cyrilzakka/clinical-trials huggingface dataset:
Post Market Clinical Experience Study of Sientra 207 Breast Implants

A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.

Eligibility Criteria:
Inclusion Criteria:

1. Is a candidate for primary or revision breast augmentation and is at least 22 years of age,
2. Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.

Exclusion Criteria:

1. Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery
2. Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.
Study of CM310 in Subjects With Seasonal Allergic Rhinitis

This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.

Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-65.
* Understand the study and sign the Informed Consent Form voluntarily.
* Take effective contraception measures throughout the study period.

Exclusion Criteria:

* Used other investigational drugs.
* Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310.
* Plan to participate in other studies during this clinical trial.
* With malignant or benign tumors of the nasal cavity.
* Other reasons the researcher believes that the subject is not suitable to participate in this study.
Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis

The hypothesis of this study is that using "Bio Mineral" toothpaste for 4 weeks will decrease plaque and gingivitis of mild periodontitis patients compared to patients using "Perio Total Care" toothpaste.

This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis.

This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis. 30 patients of treatment group and 30 patients of control group, total 60 patients will be enrolled to this study. Every patients will use investigational toothpaste 2 times everyday for 4 weeks and brush their teeth at least 3 minutes each time with 1ml of toothpaste.

Eligibility Criteria:
Inclusion Criteria:

1. A healthy man or menopausal woman who is at least 18 to maximum 63 years of age.
2. Agreed to participate voluntarily in the study.
3. Must have over 20 maxillary teeth
4. Must have mild periodontal disease which can induce mild plaque.
5. Having no general disease except for dental disease.
6. Must be able to understand and carry out the trial's objective and method.

Exclusion Criteria:

1. Who has history of using antimicrobials or antibiotics during the past 30 days.
2. Who has history of periodontal treatment during the past 30 days.
3. Who has acute pain or severe suppuration caused by pericoronitis of the wisdom tooth.
4. Who has hypersensitive conditions caused by Gingivitis or periodontitis.
5. Who having restorative dentistry or wearing braces widely.
6. Who using tobacco products (Except for who quit smoking)
7. Who has been participated in other clinical trials during the past 4 weeks.
8. Who judged inappropriate to participate in the study by investigator
A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.

In this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. The investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. The investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as colorectal cancer
* Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

Exclusion Criteria:

* The patient refused to join the study
* The patient refused to collect the biological sample
* The patient refused to follow up
Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease

The current proposal is designed as a first-in-human Phase 1 open-label, dose-escalation study to assess the safety, pharmacokinetics, and the maximum tolerated dose of DHM among healthy volunteers using a purified form of DHM from a local cGMP compliant source (Master Herbs, Inc).

Dihydromyricetin (DHM), a bioactive flavonoid from an edible plant (ampelopsis grossedentata), is reported to have multiple protective effects against chemical-induced liver injuries. For example, the antioxidant activity and cellular metabolic protective effects of DHM may act via the AMP kinase (AMPK) and nicotinamide adenine dinucleotide (NAD+)-dependent Sirtuin (Sirt)-1 energy regulating pathway. Furthermore, there is accumulating evidence supporting the use of DHM for the treatment of alcohol use disorder and the possible reduction/prevention of alcohol-associated liver disease in animal models. DHM may represent a novel approach to counteract alcohol-induced liver damage and promote alcohol metabolism via changes in hepatocellular bioenergetics and mitochondrial biogenesis driven by the AMPK/Sirt-1/PGC-1α axis.

These preclinical data suggest the potential of DHM as a novel therapeutic agent in alcohol-related diseases. However, further study in humans is warranted. While DHM has been used for herbal tea in traditional Chinese medicine for hundreds of years, and there has been a small clinical trial using DHM in China among individuals with non-alcoholic fatty liver disease, there have been no controlled human studies published that have assessed the safety, pharmacokinetics, or optimal dosing of DHM in humans.

DHM is marketed as a dietary supplement in the United States and is not regulated by the Food and Drug Administration (FDA) as a drug. Because the FDA has little control over the quality of herbal products such as DHM, it is necessary to quantitatively estimate the potentially active ingredients and the pharmacokinetic (PK) profile with oral administration.

The current proposal is designed as a first-in-human Phase 1 open-label, dose-escalation study to assess the safety, pharmacokinetics, and the maximum tolerated dose of DHM among healthy volunteers using a purified form of DHM from a local cGMP compliant source (Master Herbs, Inc).

