cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy

This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.

Patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the presence of progressive disease or unacceptable toxicity. All patients took dexamethasone 3.75 mg twice daily, starting from the day before and continuing to the day after the drug administration. Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy.Patients received Vitamin B12 very 3 cycle of chemoherapy. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) or Erythropoietin (EPO) was not allowed, but they could be used when the patients suffered from bone marrow depression.

Eligibility Criteria:
Inclusion Criteria:

1. histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
2. age between 18 and 80 years
3. ECOG performance status of 0 to 2
4. life expectancy ≥ 12 weeks
5. has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
6. at least one prior chemotherapy regimen
7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
9. adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
10. adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.

Exclusion Criteria:

1. other primary malignancy
2. symptomatic central nervous system metastasis
3. pregnancy or lactation
4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
5. ongoing infection
6. inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin B12 supplementation.
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.


Eligibility Criteria:
Inclusion Criteria:

* undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation

Exclusion Criteria:

* History of corneal transplantation in the study eye, Best corrected visual acuity (BCVA) worse than 20/40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil.

The following special populations will be excluded.

* Adults unable to consent
* Pregnant women
* Prisoners
A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 18 years.
2. Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
4. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type psoriasis.
2. History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
3. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
4. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.
6. History of IL12/23 or IL-23 inhibitors therapy.
7. Inadequate washout period of prior biological therapy.
8. History of malignant tumour within 5 years before screening.
9. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.


Eligibility Criteria:
Inclusion Criteria:

* Has HbA1c \>7.0% and \<=10.5%
* Has a body mass index (BMI) \>=25 kg/m2 and \<=45 kg/m2
* Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
* If taking oral antidiabetic agents, has been on a stable dose for at least 2 months

Exclusion Criteria:

* Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
* Has received any investigational drug within 1 month of screening
The Effects of Wearing Operation Gown With Cartoon Characters on Reducing Preoperative Anxiety in Children: Randomized Controlled Study

The operating room environment can be frightening for pediatric patients. Many techniques have been used to make the operating room environment less intimidating, including allowing parents to accompany part of this procedure, play therapy and various distraction strategies during the entrance to the operating room. In a survey study, it was reported that parents were expected to create hospital conditions with a more child-friendly atmosphere. In this context, it is thought that creating a warmer environment for children, including the clothes worn in the operating room, may reduce the anxiety level of children. In this study, investigators' aim was to investigate the effect of wearing an hospital gown with cartoon characters on the reduction of preoperative anxiety in children scheduled for Orthopedic surgery by in the operating room.

Pediatric patients aged between 4-12 years, who are planned to be operated by the Orthopedic Surgery Clinic in Bursa Uludag University Faculty of Medicine Hospital Surgical Theatre, will be randomized preoperatively by closed envelope method. One group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance. The other group also will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance. Then the patients will be taken to the operating room as in the routine procedure. Before induction of anesthesia in the operating room, another investigator will re-evaluate the child's anxiety level using the m-YPAS scale. Vital signs, analgesic use and duration of surgery will be recorded during the operation. Afterwards, the satisfaction level of the parents will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned to have elective orthopedic surgery
* Patients whose American Society of Anesthesiologists (ASA) physical status classification are between 1-3
* Patients who have approved the informed consent form

Exclusion Criteria:

* Motor and/or mentally retarded patients
* Patients with hearing-speech impairment
* Patients whose ASA physical status classification IV-V
* Patients who do not accept informed consent and/or refused to participate in the study
Harmony TPV Post-Approval Study

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
* Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion Criteria:

* Obstruction of the central veins
* Planned concomitant branch pulmonary artery stenting at time of implant
* Subject is pregnant at time of implant procedure
* Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
* A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
* Planned implantation of the Harmony TPV in the left heart
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Pre-existing prosthetic heart valve or prosthetic ring in any position
Safety and Efficacy of Rasagiline in Restless Legs Syndrome

The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.

The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile for the treatment of RLS, as measured by the International RLS Study Group Rating Scale (IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12.

