cyrilzakka/clinical-trials huggingface dataset:
Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer

Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.

The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :

* Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
* Evaluate from patient and jury, the tall, form, color and areola position defects
* Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria

Eligibility Criteria:
Inclusion Criteria:

* technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer

Exclusion Criteria:

* Two breasts operated patient
* surgical reconstruction
Effects of Power Ball on Proximal Muscle and Refractive Errors in Developmental Delay.

When a child does not meet developmental milestones at the anticipated times, it is referred to as having a developmental delay. These benchmarks cover social, emotional, cognitive, physical, and communication abilities. Developmental delays can result from a number of factors, including genetic circumstances, early delivery, specific medical issues, or external variables. Although they mainly impair vision, refractive errors are unrelated to developmental delays. Because vision facilitates interaction with the environment, it is vital to a child's development. Early detection of uncorrected refractive defects and related vision loss in children can pose a challenge. To ascertain whether an increase is suitable and successful, a thorough evaluation of the child's readiness and the application of pertinent measurement techniques may be necessary. An analysis looks into Randomized Controlled Trial will be the type of study design used. There will be two groups of conveniently randomized sample size of thirty-two. The data analysis will be done using SPSS version 22.0. To verify normality, the Shapiro-Wilk test will be employed. The study will be carried out in the department of physical therapy of the rising sun and the Lahore rehab facility. The study will be finished six months from the time the synopsis is approved. A sample size of thirty-two was determined using the OPENEPI tool. The VQOL/item Tool and pediatric manual muscle testing will be used. For four weeks, the control group will receive standard physical therapy care. Group B: Experimental Group: For five weeks, a traditional physical therapy regimen and Powerball exercises will be administered.

Group A: conventional physiotherapy will be administered to this group. Manual resistance exercises for neck strengthening are part of conventional physical therapy. Cervical flexion, extension, side flexion, side flexion with rotation, and pure rotation with mild resistance are the exercises used to strengthen the neck. There will be three 30-minute sessions. Strengthening will take place over the course of 15 mints.

Group B: In addition to standard care, this group will engage in power ball exercises for neck stability and strengthening. Gradually, the resistance will rise.

Three mints in each position for a total of fifteen mints of ball exercises. At first, Powerball reduced the pain, progressively strengthened them, and with continued development, allowed them to move in a pain-free range.

Eligibility Criteria:
Inclusion Criteria:

* Age 7-12 years
* Both genders
* Children with refractive error
* Children with affected developmental delay

Exclusion Criteria:

* Any neurological condition (Epilepsy and seizures)
* Any congenital defects
* Genetic disorder
* Surgery in last 6 months
Influence of Stress on Non Surgical Periodontal Treatment

Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Severe generalized chronic periodontitis
* Minimum 15 teeth
* Attachment loss \> 5mm
* 30% of sites affected- 5% of pockets\>5mm
* Bone loss- Bleeding on probing

Exclusion Criteria:

* Patient at risk of endocarditis
* Pregnant women
* Patient under therapy for depression
* Patient treated for periodontal diseases previously
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI

One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. The trial aims to investigate how VR can affect processing speed in the ABI population, and if these effects can transfer into everyday activities. The training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. The training period will last five weeks. Participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. In depth experiences with VR as a training method will be gathered through performing focus group interviews with some of the participants from the VR group, in addition to self-reported questionnaires from all the participants.

A randomized controlled trial (RCT) will be conducted where the experimental intervention is playing a commercial VR game. The VR group will follow a training regime of a 30 min VR session five times per week for 5 weeks. The control group will carry on with treatment as usual, in addition, participants will receive an information booklet covering cognitive training in everyday life. Baseline and outcome measures in terms of neuropsychological assessment and questionnaires will be performed at baseline (T1), at the end of the intervention period (T2) and at the 16-week follow-up (T3).

The VR group will train with a rhythm VR game that is considered as a good candidate for basic training of the multifaceted aspects of attention including speed of information processing, selection, sustained attention, shifting/dividing of attention, and working memory.

The VR game is selected on the grounds of clinical experience with VR training of processing speed, attention and working memory, and is also suggested in research as suitable games for cognitive rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients in stable phase after Acquired brain injury, minimum one year after injury
* Physically able to operate VR-technology
* Norwegian or English skills adequate to understand instructions, play the VR-games and to provide valid responses to assessment methods

Exclusion Criteria:

* Severe aphasia affecting their understanding of instructions
* Apraxia affecting their ability to use VR-equipment
* Visual neglect
* Severe mental illness, substance abuse or co-existing neurological disorders
Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma

A retrospective medical record abstraction study of at least 200 advanced renal cell carcinoma patients treated in the following settings:

* Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy (about 100 patients)
* Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100 patients)

