cyrilzakka/clinical-trials huggingface dataset:
Evaluation of NV701 (Pilocarpine 1.25%) Compared with Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects with Presbyopia

Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-55 years with presbyopia
* Able to understand and willing to sign the informed consent for the study
* Resting mesopic pupil diameter of \>4 mm in both eyes
* Change in mesopic pupil diameter of \>1 mm after 1 hour in response to pilocarpine 1.25% in both eyes
* Willing to abstain from contact lens use for 7 days before the study visit
* Women of childbearing age must have a negative urine pregnancy test at the screening visit and be willing to use a reliable method of birth control during the study

Exclusion Criteria:

* Anisocoria \>1 mm in photopic or mesopic conditions
* High myopia (-6.00 diopters or greater)
* Any iris abnormality making it difficult to judge pupil diameter as determined by the principal investigator
* Known allergy to any of the study products or medications
* Concurrent use of any topical prescription ophthalmic products
* History of uveitis or intraocular inflammation
* Inability to complete any of the study procedures
* History of ocular surgery other than LASIK or PRK
* History of retinal tear or retinal detachment
* Presence of retinal lattice degeneration, operculated hole, or other retinal pathology on screening exam.
* History of punctal plugs or punctal cautery in one or both eyes
* History of nasolacrimal duct surgery in one or both eyes
* History of blepharoplasty or ptosis surgery in one or both eyes
* History of glaucoma, glaucoma suspect or ocular hypertension diagnosis
* History of acute angle closure or laser peripheral iridotomy
* History of moderate or severe dry eye disease
* Females who are pregnant, nursing, or planning a pregnancy during the study
* Females of childbearing potential and males with partners of childbearing potential who do not agree to use reliable contraception during the study
* Uncontrolled systemic disease
A Prospective Natural History Study of Mucopolysaccharidosis Type IIIB (MPS IIIB)

This is a natural history study for children up to 18 years of age who have been diagnosed with Mucopolysaccharidosis Type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B). Mucopolysaccharidosis type IIIB is a severe neurodegenerative disorder. The information gathered from this trial may help inform the design and interpretation of subsequent interventional studies. No clinical intervention or study drug is provided by Allievex in this study.


Eligibility Criteria:
Inclusion Criteria:

* Have deficient NAGLU enzyme activity at Baseline. Blood for NAGLU enzyme activity will be collected and analyzed centrally.
* Is up to 18 years of age
* Written informed consent from parent or legal guardian and assent from subject, if required
* Has the ability to comply with protocol requirements, in the opinion of the investigator

Exclusion Criteria:

* Has another neurological illness that may have caused cognitive decline (e.g., trauma, meningitis, or hemorrhage) before study entry
* Has received stem cell, gene therapy, or enzyme replacement therapy for MPS IIIB
* Has received any investigational medication within 30 days prior to the Baseline visit or is scheduled to receive any investigational drug during the course of the study
* Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's wellbeing or safety, or the interpretability of the subject's clinical data.
* Is currently participating in another natural history study
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA\<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.


Eligibility Criteria:
Inclusion Criteria:

* patients received a first or a second kidney transplantation
* patients with panel reactive antibody \<or= 50 %
* patients with cellcept treatment since fewer 3 days
* patients receiving or being received ciclosporine treatment
* patients without retention, important hepatic cytolysis
* patients without post-surgical complication or intercurrent disease
* informed consent signed

Exclusion Criteria:

* patients included in other study
* patients with MMF or mycophenolic acid hypersensibility or MMF contraindication
* patients with gastroduodenal disorder before the beginning of the study
* pregnant women or without contraception
* patients with rapamycin or analogous
* patients with toxicomania or psychiatric disorder
DEep VEin Lesion OPtimisation (DEVELOP) Trial

This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (\>50%) iliac vein lesions plus compression therapy. The primary endpoints will be ulcer healing and procedural safety. Secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow up will be over a five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.

The single main research question for this trial is as follows: in adult patients with venous ulceration and great saphenous vein incompetence; does iliac vein assessment with IVUS and stenting of significant occlusive disease in addition to superficial great saphenous venous ablation and compression compared to superficial venous ablation and compression alone offer improved ulcer healing rates at three months following treatment?

Primary Objective To determine whether superficial venous ablation plus early iliac vein interrogation plus endovascular stenting in the presence of significant occlusive disease results in improved venous ulcer healing compared to superficial venous ablation plus compression therapy alone.