The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures of global clinical change, sleep quality, excessive sleepiness, quality of life, or depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years of age, capable of providing informed consent
* Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group diagnostic criteria without evidence for secondary causes of RLS
* Moderate or severe symptoms, defined as a score of 15 or greater on the International RLS Study Group Rating Scale (IRLS)
* Not currently receiving treatment for RLS. A 30-day washout period will be required for participants on dopamine agonists or other therapies. Stable doses of iron supplementation will be allowed
* On a stable dose of the following antidepressants, for at least 30 days prior to baseline visit:

  * Amitriptyline, up to 50mg/day
  * Trazodone, up to 100mg/day
  * Citalopram, up to 20mg/day
  * Escitalopram, up to 10mg/day
  * Paroxetine, up to 30mg/day
  * Sertraline, up to 100mg/day
* Female subjects must not be of childbearing potential or must agree to use of contraception for duration of study

Exclusion Criteria:

* Signs consistent with a secondary cause of RLS:
* History of initial unresponsiveness to dopaminergic RLS treatment despite adequate dose of initial therapy
* Use of another MAO inhibitor within 30 days of baseline visit
* Allergy or adverse reaction to rasagiline
* Prior adverse reaction to tyramine-containing foods
* Use of meperidine or other opiates within 30 days of the baseline visit
* Use of benzodiazepines within 30 days of the baseline visit
* Use of antidepressants, including TCAs, SSRIs, and SNRIs, except for those permitted as listed above
* Use of other drugs or supplements contraindicated with rasagiline, including St. John's wort, mirtazapine, cyclobenzaprine, dextromethorphan, cold products that contain ephedrine, pseudoephedrine
* Scheduled to undergo elective surgery during the course of the study
* Active medical or psychiatric illness that requires changes to treatment during the course of the study or jeopardize the subject's ability to remain in the study
Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery

Investigators propose this multi-center randomised controlled study to test the preventive effect of intravenouse acetaminophen in delirium over 5 postoperative days among older patients recovering from major non-cardiac surgery.

Delirium is a common complication in elderly patients after major surgeries and can lead to poor outcomes such as neurocognitive decline. Acetaminophen is a widely used adjuvant for perioperative multimodal analgesia. It can effectively alleviate postoperative pain, promote opioid-sparing and exert anti-neuroinflammatory response, showing strong potential for preventing postoperative delirium. There is evidence that intravenous acetaminophen reduces delirium in older patients following cardiac surgery, but its effectiveness is inconclusive among non-cardiac surgical patients. Investigators propose this multi-center, randomized, placebo-controlled, parallel-group trial in patients aged \>65 years old scheduled for non-cardiac major surgery with general anesthesia expected to last at least 2 h. A total of 1930 elderly patients will be enrolled and randomized at 1:1 ratio to acetaminophen or saline placebo groups, stratified by age, education level, and trial site with random-sized blocking. Acetaminophen or saline will be given when the surgical suture begin at the end of surgery and thereafter a total of 7 doses within 48h after surgery. The primary outcome will be the incidence of delirium, assessed twice daily, through the five postoperative days. Secondary outcomes will include pain scores with movement, opioid use within the first 48 postoperative hours, severity of delirium, ICU and hospital lengths of stay.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years.
2. Scheduled for non-cardiac major surgery with general anesthesia that is expected to last more than 2h.
3. ASA Physical Status I-III.
4. Weight \>50 kg.
5. Written informed consent.

Exclusion Criteria:

1. Pre-existing neuropsychiatric diseases (Alzheimer's disease, Schizophrenia, Parkinson's Disease, Seizures, etc.).
2. Pre-existing cognitive impairment (MMSE\<18).
3. Preoperative delirium.
4. Severe circulatory instability (preoperative left ventricular ejection fraction less than 30%, unstable angina, severe coronary artery disease, sick sinus syndrome, etc.).
5. Contraindication to the acetaminophen use, including serum creatinine \> 177µmol/L or aminotransferses \> 3 times the upper limit of normal.
6. Alcohol or drug abuse within a year before surgery.
7. Inability to communicate because of severe visual/auditory dysfunction or language barrier.
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes

Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

* Important cartilage injury in the knee

Exclusion Criteria:

* Important axis deviation
* Inflammatory joint disorder
* Severe obesity
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

This is a randomized, double blind, placebo controlled study of the effect of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic nocturnal enuresis (MNE).