Recently, a number of targeted agents have demonstrated single-agent activity in the treatment of advanced renal cell carcinoma. Bevacizumab, a humanized monoclonal antibody directed against VEGF, resulted in an improvement in median progression-free survival when compared to placebo in a prospective, randomized trial. More recently, the multitargeted agents sorafenib and sunitinib have been approved for use in the treatment of advanced renal cell carcinoma. Both have proven superior to previous interferon and other standard treatment; however it is not clear how these drugs should be used in the treatment sequence. With roughly 80% of cancer patients receiving their oncology care in the community setting, we are proposing a review and evaluation of at least 200 advanced renal cell carcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patient cases are those that have received Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy or those patients that were treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as secondline therapy.
Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction

Study of the prognosis of patients with heart failure with preserved ejection fraction

Obesity is an independent risk factor for heart failure with preserved ejection fraction (HFpEF), however, the impact of visceral fat area (VFA) in patients with HFpEF is unclear. According to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). All patients were divided into two groups based on the best cut-off value of VFA, and the primary outcome of this study was all-cause death in patients with HFpEF. The aim of this study was to clarify whether VFA has prognostic value in patients with HFpEF by Kaplan-Meier analysis and cox analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged \>=18years old;
2. Diagnosed with HFpEF.Diagnostic criteria including:

1）left ventricular ejection fraction ≥50%； 2）with the symptoms and/or signs of heart failure； 3）BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； 4）at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

Exclusion Criteria:

1. Age \<18 years old；
2. LVEF less than 45% at any time;
3. cancer diagnosis.
Risk Factors for Pulmonary Hypertension of the Newborn

To conduct a multicenter case-control study of persistent pulmonary hypertension of the newborn (PPHN) in relation to maternal exposure to smoking and non-steroidal anti-inflammatory drugs (NSAIDs). Also, to assess other potential antenatal risk factors and collect and store buccal cell specimens for future analyses.

BACKGROUND:

Persistent pulmonary hypertension of the newborn (PPHN), previously called persistent fetal circulation, is a birth defect affecting approximately 1 in 1250 liveborn term infants; even with complex and high-risk interventions, PPHN results in substantial mortality and morbidity. This defect results from the inappropriate muscularization of fetal pulmonary vessels, and experimental and human evidence consistently suggests that maternal cigarette smoking and antenatal exposure to NSAIDs, particularly aspirin or ibuprofen, may play a role in the etiology of this condition. Because these exposures are quite prevalent (e.g., ibuprofen is currently taken in the first trimester or later in pregnancy by 15 percent and 3.2 percent of women, respectively), testing these hypotheses is of considerable public health importance.

DESIGN NARRATIVE:

The multicenter study had a case-control design. There were 560 case infants with PPHN and four controls per case (2240). All controls were drawn from the birth hospitals of cases; half the controls had malformations other than PPHN, and half had normal formations. Cases and controls were identified within five months of birth at 88 birth and tertiary hospitals in the areas surrounding Boston, Philadelphia, and Toronto. Mothers of subjects were interviewed by telephone within six months of delivery; a standardized questionnaire inquired in detail about demographic factors; reproductive, medical, and pregnancy illness histories; medication use (including a detailed focus on use of over-the-counter analgesic/antipyretic medications), smoking, and nutrition. Because of emerging genetic research suggesting an effect of NSAIDs on pathways possibly related to the etiology of PPHN, buccal swabs were also collected and stored for future analyses. Exposure prevalences were compared between mothers of cases and controls and relative risks were estimated, controlling for potential confounding factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Correlation Between Cycle Threshold (Ct) Values in COVID-19, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory.

This study will evaluate the correlation between the symptomaticity, Ct value, laboratory biomarkers associated to COVID-19 and the disease progression in hospitalized patients and outpatients with SARS-CoV2 infection diagnosed by RT-PCR assay for nasopharyngeal swab specimens in a specialized laboratory at Medellin,Colombia.

After being informed about the study, all patients giving written informed consent will undergo a serial of test related to COVID-19. Rh and blood type will be obtained using the Colombian ID card or official document.

All symptomatic and asymptomatic COVID19-positive patients will be evaluated for a period of 4 weeks at three different times of the study. In a single time, the mitochondrial DNA will be measured, and the variability in the CT value, hemogram, cytokine levels, ratio of CD4 + / CD8 + lymphocytes, levels of dehydrogenase lactate, ferritin and D-dimer, antibodies IgG and IgM, will be measured on day 5, day 14 and day 28. In addition, spike S protein sequencing and growing the virus in cell culture that meet specific criteria will be performed. A physician will do clinical follow up through the period of the study for each patient.

