cyrilzakka/clinical-trials huggingface dataset:
Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting

clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
2. Systemically healthy

Exclusion Criteria:

1. Severe gagging reflex
2. Smokers
3. Occlusal trauma at site of graft
4. Pregnancy
5. Psychiatric disorder
6. Patients allergic to the used agents
Community Based Promotion of Physical Activity in Nepal (COBIN-PA)

Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 69 years
* without the intention of migrating out of the area for the next 6 months

Exclusion Criteria:

* Those severely ill
* History of mental illness
* Decline to provide consent
Experimental Study Measuring Power and Execution Speed in 44 Athletes in Push-up Exercise.

Investigation of power and speed in relation to the increasing instability in a group of untrained athletes and a group of expert athletes. In this way, the effectiveness of unstable training for different types of athletes can be tested.

Our hypothesis is that as instability increases there is a gradual decrease in power and speed of execution, but not too relevant in the expert group.

Introduction

Strength training using devices that induce varying degrees of instability is widely practiced in numerous contexts and has been credited with benefits in prevention, rehabilitation and general health. Several studies have found a progressive decrease in power as the degree of instability increases. However, it is not known how mildly unstable situations are affected, nor are the differences between trained and untrained subjects.

The purpose of the present study was to compare the effect of different degrees of instability on power and speed of execution in a push-up or arm-bottoms exercise, in trained and untrained subjects.

Method

Maximum power (MP) and mean power (BP), and maximum speed (MV) and mean propulsive speed (VA) of push-up were analyzed in 44 subjects, 24 untrained (176.38±5.35 cm, 76.38±6.85 kg, 2.5±1.5 months experience) and 20 trained (178.45±5.91 cm, 83.4±21.56 kg, 15.5±5.3 months experience), under six conditions of increasing instability: 1) stable, 2) device in suspension: rings, 3) monopodal, 4) device in suspension: TRX®, 5) with hands-on Bosu® and 6) with hands-on TRX® and feet on Bosu®.

Eligibility Criteria:
Inclusion Criteria:

* 2 years of continuous strength training
* No injuries of any kind within the last year
* Perform a regular push-up exercise
* Having ever used an unstable device

Exclusion Criteria:

* Previous injuries
* Never have used unstable devices
* Newcomers to strength training
Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017

The aim of the study is to assess the safety and tolerability of increasing doses of ATOR-1017 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.


Eligibility Criteria:
Major Inclusion Criteria:

A patient is eligible to be included in the study if all the following criteria apply:

* Has a diagnosis of advanced and/or refractory solid malignancy (histologically or cytologically documented)
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has a minimum of one measurable tumor lesion
* Has acceptable hematologic and clinical chemistry laboratory values

Major Exclusion Criteria:

A patient is excluded if any of the following criteria apply:

* Has not recovered from AEs to at least grade 1 by CTCAE version 5.0 due to prior anti-cancer medications
* Has symptomatic, steroid-dependent or progressive brain metastasis/metastases
* Has a history of another primary malignancy, except for: a) Malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of ATOR-1017, b) Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma, c) Adequately treated uterine cervical cancer stage 1B or less
* Has an autoimmune disorder requiring immune modulating treatment during the last 2 years
* Receives treatment with systemic immunosuppressant medication (except for inhaled and low dose systemic corticosteroids, i.e. ≤10 mg prednisolone or equivalent per day)
* Is a female patient who is pregnant or nursing
Cerebral Hemodynamics in Sleep Disorders

The purpose of this study is to determine the relationship between sleep disorders and cerebral hemodynamics.

Sleep disorders continue to be the most unrecognized modifiable risk factor for stroke. The relationship between sleep disorders and vascular risk factors and stroke has been well-documented but not fully understood. The investigators hypothesize hemodynamics impairment to be its potential mechanism. It has been reported that sleep-related breathing disorder, a type of sleep disorders, contributed as a risk factor for stroke through hemodynamic and hematologic changes. The purpose of this study is to determine the relationship between different kind of sleep disorders and cerebral hemodynamics, including OSHAS, RLS, RBD, narcolepsy, etc. The dynamic cerebral auto-regulation (dCA) and Transcranial Doppler (TCD) will be used to evaluate cerebral hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* patients with sleep disorders
* meet the Diagnostic Criteria for Sleep Dyssomnias
* sufficient bilateral temporal bone windows for insonation of the MCA

Exclusion Criteria:

* middle cerebral artery (MCA) and/or other intracranial and/or extracranial major vascular 4 stenosis/occlusion, as diagnosed by a transcranial Doppler
* having a prior symptomatic cerebral vascular disease
* current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability
* inability to cooperate sufficiently to complete the dCA examination
An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644.

