cyrilzakka/clinical-trials huggingface dataset:
A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control
* Outpatients

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant cardiovascular disease
* Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply
Study of Diclofenac Capsules to Treat Osteoarthritis Pain

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline
* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
* Discontinued all analgesic therapy at Screening
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

Exclusion Criteria:

* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDS, including diclofenac
* Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Significant difficulties swallowing capsules or unable to tolerate oral medication
* Previous participation in another clinical study of Diclofenac Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening.
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).

Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.

This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).

Eligibility Criteria:
Inclusion Criteria:

* Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening
* Age ≥ 18 years
* Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening
* Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening
* eGFR \<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation

Exclusion Criteria:

* Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening
* Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \\ Screening
* Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening
* Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening
* History of hemochromatosis
* IV iron administered within 4 weeks prior to Screening
* Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening
* Blood transfusion within 4 weeks prior to Screening
* Receipt of any investigational drug within 4 weeks prior to Screening
* Cause of anemia other than iron deficiency or chronic kidney disease
* History of malignancy in the last five years
* Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening
* Any known allergies to iron products
* Previous intolerance to oral ferric citrate
* Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
* Planned surgery or hospitalization during the trial
* Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease

The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.

The investigators are recruiting 32 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with Idiopathic Parkinson's Disease
2. Age between 18 - 75 years
3. Hoehn and Yahr stage less than or equal to 3
4. Mini-Mental State Exam (MMSE) score of over 23 at screening
5. If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
6. Subjects willing and able to give informed consent

Exclusion Criteria:

1. Subjects with a diagnosis of an atypical Parkinsonism
2. Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
3. Score of 60 or more on UPDRS III at screening
4. Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
5. Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
6. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study
Surface Decontamination in Treatment of Peri-Implantitis

Peri-implantitis represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. The disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. To treat this inflammatory disease, surgical and non-surgical therapies have been proposed, all of which entail biofilm removal through implant surface decontamination. Systematic review of various surface decontamination protocols has failed to demonstrate superiority of any of the protocols. One possible explanation is that most studies have examined decontamination of implant surfaces following experimentally-induced peri-implantitis, where implant surfaces lack the tenacious mineralized biofilm often found in clinical peri-implantitis and are therefore easily decontaminated.

The investigators have hypothesized that control of inflammation and repair of pathologically damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface decontamination therapy. The aims of this study are to 1) determine the most effective surface decontamination protocol that can lead to control of peri-implant inflammation and 2) delineate the microbial and immunological mediators that are associated with the changes in peri-implant inflammation. The investigators propose to compare conventional implant surface contamination techniques to a comprehensive mechanical plus chemical protocol. This randomized controlled clinical trial seeks to enroll 68 participants with at least one implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned to one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive surface decontamination, including titanium brush, air powder abrasion and surface etching with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment will be repeated. The clinical examination will be used to analyze the efficacy of each treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this research is not only to identify an effective method for control of peri-implant inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that can potentially be helpful in future studies as risk factors of this disease.


Eligibility Criteria:
Inclusion Criteria:

* PPD \>6 mm
* Positive BOP
* Peri-implant marginal bone loss (MBL) \>3 mm
* Age: 18 to 75 years

Exclusion Criteria

* Implant mobility
* Smoking
* Current cancer
* Steroids use (last 2 years)
* Bisphosphonates use (last 4 years)
* Uncontrolled diabetes (HBA1c \>7)
* Other systemic conditions that affect wound healing
Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population

Chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones, GHB/GBL, methamphetamine, cocaine and ketamine. This can cause infectious or psychiatric complications, addictions, and often goes with high risk sexual behaviours. Recent studies have highlighted the relationship between personality disorders, substance use disorders and risky sexual behaviours. It is important to understand the factors associated with chemsex in order to offer adapted prevention and care plans.

