cyrilzakka/clinical-trials huggingface dataset:
Buttock Augmentation With Polymethylmethacrylate

Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.

The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.

The sample will be 133 patients. Specific patients will be screened at study sites according to eligibility classifications. After signing the consent form, patients will be included in the study and will be monitored for 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years old;
* Signed Informed Consent Form (ICF);
* Participant understands and is willing to participate in the clinical study and attend visits.

Exclusion Criteria:

* Known history of allergy to formula components;
* Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
* Pregnancy;
* Prior filling of glutes;
* Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.
* Vitamin D supplementation, with normal serum levels and which you do not agree to suspend;
* Use of anabolic hormones;
* Vitamin D (25 hydroxyvitamin D) greater than 70 ng/mL;
* Serum calcium greater than 10 mg/dL;
* Patients with total body PMMA volume of 650mL or more.
Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
* Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
* At least 3 weeks since last major surgery
* At least 12 months since last adjuvant chemotherapy
* At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
* Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
* Patients with reproductive potential must use effective BC
* Required Screening Laboratory Criteria:

Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min

* A probable life expectancy of at least 6 months

Exclusion Criteria:

* Brain metastases
* Female of childbearing potential, pregnancy test is positive
* Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
* Active infection
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
* Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
* History of grade 3 or 4 toxicity to fluoropyrimidines
Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual Analysis System

The purpose of this study is to test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system.


Eligibility Criteria:
Inclusion Criteria:

* Transfemoral Amputees, walking without any assistive device, at least one year.

Exclusion Criteria:

* Amputees who suffer from a Neurological Injury/ disease that has implication on balance control.
* Amputees who suffer from Orthopedic Injury that has implication on balance control.
* Amputees who suffer from Cardiology disease that has implication on balance reactions.
Female LUTS and Quality of Life

Storage symptoms include frequency, urgency, nocturia and incontinence. Based on bladder diaries, we could get the objective data of the above symptoms. To the best of our knowledge, there is lack of correlation of quality of life with lower urinary tract symptoms based on bladder diaries. Thus, we aimed to perform the study.

The bladder diaries and the King's Health Questionnaires of all consecutive women with lower urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were reviewed. Based on bladder diaries, women with at least one episode of urgency and urinary incontinence (UI) were allocated to the overactive bladder syndrome (OAB) -wet group. Women with at least one episode of urgency but without incontinence were allocated to the OAB-dry group. Women with at least one episode of UI but without urgency were allocated to the UI group. Women with more or equal to 2 episodes of nocturia but without urgency and UI were allocated to the nocturia group. Women with more or equal to 8 episodes of daytime frequency but without urgency, UI and nocturia were allocated to the frequency group. Otherwise, normal group. Analysis of variance with Bonferroni correction was used to perform statistical analysis for between-group comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Women with lower urinary tract symptoms
* Finish 3-day bladder diary
* Finish King's Health Questionnaire

Exclusion Criteria:

* Incomplete data
* Pregnant women
* Urinary tract infection, acute or chronic
* History of pelvic malignancy
Mobility and Physical Activity in Adolescent and Young Adult Cancer Patients or Survivors at Risk for Cardiovascular Morbidity and Frailty, The MOBILE AYA Study

This study attempts to learn more about the activity levels of adolescent and young adult (AYA) cancer patients or survivors at risk for cardiovascular morbidity and frailty by using a smartphone application called Beiwe. Collecting activity level data on AYA cancer patients or survivors may help patients achieve better quality of life.

PRIMARY OBJECTIVES:

I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).

II. To characterize patient physical activity over time based upon smartphone sensor data, during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).

SECONDARY OBJECTIVES:

I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and body mass index (BMI).

II. To characterize patient physical activity over time based upon smartphone sensor data during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and BMI.

