cyrilzakka/clinical-trials huggingface dataset:
Continuous Glucose Monitor Use in Pregnancy

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology.

The study team therefore propose to perform a randomized controlled trial among 180 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Eligibility Criteria:
Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:

* 1) age greater than or equal to 18 years old
* 2) singleton gestation less than or equal to 14 weeks at initial obstetric visit
* 3) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
* 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
* 5) able and willing to provide informed consent

Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:

* 1) known diagnosis of type 1 diabetes or gestational diabetes
* 2) plan to receive prenatal care or delivery outside of UMMHC
* 3) inability to provide informed consent
* 4) multifetal gestation
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]

This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.


Eligibility Criteria:
Inclusion Criteria:

* recent use of inhaled (i.e., snorted), smoked or injected methamphetamine

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant.
* Current or past histories of substance use that are deemed by the study physicians to interfere with study completion.
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation.
* Females not currently using effective birth control.
* Contraindications to methamphetamine, methylphenidate, or duloxetine.
The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps

This study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.

Colorectal polyps are precancerous lesions of the colorectal cancer. Colonoscopy can reduce the risk of colorectal cancer. Painless endoscopy could reduce patient discomfort and improves the acceptance of treatment, especially for the endoscopic treatment of colorectal polyps. Intravenous anesthesia colonoscopy has a strong sedative effect and has obvious inhibitory effects on the respiratory and circulatory systems. It requires the assistance of an anesthesiologist. The lack of anesthesiologists makes it difficult to make an appointment for anesthesia colonoscopy, which is a bottleneck in the diagnosis and treatment of gastrointestinal diseases in China. Therefore, there is an urgent need to find a painless diagnosis and treatment method that is not inferior to anesthesia colonoscopy in comfort to meet the needs of patients. Comparing to anesthesia colonoscopy, sedative and analgesic colonoscopy have similar sedative and analgesic effects and do not require the assistance of an anesthesiologist. However, there is no relevant evaluation on the effectiveness of sedation and analgesia during the endoscopic treatment of colorectal polyps. Our department has used midazolam combined with dezocine to treat 185 patients with colorectal polyps in these years. Retrospective analysis showed that the sedative and analgesic effect is satisfactory. Therefore, it is necessary to make a single-center randomized parallel group controlled non-inferiority study to directly compare the effectiveness of sedation and analgesia versus intravenous anesthesia in endoscopic treatment of colorectal polyps.

Eligibility Criteria:
Inclusion Criteria:

* Colonoscopy diagnosed as a colorectal polyp, the number of polyps is less than 5, and the size of single polyp is less than 2.0 cm
* Age more than 18 years and less than 70 years

Exclusion Criteria:

* Allergy to propofol, dezocine, midazolam or eggs
* ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
* Suspected of gastrointestinal perforation, bleeding or obstruction
* Acute gastrointestinal infection period
* History of abdominal surgery
* Patients during pregnancy or lactation
Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery

This randomized clinical trial studies and compares 3 techniques in performing autologous fat grafting (AFG) in patients undergoing surgery to reshape or rebuild (reconstruct) a part of the body changed by previous surgery and inserted into another part of the body. AFG, also called fat injections or fat transplant, is a procedure in which an individual's own body fat (usually from abdomen or legs) is used during reconstructive surgery. Doctors want to compare 3 techniques for processing the fat tissue collected during surgery and the length of time needed to complete each AFG technique and surgery. Comparing 3 AFG techniques and the time to complete them during surgery may help doctors determine the best technique to perform fat grafting in the future.

PRIMARY OBJECTIVES:

I. Measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three aforementioned adipose tissue processing techniques.

SECONDARY OBJECTIVES:

I. To measure total fat grafting time: time from initiation of fat harvesting to the end of fat injection.

II. To measure volume of fat processed: volume of fat obtained after fat processing.

III. To measure total operation room (OR) time: time from patient entry into the OR (or when the patient barcode is read on entering the OR) to the time at which the patient leaves the OR.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (REVOLVE TM): Patients undergo AFG reconstructive surgery comprising washing and low velocity spinning using a commercially available system that washes the lipoaspirate with lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal force and suction.

