cyrilzakka/clinical-trials huggingface dataset:
Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting

Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).


Eligibility Criteria:
Inclusion Criteria:

* healthy
* totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region.

Exclusion Criteria:

* recent sinusitis history
* hypersensibility for sinus allergens, tabagism, ethylism
* severe periodontal disease, diabetes, hypertension.
* Cases that occur schneiderian membrane perforation will be excluded from the final sample.
Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women

This study aims to increase the level of self-compassion, improve their self-esteem and cope with stress so that women who are exposed to violence can fight violence more effectively, protect their physical and mental health, find the strength they need to direct their lives, and do all these through self-awareness, compassion and kindness. It is aimed to gain coping skills. For this purpose, a mindfulness-based strengthening program will be implemented.

When the statistics on violence against women in the world are analyzed, it is seen that 16-25% of women are physically abused by their husbands, boyfriends or fiancees, and one out of every five women is exposed to this type of violence in their own home. It has been concluded that the approaches applied in intervention studies for women exposed to violence affect women's mental health positively, increase their self-esteem, improve their coping, problem-solving and decision-making skills, reduce their anger and stress levels, and increase their self-efficacy. In addition, it has been determined that mindfulness-based interventions applied to women who have been subjected to violence strengthen awareness and self-compassion, improve sense of belonging, compassion and problem-solving skills, reduce self-blame, depression, anxiety and suicidal thoughts, increase psychological well-being, and reduce PTSD symptoms. With the continuation of exposure to violence, women are insufficient to change their feelings and lives in a positive way, they are affected by the negative and judgmental attitudes of their environment, they struggle with all the negative effects of violence throughout their lives, they experience physical and mental disorders due to violence, and therefore they resort to harmful coping methods. In this sense, the aim of the study is to determine the effect of mindfulness-based empowerment program on self-compassion, self-esteem and ways of coping with stress in women exposed to violence.

The hypotheses of this study:

In the mindfulness-based empowerment program applied to women who have been subjected to violence, H0-1: There is no difference between the intervention group and the control group in terms of self-compassion.

H0-2: There is no difference between the intervention group and the control group in terms of self-esteem.

H0-3: There is no difference between the intervention group and the control group in terms of coping styles with stress.

Eligibility Criteria:
Inclusion Criteria:

* Women who have been exposed to at least one of the types of violence,
* Women who can read, write and understand Turkish will be included in the study.

Exclusion Criteria:

* Women with severe mental retardation,
* Women with psychotic symptoms and impaired ability to assess reality,
* Women who do not have insight due to psychiatric disorder,
* Women whose cognitive functionality is impaired,
* Women with any physical limitations will not be included in the study.
The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation

This study investigates the hypothesis that diffuse interstitial cardiac fibrosis develops in response to chronic volume overload from severe degenerative mitral regurgitation. The investigators will investigate the functional (exercise) and symptomatic (PROMS) outcomes of patients with severe but asymptomatic mitral regurgitation who have the option of choosing surgical repair or watchful waiting.

The optimal management of chronic severe primary degenerative mitral regurgitation (MR) is to repair the valve, but timing of surgery remains controversial. Current guidelines suggest 'watchful waiting' until the onset of symptoms or left ventricular dysfunction but have been criticized for promoting 'rescue surgery'. Better predictors are required to optimize timing of surgery and patient outcomes.

Chronic volume overload is a stimulus for adverse adaptive left ventricular (LV) remodeling. Subclinical reduction in LV strain before mitral repair predicts a fall in LV ejection fraction following surgery and is thought to reflect myocardial fibrosis. The investigators' pilot cardiac magnetic resonance (CMR) data support this hypothesis. The aims of this study are:

1. identify whether diffuse interstitial myocardial fibrosis impacts upon post-operative complications, symptomatic improvement and ventricular recovery following surgery,
2. to show that diffuse fibrosis (assessed by T1 mapping CMR) is validated by histological assessment on myocardial biopsy,
3. identify independent pre-operative imaging / biomarker / exercise predictors of post-operative clinical outcomes

The investigators will investigate and follow up patients with severe degenerative mitral regurgitation, who do meet a class 1 indication for mitral valve surgery using present AHA guidelines. Patients have the option of choosing either close monitoring or early surgical repair of their mitral valve (class 2a indication). The relationship between patient symptoms, CMR findings, blood and histological measures of fibrosis will be studied and correlated with patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

(1) All patients with asymptomatic chronic, severe primary degenerative MR known to the Queen Elizabeth Hospital Birmingham (of note, the aetiology and severity of MR will be based on the echocardiography findings , interpreted according to the European Association of Echocardiography recommendations).

