cyrilzakka/clinical-trials huggingface dataset:
Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited setting.

This is a single center, operational research study with two components. A formative component and randomized intervention trial. The study aims are to inform, promote and evaluate strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited settings.

The primary objective of the qualitative formative research which includes Focus Group Discussions (FGD) and Key Informant Interviews (KII) is to explore factors affecting decisions on EBF and continued breastfeeding among HIV infected women.

The primary objective for the Intervention phase is to compare either of two intervention strategies against the standard arm using Ministry of Health (MOH) messages aimed at promoting EBF for 6 month.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive pregnant women in their late second or third trimester
* On antiretroviral therapy (ARVs) for PMTCT or meets MOH guidelines for ARV therapy
* Intention to breast feed
* Willingness to deliver at Mulago Hospital
* Living within Kampala and planning to stay within Kampala district for months after delivery
* Willingness to participate during post partum period
* Willingness to be home visited
* Willingness and ability to bring a close family member of choice to the clinic, who is ≥ 18 years, who will be able to be in touch with the at least three times a week and to give support on EBF

Exclusion Criteria:

* none
Testing a Wellness App for First Responders, Military Personnel and Veterans

The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants.

There is an urgent need to address mental wellbeing, isolation, and burnout among first responders, military personnel and veterans. Research shows that these groups are at a greater risk for suicide, depression, and post-traumatic stress disorder (PTSD) than the general civilian population, and that their occupations make them more likely to feel isolation and burnout. Despite these risks, first responders, soldiers and veterans tend not to seek help due to stigma, time burden and other barriers to entry. The GUIDE App was designed with this population in mind. The lessons and exercises take only minutes to complete, and the group chats are anonymous, so users can share their thoughts with likeminded peers, without the stigma. In a 4-week pilot study with 16 participants from the Wilkes Barre Police Department, the GUIDE App showed promising results in promoting wellbeing, reducing anxiety and encouraging personal growth. This clinical trial builds off the pilot study. The investigators will use a three-armed randomized waitlist pilot feasibility trial with 150 participants (first responders, soldiers, and veterans) to test whether use of the GUIDE App will lead to increased social connectedness, personal growth, and mental health/wellbeing; and whether these outcomes will in turn increase work engagement and reduce burnout. The investigators will also investigate implementation outcomes (e.g., the feasibility of using the app) and technical merit (e.g., how user-friendly the app is).

Eligibility Criteria:
Inclusion Criteria:

* Law enforcement, military personnel, or veteran.
* Employed (part-time, full-time, self-employed).
* Owns compatible smartphone.
* Not paid by the GUIDE App/Nlyten Corp.
* No previous use of GUIDE App.

Exclusion Criteria:

* Not law enforcement, military personnel, or veteran.
* Not employed.
* Paid by GUIDE App/Nlyten Corp.
* Previous use of GUIDE App.
Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.

Approximately 60 subjects and up to 120 household contacts will be enrolled in the United States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1 ratio and will be followed for 180 days postdose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges)
* Women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated
* Vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study
* Household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive)

Exclusion Criteria:

* Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have unstable medical condition or are under the age of 18
* Childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry
* Resides with HHCs who are under the age of 18 or over the age of 65
* Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months
* Has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin
* Previously received a licensed or investigational cholera vaccine
* Has history of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge)
* Travel to a cholera-endemic area and experienced symptoms consistent with traveler's diarrhea in the previous 5 years
* Received or plans to receive any other licensed vaccines from 14 days prior to the study vaccination until Day 28
* Received or plans to receive antibiotics (other than protocol-specified) or chloroquine within 14 days prior to the study vaccination through to Day 28
Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression

Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.

This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.


Eligibility Criteria:
Inclusion Criteria:

* major Depression
* informed consent

Exclusion Criteria:

* seizures in medical history
* metallic implants
* deep brain stimulation
* cardiac pacemaker
* brain trauma
* psychotic symptoms
* substance abuse
* pregnancy
* Benzodiazepines other than Lorazepam \>1mg/d
Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics

The present study has the objective of being a first approach of the full feasibility study in order to find out whether the Full Pulpotomy performed by a general practice dentist in a primary care dental clinic at the public health system with limited armamentarium could be suitable and present an appropriate success rate as well as patient satisfaction.

The present study has the objective of being a first approach of the full feasibility study in order to find out whether the Full Pulpotomy performed by a general practice dentist in a primary care dental clinic at the public health system with limited armamentarium could be suitable and present an appropriate success rate as well as patient satisfaction. This information will help to decide if a multi-center non-randomized intervention designed study is carried out to determine if it is feasible to provide Full Pulpotomy as a routine treatment to symptomatic irreversible pulpitis or caries pulp exposure at the primary care dental clinics of the public health system in Mexico.

Eligibility Criteria:
Inclusion Criteria:

All the patients attending the primary care dental clinic with deep caries and/or pain in a permanent premolar or molar tooth.

