cyrilzakka/clinical-trials huggingface dataset:
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes

Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

The mobile phone app Sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. The rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. Compared to similar smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. Second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and GPS (Global Positioning System) sensors on smartphones. In contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. For these reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 -75 years with prediabetes (fasting BG 100-125 mg/dl, A1C 5.7% - 6.4%, or 2 hour BG of 140-199 mg/dl following 75-gram oral glucose tolerance test)
* Body mass index 24 - 40 kg/m2
* English speaker
* Smartphone user (Android or Apple 5s and above)

Exclusion Criteria:

* Currently doing more than 150 minutes/week of moderate/vigorous physical activity
* Presence of medical conditions that prevent adoption of moderate physical activity
* Use of any glucose-lowering or weight loss medications within the previous 3 months
* Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
* Presence of any condition that can result in spurious A1C readings (e.g. anemia \[hemoglobin level below lower limit of normal\] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
* Use of systemic glucocorticoids
* Use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed)
* Severe mental illness or learning disability
* Current participation in another clinical trial
* Liver enzymes \>3 x upper limit of normal
* Poor literacy (REALM-R score of 6 or less)
Crossover Trial of AD109 in Obstructive Sleep Apnea

This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
* AHI 10 to \<20, or AHI ≥20 if meets other PSG criteria

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
The Use of Mucograft® to Treat Gingival Recession

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Eligibility Criteria:
Inclusion Criteria:

* Presence of Type I or II (Miller Classification) of gingival recession

Exclusion Criteria:

* Smoking
* Pregnancy or lactating
* Presence of any systematic diseases can affect the periodontal surgery.
* Subjects with significant moderate to severe periodontal disease.
* Patients under orthodontic treatment
* Presence of restorative materials (e.g. crown)
* Effectiveness of frenum
* Subjects have failed to maintain good plaque control.
* Subjects having previous surgical treatment for covering the recession in the chosen area.
Prognostic Significance of the Lung Immune Prognostic Index (LIPI) in Postoperative Clear Cell Renal Cell Carcinoma: a Multicenter Retrospective Cohort Study

This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy. Patients were stratified into the LIPI good group and the intermediate/poor (int./poor) group based on dNLR (≥ 3) and LDH (≥ 245 U/L) levels. Propensity score matching (PSM) was used to adjust for baseline differences and minimize selection bias. Kaplan-Meier survival curves and Cox regression models were employed to evaluate the impact of LIPI and other clinical factors on recurrence-free survival (RFS) and overall survival (OS).


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed with ccRCC;
2. Underwent radical or partial nephrectomy.

Exclusion Criteria:

1. presence of concurrent malignancies;
2. missing data or failure to follow-up
A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants

The purpose of this study is to examine the potential for drug-drug interactions.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) within the range of ≥18.5 to ≤30.0 kilograms (kg)/square meter (m\^2) at the screening.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and either of the following conditions applies:

  * Is a woman of childbearing potential (WOCBP), having not received any oral contraceptives for at least 28 days prior to the first dose of study intervention, and using a contraceptive method that is highly effective during the treatment period and for at least 14 days after the last dose of study intervention.
  * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.

Key Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* Presence (suspected) or history of having breast cancer, endometrial cancer, or cervical cancer.
* Presence of unexplained genital bleeding.
* Participants who have taken injectable or implantable contraceptives, hormonal intrauterine devices, intrauterine hormone-releasing system within 12 months prior to the first dose of study intervention or hormonal contraceptives (intravaginal or transdermal) for 3 months prior to the first dose of study intervention.
* Participants who are otherwise considered ineligible for the study by the investigator for any other reason.

NOTE: Other inclusion and exclusion criteria may apply.
Reaching for Equity in Sleep Apnea Treatment (REST) Study

This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.

