cyrilzakka/clinical-trials huggingface dataset:
Participation of Manual Wheelchair Users in the Community

To explore the relationship between ability to do different wheelchair skills and the participation and quality of life of wheelchair users in and around their home and community. The investigators study hypothesis:

1. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is strongly related to self-reported participation.
2. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is related to the average daily distance traveled in their wheelchair.


Eligibility Criteria:
Inclusion Criteria:

* have a manual wheelchair for home and community use;
* use a manual wheelchair at least once a week;
* have a minimum of 3 months experience using a manual wheelchair outside the hospital setting;
* be over the age of 18;
* be able to read and understand English and follow verbal and visual instructions;
* be competent to give informed consent;
* be willing to take part in the study, including signing the consent after carefully reading it;
* not have been under significant bed rest for the past month.
Fabry : National Initiative of Screening

Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke.

The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke.

This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized ischemic stroke
* Written and signed informed consent from patient or legal representative

Exclusion Criteria:

* Patients belonging to a family which has a Fabry disease's diagnosis confirmed
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

This is a single-center, placebo-controlled, parallel-group, single dose, randomized, controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected at defined times to measure glycemia, FGF-19 and incretins (GLP-1 \[glucagon-like peptide-1\], OXM \[oxyntomodulin\], PYY 3-36 \[peptide YY\]) fasting levels and responses to the meal.

Eligibility Criteria:
Inclusion criteria:

1. Overweight or obese subjects with BMI \> 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.
2. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.

Exclusion criteria:

1. Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
2. Irritable bowel syndrome
3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.
4. Subjects with other treatment for type 2 diabetes mellitus.
5. Subjects with HbA1c \> 8%
6. Females who are pregnant or breastfeeding
7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease.
9. Subjects who have donated blood or plasma in the past 8 weeks.
10. Subjects who have participated in another study within the past 30 days.
Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren

The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy school going children
* not severely malnourished weight-for-height z-score ≥-2 not severely anemic (Hb\<8g/dl)
* Age: 7-10 years
* Not taking any food supplements/fortified drinks
* Not planning to move out during the study duration

Exclusion Criteria:

* Age: \<7 and \>10 years
* Severe anemia (Hb \< 8 g/dl)
* Severely malnourished children with weight-for-height z-score \<-3 will be excluded.
* Cardiovascular disease on clinical examination or history
* Underlying respiratory disease with impairment of lung function
* Physical disability which can interfere or limit performance of tests
* Recent history (3 months prior) of serious infections, injuries and/ or surgeries
* Any food allergy or food intolerance
* Participation in any nutritional study in the last 1year
* Children consuming nutritional supplements and/ or health food drinks
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis

This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis.

HYPOTHESES

In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:

1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 1-18 months.
2. Hospitalization for the first episode of RSV bronchiolitis:

   * Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND
   * At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions).
3. Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.
4. Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
5. Willingness to provide informed consent by the child's parent or guardian

   -

Exclusion Criteria:

1. Prematurity (gestational age \< 36 weeks).
2. Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.
3. Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
4. The child has significant developmental delay/failure to thrive, defined as weight \< 3% for age and gender.
5. History of previous (before the current episode) wheeze or previous treatment with albuterol.
6. Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
7. Treatment with any antibiotics in the past 2 weeks.
8. Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
9. Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
10. Participation in another clinical trial.
11. Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
12. Contraindication of use of azithromycin or any other macrolide antibiotics.
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos\[t\]ide analog \[NA\] and pegylated interferon alpha-2a \[PegIFN-alpha2a\]).

This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but has been removed as part of amendment 3 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B virus (HBV) infection, hepatitis B e Antigen (HBeAg) positive or negative with suppressed viral replication under nucleos(t)ide analogue treatment for at least 6 months prior to screening
* Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included
* Must have serum HBsAg greater than (\>) 100 international units per milliliter (IU/mL) at screening, as assessed by quantitative HBsAg assay
* Must have a fibroscan stiffness measurement less than or equal to (\<=) 9.0 Kilopascal (kPa) at screening

Exclusion Criteria:

* Evidence of hepatitis A, C, D or E virus infection or human immunodeficiency, virus type 1 (HIV) or HIV-2 infection at screening
* History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* Evidence of liver disease of non-HBV etiology
* Participants with a history of malignancy within 5 years before screening
* Contraindications to the use of pegylated interferon alpha-2a
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-75 years of age;
* type 2 diabetes;
* stable metformin therapy for \>=3 months before screening.

Exclusion Criteria:

* women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
* type 1 diabetes;
* any anti-hyperglycemic medication other than metformin in the last 3 months.
Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients

COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.


Eligibility Criteria:
Inclusion criteria:

- Confirmed COVID-19 diagnosis (positive PCR or serology) in RA patients or healthy controls.

Exclusion criteria:

* Age under 18 years old
* Suspected COVID-19 diagnosis (typical symptoms without a positive PCR or serology)
Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Hb A1c lower or equal to 11%

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence of diabetic complications with significant end-organ damage
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions

ROSSINI 2 is a phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor), multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of several in-theatre interventions, used alone or in combination, to reduce SSI rates in patients undergoing surgery.

The primary objective of ROSSINI 2 is to determine whether several specific in-theatre interventions, used alone or in combination, result in decreased rates of surgical site infection (SSI) up to 30 days post operation in adult patients undergoing abdominal surgery.

At least 60 NHS hospitals in the UK will participate in ROSSINI 2.

