg RDL, (7) reverse lunge with rotation and (8) clean, in two different conditions: (i) 30 sec and (ii) 45 sec exercise duration, in a random order. Prior to each exercise resting heart rate, blood lactate concentration, oxygen consumption and rate of perceived exertion will be recorded. Heart rate and oxygen consumption (through portable gas analyzer) will be continuously monitored during the exercise and after the end of it, until the oxygen consumption reach the pre-exercise values (excess post-exercise oxygen consumption). Blood lactate and rate of perceived exertion will be reassessed post-exercise.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35 years
* Physically active individuals
* Free of chronic diseases
* Free of musculoskeletal injuries
* Nonsmokers

Exclusion Criteria:

* Chronic disease
* Musculoskeletal injury
* Consumption of alcohol, caffeine and any type of ergogenic supplement during the study.
Hepatocyte Transplantation as a Life Support Bridge

The purpose of this study is to gain knowledge about the result of infusing liver cells, carefully matched to blood type, into a subject's body. The hope is that this procedure will aid functions of the liver and prevent death, enable a transplant procedure to be carried out if a donated liver becomes available, and lessen complications in postoperative recovery. There is no guarantee that any of these benefits will be re eived, but even if they are not, the hope is that knowledge gained by using this procedure will be of future benefit to others who also suffer from liver disease.

Adult and pediatric patients eligible for liver transplantation who require intensive care unit admission for multisystem organ failure in addition to liver failure, without systemic sepsis, are eligible for liver cell transplantation regardless of race, sex or financial support.

Failure of 3 or more organ systems are the criterion used to select patients with as close to 100% mortality as possible without solid organ transplant.

Hepatocytes, isolated from excess liver tissure from reduced liver transplant procedures or from donor livers not used for transplantation, are prepared by a complex process and then are infused, guided by radiology into the splenic artery or portal vein of the patient. Patients must be on immunosuppression therapy for as long as the hepatocytes are living and beneficial to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to VCU Health System ICU in fulminant Liver Failure in addition to multisystem organ failure

Exclusion Criteria: Patients with Sepsis

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Improving Communication and Adherence in Black Breast Cancer Survivors (Sisters Informing Sisters)

The purpose of this study is to test an evidence-based intervention designed to increase adherence to systemic therapy in Black women compared to enhanced usual care.

Black women continue to experience worse breast cancer outcomes, which may be due to inadequate adherence to systemic therapies that can be improved via patient-centered communication. We developed and piloted the Sisters Informing SistersSM (SIS) intervention (survivor-led skill-building sessions and culturally tailored materials to activate Black breast cancer survivors in their medical encounters) and obtained promising findings. This project will compare in a two-arm RCT the impact of SIS vs. enhanced usual care (treatment recommendation summary form) on patient-centered communication and systemic treatment adherence; SIS tools may be integrated within existing clinical and support services.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Black
* Newly diagnosed (\~4 weeks post-definitive surgery and prior to initiation of adjuvant chemotherapy or endocrine therapy) patients (stage I-III)
* Eligible for chemotherapy or endocrine therapy according to NCCN guidelines, but have not initiated systemic therapy
* Ability to read and speak English
* Ability to provide meaningful consent as determined by trained study personnel and/or a member of the patient's care team
* No prior cancer treatment (other than skin cancer) in the two years preceding enrollment
* Physicians Must be a license doctor of study patient(s)
* Ability to speak English
Prophylaxis Against Metoclopramide-Induced Akathisia

ABSTRACT

Study Objective:

To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide induced akathisia.

Methods:

This randomized, double-blind and controlled trial aimed to investigate co-administered midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia. Patients 18 through 65 years of age who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10 mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10 mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam, diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole procedure was observed, akathisia and sedation scores and vital changes were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study.

Exclusion Criteria:

* Patients who had liver and renal insufficiency
* Electrolyte imbalance
* Acute respiratory symptoms
* Chronic obstructive pulmonary disease
* Blood pressure less than 90/60 mmHg
* Uncooperative individuals
* Pregnant or lactating
* Pre-existing motor disorder
* Restless legs syndrome-parkinson's disease
* Organic brain disorder, (dementia etc.), epilepsy
* Admitted to the ED due to acute psychiatric symptoms
* Deprived mental status
* Advanced hearing loss
* Malnutrition
* Acute asthma attack
* Serious physical illness, especially glaucoma, prostatic hypertrophy, or cardiac disease
* Had a contraindication to anticholinergic medications
* Within 3 days of study entry patients who had taken an antiemetic antihistaminic, antipsychotic, antispasmodic, alpha-blocker, or Ca++2-channel blocker, or within 2 weeks of study entry patients who had taken an antidepressant, barbiturate, benzodiazepine, other sedative/hypnotic, opioid, lithium, or illicit sympathomimetic agent were excluded
Investigating the Impact of a Shared Decision-Making Tool

The purpose of this research study is to learn more about how the use of a Shared Decision-Making Tool (SDMT) will impact a patient's decision-making to pursue treatment for knee osteoarthritis.

The main purpose of this study is to determine the impact of the SDMT on patient decision- making regarding various treatment modalities for knee osteoarthritis. If the SDMT is found to be beneficial, it can be implemented to help engage patients in their care and support more efficient implementation of treatment suggestions. This subsequently will improve patient's quality of life. Getting patients who have not taken advantage of preventive care or healthy lifestyles to change is paramount to making the medical experience in America more equal for all its citizens and reducing total societal costs. Building provider-patient communication tools that resonate with all stakeholders should inform patients as they work to make health decisions that reflect their individual beliefs.

Eligibility Criteria:
Inclusion Criteria:

* age 45-64
* mild to moderate knee pain consistent with a diagnosis of osteoarthritis

Exclusion Criteria:

* known inflammatory disease diagnosis (ex. Lupus, Sjogren, or rheumatoid arthritis, prior knee replacement, acute knee trauma)
* BMI over 45
* persons from vulnerable populations
Myofascial Pain and Central Sensitization

This prospective, observational cohort pilot study compared pain phenotyping and functional measures in 30 participants with non-acute neck and/or shoulder girdle pain consistent with primary myofascial pain at 3-months following a physical therapy referral to study the impact of their baseline degree of pain amplification.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking participants
* Diagnosed by their physician with non-acute (more than two weeks) neck and/or shoulder girdle primary myofascial pain
* Referred to a physical therapy treatment.

Exclusion Criteria:

* In an effort to reduce the potential that another medical condition could lead to a secondary myofascial pain response, extensive comorbid exclusion criterion.
* Use of chronic high-dose opioid medication greater than 100 mg oral morphine equivalents per day.
* Individuals receiving or applying for compensation or disability.
* The inability to provide informed consent.
* Severe physical impairment (e.g., blindness, deafness)
* Co-morbid medical condition limiting function (e.g., malignant cancer)
* Reported illicit drug use
* Severe psychiatric condition that would limit judgment.
* Lack of internet access.
Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.

The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.


Eligibility Criteria:
Inclusion Criteria:

1. 18≤Age≤45, male or female;
2. Body weight (\> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (\< BMI) = 26.0 kg/m2);
3. Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;
4. All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
5. Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.

Exclusion Criteria:

1. Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm;
2. Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history;
3. Surgery history within six months before signing the informed consent;
4. Allergic history to more than one drug or other serious allergic rhistory.
5. Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval;
6. Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;
7. History of drugs or drug abuse or alcoholics;
8. History of blood donation more than 200 mL within 8 weeks before signing informed consent;
9. Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;
10. Not suitable for this trial according to the investigator.