cyrilzakka/clinical-trials huggingface dataset:
A Novel Iron Supplement for Athletes: Phase I

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance.

Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the tolerability of the developed supplement and any associated symptoms before conducting a clinical trial on this product. Participants will consume 40mg of elemental iron every second day for 14 days. Participants will complete a daily survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms. Additionally, participants will complete a more thorough survey of gastrointestinal symptoms at baseline, the mid-point, and the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* cis-gendered female 18-25years old
* BMI \<25 kg/m2
* engaging in moderate to vigorous physical activity for ≥3 hours per week

Exclusion Criteria:

* gastrointestinal issues (e.g. Irritable bowel disease/syndrome)
* chronic illnesses
* prescription medication (including oral contraceptives)
* allergies to supplement ingredients
* iron supplementation in the last 3 months
Bright by Three (BB3) Effectiveness Study

The Investigators propose to conduct a pragmatic randomized controlled trial of 350 one to four year old children and their caregivers to study the effectiveness of 1) the Bright By Three (BB3) intervention for promoting children's language and socio-emotional development and 2) a modified version of the Safe 'N Sound (SNS) intervention for reducing safety hazards and injuries. The SNS intervention will serve as a control for the BB3 group and vice versa so that all study participants will receive a clinically meaningful intervention. In collaboration with primary care clinics that serve low-income and minority children, the Investigators will recruit and randomize 350 twelve to fifteen month olds and their parents/caregivers to one of the two intervention arms and deliver the interventions over a 2 year period.


Eligibility Criteria:
Inclusion Criteria:

* Low-income (based on insurance status of child being Medicaid or CHIP),
* Lower educational level (less than college level education) parents of 12 to 15 month old children from the Rocky Mountain Youth Clinic and the Child Health Clinic who speak either English or Spanish or both and their 12-15 month old toddlers.

Exclusion Criteria:

* Parents with children born prior to 36 weeks gestation (premature infants)
* Children with chronic conditions known to affect neuro-development, such as trisomy 21, or
* Children who have a positive screen on the Children with Special Health Care Needs screener 57
* Parents who have already participated in the BB3 program
* Parents without access to a smart phone
* Parents who cannot read or converse in either English or Spanish
Low Dose IL2 Immunotherapy in AD

Neuroinflammation is a significant component of Alzheimer disease (AD). Our data demonstrated compromised regulatory T cells (Tregs) phenotype and suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing in disease progression. Low dose interleukin-2 (IL-2) is now viewed as a very promising immunoregulatory drug having the capacity to selectively expand and restore functional Tregs. This study is a phase I open-label study to assess subcutaneous interleukin-2 (IL2) safety and potential efficacy as a Treg inducer in AD. 8 Alzheimer dementia patients with mild clinical dementia will be recruited into the study. The baseline cognitive status will be evaluated in these patients. Monthly five-day-courses of subcutaneous IL2 (1MUI/day) will be administered for a total of 4 months. Changes in Tregs from pre to post injections will be measured during the study period. The expected time participants will be in the study is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.
* Male or female age 60 to 86 years
* Clinical dementia rating scale of 1
* Total bilirubin less than or equal to 1.5mg/dL
* Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0gm/dL
* Serum creatinine less than 1.5 mg/dL
* English language speaking
* A family member or caretaker who is expected to be consistently available, administer study drug and attend study visits throughout the study.

Exclusion Criteria:

* Serious, active bacterial, fungal or viral infection
* Severe pulmonary dysfunction. FEV1 and FVC less than 40% of predicted (or 3 SD below normal) at baseline, If a pulmonary function test is clinically indicated. Hx of intubation for \>72 hours.
* Severe cardiac dysfunction defined as left ventricular ejection fraction \<40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
* Hypersensitivity or allergy to IL-2
* Bowel ischemia/perforation, GI bleeding requiring surgery
* Resistant seizures, history of coma or toxic psychosis lasting \>48 hours
* Patients with White Blood Count (WBC) \<4,000/mm3; platelets \<100,000/mm3; hematocrit (HCT) \<30%.
Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists

Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.