Secondary Objectives

1. To determine the relative performance of duplex ultrasound compared to IVUS for the prediction of NIVLs 3. To determine the rate of primary or recurrent ulceration up to five years following intervention 4. To assess patient quality of life in the short and medium term following each mode of intervention

Eligibility Criteria:
Inclusion Criteria:

* Consenting patients
* aged 18 and over
* ultrasound detected Great Saphenous Venous incompetence
* an associated primary or recurrent lower limb venous ulcer(s)

Exclusion Criteria:

* Ankle-brachial pressure index \<0.8
* Previous inability to tolerate lower limb compression bandaging
* Inability to provide informed consent
* Previous lower limb arterial revascularisation procedure
* Contrast allergy
* Previous history of pelvic malignancy or pelvic radiotherapy
* Pregnancy
* Previous iliac vein intervention
* Previous superficial vein intervention
* Infection in previous 30 days
* Estimated glomerular filtration rate (eGFR) \< 60 mls/kg/min
* Isolated short saphenous or perforator vein reflux only
* Leg ulcer of non-venous aetiology (as assessed by clinician)
* Unfit for endovascular intervention based on history and examination
* Any compression therapy within six-months
* Evidence of deep venous incompetence/thrombosis
Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2 (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will be assigned to either arm by convenience. One arm will receive the joint treatment strategy and another the routine treatment used in health services.

In Mexico DM2 is the main complication of patients with TB (22.2%), more so than HIV, malnutrition and chronic pulmonary obstructive disease (COPD).

The World Health Organization (WHO) has proposed a framework for the joint management of TB and DM2 and one of the key points is the need for studies that evaluate the viability and efficacy of programs that manage both diseases jointly. There are social and clinical determinants that are associated to a higher mortality in patients with DM2 and TB such as poor glucose level control (glycosylated hemoglobin \>7mg/dl) and immunosuppression which in turn increases the risk of developing a recurrent episode of TB, being multi drug resistant (MDR) and/or failing TB treatment. The determinants associated to TB are the lack of awareness of the disease, drug toxicity and interaction with DM2 medication and treatment default. Social determinants are low income level, living in a crowded household, living in rural areas, not having access to health care, having been in prison and living with people with TB.

The strategy consists of interventions on patients, health personnel, community health workers and directors of health services. Researchers will train patients in the use of glucometers, health personnel in management of comorbidities of DM2 and TB, health workers in how to support patients and increase treatment adherence. Bidirectional screening in patients with TB or DM2 using bacilloscopies and glycosylated hemoglobin (HbA1c). During the 6 months of directly observed treatment (DOTS) study nurses will monitor levels of glucose weekly with capillary glucose, monthly with fasting glucose, in months 1, 3 and 6 with HbA1c. Patients with high glucose levels will be referred to metabolic control which will be assessed by experts. Regarding DOTs, first line TB drugs will be available and study nurses will supervise that they are taken correctly. A nutritionist will carry out home visits to guide dietary intake.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of active PTB, Diagnosis of DM2, Not having started TB treatment, Attend a selected health clinic, Sign a written informed consent

Exclusion Criteria:

* Unable to provide information, Pregnancy, HIV infection
SeeMe: An Automated Tool to Detect Early Recovery After Brain Injury

Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, "SeeMe," to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.

Acute brain injury (ABI) recovers at a variable rate. While some progress has been made in predicting long-term outcomes in traumatic brain injury (TBI) and intracranial hemorrhage, there is a critical need for short-term prediction of outcomes, in the first days and weeks after injury. With advances in machine learning and artificial intelligence, there is a growing interest in facial analysis and its application in neurological and psychiatric disorders. Here we describe "SeeMe," a novel automated objective measure of consciousness based on microexpression analyses in response to auditory commands. In measuring the smallest muscular movements undetectable by clinical observation, this technique has the high spatial resolution needed to detect hidden signs of recovery and the high temporal resolution needed to study neural circuits.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Healthy Volunteers
* Comatose patients (patients with a GCS \< 9) due to an acute brain injury (traumatic brain injury, spontaneous subarachnoid hemorrhage, severe meningoencephalitis, etc.)

Exclusion Criteria:

* A history of a neurologically debilitating disease (i.e., dementia, glioblastoma, Alzheimer's, multiple sclerosis, major vessel stroke, previous severe TBI, etc.)
* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
* Pregnant subjects
* Comatose patients without a legal authorized representative (LAR)
* Prisoners or wards of the state
* Persons who have not attained the legal age for consent to treatments or procedures
RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis

A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.

RENOVATE Fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables (pCO2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.

Eligibility Criteria:
Inclusion Criteria: Sequential adult patients 18 years of age or older admitted to the hospital with pulmonary fibrosis and acute onset of respiratory failure that meets criteria A and B bellow.

