cyrilzakka/clinical-trials huggingface dataset:
Improving Nighttime Access to Care and Treatment; Part 4-Haiti

Children in resource-limited settings who develop illness at night are often isolated from care, resulting in progression to an emergency. A telemedicine and medication delivery service (TMDS) is a viable healthcare delivery option to bridge the gap in nighttime care. This interrupted time series study (pre/post) will evaluate a digital clinical decision-support (dCDS) tool. The objective is to assess if the tool is associated with an improvement in guideline adherence by TMDS providers.

Acute respiratory infection and diarrheal disease are the two leading causes of pediatric death between 1 month and 5 years of age globally. These common problems have well-established low-cost treatments. However, these treatments are most effective when administered early which is difficult in resource-limited settings, especially at night. Based on five years of formative NIH-funded research, the team has built a Telemedicine and Medication Delivery Service (TMDS) in Haiti to improve nighttime access to care and treatment for children called MotoMeds. The strategic plan is to design, deploy and evaluate MotoMeds by conducting four clinical studies titled Improving Nighttime Access to Care and Treatment (INACT1/2/3/4) in Haiti. INACT1-H was a needs assessment (2018-2019), INACT2-H was a pre-pilot deployment of MotoMeds that compared the congruence of clinical assessments at the call-center to in-person household assessments by providers (2019-2020), and INACT3-H was a pilot of a scalable model of MotoMeds that had provider assessment only at the call-center for most non-severe cases and had provider assessment at both the call-center and household for some non-severe/ moderate cases. In addition, the central call center serviced a geographically distant delivery zone, demonstrating proof of concept for a fully scaled model. INACT4-H will evaluate a digital clinical decision support (dCDS) tool designed for use at a pediatric TMDS in an interrupted time series study. The pre-intervention is use of the existing paper CDS tool and the intervention is use of the dCDS tool. This initiative is significant because it uses telemedicine and medication delivery to address one of the most fundamental challenges in pediatrics early access to pediatric healthcare.

Eligibility Criteria:
Inclusion criteria for child, parent/guardian participants:

* Children 10 years of age or younger with an acute illness
* Parent/guardian contacts the TMDS in regards to the illness during hours of operation
* Parental/guardian agreement to a waiver of documentation of consent when contact is by phone only OR written consent/assent at the household from the parent/guardian and child (7yrs and older) for participants who receive a household visit.

Exclusion criteria for child, parent/guardian participants:

* No consent
Solifenacin Succinate Versus Tolterodine 4mg Once Daily

Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.


Eligibility Criteria:
Inclusion Criteria:

At study entry:

* Patient is willing and able to complete the micturition diary correctly
* Symptoms of overactive bladder (including urinary frequency, urgency or urge incontinence) for \>= 3 months

At randomization:

* Patient must experience frequency of micturition on average \>= 8 times per 24 hour period during the 3 day micturition diary period
* Patient must experience at least one of the following symptoms during the 3 day micturition diary period:

  * At least 3 episodes of urinary incontinence or,
  * Patients must exhibit urgency at least 3 times

Exclusion Criteria:

At study entry:

* Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
* Clinically significant outflow obstruction (at the discretion of the investigator)
* Significant post void residual volume (PVR\>200ml)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* Patient with a neurological cause for abnormal detrusor activity
* Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
* Non drug treatment including electrostimulation therapy or start of a bladder training program during the 2 weeks prior to entry into, or during the study
* Use of drugs intended to treat urinary incontinence
* Diabetic neuropathy
* Known or suspected hypersensitivity to solifenacin, tolterodine, other anticholinergics or lactose
* Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
* Participation in any clinical trial within 30 (90 in the UK) days prior to randomisation
* Employees of the Yamanouchi Group, third parties associated with the study, or the study site

At randomization:

* Patient who did not complete the micturition diary according to the instructions
* Total daily urine volume \> 3000 ml as verified in the micturition diary
Validity of a Test of Functional Cognition in Persons With Acquired Brain Injury

The purpose of this study is to test the validity of the Weekly Calendar Planning Activity (WCPA), a test of functional cognition in persons with acquired brain injury. We will formally examine the utility, baseline profile and validity of the WCPA with adults ages 21 and above with acquired brain injury for both the WCPA 17 and WCPA 10 versions.

