cyrilzakka/clinical-trials huggingface dataset:
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users

This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.

New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. The most common reason for discontinuation of the copper IUD is symptoms related to bleeding. Research looking at disturbances in bleeding patterns among new IUD users is sparse and dated. Perceived changes in vaginal bleeding may impact method satisfaction, acceptability, and continuation. There is a need for updated research evaluating changes in bleeding patterns in order for providers to better counsel patients on what to expect during the months after initiation of an IUD.

A variety of methods to evaluate bleeding profiles are available. The World Health Organization (WHO) published recommendations for methods of collection and analysis of bleeding patterns. The WHO method includes data collection on bleeding days (days when blood loss requires the use of a menstrual pad or tampon) and spotting days (when no protection was needed) using 90-day referent periods. A second tool, the pictorial blood loss assessment chart (PBAC) has been shown to be an inexpensive and objective method of assessing blood loss. The PBAC takes into consideration how heavy blood flow is as well as the number of sanitary napkins and tampons used. Additionally, new technologies (including mobile period tracking applications) have made retrospective collection of bleeding data more feasible and prospective data collection more accurate.

This study aims to incorporate these validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD
* Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days
* Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles)

Exclusion Criteria:

* Use of any hormonal contraceptive method in the previous 3 months
* Irregular duration of menstrual cycles in the last 3 cycles (\<21 or \>35 days)
* Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles
* Contraindication to use of the ParaGard® T380A IUD
* Mucopurulent cervicitis at the time of IUD insertion
* Unable to speak, read, and write in English
* Currently pregnant
* Plans for or desire for pregnancy in the next 6 months
* Currently breastfeeding
* Women who are \<6 months postpartum
* Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment
* Wilson's disease
* Known coagulopathy or bleeding disorder
Comparison of Fast-Absorbing Sutures for Mohs Surgery

This study is being carried out to assess equivalence of scar outcome for two absorbable sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there is no evidence indicating if any of the sutures above allow for a better cosmetic outcome (less erythema, edema, and scarring).

Prospective randomized controlled split-scar observer-blinded study.

After dermatologic surgery on the face, surgeons have a choice between using non-absorbable or absorbable sutures for skin closure. A dermatologic surgeon favoring absorbable sutures for wound closure will consider many factors in material selection, including ease of manipulation, cost, and absorption time. However, there have been no randomized trials comparing the most important measure: aesthetic/cosmetic outcome.

Study endpoint/outcome: use three validated scar assessment tools.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 18 years and are having Mohs surgery on the face.

Exclusion Criteria:

* Patients with surgical wounds less than 4cm in length
* Patients requiring full thickness skin grafts for reconstruction
* Patients who are unable to attend routine postoperative follow-up appointments
* Patients who are receiving radiation therapy after surgery.
Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.

In a prospective protocol with retrospective information, patients (N=240) undergoing bariatric Roux-en-Y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up \>3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. Patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. Preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. Using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. The study should answer whether gastric and colorectal surgery for cancer 1) Are beneficial for established diabetes; 2) Attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;

Eligibility Criteria:
Inclusion Criteria:

* Follow-up period \> 3 years,
* weight stable in the last year

Exclusion Criteria:

* Reoperation or take-down of original operation,
* consumptive diseases,
* protein-calorie malnutrition,
* organ failures,
* pancreatic surgery,
* cell or organ transplantation,
* type 1 diabetes,
* cognitive impairment or Alzheimer disease,
* refusal to participate in the protocol
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain

RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine.

PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.

OBJECTIVES: I. Assess the long-term safety and efficacy of oral naloxone in treating opioid-induced constipation in patients with chronic malignant or non-malignant pain.

OUTLINE: This is a multicenter study. Patients receive oral naloxone twice daily. Each patient receives an escalating dose until the minimum effective dose or the maximum dose allowed is reached. The minimum effective dose is defined as the dose at which a patient has at least 4 bowel movements within 7 days. Patients receive the minimum effective dose for 7 days and then continue long-term treatment for a maximum of 72 weeks. Patients receiving the maximum dose allowed with fewer than 4 bowel movements per week will discontinue study therapy.