The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

This is a prospective, multicenter, post-market clinical follow-up, non-randomized registry of the TREO Stent-Graft. Subjects diagnosed with infrarenal aortic aneurysms and treated with the TREO Stent-Graft or TREO aorto-uni-iliac (AUI) device can be included into the registry. Pre-procedure baseline data will be gathered as well as post-procedure assessments prior to hospital discharge and one to three months and 1, 2, 3, 4, and 5-year post-implantation.

The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms (AAA).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Signed informed consent
* Willingness to comply with study follow-up
* Indication for elective endovascular repair
* Planned implantation of single Treo device system or aorto uni-iliac (AUI) device to include any auxiliary device components

Exclusion Criteria:

* Intolerance to contrast media
* Emergency procedure
* Chimneys or fenestrated device procedures
* Connective tissue disease (e.g., Marfan's syndrome)
* High probability of non-adherence to follow-up requirements
* Current participation in a concurrent trial that may confound study results
* Female of childbearing potential in whom pregnancy cannot be excluded
* Previous endovascular or surgical AAA repair
Zinc and Bone Turnover Study in Adolescent Females

The purpose of the study is to determine the effects of zinc supplementation on bone growth over four weeks. Participants will agree to attend two visits to our laboratory and at each will complete blood and urine samples, questionnaires related to diet and physical activity and will receive a bone scan at the first appointment.

Significant accomplishments have been achieved with respect to our understanding of calcium and vitamin D and skeletal health, yet a body of scientific evidence has also identified understudied nutrients that have potential for reducing the burden of osteoporosis. Zinc has important roles in bone metabolism and there are indications from animal and human studies that beyond correcting skeletal and growth impairments under deficiency conditions, supplementation with zinc may have a bone health-promoting role. It has been postulated that the action of zinc on bone metabolism is partially mediated by Insulin-like growth factor one (IGF-I). Prior to undertaking a long-term bone trial, a short-term zinc supplementation trial is proposed to first determine if zinc alters intermediate markers of bone metabolism in healthy, early pubertal females (9-10.5 years of age). We hypothesize that healthy females receiving 24 mg zinc /day over 4 weeks will have elevated serum markers of bone formation and plasma growth factors compared to those receiving placebo. We further hypothesize that the differences between the zinc and placebo groups will vary by race. To test these hypotheses, we will screen early pubertal females to assure similar maturational status and conduct a 3-week, randomized, double-blind, placebo-controlled trial with a zinc supplementation (zinc sulfate; n=80) and a placebo (n=80) arm. The groups will be further divided by race (non-Hispanic White and non-Hispanic Black; n=40 per group). The specific aims are to determine if early pubertal females supplemented with zinc compared to those receiving placebo will have: 1) greater increases in markers of bone turnover favoring bone formation; 2) greater increases in plasma IGF-1 and IGFBP-3; and 3) changes in bone turnover markers, IGF-1 and IGFBP-3 that differ by race. In addition, anthropometric measures, maturity offset, sexual maturation, erythrocyte superoxide dismutase activity, ceruloplasmin, dietary intakes and physical activity will be determined. Findings from this study will provide preliminary evidence of whether supplementation with zinc is a viable nutrition strategy to improve biochemical indices of bone turnover and growth factors in young females. Moreover, the results will help determine if a long-term clinical bone trial is warranted to more definitely assess the potential for supplemental zinc to reduce the risk for osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Female
* Ages 9-11
* Pre-menarchal
* Caucasian or African American

Exclusion Criteria:

* Menses
* Disease known to affect bone
* Drugs known to affect bone
* Vitamin/mineral supplements
Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI

This study is a single-center, prospective controlled trial addressing effectiveness of empagliflozin on cardiac-renal injury in patients with STEMI. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Investigators, participants, and other study personnel were blinded to the assigned treatment for the duration of the study. The primary objective of this study is to investigate the effects of empagliflozin on myocardial infarct size measured using cardiac magnetic resonance (CMR) methods at 3 months. Key secondary endpoint: incidence of CIAKI within 48h after PCI. Inclusion Criteria:Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between Ocotor 2018 and January 2019. STEMI was defined as typical chest pain lasting \>30 minutes within the previous 12 hours, a clear ST-segment elevation of \>0.1 mV in two or more contiguous electrocardiographic leads, and elevated blood levels of troponin T.Exclusion Criteria:Cardiogenic shock ,Hypoglycaemia ,Diabetic ketoacidosis,Genital and urinary infections,History of myocardial infarction,Stent thrombosis,Previous coronary artery bypass surgery,Type 1 Diabetes,Severe hepatic insufficiency,Advanced cancer patients,eGFR\<30 ml/min.