The purpose of this study is to test the validity of the Weekly Calendar Planning Activity (WCPA), a test of functional cognition in persons with acquired brain injury. We will formally examine the utility, baseline profile and validity of the WCPA with adults ages 21 and above with acquired brain injury for both the WCPA 17 and WCPA 10 versions. The Weekly Calendar Planning Activity (WCPA) is a performance-based Cognitive Instrumental activities of daily living (C-IADL) task that requires working memory, planning, shifting, inhibition, and self-monitoring. The WCPA requires the examinee to input a series of 10 appointments, into a mock weekly calendar/schedule while following multiple rules, managing appointment conflicts, ignoring distracting questions by the examiner and keeping track of time. The WCPA is used routinely by occupational therapists for those with acquired brain injury, during their stay on the inpatient rehabilitation unit, prior to discharge as a measure of IADL. Persons who are currently receiving occupational therapy and would typically be given the WCPA within the course of routine occupational therapy, will be asked for permission to include their results within a database for the project. Persons who are alert, oriented x3, able to attend for at least 10 minutes, are able to read and write legibly in English would typically be administered the WCPA. Potential participants will be identified by their primary therapist. If the person does not provide consent, the WCPA will be administered as part of usual care but the results will not be included within the project.

Eligibility Criteria:
Inclusion Criteria:

* Able to attend for at least 10 minutes
* Able to read and write legibly in English
Exploring Mechanisms and Morphology of QT Interval Prolongation

The projects will try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing".

First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.

The aim of the projects is to try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing".

First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.

Eligibility Criteria:
Inclusion Criteria:

* Verified Long QT syndrome mutation, subtype 1 or 2.
* over 18 years of age

Exclusion Criteria:

* Atrioventricular block,
* Left bundle branch block,
* Left ventricular hypertrophy,
* Pace rhythm,
* ST-deviations \>1 mm),
* Left ventricular ejection fraction \<50 % and significant valvulopathy,
* Unstable psychiatric disease
* Unstable cardiovascular disease.
Clinical Characteristics of Acutely Hospitalized Adults With Community-acquired- Pneumonia

There is no gold standard when diagnosing of pneumonia. The variability of clinical signs and symptoms make it difficult to distinguish pneumonia from other causes of respiratory conditions. Well defined characteristics upon arrival to the emergency department will contribute to the better and quicker diagnosis of community-acquired pneumonia.

Currently, pneumonia diagnosis is primarily based on clinical symptoms such as cough, shortness of breath, chest pain, fever and sputum production, combined with X-ray of the lungs, relevant blood tests and microbiological analysis of sputum samples. The X-ray is an imprecise diagnostic tool, and results from sputum assays are first available after 2 days. In the elderly, pneumonia presents with clinically differing signs such as delirium, malnutrition, and there may be an absence of fever, cough and dyspnea. The physical examination is also challenged by a broad variety of atypical symptoms like headache, dry cough and gastrointestinal symptoms in the form of nausea, vomiting or diarrhea. Our hypothesis is that well-defined clinical characteristics upon arrival to the emergency department will contribute to the better and quicker diagnosis of pneumonia.

The aim is to identify the information available upon arrival to the Emergency Department that contributes to diagnosis and prognosis of community-acquired-pneumonia.

The objectives are:

1. Identify the information available upon arrival that correlates to the diagnosis of community-acquired pneumonia
2. Identify the information available upon arrival that correlates to severity of community-acquired pneumonia

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Patients suspected with CAP by the attending physician. The physician will base his/her suspicion on e.g. clinical symptoms such as cough, increased sputum production, chest tights, dyspnea and fever\>38C, and indication for x-ray.

Exclusion Criteria:

* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
* Admission within the last 14 days
* Verified COVID-19 disease within 14 days before admission
* Pregnant women
* Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 \<200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (\>20 mg/day prednisone or equivalent for \>14 days within the last 30 days), Chemotherapy within 30 days)
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV

Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV

A SLAP (Superior Labrum Anterior to Posterior) lesion is a specific type of shoulder injury that involves damage to the superior labrum, which is the cartilage rim around the socket of the shoulder joint. This type of injury typically occurs at the long head of the biceps tendon attaches to the labrum. The patient may feel pain, popping sensations and decreased range of motion in the shoulder.1 SLAP lesions are occurring in younger individuals,who playing sports that require repetitive overhead motions and presenting in individuals who have shoulder trauma injury,such as a fall or a direct blow to the shoulder.5There are four main types of SLAP lesions: in this research including Type IV: That is characterized by a bucket-handle tear of the superior labrum that extends into the biceps tendon. The torn portion of the labrum is displaced into the joint and the biceps tendon may be partially or completely detached.The prevalence of SLAP lesions as a cause of shoulder pain is estimated to be around 6-26% in the general population. However, the prevalence can vary depending on the specific population being studied, such as athletes or individuals with specific occupations that involve repetitive overhead activities.Treatment of SLAP type IV is Biceps tenodesis which was recently described, used suture anchor for fixation the biceps tendon to proximal humerus to obtain the stability of glenohumeral muscle. Fixation methods include tenodesis through a bone tunnel, the keyhole method, soft tissue tenodesis to the rotator interval or conjoint tendon, interference screw fixation, and suture anchors tenodesis which have a role in pain relief and maintain biceps muscle strength and have a role in preventing cramping. Recently treatment of SLAP lesion is repairing the labrum using suture anchors with Biceps tenodesis.This study prepared to compare the results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV ?

