cyrilzakka/clinical-trials huggingface dataset:
C2P Mobilization Intervention (Pilot)

Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is a multi-site, three-phase project developed by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The overall goal of the project is to ultimately reduce HIV incidence and prevalence in youth 12-24 years old through a community mobilization intervention. This protocol (ATN 040) describes part one of Phase III. Part two of Phase III will be submitted as a separate protocol (ATN 041).

The objective of Phase III is to initiate and complete a community mobilization intervention aimed at ultimately reducing HIV incidence and prevalence among youth. The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. These activities will be described in this document. Details related to the training, technical assistance, adaptation, and implementation of the selected CDC program will be subsequently submitted for IRB review as part two of Phase III (ATN 041).

The intervention consists of community mobilization activities that are expected to lead to structural change and the adaptation and delivery of a CDC-endorsed HIV-prevention program. ATN/C2P staff at each site, with training and technical assistance from a C2P National Coordinating Center, will engage in a strategic planning process with their coalition members that results in the development and implementation of a local action plan.

The evaluation of the intervention will be within and across ATN/C2P sites implementing this protocol. For assessing the overall efficacy of the community mobilization intervention, data will be collected and analyzed from:

1. ATN/C2P site staff, in the form of systematic documentation of the community mobilization process and accomplishments (e.g., structural change achieved); and
2. Local public health departments and other similar sources of epidemiological information, as was done for generating Phase I epidemiologic profiles.

Duration: 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Community each ATN/C2P site is attempting to mobilize

Exclusion Criteria:

* Non-ATN funded site
Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples

The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both men of the couple into a randomized controlled trial. Participants/couples randomized to the intervention will have access to the app for two months while those assigned to the waitlist group will receive and have access to the app for one month. Participants will complete surveys at baseline and at month 2.

The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both partners of the 42 male couples into a 2-month randomized controlled trial with a waitlist control condition of one month. Couples will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the app upon randomization to that group. The waitlist-control group will follow the same procedures one month later. Participants/couples randomized to the intervention arm will have access to the intervention app for two months (ie, day 1-60) while those assigned to the waitlist-control group will have access to the app for one month (ie, day 31-60). All participants in the randomized controlled trial will complete a short follow-up survey at month 2 and a brief exit interview.

Eligibility Criteria:
Inclusion Criteria for both partners of the male couple:

* self-reported that currently self-identifies as a male
* self-reported in a sexual relationship with another self-identified male
* self-reported relationship length between 1 and 12 months
* self-reported anal sex with relationship partner in past 2 months
* owns and uses an Internet-connected smartphone or tablet
* resides in the U.S.
* self-reported ability to read and understand English-language

Exclusion Criteria:

* Does not meet one or more the inclusion criteria
Group B Streptococcus: Attitudes to Immunisation in Pregnancy

Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development.

Vaccinating pregnant women against GBS in order to protect their newborn babies is a promising area of research.However, many women are reluctant to accept vaccination during pregnancy for fear it will harm their unborn child and there is often a lack of understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive experience of immunisation against pertussis in the United Kingdom, suggest that antenatal immunisation can be acceptable.

Previous research has shown that advice from maternity healthcare professionals regarding vaccination is highly valued by pregnant women so it is also important to explore the attitudes and opinions of this group.

The objective of this study is to assess the knowledge and attitudes of pregnant women and maternity healthcare professionals in England and Scotland regarding GBS disease and the acceptability of a potential vaccine.

There are two parts to this study. The first part will invite pregnant women, maternity healthcare professionals and parents who have had a child affected by GBS disease to take part in either a focus group or an individual interview.

This will allow for an in-depth exploration of the participants thoughts and opinions about GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site only. The results will guide the development of a self completed, paper questionnaire which will be distributed to a wider range of pregnant women and maternity healthcare professionals across four different study sites.

