cyrilzakka/clinical-trials huggingface dataset:
A Study of RX-10045 in the Treatment of Dry Eye Disease

The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Have a patient reported history of dry eye in both eyes
2. Presence of dry eye symptoms
3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining

Exclusion Criteria:

1. Known contraindications or sensitivities to study medication or its components
2. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
3. Use of disallowed medication during the period indicated prior to the enrollment or during the study
4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Steps Against the Burden of Parkinson's Disease - StepuP

The goals of our StepuP project are:

1. To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD;
2. To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
3. To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
4. To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.


Eligibility Criteria:
Inclusion Criteria:

Specific criteria for Parkinson's disease - PD

* Diagnosis of Parkinson's disease according to the MDS World Movement Disorders Society criteria Disease severity H\&Y I-III
* Score section 3.10 (ability to walk) MDS-UPDRS 3.10 ≥ 1
* MoCA cognitive assessment \> 15
* Stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity
* Without orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher.

Exclusion Criteria:

* Moderate or severe depression (BDI-II ≥18)
* Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher
CT Perfusion Scans for Assessment of Lung Cancer Before and After Chemo +/- Radiotherapy

Cancer of the lung is treated with surgery, radiation or chemotherapy, depending on the stage or extent of the disease. Some patients are treated with chemotherapy and/or radiation therapy before surgery to improve the results of surgery. After these treatments, we do not know whether the residual tumour tissue is still alive or dead, which is why some physicians feel that surgery is required to remove it.

This study is designed to assess if computed tomography (CT, CAT-scan) enhanced with intravenous contrast agent (dye) can characterize a lung cancer, and say whether it is alive or dead. The researchers hope that in the future such a contrast-enhanced CAT-scan will make surgery less often necessary or improve the results of chemotherapy and/or radiation given before surgery.

The proposed study will be performed in patients with a proven lung cancer for whom induction therapy and subsequent surgical resection of any kind is planned. Kinetic analysis of dynamic contrast-enhanced CT will performed using the CT Perfusion 3 software (General Electric Medical Systems), yielding parameters characterizing tumor microvasculature in terms of the vascularity, or the blood volume (BV), the tumor perfusion or blood flow (BF), and the immaturity of the vascular wall, in terms of the microvascular permeability (permeability surface area, PS).

To test the assumption that dynamic CT-assessed tumor microvascular characteristics represent reliable, user-independent and reproducible parameters, microvascular values and parameter maps will be derived from two independent observers. To address the interobserver variability, each study will be analyzed by the PI and by a second researcher (blinded to the results of the PI). Kappa-statistics will be used to assess inter-rater concordance.

To test the hypothesis that the microvascular parameters obtained from dynamic contrast-enhanced CT predict the response to induction therapy, the parameters BV, BF and PS obtained prior to any treatment will be correlated with the histological result from the resected specimen (path CR or path non-CR). Spearman correlation will be used to compare non-parametric histology results with quantitative CT microvascular parameters.

To test the hypothesis that the microvascular parameters obtained from dynamic contrast-enhanced CT reflect the response to induction therapy, the parameters BV, BF and PS obtained after completion of induction treatment will be correlated with the histological result from the resected specimen (path CR or path non-CR). Spearman correlation will be used to compare non-parametric histology results with quantitative CT microvascular parameters.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of non-small cell lung cancer
* Patients who are scheduled for any neo-adjuvant treatment

Exclusion Criteria:

* Females who are known to be pregnant or nursing
* Patients with a history of adverse reaction to previous contrast agent administration
* Patients with known renal disease
A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)

The study is designed to compare the risk of cardiovascular events (heart attacks, strokes) in patients receiving either etoricoxib or diclofenac. It will also compare the gastrointestinal tolerability of the two medicines. The study will be conducted in patients with either rheumatoid or osteo-arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years

Exclusion Criteria:

* Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation.
* Concomitant therapy of warfarin, heparin, high-dose aspirin (\>100 mg/day).
* Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontrolled high blood pressure, active hepatitis/hepatic disease
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients with Steroid-Refractory Acute Graft-versus-Host Disease

This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults or adolescents (\>12 years old).
* Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
* Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
* No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.
* Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/mL for at least 3 consecutive measurements and not supported by growth factor supplementation
* Weight \>40 kg and ≤ 140 kg at screening.

Exclusion Criteria:

* Has received more than 1 allo-HSCT
* Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
* Previous failure of ruxolitinib treatment
* Uncontrolled GI infection
* Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD
* Chronic GvHD
* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
* Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT
* Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment.
* Severe organ dysfunction unrelated to underlying aGvHD
* Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)
* Significant liver disease that is unrelated to GvHD
* Moderate to severe kidney disease
* Currently breast feeding.
* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.
* Active sepsis
Dual Use Approach Bias Training for Nicotine Addiction

The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.

The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* At least 15 days of CC use for the previous month
* ECIG use with nicotine at least 15 days for the previous month
* Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)
* Ability to speak and read English fluently
* Not have decreased number of cigarettes by more than half in the past month
* Own an android smartphone (for EMA).

