cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both

The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both.

This research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.

The Ottobock helmet is a cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. This medical device is a 3D-printed helmet, with an elastic closing system which allow the head growth, maintain a constant pressure in the helmet and ensure a good adjustment.

Even though there is an effectiveness observed, there are no existing clinical evidences on this type of helmet so far, and there is a need to conduct a research on a large number of patients to measure the effectiveness and describe the population treated. This study will give more information to health professionals (doctors, orthopedic technicians, etc.) and health authorities, about the benefits of the orthopedic treatment of the positional cranial deformations in infants.

The study is composed of an electronic case report form (eCRF) to be fulfilled by the orthotists and an electronic questionnaire (ePRO) to be fulfilled by the patient's parents. The electronic questionnaires, data treatment and analysis are handled by a Contract Research Organization (CRO).

Eligibility Criteria:
Inclusion Criteria:

* Infant with positional cranial deformation
* Infant treated with an Ottobock helmet between May 1st, 2020 and May 1st, 2021

Exclusion Criteria:

* Patient whose parents (or legal guardians) disagree to participate in the study.
* Patient whose parents (or legal guardians) are unable to understand or answer the questionnaire.
Trained Immunity in Fungal Infection and Its Mechanism

Investigator vaccinated 76 healthy BCG-naive participant with BCG, while 3 participants received. Half of BCG-vaccinated participants (n = 38) received an incremental dose of metformin for 6 days (up to 1,000 mg twice daily on day 6). On the day 0 (total 20; n = 10 for BCG vaccination, n = 10 for BCG vaccination plus taking metformin), day 14 (total 30; n=15 for BCG vaccination, n = 15 for BCG vaccination plus taking metformin), day 90 (total 26; n = 13 for BCG vaccination, n=13 for BCG vaccination plus taking metformin) of BCG vaccination, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy BCG-naive participants.
* The ages range from 20 to 45.
* Participants without any infections or immune deficiencies.

Exclusion Criteria:

* Participants when infections or other illnesses occurred during the clinical trial.
* Participants who have a fever of unknown causes during the clinical trial.
* Participants who have gotten other vaccines during the clinical trial.
The Effect of Standardizing Procedures for SC Injections of LMWH on Patients with CVD

Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.

This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day
* Chinese

Exclusion Criteria:

* cognitively impaired
* unconscious
* refuse to participate
Real-time Videoconference-based Exercise in Eldercare Workers

Formal caregiving of elderly dependent people is a both physically and psychologically demanding job, and both musculoskeletal and mental disorders with a negative impact in general health and quality of life are habitual among eldercare workers. Previous research has shown that physical exercise programs can reduce and/or prevent those disorders, consequently improving well-being at work.

Online exercise interventions might be a cost-effective tool, as they can reach a large number of people at a relatively low cost. Moreover, they are compatible with situations in which interpersonal physical distancing is required, such as the current COVID-19 pandemic. However, real-time videoconference-based exercise interventions have not yet been studied in working populations.

Thus, the aim of this study is to assess the effects of a real-time videoconference-based exercise intervention in eldercare workers. The primary outcome will be low back pain. Pain in neck, shoulders and wrists/hands will also be recorded, as well as additional measures of physical fitness, psychoaffective state, health and work-related variables. All outcomes will be measured at baseline and at 12-week and 48-week follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Professional eldercare workers with ≥3 months of experience in the profession
* Employment contract at least until the anticipated date of study end

Exclusion Criteria:

* Pregnancy
* Contraindication to exercise according to the American College of Sports Medicine Guidelines
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes

The main purpose of this study is to evaluate a novel approach for insulin glargine (LY2963016) titration for insulin-naïve adults with type 2 diabetes (T2D)

The study will last about 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults with type 2 diabetes as diagnosed by endocrinologist
* No insulin over past 3 months
* Inadequate glycemic control with A1c ≥8.0% at or within 1 month prior to screening visit
* No history of diabetic ketoacidosis (DKA) or severe hypoglycemia leading to mental status change in the past 6 months
* Willingness and ability to follow the protocol including willingness to commence basal insulin, wear CGM, and communicate with healthcare provider.

Exclusion Criteria:

* Contraindication to use of insulin glargine (e.g., allergy)
* Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
Study of Factors Influencing Post-stroke Dementia

If the risk of dementia occurrence after stroke is well known, few data exist about the factors influencing positively or negatively the developement of cognitive disorders or dementia. The aim of the study is so to determine prospectively the clinical, biological, lesional and pharmacological factors associated with post-stroke dementia by the long-term follow-up of a stroke patient cohort.