Objectives:

Nighttime urinary incontinence (enuresis) is seen by 5-10% of children from six to fifteen years. Enuresis is a socially and psychologically stressful condition that can lead to bullying and low self esteem. Today the condition is treated with desmopressin or bells, that awake children at nighttime urination. One third of children suffering from enuresis are refractory to first line of treatment. Transcutaneous Electric Nerve Stimulation (TENS) has been documented efficacious on symptoms in children with daytime incontinence. Little is known regarding the effect of TENS on monosymptomatic nocturnal enuresis (MNE). The aim of our study is to investigate the effect of TENS on children diagnosed with MNE.

Methods:

This is a randomized, double blind, placebo controlled study of the effect of TENS in fifty-two children with MNE. The study period is from September 2015 to September 2016. The children recruited will receive TENS one hour during daytime and one hour during sleep for a total treatment period of ten weeks. The surface electrodes will be placed on the skin over s2-s3. TENS is safe and not associated with adverse effects.

Expected results:

The investigators hypothesize a reduction in number of wet nights in the enuretic children receiving active TENS. If TENS proves effective in children with enuresis it will be implemented as part of enuresis treatment in the clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Unremarkable clinical examination
* 3 or more wet nights per week
* No treatment of enuresis 1 week before the treatment starts (for bells two weeks)

Exclusion Criteria:

* Nighttime urine production on wet nights \> 130 % of "maximum voided volume" (MVV) for age
* Ongoing constipation and/or faecal incontinence that are not successfully treated
* Daytime incontinence
* Prior or ongoing treatment with TENS
* Current or previous clinical history, clinical or laboratory findings or daily treatment with drugs that can be related to diseases or conditions that are expected to change the parameters investigated, especially diseases of the kidney and urinary tract or endocrine disorder
* Neurological and/or significant anatomical abnormalities of the urinary tract
* Previous operation in the urinary tract
* Recurrent urinary tract infections
* Incomplete bladder emptying (assessed with ultrasound) which means post micturition urine volume in the bladder \> 20 ml or \> 10 % of the total urine production
Effect of Reslizumab in Chronic Rhinosinusitis

The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Willingness and ability to comply with the requirements of the study
3. Female or male patients ages 18-75 at the time of screening
4. A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
5. Elevated blood eosinophils
6. Significant findings on computed tomography (CT) scan

Exclusion Criteria:

1. Unable to sign informed consent form
2. A woman that is pregnant or nursing a child
3. Known hypersensitivity to Reslizumab
4. Active cigarette smoking in the year prior to screening
5. Known underlying immunodeficiency
6. History of alcohol or drug abuse in the year prior to screening

Other criteria may apply. Please contact the investigator for more information
A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle

This study evaluates the effectiveness of a topical product in reducing discomfort associated with menstrual cramps and back pain. Participants will apply the product during two menstrual cycles and complete study-specific questionnaires to assess the impact on symptoms and user perceptions.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18-35.
* Has had a regular menstrual cycle for the past six months and is to predict their menstrual cycle and the timing of their menstruation.
* Mild to moderate self-reported discomfort during menstruation related to pelvic cramps and back pain.
* Generally healthy and not living with any uncontrolled chronic disease.
* Has a menstrual cycle between 21 and 35 days in length.
* Willing to maintain current diet, sleep, and activity level for the duration of the study.
* Resides in the United States.

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Current use of any blood thinning medication.
* Anyone with known severe allergic reactions.
* Anyone with any allergies requiring the use of an Epi-Pen.
* Anyone with any allergies or sensitivities to any of the study product ingredients.
* Anyone who is pregnant, breastfeeding, or trying to conceive currently or at any point until the end of the study period.
* Anyone unwilling to follow the study protocol.
* Anyone taking prescription medications for acute or chronic pain.
* Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system-e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
* Anyone diagnosed with other conditions that may cause lower back, abdominal, or pelvic discomfort- e.g., fibromyalgia, Crohn's, IBS, UC, chronic constipation, frequent UTIs, bacterial vaginosis (BV), or history or kidney stones.
* Anyone who has changed their birth control in the past three months.
* Anyone who has had any surgeries or invasive treatments in the past six months or has any planned up until the end of the study period.
* Anyone with any major illness in the past three months.
* Anyone currently experiencing symptoms associated with perimenopause.
* Anyone taking part in any other clinical trials or studies during this study's duration.
* Anyone with a history of substance abuse.
* Anyone who is currently a smoker or has been in the past three months.