cyrilzakka/clinical-trials huggingface dataset:
Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Pilocarpine or any comparable or similar product.
Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers

Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 and ≤ 35 years
* Weight : Body Mass Index ≥ 18.5 and \< 25
* Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
* Subjects who volunteer to participate and are able to fully understand and agree to this study by written informed consent

Exclusion Criteria:

* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
* History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
* History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
* A tendency of bleeding
* History of alcohol or drug abuse
* Taking an investigational drug within 4 months prior to the trial
* Whole blood donation more than 400 mL within 3 months prior to the trial
* Whole blood donation more than 100 mL within 1 month prior to the trial
* Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
* Any medication which could influence the results of the trial within 10 days prior to the trial
* Excessive physical activities within 7 days prior to the trial
* Alcohol drinking within 3 days prior to the trial
* History of orthostatic hypotension, fainting spells or blackouts
* Other than above, those who were judged by the investigator to be inappropriate as the subjects of the study
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)

This was a 2-part study of dexpramipexole in patients with ALS.

Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks.

Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole for up to 72 weeks.

This study was a two-part, multicenter, double-blind study in subjects with ALS to evaluate the safety and tolerability of dexpramipexole treatment, as well as the preliminary effects on measures of clinical function and mortality of dexpramipexole treatment.

In part 1, 102 subjects with ALS were randomized at 20 US sites to receive placebo, dexpramipexole at 50 mg/day; dexpramipexole at 150 mg/day; or dexpramipexole at 300 mg/day for 12 weeks. Participants who completed Part 1 were eligible to enroll into Part 2.

Part 2 was a randomized, double-blind, 2-arm, parallel-group, extension study evaluating the longer-term safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole. In part 2, following a 4-week, placebo washout, continuing subjects received dexpramipexole at 50 mg/day or 300 mg/day as double-blind treatment for up to 72 additional weeks (Part 2 duration was up to a total of 76 weeks, including the 4 week placebo portion).

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria
* Patients with ALS symptom onset \< 24 months from randomization
* Patients with upright vital capacity (VC) \> 65% of predicted for age, height, and gender

Exclusion Criteria:

* Patients in whom causes of neuromuscular weakness other than ALS have not been excluded
* Patients without clinical evidence of upper motor neuron dysfunction
* Patients with clinically suspected ALS according to the World Federation of Neurology El Escorial criteria
* Patients with prior exposure to KNS-760704 or the R(+) enantiomer of pramipexole (i.e., R(+)-pramipexole)
* Patients taking other investigational agents (including lithium) within 30 days of randomization or during the study
Biomarker Discovery in Lung Cancer - Malaysia

This study aims to

1. Identify biomarkers and signatures to differentiate between high-risk and lung cancer patients.
2. Discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.

With existing evidence showing the utility of using liquid biopsy for early cancer detection, the investigators hypothesized that cell-free DNA and/or RNA expression changes during disease progression, and biomarker signature can be derived from the changes in expression levels. The investigators aim to discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 30 and above.
* No previous history of any cancers.
* Able to provide X-ray and/or LDCT results.
* Have either COPD or pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician
* Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow up as per standard of care.
* Willing to provide up to 30mL of blood in month-0 (first visit) and up to 21mL in the next standard of care follow up visit (second visit).

Exclusion Criteria:

* Subject has received chemotherapy or radiotherapy for cancer treatment, and any other cancer-related treatment.
* Subject is pregnant or lactating (self-declaration).
* Subject is unwilling or unable to provide signed informed consent
Follow-up Study for Participants Jointstem Clinical Trial

This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients must consent in writing to participate in the study by signing and dating an informed consent document
* Patients who transplanted Jointstem on phase 2b clinical trial

Exclusion Criteria:

* Preparing for Pregnancy or Pregnant women or lactating mothers.
* Patients who the principal investigator considers inappropriate for the clinical tria
Acceptance and Commitment Therapy (ACT) for Combating the Effects of Race-Related Stress Among Black Adolescents

The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.


Eligibility Criteria:
Inclusion Criteria:

* Identify as Black/African American
* English-speaking

Exclusion Criteria:

* Prisoners or youth in detention centers will be excluded.
* Not capable of participating meaningfully in the assent/consent process.
* Being at significant risk for suicide and self-injury
* Currently experiencing psychosis
* Having severe health concerns that will impact study participation or attendance
Saline At Different Temperatures After 3rd Molar Surgery

This double-blind, single-center, split-mouth, randomized prospective clinical trial was conducted among 48 systemically and periodontally healthy patients who had bilaterally asymptomatic mandibular third molars.

Patients were randomly allocated into 2 groups (n = 24) according to the temperature of the saline used. In each patient, one impacted third molar was determined as the test group Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded. Data were analyzed using the Shapiro-Wilk test, the chi-square test, one-way analysis of variance, Duncan test, the Kruskal-Wallis test, the Dunn test, and the Friedman test (P \< .05).

Eligibility Criteria:
Inclusion Criteria:1. Patients who met the requirements of the study, such as attending follow-up sessions and signing the informed consent. 2. Patients with bilateral mandibular asymptomatic vertical third molar teeth with impaction of Class I, level C.22 3. Patients who did not have any significant medical diseases or drug use, were not pregnant, had no allergy, and did not smoke.

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Exclusion Criteria:

1 Patients with complicating systemic disease ( American Society of Anesthesiologists : 3- 6). 2. Patients who have second molars with severe periodontal defect or deep periodontal pocket (probing depth \>4 mm). 3. Patients with poor oral hygiene. 4. Patients with a history of using analgesics 12 hours ago or antibiotics 1 month before. 5. The presence of cysts or tumors around the impacted third molar.

