cyrilzakka/clinical-trials huggingface dataset:
CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment

The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.


Eligibility Criteria:
Inclusion Criteria:

* consent to participate via RedCap
* indicate a mild or greater elevation on screening measures of anxiety, depression and/or traumatic stress
* have a child between 6 and 13 years
* speak/read English or Spanish fluently

Exclusion Criteria:

* reported severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual disability, psychosis, alcohol use disorder, substance use disorder) or hospitalization for mental health concerns or suicide attempt.
* reported prior arrest for child endangerment, child abuse or child neglect, or prior investigation by the Florida Department of Children and Families (DCF)
* may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate
Effects of Power Mobility on Young Children With Severe Motor Impairments

The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.


Eligibility Criteria:
Inclusion Criteria:

* Must be between 14- and 30-months of age
* Must have clinical diagnosis of a motor impairment that prevents functional independent mobility
* Must have adequate vision and hearing to use power mobility device safely
* Must have cognitive abilities equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted
Cerebral Blood Flow Using Transfontanelle Ultrasound

We planned to evaluate cerebral blood flow and its association with age, blood pressure, and end tidal carbon dioxide in small pediatric using transfontanelle ultrasound during general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing general anesthesia

Exclusion Criteria:

* patients with hydrocephalus, brain tumor
Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

The overarching goal of this project is to examine the effect of combining theta burst stimulation (TBS) and N-acetylcysteine (NAC) on cocaine craving and brain response to cocaine-related images.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 2. English fluency 4. Meet criteria for cocaine use disorder (CUD), as determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.

5. Enrolled in an intensive outpatient treatment program (MUSC Center for Drug and Alcohol Programs Intensive Outpatient Program (CDAP-IOP) or currently engaged in treatment for substance related problems.

6. Able to read and understand questionnaires and informed consent 7. Lives within 50 miles of the study site. 8. Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold) 9. Does not have metal objects in the head/neck. 10. Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.

11. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

Exclusion Criteria:

1. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
2. Any physical or intellectual disability affecting completion of assessments
3. Any contraindication to MRI
4. Current or past psychosis
5. ECT in last 6 months
6. Among females, pregnancy at screening will be exclusionary. Females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fMRI scanning session and regularly before and during the medication trial. They must further agree to notify the study physician or PA if they become pregnant during the study.
7. Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA \> 8 will be excluded.
8. Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)
9. Has current suicidal ideation or homicidal ideation.
10. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD
11. Suffers from chronic migraines
12. Any physical or intellectual disability affecting completion of assessments
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial

This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;
2. Relapse occurred after 6 month since platinum-based chemotherapy;
3. PARPi maintenance therapy for more than 6 months before relapse;
4. R0 ideal debulking in initial surgery;
5. PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
6. ECOG/WHO Performance score of 0 to 1;
7. No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
8. No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method
9. Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
10. No contraindication to general anaesthesia for heavy surgery
11. Patients having read, signed and dated Informed consent before any study procedure

Exclusion Criteria:

1. Platinum-refractory/uncontrolled epithelial ovarian cancer;
2. Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;
3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
4. Received radiotherapy within 2 weeks before the start of the study intervention;
5. General conditions cannot tolerate secondary cytoreduction;
6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.
DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis

The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis


Eligibility Criteria:
Inclusion Criteria:

* Males or females \>18 years old
* History of evidence suggestive of cardiac amyloidosis
* Subject is willing and able to comply with protocol required assessments and provide written informed consent

Exclusion Criteria:

* Known diagnosis of primary (AL) amyloidosis
* Known diagnosis of hereditary cardiomyopathy or cardiomyopathy due to aortic stenosis
* Patient is currently pregnant
Ketone Supplementation in Eating Disorders

This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals with anorexia or bulimia nervosa. In addition, the investigators will contrast the effects of active ketone supplementation versus placebo on electroencephalogram (EEG) measurement. All subjects enrolled in the study will undergo EEG on two consecutive days at the beginning of the study, after active ketone supplementation or placebo drink, matched in taste to the ketone drink. Days will be randomized. Thereafter, all subjects will take the ketone supplementation drink for two weeks, twice daily.

The goals of the study are:

1) to test the effect of BHB as a nutritional supplement for AN and BN and 2) to test the ingestion of BHB on brain function.

