cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.

The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way Crossover Study to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin_D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in Healthy adult Volunteers Under Fed Conditions In each period, subjects were housed from the evenings before the dosing until after the 36 hour blood draw and were to return for subsequent blood draws at 48, 72, 96 and 120 hours post dose. Single oral 10 mg Loratadine/ 240 mg Pseudoephedrine Sulfate doses were separated by a washout period of 21 days.

A total of 40 subjects and 1 alternate (34 males and 7 females) were included in this study, of which 37 (32 males and 5 females) finished the study according to the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female volunteers, 18-45 years of agestart of the study.
* Other birth control methods may be deemed acceptable
* Postmenopausal women with amenorrhea for at least 2 years will be eligible
* Voluntarily consent to participate in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* In addition, history or presence of:

  * alcoholism or drug abuse within the past year
  * hypersensitivity or idiosyncratic reaction to Loratadine or any other H1-receptor antagonist
  * hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other sympathomimetic amines
* Glaucoma or hypermetropia
* Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor, or any sympathomimetic amines
* Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start
* Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start
* Female subjects who are pregnant or lactating
* Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dose
* Subjects who, through completion of the study, would have donated in excess of:

  * 500 mL of blood in 14 days
  * 500-750 mL of blood in 14 days (unless approved by the principal Investigator)
  * 1000 mL of blood in 90 days
  * 1250 mL of blood in 120 days
  * 1500 mL of blood in 180 days
  * 2000 mL of blood in 270 days
  * 2500 mL of blood in 1 days
* Subjects who have participated in another clinical trial within 28 days prior to the study start
Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.

Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.

Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.


Eligibility Criteria:
Inclusion Criteria:

1. Phase 1: 5 to 10 tremor patients already treated with VIM-DBS but not doing well due to early and/or late loss of benefits (i.e. tremor scores ON stimulation identical or greater than before surgery in absence of stimulation).
2. Phase 2: 10 Essential Tremor patients in need of DBS surgery.
3. Written and signed Informed Consent.
4. Age 18 to 85 years old.
5. Subject must have Essential Tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral action tremor; (b) at least three years duration; and (c) with or without tremor in other locations (e.g., head, voice, or low limbs) \[1\].
6. Soft signs (categorizing patients as Essential Tremor-plus) will be allowed and noted in the patient's chart.
7. Subject must be on stable dose of anti-tremor medication for at least 4 weeks prior to screening.
8. Subject had no botulinum injection for at least three months prior to screening.
9. Subject does not have a significant other medical condition biasing the study finding in investigator's opinion.

Exclusion Criteria:

1. Unwilling or inability to follow the procedures specified by the protocol.
2. Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol.
3. Untreated clinically significant depression.
4. Any current drug or alcohol abuse, as determined by the investigator.
5. History of suicidal attempt within the last 1 year prior to consent or current active suicidal ideation as determined by the investigator.
6. Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
7. Any terminal illness with life expectancy of \< 12 months.
8. Participation in any other interventional clinical trial (e.g. drug, device).
Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. The critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. The overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.


Eligibility Criteria:
Inclusion Criteria:

* a mild stroke as NIHSS total scores 0-5
* 18-90 years of age
* English speaking
* identified as having at least one other chronic condition besides stroke

Exclusion Criteria:

* severe aphasia (NIHSS aphasia score=2)
* moderate to severe cognitive impairment (MOCA \< 21)
* history of dementia
* hemorrhagic stroke
* neurological diagnoses other than stroke
* major psychiatric illness (A diagnosis of bipolar disorder, obsessive compulsive disorder, panic disorder, schizophrenia, post-traumatic stress disorder, and borderline personality disorder)
* a score of no-higher than 20 on the PHQ-9 indicating significant depressive symptoms
* terminal illness
Acceptance and Perceived Benefits of Digitalization by Medical Assistants

The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare.

This study uses an online questionnaire to collect data from respondents regarding their experiences and observations as healthcare professionals in the implementation of digital processes, as well as their perception of digital processes post-implementation. The survey will be conducted at two different time points, in 2023 and 2024. As part of this initiative, we plan to share the feedback and recommendations gathered with the Federal Minister of Health and relevant authorities in collaboration with GEMATIK.

Main research questions are

I. What challenges do healthcare professionals encounter in the implementation of digital processes? II. How can the offers for the implementation and introduction of digital processes (e.g. e-prescription) in medical practice for medical and dental professionals be supported and optimized? III. What changes from the first measurement wave in 2023 to the second in 2024 with regard to the perception of digital offers, experiences, and observations?