ARM II (CYTORI PUREGRAT TM): Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated Ringer's solution (RL) and the non-fat material is filtered through mesh.

ARM III (COLEMAN TECHNIQUE): Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 revolutions per minute (rpm) for 3 minutes with the resulting oil and aqueous layers discarded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with available harvest sites for fat grafting
* Patients with body mass index (BMI) \> 20
* Estimated harvested fat volume \>= 100 cc
* Patients are willing and able to give consent

Exclusion Criteria:

* Patients with active cancer, including primary cancer, recurrent cancer, or locally or distant metastasis
* Patients who are unable to provide consent
* Patients who are suspected or known to be pregnant
Specular Microscopy Study

The corneal endothelium plays an important role in regulating stromal hydration and maintaining the transparency of the cornea. For evaluating the cornea, the most important parameters are corneal endothelial morphology and central corneal thickness. The specular microscope does this. The image in specular microscope is obtained by the specular reflex at a regular, smooth-surfaced interface of two refractive indices, with the angle of the light passing into the cornea equal to the angle of reflection to the observer. To obtain a clear image, the endothelial apical surface must be smooth and uniform and the cornea must be transparent. Nowadays different types of specular microscope exist.

The investigators propose to compare the endothelial cells with two specular microscopes: the Konan SP4000, which is the current model and used for standard of care, to the Nidek CEM-350, which is a newly marketed device.

The investigators would like to evaluate the patients in the clinic and have assessments completed with both specular microscopes.

Nidek will be loaning the specular microscope, NIDEK CEM-530, for the study.

Subjects that provide informed consent will be clinically evaluated (visual acuity, refraction, slit-lamp biomicroscopy, tonometry) by a corneal specialist. After endothelium evaluation with use of slit-lamp biomicroscopy a grade of severity will be given. The grades will be based on the density and confluence of guttae and presence of clinical edema.

Two microscopes, non-contact specular microscope (KONAN SP4000) and paracentral non-contact specular microscope (NIDEK CEM-350), will be used for the exam.

For each patient both eyes will be examined by the two non-contact specular microscopes.

Three pictures of the central cornea will be captured from the standard specular microscope.

The paracentral specular microscope can capture image of one central point, eight paracentral points with 5° visual angle and six peripheral points with 27° visual angle. It will capture 16 images and automatically will classify based on quality and the ability to be analyzed. The optimal image for analysis will be indicated with orange highlight. Once the image is selected, a new manual or automatic software will be used to count the endothelial cells, complete analysis will be automatically performed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older;
* Patients with primary corneal endotheliopathies (posterior polymorphous dystrophy, congenital hereditary endothelial dystrophy, Fuchs' dystrophy, iridocorneal endothelial syndrome;
* Healthy patients without corneal endotheliopathies.

Exclusion Criteria:

* Patients with history of corneal and/or intraocular surgery;
* Patients with existing corneal and/or anterior segment disease, except for the inclusion criteria;
* Intraocular pressure ≥21mmHg;
* Contact lens wearer;
* History of ocular trauma;
* Patients with diabetes mellitus.
Cranoc Lipid Study in Renal Transplantation

Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (\<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (\<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Eligibility Criteria:
Inclusion Criteria:

* patients (18 - 65, inclusive)
* cadaver and living kidney transplantation (1. Ntx, 2. Ntx)
* LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx)
* Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl
* Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil
* patients indulgence

Exclusion Criteria:

* statin before the study

  * LDL-Cholesterol \>130mg/dl before transplantation
  * Instabil Angina, Myocard infarct \<6 months before transplantation
  * symptomatic Hypothyreosis
  * child bearing, lactating
  * elavated liver encymes (\> 2x elavated: AST, ALT, bilirubine, PCK)
  * Fibrates are not allowed
  * multiorgantransplantation
Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study

The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
* Need for spherical IOL correction between +0.00 and +32.00 D
* Pupil dilation of ≥ 7.0 mm
* Age 45 to 95

Exclusion Criteria:

* Corneal abnormality (Corneal scaring)
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
* Pregnancy
* Lactation
Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa

Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that 200 million people world wide. Infection with Schistosoma haematobium may cause Female Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract, especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of young women in endemic poor tropical countries, deserving further attention. A cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were unchanged two years after praziquantel treatment in adult women whereas in those who had been treated with praziquantel in childhood the prevalence of genital lesions was significantly lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to those without. The proposed project aims at achieving a better understanding of how annual distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This information can be of use in current schistosomiasis control programs in the near term resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and genital lesions will lead to improved reproductive health among in women living in schistosomiasis endemic areas.