OUTLINE:

Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 15-39 at the time of study entry
* Patients must be within 3 weeks of starting anti-cancer therapy
* Patients must have a diagnosis of Hodgkin lymphoma, non-Hodgkin lymphoma, sarcoma and have plans to receive anthracyclines or radiation therapy to the chest OR

  * have a diagnosis of a central nervous system (CNS) tumor OR
  * have plans to receive a stem cell transplant
* Patients must have smartphone device and regular access to internet
* Patients must be English-speaking

Exclusion Criteria:

* Patients that are a ward of the state
Chidamide Combines With VP-16 and Methylprednisolone in the Treatment of HLH

Chidamide combines with VP-16 and methylprednisolone in HLH

This study aimed to investigate the efficacy and safety of Chidamide together with Etoposide and methylprednisolone for hemophagocytic lymphohistiocytosis

Eligibility Criteria:
Inclusion Criteria:Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; patients were diagnosed with EBV associated HLH (EBV-HLH) and lymphoma associated HLH.Age ≥18 years old, gender is not limited. Serum creatinine ≤ 1.5 times normal；NT-proBNP ≤ normal；Informed consent obtained.

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Exclusion Criteria: Active bleeding of the internal organs or patients with new thrombotic diseases；Allergic to Chidamide and etoposide；Participate in other clinical research at the same time；HIV , HBV and HCV infected patients (HIV antibody positive)；History of QT interval prolongation, atrioventricular block, ventricular tachycardia, coronary atherosclerotic heart disease；Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial. If the patient was male, he refused to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study；patients judged by the investigator to be unsuitable to participate in this study.

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Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors

The purpose of this study is to examine the effects of exercise on diverse cardiometabolic risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* stable body weight
* sedentary lifestyle

Exclusion Criteria:

* smoked cigarettes
* cardiovascular disease
* chronic kidney
* chronic liver disease
* pregnant or breastfeeding
* any other major illness
Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.

Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.

Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Good health
* No previous periodontal treatment
* Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non-adjacent teeth)
* Ability to understand the study procedures and comply with them through the length of the study

Exclusion Criteria:

* Pregnancy and breast feeding
* Need for antibiotic treatment during periodontal therapy
* Chronic infections
* Systemic diseases
* Patients who report current smoking over 20 cigarettes per day
Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD

It has been reported in several studies that ionized hypomagnesemia is associated with higher morbidity and mortality rates. During continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered by magnesium concentration in ordinary dialysis fluid. This may lead to ionized hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium monitoring could be of interest. This study aim to assess the incidence of ionized hypomagnesemia induced by CRRT-RCA.


Eligibility Criteria:
Inclusion criteria:

* Consecutive patients admitted to the ICU and requiring continuous renal replacement therapy with regional citrate anticoagulation
* age \> 18 ans

Exclusion criteria:

* Persons under protection
* Paritcipation rejections
An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging

This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom twice daily and complete questionnaires at Baseline, Week 2, Week 4, and Week 8.

Participants will also undergo skin analysis via the Optic Elite facial skin analysis system at Baseline and Week 8.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* 40-55 years of age.
* Must be in good general health.
* Must have concerns with overall skin health and appearance, including:

Fine lines and wrinkles The appearance of dark spots

* Must be using the same cleanser and toner for at least one month prior to starting the study.
* Must be willing to keep using the same cleanser and toner for the duration of the study.
* Must not be using oral or topical retinoids.
* In the last three months, has not introduced any new medications or supplements that target skin health.
* Must be willing to comply with the protocol.

Exclusion Criteria:

* Anyone with an allergy to bees or bee products.
* Females who are pregnant or breastfeeding.
* Unwilling to follow the protocol.
* Unwilling to maintain use of the same cleaner and toner for the duration of the study.
* Currently participating in another study.
* Use of oral or topical retinoids.
* Individuals with cystic acne or otherwise self-reported very acne-prone skin.
* Use of a prescription medication relevant to the skin.
* Anyone undergoing cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
* Anyone sensitive or allergic to any ingredients found in the products.
* Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes.
Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing

This study is intended to measure serum trefoil factor 3 at baseline and 3 months after, following nonsurgical periodontal therapy in patients with Gingivitis and Chronic Periodontitis.

A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.

Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.

Eligibility Criteria:
Inclusion Criteria:

For Gingivitis:

* Gingival Index: 1.1 to 2.
* Modifies Plaque Index: 1.0 to 1.9

For Periodontitis:

* Gingival Index: 1.1 to 2.
* Modifies Plaque Index: 1.0 to 1.9
* Probing depth \> 4mm
* Clinical attachment loss \> 2mm

Exclusion Criteria:

For Gingivitis:

* Presence of gingival recession.
* Presence of clinical attachment loss.
* Presence of furcation.
* Presence of systemic infections like diabetes, infections.
* Smokers.
* Antibiotic therapy received preceding 3 months.
* Patients who underwent periodontal therapy within 3 months.
* Pregnant and Lactating women.