A. Pulmonary fibrosis will be defined by all of the criteria below:

* presence of Velcro-type crackles on physical examination
* imaging compatible with pulmonary fibrosis
* diffuse disease on imaging

B. Acute respiratory failure (ARF) will be defined by hypoxemia evidenced by SpO2 \<90% or PaO2 \<60 mmHg in room air and at least two of the criteria below within the last four weeks:

* worsening dyspnea
* worsening breathing effort
* worsening gas exchange (worsening SpO2 or paO2)
* worsening respiratory rate, above 25 irpm

Exclusion Criteria:

* Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;
* Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index \<2L / min / m2 in catheterization of right chambers;
* Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;
* Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;
* Presence of delirium or non-cooperation at the time of randomization;
* Anatomical facial abnormalities;
* Incoercible vomiting or hypersecretion of the airways;
* Use of continuous VNIPP or HFNC for more than 8h before randomization;
* pregnancy;
* Refusal to participate.
A Tube Feeding Study in Malnourished Population With Diabetes

This is a prospective, non-interventional, observational study. Malnourished subjects with diabetes, who are receiving a high calorie, high protein tube feeding with slow release carbohydrates and MUFA by their health care professional (HCP) per standard of care will be enrolled into the study.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study
* Considered malnourished, or at risk for malnutrition
* Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin
* Conforms to the requirements set forth on the study product label
* Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional
* Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay \> 3 days and \< 12 days

Exclusion Criteria:

* Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product
* Renal or liver failure
* Participates in another study that has not been approved as a concomitant study by AN
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.

Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. Once the maximum tolerated dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer
* Eighteen years of age or above
* Candidates for chemotherapy
* Able to understand and sign an informed consent (or have a legal representative who is able to do so)
* Measurable disease according to RECIST v1.1
* ECOG Performance Score (PS) of ≤ 2
* Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-121

Exclusion Criteria:

* Prior radiation therapy to \>25% of bone marrow-bearing areas
* Evidence of any other active malignancy
* Active infection or fever\> 38.5°C during screening visits or on the first scheduled day of dosing
* Symptomatic CNS disease
* Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies
* Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state
* Pregnant or breast feeding
Meal Presentation and Liking

This study will investigate the energy consumed from an entree with high- or low-volume vegetables incorporated into the entree or served along side of the entree, in normal weight adults.

Participants will complete four experimental sessions, where a main entree with high- or-low volume vegetables (either added as a side item or mixed with the main entree) will be served for lunch, to determine the impact that presentation and liking may have on the consumption of energy dense foods.

Once screened participants arrive for their first experimental session, they will record the foods and beverages they consumed in the past 24 hours, as well as write down the minutes of physical activity they participated in, within that same 24 hour period. The participants will rate their hunger, fullness, and liking of foods using a 100 mm VAS. After completing these forms, participants will be presented the appropriate meal, for their condition. Following the presentation of the meal, the participant will rate their liking of the meal appearance and then be instructed to eat as much or as little as they want of the meal provided in 20 minutes. At the completion of the allotted time, the meal will be removed, and the participant will evaluate their level of hunger, fullness, and liking of the foods consumed. The session will conclude with the collection of the hunger, fullness, and liking forms.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 to 24.9 kg/m\^2
* Unrestrained eater (\<12 on Three Factor Eating Questionnaire \[TFEQ\])
* Report liking Fettucini Alfredo, zucchini, and squash (rate all items \>50mm on a visual analogue scale \[VAS\])
* Report regularly eating before 10 am
* Can compete all sessions within 8 weeks of the screening session

Exclusion Criteria:

* Report binge eating
* Report a medical condition that influences eating
* Report allergies to foods used in the investigation
* Currently smoke
* Report dietary restrictions
* Report taking a medication that affects appetite
* Report being pregnant or breast-feeding
* Report being an athlete in training
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control


Eligibility Criteria:
Inclusion criteria:

1. Type 2 diabetes mellitus
2. HbA1c \>= 7.0%
3. Age \>= 70 years
4. Signed and dated written informed consent

Exclusion criteria:

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
2. Impaired hepatic function
3. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins
4. Treatment with anti-obesity drugs
Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.

The current standard of care for patients who experience insufficient weight loss, weight re-gain or Type II diabetes relapse after a sleeve gastrectomy is a revisional laparoscopic sleeve gastrectomy.

However, such revisional procedure is commonly associated with high mortality and morbidity due to protein malnutrition. A noval bariatric procedure, single anastomosis sleeve ileal (SASI) bypass has emerged recently.

In this study, we are utilizing an incisionless novel endoscopic technique to efficiently replicate the anatomical features and physiological effects of SASI.

Eligibility Criteria:
Inclusion Criteria:

Subject must meet all the inclusion criteria to participate in this study and list each criterion.

1. Age: 21-65 years
2. Patients going for LSG at participating hospitals.
3. Able to provide informed consent

Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.

Exclusion Criteria:

1. Patients who were breast feeding or pregnant
2. Severe psychiatric illness
3. Eating disorder
4. Active neoplastic disease
5. End-stage renal disease
6. Patients with bleeding diathesis
7. Patients with pacemakers or implantable cardiac defibrillators
8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
10. Treatment with anti-platelet agents that could not be temporarily discontinued