Eligibility Criteria:
Inclusion Criteria:

* Traumatic and degenerative etiology.
* No shoulder deformity .
* No inflammatory joint disorders.
* Type of the SLAP is SLAP type IV.

Exclusion Criteria:

* History of the disease.
* Bilateral shoulder.
* DM .
* Epilepsy .
* psychological disturbance.
Gene Therapy in Patients With Mucopolysaccharidosis Disease

This study investigated the safety and efficacy of gene therapy approaches for Mucopolysaccharidosis type VI disease caused by the deficiency of arylsulfatase B (ARSB) enzyme. The aim of the study is to evaluate the safety and efficacy of the treatment.

Mucopolysaccharidosis type VI disease is involved in Lysosomal Storage Disorder. The MPS VI disease is characterized by growth retardation, corneal clouding, cardiac valve disease, organomegaly, skeletal dysplasia, without central nervous system involvement.

Eligibility Criteria:
Inclusion Criteria:

1. Documented biochemical and molecular diagnosis of MPS VI. Testing for homozygous or compound heterozygous disease-causing mutations of the ARSB gene must have been performed by an accredited laboratory.
2. Subjects must be of 4 years of age or older.
3. Subjects should have received ERT for at least 12 months before enrolment and should continue to receive ERT until 7-14 days before IMP administration.
4. Documented informed consent; willingness to adhere to protocol and to participate to long-term follow-up, as evidenced by written informed consent.

Exclusion Criteria:

1. Subjects unable or unwilling to meet requirements of the study.
2. Participation in a clinical study with an investigational drug in the 6 months prior to enrolment in this trial.
3. Subjects unable to perform the 6MWT.
4. History of severe anaphylactoid reaction to Naglazyme in subjects receiving ERT that could affect the safety (severe reaction is meant to be a respiratory impairment event that is life-threatening).
5. Presence of tracheostomy or need of ventilatory assistance.
6. Subjects with evidence of progressive myelomalacia that is considered severe enough to require neck surgery in the first six months after enrolment.
7. Values of AST or ALT above the upper limit of normal range at baseline 2 (at -5days) evaluations.
8. Co-existence of chronic diseases or clinically relevant abnormal baseline laboratory values; infections with hepatitis B, C, or HIV (Baseline 1).
9. Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs within 2 months prior to IMP administration.
10. Female individuals of childbearing age who are pregnant or nursing or unwilling to use effective contraception for at least one year post-IMP administration.
11. Fertile male individuals who are unwilling to use male barrier contraceptives such as condom.
12. Any other condition that would not allow the subject to complete follow-up examinations during the course of the study and that, in the opinion of the Investigator, would make the subject unsuitable for the study.
13. Presence of serum NAB to AAV8 above the limit of detection of the assay (Screening and Baseline 1).
14. Presence of serum antibodies anti-ARSB above the upper limit of detection of the assay (antibodies anti-ARSB level \>31250 or declared positive at the value of serum dilution 1.10 according to the performed assay) at Screening and Baseline 1.
Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)

To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
* Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion Criteria:

* Patients with type 1 diabetes
* History of ketoacidosis or requires insulin use
* Alanine aminotransferase / aspartate aminotransferase \> 2.5 X ULN, triglycerides \> 600 mg/dL, creatinine clearance \< 35 mL/min
* Fasting plasma glucose consistently \> 260 mg/dL
* Poorly controlled hypertension
Urine Omics Predicting IO Therapy Responses in mUC Patients

The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.

This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age \> 20 years
* 2. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
* 3. Subjects who are about to receive IO-based therapy
* 4. ECOG performance 0, 1, 2, and 3
* 5. Life expectancy 3 months
* 6. eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
* 7. Willing to sign the informed consent form

Exclusion Criteria:

* 1. Subjects NOT willing to sign the informed consent form
* 2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
* 3. Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.
* 4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
* 5. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
* 6. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \>12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)

Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Duration of diabetes ≥ 3 years
* Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)

Exclusion Criteria:

* Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
* Pregnancy
* Medical conditions requiring acute hospitalisation
* Severe diabetes complications or associated medical conditions \[such as blindness, end-stage renal failure (i.e. serum creatinine \>2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)\]
* Recent (within preceding 12 months) myocardial infarction, stroke or TIA
* Unstable angina pectoris
* Psychological conditions which may hamper patient's cooperation
* Geographic inaccessibility
* Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results