cyrilzakka/clinical-trials huggingface dataset:
Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma

In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography. To analyze the high risk factors and the possible pathogenesis of the disease and discuss the long-term effect of different treatment methods.

Outcome Measures:

Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria: (1) history of operation, (2) diagnosis of MG, and (3) eyes with clear optical media.

Exclusion Criteria:(1)hypertension or diabetes and (2) diagnosis of ocular fundus diseases.
Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.

Patients with locally advanced rectal cancer can benefit from neoadjuvant chemoradiotherapy, and 20%-30% of patients receiving such therapy can attain a pathologic complete response, defined as the eradication of cancer cells. For those who reach pathologic complete response, a watch-and-wait strategy is supposed to be the best choice. However, low concordance (36%) was found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. There is a compelling need to improve the consistency.

Probed-based confocal laser endoscopy (pCLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces. By using intravenous fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical biopsy in real time. It provides a promising targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.

The investigators perform this study to investigate whether pCLE-targeted optical biopsy could improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy. In this study, rectal cancer patients after neoadjuvant chemoradiotherapy will be successively arranged to accept traditional endoscopic biopsy and pCLE-based targeted optical biopsy. The consistency rate will be calculated according to the postoperative pathological results.

Eligibility Criteria:
Inclusion Criteria:

1. Age from over 18 to under 80 years
2. American Society of Anesthesiology(ASA) score class I,II,or III
3. Locally advanced rectal cancer
4. Patient has completed standard neoadjuvant therapy
5. Expected surgical resection
6. Written informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Acute renal insufficiency or stage II to IV chronic renal insufficiency
3. Patients with allergic constitution
A Study in Japanese Participants With Moderate-to-Severe Psoriasis

This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Candidates for phototherapy and/or systemic therapy
* Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis

Exclusion Criteria:

* History of drug-induced psoriasis
* Concurrent or recent use of any biologic agent
* Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
* Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis
The Efficacy of Topical Serum X for Skin Brightening

This study is conducted to evaluate the effectiveness of topical serum X containing arbutin and glutathione for skin brightening. The study duration is 12 weeks and the skin assessment will be carried out at baseline, week 4, 8 and week 12.The main questions this study aims to answer are:

1. The skin brightening effect of the product on facial skin.
2. To observe any adverse effect occurrence with the usage of the product.


Eligibility Criteria:
Inclusion Criteria:

* Malaysia citizen
* Male and female (age 18-30 years old)

Exclusion Criteria:

* Participant with severe acne skin condition
* Participant who is taking isotretinoin, immunocompromised patients and received laser and light treatment within the last three months
* Participant who undergo whitening or cosmetic treatments such as botox and dermal fillers within the previous six month
* Participant with a history of facial surgery such as facelift or nose reshaping
* Participant with history of allergies to any ingredient in the study product
* Participant who is pregnant or plan to get pregnant
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits.

Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18-70 years (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c level between 6.5% and 9.0 % (both inclusive)
* Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
* Body weight \<= 125.0 kg at the screening visit
* Insulin-treated subjects. Total insulin dose of \<= 1.2 (I)U/kg/day

Exclusion Criteria:

* Type 1 diabetes mellitus
* Known or suspected hypersensitivity to IMP(s) or related products
* Previous participation in this trial. Participation is defined as randomised.
* Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
* Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
* Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
* Women of child bearing potential not willing to use contraceptive methods.
"We Walk": Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75

The overall goal is to determine whether any energy expenditure compensation in response to 16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose intervention in older women, and to begin to investigate underlying physiological mechanisms that influence energy expenditure changes in older women.

The overall goal is to determine whether any energy expenditure compensation in response to 16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose intervention in older women, and to begin to investigate underlying physiological mechanisms that influence energy expenditure changes in older women. Changes in all components of energy expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4 days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).

Specific Aim 1: To determine whether differential changes in total daily energy expenditure and its components occur in older women in response to two exercise programs of different doses. State-of-the-art methods will be used (total daily energy expenditure by doubly labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System; resting metabolic rate and thermic effect of food via indirect calorimetry).

Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase in total daily energy expenditure in response to the higher-dose, compared to the lower-dose, exercise program, despite greater increases in resting metabolic rate and thermic effect of food.

Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic exercise programs of two different doses.

We hypothesize that in response to the higher-dose exercise program, women will exhibit larger decreases in plasma leptin and serum free T3 concentrations, compared to the lower-dose exercise program.

We will also determine whether women exhibit greater improvements in plasma lipids, insulin sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic fitness in response to the higher-dose, compared to the lower-dose, exercise program.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30
* Sedentary (exercising less than 20 minutes no more than 3 times per week)
* Non-smoking
* Weight stable (+/- 5%) over past 3 months

Exclusion Criteria:

* Self-reported cardiovascular disease
* Additional self-reported medical conditions
* Medications known to affect metabolism
* Excess caffeine use
* Self-reported contradictions according to ACSM
* Unwillingness to provide informed consent
Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System

Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.