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Peripheral Venous Pressure Variation and Fluid Responsiveness

The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders.

Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.

Predicting fluid responsiveness is important in the operating room in order to avoid unnecessary fluid administration. Over the last 15 years, a number of dynamic tests have been developed which are based on the principle of inducing short-term changes in cardiac preload, using heart-lung interactions, the passive leg raise or by the infusion of small volumes of fluid, and to observe the resulting effect on cardiac output or stroke volume. Pulse pressure and stroke volume variations were first developed, but they are reliable only under strict conditions. The variations in vena caval diameters share many limitations of pulse pressure variations. The passive leg-raising test is now supported by solid evidence and is more frequently used but not practical in the operating room. More recently, the end-expiratory occlusion test has also been described, which is easily performed in ventilated patients. Unlike the traditional fluid challenge, these dynamic tests do not lead to fluid overload. The dynamic tests require the insertion of an arterial catheter linked to an advanced cardiac output monitoring device which is costly and not applicable in lower risk patients without an arterial line.

In the operating room, it is recommended to use alveolar recruitment maneuvers, consisting in the transient administration of higher pressure levels, allowing to re-ventilate certain pulmonary territories by re-expanding alveoli that would have collapsed under mechanical ventilation. In daily practice, it is generally accepted that a patient presenting a significant fall in stroke volume or mean arterial pressure during an alveolar recruitment maneuver is preload dependent, but the scientific evidence in the literature remains insufficient to date. A previous study has also demonstrated the ability to predict fluid responsiveness via analysis of central venous pressure during a recruitment maneuver. By extrapolation, we would like to evaluate the capacity of peripheral venous pressure to predict this fluid responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients scheduled for a high-risk abdominal surgery
* Patients equipped with an arterial line connected to an cardiac output hemodynamic monitoring device ( Flotrac, EV1000, Edwards Lifesciences, Irvine, USA)
* Patients in whom a recrutment maneuver is planned as per standard of care

Exclusion Criteria:

* Arythmia ( atrial fibrillation)
* Right ventricular dysfunction
Maggot Therapy for Wound Debridement

The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.


Eligibility Criteria:
Inclusion Criteria:

* patient between 18 and 90 years old
* patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers
* pressure ulcers were less than 2cm-deep
* limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8
* signed informed consent

Exclusion Criteria:

* patients pregnant or lactating
* patients with neuropathy
* patients perforant ulcer of the foot
* patients with dementia
MRI Guided SBRT for Localized Prostate Cancer

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions.

In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered.

In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.

Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study combines the benefits of RT dose escalation while shortening the overall RT treatment course.

In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified to two separate SBRT regimens depending on whether prostate lesions are present. For patients without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB) (21 Gy in 3 fractions) to intraprostatic lesion(s) only.

Patients will be regularly assessed every 3 months for the first 2 years and then every 6 months, indefinitely. Side effects will be monitored using the standardized international prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at baseline and subsequent follow-up appointments.

Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor control without increasing toxicity, all in a shortened treatment duration.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma within 1 year of randomization
* NCCN Low to High Risk localized prostate cancer
* Zubrod Performance Status 0-1 within 60 days prior to registration

Exclusion Criteria:

* Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
* Regional Lymph Node (N1) involvement
* Distant Metastases (M1) involvement
* History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
* Prior chemotherapy
* Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS)
* Acute bacterial or fungal infection requiring IV antibiotics
* Inability to undergo MRI
* Inability to receive fiducial markers
Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand

The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

Pain is frequently reported in patients admitted to an ICU, with an incidence of up to 50% in medical patients during admission, and increasing up to 80% during standard care procedures. Agitation was also reported in 52% of the patients, typically within 4-9 days after admission. However, there were studies reporting inadequate pain, agitation and delirium assessment and management in real-world clinical practice. The clinical practice guideline for the management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU was recently published in 2018 and emphasized routinely monitoring pain, agitation and delirium during ICU admissions. Also, appropriate management of pain and agitation in critically ill patients resulted in reduction in ICU length of stay, hospital length of stay, delirium and mortality. Therefore, structural pain, agitation/sedation, delirium assessment and treatment in the ICUs, Thailand might be necessary.

Since pain, agitation/sedation and delirium protocol has not yet been initiated in ICUs, Thailand, this study is designed as a before-after study in order to assess outcomes by comparing between before and after protocol initiation. The objectives of the study were to document the impact of pain, agitation/sedation, delirium protocol on clinical outcomes of ICU patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older)
* Patients admitted to medical or surgical intensive care units

Exclusion Criteria:

* Terminal ill patients, or patients unlikely to survive \> 24 hours
Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)

A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms.

A randomized, controlled study of the safety and efficacy of Squalamine Lactate eye drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. Subjects will be randomized to one of the following treatment arms:

1. Squalamine Lactate Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
2. Vehicle Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
3. Squalamine Lactate Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
4. Vehicle Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will have clinically significant diabetic macular edema of ≥ 300 microns with central involvement using the Heidelberg or Cirrus machine
* Best corrected visual acuity of 20/32 to 20/320 inclusive in the study eye
* Adults ≥ 18 years of age with type 1 or 2 diabetes mellitus with diabetic macular edema

Exclusion Criteria:

* History of vitreoretinal surgery in the study eye
* Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
* Any prior laser in study eye
* Previous use of intraocular or periocular corticosteroids in the study eye within 6 months of screening
* Previous treatment with anti-angiogenic drugs in either eye within 3 months of screening
* Uncontrolled diabetes mellitus with HbA1c levels greater than 12
* Ocular disorders in the study eye, other than diabetic macular edema, that my confound interpretation of study results