cyrilzakka/clinical-trials huggingface dataset:
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. HbA1c ≤ 12%.
5. Hypoglycemia awareness or unawareness assessed by a questionnaire.
6. Documented NH during the run-in period.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Pregnancy.
4. Severe hypoglycemic episode within two weeks of screening.
5. Current use of glucocorticoid medication (except low stable dose).
6. Known or suspected allergy to the trial products or snack contents.
7. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
8. Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
9. Failure to comply with team's recommendations (e.g. not willing to eat snacks, not willing to change pump parameters, etc).
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence

The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.


Eligibility Criteria:
Inclusion Criteria:

* pure urodynamic SUI
* sexual active before and 2 months after the surgery
* married or single
* aged over 20
* have cured after TOT operation

Exclusion Criteria:

* preoperative or postoperative detrusor disfunction
* previous history of malignancy
* prior vaginal surgery
* a partner with sexual incapabilities
* a concomitant gynecologic disorder
* patients with pelvic organ prolapse over stage II
* pelvic radiotherapy and a history of psychological diseases
* participants who had no sexual activity with in the past two months
Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis

This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis.

The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product.

The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent has been obtained.
* Age between 18 years to 65 years inclusive.
* Gender: male and female subjects.
* Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment.
* Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist.

Exclusion Criteria:

* Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment.
* Subjects with fungal nail infection on more than two toenails on their target foot.
* Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.
Foot Positions Affect Knee and Ankle Proprioception, Balance, Vertical Jump, and Muscle Activity in Individuals With Flexible and Rigid Flatfoot and Chronic Ankle Instability

To investigate the effect of various foot positions affect knee and ankle proprioception, balance, vertical jump, and muscle activity in individuals with flexible and rigid flatfoot and chronic ankle instability


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were the presence of FF and chronic ankle instability in the dominant foot. Flexible and rigid flat feet were initially diagnosed by an orthopedist using a weight-bearing position with a standardized radiograph technique. The digital X-ray detector (film) and the X-ray tube (source) are 35-40 inches apart in lateral views of the foot. Then, Jack's test was performed to differentiate between the flexible and rigid FF. Jack's test is a valid test in assessing FF 10. Finally, people with flexible a second degree FF (Meary's angle between 15° to 30°) 3 were included in this study. The degree of flatfoot was determined by measuring the talus-first metatarsal angle on a lateral weight-bearing radiograph. This angle lies between a line drawn from the centers of the longitudinal axes of the talus and the first metatarsal. An angle that is greater than 4° convex downward is considered pes planus with an angle of 15° - 30° considered moderate, and greater than 30° severe 8. Chronic ankle instability was defined as the subject had a minimum of 2 acute ankle sprains, in the last 6 months, associated with pain, swelling, and a record of various ankle giving way. The determination of the dominant foot followed Vauhnik. \& ark, modified version which stated that the dominant foot should be used minimally in 2 of the 3 subsequent activities: (1) Using the leg to step over a spider toy, (2) Drawing a diamond figure on the ground and (3) Kicking a ball.

Exclusion Criteria:

* The exclusion criteria were the existence of limited hallux dorsiflexion because Jack's test is valid only if hallux dorsiflexion is available during relaxed standing. Also, the participants were excluded if they had previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies; has any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance.
A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG

The purpose of this research study is to test new ways to improve the usefulness of the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER) by collecting data from PET scans using one of three different imaging agents: 18F-PSMA; 18F-FES; or, 68Ga DOTATATE. These imaging agents are approved by the FDA to be used for patients diagnosed with prostate cancer (18F-PSMA), neuroendocrine tumor (68Ga DOTATATE), or breast cancer (18F-FES).


Eligibility Criteria:
18F-PSMA (n=3) and 68Ga-PSMA (n=3)

Inclusion criteria:

* Persons \>18 yo with suspected prostate cancer metastasis
* Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date.

  68Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3)

Inclusion Criteria:

* Persons \> 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)
* Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.

Exclusion Criteria:

• Recent administration of long-acting somatostatin analogs

Exclusion Criteria for all participants:

* Adults unable to consent
* Pregnant/lactating persons
* Prisoners
* Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner
* Uncontrolled claustrophobia
* Any significant medical condition that in the opinion of the investigator would prevent the participant from participating and/or adhering to study related procedures or interfere with participant safety
Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates

The purpose of this study is to determine if sibutramine will decrease post-cessation weight gain and cigarette smoking in overweight and obese smokers who quit smoking.

BACKGROUND:

Cigarette smoking poses a serious but preventable health risk. Behavioral smoking cessation programs have been shown to help individuals quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers. Recently, sibutramine, a new serotonin and norepinephrine reuptake inhibitor drug, has received FDA approval to help people lose weight. Since sibutramine affects neurotransmitters that are important in regulating body weight, it is reasonable to hypothesize that it may decrease post-cessation weight gain in overweight and obese smokers who quit smoking. To date, there have been no studies that compare sibutramine to a placebo, as a way to reduce post-cessation weight gain among overweight and obese smokers who take part in a behavioral smoking cessation program. Therefore, whether sibutramine is effective at reducing post-cessation weight gain in these smokers is unknown. Further, given the neuropharmacologic effects of sibutramine, it is reasonable to speculate that this medication could also be effective in helping individuals quit smoking both initially and in the long term. It is possible that the use of sibutramine, as compared to placebo, may result in a decrease in post-cessation weight gain in overweight and obese individuals who quit smoking. The use of sibutramine may also result in an increase in smoking cessation rates.

