cyrilzakka/clinical-trials huggingface dataset:
Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.

To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents
* Enrolled in Type 2 BASICS program
* A1c between 7.0 and 11%, inclusive
* Able to understand spoken English

Exclusion Criteria:

* Insulin therapy
* Unable/unwilling to perform SMBG
* Participating in another research study
* Currently performing SMBG \>3 times/week
Monitoring of Patients With Chronic Respiratory Failure Treated With Non-invasive Home Ventilation: Contribution of New Monitoring Tools

Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Patients with chronic hypercapnic respiratory failure with a validated indication of long-term NIV
* Follow-up at the CHRU of Nancy at "Unité de Médecine Ambulatoire" (UMA) department between 11/01/2020 and 05/30/2021

Exclusion Criteria:

* Data not usable / missing
* Tracheal ventilation
* Patients' opposition to the use of their data for the purposes of this research
Treatment for Problematic Sexual Behavior of Preteen Children

Relatively little is known about the treatment of problematic sexual behavior (PSB) displayed by preteen children. Randomized controlled trials (RCTs) examining potential treatments are rare and the available results to date are generally underwhelming. A new protocol, termed Phase-Based Treatment (PBT) for Preteen PSB, has shown positive results in an early stage pilot and during community implementation efforts. This trial will be the first RCT of PBT and aim to determine whether PBT might outperform a treatment-as-usual condition.

In 2015, a new intervention, PBT, was designed that relied on the current etiological research on PSB and the state-of-the-science regarding behavior change among children. A small pilot of the protocol yielded positive results. Although the pilot included only 10 participants, statistically significant pre-post changes were observed for general PSB, intrusive forms of sexual behavior, and social modeling of sexuality in the home. Training in PBT was provided to a limited number of practicing clinicians in the state of Texas and program evaluation metrics were included. Pre-post change for general PSB was significant, as were changes for intrusive forms of sexual behavior.

Despite positive outcomes in non-controlled research, it is unclear whether PBT achieves effects larger than might be seen with more general, non-specific forms of intervention. To demonstrate such an effect requires the completion of a randomized controlled trial (RCT). However, a number of feasibility issues must be answered before conducting a large scale, definitive RCT. As such, the current RCT is conceived as a feasibility project to determine the likelihood of successfully recruiting and retaining a sufficient number of participants, to derive comparative effect size estimates between PBT and SAU to inform later power analyses, and to ascertain participant satisfaction with PBT.

Eligibility Criteria:
Inclusion Criteria:

* Child between ages 4 and 12 years
* Caregiver reports a raw score on the CSBI greater than 4.
* A primary caregiver is willing to participate in treatment.
* Child earns a scaled score above 69 on the Kaufman Brief Intelligence Test (KBIT-2)
* Child proficient in spoken English
* Caregiver proficient in written and spoken English.

Exclusion Criteria:

* Child is less than 4 years of age or older than 12 years of age.
* Caregiver reports a score on the CSBI lower than 4
* A primary caregiver is unwilling to participate in treatment.
* Child scored lower than 70 on the KBIT-2.
* The primary caregiver is suspected of perpetrating child sexual abuse.
* Child not proficient in spoken English.
* Caregiver not proficient in both written and spoken English.
Post COVID-19 Biorepository

Establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit.

Living patients or their healthcare surrogates will provide informed consent prior to participation in the biorepository. Surrogate decision makers who cannot consent in person will be consented in accordance to the KUMC remote consent guidelines. Biospecimens to be collected include serum, plasma and whole blood. Blood samples will be collected during face-to-face encounters in the Post-COVID-19 clinic within the TUKHS pulmonary clinic or will be coordinated with other outpatient follow-up appointments (including separate procedure/lab-related visits) or separate study visits for ongoing, indepent studies. Samples will be collected at time of consent as well as at potential follow-up visits at approximately 3, 6, 12, and 12 months from enrollment. Blood samples will be processed, aliquoted, and stored at -80°C. A portion of the blood samples will be kept for DNA and RNA isolation, and a portion of plasma collected might be utilized to isolate peripheral blood mononuclear cells. Biospecimens will be labeled with the patient's study ID number, date of sample processing, and specimen type. Biospecimens will be stored through the duration of the study. If the patient chooses to withdraw consent, his or her samples in the biorepository will be destroyed. Biospecimens that have been previously used or disseminated will continue to be utilized. Future research may include whole genome testing, and these results will not be shared with the patient or their standard of care physician.

Patient data and historical radiographic imaging from after the date of consent will be collected using TUKHS medical records and stored in RedCap. The data to be collected is outlined in the data collection sheets.

Eligibility Criteria:
Inclusion Criteria:

1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
2. The participant has a previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up.
3. Patient is ≥ 18 years of age or older.