* Teeth with complete radicular growth.
* Preoperative symptoms of irreversible pulpitis (Spontaneous pain or exacerbated by thermal stimuli and lasting for a few seconds to several hours interpreted as lingering pain compared with a control tooth and that could be reproduced using thermal testing)

Exclusion Criteria:

Medically comprised or pregnant patients.

* Teeth exclusion criteria:
* Pathological mobility
* Sinus tract
* Teeth that cannot be restored with amalgam
* Radiographic internal or external resorption
* Presence of apical rarefaction
Melodic Intonation Therapy for Tone Language Speakers

One of the traditional therapies for restoring the ability of speech in aphasic patients is Melodic Intonation Therapy (MIT), in which everyday phrases are taught in a singing-like manner. The suggested mechanism for speech recovery is that because of the sharing of brain resources for language and music, the regions normally reserved for singing can be trained to help compensate the speech functions originally subserved by the damaged regions. However, this therapy has primarily been applied to speakers of non-tone languages, in which prosodic features carry a more important role than pitch features in conveying meanings. It remains unknown whether MIT will be equally applicable for speakers of tone languages, in which pitch features likely play a more important role. Another uncertainty concerns whether the efficacy of MIT can be extended to patients with expressive speech impairment due to dementia. This pilot study aims to find out the efficacy of MIT for speech-impaired dementia patients in different verbal tasks. The results of this study will provide preliminary empirical evidence to establish the utility of MIT for Cantonese speakers in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* Early to moderate stage dementia patient
* Normal hearing (hearing aid accepted)
* Non-fluent speech (max. score of fluency in Cantonese Aphasia Battery spontaneous speech subtest = 6/10)

Exclusion Criteria:

* Non-native Cantonese speaker
* Illiterate
* Aphasic patients
* Subjects who receive other speech therapy during study
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.

This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.


Eligibility Criteria:
Inclusion Criteria:

* postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence
* patients aged ≥ 18 years

Exclusion Criteria:

* acute urinary tract infection at the moment of inclusion in the study
* antibiotic treatment prescribed for any other cause than urinary tract infection
* pregnancy
* known allergy to one of the elements of the active compound
* surgery for mesh excision
* surgery for urethral diverticulum
* surgery for fistula repair
* surgery for sacral neuromodulation
* any condition precluding the acquisition of written consent
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability

This is a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the treatment of recurrent anterior glenohumeral instability with subcritical bone loss.

Presently, consensus guidelines for the surgical management of anterior glenohumeral instability are lacking. While there has been continual evolution in available arthroscopic instrumentation, this has not translated to improvements in patient outcomes. Isolated arthroscopic bankart repair is often associated with unacceptably high rates of failure, with a recent systematic review identifying continued recurrence rates of 14.2%. Improved recognition of bone defects and identification of critical defect sizes that contribute to recurrent instability and failed stabilization have lead to improvements in treatment algorithms. It has been widely accepted that glenoid defects exceeding 20% of anteroposterior (AP) width and humeral head defects exceeding 30% of the humeral head width contribute to recurrent instability. For defects of this magnitude, isolated arthroscopic Bankart repair is insufficient in restoring joint stability, and more extensive procedures are required. This can include adding a remplissage to the arthroscopic Bankart repair or open allograft reconstruction for humeral defects; or Latarjet coracoid transfer for glenoid defects.

However, often patients present with combined 'bipolar' bone loss, where individual defects are subcritical in size. There is increasing recognition that the presence of this combined bone loss may lead to increased rates of failure with an isolated arthroscopic bankart repair. Currently, accepted treatment options for bipolar bone loss include a combined arthroscopic Bankart repair and remplissage, or a Latarjet coracoid transfer. While there is supportive biomechanical data for each procedure, and limited case series in the literature, there remains a paucity of high-quality evidence to guide treatment for this complex clinical scenario. Consequently, we aim to perform a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer.

Eligibility Criteria:
Inclusion Criteria:

* anterior shoulder instability (\>1 dislocation)
* age \>14 years
* evidence of a Hill-Sachs defect on MRI or CT,
* \< 20% anteroposterior glenoid bone loss

Exclusion Criteria:

* \>20% anteroposterior glenoid bone loss
* significant shoulder comorbidities (i.e., osteoarthritis, previous surgery other than previous instability), active joint or systemic infection, significant muscle paralysis, rotator cuff or Charcot's arthropathy,
* significant medical comorbidity that may alter effectiveness of surgical intervention
* major medical illness,
* unable to speak French or English,
* psychiatric illness that precludes informed consent,
* unwilling to be followed for 2 years
MEVALONATE KINASE GENE MUTATIONS AND THEIR CLINICAL CORRELATIONS IN BEHÇET'S DISEASE

Background: Genetics is suggested to play a critical role in the development of Behçet's disease (BD). Shared phenotypic features requires an approach to the differential diagnosis from periodic febrile syndromes particularly from mevalonate kinase deficiency related diseases. We planned to study for evaluating the frequency of mutations and their clinical significance in mevalonate kinase gene in Turkish patients with Behçet's disease.