Eligibility Criteria:
Inclusion Criteria:

- Ability to participate in surveys (e.g., sufficient German or English language skills)

Exclusion Criteria:

* Younger than 18 years
* Illiteracy
* Massively limited cognitive abilities, i.e., linguistic components of the digital offerings must be able to be used to complete questionnaires or participate in interviews
Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients

Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of this study is the long-term prognostic values of carotid intima-media thickness and coronary flow reserve in cardiovascular mortality of peritoneal dialysis patients.

Endothelial dysfunction (ED) is a precursor and cause of cardiovascular diseases. Defining of endothelial thickness and coronary microvascular function could be useful for detecting ED. Endothelial dysfunction could be assessed by coronary flow reserve (CFR), carotid intima media thickness (IMT). Repeating measurement of IMT and CFR could be predictor of cardiovascular events and mortality in peritoneal dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis patients whose followed up at least six months from October 1994 to October 2011 (for study group)
* Kidney transplant recipients whose followed up at least six months from October 1994 to October 2011 (for control group)

Exclusion Criteria:

* diabetes mellitus
* valvular heart disease,
* any prior coronary intervention and congestive heart failure
* Patients whose left anterior descending coronary artery (LAD) could not be visualized adequately by Doppler echocardiography were also excluded.
Outcomes of Laparoscopic Sleeve Gastrectomy

The aim of this study is to assess 5 year long-term outcomes of laparoscopic sleeve gastrectomy emphasizing weight loss and modification of comorbidities such as type 2 diabetes mellitus, hypertension and gastroesophageal reflux disease from a developing country, Turkey. Prospectively-collected patient data will retrospectively reviewed. To measure the efficacy of the procedure, we will calculate the excess weight loss percentage (EWL %). Effective weight loss after LSG will accepted as more than 50%. The changes in the status of the type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease will be observed.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were, patients between 18 to 65 years old, initial body mass index (BMI) 40 kg/m2 or BMI of 35 kg/m2 in the presence of additional comorbidity and failure of conservative treatment for 2 years.

Exclusion Criteria:

* None
Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.

In a prospective study, we will achieve the following aims:

To determine the feasibility and ease of use of the ClearSight monitoring system in the labor-delivery room (LDR) in detecting and monitoring hypotensive events post-epidural labor analgesia placement.

To compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Age ≥ 18 years of age.
* Receiving epidural labor analgesia (ELA)

Exclusion Criteria:

* Non-reassuring fetal tracing at the time of ELA request
* Contraindications to ELA
* Significant cardiac arrhythmias or aortic regurgitation
* Arrhythmia
* Treatment with antihypertensive medications
* Pre-eclampsia with or without severe features
* Preoperative infection
* Inability to use ClearSight device for any reason
* Incomplete data
Morbidity and Mortality Rates Among Children Aged 0-59 Months

This retrospective observational study aimed to investigate the patterns of morbidity and mortality among children under 5 years of age in the population served by Kalkaal Hospital. Researchers analyzed 2023 data from the hospital's electronic medical records and administrative databases to identify the most common pediatric diagnoses and causes of illness and death in this community.

This study investigated the patterns of morbidity and mortality among children under 5 years of age in the population served by Kalkaal Hospital. The specific objectives were to:

Identify the most common diagnoses and causes of illness and death in the under-5 population presenting to Kalkaal Hospital.

Analyze demographic factors (e.g. age, sex) associated with certain disease profiles and health outcomes.

Evaluate treatment practices, health service utilization, and mortality rates for the key pediatric health issues identified.

Provide a comprehensive epidemiological assessment of the burden of childhood illness and mortality in this local community.

Methods:

This was a retrospective, observational study that analyzed 2023 data from the electronic medical records and administrative databases of Kalkaal Hospital. The researchers extracted and analyzed the following data:

Outpatient department records: Diagnoses, treatments, patient demographics Inpatient admission records: Admission diagnoses, treatments, patient outcomes (discharged, transferred, died) Mortality records: Causes of death for pediatric patients The data was cleaned, coded, and analyzed using statistical software. Descriptive statistics were calculated to characterize the morbidity and mortality patterns. Regression analyses were conducted to identify demographic and clinical factors associated with key health outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 0-59 months who were admitted to Kalkaal Hospital during the specified study period.
2. Medical records with complete and adequate information regarding age, gender, presenting symptoms, and diagnoses.

   -

Exclusion Criteria:

1. Children outside the age range of 0-59 months.
2. Medical records with missing or incomplete information necessary for the analysis.
3. Children admitted to Kalkaal Hospital for reasons unrelated to the study objectives (adult patients, non-pediatric cases).
Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)

In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.

