cyrilzakka/clinical-trials huggingface dataset:
Health4Life a Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life

The overall aim of this project is to evaluate the effectiveness and implementation of a digital intervention to support parents to create healthy lifestyle behaviours from the start of their infant's life, in order to prevent overweight and obesity. Using a randomized controlled trial with a hybrid type I implementation-effectiveness design we will:

1. evaluate the effectiveness of the 16-month Health4Life intervention on:

   1. Children's' dietary intake, screen time, physical activity, and sleep
   2. Children's body mass index (BMI) z-scores
   3. Parental self-efficacy
2. Evaluate the cost-effectiveness of the Health4Life app.
3. Evaluate and explore the implementation of the Health4Life app within primary child healthcare with regards to its:

   1. acceptability, appropriateness, and feasibility according to child healthcare nurses.
   2. satisfaction and usage by parents.


Eligibility Criteria:
Inclusion Criteria:

* 0-2 month old infants at routine visits at selected child healthcare centers in Sweden.

Exclusion Criteria:

* Infants diagnosed with a neurological or endocrine disorder.
* Infants who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
* Infants from families who will not be able understand the content of the app.
Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium

Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches.

At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks.

The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing.

How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.


Eligibility Criteria:
Inclusion Criteria:

* Skin biopsy for leishmania test requested by treating ITM clinician OR
* externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation \<7 days of the biopsy sample
* willing and able to provide consent/assent
* not on CL treatment
Exploring the Benefits of Pelvic Floor Muscle Training on Bladder, Bowel, and Sexual Function in People with Spinal Cord Injury

The goal of this trial is to learn about the feasibility and benefits of delivering a pelvic floor muscle training program to people with motor-incomplete spinal cord injury. The main questions it aims to answer are:

1. To evaluate the feasibility of delivering a pelvic floor muscle training program to people with spinal cord injury. The investigators will examine recruitment rate, compliance and adherence to the intervention and other study protocols, adverse events, and participant perspectives of the study protocols.
2. To explore the potential effectiveness of pelvic floor muscle training on pelvic floor, bladder, bowel, and sexual function.

Participants will be asked to complete a pelvic floor muscle training program for 3 months. At the beginning, middle, and end of the program, researchers will conduct a series of tests to determine the feasibility and potential effectiveness of this program.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 19 years of age.
* Have a non-progressive, motor-incomplete spinal cord injury that is at or above the T12 neurological level at least 12 months ago.
* Have symptoms of bladder, bowel, and/or sexual dysfunction that are caused by your spinal cord injury.
* Have stable management of spinal cord related secondary health concerns (e.g., spasticity, neuropathic pain).
* Are able to speak and understand English.

Exclusion Criteria:

* Are currently pregnant, have been pregnant within the past 6 months, or are planning to become pregnant in the next 6 months.
* Have had urogenital surgery within the past 12 months.
* Have received Botox bladder injections within the past 4 weeks, or anticipate receiving an injection in the next 6 months.
* Have presence of severe medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to pressure sores, cardiovascular disease, and unmanaged diabetes.
* Have any permanent metal fixtures in their head (excluding dental fillings), or pacemakers, stimulators, or implanted medication pumps.
* Have a history of seizures, are taking medications that lower the seizure threshold, or experience recurring headaches.
* Have a condition for which exercise is contraindicated.
A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache

Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. The nerve runs superficially in this area, therefore the drugs are injected just under the skin. The injected drugs block electrical transmission through the nerve, resulting in reduced head pain. There are treatment options for patients receiving a GONB, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. The purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for GONB. We expect to enroll 60 patients into this research study at Thomas Jefferson University only.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18-65 inclusive
* Patients who have chronic daily headache (15 or more headache days per month) for at least 3 months prior to enrollment in the study.
* Headache level should be 5/10 or more at time of GON block.
* Patients should have posterior cervical muscle tenderness at time of nerve block.