The investigators will carry out a pilot study in which patients will be randomly assigned to receive health coaching or usual care. Participants are English- and Spanish-speaking patients from a county-based public health system who have received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach will call patients three times to resolve barriers to adherence. Primary outcomes include both adherence measures collected by the device modem at baseline and 4 months, and patient-reported outcomes such as daytime sleepiness.

Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking
* At least 18 years of age
* Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
* Not currently meeting Medicare standards for adherence of at least 4 hours per night for at least 70% of the last 30 nights
* Received care from the San Francisco General Hospital Sleep Clinic

Exclusion Criteria:

* Not English- or Spanish-speaking
* Younger than 18 years
* Does not have phone number at which could be reached
Building Research for Intervention Development in Gliosis and Eating Habits

The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
* Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
* Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.

Exclusion Criteria (study 1 child participants and study 3 criteria for children of adult participants):

* Significant health conditions including type 2 diabetes
* History of major weight loss or eating disorder
* Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
* Documented cognitive disorder
* Severe food allergies, vegetarian, or vegan (Study 1 only)
* Unable to make the session date

Exclusion Criteria (study 2, child participants):

* Significant health conditions including type 2 diabetes
* History of major weight loss or eating disorder
* Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
* Documented cognitive disorder
* MRI contraindication (e.g., braces, claustrophobia)
* Weight \>330 pounds (MRI limit)
* Severe food allergies, vegetarian, or vegan
* Currently in formal weight loss program
Bedside Silo Versus Operative Closure for Gastroschisis

The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.

The primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

A strategy of blocked randomization will be utilized. The randomization will be blocked in groups of 4. Randomization sequence will be kept by the principal investigator. After permission is obtained, the next assignment will be obtained. This method assures that the physician obtaining permission will be blind to the treatment group.

The treatment groups will consist of the same medical management, feeding regimen and discharge criteria.

The interventions will be either bedside silo or operative attempt at closure. During attempt at primary closure, the abdomen will be closed completely if the staff anesthesiologist and surgeon agree the belly is not too tight based on ventilatory parameters, vital signs and appearance. If either the surgeon or anesthesiologist should feel the closed abdomen is too tight, a ringed silo will be placed in the operating room, the same silo used in the bedside treatment arm, and the child will continue in the study. When a silo is placed either in the operating room due to inability to close the abdomen or at the bedside, they will be managed the same way. The skin will be dressed in the standard fashion (betadine jelly, xeroform and kerlix). The dressing allows visualization of the bowel. No reductions will be done the day of placement. After one night of observation a tie will be gently placed to apply downward pressure on the bowel. This pressure will not be allowed to increase the peak ventilator pressure by more than 2 cm H2O. One tie will be placed each subsequent day until the tie is within 2 cm of the skin at which point the patient will be scheduled for operative closure the day following the placement of the tie.

The medical management is controlled for resuscitation, sedation, ventilation and feeding between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastroschisis

Exclusion Criteria:

* Born prior to 34 weeks estimated gestational age
* Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia

A randomized controlled pilot study on the safety \& efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.

As the coronavirus disease (COVID-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. A highly elevated levels of cytokines in COVID-19 patients requiring ICU admission, has suggested that a "cytokine storm" was associated with disease severity. Data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. This data is especially derived from imatinib, the most studied Abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. Based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with SARS-CoV-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PCR positive for SARS-COV-2
* Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines
* Informed consent explained \& signed by patient or his 1st degree relatives or legally authorized representative.