The study hypothesis is that personality disorders, evaluated with the PDQ-4+ questionnaire, are more frequent among man having sex with other men with a substance use disorder linked to chemsex than among man having sex with other men who have never practised chemsex.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Men who have Sex with Men
* No opposition to participate to the study
* Chemsex group: to attend an addiction care center for past or present mild, moderate or severe substance-related disorder(s) according to DSM-V criteria, occurring in a sexual context and concerning cathinones, GHB/GBL, methamphetamine, cocaine and/or ketamine.
* Control group: to consult for a PrEP prescription and never have used cathinones, GHB/GBL, methamphetamine, cocaine or ketamine before or during sex.

Exclusion Criteria:

* Deprivation of liberty
* Guardianship
* Chemsex group: simple experience of chemsex without substance use disorder
Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer

The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide


Eligibility Criteria:
Inclusion Criteria:

* Documented metastatic colorectal cancer
* ECOG Performance Status of 0 to 1
* Adequate organ function as defined by study-specified laboratory tests
* Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
* Signed informed consent form
* Life expectance \> 12 weeks

Exclusion Criteria:

* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, or other medical conditions
* Systemically active steroid use
* Another investigational product within 28 days prior to receiving study drug
* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
* Chemotherapy, radiation, or biological cancer therapy within 28 days prior to receiving study drug
* No known history or evidence of CNS metastases \< 2 years.
* Pregnant or lactating
* Unwilling or unable to comply with study procedures
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients with Hemiparesis in the Acute/subacute Phase (Month 1 to 4)

The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial.

This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group.

The duration of the intervention period in both groups is 6 weeks.

* For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.
* For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).

The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* First clinically significant disability due to stroke
* Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
* Functional Ambulation Category score (FAC) \<2
* Patient with health insurance
* Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he/she can still be included if the signature can be done by an impartial witness.

Exclusion Criteria:

* Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
* Recent fracture (\< 3 months) or any therapy inducing secondary osteoporosis
* Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
* Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
* Medical contra-indication to medium intensity physical strain
* Orthostatic hypotension (loss of \> 20 mmHg systolic BP after 3 minutes in standing position)
* Uncontrolled seizures
* Morphological contra-indications to the use of Atalante (as per user's manual)
* Pregnant woman
* Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention
* Concurrent participation in another interventional trial
Me and the Others: Expectations and Evaluation of Social Relationships

Chronic and pervasive loneliness has been identified as an important factor in the relationship between adverse childhood experiences (ACE) (e.g. abuse and neglect) and mental disorders. However, the mechanisms determining loneliness after ACE are still needed to be disentangled. Therefore, this study aims to investigate the differential effect of ACE on alterations in cognition and the link between ACE and loneliness with an emphasis on the effect of type and timing of ACE.

With the rationale of the detrimental effects of loneliness on mental and physical health may be based on the interactions between genetic predispositions and social-environmental influences (e.g. ACE) via affecting neurobiological and cognitive processing, goals of this project are 1) characterization of loneliness to understand whether people suffer from mental/somatic disorders, feel lonelier and this effect is particularly strong in those with a history of ACE, 2) understanding the determinants of chronic loneliness by investigating certain personality dispositions such as rejection sensitivity and justice sensitivity, genetic predisposition for loneliness and social environments during childhood and adolescence and 3) inquiring into the social-cognitive correlates of these potential determinants in people's life today

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with and without adverse childhood experiences + clinical control group (i.e. individuals with borderline personality disorder)

Exclusion Criteria:

* A lifetime history of psychotic or bipolar I disorders, current pregnancy, history of organic brain disease, skull or brain damage, or severe neurological illnesses.
Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU

This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively.

The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

In December 2019, an outbreak of Severe Acute Respiratory Syndrome (SARS) attributed to a new coronavirus, called SARS-CoV-2, was described in the Wuhan region of China. This SARS, caused by SARS-CoV-2 was called COVID-19, spread across the globe, causing millions of cases on all continents, and thousands of deaths, being characterized as a pandemic.

COVID-19 is characterized by a flu-like syndrome, with symptoms such as fever, cough, myalgia and gastrointestinal symptoms. Most cases are mild, some even asymptomatic, but approximately 15% of patients have more severe presentation, and approximately 5% are critical (7).