Eligibility Criteria:
Inclusion Criteria:

* Behçet patients

Exclusion Criteria:

* Diagnosis of periodic fever syndromes
Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

The purpose of this study is to determine the feasibility and acceptability of a hybrid in-person and virtual individualized physiotherapy program using the Healthy Eating and Active Living (HEAL-ME) online platform for children diagnosed with acute lymphoblastic leukemia. We would like to know if this type of hybrid program delivery model is feasible, and if children and their parents are willing and able to participate in the program. We will do this by recording how many, and what type of physiotherapy sessions (in-person or virtual) are completed, what resources offered on the platform are accessed, and how many children complete the assessments.

Acute lymphoblastic leukemia is the most common childhood cancer, representing approximately 25% of cancers in children. Improvements in survival rates have resulted in an increased number of children living with neuromuscular and musculoskeletal side effects of cancer treatments-effects that may persist or worsen over the long-term into adulthood.

The overall goal of the study is to determine the feasibility of a tailored physiotherapy (PT) program using an online platform for children diagnosed with acute lymphoblastic leukemia.

A quasi-experimental, single group, before and after intervention feasibility study will be conducted, comprising a convenience sample of a minimum of 10 children between 4 and 17 years of age undergoing or having completed chemotherapy treatment for acute lymphoblastic leukemia. Children will participate in a hybrid 12-week PT program delivered in-person at the Stollery Children's Hospital with educational components provided virtually via the Healthy Eating and Active Living web-based platform. Children will participate in six physical therapy sessions over a period of three months and will have the option to choose the mode of delivery: 1:1 in-person, 1:1 virtual, group virtual, or combination of all. The main outcome will be feasibility, as determined by recruitment and retention rates, completion rates of measurements, adherence to sessions, and safety and acceptability.

Eligibility Criteria:
Inclusion Criteria:

1. Children diagnosed with acute lymphoblastic leukemia aged between 4 and 17 years (at time of diagnosis) and their mother, father, or primary carer;
2. Undergoing or completed cancer treatment as established by the Children's Oncology Group;
3. Access to the internet through a home computer or tablet;
4. Patient or caregiver is able to speak and comprehend English; and
5. The child is approved by their Oncologist to participate in the program.

Exclusion Criteria:

1. Children with a history of a neurodevelopmental or genetic disorder (i.e., Down syndrome, autism, seizure disorder) prior to the cancer diagnosis; and
2. Children with a concurrent condition (illness, disease, psychiatric disorder), as determined by oncologist or physiotherapist, that would compromise study participation or interpretation of study results.
Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis

In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.

The primary objectives of this pilot study in 30 patients are:

1. To determine the effect of rifampin-containing tuberculostatic treatment on the pharmacokinetic profile of emtricitabine+tenofovir+efavirenz, when co-formulated in one tablet, in HIV-infected patients with smear-positive pulmonary tuberculosis in Tanzania.
2. To determine the effect of the emtricitabine+tenofovir+efavirenz regimen on the pharmacokinetics of tuberculostatics in the same population.

The secondary objectives are:

1. To determine the safety of co-administration of emtricitabine+tenofovir+efavirenz with treatment for smear-positive pulmonary tuberculosis.
2. To determine the short-term (24 weeks) virological efficacy on HIV of an emtricitabine+tenofovir+efavirenz regimen in patients with smear-positive pulmonary tuberculosis.
3. To determine the short-term bacteriological efficacy on smear-positive tuberculosis of the co-administration of a standard regimen for tuberculosis and an emtricitabine+tenofovir+efavirenz regimen.

Eligibility Criteria:
Inclusion Criteria:

* A smear-positive pulmonary tuberculosis, based on positive smear of at least two sputum samples with Ziehl-Neelsen (ZN) staining.
* HIV-infected as documented by positive HIV antibody test.
* Subject is at least 18 years of age at the day of the first dosing of study medication.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* CD4 cell count \> 50 copies/mm3.
* Karnofsky score \> 40.
* Willing and able to regularly attend the Kibung'oto National Tuberculosis Hospital (KNTH) clinic.

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
* Previously treated for HIV infection with antiretroviral agents.
* Pregnant or breastfeeding.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* A history of severe psychiatric disease such as psychosis, schizophrenia, etc.
* Inability to understand the nature and extent of the trial and the procedures required.
* Abnormal serum transaminases or creatinine, determined as levels being \> 5 times upper limit of normal.
* Active hepatobiliary or hepatic disease (Non B Chronic Hepatitis B/C co-infection is allowed).
* CD4 cell count \> 350 cells/mm3.
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON

Development of a bio-mathematical model of the human female cycle

From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.

Eligibility Criteria:
Inclusion criteria:

- Women during their reproductive phase, no hormonal therapy

Exclusion criteria:

- Amenorrhoae
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.

Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.

Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.

Eligibility Criteria:
Inclusion Criteria:

* Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
* Indication of root coverage by dentin hypersensitivity or esthetic

Exclusion Criteria:

* Smokers
* Pregnancy
* Systemic medication use that could impair wound healing or surgery procedure
* Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.