Project Goal: Contribute to a reduction of the global burden of female genital schistosomiasis (FGS) through improved knowledge about the prevention of gynecological lesions and through improved diagnosis of FGS.

Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures

Eligibility Criteria:
Inclusion Criteria:

* Females in Schistosoma haematobium endemic areas

Exclusion Criteria:

* Boys
* Pregnancy
* Allergic to praziquantel
* Severe disease
Effect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery

The purpose of this study is to examine if morphine administered by bolus before initiating Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as demonstrated by decreased post - operative morphine consumption in children undergoing scoliosis surgery.

At our institution, a study has recently demonstrated that intraoperative infusion of remifentanil is associated with development of clinically relevant acute opioid tolerance in adolescents undergoing scoliosis surgery. This results in increased morphine consumption which in turn is associated with increased incidence of side effects such as respiratory depression, nausea and vomiting, pruritus, ileus and urinary retention. All of these side effects can result in increased consumption of rescue medications with the additional potential for increased duration of patient stay. Any measures that can be introduced to decrease the development of acute opioid tolerance in this patient population would have significant impact on patient morbidity, patient comfort and possibly duration of patient stay.

Eligibility Criteria:
Inclusion Criteria:

* Unpremedicated
* ASA physical status 1 or 2
* Aged 11 - 18
* Scheduled to undergo posterior instrumentation for correction of idiopathic scoliosis

Exclusion Criteria:

* Chronic opioid use within three months prior to surgery
* Inability to self-administer morphine using a patient-controlled analgesia (PCA) device
* Elective postoperative ventilation
* Obesity (\> 130% ideal body weight)
* Known sensitivity to morphine, remifentanil or any other agent within the standardized protocol
* Failure to obtain written consent or assent
Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment

To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.

Taking MCI as a potential gateway, early intervention to delay the occurrence of dementia has become an important consensus in this field. Exercise is an important means to improve cognitive function in MCI, but the effect of exercise is influenced by the dosage. Tai Chi Chuan, is a moderate intensity aerobic exercise. Previous studies by our team and others had confirmed its effect on cognitive function in MCI. However, the dose parameters of Tai Chi Chuan exercise varied in these studies, and the dose-response relationship is still unclear. The purpose of this study is to explore the dose-response relationship between different volume of Tai Chi Chuan exercise and cognitive function（global cognition and cognition of subdomains）in elderly MCI patients.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of mild cognitive impairment, not demented;
2. Age ≥ 60 years old;
3. Informed consent and voluntary participation.

Exclusion Criteria:

1. Geriatric Depression Scale score ≥ 9 points
2. Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
3. Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;
4. Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
5. Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
6. Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
7. Participating in other experiments that influence this study;
8. Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time.
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+

Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Clinically healthy volunteers
* Being capable of voluntarily grant a signed informed consent.
* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
* Being between 18 and 45 years old.
* Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study.
* Having a best corrected visual acuity equal or better than 20/30 in both eyes.
* Showing normal vital signs.
* Having an intraocular pressure between 10 and 21 mmHg.

Exclusion Criteria:

* Using any kind of ophthalmic topical product.
* Using drugs or herbal products, through any administration route.
* For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study.
* Having participated in clinical trials 90 days prior to inclusion in this study.
* Having participated previously in this study.
* Using contact lenses and not being able to suspend such use during the period of the study.
* Being unable to follow the lifestyle modification considerations required for the study.
* Having started the use of hormonal contraceptives of IUD within 30 days previous of inclusion in this study.
* Suffering any chronic degenerative diseases.
* Suffering active inflammatory of infectious disease when entering this study.
* Suffering unresolved lesions or traumas when entering this study.
* Having a previous history of any kind of ocular surgery.
* Having a previous history of any surgical procedure, non ophthalmological, within the last 3 months.