cyrilzakka/clinical-trials huggingface dataset:
Evaluating a Type 2 Diabetes Prevention Program

This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 65
2. Overweight (BMI between 25 and 40 kg/m2)
3. Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).

Exclusion Criteria:

1. Not between the ages of 18 and 65
2. Not overweight (BMI between 25 and 40 kg/m2)
3. Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Carbon Dioxide Insufflation Colonoscopy in IBD Patients

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* known diagnosis of Crohn´s disease and ulcerative colitis
* indication for diagnostic colonoscopy
* informed consent
* unsedated or minimally sedated procedure (\< 3 mg of midazolam)

Exclusion Criteria:

* planned incomplete or therapeutic procedure
* deep sedation or general anesthesia
* intestinal resection longer than ileocecal resection
* isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
* ulcerative proctitis (E1)
Mothers' Parenting Satisfaction and Parenting Self-efficacy: An Evaluation of a Infant Calming Method

The main aim of this study is to investigate how to support families with an excessively crying or fussy infant during the first months of the child. The purpose is to discover how an excessively crying or fussy infant affects the mothers' parenting satisfaction and parenting self-efficacy. Furthermore the purpose is to investigate how a behavioral intervention (The 5 S's) affects the infants' mothers' parenting satisfaction and self-efficacy and to evaluate the effectiveness of the intervention.

This is a randomized controlled follow-up parallel trial that compares PSE and PS in an intervention and control group. The data was collected during March 1st to May 20th, 2019 from three postpartum wards. The mothers were recruited by midwives on the wards after childbirth. The baseline sample size was 250 mothers, which is based on a conducted power analysis. The sample size calculation was based on previous study, from which the standard deviation (0.81) for change in parental satisfaction was calculated. Baseline data were collected before randomization in the hospital. Follow-up data were collected six to eight weeks postpartum at home.

The instruments to assess the study outcomes were the parenting self-efficacy (PSE) scale developed and validated by Salonen et al. and parenting satisfaction (PS) scale, the evaluation subscale of the questionnaire "What Being the Parent of a New Baby is Like" by Pridham \& Chang, 1989.

Data were analyzed with SPSS statistical software for Windows, release 25. Descriptive statistics included frequencies, percentages, means and medians. Total scores for the PSE instrument and WBPL-R evaluation subscale (PS) were calculated by summing the scores for all items and dividing the sum by the number of items. Higher scores indicated better outcomes. Comparisons between groups were made of mother characteristics, PSE and PS. Due to skewed distributions, non-parametric tests were used. Mann-Whitney U tests were used for two group comparisons, and Kruskal Wallis tests were used for three or more group comparisons.

Results have not yet been reported.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous mothers
* Multiparous mothers
* Mothers of healthy infants rooming in (with mother)

Exclusion Criteria:

* Mothers with infants who were treated on another ward during data collection
* Mothers with multiple infants
* Mothers with inability to understand Finnish
Are Static and Dynamic Balance Tests A Criteria Showing Cognitive Impairments In the Elderly?

The aim of our study is to reveal whether static and dynamic balance tests can be an indicator of deterioration in cognitive impairments in geriatric individuals.

the static and dynamic balance test will be used to predict cognitive impairments in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Relative, healthy elderly individuals aged 65-85 years
* Individuals who do not have neurological / orthopedic problems that will prevent them from performing the test
* Independent elderly individuals in activities of daily living
* Men and women living in a nursing home
* No pre-defined vision and hearing problems
* No history of lower extremity or lumbar spinal surgery

Exclusion Criteria:

* Hadkinson's Abbreviated Mental Test less than 7 points
* Presence of defined neurological, orthopedic, systemic (cardiovascular) disease that interferes with walking and mobility
* Presence of defined psychiatric illness
* Having a communication problem
* Presence of using aids for walking
* Use of prostheses or orthoses associated with the lower extremity
* Presence of cognitive, visual or auditory impairment
* Balance-affected individuals with lower extremity disorders
Prostate Cancer Circulating Tumor Cells Based on Epithelial-Mesenchymal Transition Biology

This is a minimal risk correlative clinical blood-drawing protocol. The objective of this lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP. If successful, the capture method will be evaluated further in the larger comparative study.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of adenocarcinoma of the prostate
* Clinical or radiographic evidence of metastatic disease
* Evidence of disease progression on androgen deprivation therapy (ADT) as evidenced by either of the following in the past:

  1. Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
  2. Radiographic evidence of disease progression as defined by new bone scan lesions or soft tissue/visceral metastases \>2 cm in diameter.
  3. Clinical progression as determined by the treating physician.
* Age greater than 18 years.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)
Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure

This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.

