cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)

The purpose of this study is to see if it is safe and effective to give topotecan through a vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection caused by a virus that infects brain tissue and causes damage to the brain and the spinal cord.

Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.

Topotecan, a cytotoxic DNA topoisomerase-I inhibitor that crosses the blood-brain barrier, inhibits the replication of JC virus (the virus that causes PML) in vitro, at concentrations that are not toxic to human cells. Topotecan also inhibits the replication of HIV-1 and the function of Tat (which upregulates the replication of JC virus).

Patients are randomized to be treated immediately with topotecan or to have treatment delayed for 8 weeks. The dosing schedule for patients receiving immediate or delayed treatment is topotecan as a continuous 21-day intravenous infusion every 28 days. All patients must have received optimal, stable antiretroviral therapy for 3 weeks prior to entry and preferably will continue that therapy during the study.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have PML, including symptoms of PML.
* Are able to complete the study.
* Agree to have a catheter inserted in a vein.
* Have taken at least 3 weeks of a stable anti-HIV drug combination (unless they are unable to take anti-HIV drugs).
* Are at least 18 years old.
* Agree to use effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of certain central nervous system (CNS) diseases.
* Have a history of certain psychiatric disorders, such as bipolar disorder or schizophrenia.
* Have syphilis that has not been treated.
* Have certain severe medical problems, including AIDS-related opportunistic infections (such as PCP) that require treatment.
* Have received chemotherapy in the past 30 days.
* Have ever received chemotherapy for PML.
* Are pregnant or breast-feeding.
* Are taking certain medications, including any other investigational drugs.
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

The goal of this observational study is to compare, in real-world clinical practice, the effect of fremanezumab on menstrual migraine to the effect of fremanezumab on non-perimenstrual attacks. The main question it aims to answer is, if menstrually-related migraine attacks respond equally well to anti-CGRP mAb treatment with fremanezumab as non-menstrually-related attacks.

Participants diagnosed with episodic or chronic migraine with menstrually-related migraine with or without aura and treated with fremanzumab according to the SmPC will be required to maintain a headache diary over at least 3 months prior to and 6 months after fremanezumab initiation.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women of 18 years of age or older.
* Women with a regular cycle 21-32 days.
* The patient has a diagnosis of chronic or episodic migraine.
* Women suffering from migraine with or without aura according to International Headache Society (IHS) Classification (ICHD-3 code A1.1.2 or A1.2.0.2) for at least one year.
* Women suffering of at least 2 days of menstrually-related migraine per period on average in the last three periods (baseline measurements and inclusion criteria).
* The patient has been maintaining a daily headache diary as part of her routine disease management per her treating physician and has 3 months headache diary data prior to baseline/ treatment initiation. Notes: The patient's headache diary captures information on each headache day, headache duration, headache severity, medication intake, each day of menstrual bleeding, pain intensity of symptoms associated with the menstrual bleeding and symptoms of endometriosis (if present): dysmenorrhoea, dyschezia, dyspareunia, dysuria.
* The patient understands and is willing to keep records in their headache diary for the course of the study.
* Initiation of anti-CGRP mAb (fremanezumab) treatment according to the Summary of Product Characteristics (SmPC) during clinical routine as a treatment of their physician (no study-specific intervention). This means that patients have to fulfil criteria for treatment with anti-CGRP mAbs in Switzerland, i.e. they have at least 8 days of migraine per month in the last three months.
* The patient has signed the informed consent.

Exclusion Criteria:

* Patients with pure menstrual migraine.
* The patient is treated with another anti-CGRP mAb.
* The patient is not treated with fremanezumab according to the SmPC.
* The patient is being treated with another anti-CGRP-based preventive migraine medication within 6 months of enrolment.
* The patient is participating in an interventional clinical trial in EM or CM.
* Change of hormone therapy during study treatment.
* Progestin-only contraception.
Oral Hygiene Intervention for Adolescents

The purpose of this study is to promote oral hygiene behaviors (toothbrushing, flossing) and oral health with high-risk adolescents in San Diego, CA, through a Motivational Interviewing (MI) Intervention.

This randomized controlled trial (RCT) will evaluate the efficacy of a new, brief motivational interviewing (MI)- based intervention and assess its impact on several sets of outcomes among 14-19 years old Latino adolescents: clinical oral health and hygiene indices, counts of biological caries-causing bacteria, and oral hygiene behaviors. Three one-on-one, half hour educational and skill-building MI sessions will address: proper oral hygiene technique, bacteria and dental caries process, and nutrition. Intervention group adolescents will also receive three telephone calls (one/month reinforcing their hygiene behavior goals. Outcomes will be assessed at baseline (T1), and at one-month (T2), after the intervention group received three MI sessions and three booster calls.