This study has been funded by Meningitis UK. Additional collaborators to those listed include the charity Group B Strep Support.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 years and above who have not previously had a child with GBS disease and are willing and able to give written, informed consent and are able to read and speak English. OR
* Obstetricians (including consultants and trainees) or midwives working at one of the study site who are willing and able to give written, informed consent OR
* Parents (mothers or fathers) of children who have had GBS disease (early or late onset), potentially including parents of children who have died from GBS disease who are willing and able to given written, informed consent Able to read and speak English

Exclusion Criteria:

* The inclusion criteria are not met
* Volunteer is part of the study team at any of the study sites
Simple Suppers Scale-up (S3)

The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year.

Exclusion Criteria:

* Family member: Following a restrictive or therapeutic diet.
Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin

The aim of the study was to compare the change in augmentation thickness after guided bone regeneration (GBR) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-PRF).

This randomized-controlled clinical trial was conducted on patients with horizontal bone deficiency in the posterior regions of mandible. After implant placement, GBR procedures were randomly performed using i-PRF enriched bovine-derived xenograft (test group) or bovine derived xenograft alone (control group). Cone-beam computed tomography was taken at the implant sites immediately, and 6 months after surgery for assess the change in augmentation thickness as the primary outcome of the study. The secondary outcomes included marginal bone level and implant survival rate.

The study was conducted on patients who had partially edentulism with horizontal deficiency of the alveolar bone in the posterior regions of mandible.

All patients were informed about treatment protocol of the study and also, the risks and benefits associated with participation. Each patient provided written informed consent prior to enrollment.

Randomization was performed after the dental implant surgeries and the patients were randomly assigned to one of the study groups:

Test group included 22 patients treated with GBR using i-PRF-enriched bovine-derived xenograft + resorbable membrane Control group included 22 patients treated with GBR using bovine-derived xenograft + resorbable membrane All patients underwent two-stage surgical protocol that performed by the same experienced surgeon. Following implant placement, i-PRF-enriched bovine-derived xenograft for the test group and bovine-derived xenograft alone for the control group was carefully positioned with light compression around the implants. Finally, the resorbable membrane was placed to cover the augmented area.

As the second stage of surgery, healing caps were placed and the implant-supported fixed prosthesis were completed in approximately one to two months.

Eligibility Criteria:
Inclusion Criteria:

* horizontal deficiency of the alveolar bone in the posterior regions of mandible
* absence of periodontal disease or previously treated
* with blood tests showing platelet counts at least 150.000 mm3
* ability to understand and accept the requirements of the study.

Exclusion Criteria:

* any disorders or infection at the implantation site or adjacent tissue
* tooth loss or extraction in the planned implant site within 6 months
* poor oral hygiene
* medical conditions that compromised tissue healing (uncontrolled diabetes, etc.)
* treatments with an interfering medications (bisphosphonates, steroids etc.)
* smoking habit
* pregnancy or nursing
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.
Hospital-Based Breastfeeding Training İn The Early Postpartum Period

H1: "Breastfeeding Self-Efficacy Status" is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group receiving routine care.

H2: The level of knowledge obtained according to the "Pre-test Post-test Question Form" in mothers who received postnatal hospital-based breastfeeding group training is higher than before the education.

H3: The status of starting and successfully continuing breastfeeding is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group who received routine care.

Follow-up data of all mothers were collected by phone at 4 and 12 weeks. For this reason, the phone numbers of the mothers and a relative were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Can be contacted,
2. had a single birth,
3. Those who are 18 years old or older,
4. Residing in Izmir,
5. able to use phone
6. were determined to be mothers with no health problems in the mother and the baby

Exclusion Criteria:

-
Photodynamic Therapy for Oral Precursor Lesions

Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
* Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
* Oral Lichen planus SIN III (diagnostics by Biopsie)
* Good mouth hygiene status (tartar, surface)
* Correct seat of the prosthesis and/or the denture
* Located erosions in the oral cavity
* Minimum age:18 years
* Women at the age capable of child-bearing with an appropriate contraception

Exclusion Criteria:

* Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
* Pregnancy
* less than 18
* Satisfying women
* No tobacco abuse
* satisfying therapy with local immunmodulators in lichen ruber
* surgical therapy of leukoplakia indicated
Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia

The aim of the study is to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in improving the response to imatinib in CML patients not achieving an optimal response with imatinib alone.

