cyrilzakka/clinical-trials huggingface dataset:
Peri-Implant Soft Tissue Integration in Humans: Influence of Material

The purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished.

After being informed about the study and potential risks, all participants give written informed consent and eligibility for study entry.

The day of the surgery, patients will be randomized in machined zirconia or ultra-polished zirconia.

After 8 weeks of healing, biopsy are separated in two groups according to the removal:

* if the abutment come together with the surrounding soft tissues, it goes for a non decalcified histology for histometric measurements to determine the dimensions of biological width (sulcus depth, epithelial and connective adhesion)
* if the abutment come separate of the surrounding tissue, the soft tissue goes for immunohistochemistry to analyse pro-inflammatory cells and vascularisation and the abutment for SEM analysis to calculate the percentage of adhesion of the cells on the abutment

Eligibility Criteria:
Inclusion Criteria:

* Participants have to voluntarily sign the informed consent form before any study related action
* Patients aged 18 or over
* Patients with one or more missing teeth in the maxillary or mandible area, seeking implant therapy
* Men/women
* Patients in good systemic health (ASA I/ II) and no contraindication for oral surgical interventions
* Patients requiring a replacement of missing teeth; the tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation
* At least 3 mm of fibrous mucosa in the bucco-lingual dimension
* Full mouth plaque score (FMPI) lower than or equal to 25%
* At least a diameter of 4 mm for the implant (regular diameter)

Exclusion Criteria:

* Autoimmune disease requiring medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonates intravenously or more than 3 years of oral use
* Infection (local or systemic) - patients with gingivitis or active local infection will undergo a medical treatment prior to the entrance to the study, and each individual will be evaluated for suitability; in case of a systemic infection, the evaluation will be based on medical anamneses, and if necessary, a patient will be referred to relevant medical tests
* Current pregnancy or breastfeeding women
* Alcoholism or chronical drug abuse
* Immunocompromised patients
* Uncontrolled diabetes
* Smokers
* Prisoners
* Implant's diameter under 4 mm (narrow implant)
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of the study or interference with analysis of study results, such as history of non-compliance, or unreliability
Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy

To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on depression and Quality of life in females with hysterotomy


Eligibility Criteria:
Inclusion Criteria:

* Age 35-55
* Females gone through all types of hysterotomy
* Hysterotomy done due to heavy menstrual bleeding, fibroids, pelvic pain, endometriosis and MAP ( Morbidly adherent placenta ).

Exclusion Criteria:

* Females with hormonal replacement therapy
* Any history of cancer
* Diagnosed patient of any psychiatric illness
Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes

The purpose of the study is to assess self-reported side effects and neurocognitive (brain, mood and thinking) functioning among patients treated with commercial axi-cel therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diffuse large b-cell lymphoma, primary mediastinal b-cell lymphoma or transformed follicular lymphoma
* Scheduled to receive commercial axi-cel at Moffitt Cancer Center
* Able to speak and read standard english
* Have no documented or observable psychiatric or neurological diagnoses that interfere with study participation (e.g., schizophrenia)
* Have no history of traumatic brain injury, stroke, or dementia
* Able to provide informed consent
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer

99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA positive expression (supporting evidence may include MRI, CT, and pathology report, etc).

Exclusion Criteria:

1. Patients with PSMA negative expression.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-42847922 in adult participants with hepatic impairment when compared to healthy participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

All

* Be a man or woman 18 to 79 years of age, inclusive Participants with normal hepatic function
* Generally healthy
* Must not exceed upper limit of normal limits for serum bilirubin, transaminase levels, albumin levels, prothrombin time (PT), and International Normalized Ratio (INR) when measured at screening and Day 1 Participants with (Mild, Moderate or Severe) hepatic impairment
* Medically stable
* Total Child-Pugh score of 5 or 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10 to 15, inclusive (severe) as determined by the investigator
* Stable hepatic function during screening and those measured on Day 1
* Stable renal function

Exclusion Criteria:

Participants with normal hepatic function

* Hepatitis B surface antigen (HBsAg) or hepatitis C antibodies at screening Participants with (Mild, Moderate or Severe) hepatic impairment
* Severe ascites or pleural effusion; prothrombin time greater than (\>)18 seconds; evidence of progressive liver disease within the previous 4 weeks, as indicated by changes in hepatic transaminases, alkaline phosphatase, and gamma-glutamyl transferase
* History of hepatopulmonary syndrome, hydrothorax, or significant hepatorenal syndrome
* Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor
* Clinically significant laboratory findings except as related to hepatic impairment
Our Emergency Fasciotomy and Amputation Experiences

Earthquakes are natural disasters that threaten human life and cause loss of life and property in a very short time. In our country, where a large part of the population faces the risk of earthquakes, unfortunately, destructive earthquakes that put the country at a disadvantage in social and economic terms are frequently experienced.