Exclusion Criteria:

1. symptoms due to severe MR;
2. LV endsystolic diameter \>45mm at baseline;
3. LV ejection fraction \<60%;
4. history of myocardial infarction, previous coronary artery bypass graft, or valve surgery;
5. inherited or acquired cardiomyopathy;
6. congenital heart disease; including common atrio-ventricular canal defects;
7. more than mild coexisting aortic valve stenosis or regurgitation
8. primary mitral regurgitation not due to degenerative disease, including rheumatic disease and infective endocarditis;
9. uncontrolled atrial fibrillation (resting HR\>100/min average on 24 hour Holter );
10. unable to undergo CMR;
11. unable to walk on treadmill or use supine bicycle.
Ultrasound Quantification of Liver Fat

The investigators plan a prospective study designed to evaluate the accuracy of a new ultrasound method for quantification of liver fat content.

MRI proton density fat fraction (PDFF) will serve as the reference standard for liver fat fraction measurements. The strength of agreement between ultrasound derived fat fraction (UDFF) and PDFF will be the outcome of interest for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients 16 years of age or older with known fatty liver disease (based upon prior MRI or ultrasound), or at risk for fatty liver disease (obese).

Exclusion Criteria:

* Subject under the age of 16
* Pregnant subject
* Subjects who cannot cooperate with performance of the ultrasound exam
* Subjects who cannot cooperate with performance of the MRI exam
* Subjects who have contraindications to MRI
* Subjects who might require sedation or anesthesia to undergo study imaging
Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement

The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male patients with small-penis syndrome \*.

\*Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it isn't.

This study was designed as a 24-week, randomized, blinded, active control trial.

If a subject signing a clinical trial agreement and satisfying the selection / exclusion criteria is enrolled in this clinical trial, he / she will receive the medical device for clinical testing at the baseline time, return to his / her home after the training . At 4 weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical testing at baseline, the safety, penile girth, length, and satisfaction of the subject were evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the data necessary for the analysis of results, such as case records, for the purpose of validity and safety evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Men over 20 years old and under 65 years of age
2. In screening, subjects' perception of penile size for dysmenorrhoea syndrome Those who responded with "small", "small", "normal", "large", "very large"
3. Persons who have agreed to discontinue other procedures or treatments for penile enlargement during the course of the trial
4. If the person is circumcised or has not undergone circumcision, A person who does not cover the glans
5. Those who have agreed to abstinence (sexual intercourse, masturbation, etc.) for at least one month after the medical device for clinical trial
6. Those who can understand and follow instructions
7. A person who voluntarily participates in the clinical trial and has agreed in writing to the subject consent form

Exclusion Criteria:

1. A person who has received anticoagulant or antiplatelet agent within 2 weeks before application of medical device for clinical trial or Those who need to be administered until two weeks after application (However, low-dose aspirin (300 mg / day or less) is permitted.
2. A person who has received a vitamin E preparation, NSAID preparation within 1 week of application of medical device for clinical trial or Those who need to take medicine until 1 week after application
3. Those who have a history of bleeding in past or present time
4. Persons who are adversely affected by excessive penis enlargement, which may adversely affect the operation of the medical device
5. Those who have undergone penis enlargement surgery (fat, alternative dermatologic transplantation) in the past (except for hyaluronic acid or collagen. Two years after transplantation and extension of the penis, such as suprapubic fat preparation and suspension ligament resection In the case of surgery, it is allowed.)
6. Peyronie's disease of the penis (Peyronie's disease) malformation
7. Anaphylaxis or severe allergic symptoms.
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.


Eligibility Criteria:
Inclusion Criteria:

* Age :18-70, males and females.
* Subjects who understand and sign the consent form for this study.
* Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
* Steinberg stage I, II, ⅢA
* Patients whose lesion is more than 30% (by Kim's Method)

Exclusion Criteria:

* Patients who have collapsed femoral head
* Patient has had a Core Decompression or Multiple Drilling in the affected hip
* Patients who received osteoporosis medicines and parathyroid hormone drugs
* Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
* Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
* Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants)
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Positive serology for HIV and hepatitis
* Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases
* Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up

The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.

The registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. The resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. In addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines

Exclusion Criteria:

* no exclusion criteria and no age restriction
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas

This study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.

The main objective of this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. A secondary objective of this study is to better understand the 1540 nanometer Erbium glass laser and its impact on the skin.

This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then have 2 additional follow-up visits (no laser treatment at these visits). Photographs will be taken at each visit and photographs from pre-treatment and follow-up 1 (week 8) will rated by blinded reviewers after the study to determine efficacy.