To improve cytogenetic and molecular response of CML patients receiving Imatinib, who have not achieved an optimal response according to European LeukemiaNet (ELN) definitions , or MR4 after 24 months with Imatinib. This will be achieved by addition of the CXCR4 antagonist BL-8040, mobilizing CML leukemia stem cells from their protective bone marrow niche and exposing them to Imatinib and BL-8040-mediated apoptosis.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women subjects aged 18 to 70, inclusive.
2. Confirmed diagnosis of chronic phase CML according to the WHO criteria (WHO 2008)
3. CML patients with sub-optimal response to Tyrosine Kinase Inhibitors, defined as "warning" in the ELN recommendations:

   Following 3 months: BCR-ABL1 \> 10%, and/or Ph+ 36-95% Following 6 months: BCR-ABL1 1-10%, and/or Ph + 1-35% Following 12 months: BCR-ABL1 0.1-1 % Following 24 months: Less than MR4
4. Clinical laboratory values should be as follows:

   White blood cell count \< 30 X 10\*9/L Creatinine \< 1.5 ULN
5. Women of childbearing potential and all men must agree to use approved form of contraception
6. Subject is able and willing to comply with the requirements of the protocol.
7. Subject is able to voluntarily provide written informed consent.

Exclusion Criteria:

1. CML patients not in chronic phase.
2. CML patients receiving Tyrosine Kinase Inhibitors other than Imatinib.
3. CML patients receiving Imatinib \> 400 mg/day.
4. Patients not able to sign informed consent.
5. Known allergy or hypersensitivity to any of the test compounds or materials or contraindication to test product.
6. Low Performance Status (ECOG \> 2).
7. Abnormal liver function tests:

   1. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 2 x upper limit of normal (ULN).
   2. Serum bilirubin. Total bilirubin \> 2.0 mg/dL (34 µmol/L), conjugated bilirubin \> 0.8 mg/dL
8. Abnormal left ventricular ejection fraction, \< 40 %.
9. Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:

   1. Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy
   2. A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
10. Women subjects who are pregnant or breastfeeding.
Enterovirus Surveillance During the Perinatal Period

Neonates could be infected by non-polio enterovirus easily. Some of the neonates may develop fatal complications within one week. The objective of this study were as following: 1.To understand the composition and epidemiological characteristics of enterovirus infection in pregnant women in some areas of China; 2.To understand the transmission from mother to their neonates; 3.To understand the pathogenic spectrum composition, epidemiological characteristics and clinical characteristics of enterovirus infection in neonates; 4.To understand the genetic variation and changes of enteroviruses; 5.To establish a quality management system for maternal and neonatal enterovirus laboratory testing and monitoring.


Eligibility Criteria:
Inclusion Criteria:

* 1. General parturient: on the first day of the third week of each month, all parturients and their newborns admitted to the hospital (day shift 8:00-18:00) within that day; 2. Puerpera with fever: all puerperas with fever (body temperature \>=37.5 degree C) and their newborns were included in summer and autumn (from May); 3. Febrile newborns: those included in summer and autumn (from May) with the following clinical characteristics: fever \>=37.5 degree C, lasting for more than one day. And sign the informed consent form with the consent of the guardian.

