cyrilzakka/clinical-trials huggingface dataset:
Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers

The current study has the following objectives:

1. To determine additional stroke patient (SP) and stroke caregiver (SC) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess SP and SC preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention.
2. To develop, \[using the preliminary data and information from aim 1\], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.


Eligibility Criteria:
Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:

* Age 18 or older
* English fluency and literacy
* Hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) OR primary stroke caregiver of a stroke patient currently admitted with an acute stroke
* Stroke patient or stroke caregiver screens in for depression and/or PTSD

One or more of the following exclusion criteria will render a stroke patient (only) ineligible:

* Stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis

This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.


Eligibility Criteria:
Inclusion Criteria:

* Adults age \>18 years
* Evidence of NASH indicated by at least one of the following

  * Liver biopsy with evidence of steatohepatitis (NAS \>=4) within 6 months of the screening interval or;
  * Historical Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following non-invasive tests within 6 months of the screening interval: i. FIB-4 \>= 1.3 or; ii. NFS \>= -1.44 or; iii. ELF \>= 7.7 or; iv. VCTE kPa \>=8 or; v. ARFI \>=1.3 or; vi. FAST \>= 0.35 or; vii. MRE kPa \>=2.55 or; viii. MAST \> 0.165 or;
* Possession of a smartphone

Exclusion Criteria:

* Active cardiac symptoms precluding participation in vigorous exercise
* Active or recent participation in exercise training program within the last 90 days
* Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use)
* Active illicit substance use
* Cancer that is active
* Cirrhosis
* Exercise identified to be unsafe by study PI or EL-FIT mHealth program
* Inability to provide informed consent
* Inability to walk \> 2 blocks
* Institutionalized/prisoner
* Other chronic liver disease (e.g., viral hepatitis)
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Japan, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor.

The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 20 years at the time of signing informed consent
* Available glycated haemoglobin (HbA1c) value greater than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery

Background: Postoperative hypothermia may result in relevant complications such as adverse cardiovascular events, wound infection, and coagulopathy with consecutive blood loss. Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158 patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface including wound surface are exposed. Many of these patients receive large amounts of infusions and transfusions, and undergo hemodilution during CPB, which may additionally contribute to development of hypothermia.

Objective of the planned study is to find out incidence and duration of postoperative hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is the incidence of postoperative complications and its relation to postoperative core temperature.

Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative hyperthermia (\> 37.8 °C) and hypothermia (\> 36 °C).

The following parameters will be recorded: temperature is measured at ICU after arrived and after 6 hours which is primary outcome, biometric data include age, sex, body weight, height, ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest temperature during bypass, method of temperature protection, and the outcome of operation .

All data will be described in number and percent and Pearson chi-square method will be used for analyze correlation between hypothermia and risk factor . P-value \<0.05 will be defined to significant.


Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years old

Exclusion Criteria:

* patients with preoperative hyperthermia (\> 37.8 °C) and hypothermia (\< 36 °C).
Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Eligibility Criteria:
Inclusion Criteria:

* age older than 40 years
* diagnosis of pituitary adenoma
* treatment-naïve with Endoscopic Endonasal Pituitary Surgery
* absence of other neurological diseases
* absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 40 years
* No diagnosis of pituitary adenoma
* previous treatments with Endoscopic Endonasal Pituitary Surgery
* presence of neurological diseases
* presence of vitreoretinal and vascular retinal diseases
68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG

As a new dual receptor (SSTR2 and FAP) targeting PET radiotracer, 68Ga-FAPI-LM3 is promising as an excellent imaging agent applicable to SSTR2 positive diseases. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-LM3 in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of lesions in SSTR2 positive diseases, and compared with 18F-FDG PET/CT.

As a new dual receptor (SSTR2 and FAP) targeting PET radiotracer, 68Ga-FAPI-LM3 is promising as an excellent imaging agent applicable to SSTR2 positive diseases In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-LM3 in healthy volunteers. Moreover, subjects with SSTR2 positive diseases underwent contemporaneous 68Ga-FAPI-LM3 and 18F-FDG PET/CT for diseases assessment. Lesions uptakes were quantified by the maximum standard uptake value (SUVmax). The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-LM3 were calculated and compared to 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order);
* (ii) patients with suspected or newly diagnosed or previously malignant disease, with either FAP or SSTR2 positive expression (supporting evidence may include MRI, CT, and pathology report etc);
* (iii) patients who had scheduled both 18F-FDG and 68Ga-FAPI-LM3 PET/CT scans;
* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant disease;
* (ii) patients with pregnancy;
* (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Pulmonary Vein Isolation with the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent symptomatic PAF with at least one documented episode
* Failure or intolerance of at least one AAD
* Age 18-75 years
* Patient is indicated for an ablation procedure according to society guidelines or study site practice
* Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study

Exclusion Criteria:

* overall good health as established by multiple criteria
Impact of Neck and Facial Exercises on Swallowing Function in Elderly Individuals

The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

The investigators have designed a simple and user-friendly swallowing rehabilitation training method called "systematic simple swallowing training" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. It has shown promising preliminary efficacy. However, before we can promote its widespread adoption, a series of studies must be conducted to establish its effectiveness. The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
Neurobehavioral Mechanisms of Cocaine Choice

The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making "profile" associated with the decision to take cocaine and the reduced cocaine choice that occurs during a behavioral intervention (alternative money reinforcer) that models contingency management.