Exclusion Criteria:

1. Participant declines to participate.
2. Participant or healthcare surrogate is unable to provide informed consent.
Bioinductive Patch for Full-Thickness Rotator Cuff Tears

The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.

A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Eligibility Criteria:
Inclusion Criteria:

* Indicated and scheduled for arthroscopic rotator cuff repair.
* Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
* Chronic, degenerative rotator cuff tears.
* Ability to read and understand English.
* Age ≥18 years
* Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy

Exclusion Criteria:

* Patient scheduled for open or mini-open rotator cuff repair
* Prior surgery of affected shoulder (except diagnostic arthroscopy)
* Partial-thickness rotator cuff tears
* Small (\<1 cm) rotator cuff tears
* Rotator cuff tears involving the subscapularis tendon
* Acute and traumatic rotator cuff tears
* Active infection
* Cancer
* Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

Project ReLearn is testing the efficacy and cost-effectiveness of an Artificial Intelligence system for optimizing weight loss coaching. Participants are randomized to a 1-year weekly gold standard behavioral weight loss remote (video) group treatment or the AI-optimized treatment, which is made up of a combination of remote group treatment, short video call and automated message. In the AI-optimized condition, the system monitors outcomes (via wireless scale, mobile phone app, and wristworn tracker) and, each week, assigns each participant the treatments they have responding to the best, within certain time constraints.


Eligibility Criteria:
Inclusion Criteria:

* Individuals must be of overweight or obese BMI (27-50 kg/m)
* Individuals must be adults (aged 18-70)
* Able and willing to engage in the remote program
* Able to engage in physical activity (defined as walking two city blocks without stopping)
* Individuals must also provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
* Access and willingness to use an Apple or Android smartphone
* Satisfactory completion of all enrollment procedures

Exclusion Criteria:

* Medical condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
* Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months
* Recently began or changed the dosage of medication that can cause significant change in weight
* History of bariatric surgery
* Weight loss of \> 5% in the previous 3 months
Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk

1. The aim of this large scale study to survey the prevalence of nutritional risk and malnutrition in China,Europe and USA.
2. The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness

Already get the approval by Ethics Committee of Peking Union medical college and Johns Hopkins Hospital.

Although it was often to hear that malnutrition ratio in Aisa hospitalized patient was 40%-70% , there was no evidence to elaborate the prevalence of nutritional risk and malnutrition on hospitalized patients of Asia. Also in USA no data for nutritional risk. In 2002, scientists group headed by Kondrup from : European Society for Parenteral and Enteral Nutrition demonstrated that randomized controlled clinical trials showed patients may get benefit from nutrition support when they with nutrition risk. Based on these evidences, a simpler method was established by European Society for Parenteral and Enteral Nutrition in year 2002 in Munich \& it was demonstrated useful to evaluate the appropriate use of nutrition support at present time. This method was named as Nutrition Risk Screening (NRS).

We propose to survey the prevalence of malnutrition \& nutrition risk in large cities' large/middle size hospitalized patients in China, Europe and USA use NRS tool. As well, we also aim to figure out the current nutrition support status in current large/middle size hospitals through this survey.

we also propose to evaluate the cost-effectiveness of parenteral nutrition, enteral nutrition and non-nutritional support, and to examine the clinical outcomes of nutritional support in certain patients at nutritional risk identified by NRS-2002.

For international cooperation,our partners are Professor Kondrup of Europe and Professor Nolan from Johns Hopkins Hospital,there are students from a cooperative project with Johns Hopkins Hospital for Doctor of Philosophy students 2005-2011.

In plan this protocol might be completed around 2016 also.

Eligibility Criteria:
Inclusion Criteria:

* patients be in hospital overnight
* diagnoses according to the protocol of cohort study for cost effectiveness

Exclusion Criteria:

* patients admitting from emergency department
* patients who undergone operation before second morning of hospitalization
* patients who dose not give Informed Consents
REINFORCEMENT ANASTOMOSIS WITH Modified Cyanacrylate IN Patients Undergoing to Oncologic Colorectal Surgery With Colorectal Anastomosis

In colorectal surgery about 30% of postoperative mortality is attributed to anastomotic leak, whit an incidence range between 1.8% and 15.9%. Preventing the anastomotic leak can therefore bring benefits to the patient and the health system. To date we have technologically advanced suturizers and the correct realization (well-vascularized margins, not in tension, etc.) remains crucial to prevent anastomotic dehiscence. Experimental results demonstrate that modified cyanacrylate is a suitable potential "reinforcement" on intestinal anastomoses (manual or linear intra-corporeal). Applied after mechanical anastomosis, it polymerizes in a short time, closing the spaces of the suture line between one point and the other, expressing an adhesive, hemostatic and sealing action on the tissues, also creating an effective antiseptic barrier towards of the most common infectious or pathogenic agents.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* patients undergoing to oncologic colorectal surgery with colorectal anastomosis