The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer

The project will be divided into 2 phases:

Objectives of the first phase:

* Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
* Fill in as completely as possible their colonoscopic history in the past 5 years,
* Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).

Objective of the second phase:

Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* residing in Indre et Loire (France)
* with increased risk for colorectal cancer
* who did not perform a colonoscopy in the past 58 months

Exclusion Criteria:

- none
Rib Fixation for Clinically Severe Rib Fractures From Trauma

This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.

This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.

Eligibility Criteria:
Inclusion Criteria:

* Flail chest, defined as 3 or more consecutive ribs fractured in more than one place
* Pain and disability of an FPS (Functional Pain Scale) rating of 3 or higher
* Deformity and Defect
* Non-Union
* Thoracotomy for other indications
* 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter
* Failure to wean from ventilator

Exclusion Criteria:

* Active bacteremia
* Active shock
* Severe Traumatic Brain Injury with GCS \< 8
* Age 17 years or less or age greater than 90 years old
* Chronic pulmonary disease requiring home oxygenation
* Acute Respiratory Distress Syndrome
* Penetrating chest trauma
* Chronic opioid dependence
* Fractures less than 3cm from vertebral spine
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign a written informed consent form.
2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
6. Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
7. Suitable for monotherapy with taxane-based agents.
8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
9. Adequate organ function.

Exclusion Criteria:

1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
2. History of other malignancies within the past 5 years.
3. Active autoimmune disease requiring systemic treatment within the past 2 years.
4. Pregnant or breastfeeding women.
5. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
7. Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
8. Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.
Diet, Food, Exercise and Nutrition During Social Distancing

Our long-term goal is to contribute to the development of evidence-based nutritional and physical activity recommendations for the prevention and management of overweight and obesity and related chronic diseases.

The overall objective for this study is to determine if a 20-week educational program, project DFEND, related to behavior change and health will improve nutrition and physical activity outcomes as well as indicators of wellbeing.

Our central hypothesis is that regular attendance of weekly lectures, weekly meetings with personalized coaches, and weekly health challenges via virtual platforms (e.g. Zoom, Facebook, YouTube) will improve health outcomes related to nutrition and physical activity.

Our rationale for these studies is that the results of this research will enhance the potential to develop evidence-based nutritional and physical activity behavioral recommendations to treat and/or prevent development of overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* Resides in Arkansas
* All ethnicities
* Female and male

Exclusion Criteria:

* None
Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.

In this study, investigators will examine the treatment effect of transcutaneous electrical nerve stimulation at auricular area with vagus nerve distribution on high-functioning individuals with autism. Specifically, investigators will choose two ear acupoints: heart and shenmen. Participants will be randomized to either 1 Hz or 20 Hz tVNS group (up to 5 times per week) for three weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Autism diagnosed based on DSM-V classification criteria
2. 18-60 year old high functioning adult autism patients (e.g. Asperger's, IQ equal or greater than 80)
3. Subjects who do not show aggressive behaviors based on neuro/psychiatric evaluations as determined by a licensed study physician.

Exclusion Criteria:

1. A history of chronic serious infection, any current infection, any type of cancer or autoimmune disease or other severe diseases;
2. Subjects taking any medications that confound the study results
Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes:

1. Arrestment of caries lesion and the emergence of a new one
2. Time required for the treatment
3. Adverse events
4. Children's anxiety

The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. However, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp.

The purpose of this research was to evaluate three minimally invasive therapies via the assessment of:

1. Duration of treatment
2. (feeling of pain) and the need for anesthetic
3. Incidents with negative outcomes that have been officially documented
4. Filling material adhesiveness fellow up

The null hypothesis was that there was no difference among Silver Diamine Fluoride, Brix3000 Papain based Chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect

Randomized control clinical trial will be allocated into 3 groups: S group (treatment with SDF), B group (treatment with Brix3000 Papain based gel), and C group as control (treatment by rotary handpiece Smart bur)

Setting:

Sample collection: the samples are to be collected at The College of Dentistry, Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions.

Eligibility Criteria:
Inclusion Criteria:

* Each child should have primary molars with open carious lesions, either on the occlusal surface or Proximal one with the absence of a neighboring tooth.
* These lesions should affect the dentin but not expose the pulp.
* The depth of the cavities should measure between 40-99 using a DIAGNOdent caries detection instrument for standardization

Exclusion Criteria:

* Children were excluded if parents were unwilling to be assigned to any of the approaches
* Children that had any abnormal medical condition or silver or papain allergy
* Chose molars with clinical or radiographic signals of pulp involvement
Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 80 years of age.
* Subject is able to read and communicate in English.

Exclusion Criteria:

* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.