cyrilzakka/clinical-trials huggingface dataset:
A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial

his feasibility study aims to compare the effectiveness of Psychological First Aid (PFA) and Dialectical Behavior Therapy (DBT) interventions in reducing suicide risk among undergraduate students. The study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.

Suicide risk among undergraduate students is a pressing mental health concern, exacerbated by academic pressures and social isolation. Psychological First Aid (PFA) is a supportive intervention designed to reduce distress and foster coping in the immediate aftermath of a crisis. Conversely, Dialectical Behavior Therapy (DBT) is a structured, evidence-based therapy that focuses on emotional regulation, interpersonal effectiveness, and distress tolerance. This study explores the feasibility and effectiveness of these two interventions in a university setting.

Eligibility Criteria:
Inclusion Criteria:

Participants in this feasibility study must be undergraduate students aged 18-25 years who are identified as at risk for suicide based on a validated screening tool. They must be currently enrolled in a degree program, able to provide informed consent, and proficient in English.

Exclusion Criteria:

Individuals with severe mental illnesses (e.g., schizophrenia, bipolar disorder), those in acute crisis requiring immediate intervention, current substance abuse issues, significant cognitive impairments, prior experience with DBT or similar therapies within the last year, and physical health conditions that could complicate participation.
Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU

About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical University (TMU) and Wellcome Clinic. They will be randomly assigned either to Usual Care (UC) or Usual Care plus 3M4Chan Intervention group (IG). A randomized comparative effectiveness trial will be conducted. Patient will enroll from September 2017 to May 2018. In UC group, the physician provides a brief advice to quit during first consultation, a quit plan template, and medication prescription (Varenicline, Bupropion, Champix, Nicotinell TTS20) as decided by the physician. IG group includes UC plus a mobile App that is programmed to push tailored messages for health concern and readiness to quit, tips for sustaining abstinence, use of interactive self-assessments, helpful cessation information. This group of smokers will benefit from tailored cessation interventions with integrated body weight management elements that take into consideration the prevailing local and cultural influences on diet and levels of physical activity. IG will be continued even after stopping of the UC.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older and approach smoke cessation clinic at TMU hospital
* Have an Android mobile phone
* Able to read Traditional Chinese
* Willing to participate in all study components
* Willing to be followed-up for 6 months
* Smoked at least once every month in the last two years
* Current smoker

Exclusion Criteria:

* • Below 20 years on the day of enrolment

  * Not willing to participate in the study
  * Those who do not have Android mobile phone or unable to read Mandarin
  * Not willing to share medical information from EHR
  * Subjects who develop adverse effects related to the pharmacological treatment included in the study
Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer

The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer

  * If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened
  * If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened
  * Patients at least 40 years old or 10 years younger than the youngest affected individual
* Peutz-Jeghers Syndrome (PJS) patients age\>30
* Hereditary pancreatitis patients
* Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
* Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
* Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
* Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
* Willingness to undergo radiographic evaluation if screening findings are abnormal

Exclusion Criteria:

* Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope
* Personal history of pancreatic adenocarcinoma
* Previous partial or complete resection of the pancreas for adenocarcinoma
* Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis
* Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years
* Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV)
* Life expectancy less than 5 years
* Pregnancy
Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine

Patients suffering from migraine will be randomly allocated to one of two different behavioral interventions:

* mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation \& yoga techniques and teaching information regarding the relationship between stress and health.
* into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigators will measure the frequency and intensity of migraine attacks before during and after the intervention as well as secondary variables on quality of life and psychological functioning. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.

Sixty patients suffering from migraine will be randomly allocated to one of two different behavioral interventions: (i) mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation \& yoga techniques and teaching information regarding the relationship between stress and health. or (ii) into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigator will measure the frequency and intensity of migraine attacks before during and after the intervention by headache diaries as well as secondary variables on pain sensation, psychological well being, generic quality of life, pain regulation, pain acceptance, mindfulness, compliance and satisfaction with the intervention. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.

Eligibility Criteria:
Inclusion Criteria:

* migraine for at least 6 months
* commandment of German language
* 3-8 migraine attacks per month
* willingness to participate in a behavioral intervention and to conduct the daily homework
* if patients take a drug as prophylaxis for migraine no change of drug for at least three months and no change of dose for at least one month prior to enrollment

Exclusion Criteria:

* psychiatric disorders at the time of enrollment
* addiction
* participation in other trials
* prior experience with mbsr
* migraine related to the ovary cycle
* abuse of acute medication for migraine
* other psychological disorders which impair the communication and interaction with the patient
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza.

The main purpose of this study is to understand:

* the symptoms of COVID-19 or influenza
* health-related outcomes of people with COVID-19 or influenza
* the effects of vaccines in people with COVID-19 or influenza.

This study will take in participants who are:

* 18 years or older
* reported to have symptoms with lab tests that have confirmed illness. The lab tests can be tested at any of Walgreens pharmacy COVID-19 or influenza test sites.

The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during twelve follow-ups over a 6-month period.

This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, WPAI and PROMIS-Fatigue short form 8a over 6 months will be collected and evaluated.

COVID-19 Cohort: Participants 18 years or older with laboratory-confirmed COVID-19 illness and at least one patient-reported symptom.

Influenza Cohort: Participants 18 years or older with laboratory-confirmed influenza illness and at least one patient-reported symptom.

All study objectives and outcomes will be assessed separately for the two study cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Self-reported at least one symptom in the screening questionnaire
* Positive result reported from the laboratory
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
* Able to complete the questionnaires by themselves in English

Exclusion Criteria:

* Positive result for both COVID-19 and influenza (coinfection)
* COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.

Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.


Eligibility Criteria:
Inclusion:

* Healthy as determined by responsible physician.
* Male or female between 18 to 65 years old.
* Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.
* Males that agree to use appropriate method of contraception for appropriate amount of time.
* Neither too fat nor too thin.
* Capable of giving written informed consent and being compliant with requirements within the informed consent.

Exclusion:

* Any current medical or psychiatric illness.
* Any history of chronic medical or psychiatric illnesses.
* Previous or current alcohol or drug abuse/dependence including nicotine.
* Female subjects must not be breastfeeding or been breastfeeding for a month.
* Serum prolactin exceeding normal range.
* Personal or family history of prolonged QTc syndrome.
ECMM Candida Registry - CandiReg

The objective of the European Confederation of Medical Mycology - ECMM Candida Registry (CandiReg) is to overcome the lack of knowledge on epidemiology, clinical course, and molecular characteristics of invasive infections due to invasive Candida infections and to function as a platform for future studies and in case of outbreaks.

The specific objectives are:

To describe the global incidence of invasive Candida infection To monitor trends globally and locally over time To define patient risk groups To assess antifungal resistance among Candida spp. causing invasive diseases worldwide To assess attributable mortality of invasive Candida infection To assess incremental costs associated with invasive Candida infection

To describe the clinical pattern of disease To document diagnostic procedures performed for confirmation of diagnosis To describe first-line and salvage treatment regimens applied, guideline adherence, their efficacy and impact on patient survival To inform consensus guidelines To develop clinical screening and diagnostic procedures

Set up of a collection of isolates with molecular characterization and evaluation of resistance genes

Eligibility Criteria:
Inclusion Criteria:

* Cultural, histopathological, antigen or DNA evidence of invasive fungal infection with Candida species.
* Hepatosplenic candidiasis with signs of disseminated Candida infection without culture, histological or microscopic evidence
* Case control

Matching procedure for controls:

In part, controls will be included at the same hospitals that include cases (i.e. each one control per case, both in the same hospital).

Controls will be matched by demographics, underlying diseases and risk factors as well as duration of hospitalization

Exclusion Criteria:

- Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.
Multi-country Survey on Violence Against Women Among Women

The goal of this observational study is to explore and learn about violence against women (VAW) among reproductive-aged women in Asia and Oceania countries. The main questions it aims to answer are:

* pattern and prevalence of VAW among reproductive-aged women
* knowledge, attitude, and practice (KAP) towards VAW among reproductive-aged women
* the need of support services for VAW among reproductive-aged women

Participants will be ever-partnered women aged 15-49 years. The definition of "ever-partnered women" included women who have current and former husbands; current and former cohabiting; or non-cohabiting male intimate partners.

Violence against women (VAW) is a global issue that threatens women's physical and emotional wellbeing, and impacts women worldwide, regardless of age, race, ethnicity, or nationality. This survey aims to investigate 1) the pattern and prevalence of VAW among reproductive-aged women; 2) the knowledge, attitude, and practice (KAP) towards VAW among reproductive-aged women; and 3) the need of support services for VAW among reproductive-aged women.

This multinational, hospital-based, cross-sectional study will be carried out in Asia and Oceania countries. We will select the Obstetrics and Gynecology Outpatient Department or Women Health Unit in each nation. Minimum of 400 female citizen in each country will be recruited if they are aged 15-49 years, ever-partnered women, and agree to finish the questionnaire.

The questionnaire, developed in English with inputs from literature and experts, comprises four sections: 1) basic participant characteristics, 2) patterns and prevalence of violence, 3) knowledge, attitudes, and practices towards violence, and 4) the need for support services. A pilot study will validate and translate the questionnaire into the target languages, ensuring content relevance and sensitivity to the target culture through forward and backward translation processes. The reliability of the questionnaire will be assessed using Cronbach's alpha.

Data collection involves preparatory steps such as developing a training manual for interviewers, addressing potential issues, and advertising the survey. Central investigators will monitor the data collection process, with data collected through self-administered questionnaires. The use of REDCap software aims to manage surveys efficiently and prevent multiple participations. A paper-based questionnaire could be used in some areas when necessary.

Eligibility Criteria:
Inclusion Criteria:

* ever-partnered women
* aged 15-49 years

The definition of "ever-partnered women" included women who have current and former husbands; current and former cohabiting; or non-cohabiting male intimate partners.

Exclusion Criteria:

* declined to participate
* dropped out midway
Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids.

Hence, regional block, using local anesthetics, becomes a good option in this surgery.

The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain.

Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries

When compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. Hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children in the age of 2-12 years
* Children undergoing elective surgery for cleft palate.
* Children who are conscious and willing to participate in the study.
* Children who speak and understand English, Hindi, local or others.

Exclusion Criteria:

* Patient's refusal
* Allergy to the amide group of local anaesthetic agent
* Patient on anticoagulants or bleeding disorder
* Underlying other significant systemic diseases.
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.

The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)

The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Moderate or severe polyneuropathy confirmed with the fuzzy software
* Ability to walk independently in the laboratory
* Accessibility to electronic devices
* Loss of at least 4 degrees of ankle range of motion
* Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles

Exclusion Criteria:

* Ulceration not healed for at least 6 months
* Hallux amputation or total amputation of the foot
* Receiving any physiotherapy intervention or offloading devices
* Neurological or orthopedic impairments
* Major vascular complications
* Severe retinopathy