Eligibility Criteria:
Inclusion Criteria:

* female or male, age 18-65, have at least one dermatofibroma of the skin, on the trunk or extremities, diagnosed by dermatologist, dermatofibroma is either itchy, painful or unattractive to the patient.

Exclusion Criteria:

* previous treatment to the dermatofibroma(s), pregnant or nursing women, diabetic, smoker, psoriasis, lupus or other autoimmune diseases, patient with a clear history of keloids or poor wound healing. This study will exclude dermatofibroma lesions on the face and genitals.
Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

This is a one-armed trial of two regional anesthesia (peripheral nerve block) techniques to provide postoperative analgesia after bilateral mastectomy. The two techniques are paravertebral block and erector spinae plane (ESP) block. Patients will serve as their own controls, with one block technique applied on one side of the body and the other technique contralaterally. Anatomical distribution of block effectiveness will be assessed with thermal imaging, and this distribution will be visually compared between the two techniques.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility
* Age \>18 years
* Consenting to regional anesthesia for postoperative pain control

Exclusion Criteria:

* Age \<18 years
* Unable to consent
* Using anticoagulant medication or have a bleeding disorder
* Pregnancy
* Inability to speak English for consent process
Reliability of PVI Changes During Tidal Volume Challenge in ICU Patients

The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.

Among patients in a state of shock one of the first treatments is volume expansion, consisting in a fast intravenous injection of crystalloid or colloid solutions in order to increase cardiac preload and consequently cardiac output. However, this augmentation of the cardiac output happens only in half of the patients.To avoid ineffective fluid administration several tests have been developed.

One of these tests is called the "tidal volume challenge" (TVC). It consists of transiently increasing for 1 minute the volume of air inhaled with each breath, in mechanically ventilated patients, and then evaluating whether this change impacts the pulsatility of the arterial blood pressure, detected by an arterial catheter. This test seems reliable, but it requires an arterial catheter to be in place.

It has been suggested in previous studies that pulsatility of blood pressure can be estimated by the pulsatility of the plethysmography signal ("plethysmography variability index"), obtained from the oxygen saturation signal that's measured in all intensive care patients. The advantage is that this measurement only requires a sensor placed at the end of a finger, on the earlobe or on the forehead.

The aim of the study is to assess whether changes in the plethysmography variability index (PVI) during a TVC can reliably detect simultaneous changes in blood pressure pulsatility. This study will include patients hospitalized in intensive care unit, mechanically ventilated, in whom physicians have decided to perform a TVC as common practice. Changes, occurred during this test, in arterial blood pressure pulsatility and in plethysmography pulsatility index will be measured and compared. If results will show that changes in PVI during TVC are reliable for measuring blood pressure pulsatility changes during this test, this will allow the test to be used even in the absence of an arterial catheter.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in intensive care unit
* physicians' decision to perform a tidal volume challenge
* hemodynamic monitoring with a calibrated pulse contour analysis device (PICCO2) in place
* monitoring of oxygen saturation with Masimo SET
* mechanical ventilation with tidal volume of 6 ml/kg on ideal body weight

Exclusion Criteria:

* thoracic drainage
* patient under judicial protection
Fluid Resuscitation in Burn Patients

Balanced solutions with low chloride concentration could represent an alternative to high chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e. acetate and/or gluconate). However, acetate has been associated with alteration of cardiac function when used as buffer in dialysate when high acetate concentrations are used and could promote the development of metabolic acidosis if it accumulates. Therefore, the safety of such solutions remains poorly explored. Because critically ill patients receive large amount of fluid during the early phase of resuscitation, large amount of acetate are to be administrated if such solutions are used. While acetate-containing solutions have been suggested to be safe in this setting, studies are still lacking regarding clearance and accumulation in critically ill patients.

It is expected to include 28 patients, the objective to analyze the data of 20 patients.

The main objectives of the study is 1) to determine whether Plasmalyte® promote the development of metabolic acidosis in comparison with an acetate-free balanced solutions: Ringer lactate (chloride concentration of 111 mmol/L) and 2) to determine Acetate \& gluconate clearance during fluid resuscitation of severely burn patients Plasmalyte® (chloride concentration of 98 mmol/L) . Severely burn patients will be randomized to receive Plasmalyte® or Ringer Lactate for initial fluid resuscitation during the first 5 days following admission.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* TBSA\>30%
* Admission to an intensive care unit within 12 hours after burn injury
* Signed informed consent to Patient / Parent / ( Inclusion in Emergency and Consent is Collected)
* social Insurance cover

Exclusion Criteria:

* Decline to participate
* pregnancy
* Metabolic alkalosis (excess of base\> 5mmol / L)
* legal obstacle to participate