More than two million new cases of breast cancer occur each year worldwide. Implementing mammography screening is complex and resource-intensive, making it impractical in resource-limited settings. Clinical breast examination (CBE) has been recommended as an alternative screening option for low- and middle-income countries. Several studies have shown a significant shift towards earlier stage tumours detected by CBE. However, the high false-positive rate and low positive predictive value of CBE expose women to unnecessary and costly further diagnostic procedures, as well as the negative psychological consequences. There is an urgent need for a more accurate, cost-effective and reliable triage technology that can be performed by any healthcare provider.

Eligibility Criteria:
Inclusion Criteria:

* Clinical breast examination positive women with no debilitating illness.
* Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers.

Exclusion Criteria:

* Women with confirmed diagnosis of breast cancer or those already treated for the disease.
Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery

Background:

1. . The incidence and mortality of colon cancer are high in China and in the world.
2. . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery.

The purpose of research:

1. . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
2. . Comparison of efficacy and safety of different adjuvant chemotherapy time (\<3 months vs. \>=3 months) in high-risk stage II and III colon cancer patients in the real world
3. . Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world


Eligibility Criteria:
Inclusion Criteria:

* Patients who are sick after January 2010
* Age is older than 18
* Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer

Exclusion Criteria:

* Combine other tumors
* Pathological information is not clear
* Researchers believe that other reasons are not suitable for enrollment
Promoting Patient-Centered Care Through a Heart Failure Simulation Study

The initial aim of this study will be to assess current methods of heart failure (HF) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. The second aim will be to design and create a "living with HF at home" simulation session. The third aim will test the hypothesis that hospitalized HF patients who receive education in a simulation room in addition to usual HF education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female \> 18 years of age.
2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
3. Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis.
4. Heart failure of either preserved or reduced ventricular function.

Exclusion Criteria:

1. Patients requiring ICU monitoring
2. LVAD candidate/recipient
3. Cardiac transplant candidate/recipient
4. Confusion
5. Sepsis
6. Terminal illness (other than HF) with expected survival of less than 1 year
7. Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
8. Inability to comply with planned study procedures
9. Active illicit drug use
10. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
11. Other conditions that in the opinion of the Primary Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
The Application of BOPPPS（Bridge-in,Objective,Pre-assessment,Participatory Learning,Post-assessment,Summary） Model in the Ward Rounds of Nurses' Standardized Training

Nursing standardization training students in a top-three hospital in Chongqing from July 2017 to June 2022 were selected as the research objects, excluding nursing students who participated in online courses during the epidemic period. The BOPPPS(Bridge-in,Objective,Pre-assessment,Participatory learning,Post-assessment,Summary) teaching model was applied to the standardized training of nurses and compared with the conventional teaching methods to evaluate the effect of improving the theoretical knowledge, professional skills and comprehensive ability of nursing students.


Eligibility Criteria:
Inclusion Criteria:

* Nursing standardization training students in a top-three hospital in Chongqing

Exclusion Criteria:

* Nursing students who participated in online courses during the epidemic period
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

* Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
* Subjects chronically infected with hepatitis C virus (HCV) genotype 3
* Subjects who are HCV treatment-naive
* Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
* HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

* HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
* Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Postpartum Opioid Prescribing Patterns and Patient Utilization

This study seeks to investigate the prescribing patterns and patient utilization of opioid pain medication in the postpartum setting. Postpartum women will be surveyed prior to hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid tablets they used (in relation to the number prescribed), pain satisfaction, and storage/disposal of any remaining opioid tablets.

Opiate abuse is a national epidemic and has paralleled the increase in opioid prescriptions, with diversion of surplus medication playing a key contributing role. As the majority of reproductive age women in the U.S. will experience childbirth, understanding opioid prescription patterns and patient opioid utilization in the postpartum period is critical.

Postpartum women will be recruited during a 9-month period to take part in pre-hospital discharge and 2-4 week postpartum surveys to prospectively assess opioid medication use with regard to quantity of opioid tablets prescribed and quantity used, storage and disposal of unused opioids and satisfaction with pain control.