DESIGN NARRATIVE:

This study tests the hypothesis that the use of sibutramine, as compared to placebo, will result in a decrease in post-cessation weight gain in overweight and obese individuals who quit smoking, and result in an increase in smoking cessation rates. Participants will be randomly assigned to one of the following two groups: 1) sibutramine plus a behavioral smoking cessation program; or 2) placebo sibutramine plus a behavioral smoking cessation program. Assessments will include post-cessation weight change and smoking cessation rates measured during the study and 9 months following the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* In good general health
* Body mass index greater than or equal to 25
* Currently smoke cigarettes
Enhancing PrEP in Community Settings (EPIC)

To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).


Eligibility Criteria:
Inclusion Criteria:

* HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
* Interested in initiating PrEP
* Eligible to initiate PrEP

  * Creatinine clearance \> 60 ml/min as estimated by the Cockcroft-Gault equation within 6 weeks of enrollment
  * Hepatitis B surface antigen (HBsAg) negative within 6 weeks Enrollment
  * No other medical contraindications to PrEP
* Age 18 years - 29 years
* Willing and able to provide written informed consent
* Report having had anal sex with a man in the previous 6 months
* Meet any of the following risk criteria for the prior 6 months:

  * Any condomless anal sex
  * Three or more anal sex partners
  * Self-reported new STI
  * Known HIV-infected sex partner
* Have regular access to a computer and/or a smart phone to access the internet and/or apps
* Have the ability to send and receive text messages
* Able to read and speak in English

Exclusion Criteria:

* PrEP use within the past year (PrEP naïve participants will be prioritized).
* Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
* Prior or current participation in the active arm of an HIV vaccine trial
* At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
* Signs or symptoms of acute HIV infection (as described in the SSP Manual)
* History of pathological bone fracture not related to trauma.
NOTES-Assisted Laparoscopic Cholecystectomy Surgery

This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Eligibility Criteria:
Inclusion Criteria:

* Ability to undergo general anesthesia
* Age \>= 18 yrs. of age and \<= 85 yrs. of age
* Ability to give informed consent

Exclusion Criteria:

* Acute cholecystitis
* BMI \>= 40
* Contraindicated for EGD
* Presence of common duct stones
* Presence of esophageal stricture
* Altered gastric anatomy
Visfatin Levels Before and After Periodontal Treatment

The purpose of this study was to evaluate visfatin levels in different stages of periodontal diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin levels in Gingival Crevicular Fluid (GCF) and Serum.

Total of 45 patients were divided into three groups based on their clinical and radiographical examination. Group 1 chronic periodontitis (n: 15), group 2 plaque induced gingivitis (n: 15) and group 3 Periodontal health (n: 15). GCF and serum samples were collected before treatment and 1, 3, 6 months after treatment and were assayed using enzyme linked immunosorbent assay kit.

Eligibility Criteria:
Group 1 Inclusion Criteria:

* GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
* Systematically healthy patients

Group 2 Inclusion Criteria:

* No alveolar bone and attachment loss
* Inflammation signs such as redness, edema and increased BOP levels,
* GI≥2, PPD≤3mm, CAL≤3mm.
* Systematically healthy patients

Group 3 Inclusion Criteria:

* No bone and attachment loss,
* GI=0, PPD≤3mm, CAL≤3mm
* Systematically healthy patients

Exclusion Criteria for all groups:

* Aggressive Periodontitis,
* Oral pathologies,
* Patients with any other systemic diseases,
* Pregnant women and those in the lactation period,
* Patients with smoking habit and taking medication
* Patients received periodontal therapy in last 6 months
Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.

The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.

Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.

The study was performed out of pollen season.


Eligibility Criteria:
Inclusion Criteria:

* monoallergy to grass
* symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
* asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
* age 18 or older

Exclusion Criteria:

* pregnancy or lactation
* fertile women, not sterilised or using sufficient anticonception
* Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
* Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results
Investigation of the Psychometric Properties of the Squares Test in Measuring Hand Function in Parkinson's Disease

The first aim of the present study was to investigate reliability, validity and responsiveness to the minimal clinically important difference, which is defined as the smallest change in score corresponding to clinically meaningful change realized by patient, of the squares test in people with PD.

The second aim of the study is to determine the relationship between hand function and both trunk control and balance in PD population.

At baseline, the ST, Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn and Yahr (H\&Y) Scale, Berg Balance Scale (BBS) and Trunk Impairment Scale (TIS) was applied to the PS group when the patients were "on" period. The ST was repeated after seven days from the first application when PD group were "on" period to evaluate its reliability.

Eligibility Criteria:
Inclusion Criteria:

* at least 40 years of age
* neurologist-diagnosed idiopathic PD (using UK Brain Bank criteria)
* Hoehn \& Yahr (H\&Y) stages 1 to 4
* Mini-Mental State Examination ≥ 22/30 (literate and with 5 or more years of education) and ≥18/30 (illiterate and with less than 5 years of education)
* living in the community

Exclusion Criteria:

* individuals with other major diseases (e.g., cancer, stroke, epilepsy, dementia, and severe rheumatoid arthritis)
* preexisting disabilities
* visual impairments
* diagnosis of atypical Parkinsonism
* H\&Y stage 5
* previous surgical management of PD
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 18 years and above
* documented clinical diagnosis of overactive bladder with urinary frequency \>= 8 times / 24 hours and number of urgency episodes \> 1 episode / 24 hours.

Exclusion Criteria:

* Neurological diseases known to affect bladder function.
* Urinary tract infection.
Comparing Surgical and Economical Parameters of Total Knee Replacement.

Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.

Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks

Exclusion Criteria:

* Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)