Eligibility Criteria:
Inclusion Criteria:

* Recent cocaine use, otherwise healthy

Exclusion Criteria:

* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models

Breast cancer has the highest incidence rate among female cancers, and breast radiotherapy plays an essential role in the treatment of breast cancer. However, the acute and chronic skin reactions caused by radiotherapy, especially radiation dermatitis, have a significant impact on the physical and mental health of breast cancer patients. Severe acute radiation dermatitis can affect the patient's quality of life and may even lead to treatment interruption, thereby affecting treatment efficacy. Chronic radiation dermatitis can lead to irreversible skin problems, such as "radiation-irritated skin" and skin pigmentation, which can affect the quality of life of breast cancer patients after treatment.

This study aimed to evaluate and examine the skin reactions of 30 breast cancer patients who underwent whole-breast radiotherapy after breast conserving surgery. The subjects returned to the hospital for evaluation every week during radiotherapy, and in the second and sixth weeks after the end of the treatment, they received physical examinations and surveys, including questionnaire surveys, skin observations and measurements. The study lasted for 3 months. Skin observation items included physiological parameters such as skin moisture, temperature, melanin, transepidermal water loss (TEWL), and clinical evaluation of skin reactions by physicians. Through statistical analysis of skin physiological parameters, scientific instruments can quantify the radiation skin reactions traditionally judged by clinical physicians by visual examination and can perform real-time clinical prediction monitoring, which can be used to establish a skin reaction prediction model in the future.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be males or non-pregnant females at least 18 years of age.
* Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which will be treated by radiotherapy after operation.
* Patient had unilateral breast conservation surgery with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
* Patients were scheduled to receive at least five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy.
* Participant must give informed consent.

Exclusion Criteria:

* Bilateral breast cancer
* Previous radiotherapy to the chest
* Prior breast reconstructions, implants, and/or expanders
* Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
* Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
* Participation in any clinical trial in the prior 30 days from baseline.
* Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora

Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. The aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.


Eligibility Criteria:
Inclusion Criteria:

* presence of intestinal helminths eggs in the stool

Exclusion Criteria:

* allergy to imidazole derivate
* No intestinal helminths
Impacts of Oral Irrigation in Patients With Periimplant Mucositis

The present study aimed to investigate clinically the cleaning effectiveness of different treatment modalities, that is, oral irrigator or interdental brush usage addition to routine brushing and examine TGF-β1, IL-1β, t-PA, and PAI-1 levels in periimplant crevicular fluid of patients with periimplant mucositis. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who use implant-supported protheses.

Detailed Description: Our aim was to evaluate efficacy of a manual tooth-brush with either interdental brush or oral irrigator in treatment of periimplant mucositis.

Material and Method: Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. After baseline examinations \[Silness-Löe plaque index(PI), Löe-Silness gingival index(GI), probing pocket depth(PPD), clinical attachment level(CAL), bleeding on probing(BOP)\], initial periodontal therapy was completed using full-mouth disinfection method. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.

The hypothesis of our study is that oral irrigators may be effective in oral care of individuals using an implant-supported prosthesis because of the ease of use.

Eligibility Criteria:
Inclusion Criteria:

* subject with no systemic diseases that affect oral tissues and the nature of plaque,
* with no professional cleaning for at least six months prior to baseline examination,
* with one or more implants (Straumann, Waldenburg, Switzerland) functioning at least 24 months before the start of the study
* having implants with BOP in at least two of the six regions
* The people who agreed to refrain from the use of any nonstudy dental device or oral care product for the study duration were included in the study

Exclusion Criteria:

Exclusion criteria

* subjects not cooperative,
* having disease associated with bacteremia,
* taking medication influencing gingival health (eg. dilantin, calcium channel blockers, cyclosporine, anticoagulants),
* using long-term antibiotic and anti-inflammatory agents,
* smokers and
* women who were pregnant and in lactation period
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of DSM-IV ADHD
* Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
* Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test

Exclusion Criteria:

* Current DSM-IV Axis I psychiatric disorder (other than ADHD)
* Current user of cigarettes or other nicotine-containing product.
* Slow metabolizers as indicated by CYP2D6 genotyping.
* Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.