Exclusion Criteria:

* 1. Pregnant women with urinary tract infection, chorioamnionitis and bacterial infection; 2. Puerpera with fever due to urinary tract infection, chorioamnionitis and bacterial infection; 3. Newborns infected with other pathogens.
Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder

Standard Dialectical Behavioral Therapy (DBT)is an effective treatment for Borderline Personality Disorder (BPD), particularly for patients with significant behavioral and affective dysregulation, including suicidality. However, DBT in its original format is delivered in 12 months, and even though currently there are shorter versions of the treatment being developed and tested, in the context of public mental health care in Chile a shorter, intensive and lighter version of the treatment is likely needed to help patients seeking help for BPD symptoms. This study will test whether a 3 month, intensive and simplified version of DBT is at least equivalent to standard six months DBT with all its components (skills training, individual therapy, coaching calls, and treatment-team consulting). 120 patients diagnosed with BPD we'll be randomly assigned to receive either the short, intensive 3-month intervention or the longer standard 6-month DBT intervention. Baseline measures will be taken pre-treatment, upon treatment completion, and at a 4-month follow-up. Session-to-session change in BPD symptoms will also be measured throughout the treatments. Primary outcomes for the study are BPD symptoms, frequency, and intensity of suicidal activity. Secondary outcome measures include depression scores, quality of life, and ER visits, and days in inpatient care.


Eligibility Criteria:
Inclusion Criteria:

* BPD diagnosis according to DSM-IV criteria, evaluated through a SCID-II structured interview.
* History of suicide attempt or self-harm operationalized as at least two episodes of suicide or self-harm in the last 24 months
* Provide signed informed consent to participate in the study.
* Participant has not received more than 8 weeks of DBT in the past 24 months.

Exclusion Criteria:

* Fulfill diagnostic criteria for psychotic disorders classified in ICD-10 (F20-F29), evaluated through the MINI interview.
* Diagnosis of Antisocial Personality Disorder evaluated through the SCID-II.
* Active substance use disorder within the last 3 months, assessed by ASSIST.
* Harmful use or problem dependence on alcohol assessed through AUDIT.
* Meet criteria for Bipolar Affective Disorder type I assessed through the MINI Mania module.
* Significant cognitive impairment assessed through Moca (Moca\> 21).
* Diagnosis recorded in the clinical record of intellectual-cognitive disability.
* Recording in the clinical record of medical or surgical problems that could imply a probable hospitalization within one year of the start of the study (for example, cancer, coronary heart disease, etc.).
Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation

Liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. The intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. However, this hemorrhagic risk has been drastically reduced in the last 20 years and liver transplants without the use of blood products are now possible. Indeed, improvements in medical and surgical techniques associated with a better understanding of the pathophysiology of the cirrhotic patient have enabled this advance. One of the targeted therapeutic strategies is the control of portal hypertension. Several treatments have been sought, such as the use of splanchnic vasoconstrictors (such as vasopressin) and hypovolemic phlebotomy. These techniques reduce portal pressure and seem to reduce intraoperative bleeding with, even, a protective effect on kidney function. Their single-use or their combination is currently used in certain centers of expertise in liver transplantation. However, the hemodynamic effects of the combination of these 2 treatments on portal pressure has never been demonstrated. In this study, the effect of vasopressin, combined with a hypovolemic phlebotomy, on portal pressure in cirrhotic patients undergoing liver transplantation will be evaluated.

METHODS

Objectives

The primary objective will be to measure the hemodynamic effects of vasopressin on portal pressure in cirrhotic patients who have had a hypovolemic phlebotomy during a liver transplant.

The secondary objectives will be to measure the effects of vasopressin on portal pressure in patients who have not had a phlebotomy and to compare this effect between patients who have or have not had a hypovolemic phlebotomy.

The tertiary objective will be to assess the effect of the variation in portal pressure under vasopressin, associated or not with a hypovolemic phlebotomy, on hemorrhagic clinical outcomes (intraoperative bleeding and blood transfusions).

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients undergoing a liver transplantation
* 18 years and older
* Planned use of vasopressin during the surgery

Exclusion Criteria:

* Fulminant or sub-fulminant hepatitis without underlying chronic liver disease
* Anesthetic plan does not include the use of vasopressin (contraindication or not relevant according to the anesthesiologist)