cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue

Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years
* Has received a diagnosis of chronic babesiosis
* Severe disabling fatigue
* Able and willing to give written informed consent
* Able and willing to perform all study assessments
* If female negative urine pregnancy test and
* If female agree to use an acceptable method of birth control

Exclusion Criteria:

* Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
* Breastfeeding
* Unmanaged Psychotic disorder
* Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines
* Current or planned treatment with quinine
* Any concomitant significant illness unrelated to babesiosis
* Any excluded concomitant medication
* Taking or intending to take quinine
* The patient is unable to tolerate medication by the oral route
* The patient has previously taken tafenoquine
Light Therapy for Depression During Pregnancy

The purpose of this study is to determine whether morning bright light therapy is an effective treatment for major depression during pregnancy compared with low-intensity placebo light therapy, when administered 60 minutes daily for 5 weeks.

Affective disorder during pregnancy is a common and severe condition, associated with a higher risk for prenatal complications, preterm delivery, a higher rate of surgical birth and vaginal operative delivery. Depressed pregnant women are at risk for inadequate nutrition, poor weight gain, increased use of nicotine, drugs and alcohol, and failure to obtain adequate prenatal care, as well as poor mother-child attachment. Their infants have a higher risk for low birth weight, a higher rate of admission to neonatal intensive care, and cognitive, emotional and behavioural disturbances.Treatment of antepartum depression requires careful judgement to minimise risk to the foetus. Pharmacological treatment is an option, but all antidepressants cross the placenta, and both practitioners and patients are concerned about possible teratogenicity, pre- and perinatal adverse effects for the infant, as well as negative effects on long-term development. Thus, psychiatric medication use for depression in pregnancy may also pose an excess risk of preterm delivery and withdrawal symptoms in the newborn. Treatment of depression during pregnancy that is efficacious, reliable, safe, and with minor side effects is an urgent unmet clinical need. Light therapy may provide this somatic, non-pharmaceutical alternative. It is well established as the treatment of choice for Seasonal Affective Disorder (SAD), and there is a growing data base for response in nonseasonal major depression. Two promising pilot studies led to the present randomised, double-blind, placebo-controlled trial of 5 weeks daily morning bright light therapy (1h, 7000 lux white) compared with low-intensity placebo light therapy (1h, 70 lux red).

Eligibility Criteria:
Inclusion Criteria:

* German-speaking
* Medically healthy with normal ocular function
* Pregnancy 4 through 32 weeks gestation based on first trimester ultrasound
* DSM-IV diagnosis of major depressive disorder
* SIGH-ADS \[Structured Interview Guide for the Hamilton Depression Rating Scale (HAMD) with Atypical Depression Supplement\] score of \>20
* Able to provide informed consent
* Preferably untreated; exception when on antidepressant for more than 3 months without any improvement, keeping medication constant during the study

Exclusion Criteria:

* DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode
* Substance abuse within the last 6 months
* Primary anxiety disorder
* Recent history of suicide attempt (6 months)
* Delayed sleep phase disorder or hypersomnia with habitual sleep onset later than 1 a.m. or wakening later than 9 a.m.
* Obstetrical care or medications for medical disorders which might confound treatment results
* Fetal malformations and intrauterine fetal death
Exploration of HIV Reservoirs

Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.

Evaluation of the mucosal HIV reservoirs (HIV-DNA quantification and distribution of the infected T lymphocytes in the gut mucosa associated lymphoid tissue compared to the blood in HIV-1 infected patients under antiretroviral treatment with an undetectable plasma viral load below the 50 copies/ml limit of detection for at least 5 years).

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 documented infection
* HIV-1 plasma viral load measurable before antiretroviral treatment initiation
* Patients treated with an antiretroviral combination containing a protease inhibitor and/or a non-nucleosidic reverse transcriptase inhibitor without any interruption since treatment initiation
* Patients with a stable plasma viral load below the limit of detection (HIV-RNA \< 50 copies/ml since January 2006 and/or HIV-RNA \< 200 copies/ml during the anterior period) under antiretroviral treatment for at least 5 years and for at least 90 % of the measures

Exclusion Criteria:

* Contraindication to the biopsy
* No ability or willingness to provide informed consent
* Concomitant treatment with antithrombotics or platelets antiaggregatory
* Patients co-infected with HCV and or HBV
* Patients who received an immunosuppressive treatment during 3 months prior enrollment (chemotherapy, radiotherapy, corticotherapy, splenectomy) or an immunotherapy during 5 years prior enrolment (IL-2, anti-HIV vaccine, IFN-alpha)
School-Age Children With Autism With Limited Expressive Language Skills

This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).

Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, \& Risi, 1999)
* Chronological age between 4.0 years and 7 years, 11 months
* Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
* Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid \& Miller, 2007)
* Children have participated in and completed follow-up testing for the ICAN study.

Exclusion Criteria:

* Major medical conditions other than autism (e.g., genetic disorders \[e.g., Fragile X, Down syndrome, tuberous sclerosis\], blindness or deafness, and motor disabilities such as cerebral palsy;
* Uncontrolled seizures;
* Self-injurious behavior or moderate to severe aggression.
* Children in foster care.
* Children who are exposed to \< 50% English throughout their typical day.
* Children currently participating in another intervention/treatment study.
Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

We designed a non randomized control study to compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment We planed to enroll 48 patients.Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria. Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\> 11%, triglycerides \>600 mg/dl).

Then we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1 group, metformin group and acarbose group, and each group 12 samples. Each group use specific treatment(showed as the group name) 3 months. Before and after the intervention, the blood samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood chemistry for liver and kidney function ect, as well as the image examinations.

We will compare the data of each patient, finally identify the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria.

Exclusion Criteria:

* Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\> 11%, triglycerides \>600 mg/dl).
Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children

The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.

Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-8 years of age
Classifying Ectopia Lentis in Marfan Syndrome Into Five Grades of Increasing Severity

Marfan syndrome is characterized by musculoskeletal manifestations, cardiovascular disease and ocular abnormalities, particularly ectopia lentis. Diagnosis depends on clinical evaluation, family history and molecular data: mutation in the fibrillin-1 gene (FBN1). Ectopia lentis is the most common ocular manifestation in Marfan syndrome with FBN1 mutation and is relatively specific to this disease when associated with other features. However, clinical examinations for identifying ectopia lentis have not really been codified. The purpose of this study is to describe a 5-grade classification of increasing severity for ectopia lentis based on clinical examination and to evaluate the predictive value for the early grades of ectopia lentis in order to help characterize this major clinical diagnosis criterion.


Eligibility Criteria:
Inclusion Criteria:

* MFS patient, clinical diagnosis according to revised Ghent criteria, confirmed by FBN1 mutation.
* Relatives of MFS patients with none of the clinical features of MFS and in whom testing for the familial FBN1 mutation was negative.

Exclusion Criteria:

* Patients who had surgery for ectopia lentis
* Patients for whom dilation was not optimal.
Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

The primary purpose of this study is to compare the Celect and Denali filters in terms of complicated filter retrieval and indwelling complications after a 2-month indwelling time.

With anticoagulation being the standard treatment for deep venous thrombosis and pulmonary embolism, inferior vena cava filter placement plays an important role in patients who are amenable to anticoagulant therapy. Currently, many different types of retrievable filters are being used in clinical practice and the choice of the filters depends on operators' preference and institutional availability. Each filter has different designs to maximize retrievability and minimize indwelling complications. Up until now, the prior studies on the filter retrievability and indwelling complications have been retrospective in nature and had relatively long dwell times. Comparative data regarding the retrievability of the inferior vena cava filters may help to choose filter selection. Therefore, the aim of this trial is to compare two commonly used inferior vena cava filters (Denali and Celet filters)

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who develop deep venous thrombosis and/or pulmonary embolism but are good candidates for anticoagulant therapy
* 2. Inferior vena cava filtration before mechanical thrombectomy for deep venous thrombosis
* 3. Prophylactic filter placement because of trauma or major surgery

Exclusion Criteria:

* 1. Sepsis
* 2. Those who need permanent filter placement
* 3. Congenital anatomical anomaly (IVC duplication, interrupted IVC)
* 4. patients who need filter placement in the suprarenal inferior vena cava
Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery

After one-stage hybrid arrhythmia ablation surgery there are possible side effects like acute and chronic pain. There is a lot of research surrounding these pains but not specifically after one-stage hybrid arrhythmia ablation surgery. The investigators want to research factors that may be associated with the absence of chronic pain after hybrid ablation include ketamine, peroperative opioids, loco-regional blocks, neuraxial blocks, wound infiltration, postoperative patient-controlled analgesia. The presence of corticosteroids or NSAIDS, will also be evaluated. Furthermore, non-adaptable factors such as genetics complicate the onset of chronic post-operative pain. Taking existing knowledge in this field into account, incidence risk as well as acute pain duration and intensity and their effects on chronic pain will become the primary focus of this study.