Eligibility Criteria:
Inclusion Criteria:

* Women who deliver during the recruitment period
* English-speaking
* Opiate-naïve (as determined by admission medication reconciliation)
* Receive oral opioid medications during inpatient postpartum admission
* 18 years or older

Exclusion Criteria:

* Contraindication to NSAID use
* Required use of general anesthesia without concurrent neuraxial analgesia
* Undergo hysterectomy, or unanticipated surgical procedures during the postpartum period
* Are admitted to the intensive care unit during their admission.
Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision

This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy

Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy
* willing to participate

Exclusion Criteria:

* pregnancy
* immunocompromised host
* on continuous ambulatory peritoneal dialysis
* morbid obesity (Body mass index \> 35 kg/m2)
* End-stage renal disease with hemodialysis dependent
* ascites
* uncontrolled coagulopathy
Observational Retrospective Study on the Clinical and Radiographic Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb

The aim of this study is to collect boh clinical and radiographic data coming from the treated patients for pseudarthrosis of the upper limbs from 2000 to 2017 at the SC Orthopedic Surgery, Innovative Techniques of the Istituto Ortopedico Rizzoli in order to evaluate the clinical and radiographic outcomes of the treatment, with or without the application of biological adjuvants.

The bone healing requires the integrations of two main principles: biomechanical aspect and biological aspect. The second one has having growing interest.

The use of the biological adjuvants, as growth factors (rhBMP2 and 7), platelet-derived growth factors (PDGFs), Platelet gel (PG) or Plasma Rich Fibrin (PRF), as well as peptides and molecules are demonstrating promising results in the field of bone regeneration.

The addition of autologous bone marrow concentrate cells has proven to be an effective option in the treatment of bone defects, although to date there is no clear superiority of one method over the other.

In light of this, the purpose of the study is to evaluate the clinical and radiographic outcomes of the treatment, with or without the application of biological adjuvants, collecting data coming from the treated patients for pseudarthrosis of the upper limbs from 2000 to 2017 at the SC Orthopedic Surgery, Innovative Techniques of the Istituto Ortopedico Rizzoli

Eligibility Criteria:
Inclusion Criteria:

* Patients with post-traumatic pseudoarthrosis of the long bones of the upper limb
* Duration of at least 6-9 months without clinical-radiographic signs of healing in the 3 months prior to pseudoarthroses

Exclusion Criteria:

* Pseudoarthrosis due to pathological fracture
* Infected pseudarthrosis
* Pseudoarthrosis treated with external fixation
* BMI\> 35
Efficacy of Two Yogurt Formulations in Healthy Humans

This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as gastrointestinal microflora distribution in hyperlipidemic individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* aged 18-60 yr
* plasma LDL-C 130-260 mg/dl
* TG levels below 400 mg/dl
* body mass index (BMI) rangewill be 22 to 32 kg/m2
* permitted to take stable doses of thyroid hormone and anti hypertensive agents, as long as these are continued equivalently throughout the duration of study

Exclusion Criteria:

* history of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo, - history of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin,
* myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months
* recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year
* chronic user of probiotics, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.
Prospective Real World Study on Therapy Prediction Algorithm Training

This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content.

From 2,786 unique individuals engaging between March 2015 and December 2022 in English language psychotherapy sessions and providing pre- and post-session self-report and facial biometric data via the AmDTx mental health platform (Mobio Interactive Pte Ltd, Singapore), analysis was conducted on 67 "super users" that completed at least 28 sessions with all pre- and post-session measures. AmDTx is a clinically validated mental health platform that provides patients with audio recordings supporting mental wellbeing (asynchronous and on-demand psychotherapy). AmDTx also contains easy to use tools that rapidly assess mental wellbeing, including an objective measure of psychological stress derived from AI analysis of facial biomarkers (Objective Stress Level; ∆OSL), and ecological momentary assessments (EMAs). Two commonly used EMAs within AmDTx are self-reported stress (∆SRS) and self-reported mood (∆SRM). These three data sources were used to independently train an algorithm designed to predict what future therapy sessions would prove most efficacious for each individual. Algorithm predictions were compared against the efficacy of the individual's self-selected sessions.

Eligibility Criteria:
Inclusion Criteria:

* Completion of at least 28 English-language psychotherapy sessions that contained the required session payloads for algorithm inclusion, and only when the objective and two subjective measures were all completed both before and after each session.

Exclusion Criteria:

* Under 18 years old
A Validation Study of the NightOwl Home Sleep Apnea Test

The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the apnea hypopnea index (AHI) estimate, defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. This study will be performed in a sleep lab environment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with an indication for an in-lab polysomnography

Exclusion Criteria:

* Intellectually disabled people