cyrilzakka/clinical-trials huggingface dataset:
A Randomized-Controlled Trial to Increase the Uptake of LARCs in Cameroon

Cameroon exhibits a high and non-decreasing level of maternal mortality (roughly 600 per 100,000 live births), partially related to its relatively high total fertility rate (roughly 4.6). Survey evidence furthermore suggests that a significant fraction of these pregnancies is unwanted or considered mistimed by the mother, especially among females aged 15-19. Despite this, the rate of utilization of family planning (FP) is low: e.g. only 48% of sexually active unmarried women use any form of (modern) contraception, or MC, and even then, it is primarily condoms. The use of LARCs (long-acting reversible contraceptives, i.e. the IUD and implant) is less than 1% according to the most recent Demographic Health Survey.

The study investigators propose to use an integrated behavioral science approach to increase the take-up of both SARCs (short-acting reversible contraceptives, i.e. the pill and injectable) and especially LARCs among reproductive-age females in Cameroon, including adolescents who may be unmarried and/or nulliparous. In addition to decreasing maternal mortality and undesired pregnancies, indirect effects for the community will include: increased welfare from reduced side effects that arise due to current one-size-fits-all FP counseling; healthier children due to improved birth spacing; and increased human capital formation both for children and for young (often school-aged) potential mothers.

The study investigators propose to conduct the study at HGOPY for a duration of 12 months. The study investigators will provide tablets to each of five nurses that conduct FP counseling to participants at the hospital. The tablets contain a counseling "app" (or decision-support tool or a job-aid) that was jointly developed by professionals from HGOPY, the World Bank, and the Ministry of Health. The study investigators propose an individually-randomized experiment, where the participants will be offered randomly varying discounts for the modern contraceptive methods they wish to adopt. The study investigators also propose to experiment with certain aspects of the "app" to improve its effectiveness - both for the participant and for the nurse. More details on the experimental design are provided below.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 10-49
* Presenting at HGOPY seeking FP counseling/services
* HGOPY clients referred to the family planning unit for consultation

Exclusion Criteria:

\* No exclusion criteria
LIBERATE Trial in COVID-19

The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18 years and above;
2. Hospitalised;
3. Confirmed or suspected SARS-CoV-2 infection;
4. National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter or NEWS2 \> 5 overall;
5. Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR SpO2/FiO2 ratio \< 315 (Kigali Modification)
6. Provision of written informed consent by the patient OR by the patient's Legal Representative OR professional consultee.

Exclusion Criteria:

1. Any of the following contraindications to ibuprofen:

   * A known hypersensitivity to ibuprofen or any other constituent of the medicinal product;
   * Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
   * Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs;
   * Patients with severe hepatic failure;
   * Patients with acute renal failure;
   * Patients with severe heart failure.
2. Participation in any other investigational drug products less than 30 days prior to study enrolment;
3. Glasgow Coma Score \< 12;
4. Patients who cannot swallow oral capsules;
5. Pregnant or lactating women;
6. Any medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial.
The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste.

Qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three and six months of product use. All subjects will be followed for adverse events throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the clinical research study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Antibiotic use any time during the one-month period prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Self-reported pregnant or lactating subjects.
Intravenous Levodopa for the Diagnosis of Parkinson's Disease

Patients with Parkinson's disease have low levels of the neurotransmitter dopamine. Dopamine is responsible for motor function and normal physical activity. Patients with Parkinson's disease typically suffer from tremors, rigid muscles, stooped postures, and walk with a shuffle. The drug levodopa acts as a replacement for dopamine and has been has been used effectively for over 30 years as treatment for Parkinsons disease. Because of its effectiveness, levodopa has been used to distinguish Parkinson's disease from other conditions that may resemble Parkinson's disease.

Traditionally, levodopa has been given as a pill. In this study, researchers would like to inject levodopa directly into a vein (intravenous) in order to diagnose cases of Parkinson's disease. This method provides immediate results and allows doctors to adjust the dose of levodopa very carefully. Because the intravenous method of giving levodopa is less practical than oral medication, it is not an available alternative for the routine treatment of Parkinson's disease. However, it may be useful for faster diagnosis of the disease and for determining effective doses of oral medication.

A positive response to levodopa is now considered a condition sine qua non for the diagnosis of idiopathic Parkinson's disease. Under this protocol, patients with parkinsonism of uncertain etiology will be tested for their motor response to intravenous levodopa to aid in the diagnosis of Parkinson's disease. This protocol regulates and stipulates the acute administration of intravenous levodopa and associated safety issues.

Eligibility Criteria:
All patients will have parkinsonism of undetermined etiology.

Males and females between the ages of 18 and 85 are eligible for the study.