Eligibility Criteria:
Inclusion Criteria:

* People under 18 years old.
* Covid-19 diagnosis in the last seven days.
* Specimen analyzed at LIME laboratory
* Description of symptoms related to COVID-19

Exclusion Criteria:

* Immunocompromised patients
* Immunosuppressive treatments, chemotherapy or antiretroviral therapy
* Outpatient anticoagulation therapy
* Prior immunization for any vaccine in the last 3 months
Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients

The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer.

200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.


Eligibility Criteria:
Inclusion Criteria:

* Infertile PCOS women;
* aged 20-35 years;
* had BMI \<35 kg/m2.

Exclusion Criteria:

* Women who were younger than 20 or older than 35 years,
* obese of grade II or III,
* had poor OR, other causes of infertility,
* had previous attempts of IVF, had a history of repeated pregnancy loss.
Harmony TPV EMEA PMS

The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.

Prospective, non-randomized, multi-center, post-market interventional clinical study

Eligibility Criteria:
Inclusion Criteria:

1. Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment.
2. Subject or subject's parent(s)/legal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements

Exclusion Criteria:

1. Obstruction of the central veins.
2. Planned concomitant branch pulmonary artery stenting at time of implant.
3. Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis.
4. A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year.
5. Planned implantation of the Harmony TPV in the left heart.
6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
7. Pre-existing prosthetic heart valve or prosthetic ring in any position
8. Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential.
9. Subjects that are vulnerable as defined in the Section 10.5 Subject Consent

Subject Consent Section excerpt:

* Vulnerable adults, defined as subjects incapable of giving consent, as assessed per Investigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study.
* Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the Investigator for vulnerable status. If pediatric or adult subject is deemed by the Investigator mentally incompetent as described above, the subject will not be included in this study.
Prevention of Acute Pancreatitis After Endoscopic Interventions

The aim of the study is to develop a method for the prevention of acute pancreatitis after minimally invasive interventions of the bile ducts using a drug regimen.

A prospective, randomized, single-center study is planned to identify the most effective drug regimen in order to prevent the development of acute pancreatitis after transpapillary interventions of the bile ducts.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with cholangiolithiasis.
2. Patients with benign formations of the bile ducts.
3. Patients with malignant formations of the bile ducts.
4. Patients with extrahepatic bile duct cysts.
5. Patients with biliary hypertension of unknown etiology.
6. Patients with cholangitis.
7. Patients with extrahepatic bile duct strictures.
8. Patients suffering from oncopathology of the head of the pancreas, complicated by obstructive jaundice.
9. Patients with malignant pathology of the pancreas.
10. Patients with benign pancreatic pathology.

Exclusion Criteria:

1. ASA scale\> III (severe concomitant cardiovascular pathology)
2. Severe pathology of the respiratory system.
3. Acute period of myocardial infarction.
4. Acute period of cerebral infarction.
Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy


Eligibility Criteria:
Inclusion Criteria:

- non-small cell lung cancer patients with less than brain metastases Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment Patients who have not received intracranial local treatment before

Exclusion Criteria:

- Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis
A Study of Dental Implants Coated With Bone Morphogenetic Protein

The purpose of the study is to evaluate implant stability and stimulate clinically relevant horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.

Common complications encountered when replacing missing teeth with Endosseous dental implants include lack of adequate bone volume limiting the possibility of optimal patient treatment. Typical limitations include severely resorbed alveolar ridges (height and width) in patients following long-term edentulism. In other cases, the alveolar ridge may have become compromised due to advanced periodontal disease, traumatic extractions, and other trauma disallowing Endosseous dental implant placement to meet aesthetic and functional demands. Conversely, placing Endosseous dental implants to optimally meet aesthetic and functional demands in sites exhibiting alveolar ridge aberrations often results in partial exposure of the Endosseous dental implant bone-anchoring surface. In some cases clinicians have attempted to overcome the deficient bone volume by augmenting the anticipated Endosseous dental implant site using bone biomaterials, commonly originating from human or animal cadaveric sources, or synthetic biomaterials. The biomaterials have been used alone and in combinations including autologous bone grafts. Non-resorbable and bioresorbable barrier devices have been used to prevent dislocation of implanted biomaterials. The ability of the Bone Inductive Implant to form new bone above the level of the resorbed alveolar ridge to immerse the exposed portion of the Endosseous dental implant in bone (Treatment group 1) and the ability of the Bone Inductive Implant to induce bone formation around stable Endosseous dental implants placed into tooth extraction sockets (Treatment group 2) without the use of bone grafts, bone biomaterials, or barrier devices will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18 years.
* 2 teeth or more are missing either upper/lower jaw (Treatment Gp 1)
* 2 or more teeth require extraction either upper/lower jaw.(Treatment Gp 2)

Exclusion Criteria:

* Medical risk patients
* Smoking.