The investigators will contact all patients who had a one-stage hybrid arrhythmia ablation surgery at UZ Brussels. Participants will be sent a questionnaire with a consent form in and a survey asking about their pain 3 months postop and their current pain management therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* he/she must understand and read the Dutch, French or English language
* be able to digitally agree to participate in the study
* had to have a one stage hybrid procedure at least three months ago
* have an ASA score of I, II or III.

Exclusion Criteria:

* Patients with previously known chronic pain syndromes, fibromyalgia, complex regional pain syndrome are excluded.
* Subjects with previous known chronic conditions such as diabetes neuropathy, rheumatoid arthri-tis, ... are also excluded.
* Subject are excluded if they underwent a surgical treatment within the observed period.
* Patients are excluded when under treatment with chemotherapy/radiotherapy
* Pregnant patients are also excluded.
* Patients with known psychological conditions such as depression are excluded.
Community Participation Transition After Stroke

Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.

We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16

We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke.

We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.

Eligibility Criteria:
Inclusion Criteria:

1. ≥45 years old
2. acute ischemic stroke, verified by a neurologist
3. baseline National Institutes of Health Stroke Scale (NIHSS) ≥8
4. independent in activities of daily living prior to stroke (premorbid Rankin score of ≤2)
5. plan to discharge to home

Exclusion Criteria:

1. severe terminal systemic disease that limits life expectancy to \<6 months
2. previous disorder (e.g., dementia) that makes interpretation of the self-rated scales difficult or a Short Blessed Test (SBT) score of ≥9 (indicating significant cognitive impairment)
3. moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2
4. residence in a congregate living facility
5. not eligible for a therapeutic pass
Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.

The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.


Eligibility Criteria:
Inclusion Criteria:

* MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)
* Fabry patients with cornea verticillata \> grade 1
* Age ≥ 12 years
* Patient is able to comply with the study procedure
* Patient has consented to be in the trial
* Ability to fixate a target

Exclusion Criteria:

* History of corneal transplantation or refractive surgery
* Corneal pathologies other than MPS-associated corneal opacity
* Corneal, conjunctival or intraocular inflammation
Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT®

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® \[coagulation factor VIIa (recombinant)-jncw\] in the USA.

The current study will provide a unique opportunity to describe the profile of the early patients selected for treatment with SEVENFACT® and to assess the real-world utilization (effectiveness, safety, tolerability, and modalities of treatment) of SEVENFACT®.

Parameters collected will include patient socio-demographics, medical history / comorbidities, bleeding disorder history, physical examination, vital signs, prior and concomitant bleeding disorder treatments, bleeding episode / surgery or invasive procedure / prophylaxis details, information on SEVENFACTâ treatment modalities, retrospective investigator rating of SEVENFACTâ effectiveness using the Clinical Global Impression Efficacy Index (CGI-E) and time for bleed control, Adverse Drug Experiences (ADEs) temporally associated with SEVENFACTâ administration, special situations that occurred during SEVENFACTâ administration, whether or not associated with ADE, laboratory testing for activation of the coagulation system or thrombosis, physical examination, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

1. Patient received SEVENFACT® before study initiation.
2. If collection of a written informed consent is required for an investigational site (see Section 5.1 General Informed Consent), patient has read, understood, and documented written informed consent/assent.

Exclusion Criteria:

Not applicable
Testing STAR and TexSTAR: A Video and Text Messaging Intervention

This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.

This pilot trial is part of a larger R61/R33 to test the effectiveness of brief video and text messaging interventions on PTSD and opioid misuse among recent survivors of sexual assault presenting for medical care. In the R61 phase, researchers are working with a sexual assault advisory board to develop the video and text interventions. The research team is partnering with 5-6 Sexual Assault Nurse Examiner programs across the United States to recruit 50 participants. In this pilot trial, researchers aim to test the feasibility of recruitment strategies, acceptability of the interventions among survivors, and preliminary effectiveness of the interventions at addressing PTSD and opioid misuse.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 or older
* Can read and respond to questions in English
* Are receiving a SANE exam for sexual assault victimization within the previous week (7 days)
* Not currently or about to be hospitalized for severe injuries, suicidality, or psychosis
* Not currently or about to be incarcerated

Exclusion Criteria:

* Patients under age 18
* Those who cannot read and respond to questionnaires in English
* Those seeking care that does not include a SANE exam
* Those who cannot consent to receive SANE care.
* Those who are currently or about to be hospitalized for severe injuries, suicidality, or psychosis
* Those who are currently or about to be incarcerated (e.g., suspects, those who have experienced sexual assault within a prison setting and are returning to that setting, etc)