Exclusion Criteria:

* Patients who had surgery or any other invasive procedure in the occipital area.
* Patients with abnormal sensory findings on examination or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
* Patients diagnosed with cluster headache
* Patients with skin diseases that may affect skin sensation.
* Patients who are cognitively impaired.
* Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
* Patients who are pregnant or breast-feeding.
A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension

The objective of this study is to investigate whether the IOP (intraocular pressure) -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China as well as comparison of safety.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma (including primary open angle glaucoma, exfoliation glaucoma or pigmentary glaucoma) in one or both eyes or ocular hypertension for which the subject has been using prostaglandin or beta-adrenergic blocker IOP (intraocular pressure) -lowering drugs before the screening visit
* Those who have signed the informed consent form

Exclusion Criteria:

* Women who are pregnant, nursing or planning pregnancy, or women of child-bearing potential who are not using a reliable method of contraception
* Anterior chamber angle in either eye to be treated with the level \<2 according to Shaffer classification as measured by gonioscopy
* Corneal disorder or other disease preventing reliable applanation tonometry in the treated eyes, including refractive surgery of ocular anterior segment)
* Alcohol or drug abuse
* Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within 30 days before Screening visit
Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)

A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke

This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject ≥18 and ≤80 years of age.
* Subject with a confirmed diagnosis of AIS and hemiplegia

Exclusion Criteria:

* Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.
PDT As An Adjunct To SRP In The Management of Chronic Periodontitis

The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.

Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.

Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).

Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.

Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment.

Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
* Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.

Exclusion Criteria:

* Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
* Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
* Chronic Smokers, Alcoholics, Smokeless tobacco users.
* Subjects with acute illnesses/acute intraoral lesions.
* Pregnant women and lactating mothers.
* Medically compromised subjects.
Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.

Close to 2.5 million Americans are currently living with post-stroke aphasia, a debilitating communication disorder affecting multiple language modalities. Most stroke survivors with aphasia have acquired reading deficits, which persist chronically and severely limit life participation and autonomy. There is an urgent need for effective treatments grounded in stroke neurobiology which yield robust functional improvements. This project is a randomized controlled trial, which will recruit 70 individuals with chronic left-hemisphere stroke. Participants will complete 40 sessions of targeted reading treatment combined with either 20 minutes of moderate aerobic exercise or light stretching. Participants will undergo 3 Magnetic Resonance Imaging (MRI) scans, administered before the intervention, after the initial exercise session, and after the full course of treatment. They will also complete behavioral testing before and after the intervention. The outcome of this study has the potential to radically change how reading treatments are applied, increasing their effectiveness, and ultimately improving the lives of 2.5 million Americans living with stroke-related aphasia. In addition, it is likely that the results will contribute to the understanding of stroke recovery mechanisms thereby fundamentally advancing the field of neurorehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* fluent and literate in English prior to stroke
* 1st ever stroke
* more than 3 months post-stroke
* post-stroke reading deficits, defined as reading aloud accuracy \<83% for single words or \<65% for readable nonwords
* living within a 50-mile radius from Kessler Foundation.

Exclusion Criteria:

* contraindication to MRI
* prior neurological disease
* developmental learning or reading disability (i.e., developmental dyslexia)
* contraindication to exercise
* concurrent speech and language therapy
Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia

Cerebellar disorders are often disabling and symptomatic therapies are limited to few options that are partially effective. It seems therefore appropriate to search for additional approaches.

Purkinje cells are the sole output of the cerebellar cortex: they project inhibitory signals to the deep cerebellar nuclei (DCN), which have a critical role in cerebellar function and motor performance. DCN neurons fire spontaneously in the absence of synaptic input from Purkinje neurons and modulation of the DCN response by Purkinje input is believed to be responsible for coordination of movement. Recent evidences support the notion that an increase in DCN excitability may be an important step in the development of cerebellar ataxia and point to the underlying molecular mechanisms: the inhibition of small-conductance calcium-activated potassium (SK) channels, that causes an increase of the firing frequency in DCN, correlates with cerebellar ataxia.

The rationale of the present project is that SK channel openers, such as riluzole, may have a beneficial effect on cerebellar ataxia.

The researchers propose to perform a pilot study investigating safety and efficacy of riluzole, an approved treatment for amyotrophic lateral sclerosis, as a symptomatic approach in patients with chronic cerebellar ataxia.

Forty patients with chronic cerebellar ataxia will be enrolled in a double-bind, randomized, placebo-controlled trial.

By central randomisation, patients will take 50 mg of riluzole or placebo twice daily for 8 weeks.