Aim 1. To develop and assess a new Motivational Interviewing (MI)-based behavioral oral health intervention for Latino adolescents in a randomized controlled trial (RCT) design. Finalize all intervention educational materials and scripts and assessment tools.

Aim 2. To assess the efficacy of the brief intervention on reductions in clinically determined outcomes among intervention versus control participants.

Aim 3. To assess the efficacy of the brief intervention on reductions in the presence and count of two types of biological bacteria involved in the dental caries disease process.

Aim 4. To assess the efficacy of the brief intervention in increasing the frequency of daily oral hygiene behaviors, including properly brushing, flossing, and rinsing.

Aim 5. Conduct process evaluation via two focus groups post-intervention to assess the acceptability and feasibility of the intervention and assessments (one for intervention group; one for control group).

The investigators hypothesize that the intervention group will see improved clinical outcomes, lower bacteria counts, and better oral hygiene behavior than the control group.

Eligibility Criteria:
Inclusion Criteria:

* self identifies as Mexican or Mexican-American
* living in Northern San Diego County
* speaks English
* able to access stable internet
* participates in 1 or more program or service at VCC
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer

This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.

The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer cells. The second gene is for human interleukin 2 (IL2) which the body's immune system makes to help it fight cancer. The TG4010 is given as an injection under the skin (subcutaneous) once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve (12) weeks. If the therapy is working, it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

* Metastasis or local disease
* Prior hormone treatment
Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer

MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.

The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.

The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;
* Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;
* Patient age of 18 years old or higher ;
* Writing informed consent to participate to the trial ;
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Treatment by non-standard fragmentation (concentrate irradiation)
* Carcinoma located in the hypopharynx or in the larynx ;
* Known hypersensitivity to heparinoids ;
* Patient who already benefited from a radiotherapy treatment ;
* Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;
* Patient participating to another biomedical research ;
* Pregnant woman, breastfeeding woman, parturient or likely to be ;
* Patient deprived of freedom, under supervision or guardianship ;
* Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons
Acute Nutritional Ketosis in GSD IIIa

The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can boost muscle mitochondrial function in vivo.

Glycogen Storage Disease type IIIa (GSD IIIa) is an inborn error of carbohydrate metabolism caused by impaired glycogen debranching enzyme (GDE) activity. The ageing GSD IIIa cohort shows that muscle involvement -despite dietary management- is a common disabling phenotype in adulthood. Currently, no specific therapy has been established for muscle problems in adult GSD IIIa patients.

However, it could be hypothesized that nutritional ketosis (NK) will be highly beneficial to patients. Amongst others, ketone bodies could take on the role of primary energy source in exercising muscle. Recently, acute NK in exercise was studied in humans. NK was found to enhance muscle mitochondrial function in athletes.

The investigators will study if acute NK in adult GSD IIIa patients can boost muscle mitochondrial function in vivo.

Eligibility Criteria:
Inclusion Criteria:

* GSD III confirmed with enzyme assay and/or AGL mutation analysis and GSD IIIa further specified as deficient debranching enzyme activity in muscle or clinical and/or biochemical signs of cardiac and/or skeletal muscular involvement.

Exclusion Criteria:

* contraindications for MRI studies (assessed by standardised questionnaire)
* inability to perform bicycle exercise.
* intercurrent illness which may influence exercise tolerance (anemia, musculoskeletal injury, or other undiagnosed illness under investigation).
* known coronary artery disease, positive history for angina or cardiomyopathy.
* insulin-dependent diabetes mellitus.
* loss of, or an inability to give informed consent.
* pregnancy or current breastfeeding.
* any other cause which in the opinion of the investigators, may affect the participant's ability to participate in the study
Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors

The goal of this clinical trial is to ensure that the mobile health application for Black patients with prostate cancer (either actively undergoing treatment or survivors) is usable and acceptable to patients, get feedback about how to improve the app and assess its usefulness in examining their quality of life.

The purpose of this study is to test the effectiveness of a culturally appropriate and specific mobile app for ethnically diverse Black men with prostate cancer (either those actively undergoing treatment or survivors) to empower them to be active participants in their care. This app will provide 1) relevant information/education about prostate cancer-specific to Black men; 2) symptoms monitoring - allowing participants to report difficulties and prompting providers to respond to concerns; and 3) testimonials from other patients with shared experiences.

All participants will be asked to complete surveys online when they start and then again at 3, 6, 9, and 12 months. A subset of randomized participants will be provided access to this app, which they will be asked to use at home for 12 months. The app users will answer daily surveys about their symptoms and activities as well as weekly mood assessments for 3 months. At the end of the 12 months, interviews will be conducted to receive feedback regarding the app.

