cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Effects of Reproductive Health Training on Provider Behavior

The goal of this randomized, controlled, single blinded trial is to evaluate the medium to long-term effects of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health in Tanzania.

All enrollees will be health students at MUHAS recruited through announcements in class, flyers on student noticeboards, and email. Students who are interested in learning more about the study can do so by asking questions of the recruiting faculty member, by going to, telephoning, or emailing the study office (at MUHAS). Students can also visit the study website. In addition, all students who contact the office will be given a copy of a flyer advertising the study and a copy of the consent documents to preview prior to participation. Students contacting the office by email will be sent electronic versions of the same documents.

Participants in Aim 1 are informed to schedule an appointment (in the month prior to the seminar) to complete a pre-evaluation. At the study site, participants complete pen and paper surveys, and are videotaped interviewing two standardized patients. Next, participants are randomized to either the intervention or waitlist control condition. Participants in the intervention will attend the 4-day sexual health seminar and complete a short post-test. In addition, at 6- and 12-month follow-up after the pre-test, participants in both arms complete surveys and two videotaped interviews (at each follow-up) and a final survey at 24-month follow-up. At the end of the study, participants assigned to the control condition can attend the seminar.

Eligibility Criteria:
Inclusion Criteria:

* A health student studying at MUHAS and verified by being registered as a pre-final year midwifery, nursing or medical student (or its equivalent).
* "Pre-final" year is defined as a student who is just about to enter year 3 of nursing, or year 4 of midwifery or medicine.
* Living or studying in Tanzania
* Experienced, operationalized as having worked at least 100 hours as a health worker in a clinic, hospital or community setting so students can discuss what happens in the clinical setting
* Able to speak English and Kiswahili.

Exclusion Criteria:

* Students who will not be able to attend all days of the seminar at their health institution or be on their campus for the follow-up.
* Students who express any reservations about attending (e.g., due to religious objections)
* Students who express a fear of violence due to attending (e.g., from a spouse or relative).
* Students who attended the sexual health seminar (e.g., during THP-1 or at another site). This is to prevent a student participating more than once.
The Effect of Vegetarian Diet on Patients With Metabolic Associated Fatty Liver Disease

In this study, 18-60 years old patients with metabolic associated fatty liver disease（MAFLD） will be recruited to test the intervention effect of vegetarian diet. This randomized clinical trial randomized individuals to a healthy vegetarian diet or a healthy omnivorous diet for 24 weeks. At the baseline and after the 24week intervention, the clinical manifestations of MAFLD, obesity levels, indices for glucose and lipid metabolism parameters, results of questionnaire and fecal samples will be collected and analyzed.

Dietary control remains an important way for nutritional intervention of metabolic related fatty liver disease. However, studies shows that patients have low compliance to the traditional diet. The topic proposed based on previous studies，recruiting of 220 obesity patients with metabolic associated fatty liver disease aged 18-60. After the informed consent, they will be randomly divided into intervention group and control group, intervention group will be given healthy vegetarian diet intervention and the control group given healthy omnivorous diet. Both diets are in line with the principles of fatty liver treatment. Interventions consisted primarily of face-to -face interview monthly and online interview every 2 weeks, which will be performed by professional dietitians. All participants were asked not to alter their exercise patterns during the study period. The primary outcome was the weight of fat mass after 24 weeks intervention. Secondary outcomes included imaging findings (B-ultrasonic examination and Fibroscan) of MAFLD, liver function, anthropometric measures, plasma lipid and glucose levels. At the meantime, serum oxidative stress indices, results of compliance survey and metabolites of Intestinal flora will be collected and analyzed. Through the above detection of the indicators related to MAFLD and obesity, it is explored whether the vegetarian diet can be an efficient and feasible way to the nutritional therapy of MAFLD.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed as fatty liver, and BMI≥24.0kg/m²;
2. 18-60 years old;
3. Have not received drug treatment if having hyperglycemia, hyperlipidemia and high uric acid ;
4. No antibiotics in the last 1 month;
5. The guardian's informed consent;

Exclusion Criteria:

1. Have received drug treatment of fatty liver disease within three months;
2. Patients with with liver cirrhosis, viral hepatitis and other liver diseases;
3. Patients with serious heart, lung, kidney diseases and patients with cancer;
4. Pregnant and nursing women;
5. Other conditions that may affect the results of the study
Effect of Aerosol Filtering on Infectious Diseases in Day Care

Effect of aerosol flitration and removal on typical infectious diseases such as upper respiratory tract infectinos is studied in day care. Many filtration methods such as filters and electrical filtering are used to remove aerosol particles from room air.


