cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan

School-based smoking cessation programmes stretched longer than a year had 12% reduction in preventing smoking uptake. With regards to smoking intervention programme among adolescents, there is a lack of evidences regarding its long-term effectiveness. This was due to lack of clear guidelines, methodological issues and the fact that adolescents were likely to be sporadic or non-daily smoker, leading to discrepancies in their self-reported claim. Adolescent's smoking relapse rate was at 47% while those who never smoke have a 13% chance to become smoker. Light and regular smokers have 30% and 75% chance becoming an adult smoker respectively. A review paper in smoking research in Malaysia showed that the provision of anti-smoking education in school was associated with reduced susceptibility in female smoking.Male students perceived printable media, radio and the Internet as effective in delivering anti-smoking messages.School-based smoking cessation programme has been shown to be cost-effective in helping the students to quit smoking both in developed and developing countries.For this reason, it is essential to explore what are the factors that amplify the success rate of smoking cessation effect of the KOTAK programme.

Through this study the investigators will seek to answer the following questions:

* To determine the quit-smoking rate of the KOTAK programme
* To determine the factors associated with quitting smoking with the KOTAK programme

Important aspects of the KOTAK programme evaluation will involve assessing its impacts on preventing smoking initiation and promoting smoking cessation among the adolescents. This form of assessment is vital in achieving the KOTAK's objectives to reduce the prevalence of smokers in Malaysian schools. An average of 8 hours of training were required for dental officers and dental nurses to deliver the modules in the KOTAK programme. This programme has an important financial implication as it involved almost 4 thousand dental officers and 3 thousand dental nurses to screen almost 4.6 million Malaysian schoolchildren in 2018.

Factors yielding promising results for adolescents to quit smoking are important to be researched. This will provide us with valuable insights from the perspectives of the stakeholders pertaining on areas that needed improvement. Despite the existence of various tobacco-prevention program in public schools, KOTAK is deemed significant as it is a yearly collaboration of School Dental Services with the schools. This study will compare the quit smoking rate between Intervention (with KOTAK Programme) and Control (without KOTAK programme ) schools. The sampling unit was the school.

Eligibility Criteria:
Inclusion Criteria:

Smoker, medically fit and consented (parental) students enrolled in;

1. Public funded school
2. Daily school
3. Non- same gendered schools (co-ed )
4. Multiracial school

Exclusion Criteria:

Students who were a smoker enrolled in;

1. Private schools
2. Boarding school
3. Same-gendered school
4. Vernacular schools
Oral Administration of STC-15 in Subjects with Advanced Malignancies

This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels determined by a modified Fibonacci algorithm. The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion cohorts will be selected based on all available PK, pharmacodynamic, target engagement, efficacy, safety, and tolerability data including long-term safety data beyond dose limiting toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and Drug Administration-approved standard of care treatment regimen, which could encompass targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint blockers.


Eligibility Criteria:
Key Inclusion Criteria:

* \> 18 years of age
* Histologic or cytologic confirmation of advanced malignancy that has failed standard of care (SOC) therapy and no further SOC therapy is available or the subject has declined additional SOC therapy
* Adequate organ and marrow function
* ECOG PS of 0 or 1

Key Exclusion Criteria:

* Treatment with any local or systemic antineoplastic therapy within 3 weeks prior to first dose of STC-15
* Major surgery or radiation within the 3 weeks
* Immune-related AEs from immunotherapy that required permanent discontinuation
* Central nervous system (CNS) disease involvement, or prior history of Grade ≥3 drug-related CNS toxicity.
* Active autoimmune disease that has required systemic treatment in the 2 years prior to Screening
Post-Bariatric Weight Regain Behavioral Intervention

This project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition. The investigators also aim to evaluate its effect on targeted weight control behaviors and acceptance-based skills. Finally, the investigators will examine the relationship between weight outcomes and changes in process variables through exploratory analyses. Treatment outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills) will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after treatment has ended.

Primary Aims.

1. To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.
2. To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).

Exploratory Aim.

(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Has undergone any type of weight loss surgery at least 1.5 years ago
* Demonstrate ≥ 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.
* Ability to give consent and speak, write, and understand English.

Exclusion Criteria:

* Currently enrolled in structured weight loss program
* Currently pregnant/plan to become pregnant within 6 months of enrollment
* Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen
* Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality
* Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening
* Use of medications known to affect body weight, such as chronic systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and antipsychotic agents
Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis

Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis.