Eligibility Criteria:
Inclusion Criteria:

* No prior medical history of alcohol use disorder or alcohol-associated liver disease
* Between 18-60 years old

Exclusion Criteria:

* Weight below 50kg.
* Advanced liver disease
* Other acute liver diseases
* HIV co-infection
* History of pancreatic or biliary disease
* Acute illness that would interfere with drug absorption
* Pregnancy
* Participants who are currently taking drugs with CYP3A4 effects
* FIB-4 Index \> 1.30
* History of Alcohol Use Disorder (AUD) determined by score \> 8 on AUDIT questionnaire
The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Statin therapy effectively reduces cardiovascular events. However, trial data1 and meta-analyses suggest that statins also confer increased risk of development of diabetes. In order to elucidate whether statins increase risk of diabetes, investigators conducted this study to evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Eligibility Criteria:
Inclusion Criteria:

1. Age 35-70 years old
2. Fasting blood glucose 100-125 mg/dL

Exclusion Criteria:

1. A1C \>7.0%
2. 2hr glucose during OGTT \>200 mg/dL
3. Total cholesterol \>280 mg/dL
4. Previous diabetic history, coronary artery disease
5. Allergy to rosuvastatin or parvastatin
6. Baseline ALT more than 3 times UNL
7. Serum Cr \> 2.0 mg/dL
8. Pregnancy, breast feeding or plan to be pregnant woman.
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants

This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in adult hypogonadal men as measured by 24-hour ABPM.


Eligibility Criteria:
Inclusion Criteria:

* Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (DHEA), including investigational products that may affect the reproductive hormonal system or has not been treated with these compounds in the past 6 months
* Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
* Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
* Body mass index (BMI) \< 35 kilograms per metre square (kg/m\^2)
* Male

Exclusion Criteria:

* Uncontrolled systemic disease or clinically significant disease, in particular, liver, kidney or heart disease, including hypertension, congestive heart failure, coronary heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that in the investigator's opinion, would put the participant at an unacceptable risk with exposure to Androderm®
* History of prostate (current or in the past) or breast cancer
* Had a recent (within 2 years) history of stroke, transient ischemic attack, acute coronary event, venous thrombotic, or thromboembolic event
* History of alcohol or other substance abuse within the previous 2 years
* Known allergy or sensitivity to the study intervention or its components or other testosterone replacement medications
* Participant who works night shifts or who will need to perform strenuous manual labor while wearing the ABPM monitor
Minimally Invasive Fixation for Distal Radius Fractures

Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments

Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

Eligibility Criteria:
Inclusion Criteria:

1. patients with unstable distal radial fracture
2. skeletally mature Patients.
3. Acute fractures within one weeks of injury

Exclusion Criteria:

1. contaminated open fractures.
2. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture
Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.

This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms:

1. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants)
2. Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.

The consent form will be reviewed and signed by the participant prior to any study-related procedures.

Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1.

A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine \[group A\] or seasonal intramuscular influenza vaccine \[group B\]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.

Eligibility Criteria:
Inclusion criteria:

* Male or female aged ≥ 60 years
* Healthy and/or medically stable with controlled chronic medical conditions (e.g. diabetes mellitus, hypertension ) able to help oneself

Exclusion criteria:

* Known history of systemic hypersensitivity to egg or chicken proteins or any of the vaccine components
* Influenza infection within the past 3 months
* History of Guillain Barre Syndrome (GBS) or brachial neuritis within 6 weeks of previous influenza vaccination
* Treatment with immunosuppressive or other immune-modifying drugs or cancer therapy within the past 6 months
* Any concomitant medication with aspirin
* Participation in other intervention study
* Incapacity to provide fully informed consent or be attentive to follow-up observations resulting from cognitive impairment, abuse of alcohol or drug addiction
* Random blood for Dextrostix more than 200 mg/dL
Video Training to Reduce Insulin Administration Errors

Efficiency of training with video to reduce injection errors in patients using insulin

The aim of this study is to examine the effects of using insulin administration video and insulin administration brochure as teaching materials in insulin administration training given to type 2 diabetes patients on correcting insulin administration errors. This randomized controlled experimental study was carried out with 94 people who applied to the diabetes outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research Hospital between December 2019 and January 2021. Using a computer-based randomization method, 52 and 42 people were assigned to the groups that received training with video and brochures, respectively. In the first interview, patients' insulin administration characteristics were evaluated, and the training was repeated using the video or brochure, after which the training material corresponding to the group according to the randomization list was given. Insulin administration characteristics of the patients were re-evaluated one week and three months later. Patient information form developed by the researcher based on the literature was used to collect the data. Data were analysed using descriptive statistics, independent sample t-test and Mann Whitney U test. The error rates in the interviews were analysed with the Cochrane Q test, and the relationship between independent categorical variables was examined with the Chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* mobile phone can download video
* video watching skills

Exclusion Criteria:

* illiterate patient
* new to insulin therapy
* who can't watch video on mobile phone
Comparison and Opinion on the Safety of Teleconsultation Versus Traditional Anaesthetic Consultation in a Day Hospital

A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023.