Eligibility Criteria:
Inclusion Criteria:

* Subject is expected to be in the same day care unit for the duration of the study

Exclusion Criteria:

* Subject is known not to be in the same day care unit for the duration of the study
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.


Eligibility Criteria:
Inclusion Criteria:

* 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* Other primary sexual disorders
* History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
* History of penile implant or clinically significant penile deformity.
* Nitrate use
* Certain heart problems
A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will be eliminated. Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Be informed of the nature of the study and have provided written informed consent
2. At least 18 years of age.
3. Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis.
4. Tumor size (renal cell carcinoma; primary tumor) at least 4.0 cm in longest diameter as measured by CT. Distant metastasis at least 1 cm diameter as measured by CT or a distant lymph node metastasis at least 2,5 cm diameter as measured by CT. Clinical stage 'T1b or more; NX; M1'
5. Adequate hematological parameters, i.e:

   B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L
6. Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.

Exclusion Criteria:

1. Performance status \> ECOG 2 after optimization of analgesics
2. Adequate coagulation parameters, i.e: P-Prothrombin complex (PK), P-APT time
3. Ongoing treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 28 days before first vaccination.
4. Previously known or ongoing active autoimmune disease which requires treatment with systemic immunosuppressive agents. E.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases.
5. Patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous cell carcinoma, melanoma), other hematological or solid malignancy or blood dysfunctions.
6. Ongoing infection that requires treatment with antibiotics.
7. Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
8. Known malignancy in CNS.
9. Active or latent virus disease (HIV, HBV and HCV).
10. Ongoing pregnancy or lactation. Females needs to have negative pregnancy test at screening visit.
11. Life expectancy less than 3 months.
12. Concomitant exposure to other investigational products.
13. Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).


Eligibility Criteria:
Inclusion Criteria:

1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
2. Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.

Exclusion Criteria:

1. Patient with impaired renal function
2. Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
3. Female of childbearing potential without adequate contraceptive protection during the study.
4. Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.
CBT Depression Intervention for Co-Occurring Chronic Headache

Having co-occurring depression and chronic headaches is challenging and can greatly impact one's professional, personal, family, and social life. People living with chronic headaches are often at a greater risk of having comorbid psychiatric disorders (depression, anxiety), reduced quality of life, and impaired functioning because of under-diagnosis, misdiagnosis or under-treatment of both chronic conditions.

This study is a pilot clinical trial that will compare the effectiveness of a brief cognitive-behavior therapy (CBT) depression intervention to a care as usual (control) group. The aim of the study is to determine how well the CBT intervention will reduce the frequency, severity and level of disability of both the headaches and depression symptoms.

STUDY LOCATIONS:

(A) University of Georgia College of Education in Athens, GA

(B) Henry Ford Hospital - Main campus in Detroit, MI.

* For the MI participants, you must be willing to travel to Detroit for the intervention if you choose to participate and are assigned to the treatment group.

\*\*Please contact me with any questions about the study.\*\*

Background: This research focuses on emphasizing alternative treatment approaches to underserved and marginalized groups. This study is a randomized pilot intervention to treat a community sample with co-occurring depression and chronic pain (i.e. headaches/migraines) - since they are at an increased risk for impaired functioning, comorbid psychiatric disorders and reduced quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age \& living in GA or MI;
* a PHQ-9 score ≥5; AND
* have frequent migraines and/or moderate to severe headaches = 10 or more headache days per month for the past 3 months
* May or may not be taking headache/migraine medication so long as still meet other criteria
* \*\* For MI participants: must be willing \& able to come to Detroit campus for the intervention (4 weeks in a row)

Exclusion Criteria:

* outside of 18-75 year old age range;
* Do not live in GA or MI
* Unable or unwilling to drive to campus location for the 4 sessions (treatment group only)
* do not have both conditions of depression and frequent/near-chronic headaches
* Active suicidal ideation (detailed plan and/or access to lethal means) or suicide attempts within the past 60 days.
Refine and Assess the Readability of Patient, Carer, and Clinician Treatment Preference in Myelodysplasia Questionnaire

The primary goal of this study is to use qualitative interviews to elicit and confirm concepts related to treatment preferences and understandability of the pTPMQ, cTPMQ, and mTPMQ. The information gathered will be used to support the appropriateness of the questionnaires as a patient-reported, caregiver-reported and clinician-reported outcome measure (PROM) in the population of interest.


Eligibility Criteria:
Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

A. Adult patients with myelodysplastic syndrome meeting any one of the following criteria:

1. They are currently being treated with azacitidine or
2. They have recently been treated with azacitidine or
3. They have been deemed eligible for treatment with azacitidine, but have not yet commenced treatment

B: Primary caregiver of a patient meeting all of the inclusion criteria (i.e. a patient who meets criteria defined above in A).

C. Clinician treating patients meeting all of the inclusion criteria (i.e. treats patients who meet criteria defined above in A).

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

Exclusion Criteria

A. Patients meeting any of the following criteria are excluded:

1. They have lower risk disease (international prognostic scoring system low or intermediate-1 risk)
2. Cognitive or physical impairment of a nature that makes it infeasible for them to effectively participate in a structured interview.
3. Deemed appropriate for stem cell transplantation and are being pre-treated or will be treated with azacitidine
4. They were treated, are being treated, or will be treated with azacitdine as part of a clinical trial
5. They are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).

B. Carers meeting any of the following criteria are excluded:

1. They are a caregiver of a patient who meets any of the exclusion criteria listed above in A
2. They are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).

C. Clinician will be excluded from participating in the study if a relative of an employee of the sponsor or research organization (e.g., Investigator, Coordinator, Technician, Interviewer).

D. Participants who are not fluent in English, or who cannot read or write in English will be excluded from the study
MINDSPACE Strategy for Risk Optimization

The purpose of this study is to find out which types of written stroke messages may help high risk stroke patients take action to improve their health.

In this project, the investigators will draw on the science that has provided a foundation for behavioral economics as a guide to activation interventions. Specifically, the investigators will use the MINDSPACE framework that was created by some of the founders of behavioral economics. That framework details nine approaches to behavioral activation that have particularly solid evidence bases. Two of these, salience and incentives, the investigative team identified as most promising and practical for stroke activation.

Aims:

1. Use electronic health record data to construct Framingham stroke risk scores in both Richard L. Roudebush Veterans Affairs Medical Center and Eskenazi Health System.
2. Conduct iterative testing with high risk stroke patients from both health systems to refine two different stroke risk messages based on the behavioral strategies of salience and incentives.
3. Conduct a randomized trial of four mailed stroke risk messages, comparing the impact on patient activation of: 1) a standard stroke risk message, 2) a salience-focused stroke risk message, 3) an incentive-focused stroke risk message, and 4) a salience plus incentive message.
4. Compare the proportion in each messaging group that completes a stroke risk factor relevant healthcare system visit within two months of receiving the stroke risk message.

Eligibility Criteria:
Inclusion Criteria:

* • High risk stroke patients 18 years of age or older, as determined by calculation of a Framingham Stroke Risk Score

  * At least one primary care visit 12 months prior to study initiation with the Richard L. Roudebush VA Medical Center (VHA) or Sidney \& Lois Eskenazi (EHS) Health System primary care clinics

Exclusion Criteria:

* • Patients with at least one primary care provider visit in the prior 12 months in both the VA and EHS systems
Cardiac Dysfunction and Remodeling in Patients With Preeclampsia

Preeclampsia (PE) is a pregnancy-related hypertensive disorder drive by an anti-angiogenic environment. Women with PE have 2-4 time higher risk of developing cardiovascular disease (CVD), although the specific mechanism relating these two conditions remains elusive. In non-pregnant patients with coronary disease, angiogenic profile proved to be an independent predictor of poor prognosis and is associated with a higher mortality rate. The investigators hypothesized that in PE, the antiangiogenic environment determines the degree of cardiac dysfunction and remodeling and the posterior cardiovascular risk.