Exclusion Criteria:

* refuse informed consent
* patients undergoing to oncologic colorectal surgery without colorectal anastomosis
Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection

Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection. Yielding high levels of corticosteroid in the retinal and choroidal layers which was detectable for more than 3 months with limited exposure in the anterior segment. Triamcinolone acetonide is a synthetic corticosteroid formulated as an injectable suspension and has been evaluated in a number of trials to be 7.5 fold more potent anti-inflammatory than cortisone. Triamcinolone acetonide enhance tight junctions between endothelial cells thus reducing vessel leakage. It also has an angiostatic action by inhibition of vascular endothelial growth factor and has a useful effect on many inflammatory retinal diseases. The recommended dose of Triamcinolone acetonide injection is 4 mg/0.1 mL which was administrated in this study. The aim of this study was to assess the efficacy of suprachoroidal Triamcinolone acetonide injection (SCTA) as adjunctive therapy in the management of Vogt-Koyanagi Harada's (VKH) multiple serous retinal detachment (RD) and evaluate best corrected visual acuity (BCVA), intraocular pressure(IOP) and central foveal thickness (CFT) by Optical Coherence Tomography (OCT) in patients diagnosed as VKH at ophthalmology clinic, Benha University, EGYPT and Ebsar eye center, Benha, EGYPT.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.

Exclusion Criteria:

* recent intraocular surgery.
* patients refuse to participate in the study.
* media opacity and other causes of serous retinal detachment than VKH.
Periconception PrEP for HIV-exposed Ugandan Women

In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration \>40ng/mL, opening pill device to take \>80% of dispensed pills) to PrEP and other safer conceptions strategies among Ugandan women exposed to HIV.

The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The primary outcomes are to evaluate uptake of and adherence to periconception PrEP among HIV-exposed women in rural Uganda.

To accomplish this, women will participate in quarterly study visits, HIV and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. Participants will be eligible to initiate PrEP at any time during the first 6 months of the 9-month study follow-up period. Participants who initiate PrEP will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV at quarterly study visits.

For women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.

Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .

Investigators will offer objective sexually transmitted infection (STI) testing to all participants in order to measure the prevalence, incidence, and factors associated with STIs. Investigators will compare incidence among women who choose and who do not choose PrEP. Investigators will also measure the number of episodes of condomless sex each month as a mediator variable for STI development.

Eligibility Criteria:
Self Report Inclusion Criteria:

1. Female
2. Aged 18-35
3. Likely to be fertile based on reproductive health history \[55\]
4. Reported personal or partner desire to have a child in the next year \[56-59\]
5. With a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed).
6. Live within 60km of clinic. Not planning on relocating to an area incompatible with ability to attend quarterly clinic over a 9-month follow-up period

Objective Inclusion Criteria:

1. HIV-negative (onsite rapid testing)
2. Not currently pregnant (onsite urine b-hcg testing)
3. Fluent in English or local language
4. Otherwise able to participate in the informed consent process

Exclusion Criteria

1. Currently pregnant
2. HIV-positive
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan 300 mg Tablets under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 45 years (inclusive).
2. Voluntary consent to participate in the study.
3. Body Mass Index (BMI) between 18 and 30 (inclusive).
4. Female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
5. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. A history of allergic or adverse responses to Irbesartan, or any comparable or similar product.
3. Subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation.
4. Subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation.
5. Subjects must not have made a plasma donation within 14 days of study initiation.
6. Participation in a clinical trial within 30 days prior to study initiation.
7. Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study.
8. Use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy.
9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study.
10. Smoking or use of tobacco products within 6 months prior to or during the study.
11. Female subjects who are lactating.
12. Positive serum pregnancy test for female subjects.
13. Positive blood screen for HIV, Hepatitis B or Hepatitis C.
14. Positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
Efficacy of Lycra Garments in Ataxic Subjects

The aim of this study iss to analyze the effect of Lycra garments in the axial stabilization in subjects affected by ataxia, both in acquired cerebellar injuries and malformative etiology.

Improvement are expected for what concerns:

* greater stability during stance
* smoother walking pattern
* reduction of risk of fall.

The two groups (acquired and malformative) will be compared.


Eligibility Criteria:
Inclusion Criteria:

* subjects recruited must show a framework of ataxia consequent to acquired brain injury or malformative etiology.
* subjects must be able to walk autonomously without any device

Exclusion Criteria:

* presence of spasticity or muscular contractures
* subjects who already used lycra garments