The STROKDEM study is based on the 5-year prospective follow-up of a population of 1100 stroke patients without dementia. At inclusion in the cohort, main antecedents and risk factors, previous treatment and lifestyle, initial severity and etiology are recorded. Biological samples (for standard ans specialized analyses) and MRI are performed at 72h after stroke occurrence. Thereafter, patients are regularly (6 months, 12 months, 36 months, 60 months) examined for clinical and cognitive assessment with biological samples and Magnetic Resonance Imaging. Patients with dementia will be compared to patients without stroke to identify, by logistic regression analysis and Cox model, the factors associated with dementia occurrence.

Eligibility Criteria:
Inclusion Criteria:

* patients \> 40 years olds
* hemispheric stroke
* stroke dating from less 72h
* IQ-code \< 64
* patient (or his family) given an informed consent

Exclusion Criteria:

* non hemispheric stroke
* malformative intracranial hemorrhage
* traumatic intracranial hemorrhage
* subarachnoidal hemorrhage
* contra-indication to MRI
* patients unable to answer to cognitive battery
Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diabetes in the mother may also lead to effects on the long term health of the baby.

Most people today use mobile phones. Our research is looking at using a mobile phone app to help with diabetes care in pregnancy. In particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. The investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care.

The investigators are planning to recruit 200 women who receive care for their gestational diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be randomised so that 100 will receive standard care, and 100 will have a mobile phone "app" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review.

Both groups will be asked to test their blood glucose levels at home regularly with a glucometer. All participants will also be given lifestyle advice to reduce the chance they will need medication. Blood glucose control will be measured also by the percentage of glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with an abnormal 75 gram 2 hour glucose tolerance test as defined by the IADPSG (International Association of Diabetes in Pregnancy Study Group)
* Willingness and able to give informed consent
* Female aged between 18-40 years
* Singleton pregnancy
* Able to travel to hospital independently

Exclusion Criteria:

* Impaired cognitive function such that she is unable to operate m-health equipment
* Any evidence of fetal compromise
* Known risk factors for obstetric complications, other than obesity and diabetes
* Gestational diabetes requiring immediate pharmacologic treatment
* Twins or higher order pregnancy
* OGTT (Oral Glucose Tolerance Test) suggesting preexisting diabetes (fasting blood glucose \>= 7.0 or 2 hour \>= 11.1 mmol/L
* Gestation greater than 34+6 at the time of potential recruitment
* Unable to speak English well enough to explain or use equipment
Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

The purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community.


Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than or equal to 18 years of age.
* Self-report of a hypertension diagnosis.

Exclusion Criteria:

* Pregnant or breastfeeding.
* End-stage renal disease on hemodialysis.
Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone

This is an open label, single dose, 1 period study of \[14C\] galeterone.

This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28 days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be administered orally. Blood, urine, and fecal samples will be collected until release criteria are met to measure total radioactivity, for analysis of galeterone concentrations, and for potential metabolic profiling.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, male, 19 to 55 years of age, inclusive, at screening.
2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing.
3. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings

This study will characterize risk factors for poor COVID-19 outcomes (hospitalization, death) and clinical progression of hospitalized COVID-19 patients in South Sudan and Eastern Democratic Republic of the Congo.

A prospective cohort design will be used to follow suspected, probable, and confirmed COVID-19 cases presenting for care at International Medical Corp \[supported\] health facilities in Juba, South Sudan and the Kivus in Eastern Democratic Republic of the Congo (DRC). This research seeks to assess risk factors for poor outcomes and characterize clinical disease progression of COVID-19 cases in resource-poor humanitarian contexts in Africa. Specifically, this study aims to characterize risk factors for poor COVID-19 outcomes, including both co-morbidities with evidence from high income settings, as well as prevalent conditions in humanitarian settings (e.g., acute malnutrition, malaria, HIV) for which data is not yet available. This research also aims to determine how the progression of confirmed COVID-19 cases in resource-poor African settings may differ from other settings where data are available.

Eligibility Criteria:
Inclusion Criteria:

* Suspected, probable, and confirmed COVID-19 cases presenting for care at participating health facilities (either by walk-in, referral or transfer) or identified by mobile contact tracing teams.

Exclusion Criteria:

* Individuals unable or unwilling to give informed consent (e.g., due to mental impairment)
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults

This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). This study will evaluate the safety, tolerability, pharmacokinetics (PK), and protective efficacy of MAM01, as well as safety and PK of repeat subcutaneous (SC) dosing. Part A will have a double-blind, placebo-controlled design. Part B will randomize participants to one of three open-label MAM01 dose groups; a separate non-randomized group will be enrolled to include participants who will receive no treatment and act as infectivity controls.