All patients were informed of the potential risks (genital mycotic infections, urinary tract infections, diabetic ketoacidosis) associated with empagliflozin and then required to submit written informed consent before being included in the study. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Patients in the empagliflozin group were treated with empagliflozin whereas patients in the control group were given placebo. The treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin or placebo administered in the ambulance. After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.


Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between June 2018 and September 2018.

Exclusion Criteria:

* Cardiogenic shock
* Hypoglycaemia
* Diabetic ketoacidosis
* Genital and urinary infections
* History of myocardial infarction
* Stent thrombosis
* Previous coronary artery bypass surgery
* Type 1 Diabetes
* Severe hepatic insufficiency
* Advanced cancer patients
* eGFR\<30 ml/min
Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula

congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection.

Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence.

Patients and methods:

A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.

Eligibility Criteria:
Inclusion Criteria:

* All female infants with congenital rectoperineal fistula

Exclusion Criteria:

* patients with major anomalies, patients who have staged repair
Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients

Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).

The Investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed AML (not APL) patients in China. Participants are randomised selected to receive the regimen of Ara-C, aclarubicin and PEG-G-CSF , or the regimen of Ara-C, aclarubicin and G-CSF (CAG ).Platelet count, bleeding and other symptoms are evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. age 60 years and older, with an upper age limit of 75 years;
2. diagnosis of AML other than APL
3. Adequate hepatic and renal function (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], bilirubin and creatinine \< 2.5 x upper normal limit).

Exclusion Criteria:

1. History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin
2. Use of recreational drugs or history of drug addiction, within the prior 6 months
3. Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies
4. Patients with documented cases of human immunodeficiency virus (HIV)
EPIDURAL- Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia

The aim of this research project is to anonymously survey pregnant patients before the anaesthesiological consultation about their prior knowledge of planned neuroaxial procedures in the context of childbirth by conducting an online survey and to evaluate the sources of that information.

Within labour and delivery, neuroaxial anaesthesia (peridural or spinal anaesthesia) is commonly used in accordance with clinical practice guidelines. However, from a professional perspective, there are still questionable and incorrect statements about possible complications and side effects that cannot be justified medically. In an increasingly technological and networked society, the dissemination of medical information via various sources of information poses a potentially serious problem in terms of disinformation, and the correct classification of information is becoming more and more difficult.

Anaesthesiologists are increasingly confronted with consultations in which, in addition to the actual informed consent for the intervention, extensive clarification of existing contradictory information is required.

The aim of this research project is to survey pregnant patients prior to receiving an anaesthesiological consultation about their previous knowledge of the intended procedure by conducting an anonymous online survey.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women prior to delivery

Exclusion Criteria:

* Women under 18 years of age
Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)

It gave a clinical trial which will be included in the 60 infants, aged up to 24 months, diagnosed with congenital's population will be divided by simple randomization into three groups: 20 infants in the intervention group, 20 infants in the control group, not receive the RTA technique and another 20 infants in a placebo group, we just get the support manual therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory rate and oxygen saturation. Then the researcher will apply three specific rating scales, based on clinical presentation and behavior of infants. Hypothesis: The RTA improves cardiorespiratory parameters and reduces signs of discomfort and pain of infants with congenital heart acyanogenic.


Eligibility Criteria:
Inclusion Criteria:

* Newborns admitted to the nursery without ventilatory support or oxygen therapy, and whose parents agree with the child's participation in the study. Will be excluded newborns who have some problems during any of the study procedures and those whose condition will change after the intervention, with shift in ventilatory support or oxygen therapy.

Exclusion Criteria:

* In case of inability to collect some of the parameters evaluated at the appropriate time, the RN also will no longer part of the sample, as well as those who show no contraindication to therapy.
Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)

30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index\>1) conditions of hyperinflation even with Plateau pressure (Pplat) \< 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation.

In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.

Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and consequently Pplat to obtain a Stress Index value equal to 1.

Eligibility Criteria:
Inclusion Criteria:

* ARDS patients with Pplat \>= 26 during NIH protective ventilation protocol

Exclusion Criteria:

* Age \< 18 years
* Brain injury and patients with intracranial pressure \> 20 mmHg
* Pregnancy
* Immunodepressed patients
* Patients already enrolled in other trials
* Renal replacement therapy
* BMI \> 40
* Contraindication anticoagulation treatment
* Morphological abnormalities of femoral veins
* NYHA III-IV
* Burns BSA\>30%
* Hepatic failure (grade C Child)