cyrilzakka/clinical-trials huggingface dataset:
Choice Architecture and Colorectal Cancer Screening Outreach

This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:

Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

Eligibility Criteria:
Inclusion Criteria:

* Between 50 and 74 years old
* Has a primary care provider who is a University City or Valley Forge Family Medicine provider
* Has had at least 2 office visits at either practice
* Is due for colorectal cancer screening
* Is asymptomatic for CRC
* Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area

Exclusion Criteria:

* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures)
* Has a history of CRC or colonic polyps
* Has a history of GI cancer
* Has a history of confirmed Inflammatory Bowel Disease (IBD)
* has a history of colitis other than Crohns disease or ulcerative colitis)
* Has a first degree relative that has been diagnosed with CRC
* Has had a colectomy
* Has been diagnosed with Familial Adenomatous Polyposis (FAP)
* Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
* Has iron-deficiency anemia
* Has a history of lower GI bleeding
* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has cirrhosis
* Has heart failure
* Has dementia
* Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest.

The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.


Eligibility Criteria:
Inclusion criteria:

* Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks
* Chest compressions for at least 2 minutes
* Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
* Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
* Definitive temperature control device initiated
* Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
* Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours

Exclusion criteria:

* Glasgow Coma Motor Score (GCMS) = 6
* LAR does not speak English or Spanish
* Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes
* Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
* Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
* Pre-existing terminal illness, unlikely to survive to one year
* Cardiac arrest associated with brain, thoracic, or abdominal trauma
* Active and refractory severe bleeding prior to randomization
* Extensive burns or skin lesions incompatible with surface cooling
* Planned early withdrawal of life support before 120 hours
* Sickle cell anemia
* Pre-existing cryoglobulinemia
* Non-fatal drowning in ice covered water
* Central nervous system tumor with ongoing chemotherapy
* Previous enrollment in P-ICECAP trial
* Prisoner
* Chronic hypothermia
* New post-cardiac arrest diabetes insipidus
* Pregnancy
COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)

The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.


Eligibility Criteria:
Inclusion Criteria:

* \> 40 years old and \< 75 years old
* Affiliated to the MSA

Exclusion Criteria:

* COPD known
Pilot Sleep Extension and Mood

The goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. The main questions it aims to answer are:

Will this intervention improve sleep? Will this intervention improve mood? Does the effect of this intervention change based on environmental factors like noise and light pollution?

Researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups.

Participants will:

* receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content
* have their sleep monitored daily with a FitBit and Somnofy sleep device and during the 6-week intervention period
* respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 30
* Have internalizing symptoms (e.g., depression, anxiety, stress)
* Have sleep concerns
* Sleep less than 7 hours per night
* Have perceived neighborhood disorder
* Smart phone that can run Somnofy app
* Access to Wifi in their home

Exclusion Criteria:

* High risk for obstructive sleep apnea
* Significant medical morbidities or psychiatric problem, or chronic substance use
* Non-English speaking (unable to participate in therapy or questionnaire)
* Taking medications for sleep
* An insomnia disorder
* Traveling for 2 weeks or more during the 10-week study period (due to loss of data from participants not sleeping in their home where the Somnofy device has been set up)
* Employed with rotating shift or night work
Registry for Stage 2 Type 1 Diabetes

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.

TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.

The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

TZIELD-Exposed Cohort

* Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
* Day 1: 65 mcg/m2
* Day 2: 125 mcg/m2
* Day 3: 250 mcg/m2
* Day 4: 500 mcg/m2
* Days 5 through 14: 1,030 mcg/m2 per day
* Cumulative dose is approximately 11,240 mcg/m2
* Appropriate written informed consent/assent as applicable for the age of the patient

TZIELD-Unexposed Cohort

* Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
* Appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria:

* Patients who initiated TZIELD treatment more than 6 months prior to enrollment
* Patients who had participated in a previous clinical trial for TZIELD
* Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled
A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects

This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects


Eligibility Criteria:
Inclusion Criteria: All Groups

* Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.
* Subjects must have a body mass index (BMI) between 18 and 32 kg/m2.
* Male subjects must agree to a highly effective method of birth control from screening until at least 90 days after the last dose of study drug.