Exclusion Criteria:

* Current psychotherapy or pharmacotherapy for mental illness or addiction
* Current use of nicotine replacement therapy, Zyban, or Chantix
* Limited mental capacity or inability to provide informed consent
* Insufficient command of the English language (\>6th grade English literacy level required)
Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery

Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Term uncomplicated singleton pregnancy
* Undergoing elective caesarean section under spinal anaesthesia
* Weight: 50-100kg
* Height: 150-180cm
* Healthy term fetus

Exclusion Criteria:

* Inability to give informed consent
* Multiple pregnancy
* Clinically significant concomitant disease states (e.g. hypertension, cardiac disease, severe asthma requiring regular medication, comorbidities affecting the autonomous nervous system, renal disease)
* On any cardiovascular medication
* Complications of pregnancy (e.g. preeclampsia, intrauterine growth restriction, fetal malformations)
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Any fetal pathology (e.g. fetal malformations, rupture of membranes before caesarean section, oligohydramnios, polyhydramnios, suspected chorioamnionitis)
The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

The study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.

This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased.

Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous women receiving cesarean delivery
* Ages between 21-35 years
* Gestation ages ≥ 37 weeks and \< 42 weeks
* Willing to give and sign an informed consent form and a photographic release form
* Willing to comply with study dosing and complete the entire course of the study

Exclusion Criteria:

* Any systemic uncontrolled disease
* Recent or current cancer
* History or presenting with a keloid formation
* Wounds or local disease in treatment area
* Planning any other cosmetic procedure to the study area during the study period
* Smoking
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese male or female adults aged ≥ 18 years;
2. Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;
3. Participants who provide signed written informed consent form.

Exclusion Criteria:

1. Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins;
2. Suspect or diagnosed as tetanus;
3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
5. Current alcohol abuse, drug abuse or drug addiction

Other protocol defined Inclusion/Exclusion criteria may apply
Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Metoclopramide is widely used as a prokinetic agent in adults and is licensed for premedication in pregnancy, but its use may be limited by its potential for producing extrapyramidal side effects. Erythromycin is an effective prokinetic agent in adults but there is no work examining its use for premedication in pregnancy. This study compared the effects of erythromycin and metoclopramide on GRV in full-term pregnant women


Eligibility Criteria:
Inclusion Criteria:

* Non-laboring pregnant women ≥36 weeks gestational age
* Parturient scheduled for elective caesarian delivery.
* Singleton pregnancy
* Age greater than 18 years
* Having followed institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food)

  2. Exclusion criteria:
* Refusal of the patient
* Deviation from fasting times
* Patients with empty stomach
* Emergency operation
* Body mass index (BMI) greater than 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status class III, IV.
* Gestational diabetes mellitus
* Multiple gestations
* Patients with polyhydramnios liquor.
* Preeclampsia patients
* Chronic kidney disease patients
* Systemic diseases may cause delayed gastric emptying (eg: myopathies and myasthenia gravis).
* Patients with gastrointestinal diseases such as hiatus hernia, intestinal disease and gastro-oesophageal reflux disease and patients with history of upper gastrointestinal surgeries.
* Patients on antidepressants and monoamine oxidase inhibitors
* Use of other medications known to affect gastric motility or secretions.
* Allergy to macrolide or metoclopramide
Exploratory Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
2. Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

1. Active ocular infection
2. Vernal keratoconjunctivitis
3. Recurrent corneal erosion
4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
5. Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
6. Anticipated use of contact lens during the study.
7. Insertion of punctal plug or fall out of punctal plug within 3 months
8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
9. Receipt of any investigational product within 4 months.
A I in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With 2 Ceramic Materials

The present study will be performed to evaluate application of artificial intelligence in the prediction of clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic)

The objective of the present study is to characterize two different margin designs (vertical "feather-edge" and horizontal "shoulder") with two different ceramic materials (zirconia and hybrid ceramic) in terms of clinical performance, marginal fit and fracture resistance.

Primary outcome:

Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.

Secondary outcome:

Evaluating the clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).

Eligibility Criteria:
Inclusion Criteria:

* 1. Age range of patients should be 20-50 years old, able to read and sign the informed consent document. 2. Patient with posterior molars indicated for full coverage restorations. 3. Patient should be able to physically and psychologically tolerate conventional restorative procedures. 4. Patients who are willing to return for follow-up examination and evaluation. 5. Indicated molar should have adequate tooth preparation length to ensure proper retention and resistance form. 6. Patient with sound contralateral or adjacent tooth to the selected tooth requiring full coverage restoration.

Exclusion Criteria:

1. Patient in the growth stage with partially erupted teeth.
2. Patient with poor oral hygiene and motivation.
3. Pregnant women.
4. Patient with psychiatric problems or unrealistic expectations.
5. Patients with no opposing occluding dentition in the area intended for restoration.
6. Patients with parafunctional habits. -
Efficacy of an Erector Spinae Plane Block in VATS/RATS

This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).

A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor \[Piritramide\] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.

The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* age between 18 to 100 years old
* ASA 1-3
* scheduled for VATS
* informed consent explained and signed

Exclusion Criteria:

* Patients \< 18 years old, \> 100 years old
* ASA physical status \> 3
* previous cardiac surgery or ipsilateral thoracic surgery
* neuropsychiatric diseases
* allergy to analgesics or local anesthetics or other medications used in the study
* abuse of opioids or sedatives
* contraindication to receive regional anesthesia (e.g. coagulation defect)
* patients who could not understand the VAS pain-scoring system
* patient refusal to follow participation
* expected post operative mechanical ventilation
* intolerance or allergy to any prescribed medication