This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational try is to identify:

* The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression
* The potential predictors and confounders for response to therapy

Patients are routinely evaluated every 3 months over a 12-months period by medical history, physical examination, pulmonary function tests, VAS lung score and SF-36, SHAQ. Also, their medication and possible medication changes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis fo SSc according to the ACR/EULAR criteria for adult or the PRES/ACR/EULAR criteria for juvenile SSc patients
* SSc patients with proven ILD (by X-ray or CT scan)
* Treatment with standard dosages according to current practice with (i) cyclophosphamide, (ii) azathioprine, (iii) mycophenolate mofetil, (iv) methotrexate, or (v) no therapy

Exclusion Criterion:

* Patients with previous exposure to silica or asbestos
Sensori-motor and Perceptual Functions of the PPC.

To produce hand's movement directed towards a target, the investigator must combine several sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.

The aim of the study is to understand the different functions of the PPC and especially how the processes of spatial coding of the sensory information influences perception and motor planning.

In this study, the investigator want to explore the sensory motor and the perceptual performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral tests.

Objectify the consequences of PPC impairment (visual-motor and perceptual consequences) on patients' quality of life and autonomy.


Eligibility Criteria:
Inclusion Criteria:

All patients and healthy subjects:

* male and female, age from 18 to 75 years included
* normal vision or corrected vision
* covered by social security
* signed written informed consent

Patients:

* neurological injury in posterior parietal cortex supported by a cerebral MRI
* present optic ataxia symptoms Healthy subjects
* no known neurological injury

Exclusion Criteria:

- unable to comply with the tasks (neurological, psychiatric, sensory or motor troubles)
Oximetry in Children for Sleep Apnea Diagnosis

Video-polygraphy or video-polysomnography (vP(S)G) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children as it allows the detection of the respiratory events presented by the child during sleep. This exam requires a one-night hospitalization and several sensors installed on the child's body, sometimes not well-accepted in children. Portable oximetry is an easier test to perform, better accepted by the child, and gives the desaturation index that may be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify a moderate-severe OSAS in children.

Video-polysomnography (vPSG) with video surveillance and monitoring by a nurse to reposition the sensors if needed during the night is the gold standard exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children. The vPSG gives the obstructive apnea-hypopnea index (OAHI), necessary for the diagnosis of OSAS and to determine its severity. But the vPSG is a rather cumbersome exam, sometimes difficult to perform in children, with several sensors and electrodes to install on a child's body (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), nasal cannula, thoracoabdominal belts, pulse oximetry, body position) that is time-consuming for installation and analysis. Video-respiratory polygraphy (vPG) is very similar to vPSG but without EEG, EOG and EMG electrodes. vPG represents an alternative for the diagnosis of OSAS. However, these sleep examinations, vP(S)G, requires a number of electrodes and sensors to be installed on the child's body and one night of hospitalization.

The desaturation index obtained by simple portable oximetry could be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. Portable oximetry is an easier test to perform. It is better accepted by the child because it only requires a finger or toe sensor and could be done on an outpatient basis or in the hospital.

The coupling of these 2 examinations, vP(S)G and oximetry, is part of our current routine practice. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify an OSAS in children.

Eligibility Criteria:
Inclusion Criteria:

Children aged 2 to 18 years suspected of OSA who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022.

Exclusion Criteria:

Children with non-interpretable recordings
Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.

A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery. The results will help us estimate treatment effect and determine sample size for a subsequent full-scale clinical trial.

Primary Endpoint: total amount of fentanyl consumed during hospital admission. Secondary Endpoints: 1) phase I recovery time; and, 2) time to fitness for discharge.

Exploratory Endpoints: 1) intraoperative hemodynamics; 2) intraoperative opioid use; 3) intraoperative sevoflurane use; 4) postoperative pain; 5) postoperative sedation and cognitive recovery 6) time to first request for analgesia; and, 7) incidence of nausea and vomiting between the end of anesthesia and hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older;
* Scheduled for elective knee arthroscopy without anticipated ligamentous repair;
* Planned general anesthesia without a regional block or wound infiltration with local anesthesia;
* Planned day-of-surgery discharge.