Exclusion Criteria:

* Subjects with a clinically relevant history or presence of any clinically significant disease.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
* History of drug or alcohol abuse within 2 years prior to Check-In.
* Alcohol consumption of \>21 units per week.
* A positive urine drug screen and/or positive alcohol breath test at Screening and/or Check-in.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening.
* Use of tobacco- or nicotine-containing products within 3 months prior to Check-In.
* History of blood donation of 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness

Therefore, the aim of this study is to assess the therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep, and depression between tibolone and E2V/MPA.

From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression.

Menopausal syndromes include overactive bladder symptom, autonomic symptoms, and even sexual dysfunction. Hormone therapy (HT) is widely used for controlling menopausal symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate (MPA), and conjugated equine estrogens (CEE) \& MPA.

However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack of comparison research about their therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep and depression. The knowledge of the above therapeutic effects should be important for choosing a suitable medication. Therefore, the aim of this study is to assess the therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability and arterial stiffness between tibolone and E2V/MPA.

All female patients with intact uterus who underwent treatment for menopausal syndrome at Far Eastern Memorial Hospital from October 2021 will be included. An open-labeled, prospective, comparative study design will be used. HT included tibolone (2.5 mg/day) or E2V (1mg) \& MPA (2.5 mg) per day. The enrolled women will be requested to complete the Greene climacteric scale, Urgency Severity Scale, Overactive Bladder Symptom Score, the International Prostate Symptom Score (IPSS), the Female Sexual Function Index (FSFI), the Pittsburgh Sleep Quality Index, Center for Epidemiological Studies Depression questionnaire, heart rate variability, arterial stiffness and atherosclerosis examinations at baseline, and 4 weeks (visit 2) and 12 weeks (visit 3) after treatment.

From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression. Currently, there is no similar research as our current study.

Eligibility Criteria:
Inclusion Criteria:

* \>20 years old female
* Menopausal symptoms, still have a uterus, and no breast or other cancers, and no vascular-blocking disease such as stroke.

Exclusion Criteria:

* Nil.
The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization

Assessment of the association between human papillomavirus vaccination (HPV) and recurrences of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women undergoing conization.

The implementation of vaccination against human papillomavirus (HPV) in the national immunization program for the young age cohort was subsequently extended to previously unvaccinated adult women who underwent conization due to cervical intraepithelial neoplasia grade 2 or worse (CIN2+).

These women are offered HPV vaccination, often completed post-excision. Observational and clinical studies conducted between 2010 and 2023 have demonstrated that HPV vaccination contributes to a \>70% reduction in CIN2+ recurrence in women after conization. However, the outcomes of these studies have not conclusively shown whether the adjuvant effect of HPV vaccination depends on the vaccine type (bi-, quadri-, or nona-valent), the timing and completeness of vaccination, and other factors.

This study aims to assess the mentioned factors and potentially reveal new ones, such as age, health status, etc. It is planned to be conducted using the laboratory records of women who underwent conization between 2010 and 2024, with their cervical screening examinations performed at the central laboratory UNILABS in Prague

Eligibility Criteria:
Inclusion Criteria:

* Women \>18 years, with conization for CIN2+ (HSIL)
* Women who had more than one examination during a follow-up period of \>6 months.

Exclusion Criteria:

- Women who underwent hysterectomy after conization.

* Women who had excision procedures other than cervical excision.
* Women who did not undergo any other cytological/histological examinations.
* Women with more than one conization before CIN2+ recurrence
Vestibular Rehabilitation for Strokepatients With Dizziness

Recently, the investigators has shown that dizziness is common among patients with first time stroke and that it affects self perceived health. There are indications that vestibular rehabilitation can have effect of neurological causes of dizziness and vertigo and it therefore seems important to find out if vestibular rehabilitation can affect dizziness among patients with stroke.

The aim of this study is to find out if vestibular rehabilitation can have any effect on function, balance and self-rated health among patients with first time stroke.


Eligibility Criteria:
Inclusion Criteria

• First time stroke with dizziness -

Exclusion Criteria

* Not first time stroke
* No dizziness
ePREP for Community Couples

The purpose of the present study is to examine the impact of ePREP when it is administered to couples. More specifically, investigators will test whether--compared to placebo controls--participants who receive ePREP will experience better outcomes for relationship relevant variables.


Eligibility Criteria:
Inclusion Criteria:

* Only those who are married or who have been in a committed romantic relationship for six months or longer will be invited to participate.