Subjects will complete a battery of self-assessments and a diagnostic assessment in order to determine eligibility and for characterization of behavior to be used in later analyses. After eligibility is confirmed, subjects will complete 2 EEG scans on separate days after ingestion of Ketone supplement drink or placebo and will complete a taste reward task during the EEG scan. Subjects will then complete 2 weeks of daily ketone supplementation and self-assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Must currently meet DSM-5 criteria for Anorexia Nervosa, Bulimia Nervosa, or OSFED Anorexia or Bulimia Nervosa based on the MINI diagnostic interview
2. Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician
3. English as primary spoken language.
4. Ability to respond to EMA questions up to 6x per day within 60 minutes of receiving the message.

Exclusion Criteria:

1. Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
2. Current substance abuse or dependence in the past 3 months
3. Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
4. Medical conditions associated with ketoacidosis: type 1 diabetes mellitus, acute pancreatitis, alcoholic gastritis, peptic ulcer disease, hepatitis or Boerhaave syndrome (esophageal rupture)
5. History of significant head trauma
6. Indication of intellectual disability or autism spectrum disorder
7. Known allergy to any of the KenetikR drink components: D-beta-hydroxybutyric acid (D-BHB), Stevia, Monkfruit, Potassium Bicarbonate, Sodium Bicarbonate Potassium Sorbate or Taste Task Solutions: Sucrose, Potassium Chloride, Sodium bicarbonate.
Estimating Premorbid Intellectual Functioning in Children and Measuring Change in Cognitive Functioning as Children Develop

Diagnosing and documenting the presence of abnormal change in cognitive functions (such as reasoning abilities) in children over time is of upmost importance when it comes to evaluating the impact of neurological injury, disease, and interventions designed to help improve wellbeing. Unfortunately however, current methods for detecting cognitive impairment and monitoring for abnormal cognitive change in children over time are seriously flawed. By assessing typically developing children's cognitive functioning at two different time points, this study intends to generate new normative data that will significantly improve measurement accuracy when it comes to evaluating the impact of neurological injury and disease on a child's cognitive abilities.

Neurological injury and disease can substantially affect how children's brains work. This can severely impair cognitive abilities and general development. On a day-to-day level, completing everyday tasks, socialising successfully with peers, and getting on with school work can become much more difficult than it was before.

Helpfully, supports and treatments are available that can reduce the negative effects of neurological impairment on a child's cognitive functioning in order to maximise developmental outcomes. However, to deliver appropriate interventions, we must correctly estimate the impact of injury or illness on cognitive abilities and accurately measure how successful treatments are at improving outcomes. Unfortunately, reliable ways of doing this simply do not exist at this time. Consequently, accurate disease (effects) monitoring is seriously undermined; potentially compromising a child's medical management and, thereby, future developmental outcomes.

This study intends to addresses this grave shortcoming by developing reliable ways of measuring the cognitive effects of neurological disease or injury at diagnosis and beyond. Of note, by providing a mechanism to better inform clinical/medical management decisions, completion of this study will help contribute to health and social care aims of enabling children to realise their developmental potential.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be aged between 6 years 0 months and 16 years 11 months 364 days
* Participants must be enrolled into a local mainstream school and have English as their first language
* Participants must not have sustained a previous brain-injury and not suffer from any other neurological illness (please see exclusion criteria below)

Exclusion Criteria:

* Individuals born significantly premature, that have a diagnosis of learning disability, a known neurological illness, or who have had a previous head-injury that required hospitalisation will be excluded from taking part in the study
* Individuals with a current mental health problem for which they are receiving treatment or those with substance misuse problems will also be excluded
* Participants unable to give informed consent will likewise be excluded
Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant Mucosal Thickness Enhancement.

The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .

The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .

The hypothesis of the study is that a similar gain in peri implant mucosal thicknesses will be obtained in sites treated by either a sub epithelial connective tissue graft or a newly developed fascia lata allograft in clinically and histologically in human.

The objective of this study will be to evaluate the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or human Fascia Lata Allograft placed simultaneously with dental implant placement.

Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Participants will be randomized to the control (simultaneous SCTGs) or test (simultaneous FLA) group.

Eligibility Criteria:
Inclusion Criteria:

Ability to maintain good oral hygiene as evidenced in recall visits. Aged 30 to 55 years. Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (\< 2mm bucco- lingual thickness).

Exclusion Criteria:

Uncontrolled diabetes mellitus. Females who were pregnant, or attempting to become pregnant, and nursing mothers.

Acute infection in the area intended for implant placement.
Femoral External Rotation Measured on CT and MRI

This study aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. 50-85 years old
2. patients with osteoarthritis (Kellgren-Lawrence Grade III or IV) underwent total knee arthroplasty.

Exclusion Criteria:

1. patients cannot endure TKA due to severe heart failure, arrhythmia, myocardial infarction, infection or other reason.
2. patients who cannot undergo MRI.
Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)

The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.

Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.