Chronic acute liver failure (ACLF) is a systemic multi-organ failure driven by acute liver injury in the basis of chronic liver disease. The main cause of chronic acute liver failure in China is hepatitis b virus infection.Previous studies on the prognosis of acute on-chronic liver failure mainly focused on the short-term survival rate and the follow-up time was relatively short, while the study on the long-term prognosis of patients with spontaneous recovery of chronic acute liver failure was still lack-ing. Thus,this study mainly retrospectively analyzed the clinical data of patients with chronic hepatitis b related acute liver failure admitted to the department of infectious diseases, the third affiliated hospital of sun yat-sen university, and con-ducted telephone follow-up survey to analyze the long-term prognosis of patients with chronic hepatitis b related acute on-chronic liver failure.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old;
* The diagnosis consistent with hepatitis b associated chronic acute liver failure；
* After hospitalization, the survival time \> 90 days；
* The inpatient clinical data are complete.

Exclusion Criteria:

* Human immunodeficiency virus infection or congenital immune deficiency diseases;
* Liver cancer and other tumors, autoimmune liver disease, genetic and metabolic liver disease, or other serious diseases that significantly affect patient survival;
* Other conditions that the researchers judged not appropriate for inclusion.
Mifepristone vs Misoprostol

The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.

Cervical preparation is a critical component for the provision of safe abortion care in the later first trimester and beyond. The risk of surgical complications increases at 12 to 13 weeks gestation and routine use of cervical preparation is recommended. Cervical preparation options include misoprostol, mifepristone, and cervical dilators. Regimen choice is often guided by provider comfort, preference, or institutional guidelines. Misoprostol offers the advantage of facilitating same-day procedures, but side effects like pain and gastrointestinal symptoms can negatively affect patients' experiences. Furthermore, using misoprostol can pose logistical challenges in hospital-based main operating room environments, where abortions occur concurrently with all other surgical cases. Mifepristone is better tolerated than misoprostol but requires a multiple-day protocol for administration, which can pose logistical challenges.

Several studies demonstrate mifepristone's efficacy and safety as a cervical ripening agent for up to 16 weeks' gestation, however, despite its effectiveness, mifepristone for cervical preparation before procedural abortion has previously been limited by availability and cost. Recent studies demonstrating mifepristone's adjunctive benefit with osmotic dilators later in pregnancy, however, have broadened its use.

While most abortion care in the United States occurs in outpatient settings, about 3% occur in hospitals. This is expected to increase as the Dobbs versus Jackson Women's Health Organization decision exacerbates disparities in abortion access. In hospital-based abortion care, particularly at academic centers providing abortion training, there is a pressing need for innovative measures for cervical ripening. The Complex Family Planning Fellowship-trained faculty members at Montefiore will serve as research study surgeons. Cases will be performed in the main operating room under sedation or general anesthesia as determined by the anesthesiologist. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish-speaking
* Capacity to consent
* Seeking induced abortion of a singleton pregnancy
* Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)

Exclusion Criteria:

* History of more than one prior Cesarean delivery
* Sonographic evidence of placenta previa
* Sonographic concern for morbidly adherent placenta
* Prior obstetric hemorrhage requiring transfusion
* Obstructive cervical or lower uterine segment fibroid
* Current therapeutic anticoagulation use
* Cerclage in situ
* History of more than one prior cervical excisional procedure
* BMI greater than 45 kg/m\^2
Phase II Study for Solid Metastatic Tumors

1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect) after chemo-radiation of a metastatic site in metastatic breast cancer patients.
2. To monitor the induction of a T cell response.
3. To explore the role of PET scanning to assess tumor responses/abscopal effect.

1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect) after chemo-radiation of a metastatic site in a pilot study of metastatic breast and other metastatic solid tumors.
2. To monitor the induction of a T cell response in patients with metastatic breast cancer.
3. To explore the role of PET scanning to assess tumor response/abscopal effect.

Eligible are women with metastatic breast cancer and patients with other metastatic solid tumors who have achieved stable disease or have disease progression after systemic therapy and have at least three separate measurable sites of disease. Extent of metastatic disease is recorded both at CT and PET scanning. Radiation is given during systemic therapy to one of the lesions, 35 Gy in ten fractions over a two week interval, conformally to maximally spare normal tissue. GM-CSF treatment is given daily for fourteen days. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with GM-CSF. Abscopal response is evaluated by assessing clinical and PET response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed breast cancer or other cancer which is persistent and metastatic or recurrent and metastatic.
* Patients with a history of treatment for other prior malignancy will be eligible, provided they remain disease-free \> 2 years after initial treatment, or were treated for non-melanoma skin cancer, or in situ cervical cancer.
* Patients must have at least 3 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter.
* Age \>18 years.
* ECOG performance status \<2 (Karnofsky \>50%).
* Life expectancy \> 3 months.