On 6 February 2023, two major earthquakes with a magnitude of 7.7 at 04:17 and 7.6 at 13:24 local time occurred in Kahramanmaraş. In southern Turkey and northern Syria, 11 cities and approximately 14 million people were affected. According to the latest official data, at least 50,783 deaths, more than 122,000 injuries, and major damage occurred. The triage, treatment, and management of the injured was a challenging administrative task. The injured were treated in many centres throughout the country. In our hospital, all relevant units provided multidisciplinary service to our earthquake victims.

Superficial injuries, fractures, open wounds due to high-energy trauma, compartment syndrome due to compression, and crush injuries are frequently encountered after earthquakes, and patients are usually exposed to multiple traumas. The most common injuries associated with earthquakes are extremity injuries and crush syndrome. First and emergency intervention, including basic life, is usually performed in the disaster area. Emergency surgical procedures such as amputation and fasciatomy may be required for patients with compartment syndrome. The planning of all these surgeries and the follow-up and evaluation of patients require a multidisciplinary approach.

In this study, we planned to retrospectively investigate the anaesthesia management in emergency fasciatomy and amputation surgeries performed in the orthopaedic operating room of patients who were transferred to or admitted to the 3rd level City Hospital during the earthquake disaster on 6 February. We found that anaesthesia data on earthquake victims in the literature were insufficient. We aimed to share our experiences in order to provide guidance in terms of anaesthesia management in possible future disasters.

Eligibility Criteria:
Inclusion Criteria:

* 6 February 2023 earthquake victims who applied to our clinic within 2 months after the earthquake and received anaesthesia and underwent emergency fasciotomy and amputation in the orthopaedic operating room, regardless of gender, aged 18 years and over.

Exclusion Criteria:

* Patients who are not earthquake survivors and under 18 years of age and who have undergone surgery other than fasciatomy or amputation will not be included.
Clinical Utility of ESWT in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. The investigators planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns.

The investigators have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. The investigators planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury
* nerve injury to the hand was confirmed by electromyography
* \< 6 months prior to the enrollment

Exclusion Criteria:

* musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands
* acute infection
* malignant tumors
* coagulopathy
* pregnancy
* potential for additional skin damage if exposed to ESWT and conventional occupational therapy.
Effect of LED Photobiomodulation on Analgesia During Labor

The aim of this study is to valuate the effects of LED photobiomodulation on analgesia during labor.ight-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.n total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into two groups: intervention group \[analgesia with LED therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\].

Background: Labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. Pharmacological and nonpharmacological analgesia methods are used to control labor pain. Epidural analgesia is the most commonly used pharmacological analgesia method. However, it may have side effects on the fetus and the mother. Light-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.

Objectives: To evaluate the effects of LED photobiomodulation on analgesia during labor.

Methods: In total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into two groups: intervention group \[analgesia with LED therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\]. The perception of pain will be assessed using the visual analogue scale (VAS), with a score from 0 to 10 at baseline, i.e., before the intervention. In both the groups, the procedures will last 10 min and will be performed at three time points during labor: during cervical dilation of (1) 4-5 cm, (2) 6-7 cm, and (3) 8-9 cm. At all three time points, pain perception will be evaluated using VAS shortly after the intervention. In addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points.

Expected outcomes: The use of LED photobiomodulation will have an analgesic effect superior to that of the bath therapy.

Eligibility Criteria:
Inclusion Criteria:

* women who request analgesia during labor
* nulliparous and multiparous
* women with term gestation
* women without previous diseases, including diabetes, neurological diseases.

Exclusion Criteria:T

* women whose labor is induced with medications;
* women who request drug analgesia during labor;
* women who undergo cesarean delivery
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure

A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients ≥ 18 years of age
* A clinical diagnosis of chronic congestive heart failure \> 6 months
* At least one episode of documented ADHF during the previous 6 months
* NYHA functional class III-IV
* Circulating levels of NT-proBNP ≥ 800 ng/L.
* Stable, optimized therapy for heart failure for at least 4 weeks prior to enrollment
* Echocardiography performed within 3 months
* Detectable ascites by ultrasound and/or computed tomography
* Diuretic resistance defined as a daily dose of furosemide \> 80 mg, torsemide \> 40 mg or bumetanide \> 2 mg
* Written informed consent