Eligibility Criteria:
Inclusion Criteria:

* Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into:
* Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates.
* Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).

Exclusion Criteria:

* Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing.
* Co-infected HCV participants (eg, human immunodeficiency virus \[HIV\] or hepatitis B virus \[HBV\]).
* Participants who received their first HCV treatment in relation to a clinical trial.
A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region

Primary Objective:

- To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting

Secondary Objectives:

* Describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months).
* To assess the healthcare resource utilization of participants with CRSwNP in countries of the Gulf region (number of visits, emergency room (ER), surgery, etc).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants.
* Participants diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) for at least one year prior to study start.
* Participants diagnosed with CRSwNP according to criteria of American Academy of Otolaryngology-Head and Neck Surgery (i.e. the diagnosis is confirmed in medical records by clinical symptoms and objective evidence of nasal polyps by using anterior rhinoscopy and nasal endoscopy when available and/or computed tomography (CT) scan).
* Participants should be at least 18 years old.
* Participants must have signed an informed consent.

Exclusion Criteria:

* Participants with chronic rhinosinusitis without nasal polyps (CRSsNP)
* Pregnant/breastfeeding participants or participants planning for a pregnancy.
* Participants participating in other interventional clinical trials involving any investigational drug.
* Participants with granulomatous diseases such as vasculitis or sarcoidosis. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
A Normal Donor Sample Collection Study in Healthy Adults

More than one site will participate in the collection of blood and urine samples from healthy adult subjects. These samples will be used for future testing to serve as aged-matched normal controls and to establish normal reference ranges in the development of new invitro diagnostic devices.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy adults (age ≥ 21 years)
* Provide written informed consent for study participation

Exclusion Criteria:

* Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
* Any known or suspected significant chronic medical conditions (such as diabetes, coronary artery disease, renal insufficiency, hypertension, hypercholesterolemia, chronic inflammatory diseases \[e.g., rheumatoid arthritis\], cancer, etc);
* Trauma-related surgery within the last 6 months;
* Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
* Received any blood product transfusion within the previous 2 months;
* Pregnant women or children;
* Prisoners or institutionalized individuals;
* Already provided blood or urine samples for this study.
Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)

Hereditary hemorrhagic telangiectasia (HHT) results from genetic deregulation of angiogenesis. It is characterized by mucocutaneous telangiectasia responsible for recurrent epistaxis affecting quality of life (anaemia, iron deficiency, social distress). More rarely, HHT is complicated by the appearance of pulmonary, hepatic or cerebral arteriovenous malformations that can lead to serious complications: cerebrovascular accidents, cerebral abscesses, high output heart failure, and massive hemoptysis (1). The intensity of symptoms increases with age but with significant individual variability, even for the same mutation in the same family. Thus, while the mutations responsible for the disease have been identified, the pathophysiology is not fully understood because these mutations do not explain the great diversity of clinical presentations. Other factors not yet identified probably play an important role. Angiogenic T cells (TANG) are a newly individualized T cell population, defined by a CD4+CXCR4+CD31+ phenotype, which plays a key role in differentiating endothelial progenitors (2).

In an earlier study, the investigators showed that patients with HHT had a decrease in CD4+ and CD8+ LT compared to a cohort of healthy subjects (3).

They hypothesize that the lymphopenia mainly involves TANG, whose quantification could make it possible to assess the individual level of angiogenesis during HHT. The evaluation of the TANG levels could thus make it possible to personalize HHT management.


Eligibility Criteria:
Inclusion Criteria:

* Person who has given consent
* Adult
* Person capable of understanding spoken and written French

"Patient" group:

* Certain HHT (3 or 4 Curacao criteria - Appendix 2):
* Recurring epistaxis
* Telangiectasia of the skin or mouth
* Family hereditary context
* Arteriovenous visceral malformations
* Causal mutation identified
* Person capable of completing monthly epistaxis charts

"Control" group :

- Control subjects will be matched to patients for age (+/- 6 years) and sex.

Exclusion Criteria:

* Person not affiliated to a national health insurance scheme
* Pregnant or breastfeeding woman
* Protected adult
* Hemoglobin levels less than 9 g/dl in the last 15 days
* Progressive or recent infectious disease, autoimmune disease or cancer (less than 6 months)
* Immunosuppressive treatment in progress or recent (less than 6 months), including systemic steroid therapy. The use of inhaled or topical steroids is not an exclusion criterion.
* Treatment in progress or stopped less than 6 months ago or to be introduced within the next 3 months of the following medications:

  * bevacizumab
  * tranexamic acid
  * dipeptidyl peptidase 4 inhibitors (diabetic patient)
  * beta-blockers (hypertensive patient)