For Periodontitis:

* Presence of any systemic conditions like diabetes, infections.
* Smokers.
* Antibiotic therapy received preceding 3 months.
* Patients who underwent periodontal therapy within 3 months.
* Pregnant and Lactating women.
Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake

The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in healthy volunteers compared to Placebo.

GLP-1 analogues are well known to stimulate glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic properties of GLP-1 analogues reduce fluid intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8 hours.

Eligibility Criteria:
Inclusion Criteria:

- Age 18 to 65 years

Exclusion Criteria:

* Known or probable central or nephrogenic Diabetes insipidus, based on patient's history
* Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
* Primary Polydipsia, defined as more than 4 liters fluid intake per day
* BMI \<18 or \>30kg/m2
* Pregnancy
* Previous treatment with GLP-1 agonists within the last 3 month
* History of pancreatitis
* Severe renal insufficiency (eGFR (CKD EPI) \<30 ml/min/1,73 m2)
* Cancer
Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor \>5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.

150 HCC patients with tumor \>5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety.

Eligibility Criteria:
Inclusion Criteria:

1. tumor \>5cm;
2. multiple tumor located in one liver lobe;
3. margin of tumor is not clear;
4. cutting edge to tumor \<1cm;
5. portal vein branch invasion;
6. without extra-liver metastasis;
7. patient's liver function and condition is able to accept hepatectomy.

Exclusion Criteria:

1. single tumor \<=5cm;
2. multiple tumor located more than in one liver lobe;
3. margin of tumor is clear;
4. cutting edge to tumor \>=1cm;
5. portal vein stem invasion
6. extra-liver metastasis;
7. patient's liver function and condition cannot accept hepatectomy.
Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?

Our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters.

Anxiety is common in perioperative patients with incidence of 60-89 %. Lack of knowledge about surgery and anesthesia, anesthesia procedures and unfamiliar surroundings are the common causes of anxiety . Anxiety related to anesthesia can be due to lack of knowledge about its process, procedures and risk associated with it or misconceptions about it. Long NPO status and unexpected delay before and during anesthesia procedure and surgery further increases the anxiety in perioperative patients. Anxiety increases the activity of sympathetic nervous system and cause preoperative and intraoperative tachycardia, hypertension, arrhythmias, increased pain perception and increase requirement of anaesthetic drugs. This may lead to harmful effect on patient health and decrease overall patient satisfaction and even traumatic experience for rest of life. This may affect process of giving informed consent for the planned surgery. Many measures are taken to allay anxiety in perioperative patients. Anxiolytic medications are given preoperative period to allay anxiety but they may have detrimental effect on patient health, requires administration under supervision of health professional and may not be effective unless the cause of anxiety is taken care. Counselling regarding the procedure of anesthesia during pre-anesthetic check up is other way to allay anxiety but transfer of knowledge is usually limited and may not be entirely retained. Other method in the form of written pamphlets, booklet or questionnaires have been tried but most of the patients in Nepal are not literate enough to read and understand it. Multimedia information to allay patient's anxiety has been successfully tried. Previous study shows a significant reduction in anxiety level due to preoperative multimedia information among the patients undergoing surgery. Investigators have developed a short visual clip of 4.5 minutes duration depicting the procedure of spinal anaesthesia .Investigators will be using Hamilton Anxiety Score in patients undergoing surgical procedures under spinal anesthesia .

Eligibility Criteria:
Inclusion Criteria:

- All patients between 18 and 65 years of age of either sex undergoing elective surgery under SAB were included.Only patients in ASA category 1 and 2 will be included.

Exclusion Criteria:

* Patients refusing to give consent for the study,

  * Patients Having significant cardiovascular or neurological disease,
  * Patients On medications such as beta blockers, antidepressants, cardiac or psychiatric drugs,
  * Pregnant patients and
  * Patients those who had undergone procedures under SAB in the past
  * Patients facing any major complications after the surgery such as massive blood loss, having to convert to general anesthesia due to lengthy surgical procedure, patients requiring critical care administration after the surgery