This pilot study aims to evaluate the feasibility and effectiveness of adding a computer based training program in Cognitive Behavior Therapy ("CBT4CBT") for the treatment of addictions in a VA substance abuse outpatient clinic. Key secondary aims are to assess the impact of adding CBT4CBT to standard care on treatment attendance, engagement, retention, and to investigate if certain process measures are associated with substance use outcomes. Approximately 80 patients enrolled in the Newington Outpatient Substance Abuse Treatment Program (SATP) will be randomly assigned to either (A) treatment as usual, or (B) treatment as usual plus exposure to the CBT4CBT program.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Recent (within 3 months) substance use
* meet current DSM-IV (Diagnostic and Statistical Manual-IV) criteria for substance use disorder
* fluent in English or at least a 6th grade reading level
* can commit to at least 8 weeks of treatment and willing to be randomized to treatment

Exclusion Criteria:

* Unstable housing situation
* Likelihood of going to prison during the intervention portion of study
* Recent opiate or benzodiazepine prescription
Cost and Cost-effectiveness of PTB+ Treatment in Southern Ethiopia

Evidences for policy making and decision related to the cost of delivering tuberculosis (TB) control is lacking in Ethiopia. The investigators aimed to determine the cost and cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the community-based initiative in Ethiopia.

Two treatment options were compared - health facility and community DOT. In 1995, Ethiopia adopted World Health Organization (WHO) recommended DOTS strategy for TB control. The treatment regimen for new smear-positive patients includes two months of ethambutol, rifampicin, isoniazid and pyrazinamide followed by six months of ethambutol and isoniazid. For children the continuation phase treatment was replaced by four months of rifampicin and isoniazid. Follow up sputum examinations were conducted at the end of 2, 5 and 7 months treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary tuberculosis suspects of any age and sex

Exclusion Criteria:

* Healthy individuals or non tuberculosis patients
Microglial Activation Role In ALS (MARIA)

Neuroinflammation, characterized in particular by microglia activation, is an essential component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease activity. An experimental radiopharmaceutical specific of TSPO expression, namely \[18F\]DPA714, allow to quantify this microglial activation using Positon Emission Tomography (PET) imaging.

The purpose of this study is to longitudinally correlate the spatial distribution of neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary approaches in 20 ALS patients:

* in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines secreted by microglial cells in the cerebrospinal fluid (CSF).
* in vivo: \[18F\]DPA714 PET imaging. These assays will be performed in the framework of the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years old
* Patient with probable or definite sporadic Amyotrophic Lateral Sclerosis (ALS) form according to the modified criteria of El Escorial
* Treated with riluzole 2 weeks
* Evolution less than 18 months
* Mini-Mental State Examination (MMS) score ≥ 26 and Frontal Assessment Battery (FAB) (normal)
* Affiliated to a social security system

Exclusion Criteria:

* Another unbalanced progressive pathology
* Vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced
* Forced vital capacity \<75%
* Weight loss\> 10% of the weight before disease
* Status "low affinity binder" or "mixed affinity binder", the TSPO respect to the \[18 F\] DPA-714, which can interfere with the process of neuroinflammation: drugs with anti-inflammatory drugs (NSAIDs, corticosteroids, azathioprine, anti-tumor necrosis factor (TNF), antibiotics)
* Benzodiazepine in the week before the PET scan \[18F\] DPA-714 given the potential consequences for TSPO receivers
* Contraindications to MRI in patients with:

  1. Metallic foreign body eye.
  2. Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
  3. Metal heart valve,
  4. Vascular clips formerly located on cranial aneurysm.
* Treatment in the month before the PET scan \[18F\] DPA-714 antagonist N-methyl-D-aspartate (NMDA) (memantine)
* Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy
* ◦Person under guardianship
Better Living With Non-memory-led Dementia

This is a feasibility study on the effects of an online-based training and education programme for carers of people with posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural-variant frontotemporal dementia (bvFTD).

The purpose of this study is:

To evaluate the feasibility of an online training course for carers of people with PCA, PPA, and bvFTD. Feasibility measures will focus on the recruitment process and measurement tools.

To determine the acceptability of an online training course for carers of people with PCA, PPA and bvFTD.

The study will involve 6 online modules over the course of 7 weeks. All sessions will take place over the internet, using an online platform. A research team member (facilitator) will be available to assist participants over the course completion.

Eligibility Criteria:
Inclusion Criteria:

1. . Adults (18+) who self-identify as an unpaid carer (partners, children, friends, etc.) of someone with PPA, PCA or bvFTD who is not living in a full-time care facility.
2. . The care recipient has to have a confirmed diagnosis of dementia (through self-report of the carer, to reflect the 'real world' application of the intervention).

Exclusion Criteria:

1. . Those unable to comprehend written English
2. . Those with no access to the internet