cyrilzakka/clinical-trials huggingface dataset:
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434).

The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 will serve as the screening visit for this trial.

All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
* Did not withdraw from Study Res-05-0002 due to drug related adverse event
* Completed End of Treatment Visit for Study Res-05-0002

Exclusion Criteria:

* Pregnant or nursing females
* Concurrent Immunodeficiency
* Current use of immunosuppressive drugs
* Did not tolerate study drug in Study Res-05-0002
Postural Sway at Menstrual Cyclus

The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.

Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.

The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.

Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated with the same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.

Results will be compared for menstrual cycles and well-being day in women with and without pain at menstrual cycles.

Eligibility Criteria:
Inclusion Criteria:

* Have dysmenorrheal syndrome
* Have menstrual cycle without pain

Exclusion Criteria:

* Have another health problem (systemic, neurologic, orthopedic or psychiatric)
A Trial Assessing the Outcome of Celecoxib Administration Versus Placebo Following Anterior Cruciate Ligament (ACL) Reconstruction

The aim of this study is to directly compare the clinical outcomes of both the celecoxib and placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have short and long term goals. Validated outcome measures will aim to quantify pain control at 2 weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared using pain control scales, and functional knee outcome scores. The first null hypothesis tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group. The second null hypothesis is that no knee function difference will be found between the celecoxib and placebo groups.


Eligibility Criteria:
Inclusion Criteria:

* Any patient 18 years and over undergoing primary anterior cruciate ligament reconstruction with hamstring grafts will be considered for this study.

Exclusion Criteria:

* Patients will be excluded if they have bilateral ACL injuries, require revision ACL reconstruction, require meniscus repair, have multiple ligament injuries, gross osteoarthritis, significant clinical malalignment or if they cannot attend appropriate follow-up. Other exclusion criteria will include use of a regional block during the surgery, a diagnosis of esophageal, gastric, or duodenal ulceration, hepatic disease, renal disease, hypertension, hypersensitivity to Celecoxib, known allergic-type reactions to sulfonamides, known allergies to ASA or other NSAIDS, inflammatory bowel disease or hyperkalemia
Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

The purpose of the study is to identify non-invasive strategies that will optimize the neurobiological environment and improve learning and memory in the treatment of chronic pain. The overall aims of the current proposal are to determine if food restriction and/or glucose administration in conjunction with a relaxation/guided imagery exercise will result in neurophysiological changes and functional improvements compared to the relaxation/guided imagery exercise alone.

Up to sixty adults with chronic knee pain with or/at risk of knee osteoarthritis will be randomized to one of three groups: food restriction (20 participants), glucose administration (20 participants), or control (20 participants). Participants will attend four sessions over a two to three week period.

Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic knee pain with or/at risk of knee osteoarthritis

Exclusion Criteria:

* Concurrent medical condition that could confound outcome measures or limit the ability to participate completely in the protocol including: neurological conditions (Parkinson's disease, multiple sclerosis, and/or seizures)
* History of a head injury or stroke
* Diabetes or taking medications to control blood sugar
* Mental health issues resulting in hospitalization or outpatient treatment in the past year, and/or psychotropic medication use
* Current issue or history of treatment for alcohol or other substance abuse
* Cognitive function \< or = 22 on the Mini-Mental Status Exam
* Pregnancy
* A baseline fasting blood sugar (plasma glucose \> 7mmol/L) or persisting blood pressure \>150/95.
* Heart condition such as a prior heart attack, heart surgery (including a stent), frequent chest pain or heart failure
* Inability to complete the EEG portion of the study
French Translation and Validation of the PEYronie's Disease QUESTionnaire

This study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with Peyronie's Disease clinically diagnosed during a consultation, with palpation of at least one plaque

Exclusion Criteria:

* Patient refusing to participate
* Patient with difficulties in understanding the French language.
* Protected persons referred to in articles L.1121-6 to L.1121-8 of the public health code
Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses

The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson\&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).

This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
* Existing soft contact lens wearers or previous experience of contact lens wear
* Being able to wear the study lenses for at least eight hours a day
* At least 6/9 visual acuity in each eye with the study lenses
* Astigmatism less than 1.50 D (Diopter) in both eyes
* Agreed to follow the protocol and not to participate in other clinical research for the duration of this study

Exclusion Criteria:

* Have an ocular disorder which would normally contraindicate contact lens wear
* Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
* Have previously had any ocular surgery such as corneal refractive surgery
* Have less than 6/9 visual acuity in each eye with the study lenses
* Are currently using any topical medication such as eye drops or ointment
* Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
* Are currently pregnant or lactating
* No previous contact lens wear
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.

Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce plasma glucose and haemoglobin A1c(HbA1c) in patients with type 2 diabetes mellitus by increasing urinary glucose excretion in a non-insulin-dependent fashion.

However, in some situations lead to a diminished number of functional glomeruli with a consequent hyperfiltration in the remaining ones. This fact may be where the use of SGLT2 inhibitor could attenuate the renal damage.

The purpose of our study is to evaluate the impact of using dapagliflozin on the renal functional deterioration of renal transplanted patients diabetics or not.

This is a prospective, randomized, single-blinded, double-center, controlled trial.

Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.


Eligibility Criteria:
Inclusion Criteria:

1. Renal Transplanted patients with one to 5 years after transplantation, being followed at the out-patient clinics of the HCFMUSP and HRim;
2. ≥18years of age;
3. 45 ≥ eGFR ≥ 25 mL/min/1.73m2 or 45\<eGFR\<60 ml/min/1.73m2 with a loss of eGFR of ≥10% in the last year.

Exclusion Criteria:

1. Type 1 diabetes;
2. New York Heart Association Class IV congestive heart failure;
3. Myocardial infarction, unstable angina, stroke or transient ischaemic attack within 8 weeks prior to enrolment;
4. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8weeks prior to enrolment;
5. Any condition outside the renal and cardiovascular study area with a life expectancy of \< 1 year based on investigator's clinical judgement;
6. Hepatic impairment \[aspartate transaminase or alanine transaminase \>3 times the upper limit of normal (ULN) or total bilirubin \>2 times the ULN at the time of enrolment;
7. Acute or chronic antibody mediated rejection;
8. Albuminuria due to other causes (mTOR inhibitors, Polyoma nephropathy, lymphoproliferative disorder etc...)
9. Patients with a previous medical history of recurrent urinary tract infections or severe genital infection;
10. Renal biopsies showing acute or chronic anti-body mediated rejection, transplant glomerulopathy, BKV nephropathy.
11. Patients under any other IS regimen besides Tacrolimus/MPA/Steroids
12. Pregnant patients as well as those breastfeeding.
Impact of Current Smoking in the Tolerance of Bronchoscopy

The purpose of this study is to study the impact of smoking in the preceding hours before a bronchoscopy on the tolerance of this exam.

Tolerance evaluation of the bronchoscopy on current and regular smokers. The investigators assess episodes of cough, dyspnea, volume of lidocain (liquid 1% and in spray 10%), duration of the procedure, episodes of desaturation and completion of the bronchoscopy.

The investigators compare patients who did not smoke in the 6 hours before the bronchoscopy and those who have smoked.

Eligibility Criteria:
Inclusion Criteria:

* current and regular smoker
* bronchoscopy under local anesthesia

Exclusion Criteria:

* patients needing EBUS or fluoroscopy
* intravenous sedative
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.

1. Primary Objective:

   To evaluate the dose-response relationship of tarafenacin on efficacy.
2. Secondary Objectives:

   * To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
   * To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .


Eligibility Criteria:
\< Inclusion Criteria\>

1. Patient of either sex aged 20 to 80 years (both inclusive);
2. Patients suffering from Overactive Bladder. based on cardinal symptoms (urgency, nocturia, frequency with or without urge incontinence) for at least 6 months prior to inclusion;
3. Patients who document the following symptoms in a 3-day diary card during the 14 day placebo run-in period

   * An average of ≥8 micturitions/24 hours;
   * Greater than or equal to three incontinence episodes
   * A total of ≥3 urgency episodes.

\<Exclusion Criteria\>

1. Patients with Clinically significant bladder outlet obstruction
2. Patients with predominant stress incontinence (\>2 episode/week)
3. Patients with significant urogenital disease such as recurrent urinary tract infection (more than 2/6 months), bladder calculi, interstitial cystitis, urothelial tumours, hysterectomy or prostatectomy in the previous six months;
4. Females diagnosed with bladder cancer
5. Males diagnosed with bladder cancer
6. Patients with obstructive disease of the gastrointestinal tract, intestinal inflammatory disease, severe ulcerative colitis, inflammatory bowel disease, toxic megacolon, intestinal atony or paralytic ileum
7. Patients with acute Noehyeolgwangye disease, significant Cardiovascular Disease (arrhythmias, unstable angina pectoris, myocardial infarct, or are using a pacemaker), significant Orthostatic hypotension in the previous six months
8. Patients diagnosed with closed angle glaucoma or shallowness of the anterior chamber
9. Patients with any contraindication to antimuscarinic drugs
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
* Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Exclusion Criteria:

* History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
* Concurrent use of systemic anti-VEGF agents
* Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
* Use of intravitreal bevacizumab in the study eye and/or fellow eye
* Macular edema in the study eye due to other causes than RVO such as diabetes
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
* Pregnancy or lactation
* Premenopausal women not using adequate contraception
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
* Current treatment for active systemic infection
* Inability to comply with study or follow-up procedures
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to provide an archived tumor sample
* Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation
* Must have received at least 1 prior standard therapy
* Must have at least 1 measurable lesion per RECIST v1.1
* Must have adequate organ function
* Must be able to swallow and retain orally administered medication

Exclusion Criteria:

* Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
* Active infection requiring systemic treatment within 14 days
* Active HIV, HBV or HCV
* Any severe and/or uncontrolled medical conditions
* LVEF\<50% assessed by ECHO
* QT interval \>470 msec
Psychophysiological Indicators of Performance in Computer-Based Simulation

As simulation is now used in many post-graduate education and assessment domains, the investigators want to learn about how autonomically engaged healthcare providers are with the investigators computer simulation paradigm. The investigators are interested in the relationship between autonomic arousal (as measured by heart rate variability and galvanic skin response), self-report of engagement, and performance in the simulation and cognitive debriefing.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare provider
* Right-handed

Exclusion Criteria:

* Has a medical condition associated with cardiac arrhythmia
* Taking medications (such as antiarrhythmic or beta-blocker) that has an effect on heart rate or autonomic function
Therapeutic Exercise Program of Physiotherapy Using Telerehabilitation on Chronic Phase Stroke Patients

Stroke is the main cause of physical disability in adults in Catalonia. Despite this, there is a lack of evidence on physiotherapy interventions during the chronic phase of the pathology. The objective of the study is evaluate the effectiveness of a therapeutic exercise program of Physiotherapy through the use of Telerehabilitation on functional capacity in activities of daily living in patients with stroke in chronic phase. For this purpose, the investigator conduct a multicenter randomized controlled clinical trial. A minimum of 75 participants will be recruited in three intervention groups (n=25 each group) from Primary Care Centers of the Institut Català de la Salut. The sample will be made up of people over 18 years of age with a medical diagnosis of Stroke, in a chronic phase and with physical sequelae. Research team will evaluate as the main variable the functional capacity for the management of activities of daily living (Barthel Index); as well as sociodemographic variables. Also secondary variables such as motor function (MMAS), muscle tone of affected limbs (MAS), muscle strength of affected limbs (MRC), balance (PASS), gait efficiency (WGS, 4MWT), perception of musculoskeletal pain (BPI), perception of fatigue (FSS), risk of falls (TUG), perception of quality of life (NEWSQOL), and perception of quality of life (NEWSQOL), and perception of perceived subjective change after treatment (GROC). The variables will be collected, before and after the intervention , which will consist of 30 sessions (3 sessions/10 weeks). The analysis will be using a mixed linear model (ANOVA 3X3). Significance level p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Medical diagnosis of stroke
* Stroke condition present for more than 6 months
* Physical sequelae secondary to stroke
* Minimum score of 1 on the Medical Research Council scale for overall muscle strength of affected limbs
* Maximum score of 3 on the Modified Ashworth scale for overall muscle tone of affected limbs
* Maximum score of 4 on the Modified Rankin scale for disability
* Access to computer equipment (tablet, desktop or laptop computer, or smartphone)

Exclusion Criteria:

* Undergoing other non-pharmacological physical treatments for stroke sequelae improvement and/or maintenance
* Previous decreased motor functional capacity with a Barthel scale score of less than 60 points
* Cognitive and/or language barriers that hinder the understanding of informed consent and intervention
* Participation in another clinical trial during the study period that may impact the results of the variables to be evaluated
Impact of Tramadol and Oxycodone on Sleep Apnea

Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
* physical status I-III

Exclusion Criteria:

* planned surgical duration more than 3 hours
* contraindication to spinal anaesthesia
* severe respiratory disease
* patient treated for sleep apnea syndrome
* allergy to tramadol or oxycodone