Eligibility Criteria:
Inclusion criteria:

* Participants who are healthy as determined by medical evaluation including medical history, physical examination and laboratory tests
* Body Mass Index (BMI) 18 to 30 kilograms per square meter (kg/m\^2) (inclusive) to a maximum of 220 pounds
* Both males and females are eligible to participate as per the following:

  a. Female participants physically capable of pregnancy, have at least one negative pregnancy test during Screening, on the day of enrollment, prior to Investigational product (IP) administration, prior to CHM and at the start of antimalarial treatment, and who agree to use effective contraception to avoid pregnancy from 28 days before enrollment through 10 months after last administration of investigational product are eligible to participate.
* Capable of giving signed Informed Consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and the trial protocol, and completion of a test of understanding if he/she may participate in the CHMI procedure
* Reported completion of primary Coronavirus Disease (COVID) vaccine series is documented

Exclusion criteria:

* Acute illness or fever ≥99.5°Fahrenheit (F) (or ≥37.5 degrees Celsius) on day of dosing
* Women who are pregnant or breastfeeding
* Evidence and/or history of clinically significant medical condition(s) as judged by the Investigator, including malignancies, diabetes mellitus, and unstable or uncontrolled hypertension
* A 5-year cardiovascular risk of ≥10% using the Gaziano nomogram
* History of any autoimmune disease or immune deficiency or other impairment to the immune system, including but not limited to Human immunodeficiency virus (HIV), autoimmune conditions or immunosuppressive therapy
* Participation in an interventional clinical trial and/or receipt of any investigational drug within 180 days prior to administration of trial drug on Day 0
* Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
GAGE Act With Her-Ethiopia Evaluation

This study evaluates the impact of Act With Her Ethiopia (AWH-E), a gender transformative multi-level program that aims to improve the lives of young adolescent boys and girls.

Unequal gender norms and power dynamics are often driven and reinforced by adolescent girls' male peers, families, communities, and the broader institutional structures that surround them. Without change in gender attitudes and norms at each of these levels, improved outcomes for key transitions are much less likely to be sustained. Efforts to nurture change must also acknowledge that adolescents' opportunities and capabilities are shaped by complex, intersectional forces including ethnicity, caste, religion, and disability, among others. This multi-arm randomized control trial aims to improve the evidence base on effective approaches to improve multi-sectoral outcomes for girls across the following domains from the Gender and Adolescence: Global Evidence (GAGE) framework: education and learning; health, nutrition and sexual and reproductive health; bodily integrity; psychosocial well-being; voice and agency; and economic empowerment.

Specifically, the trial has four goals:

1. To evaluate the impact of Act With Her in Ethiopia (AWH-E) - a gender-transformative multi-level program - on young adolescent girls' and boys' capabilities (11-13) in the short- and long-run across the six GAGE capability domains using a multi-arm cluster randomized control trial across two regions (Amhara and Oromia).
2. To compare the impact of AWH-E to a more basic gender-synchronized program (AWH-E without community engagement and systems strengthening), a standalone girls' group program (Her Spaces), and the gender-transformative program with economic support (AWH-E + Asset Transfers) on young adolescent capability achievements and transitions in the short- and longer- terms across two regions (Amhara and Oromia).
3. To evaluate the impact of AWH-E on young adolescent capability achievements and transitions in the short- and long- term in pastoralist contexts (Afar).
4. To use mixed-methods research to understand the mechanisms driving the impact, and in particular what works, for whom, and why.

Eligibility Criteria:
Inclusion Criteria:

* girls and boys 10-13 at time of enrollment in Act With Her Arms
* girls 11-13 female at time of enrollment in Her Spaces Arm

Exclusion Criteria:

* None
Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.


Eligibility Criteria:
Inclusion criteria

* MSSBP\> 140 mm Hg, and/or MSDBP\> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

Exclusion criteria

* Premature discontinuation in the core study or failure to comply with the core study protocol
* Any patient that the investigator decides should not participate in the extension

Other protocol-defined inclusion/exclusion criteria may apply
Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.

To provide an effective technique for pulpectomy in primary second molar teeth in pakistani population, local studies are required. No local studies have been done so far and limited number of international in vivo studies have been conducted previously. Hence this study will evaluate the effectiveness of this technique in pakistani population. If results of this study will be significant in favor of this technique, it will be applied with confidence in same population. There will be better compliance of patients as procedure will be done in single visit.


Eligibility Criteria:
Inclusion Criteria:

1. Children of both genders having age 4-6.5 years
2. Children having signs and symptoms of irreversible pulpitis in their second primary molar teeth on clinical examination as per operational definition.

Exclusion Criteria:

1. Children having previously accessed pulpectomy assessed clinically and on periapical radiographs.
2. Children having acute/chronic abcesses in teeth under consideration seen clinically.
3. Children having furcal or periapical radiolucency around teeth under consideration seen on periapical radiograph.
4. Diabetic, haemophilic or medically compromised children found on history
5. Children who fail to attend appointments.