cyrilzakka/clinical-trials huggingface dataset:
Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be of Non- child-bearing potential
* Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg

Exclusion Criteria:

* Presence of any clinically significant illness
* Abnormal vital signs
* History of any conditions that may put the subject at risk by participating in the study
* Participation in another clinical study.
Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE)

The purpose of the study is to evaluate the feasibility and effectiveness of a program for high school students with emotional and academic challenges U-PEACE and gaining feedback on that program.


Eligibility Criteria:
Inclusion Criteria:

Youth:

1. Adolescents between the ages of 13 and 18 years at the time of enrollment, who:

   1. display depressive symptoms above the clinical cut-off of 9 or above on the Patient Health Questionnaire-8 (PHQ-8),
   2. display elevated anxiety symptoms of 10 or above on the Generalized Anxiety Disorder 7-item Scale (GAD-7; Spitzer et al., 2006),
   3. are enrolled at the target High Schools (HS),
   4. have expressed interest in participating in the study, and
   5. have a caregiver who is available to sign study consent forms (if under 18 years of age)
2. Adolescents must be, or are willing to be, consented to receive services through School Health Initiative (SHI) (i.e., SHI consent). If they are under 18 years of age, their caregiver must provide consent.
3. Adolescents and caregivers are able to complete all study procedures in English or Spanish.

Teachers:

1. Individuals who are 18 years or older.
2. Individuals who are currently employed at the target HSs.
3. Individuals who are able to speak, read, and understand English.

Youth Exclusion Criteria:

1. The following individuals may be excluded at any time (e.g., before consent, after being enrolled).

   1. Individuals who do not wish to participate in this study and/or who are not able to read and understand the consent/assent.
   2. Individuals with self- or caregiver-reported history of seizures, neurological problems, autism spectrum disorder, substance use disorder, or serious mental illness (e.g., schizophrenia), and any indicator of a significant cognitive delay that would make U-PEACE inappropriate (e.g., full-time special education placement)
   3. Individuals with current anxiety or depressive symptoms or active suicidality at levels where more intensive services (e.g., day treatment, inpatient) would be warranted (e.g., hospitalization for suicidal behavior in the last 12 months).
2. Ineligible adolescents will be provided referrals to medical providers at the SHI, community agencies contracted with the Miami-Dade County Public Schools (M-DCPS) Office of Mental Health Services or emergency room settings, as appropriate.
3. Unclear cases will be reviewed by the PI and Director of the SHI, Co-I Lisa Gwynn, D.O.
Childcare Outdoor Learning Environments as Active Food Systems

The aim of this project is to assess the effectiveness of the fruit and vegetable (FV) gardening component of the Preventing Obesity by Design strategy to support preschool fresh fruit and vegetable knowledge, liking and consumption, and physical activity in children 3-5 years old living in under-resourced communities and attending childcare using a Randomized Controlled Trial research design. Sample: 15 childcare centers, 286 children.

Objective: To assess the effectiveness of a gardening component on preschool children's knowledge, liking and consumption of fruit and vegetable consumption, and their level of physical activity during gardening season.

Intervention: Fruit and vegetable garden installation. Childcare centers were randomly assigned to one of three groups: Group 1, intervention (5 centers); Group 2, wait list control (5 centers); Group 3, no-intervention control (5 centers).

In Year 1 (Spring), baseline data was collected from Groups 1 and Group 2 (waitlist). Group 1, initial intervention centers, received the garden intervention in the Summer and both groups were assessed in the Fall, post intervention. No further data was collected from Group 1.

In Year 2 (Spring), Group 2 (waitlist, now intervention) and Group 3 were assessed. Group 2, received the garden intervention in the Summer of Year 2 and both groups were assessed in the Fall of Year 2.

No further data was collected.

Sample: 15 centers. Children: 286 (4 and 5 years old). Center demographic profile includes child data: age, gender, parental education, race/ethnicity, special needs, and height/weight (BMI). To avoid losing "graduating" five year old children, post-intervention data was gathered before school start date.

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in selected childcare centers
* Parental consent
* Child consent to participate at the time of data collection

Exclusion Criteria:

* No parental consent
App for Acute Pain Service in Major Surgery

The app will be installed on the patient's smartphone before surgery. Patients will receive reminders to record their pain intensity and opioid-related side effects at the pre-determined time points until at least 2 days after surgery. The patient's compliance with the reminders will be assessed. On the second postoperative day, their satisfaction with pain control and app usage will be evaluated. Patients can also provide feedback on any issues they have encountered with the app during the study period.