Main objective: To determinie the relationship between antiangiogenic environment and cardioc dysfuntion and remodelin in women at risk and in established PE. M\&M: placental dysfunction markers (angiogenic factors (PlGF) and anti-angiogenic factor (sFlt1) and cardiovascular risk variables (BMI, BP, arterial stiffness, copectin, proBNP, high-sensitivity troponin, carotid intima thickness and echocardiography parameters) would be evaluated in 280 patients at risk of PE according to first trimester screening and 100 controls. Additionally, cardiac dysfunction parameters would be evaluated in women with established PE (n=60) and common transcriptomic signatures between cardiovascular disease and preeclampsia would be investigated in placental samples from 10 PE and 10 controls. It will provide evidences to evaluate and characterize the association between angiogenic factors and cardiac dysfunction and remodeling in PE.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 and \<45 years old.
2. Able to understand the study requirements.
3. Singleton pregnancy.
4. Accept of written informed consent.

Exclusion Criteria:

1. \<18 or \>45 years old.
2. Not able to understand the study requirements.
3. Multiple pregnancy.
4. Previous conditions: abnormal thrombophilia, alcohol or illicit drug use, type-1 diabetes, hyperthyroidism, renal disease, severe maternal illness, cytomegalovirus or toxoplasma infection, maternal HIV infection, , previous venous or arterial thrombotic event, and
5. known major fetal anomaly or chromosomal abnormality at inclusion
6. denial of written informed consent.
Intraoperative Electroencephalographic Biomarkers of Postoperative Pain

The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain.

This is a prospective minimal-risk observational study to collect and analyze EEG data during intraepidermal electrical stimulation in patients receiving general anesthesia (GA) for abdominal surgery. To collect nociception-related EEG signal during GA the investigators designed a standardized Intraepidermal Electrical Stimulation (IES) Protocol. The intensity of the electrical stimulus will be calibrated to each participant perception pre-surgery, with 3 different intensities: sensitivity threshold, mild-pain threshold, and moderate-pain threshold. The IES will be administered several times throughout the surgical procedure: a) At baseline, prior to induction of GA, b) Three minutes after loss of consciousness, c) Five minutes after fentanyl administration and orotracheal intubation, d) Five minutes after first incision and every 20 minutes until the end of the surgery, and f) After surgery ends and before extubation. To standardize the anesthesia management as much as possible, all patients will be attended by a reduced number of anesthesiologists. The hypnosis will be achieved with propofol, while analgesia will be mainly achieved with either fentanyl or remifentanil. EEG will be recorded with a 32-channel high standard equipment. Once the patient arrives to the Post-Anesthesia Care Unit (PACU), the investigators will record the pain reported by the patient using the Numeric Pain Rating Scale every 15 minutes during the first hour, and every 30 minutes until patient is discharged from the PACU. Also, the investigators will both, record opioid administration through the surgery and estimate their effect-site concentration with pharmacokinetic/pharmacodynamic models. Besides, the investigators will measure opioid plasmatic concentrations.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist Performance Status I or II
* Scheduled for elective laparoscopic abdominal surgery under General Anesthesia

Exclusion Criteria:

* Body Mass Index \> 35 kg/m2
* Past history or suspected difficult airway
* Craniofacial malformations
* Use of regional anesthesia technique during or after the surgery
* Severe arrhythmia or use of a pacemaker device
* Severe neuropsychiatric illness (Mayor depression, bipolar disorder, schizophrenia)
* Regular use of psychoactive drugs
* Any injury in the right hand
* Past history of peripheral neuropathy
* Diabetes Mellitus
* Known lesion in the spinothalamic tract.
* Analgesics used in the past 72 hours
* Known allergy to propofol
* Previous diagnosis of a condition associated with chronic pain (such as fibromyalgia, rheumatoid arthritis, osteoarthritis, migraine)