Exclusion Criteria:

* Present or recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
* Ongoing malignant disease with adverse prognosis
* Evidence of firmly loculated peritoneal effusion.
* Obstructive uropathy
* Severely reduced renal function (S-Creatinine 300 mol/l) or end-stage renal disease requiring dialysis
* Severe liver disease (ASAT and/or ALAT and/or total bilirubin three times upper limit of normal range laboratory values)
* Pregnancy
* Requirement for intravenous inotropes
* Acute coronary syndrome or any condition requiring emergency treatment
* Heart disease requiring surgical intervention during the course of the study
* Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (SUBCUTANEOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALS

The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP Pharmaceuticals, through the determination of activity of the following markers:

* Anti-FXa;
* Anti-FIIA.

The pharmacodynamic profile of the drug will be assessed through:

* Reason for Anti-FXa activity / Anti-FIIA;
* TFPI activity.

The aPTT activity marker will be evaluated as an exploratory objective.

Eligibility Criteria:
Inclusion Criteria:

1. Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
2. Being male, aged between 18 and 55 years old and clinically healthy;
3. BMI ≥ 18.5 and ≤ 30.

Exclusion Criteria:

1. Participation in clinical trials in the 12 months preceding the survey;
2. Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
3. acute illness in the period up to 07 days before the beginning of the study;
4. determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug;
5. Hemoglobin \<13 g / dL;
6. Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory;
7. Use of medications that interact with heparin (see Section 7.8.1);
8. history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism;
9. History of coagulopathy and bleeding diathesis;
10. Presence of bruises on physical examination.
11. Changes in skin or subcutaneous tissue of the place where the injection is made (eg liposuction in the abdomen).
12. absolute platelet count below 100 x 109 / L;
13. A history of acute haemorrhage in the last 30 days;
14. history of sensitivity to biological products derived from mammalian albumin or any component of the formulation;

a) history of allergy or major disease Steven Johnson; p) History of present use or there are at least 12 months of tobacco; q) current or previous history (less than 12 months) of illicit drug use;
Long Term Follow up of the LTOG Cohort

The purpose of the study is to follow participants who enrolled in the Lung Transplant Outcomes Group. Clinical data, functional assessments, and surveys will be collected to determine long term graft function and functional status of lung transplant recipients.

This project will involve both retrospective and prospective data collection from participants enrolled in the LTOG cohort studies. We will perform long-term Chronic Lung Allograft Dysfunction (CLAD) phenotyping of lung transplant recipients who participated in the LTOG cohort studies utilizing data collected for routine clinical visits. Surviving lung transplant recipients who participated in the LTOG cohort studies will be recruited to enroll in the longitudinal portion of the project. The longitudinal component will include follow-up data collection at 6 month intervals while alive until study termination, study withdrawal, or no longer being seen for follow-up at the participating center. Follow-up data collection will include clinical data collected by study coordinators by reviewing medical records, functional assessment through administration of the Short Physical Performance Battery (SPPB), blood collection and surveys. Data from this project will be linked to data and samples collected during the LTOG cohort or ancillary studies.

Eligibility Criteria:
Inclusion criteria

Long-term phenotyping of CLAD

* Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers

Long-term functional status and well-being

* Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers
* Alive

Exclusion Criteria

Long-term phenotyping of CLAD

* Lung transplant recipient not enrolled in LTOG cohort research studies

Long-term functional status and well-being

* Lung transplant recipient not enrolled in the LTOG cohort research studies
* Lung transplant recipient not receiving post-transplant follow-up care at a participating LTOG center
EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)

The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and lorazepam.

This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged across a topographical region of interest is decreased 6 hours after administration of MK3134 compared to placebo.

The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG using two probe compounds: MK3134 and lorazepam.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male between 18 to 40 years of age
* The subject has a Body Mass Index (BMI) greater than or equal to 31 kg/m\^2 at the prestudy (screening) visit
* Subject has normal or corrected to normal visual and auditory acuity
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
* Subject is right-handed

Exclusion Criteria:

* Subject has permanent cosmetic or metallic objects in their body that can interfere with the measurements
* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of neoplastic disease
* Subject has a current diagnosis of or a prior history of sleep apnea
* Subject has a history of fainting during blood draws
* Subject has a history of significant head injury/trauma
* Subject has a current diagnosis of or history of Bipolar illness, Schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD), or claustrophobia
* Subject works a night shift and is not able to avoid night shift work within 3 days before each treatment visit
* Subject is currently a regular user of any illicit drugs or has a significant history of drug (including alcohol) abuse