Exclusion Criteria:

* Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery;
* Known hypersensitivity to sufentanil or components of DSUVIA;
* Patients with an allergy or hypersensitivity to opioids;
* Pregnancy or actively breastfeeding;
* Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug;
* Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).

The purpose of this study is to examine whether the expression levels of a novel class of molecules, called microRNAs, are associated with acute graft-versus-host disease frequency and severity. Acute graft-versus-host disease is a Acute GVHD is a medical condition that can become very serious. It happens when the donor cells attack and damage your tissues after transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving allogeneic stem cell transplantation at the Ohio State University Blood and Marrow Transplantation program are eligible and will be consented for the study.
Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence

The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).

32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.

Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.

PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.

TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Women ages between 18 and 50 years old,
* Women who have SUI 45 days and above after giving birth
* Patients who accept to join the group sessions and will participate regularly in the treatment program

Exclusion Criteria:

* Women who have pelvic organ prolapsus and fecal incontinence
* Women who have undergone surgery for the lower urinary system
* Those who receive medication treatment for incontinence in the last 3 months
* Those with acute infection and bladder stones or tumors will not be included in the study.
"Solana™ Trichomonas Assay Field Study"

The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.

This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection.

Symptoms in women can include:

* Greenish-yellow, frothy vaginal discharge with a strong odor
* Painful urination
* Vaginal itching and irritation
* Discomfort during intercourse
* Lower abdominal pain (rare)

Exclusion Criteria:

1. The study is limited to females. Male subjects are not accepted.
2. At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes

The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are:

* Does this intervention result in measurable engagement and retention in care?
* Does this intervention result in measurable viral suppression within 6 months?

Participants will

* participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment.
* Six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.

Research design: The proposed study will test a culturally tailored engagement and retention intervention for Haitian immigrants living with HIV (HILWH). This is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (VS) for HILWH and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. The pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed HIWLH adults drawn from 2 Federally Qualified Health Centers (FQHC) sites in Miami.

Procedures to be used:

AIM 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among HILWH. Quantitative questionnaires will be completed by health care service providers and HILWH who will also participate in a Focus group. A sample of HILWH will participate in individual in-depth interviews.

AIM 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. In addition, participants will have 4 individual meetings, approximately once monthly over a six month period.

AIM 3 Photovoice participants will be 6 participants who have completed the pilot intervention (AIM 2) and agree to participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and taking photographs. This activity is expected to take approximately 8 additional hours over 2 and a half months. For these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.

Eligibility Criteria:
Inclusion Criteria:

1. Seropositive for HIV
2. Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.
3. Migrated to the US from Haiti

Exclusion Criteria:

1. Virally suppressed
Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

Squamous cell carcinoma (SCC) is a cancer that originates from the cells lining the body and can spread into the lymph glands and beyond. Some patients first present with an SCC which has moved to the lymph glands of the neck. Clinical examination and imaging investigations are performed to try and identify the site where the cancer has originated. However, if no original site can be identified, then the investigators call these 'cancers of an unknown primary' (CUP) of the head and neck.

One region where these cancers could have originated from is the oropharynx. There are two areas in the oropharynx were cancers commonly arise. One area is the palatine tonsils, which can be removed for analysis with an operation called tonsillectomy. The other area is the tissue lining the back of the tongue, known as the tongue base. A relatively new surgical technique called 'tongue base mucosectomy' (TBM) allows removal of this tissue to see if the primary cancer is contained within it. This study will then use a histological method called 'step serial sectioning' (SSS) to look in more detail at the tonsils and tongue base, hoping to increase the detection rate of the primary cancer.

Centres performing TBM will be asked to participate. Patients will be asked to consent to their tissue being used for SSS after it has undergone conventional histology. Anonymised samples will be sent to a central laboratory in Newcastle for processing. Other anonymised data regarding the patients' diagnosis and care will be collated. Patients will be asked to complete questionnaires regarding pain and swallowing recovery following surgery. A smaller cohort of patients will also be interviewed as part of a qualitative research process to establish their views on CUP and the acceptability of the above treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16 or over
* Both sexes
* Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site

Exclusion Criteria:

* Primary site identified by any means prior to being indicated for TBM
* Patients undergoing targeted biopsies or resections
* Patients known to have a history of previous H\&N cancers
* Patients known to have undergone previous radiation to the H\&N region