cyrilzakka/clinical-trials huggingface dataset:
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

* The subject will undergo a review of their medical history, physical exam, and screening laboratories.
* A pelvic ultrasound will be performed to assess baseline follicular size.
* A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
* During the course of kisspeptin administration, subjects will

  * Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
  * Undergo pelvic ultrasounds (approximately 4 sessions)
* Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin

Eligibility Criteria:
Inclusion Criteria:

* Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)

  • Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins\]
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* Laboratory Studies:

  * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
  * Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)
* Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration
* No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration

Exclusion Criteria:

* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
* Excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs

  • Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below
* Pregnant or trying to become pregnant
* Breast feeding
* History of bilateral oophorectomy (ovaries were removed)
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side

African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.


Eligibility Criteria:
Inclusion Criteria:

1. BMI 25-45 kg/m2
2. Age 18-75
3. Attend one of the West Side partnership churches at least 2 times per month
4. Able to attend in-person meetings
5. Willing to share their experiences on the West Side ALIVE Facebook page

Exclusion Criteria:

1. Blood pressure \> 170/90 (self-report or during the WSA screening)
2. Diabetes treated with insulin
3. History of cancer within the past 5 years
4. Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months
Effects of Dating Violence Education Program on Bystanders' Help-giving Intention and Behavior Among College Students

The present study was a quasi-experiment study. College students were recruited and divided into two groups: the experimental group and the control group. There were roughly 180-210 participants in each group, which totaled 360-420 people in all. The measurements of Dating Violence Myths and Dating Violence Bystander Help-giving Intention Questionnaire were implemented with a pre-, post-test, and 2-month follow-up design to analyze the immediate and continued educational effects. The investigators also invite 10 -30 participants to participate in online anonymous group interviews to collect qualitative data. The investigators expect dating violence education programs can improve college students' dating violence myths and dating violence bystander help-giving intention and behavior. The dating violence education program on the e-learning platform can be widely used in other colleges to build up safe dating relationships and friendly campuses.

Dating violence is a global health problem that strongly affects young people's physical and mental health. Whether bystanders who are witnesses or are asked for help take action to help victims influences the cycle of violence, but the studies of bystander behavior and prevention programs for dating violence have lacked in Taiwan. The investigators designed and constructed the e-learning platform as an education program on dating violence based on the theory of planned behavior to evaluate the effectiveness of the programs in improving dating violence myths and bystanders' help-giving intention and behavior among college students. The present study was a quasi-experiment study. College students were recruited and divided into two groups: the experimental group and the control group. There were roughly 180-210 participants in each group, which totaled 360-420 people in all. The measurements of Dating Violence Myths and Dating Violence Bystander Help-giving Intention Questionnaire were implemented with a pre-, post-test, and 2-month follow-up design to analyze the immediate and continued educational effects. The investigators also invite 10 -30 participants to participate in online anonymous group interviews to collect qualitative data. The investigators expect dating violence education programs can improve college students' dating violence myths and dating violence bystander help-giving intention and behavior. The dating violence education program on the e-learning platform can be widely used in other colleges to build up safe dating relationships and friendly campuses.

Eligibility Criteria:
Inclusion Criteria:

* College students aged 18-25 years, and agree to participate in this study.

Exclusion Criteria:

* Married college students.
Development of an Empowerment Intervention for Young Women Living With HIV

This study will develop/adapt a culturally appropriate secondary prevention intervention for young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation for a full-scale randomized trial.

Once the intervention is developed/adapted, the sites will pilot the interventions twice to enable modifications. The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease (STD). Data will be collected to assess the feasibility and acceptability of the newly developed intervention using both quantitative and qualitative methods at each iteration.


Eligibility Criteria:
Inclusion Criteria:

* Female at birth and currently female;
* Receives services at one of the selected ATN sites or their community partners
* HIV-infected as documented by medical record review or verbal verification with referring professional
* Between the ages of 16-24 years (inclusive) at the time of informed consent/assent
* Ability to understand both written and spoken English
* Gives informed consent/assent for study participation

Exclusion Criteria:

* Presence of active, serious psychiatric symptoms (e.g., hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements
* Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
* Intoxicated or under the influence of alcohol or other substances at the time of study enrollment\*.

  * Intoxication at the time of visit will exclude participation at that time. Participants cannot be visibly under the influence of substances at the time of enrollment or consent. If a participant returns to enroll while sober, enrollment can occur. Similarly, if a participant arrives to an intervention group visibly intoxicated, then she will be asked to leave. However, prior intoxication does not eliminate future participation. Thus, those who are dismissed from a session due to intoxication can return to a subsequent session as long as they are sober.
A Study of CI-1012 in HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.

Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Serologic evidence of infection with HIV-1.
* CD4+ cell count \>= 200 cells/mm3.
* HIV-1 RNA \>= 10,000 copies/ml.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Viral, fungal, or bacterial infection requiring therapy other than topical medications.

Concurrent Medication:

Excluded:

* Prophylactic systematic antibacterial, antifungal or antiviral agents.
* Antiretroviral therapy. NOTE:
* Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.

Prior Medication:

Excluded:

* Experimental therapy for \>= 4 weeks prior to initiation of study medication.
* Antiretroviral treatment for 3 weeks prior to initiation of study medication.
* Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.
Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.