Following admission, the application will be installed on the enrolled patient's smartphone prior to surgery, and the patient will be instructed on the content of the program and how to use it. Educational videos within the app about postoperative pain control will be introduced to the patient at this time. At the pre-determined time points, until at least 2 days post-operatively, the patient will be reminded of the assessment via an alarm function and will enter post-operative pain intensity using an 11-point numeric rating scale or verbal rating scale and the presence of opioid-related side effects into the application. If a patient responds to the alarm 2 or more times per day, they will be considered to be compliant. Postoperative opioid consumption using patient-controlled analgesia and the amount of rescue analgesics will be assessed. Patients will be assessed with a survey on postoperative day 2 for overall satisfaction with pain control and usage of the application. Patients will also be able to provide feedback via the application or research staff on any errors or inconveniences they may have experienced while using the application throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 19 to 70 years who are scheduled for regular major surgery
* American Society of Anesthesiologists (ASA) physical status classification I or II
* Patients who are using a smartphone and are not expected to have any restrictions on application use

Exclusion Criteria:

* Unable to communicate
* Patients under the age of 19 and over the age of 70
* Patients who, in the opinion of the investigator or study staff, are not appropriate for this study
Posaconazole Plus Pembrolizumab and Chemotherapy Vs Pembrolizumab and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer

Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. The Keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological Complete Response (pCR) rate in TNBC to over 60%, but nearly 40% of patients still do not achieve pCR. How to further improve the pCR rate in TNBC patients has become a hot topic of current research.

Posaconazole is an antibiotic used to prevent invasive Aspergillus and Candida infections and to treat oropharyngeal candidiasis. Our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict TNBC tumor progression. The investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of TNBC.

OBJECTIVES: On the basis of chemotherapy combined with immunotherapy, posaconazole was used to further improve the pathological complete response (pCR) rate of high-risk triple-negative breast cancer (TNBC), and to explore biomarkers.

OUTLINE: From february 1st, 2025 to june 30th, 2026 the investigators will recruit 40 patients with first-time diagnosed early-stage TNBC. Enrolled patients were randomly divided into experimental group and control group on a 1:1 basis. Both groups received standard neoadjuvant chemotherapy combined with immunotherapy. The experimental group was treated with posaconazole (day 1: 300 mg po bid, from Day 2, start maintenance dose at 300 mg po qd, q21d). Standard surgical treatment was performed after 8 cycles and the surgical specimens were pathologically tested to compare the differences in pCR rates between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Female, aged ≥ 18 and ≤ 70 years old;
2. first-confirmed TNBC;
3. cT1cN1-3M0 or cT2-4N0-3M0;
4. ECOG score 0-1 points.

Exclusion Criteria:

1. Stage I or IV;
2. History of previous breast cancer;
3. Patients with a history of other tumors who have received systemic therapy or local radiotherapy;
4. No immune system disease or connective tissue disease;
5. No history of hormone therapy;
6. Pregnant/lactating.
A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)

This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.


Eligibility Criteria:
Inclusion Criteria:

* Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease or gastroesophageal reflux disease documented on endoscopy
* Electrocardiogram (ECG) shows no clinically significant abnormalities
* Is able to swallow capsules
* is in good health

Exclusion Criteria:

* Pregnant or lactating females
* Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
* Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
* Participants 18 to 49 years of age had taken any regular, prescribed, or over-the-counter medication
* Has any significant concurrent therapies
* Has a positive drug screen
* Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
* Has given more than 450 mL of blood (one unit) in the 60 days preceding screening
* Is an active intravenous drug user or abuses alcohol
* Has had a malignancy within the last 5 years
* Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
* Has received any antibiotics within 30 days prior to first dose of study drug
* Has been hospitalized within the past 30 days prior to Study Day 1
* Has known hypersensitivity to daptomycin
A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy

This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
2. Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117
3. Agrees to use contraceptive measures consistent with local regulations and the following:

   1. Male participants: must use an acceptable contraceptive method that should be maintained at minimum until 15 months after last dose of Investigational Medicinal Product (IMP).
   2. Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before Investigational Medicinal Product can be administered.

Exclusion Criteria:

1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
2. Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
3. Currently participating in another interventional clinical study.
4. Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the Investigational Medicinal Product.
Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

The goal of this clinical trial is to evaluate the impact of Physical Exercise (PE), as an adjuvant treatment, on the cognition of patients diagnosed with Bipolar Disorder who present cognitive impairments, as well as its impact on quality of life and functionality and its association with physiological variables.

Our specific goals are:

1. Evaluate the effect of PE on the neuropsychological functions of attention, memory, verbal fluency, executive function and processing speed in patients diagnosed with BD who present cognitive impairments in these domains.
2. To evaluate the effect of PE on the quality of life and functionality of patients diagnosed with BD, as well as possible associations with cognitive functions.
3. To evaluate possible correlations between physiological variables, such as cardiorespiratory indices, strength and body composition, and improvements in cognitive functions, quality of life and functionality.