The acute respiratory failure of critically ill patients with COVID-19 has different aspects, including hypoxemia of difficult treatment, associated in some cases with clotting disorders, changes in immunity and inflammatory phenomena that pose challenges for the management of these patients, whose mortality can be high.

The Hospital das Clínicas da Faculdade de Medicina de São Paulo implemented an action plan that provides for the creation of 200 ICU beds to serve patients with COVID-19. Knowing the characteristics of critically ill patients with COVID-19 and their clinical outcomes is extremely important to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

Eligibility Criteria:
Inclusion Criteria:

* Being admitted to one of the COVID-19 ICUs during the study period
* Suspected or confirmed COVID-19
* Expected ICU stay greater than 24 hours

Exclusion Criteria:

* ICU Readmission during the same hospital stay (patients will be evaluated only during their first ICU stay)
Role of Ultrasonography in Airway Management

Ultrasound is one of the most useful devices in daily anesthesia practice. Latest purpose of ultrasound usage is prediction of difficult intubation. In this study, we aimed to predict difficult laryngoscopy and intubation by using ultrasound measurement of neck soft tissue thickness in obese patient preoperatively.

In this prospective and randomized controlled study, mallampati scores, interincisor gap, thyromental distance, neck circumference measurement and upper lip bite test scores will be recorded in sixty obese patients.

Additionally, neck tissue thickness will be recorded at 4 different levels (hyoid bone-skin distance, epiglot-skin distance , thyroid istmus-skin distance, vocal cord-skin distance) after the sniffing position by ultrasound with the linear probe. All measurements will be repeated three times and an average values will be recorded.

After all this measurements, endotracheal intubation will be performed by an experienced anesthetist who is uninformed about study. During intubation the Cormack Lehane (C/L, grade 1: full view of the vocal cords; grade 2a: partial view of the glottis; 2b: posterior part of the vocal cord and arytenoids visible; grade 3: only epiglottis visible; and grade 4: neither epiglottis nor glottis visible) and the Intubation Difficulty Scale (IDS) score (the numbers of attempts, operators, and alternative techniques used, the C/L grade of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords. Every insertion of the laryngoscope and advancement of the tracheal tube towards the glottis counted as an attempt. A score of \>5 indicates moderate-to-major difficulty) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>30
* 18-65 YEARS
* ASA 1-2-3
* Obese patients

Exclusion Criteria:

* Pregnancy
* Upper airway pathology
* Cervical spine pathology
* Laryngeal pathology
Accommodation Disorders

This project will develop clinically useful, objective measurements of accommodative insufficiency and fatigue using continuous autorefraction recordings. The development of these procedures will help vision care professionals diagnose and treat accommodative anomalies.

This project studies accommodative function, the ability to focus while doing near work. Visual discomfort symptoms, such as headaches, sore eyes, and blurred vision are commonly associated with prolonged reading or other near work. Researchers have long suspected accommodative dysfunction was involved but most clinical studies have failed to establish a relationship between weak accommodation and symptoms or reading impairments. Recent research, however, has found that clinical measure overestimate accommodative function and encourage the use of objective, autorefraction methods to measure and study accommodative weakness. This project will accomplish three goals. First, using autorefraction objective reliable procedures will be developed for measuring accommodative lag, the difference between the target location and where the eye is focused. Second, experiments will measure in real-time the impact of accommodative lag on reading fluency and visual discomfort systems. Third, studies will explore the role of the slow adaptive component in accommodative weakness. This work will lead to better methods for diagnosing and treating accommodative disorders.

Eligibility Criteria:
Inclusion Criteria:

* older adolescent and young adult
* skilled readers who attend school
* are skilled readers
* have heavy reading demands

Exclusion Criteria:

* Age \> 30.
* Abnormal vergence system.
* Dry-eye.
* Uncorrected visual defects or significant ocular pathology.
* Learning disability or low IQ
* Medical conditions that might cause uncomfortable visual symptoms (e.g., migraine headaches, epilepsy, head trauma); sensory defects (e.g., deafness), or neurological conditions (e.g., stuttering) that could impair reading development or oral reading fluency.
* Somatosensory amplification.
* Systemic illness or medication associated with accommodative dysfunction.