No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risks, specifically those who have the following: a history of convulsive, hepatic, or renal disorders; currently receiving treatment for myocardial infarction, arrhythmia or cardiac failure; and pregnant women or anyone not practicing an effective means of birth control.
High Frequency RF Current Effects on Muscle Pain and Function

The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. The participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (Acute effects) as well as 3 and 6 months after the intervention (chronic effects).

The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. Participants referred for muscle strain injury (hamstring, quadriceps, gastrocnemius) or chronic low back pain will be randomly allocated into one of the three groups: an experimental group (muscle injuries), experimental group (low back pain) and a control group. The project is divided in two phases. In the first phase, the acute effects of TECAR therapy will be examined. Outcome measures will be obtained prior to, after, 24 and 48 hours following a single intervention session. The intervention consists of 20-min electrical energy transfer session (Capacitive mode, 0.5 Mhz radiofrequency, intensity 40%) or a typical transcutaneous electrical stimulation (TENS, asymmetric biphasic mode, rectangular pulse, f = 80Hz) protocol. In the chronic stage, participants will receive 10 sessions (3 times a week) receiving either protocol while outcome measurements will be obtained before, immediately, 3 and 6 months after the intervention. Analysis of variance designs will be used to compare differences in each outcome between groups at different measurement sessions. The alpha level is set to p \<0.05.

Eligibility Criteria:
Muscle injury group

Inclusion Criteria:

* Acute hamstring or quadriceps or calf strain injury
* Age above 18 years

Exclusion Criteria:

* Other injury or musculoskeletal condition
* Any observed organ dysfunctions
* Receipt of medication or treatment for the past 3 months

Low back pain group

Inclusion criteria

* Pain between bottom of ribs and buttock creases
* Incidents for at least half the days in the past six months
* Visual analogue pain score equal or greater than 4/10
* Pain incidents for for less than half the days in the past six months

Exclusion Criteria:

* radiographic evidence of inflammatory disease affecting the spine
* fracture
* important genetic structure abnormality in the spine
* pregnancy
* use of medication that might influence heart rate and/or blood pressure
* psychiatric disorders
* receipt of medication or treatment for the past 3 months
* No neurologic deficits (sensory, motor, or reflexes)
Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;

   Participants with normal renal function only:
3. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
4. Glomerular filtration rate (GFR)≥ 90 mL/min
5. Age, BMI, and sex comparable to those of subjects of severe renal impairment

   Participants with severe renal impairment only:
6. Diagnosis of CKD (any indicators of renal impairment or GFR \< 60 mL/min/1.73 m2 for more than 3 months)
7. glomerular filtration rate (GFR) between 15-29 mL/min (including boundary)

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
2. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
3. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
4. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks

   Participants with severe renal impairment only:
5. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
7. New York heart association (NYHA) class III or IV congestive heart failure
8. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \> 1.5×ULN;
Palonosetron and Blood Coagulation

Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication
Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)

The long-term goal is to define the mechanisms of pathogenesis underlying Langerhans cell histiocytosis (LCH). The overall objectives of the current study are to characterize the role of SMAD6 inherited genetic variation on LCH susceptibility and identify germline genomic regions associated with LCH somatic mutations. Building from preliminary data, the central hypotheses are: (1) causal genetic variants in SMAD6 underlie susceptibility to LCH, and (2) differences in LCH-related somatic activating mutations by race/ethnicity are related to Amerindian (i.e., Native American) genetic ancestry. The Central hypothesis will be tested by pursuing the specific aims.

PRIMARY OBJECTIVES:

I. To comprehensively characterize germline variants in SMAD6 and their association with LCH.

II. To identify novel germline variants associated with LCH.

III.To determine the role of genetic ancestry on LCH-related somatic mutations.

EXPLORATORY OBJECTIVES:

I. To integrate clinical and epidemiologic questionnaire data with genetic risk factor data from the Primary Aims to more comprehensively elucidate LCH susceptibility.

OUTLINE:

Case identification and recruitment followed by questionnaires and specimen processing.

Eligibility Criteria:
Inclusion Criteria:

* ≤ 25 years old at the time of original LCH diagnosis
* The patient must be enrolled on ACCRN07 and/or APEC14B1 and registered with COG by a North American member institution
* The patient must have a diagnosis of LCH (ICD Codes/Morphology: 9751/1; 9752/1; 9753/1; or 9754/3).
* The patient must be diagnosed with LCH on or after January 1, 2008.
* All questionnaire respondents must understand English or Spanish.
* All patients and/or their parents or legal guardians must provide informed consent.
* All institutional, FDA, and NCI requirements for human studies must be met.
Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects

The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation in physical condition improvements of healthy subjects, in comparison to a placebo.

Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to improve physical conditions, and particularly at muscular and cardiac levels, by inducing a decrease in oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Ruffier score between 8 and 12
* 18.5 \< Body Mass Index \< 27 kg/m2
* stable weight (variation \< 5% over the last 3 months)
* stable diet over the last 3 months
* normal biological exam
* arterial pressure \< 140/90 mm Hg
* normal ECG
* no contraindication for running
* subject having given his free, informed and express consent
* subject affiliated with a social security insurance or beneficiary of such an insurance system
* time to go to the physical training twice per week

Exclusion Criteria:

* subject who do not understand the study
* \> 5 cigarets per day
* slimming diet over the last 3 months
* contraindication for running or physical test
* subject who failed the Cooper test
* anormal ECG
* anormal biological results
* dyslipidemia
* under current statins treatment
* hypertension
* diabeta II
* chronic respiratory disease
* rheumatic disease
* orthopedic disease
* positive serology for hepatitis B, C or HIV
* under current corticoids treatment
* under current drugs (medicine or not)
* any allergy to utilized one of the compounds of the experimental or placebo product
* alcool \> 36g/day
* consumption of drinks containing caffein, taurine, creatin, guarana, ginseng, ginkgo, biloba, etc
* consumption of drinks containing xanthic bases (\> 0.5L/day)
* consumption of drinks containing plants (\> 2L/day)
* consumption of grapefruit juice (\> 0.5L/day)
* under current antioxidant treatment (and during last month)
* adult protected by the law
* any subject who participated to a clinical assay within the 3 months
Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma

Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma.

Design: Prospective, comparative interventional case series. Method: Patients were randomly assigned into Group A which were treated with Diode laser cyclophotocoagulation alone, whereas group B received intravitreal Avastin (One milligram = 0.04mL of 25 mg/mL) in conjunction with the Diode Laser. The preoperative data included etiology, mean age; follow up period, and a full ophthalmological examination with emphasis on mean IOP, iris neovascularization, pain and corneal edema.

Eligibility Criteria:
Inclusion Criteria:

* Neovascular absolute glaucoma
* Painful blind eyes

Exclusion Criteria:

* Neovascular glaucoma with useful vision or potential for useful vision
Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been associated with inducing and enhancing allergies in children and adults. To investigate the basis for this association, a controlled exposure of allergic rhinitics to diesel exhaust was performed at a dose known to be pro-inflammatory in healthy individuals.

The hypothesis was that airway inflammation would be augmented in allergic rhinitics following exposure to diesel exhaust at an environmentally pertinent particulate matter concentration.

Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both diesel exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate combustion particles, mean diameter 80 nm) and filtered air for two hours on separate occasions. Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours post-exposure, and samples were analysed for markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* History of seasonal allergic rhinitis requiring medical treatment only during the pollen season and were classified as mild and intermittent according to ARIA guidelines.
* Positive skin prick test to airborne allergens
* Normal lung function
* Negative Metacholine challenge

Exclusion Criteria:

* Current smoking or a previous history of smoking.
* Asthma
* Chest infection within six weeks prior to or during the study
* Current use of non-steroidal anti-inflammatory drugs
* Current vitamin C or E supplementation
* Current use of topical nasal steroids.
HITT for the Identification of Mild Traumatic Brain Injury

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 100 TBI patients and 100 controls.


Eligibility Criteria:
Inclusion Criteria:

1. Age 13-45 years
2. Presents to the facility within 2 weeks of head trauma
3. Able to provide informed consent

   * If minor, then able to provide parental consent and minor assent
4. Able to participate in the examination, including the ability to follow simple instructions
5. Fluency in English or Spanish

Exclusion Criteria:

1. Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment
2. Under the influence of alcohol or drugs
3. Previous eye surgery
4. Visual acuity known to be 20/200 or less in either eye
5. Known strabismus, amblyopia (lazy eye), or double vision
6. Known eye movement disorder, including nystagmus
7. Known optic nerve disease, including papilledema or optic neuropathy
8. Known retinal disease, including macular degeneration or retinal degeneration
9. Known cataract
10. History of neurosurgery
11. History of stroke/brain hemorrhage, brain tumor, or epilepsy
12. Any head trauma requiring medical attention from a physician within the last 6 months
13. Diagnosed dementia or cognitive impairment requiring assistance for daily living
14. Other condition(s) under the care of a neurologist
15. Psychiatric hospitalization in the last 90 days
16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
17. Any minor brain injury regardless of loss of consciousness
Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Age 41 to 68 (inclusive).
* Spectacle add between +0.75 and +2.75D (inclusive).
* Habitual spectacle prescription ≤ 1.00DC (cyl).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in a clinical trial.
* Prior refractive surgery.
* Other protocol-defined exclusion criteria may apply.