Exclusion Criteria:

* Pregnant women (or) breast feeding women
* Patients younger than 18 years of age
* Patients with known allergy to imatinib
* Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \> 5x upper limit of normal (ULN).
* Creatinine clearance (CrCl) \< 30 mL/minute.
* Patient already on mechanical ventilation at time of screening.
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula

This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-6 Years
* ASA class 1-2
* Elective Surgery
* GA with oral uncuff endotracheal tube

Exclusion Criteria:

* Potential difficult air way from history and physical exam
* Allergy ti ultrasound gel
* neck mass
* unstable vital sign
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial

Unicompartmental knee arthroplasty (UKA) and High Tibial Osteotomy are both valid treatment options for isolated medial knee osteoarthritis. Literature to date is lacking high grade evidence of the outcomes between these procedures. This is a study protocol for randomized controlled trial comparing UKA vs HTO in late stage medial knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Isolated KL 3-4 medial knee arthrosis
* Varus \> 3 degrees
* Age 45-65 years

Exclusion Criteria:

* Post-traumatic arthrosis
* Arthrosis in the lateral compartment more than KL grade I in MRI
* Post- traumatic arthrosis
* Instability
* Malignancy Obesity
A Trial to Increase Child Vegetable Intake Through Behavioral Strategies

A community nutrition trial among a diverse low-income population that tested the effect of parent-child cooking nutrition intervention on vegetable intake among 9-12 children.

This study was a nonrandomized, controlled trial to determine whether a series of 6 weekly parent-child vegetable cooking skills classes and parent-led strategies informed by behavioral economics (1/week) (intervention group) improved dietary and non-dietary outcomes of a racially and ethnically diverse sample of low-income children (ages 9-12) more than a vegetable cooking skills program alone (control group).

Eligibility Criteria:
Inclusion Criteria:

* Participant child must be 9-12 years old
* Parent must be the main food preparer for the household
* The family must qualify for some form of public assistance
* Have a phone
* Must not have participated in a previous Cooking Matters for Families in the past 3 years
* Be able to read, speak, and understand English (or Spanish for Spanish-only courses).

Exclusion criteria:

\*No exclusions other than those that do not meet inclusion criteria
Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine green (ICG) on imaging detection and the control group, routine medical using methylene blue test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared.

This trial was a prospective, multicenter, and self controlled clinical trial. The subjects who were in line with this scheme were detected by fluorimetry and staining, and the primary effectiveness evaluation index, secondary effectiveness evaluation index and safety evaluation index were established during the operation. Record evaluation. At present, in the clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue staining method. A large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7. Therefore, choosing a self controlled clinical trial can increase the number of sentinel lymph node detection.

Eligibility Criteria:
Inclusion Criteria:

1. the age of 18-75 years, female patients;
2. the diagnosis of breast cancer by biopsy;
3. participants voluntarily participated in the clinical trial and signed informed consent.

Exclusion Criteria:

1. had received SLNB or axillary surgery;
2. breast area radiotherapy or neoadjuvant chemotherapy has been accepted.
3. clinical hints of axillary lymph node metastasis;
4. discovery of distant metastasis;
5. inflammatory breast cancer;
6. women in pregnancy;
7. people with iodine allergy;
8. the serum creatinine was \> 1.5 times as high as the upper limit of the normal value.
9. to participate in clinical trials of other devices or drugs within one month;
10. the researchers consider it inappropriate to participate in this clinical trial.
Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy

This is a prospective, longitudinal, non-therapeutic study which includes routine assessment for long-term effects, as per FDA guidelines after receipt of an allogeneic HCT or autologous genetically modified cellular products for hemoglobin disorders.

Primary objective:

- To provide long term follow up, for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation (HCT) or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy. For individuals receiving a genetically modified cellular product, this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration (FDA).

This protocol will provide a mechanism to appropriately monitor individuals with hemoglobin disorders that have received an allogenic HCT or an autologous genetically modified cellular product for hemoglobinopathies. Monitoring will include potential long-term adverse effects after receipt of these treatments, as well as long-term monitoring after the receipt of the genetically modified cellular product.

Eligibility Criteria:
Inclusion Criteria:

* Receipt, or planned receipt, of an allogeneic HSCT or infusion of genetically modified autologous cells for hemoglobin disorders within 15 years prior to enrollment

Exclusion Criteria:

* Inability or unwillingness of research participant and/or legal guardian/ representative to provide written informed consent.