Eligibility Criteria:
Inclusion Criteria:

* Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
* Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:

  1. a moderate-to-high emetogenic regimen, or
  2. oxaliplatin at doses employed for treatment of colon cancer, or
  3. the combination of AC \[AdriamycinÒ (60 mg/m2) with cyclophosphamide (600 mg/m2)\] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.

Exclusion Criteria:

* Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
* Chemotherapy agents falling into the high (Level 5) classification during study.
* Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.

This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed as Crohn's disease at least 3 months prior to screening.
* Have active Crohn's disease despite adequate conventional therapy.

Exclusion Criteria:

* Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery.
* Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and anti-IL-6 agents, etc.).
Assessing the Benefits of the Vibraject Attachment

Behavioral and physiologic observations suggest that the injection of local anesthetic is among the most feared or anxiety producing procedures during dental intervention. Discomfort during the injection is currently reduced by pharmacologic or mechanical methods. No technique has proven to be effective for every patient. The VibraJect LLC (USA) was first introduced in 1995 and was developed under the hypothesis that a vibrating needle would stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying the pain signal from the injection site. Studies on adult patients have been promising. The purpose of this study is to investigate the efficacy of the VibraJect dental syringe attachment in reducing injection discomfort and procedural anxiety in the pediatric dental population.

One hundred children will be recruited from the UNMC Pediatric Dentistry clinic. Eligible children will be selected from the 4-6 year group who are scheduled for routine dental restorative treatment and who have or have never received a dental injection. Each patient will randomly participate in either a control or experimental condition. The device will be attached for both conditions. During the control injection, the dentist will perform the dental injection as usual. During the experimental injection, the dentist will activate the attached device and perform the injection. Immediately following each injection, the patient will rate the pain on a visual analog scale and a trained observer will rate the child's behavior on a Frankl behavior scale. A videotape of the procedure will be reviewed by an independent dentist who will evaluate the child's response and any perceived disruptive behavior. This observer will be blind to whether the instrument is functioning.

Eligibility Criteria:
Inclusion Criteria:

1. Attending the UNMC pediatric dentistry clinic for dental restorations requiring injection of local anesthetic for restorative procedures with or without use of inhalation anesthesia but without physical restraint
2. age 4 to 8

Exclusion Criteria:

1. No parent or legal guardian is present
2. Parent does not give consent
3. Non-English speaking participants will be excluded because PI is English speaking and this study needs behavior guidance of children that only the dentist can deliver and not an interpreter.
U011 - Wireless Ultra Long-Term EEG Recordings in Epilepsy

The present study is a 13 months pre-market open-label, prospective study for confirmation of continuous performance and safety of UNEEG EpiSight solution in subjects with uncontrolled epilepsy (indicated for EEG monitoring with the Implant) in which seizures are detectable in an area of the Implant. The surgical procedure, device satisfaction, and effectiveness of the UNEEG EpiSight solution will also be evaluated during the clinical investigation.

The study is a multi-center study with 2-5 European sites in 2-4 countries. Each site will enrol up to 10 subjects, but total enrolment will not exceed 22 to reach 19 completers of 40 days of recording. The total recruitment period is expected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last subject out).

Eligibility Criteria:
Inclusion Criteria:

* Patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant
* Adults (above 18 years)
* Is willing and able to use the UNEEG EpiSight solution day and night for the duration of the study
* Subject is willing and able to provide written informed consent
* Subject is able to complete all study-required procedures, assessments and follow-up

Exclusion Criteria:

* Vulnerable subjects, including severe cognitive impairment precluding informed consent
* Cannot or do not have the necessary assistance, to properly operate the system
* High risk of surgical complications, such as active systemic infection and haemorrhagic disease
* Involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation
* Contraindications to the local anaesthetic used during implantation and explantation
Rhythm Disturbances After Ventricular Septal Defects

We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. We will collect the following information on each patient:

Patient Date of Birth Date of the surgical procedure

Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent pacemaker Outcome of pacing (i.e. pacing successful)

We hope to look at each data element in order to determine potential risks factors for surgical heart block. By identifying the risk factors, the investigator hopes to establish a training program regarding surgical avoidance of certain areas of the heart (if possible) and education regarding pacemaker follow-up.

Each patient will be given a unique study number. The patient's name, social security number, medical record number or initials will not be used in our research database.


Eligibility Criteria:
Inclusion Criteria:

Patients with heart block after surgery -

Exclusion Criteria:

-
Self-Help for Stress Related to COVID-19

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who score in the moderate or higher range on a stress measure during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Stress and psychosocial symptoms will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or higher stress as assessed using Stress subscale of the Depression Anxiety Stress Scales-Short Form
* Current student at a college or university in the United States
* Able to provide consent
* Proficient in English

Exclusion Criteria:

* Below age 18
* Failure to meet any of above inclusion criteria
* Current participant in separate randomized controlled trial being conducted by this research group examining efficacy of SilverCloud Health interventions
Dose Reduction and Discontinuation With Anti-Fibrotic Medications

The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date)
* Evidence of IPF: patient with at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for IPF during the study period (10/01/2013 to 09/30/2022)
* At least 18 years old at the index date
* Have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period

Exclusion Criteria:

* Any history of lung transplant during the 12-months pre-index/baseline period
* Any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period
* Evidence of non-IPF chronic fibrosis Interstitial Lung Disease (ILD) or connective tissue diseases during the 12-months pre-index period. The following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's syndrome, and mixed connective tissue disease (CTD), sarcoidosis, and hypersensitivity pneumonitis).
* Missing demographic information (i.e., age or sex)