Exclusion Criteria:

* Patients who have had immunotherapy within 4 weeks prior to entering the study.
* Patients who have had prior allergic reaction to GM-CSF
* Patients on steroid therapy or other immunosuppressive therapy.
* Patients undergoing therapy with other investigational agents.
* Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion.
* Uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina pectoris, or unstable cardiac arrhythmia requiring assessment for clinical intervention.
Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.

The refractive status is crucial to visual function and may change throughout life. For patients with congenital cataract (CC), the developmental profile of refraction is complicated due to the potential influences of diverse clinical manifestations and various treatments, and has not yet been fully characterized.

The investigator described the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC. The refraction data from CC patients provided in the study are of clinical significance to the guidelines for CC treatment, especially for IOL calculation concerning the laterality of CC.

Eligibility Criteria:
Inclusion Criteria:

* Children with uncomplicated surgeries
* Children with unilateral/bilateral cataract

Exclusion Criteria:

* Corneal diseases
* Lens luxation
* Glaucoma
* Retinal diseases
* Nystagmus and nanophthalmos
Reducing Symptoms of Depression, Stress and Anxiety and Enhancing Positive Mental Health: a Randomized-controlled Study of the Positive Emotions Training

Based on the results of the previously published paper "Positive Emotions Training (PoET) as an online intervention to improve mental health: a feasibility study" (Niemann et al., 2023) the goal of this study was to examine the effects of the "Positive Emotions Training" on mental health in a randomized-controlled study. Furthermore, possible predictors for the efficacy of PoET are to be explored.

Hypotheses:

1. It was hypothesized that participants receiving PoET would show a significant increase in positive mental health factors at the second assessment point (T2) at end of the second training day.
2. Furthermore, participants receiving PoET are to be expected to show a significant decrease in depression, anxiety and stress symptoms at T2.
3. It was hypothesized that the changes in mental health factors remain stable up to the last assessment point (T3) three month after the training.
4. Lastly, it was hypothesized that there would be no significant changes in the positive or negative mental health factors in the control group at T2 and T3.
5. The possible predictors of the training's efficacy were not hypothesized, but examined in exploratory investigations.

Methods:

The final sample was n = 207 with n = 90 in the PoET group and n = 117 in the control. The control group did not receive any intervention in the experimental period, but was offered to participate in a later PoET. The allocation was randomized. Participants in the PoET group completed two online training sessions (3 hours each) via Zoom. Group size was about 25-30 people. The sessions included the following positive psychology constructs: happiness, humour, optimism, loving kindness and gratitude on the first day, and hope, self-efficacy, meaningfulness, forgiveness and resilience on the second day. All participants completed a questionnaire at the beginning of the first training session, at the end of the second one as well as three months after the second session. Participants were given an exercise booklet for all exercises (during the training sessions and at home). The one-week break between the two sessions was advertised as a "7-day-challenge" to improve the motivation in participants to exercise at home.

Data was collected pseudonymised via "qualtrics". Data analyses were conducted with RStudio. For the possible effects of PoET on mental health two-factorial repeated measures ANOVAs were conducted. For the exploration of possible predictors for the efficacy of the training, a hierarchical regression was conducted.


Eligibility Criteria:
Inclusion Criteria:

* legal age (18), ability to use Zoom and all associated technology

Exclusion Criteria:

* none
Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients aged 12 years and older of any race.
* Males or females.
* Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
* Patients with a positive KOH examination and culture positive for dermatophyte

Exclusion Criteria:

* Presence of "yellow spikes" on the target nail.
* Presence of dermatophytoma on the target nail.
* Presence of nail thickness exceeding 2 mm.
* Patients with proximal subungual involvement
* Patients with severe plantar or moccasin tinea pedis
* Patients with nail abnormalities due to other conditions
* Patients with life expectancy less than 2 years.
* Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
* Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
* HIV infection or any other immunodeficiency.
* Alcohol or substance abuse.
* Patients with history of allergic reactions to terbinafine or its excipients.
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
Computerized Decision Support System Linked to Electronic Health Records to Improve Patient Care in a General Hospital

Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge.

The investigators designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, point-of-care reminders on clinical practice and the quality of care. The investigators hypothesize that these reminders can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to hospitalized patients. The results of the investigators study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings.

Eligibility Criteria:
Inclusion Criteria:

All of the patients admitted into the internal medicine departments of the Azienda Ospedaliera di Desio e Vimercate during the study period.

Exclusion Criteria:

None