Eligibility Criteria:
Inclusion Criteria:

- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born, within the early phase of their CaP survivorship journey (defined as within the first five years after diagnosis).

Exclusion Criteria:

* Men from other races.
* Men who have never been diagnosed with CaP
* Men who have the inability to speak English
* Men who do not own a smartphone
* Black CaP survivors who are over 5 years since the time of diagnosis
Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics - 1

The purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.

The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics.

Eligibility Criteria:
Inclusion Criterea:

* New intake to a drug-free CTP
* Evidence of cocaine or methamphetamine use, any reported use in past 2 weeks or positive urine screen at study intake. For those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment

Exclusion Criteria:

* Unable to give informed consent (fails simple consent quiz)
* Answers yes to question: Are you in recovery from gambling? That is, have you stopped gambling because of previous problems with gambling?
Mfangano Island Healthy Networks Impact Study

This pilot study is a non-randomized controlled cohort study evaluating the impact of social network-based HIV education on antiretroviral therapy (ART) adherence, clinical outcomes, food security, social support, HIV knowledge, and risk behaviors among people living with HIV/AIDS, as well as members of their associated social support networks. The intervention, known as the Mfangano Health Net Microclinic Pilot Program, consists of a 6-month education program on HIV biology, interpersonal communication and community mobilization for both HIV positive individuals and their self-selected social network members selected irrespective of HIV status. Investigators hypothesize that participation in the microclinic program will improve ART adherence, cluster of differentiation 4 (CD4) count, social support, HIV knowledge and food insecurity and will reduce HIV-related stigma, as compared to participants in control communities.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive patient on ART at Sena Health Center or member of patient's social network
* Resident of Mfangano Island
* 18 years of age or older
* conversant in DhoLuo or English languages

Exclusion Criteria:

* none
Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)

The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.

the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.


Eligibility Criteria:
Inclusion Criteria:

* Incarcerated person
* Imprisoned in La Roche sur Yon
* Male
* Age \> 18 year old
* Not opposed to participation in the study

Exclusion Criteria:

* Intellectual deficit not to understand the study
* Taking osteoporosis treatment or any other affecting the metabolism of vitamin D
* Renal failure, liver failure
* Hypercalcemia
* Thyroid dysfunction, parathyroid diseases
* Duration of imprisonment less than the expected duration of the study.
* Incarcerated person who had received supplementation of vitamin D in the 6 months prior
The Effect of the Serratus Block on Pain Control After Breast Surgery

Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.

The prevalence of severe acute postoperative pain after breast surgery is high. Regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. The search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. The serratus block is a promising technique that may combine these advantages.

Eligibility Criteria:
Inclusion Criteria:

* ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
* undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy
* day surgery procedures

Exclusion Criteria:

* inability to understand or to provide consent
* inability or unwillingness to comply with required follow-up assessments
* psychiatric disorder affecting patient assessment
* contraindication to regional anesthesia, e.g., coagulopathy
* allergy to local anesthestic
* chronic pain and/or chronic use of opioids with a daily use of over 30mg oxycodone or equivalent per day
* contraindication to a component of multimodal analgesia
* preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
* infection near the injection site
* pregnancy
* BMI \>35
* complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes
Views of Nurses on Alarm Fatigue in ICUs

This study focused on determining the views of nurses on alarm fatigue and its reduction in adult intensive care units.

Backround: Physiological monitoring of critically ill patients in ICU is a complex nursing task, and nurses are key professionals managing multiple monitoring devices.

Aim: The aim of this study is to determine the views of nurses on alarm fatigue and its prevention in adult intensive care units.

Study Design: In the study, the minimum sample size was calculated as 67 for a population size of 106 and a 95% confidence interval, taking into account the alarm fatigue standard deviation (σ=6.82) found in the Turkish validity study of the "Nurses' Alarm Fatigue Scale" (t=1.96; d=1) . Considering that there may be losses, 74 nurses will be included in the study by taking 10% more. In the qualitative phase of the research, intensive care nurses who agreed to be interviewed during the collection of quantitative data will be included.

Method: In this study, parallel data type will be used in convergent parallel mixed design. The quantitative phase of the study is a descriptive study to determine alarm fatigue levels in nurses working in adult intensive care units. In the qualitative phase of the research; A case study will be conducted at the same time in order to examine the findings revealed with quantitative data in more depth and to determine the views of nurses on reducing alarm fatigue. Individual in-depth interviews will be held in a suitable room using the "Semi-Structured Interview Form" created by the researchers with those who agree to participate in the qualitative study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Who volunteered to participate in the research
* Working in adult intensive care units

Exclusion Criteria:

* Under the age of 18
* Not working in adult intensive care unit