The study aims to assess the impact of structured physical exercise on the cognitive function of bipolar disorder patients presenting deficits, while investigating its association to quality of life and functionality. The study will include 72 euthymic BD patients from the Bipolar Disorder Research Program (PROMAN) at the Institute of Psychiatry of the University of São Paulo Medical School, randomly distributed into two groups: 1) the experimental group will be submitted to supervised training sessions, three times per week, for 12 weeks, including aerobics and strength exercises, as well as treatment as usual (TAU); and 2) the control group will be submitted exclusively to TAU. Cognitive function, depressive and manic symptoms, quality of life and functionality will be assessed at baseline and at follow-uo (week 12), for both groups. Statistical hypothesis testing, assessing the presence of statistically significant differences between groups, pre and post intervention, should be available on the third quarter of 2025.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar disorder (BD) I and II according to DSM-5
* Age: 18 - 55 years old
* Complete primary education
* Euthymic (YMRS \< 8 and MADRS \< 12)
* Presence of cognitive impairments (COBRA \> 14 and SCIP \< 75)
* Estimated IQ ≥ 80
* No medication changes in the last month
* Having been without regular PE practice for six months
* Signature of the TCLE

Exclusion Criteria:

* Organic mental disorder
* BMI \> 40
* Alcohol or drug abuse in the last 6 months
* Use of benzodiazepines or beta-blockers in the last month
Hysteroscopic Evaluation of Cesarean Scar Defect

The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 35 years.
2. Had at least one prior cesarean section

Exclusion Criteria:

1. History of uterine surgery that could change the cavity anatomy.
2. Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
3. Recent intra-uterine contraceptive device (IUCD) in place.
4. Known history of endometriosis
The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients

The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.

Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.

All patients are treated for 10 days.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Serologically documented HSV-2 and HIV-1 infection.
* History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
* No contraindications to valacyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

1. Hepatic impairment.
2. Impaired renal function (creatinine above 2 mg/dl).
3. Malabsorption syndrome or other gastrointestinal dysfunction.
4. Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir or valacyclovir.

Prior Medication:

Excluded:

* Participation in any investigational drug trial within 1 month prior to entry on study.
* Systemic anti-HSV therapy within 7 days prior to start of study drug.

  1. Probenecid.
* Suppressive treatment with medication that has anti-HSV activity.

Required:

- Stable antiretroviral therapy or no therapy for at least 1 month.
Sparing of Organs at Risk in High Dose Rate Brachytherapy

Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.

In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.

The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.

This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.

After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions.

A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.

During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.

Eligibility Criteria:
Inclusion Criteria:

* Cervix carcinoma stage Ib to IV (FIGO)
* OMS \< 2
* Tomography by positron emission and/or chirurgical staging before the external radiotherapy
* RMN before the starting of treatment and at the end af external radiotherapy
* Patient information
* Validation of the indication af high dose rate brachytherapy
* External radiation therapy (60 Gy with IMRT)

Exclusion Criteria:

* No external radiation therapy
* Surgery in the 4 weeks before before the inclusion
* Prior pelvic radiation therapy
* intestinal inflammatory disease or active pathology
* active infection or severe pathology didn't allow the treatment
* Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)
* Inclusion in another clinical trial
Pulpotomy With Various MTA Materials and Ferric Sulphate

The aim of this study was to determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars.

A total of 96 second primary second molars from 32 children ,who met inclusion criteria and were 5-9 years old were selected for the study. Teeth were randomly divided into three groups according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32 teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9 months postoperatively. The data were evaluated with Chi-square test, Cochran Q test, Post-Huc Dunn test and Kaplan-Meier analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients have at least three deep carious primary second molars
* Teeth with no spontaneous pain
* Patient who are willing to participate
* Cooperative children

Exclusion Criteria:

* Patients who are not willing to participate
* History of systemic disease
* Pathological mobility
* Presence of internal or external root resorption
* Presence of apical radiolucency
Control of Blood Loss During Caesarean Section

trial of 3 protocols to determine the best one to control blood loss during caesarean section

The study population will be divided into 3 groups each containing 200 women:

Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.

Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.

Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.

Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

1. After admission of each case in the pre-operative period.
2. Immediately post- operative.
3. 24 hours post- operative.

Eligibility Criteria:
Inclusion Criteria:

* Patients booked for elective cesarean section.
* Singleton pregnancies.
* Primigravida or multipara ,first cesarean section or previous .

Exclusion Criteria:

* Patients with obstetric hemorrhage.
* Uterine laceration.
* Placenta previa.
* Blood dyscrasias.
* Large fibroids.
* Multiple pregnancy.
* Pre-eclampsia.
* Marked maternal anemia.
* Previous history of PPH.