Exclusion Criteria:

* The only exclusionary criteria were inability to read study questionnaires and unwillingness to access the internet to receive e-mail instructions on weekly homework assignments.
Using the Roots of a Non Restorable Wisdom Tooth as a Block for Augmentation of Localized Defects

assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block.

A total of 14 patients in need of implant therapy and lateral ridge augmentation were allocated to parallel groups receiving either 1) healthy autogenous tooth roots (e.g. retained wisdom or impacted teeth or 2) cortical autogenous bone blocks harvested from the retromolar area. After 26 weeks of submerged healing the horizontal bone gain were assessed both clinically and radiographically. A core biopsy was taken during the implant placement to assess the histology of the newly formed bone.

Eligibility Criteria:
Inclusion Criteria:

1. Candidate for lateral ridge augmentation
2. Insufficient bone ridge width at the recipient site for implant placement
3. Sufficient bone height at the recipient site for implant placement
4. Healthy oral mucosa, at least 3 mm keratinized tissue.
5. Presence of wisdom teeth free from periapical infection.
6. Missing maxillary or mandibular tooth with moderate horizontal defect (4-8) according to cologne classification

Exclusion Criteria:

* 1) Patients are systemically free according to Modified Cornell Medical Index 2) smokers patients. 3) Pregnant or lactating women.
Metabolic Syndrome Feasibility Study

The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with Metabolic Syndrome identified by medical doctors.


Eligibility Criteria:
Metabolic Group

Inclusion Criteria:

1. Sex: Male or Female
2. Age range: 21 to 85
3. Qualifying Metabolic Syndrome diagnosis(using the National Cholesterol Education Program Adult Treatment Panel (ATP) III definition)(Grundy, 2004)

   Subjects will be identified as having Metabolic Syndrome if they meet at least three of the following five criteria:
   * Elevated waist circumference: ≥ 102 cm (≥40 inches) in men, ≥ 88 cm (≥35 inches) in women
   * Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L) or on drug treatment for elevated triglycerides (examples include, but are not limited to, fibrates and nicotinic acid)
   * Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in men or \< 50 mg/dL (1.3 mmol/L) in women or on drug treatment for reduced HDL-C
   * Elevated blood pressure: ≥ 130 mm Hg systolic blood pressure or ≥85 mm Hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension
   * Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated glucose
4. The patient or legal representative is able to understand and provide signed consent for the procedure.

Exclusion Criteria:

1. Patients \< 21years in age or \> 85 years in age.
2. Inability or unwillingness to provide informed consent.
3. Patients with pacemakers or another electrical device implanted somewhere in their body.
4. Pregnant women.
5. Missing all or part of fingers or cuts/burns on pads of fingers
6. Hand tremors or involuntary oscillations of the hands that prevents clear imaging

Control Group:

Inclusion Criteria:

1. Sex: Male or Female
2. Age range: 21 to 85
3. Freedom from qualifying medical diagnoses (control group)

Any one of the following will exclude the subject from participation in the study

1. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
2. Documented current diagnosis/treatment of coronary artery disease or heart attack
3. Documented as currently in Renal Failure (chronic or acute) or on renal dialysis
4. Documented current diagnosis/treatment for Hepatitis

5 .The patient or legal representative is able to understand and provide signed consent for the procedure.

Exclusion Criteria:

1. Patients \< 21 years in age or \> 85 years in age.
2. bility or unwillingness to provide informed consent.
3. Patients with pacemakers or another electrical device implanted somewhere in their body.
4. Pregnant women.
5. Missing all or part of fingers or cuts/burns on pads of fingers
6. Hand tremors or involuntary oscillations of the hands that prevents clear imaging
BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Consequences will be faster absorption and higher peak concentration of ethanol after surgery than before. There are growing concerns that surgery for obesity in this way may cause alcohol abuse.

In this study the investigators compare changes in FPM of ethanol following two different bariatric surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* volunteers from Central Norway
* morbid obese BMI \> 40 kg/m2)
* morbid obese BMI \> 35 kg/m2 given a obesity related disease that qualifies for bariatric surgery

Exclusion Criteria:

* previous or current alcohol abuse
* risk for alcohol harm as assessed by AUDIT
* alcohol abstinence
* liver disease except fatty liver, which occurs in more than 50% of those who seek bariatric surgery
* previous colon resection
* not/insufficiently able to informed consent
* drugs that interact with alcohol dehydrogenase
* drugs that slow down emptying of the stomach
* pregnancy