Electrocardiogram routine laboratory tests and pregnancy tests will be performed before drug administration, after 4 weeks of treatment and at the end of the study (after 8 weeks of treatment).

At the same time points the International Cooperative Ataxia Rating Scale (ICARS) for pharmacological assessment of the cerebellar syndrome will be administered to the two groups (riluzole and placebo) of patients. To guarantee the evaluation of the results in blind conditions, the neurologists who will evaluate the ICARS scores will be different from those who will deal with randomisation and follow-up of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cerebellar degeneration (heredoataxias, sporadic idiopathic ataxia, multiple system atrophy type C)
* Patients who meet McDonald criteria for probable or definite multiple sclerosis (MS) with chronic cerebellar ataxia (not acute cerebellar ataxia due to relapse)
* Age between 18 and 80 years

Exclusion Criteria:

* Ataxia due to other diseases
* Acute cerebellar ataxia
* Use of other drugs for chronic ataxia
* Serious concomitant illnesses (cardiac arrhythmias, haematological and hepatic diseases)
* Pregnancy or breast feeding
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)

The primary goal of this study is to test a minority stress model of psychological health outcomes for Black sexual minority men (BSMM) while using and not using a novel intervention named THRIVE 365. THRIVE 365 combines mHealth and institutional support elements to provide four areas of support for BSMM: 1) Promote HIV and psychological health knowledge and motivation; 2) Foster a sense of community and positive social connections among BSMM; 3) Connect clients to BSMM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. To examine the effects of the intervention, we will utilize a 14-day daily diary study to capture daily intervention engagement, HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. We will first examine main associations between intervention engagement and HIV (antiretroviral treatment use) and psychological health (depressive symptoms, anxiety symptoms, emotion regulation difficulties outcomes) outcomes, then consider how intervention engagement affects coping and attenuates the impacts of racial and sexual minority stressors during the 14 day period.


Eligibility Criteria:
Inclusion Criteria:

* 16 years old or older ;
* Identifying as masculine
* Identifying as Black/African American
* Reporting being attracted to and/or sexually active with men;
* Able to complete all procedures in English.
* Mobile access to the internet in order to complete the once-daily survey procedures.

Exclusion Criteria:

* evidence of unstable, unmanaged, or serious psychiatric symptoms that could be made worse by participation;
* evidence of gross cognitive impairment that would interfere with successful completion of study procedures.
Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19)

Objective: To assess the prognostic value of high-sensitive cardiac troponin T (hs-cTnT) and N-terminal pro brain natriuretic peptide (NT-proBNP) at ICU admission in patients with coronavirus disease 2019 (COVID-19).

Design: Multicenter retrospective observational cohort study Setting: Three ICUs at three hospitals in Occitanie, France. Patients: Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission, from March 9, 2020, to May 9, 2020.


Eligibility Criteria:
Inclusion criteria:

- Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission

Exclusion criteria:

- Age \< 18, pregnancy
Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health

This project aims to enhance AN university students' behavioral health by supporting their cultural identity development. While the connection between cultural identity and behavioral health is becoming clearer, comparably less research has explored methods of enhancing identity development. Consequently, the investigators will pilot a cultural identity development program for AN students at the University of Alaska Anchorage (UAA). This intervention is based on extant scientific literature, local findings from focus group with AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program incorporates storytelling, experiential learning, connection, exploration, and sharing of identity, cultural strengths, life paths, and rootedness in who they are in order to remain grounded when they face changes and challenges. Approximately 40 to 50 AN university students will be recruited for the intervention. Participants will be randomized, with half the participants receiving the intervention in the Fall 2020 semester and half the students receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this intervention will strengthen AN students' cultural identities, strengths, and sense of community; improve their behavioral health, as evidenced in higher self-reported wellbeing, and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support their academic persistence and achievement. Outcomes will be tested via mixed design analyses of covariance. Moreover, program feasibility will be examined through a process evaluation, which will entail thematic analyses of six focus groups with program participants (n=40-50) and with the Elders who facilitated the program (n=5).


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Alaska Native,
* are registered as an undergraduate student at UAA,
* are at least 18 years old,
* speak English

Exclusion Criteria:

-