PROJECTED ACCRUAL: Approximately 600 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Moderate to severe opioid-induced constipation Previously enrolled on protocols NAL-0396, NAL-0397, and/or NAL-0398 OR Low frequency of bowel movements, defined as fewer than 3 per week during the past 2 weeks, AND either of the following: Score of "some", "quite a bit", or "very much" on the constipation distress scale Laxative or enema dependence Daily opioid intake equivalent to at least 30 mg of oral morphine for chronic pain of malignant or non-malignant origin Stable dose of opioid analgesic agent for at least 2 weeks No score of "excruciating" on verbal pain scale No history of partial or complete bowel obstruction No constipation secondary to factors other than opioids (e.g., autonomic neuropathy or intra-abdominal adhesions)

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Potassium normal Other: No uncontrolled endocrinopathy or diabetes No psychiatric disorder or encephalopathy that would preclude study No clinically significant medical conditions that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed provided patient has completed at least 1 course prior to study Endocrine therapy: Concurrent hormonal therapy allowed provided dosage is stable for at least 2 weeks prior to study Radiotherapy: No concurrent palliative radiotherapy to spine, abdomen, or pelvic area Surgery: Not specified Other: At least 30 days since other investigational drug
Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair

Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare HTK cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of Fallot planned for total repair.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with tetralogy of Fallot spectrum.
* Sex (males and females)
* Age 6 months- 5 years.

Exclusion Criteria:

* Persistent left SVC draining in the coronary sinus.
* Mental or neurologic disorders.
* Preoperative critically ill patients.
* Parents or legal guardian refusal.
* Fallot repair with transannular patch( as it will affect on the RV function as a single agent after reperfusion)
A ProspectiveTrial Using Video Images in Advance Care Planning in Hospitalized Seriously Ill Patients With Advanced Cancer

The purpose of this study is to compare the decision making of hospitalized subjects with advanced cancer having a verbal discussion about CPR compared to subjects using a video.

Aim 1: To recruit 150 subjects with advanced cancer admitted to the inpatient oncology ward with an overall prognosis of one year or less and randomly assign these subjects to:

1. a video visually depicting CPR preferences or
2. the current standard of care without the use of video (control).

Hypothesis 1: It is feasible to recruit and randomize 150 hospitalized subjects with advanced cancer and an overall prognosis of one year or less.

Aim 2: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.

Aim 3: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.

Hypothesis 3: Subjects randomized to the video are more likely to have their code status documented in the electronic medical records compared to those who do not see the video.

Aim 4: To compare the decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 4: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.

Aim 5: To compare knowledge assessment of CPR of subjects randomized to video and subjects randomized to current standard of care without the video.

Hypothesis 5: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.

Aim 6: To compare code-status (CPR, and intubation) preferences in the electronic medical record on future hospitalizations up to one year post-hospital discharge of subjects randomized to video and subjects randomized to current standard of care without the video.

Hypothesis 6: Subjects randomized to the video are more likely to opt against CPR and intubation in the future compared to those who do not see the video.

Eligibility Criteria:
Inclusion Criteria:

* Potential subjects will be identified by the research assistant. The specific eligibility criteria include:

  1. Over the age of 60
  2. The ability to provide informed consent
  3. The ability to communicate in English
  4. An established diagnosis of metastatic cancer with a prognosis of one year or less confirmed with the attending physician on service.
Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy

1. To compare the corneal epithelial defect healing time between diabetic patients receiving and not receiving supplementary oxygen after vitrectomy.
2. To determine whether factors such as age, duration of diabetes, duration of surgery and level of glycemic control have any influence on corneal epithelial wound healing time in diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.

This study aims to determine whether systemic oxygen therapy delivered through face mask would have beneficial effects on the healing of corneal epithelial wound in post-vitrectomy diabetic patients. It will be a prospective, randomised interventional clinical study conducted on diabetic patients indicated for vitrectomy. Rationale of this study is to see if systemic oxygen delivered via face mask will hasten the resolution of corneal epithelial defects, which may either be iatrogenic (surgically-induced intra-operatively to enable clearer visualisation for the surgeon) or spontaneous (due to corneal epithelial fragility which is commoner in diabetics)

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients aged 18 years and above planned for pars plana vitrectomy that required intra-operative corneal epithelial debridement to allow better surgical visualisation of the fundus were recruited within the study duration

Exclusion Criteria:

* pre-existing ocular surface or corneal disease, recent eye surgery within one month from the vitrectomy, glaucoma and if the patients have any contraindications to oxygen therapy (e.g. chronic obstructive pulmonary disease).
A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis

The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
* Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example \[eg\], due to important side effects or safety risks)
* Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
* Have an eczema area and severity index (EASI) score greater than or equal (\>=) to 16 at screening and at baseline
* Have an investigator global assessment (IGA) score \>=3 and involved body surface area (BSA) \>=10 percent (%) at screening and baseline

Exclusion Criteria:

* Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
* Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
* Has or has had herpes zoster within the 2 months before screening
* Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening
Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia

This study will explore the helpfulness of a short psychological group treatment called cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it aims to improve difficulties that are related to behaviors and emotions by first working on identifying and changing negative inaccurate thoughts. The main goal of this intervention is to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia so that they can improve their social functioning and help their psychotic symptoms. The study compares the usefulness of adding CBT to standard services.

Social anxiety is highly prevalent in people with schizophrenia and represents a major obstacle to positive functional outcomes. Social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. Current existing manualized treatment for social anxiety may not be optimal for people with schizophrenia for a number of reasons described above. An adapted CBT intervention for schizophrenia must target the stigma attached to the illness, the presence of poor social skills, the presence of delusional and persecutory ideas, possible limited reading abilities, and associated cognitive deficits. The investigators propose to develop and test an adapted group CBT for social anxiety. The main objective of this research proposal is to contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) on reducing symptoms of social anxiety. Considering the relationship between certain characteristics of social anxiety (e.g. social withdrawal) with diminished quality of life and poor functional outcome, a secondary objective is to examine the impact of reduced social anxiety on functional outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a schizophrenia spectrum disorder; aged 18-50; be able to read and write at an intermediate level (Education \> 8 years or more); social anxiety scores above 34 for the SIAS, above 19 for the SPIN and above 20 for the BSPS; and the the presence of observable clinical symptoms supporting the diagnosis of a social anxiety disorder on Axis I.

Exclusion Criteria:

* Diagnosis of affective psychosis; currently clinically stable \[score of 3 or less of the SAPS ratings; Global Assessment Scale score (Endicott, et al., 1976) of ≥ 50\]; have no significant presence of social anxiety (score on scales below cut-off); hospitalized or hospitalized at the time of recruitment; and a change medication within the past 6 weeks.
Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve

The introduction of light emitting diode (LED) devices as a novel treatment for pain relief in place of low-level laser warrants fundamental research on the effect of LED devices on one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized controlled study will be conducted by measuring nerve conduction on the superficial radial nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the placebo group will be treated by sham irradiation. The purpose of this study is to investigate the effects of LED light on the conduction velocity and amplitude of the superficial radial nerve.


Eligibility Criteria:
Inclusion Criteria:

* no history of neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy

Exclusion Criteria:

* positive findings during the clinical screening examination suggestive of an underlying neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.
* a history of a neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.
Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers

The aim of this study is to pilot test a web-based, patient-centered educational program that encourages the patient to have an informed discussion about pain medication options with their emergency department (ED) provider.

This multi-site, randomized trial will evaluate an m-health program designed to aid the patient in making an informed decision about their pain treatment. Patients reporting to the ED with an injury-related chief complaint who agree to participate are randomized to receive the intervention program, My Healthy Choices, or an attention-matched control. My Healthy Choices pairs tailored education with a patient decision aid to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor. Data are collected through surveys at three time points during the ED encounter (baseline, immediately after the intervention, and just before discharge), and at a 6-week follow-up survey. The primary outcomes are whether the patient prefers an opioid pain reliever (OPR) and whether the patient takes an OPR. The investigators hope this program will facilitate patient-provider communication, as well as reduce the number of prescriptions written for OPRs and thus the number of patients exposed to prescription opioids and the associated risks of addiction and overdose.

Eligibility Criteria:
Inclusion Criteria:

1. ED visit for an injury- or pain-related chief complaint
2. 18 years of age or older
3. speak English
4. has a smart phone or email address that is used on a regular basis
5. no previous medical care for the current complaint
6. triage pain score between 7-10

Exclusion Criteria:

* allergy to pain medications
* have used a prescription pain medication for more than two days in the past month
* report renal problems or a history of dialysis