The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.


Eligibility Criteria:
Inclusion Criteria for prospective group (AFTER):

* Patients scheduled for any surgery at one day hospital and who have signed the consent form.
* Pre-anaesthetic consultation by telephone.

Inclusion Criteria for retrospective group (BEFORE):

* patients having undergone any surgery at one day hospital during the period between 01/01/2023 and 31/06/2023.
* Pre-anaesthetic consultation carried out face-to-face.
* Patients eligible for teleconsultation

Exclusion Criteria:

* Participation in another clinical study within the previous month.
* Patient unable to complete the questionnaire.
RELAX: A Mobile Application Suite Targeting Obesity and Stress

This research is being done is to evaluate the feasibility and acceptability of a novel weight loss mobile app that was designed to be less burdensome than traditional weight loss apps.

Obesity and stress are highly comorbid and both increase risk for cardiovascular disease (CVD). Stress is associated with disinhibited eating, junk food consumption and low consumption of produce and whole grains. Both stress and stress-induced eating are not only associated with obesity but also predict worst outcomes in lifestyle interventions. Stress and stress-induced eating should be targeted in interventions to maximize weight loss; however, this makes for a very intensive intervention. Technology could be leveraged to reduce intervention burden.

In this trial investigators propose to compare the feasibility, usability, acceptability, and burden of an traditional weight loss app that includes diet and physical activity self-monitoring features to an app (Slip Buddy) we developed that focuses on self-monitoring of stress eating. With Slip Buddy, the user is just asked to track overeating episodes, indicating when they are triggered by stress. The majority of weight loss apps are burdensome to users by requiring them to self-monitor diet and exercise. They also ignore major barriers to weight loss, such as stress. This work moves the field forward by addressing user burden and an important barrier to weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Have a BMI of 27-45
* Currently use an Android smartphone
* Have cell phone connectivity at home and work
* Uses a smartphone every day

Exclusion Criteria:

* Under the age of 18 and over the age of 65;
* BMI under 27 or over 45;
* Not interested in losing weight;
* Does not currently own a smartphone;
* Smartphone type and/or version not meeting app requirements;
* No phone connectivity at home and work;
* Unable to walk unaided for ¼ mile without stopping;
* Has a condition that precludes dietary changes (i.e. ulcerative colitis, Crohn's disease, active diverticulitis, renal disease);
* On a medication affecting weight;
* Type 1 or 2 diabetes;
* Had gastric bypass surgery;
* Had or plans to have gastric bypass surgery during the study period;
* Pregnant/lactating;
* Has bipolar disorder, substance abuse, bulimia, or severe depression;
* Lost 5% or more body weight in the last 3 months;
* Has not experienced emotional eating over the last week;
* On medication affecting weight;
* Has concerns about being audiotaped;
* Prisoner;
* Unable to provide consent; or
* Non-English speaking
PDIUC Protocol for Placental Accreta

The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.

Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.

Eligibility Criteria:
Inclusion Criteria:

* Women with diagnosis of placenta accreta (US or MRI based diagnosis)
* Women who decline hysterectomy
* Pregnancy at 28 weeks of gestation or beyond
* Women who accept to participate in the study

Exclusion Criteria:

* Emergency Cesarean delivery (women with active bleeding)
* Women with cardiac diseases
* Women with coagulopathy
Longterm Effects of Expectations on Mood

The study tries to identify whether positive expectations, induced with a placebo nasal-spray, have short- and longterm effects on participant's mood.

Healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. They will randomly be assigned to the experimental group (taking the antidepressant which is in fact an active placebo) or the control group (not taking a placebo). Then participants watch a well established film sequence to induce sadness. Sadness is assessed before and after receiving the nasal spray and watching the film sequence. In the seven consecutive days the participant's mood is assessed each day, only the experimental group is taking the placebo each day. Afterwards participants will watch another sad film sequence and sadness will be assessed before and afterwards.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* fluent in German language

Exclusion Criteria:

* mental disorders
* allergic to capsaicin
* allergic to sesame oil
* intake of psychopharmacological drugs
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* students in medicine, pharmacy, or psychology
* completed studies in medicine, pharmacy or psychology