Approximately 6610 patients will be required to detect a 5% absolute risk reduction in the intervention arm(s) (15% to 10%; 33% relative reduction) with 85% power.

Initially, the three health technologies that were assessed versus the control arm (standard care) were:

1. 2% alcoholic chlorhexidine skin preparation, versus any other standard skin preparation
2. Iodophor-impregnated incise drape, versus no drape
3. Gentamicin-impregnated implants/ sponge at closure, versus no implant

Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colorectal, hepatobiliary, upper GI, urological, vascular, or gynaecological operations
* Patients undergoing abdominal operations (open or laparoscopic extraction site) with a planned incision of at least 5cm.
* Patients aged 16 years or older
* Patients able and willing to undergo a wound assessment at day 30-37 after surgery
* Patients able and willing to give written informed consent
* All contamination strata, including clean, clean-contaminated, contaminated or dirty surgery.
* Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery.

Exclusion Criteria:

* Previous laparotomy within 3 months prior to randomisation
* Known to be pregnant or currently breast feeding
* Operations where the wound is not anticipated to be closed primarily
* Patients with a new or documented allergy/ intolerance to any of the study interventions (chlorhexidine, iodine, collagen or gentamicin) will not be randomised to an arm containing this intervention, but will still be eligible for recruitment to other arms of the study.
* Patients with end-stage renal failure where gentamicin administration would otherwise be contra-indicated (according to local policy) will not be randomised to arms containing the gentamicin-impregnated sponge.
Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients with Chronic Low Back Pain

The goal of this randomized clinical trial\] is to study the effect of a combined aquatic and land-based exercise program compared to an aquatic program on pain, functional disability, and quality of life in adults with chronic low back pain. The main question it aims to answer is: "Does a combined aquatic and land-based exercise program improve functional disability and quality of life and reduce pain in adults with chronic low back pain?".

Participants will perform an aquatic exercise program (control group) or a combined aquatic and land-based exercise program (experimental group).

Researchers will compare groups to find any differences in pain, funcional disability and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Both gender;
* Portuguese nationality;
* Aged over 18 years;
* Chronic Low Back Pain lasting three months or longer and with an intensity of 3 or higher on the Visual Analogue Scale at rest.

Exclusion Criteria:

* Individuals who refuse to participate or do not provide informed consent;
* Pain radiating to the lower limb;
* Recent pregnancy or childbirth (less than 8 weeks ago);
* Ongoing physical therapy treatments;
* Severe rheumatological, neurological, neoplastic, cardiovascular diseases or other conditions that could prevent full participation in the intervention;
* History of spinal surgery;
* Inflammatory, infectious, or malignant spinal diseases;
* Psychiatric disorders that may affect adherence and symptom assessment.
LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure

This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.

The primary and secondary outcomes will be determined in months 1 \& 2. Participants will continue for another 4 months and during that time data for exploratory measures will be collected.

During the first 2 months of the study, a micro-randomized trial (MRT) will be performed within the App+JITAI group (N=200). This MRT is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with essential hypertension (HTN) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (EHR) and confirmed by participant self-report.
2. A smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications
3. A valid email address
4. Fluent in spoken and written English

Exclusion Criteria:

1. Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP\>180 mmHg, diastolic BP\>120 mmHg)
2. Contraindication to a sodium restriction diet
3. An estimated sodium intake less than 1,500mg per day
4. Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
5. Estimated glomerular filtration rate (EGFR) \<30 or end-stage renal disease on dialysis
6. Heart failure
7. Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications
8. Currently pregnant or intent to become pregnant during the study period
An Observational Study to Determine the Clinical Cure Rate of Therapeutic up Front Shave Removal of Basal Cell Carcinoma of the Skin With Long Term Follow up to Evaluate Recurrence

Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell carcinoma (BCC) without the need for a follow up surgical procedure.

Basal cell carcinoma (BCC) is the most common skin cancer in the world, with approximately 3.5 million cases a year diagnosed in the United States. BCC are indolent and metastasis is extremely rare, occurring in less than .003% of cases. However, due to the high prevalence of this tumor, significant health care resources are used in its diagnosis and treatment. Management of BCC in many instances includes clinical evaluation of the lesion, biopsy or sampling of the lesion to confirm the diagnosis, followed by definitive treatment at a later date through surgical excision or medical therapy. A clinical diagnosis of BCC can be made with a high degree of confidence based on clinical findings. The investigators propose that by performing a deep shave removal of the entire lesion with histologically negative margins, based upon clinical diagnosis, complete removal can be achieved without the need for follow up therapy. Deep shave removal at time of initial evaluation is performed in many instances. The investigators believe that doing a deep shave removal would substantially reduce the number of second procedures that need to be done, thereby reducing treatment costs and patients' need to return for an additional procedure. In doing a deep shave removal, clinically diagnosed BCC will be removed entirely with narrow 2-3 mm margins, the tissue specimen will then be sent to the pathologist to confirm that margins are clear. The investigators will consider treatment of the BCC to be complete at this point and will follow the patients clinically.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a BCC, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles
* Subject is able to give informed consent
* Subject is able to commit to 6 month follow up visit

Exclusion Criteria:

* BCC \> 1cm in diameter on any one axis.
* Immunosuppressed patients
* Subjects with neutropenia
* Organ transplant patients
* Subjects with a life expectancy less than year
* Patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral Tacrolimus, any Tumor Necrosis Factor (TNF)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject
* Basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination
* Subjects unable to provide informed consent
* Subjects unable to commit to 6 month follow up