cyrilzakka/clinical-trials huggingface dataset:
A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body

The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health, as determined by the Investigator
* Subject consumes an average of no more than 2 alcoholic drinks per day within the 6 months before administration of study drug
* Subject has serum calcium and parathyroid hormone (intact) within the limits of the normal range of the laboratory

Exclusion Criteria:

* Subject has a disease or condition (medical or surgical) which, in the opinion of the Investigator, may compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous systems; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND-L02-s0201 solution, or that may place the subject at increased risk
* Subject has a history of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma
* Subject has abnormal laboratory values considered to be clinically significant by the Investigator

Other protocol inclusion/exclusion criteria may apply
Determining the Mechanisms of Loss of CAR T Cell Persistence

A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.


Eligibility Criteria:
Inclusion Criteria:

1. Children and young adults (age 25 years or younger) with relapsed/refractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)
2. Written informed consent

Exclusion Criteria:

1. Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
2. Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients

The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Diagnosed as hypoactive delirium
* Informed consent given

Exclusion Criteria:

* Pregnancy
* Epilepsy
* M. Parkinson
* Lewy-body dementia
* Prolonged QT-time
* Known allergy to the medicinals used
* Renal replacement therapy
* Hepatic encephalopathy
* Hyperthyroid
* Glaucoma
* Previous suicide attempts
* Syndrome of Gilles de la Tourette
* Patients which cannot receive the medication oral or through a nasogastric tube
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.

This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin

Exclusion Criteria:

* Plasma creatine kinase levels \> 3 times the upper normal limit
* Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) \> 2 times the upper normal limit
* Pregnancy or breastfeeding (a contraindication for statin use)
* Severe renal impairment, defined as glomerular filtration rate (GFR) \< 30 ml/min/1.73 m2
* Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3
* Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke
* Chest or abdominal surgery within the past six weeks
* Severe persistent pain related to other causes
* Unable to complete self-administered questionnaires, or unable to read or converse in English
Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used.

Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in the United States of America.

Eligibility Criteria:
Inclusion Criteria:

Subjects may be included in this study if they meet the following criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.

Exclusion Criteria:

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are scheduled for a CT cardiac calcium scoring test;
6. Who are in need of urgent or emergent care;
7. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
8. Who are unwilling to have GEHC personnel present for the CT exam.
Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting

The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This proof-of-concept study and pilot randomized clinical trial seeks to implement and evaluate a novel internet-based 5-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.

The study features piloting of a randomized trial to determine whether an internet-based positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the internet-based PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.

Eligibility Criteria:
Inclusion Criteria:

* Hispanics/Latinos recruited from UI Health Pilsen Family Health Center Lower West
* Aged ≥18
* Fluent in English or Spanish with ≥8th grade education
* Elevated sitting blood pressure (≥140/90)
* Ability to read and understand the informed consent
* Ability to access internet from home or in public setting (note, tablet PCs will be made available to all enrolled participants at no charge), and
* Self-reported comfort in with handling of a table computer and website navigation.

Exclusion Criteria:

* Cognitive impairment denoting dementia (assessed using the Short Portable Status Questionnaire-See Appendix E)
* Severely reduced life expectancy (e.g., self-reported diagnosis of metastatic cancer, congestive heart failure, or end-stage kidney disease)
* Self-reported diagnosis of sickle cell disease
* Skin damage or rash in the upper arm region where ambulatory blood pressure monitor is to be placed
* Currently enrolled in psychotherapy, and
* Self-reported history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse; or have severe depression.
Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly

Despite prophylactic measures, hypotension remains a common side-effect of spinal anesthesia. Electroacupuncture influences hemodynamics. We hypothesized that transcutaneous electrical acupuncture point stimulation (TEAS) at traditionally used acupuncture points would reduce the severity of hypotension after spinal anesthesia in geriatric patients undergoing hernia surgery.

After obtaining written informed patient consent, 60 geriatric patients undergoing hernia surgery under spinal anesthesia were randomized into two groups. In the placebo TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. The acupoint group will receive TEAS at the PC-5, PC-6, and ST-36 points bilaterally before the spinal anesthesia. The spinal anesthesia will be performed using 12.5 mg 0.5% bupivacaine was from the L3-4 or L4-5 interval with a 25G Quincke spinal needle. Hemodynamic data will be followed every five minutes.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair

Exclusion Criteria:

* Patients with neurological or psychological diseases
* Patients who have been treated with TEAS or acupuncture before,
* Patients with heart failure and pace-maker
* Those who have a local infection in the TEAS area.
Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy

In an open-label feasibility study, fifteen will be recruited to participate in the study from among those who have already chosen of their own accord to undergo ECT (standard of care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients will receive computer-assisted cognitive behavior therapy (CCBT).


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* meet DSM-5 criteria for depressive episodes
* able to use a computer

Exclusion Criteria:

* diagnosis of an axis II (personality disorder)
* active suicidal thoughts with a plan
* current substance use disorder
* non-affective psychosis
* prior treatment with ECT in the past 6 months
* CBT treatment in the past 12 months
* dementia
* delirium or another other neurological or mental disease that might affect cognition or the ability to meaningfully participate in computerized CBT
Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Radiologically confirmed advanced gastric cancer
* One previous line of chemotherapy
* Progressive disease
* One measurable lesion
* Blood tests within protocol ranges
* (WHO) Performance Status ≤ 1
* Able to sign informed consent

Exclusion Criteria:

* No symptomatic brain metastases
* No coumarin type anticoagulants
* No liver or kidney disease
* No impaired heart function
* No pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply
Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)

To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year \[52 weeks\]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal polyuria in men in daily clinical practice, and to confirm the compliance with proper use of this drug in clinical practice and to investigate the effectiveness of risk minimization activities.


Eligibility Criteria:
Inclusion Criteria:

* Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.

Exclusion Criteria:

* No exclusion criteria defined for this study.
Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI\<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal laryngeal mask airway and Group F with flexible laryngeal airway mask, respectively). After induction, selecting a appropriate size of LMA to patient,s weight, using the standard index finger-guided technique inserting the LMA, and then the patients were ventilated mechanically. The success rate of inserting laryngeal mask, the intubation time, surgery time and wake time were also recorded. Tidal volume and leakage pressure in patients with supine and lateral positioning were assessed respectively. The scale of fiberoptic bronchoscopy was also recorded to show airway exposure. Related complications such as sore throat, hoarseness, cough, laryngospasm, bloating, nausea and vomiting, soft tissue injury, blood residue after pulling out the LMA were analyzed.Postoperative voice and laryngopharyngeal symptom are also recorded.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of otitis media.

Exclusion Criteria:

Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.
Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting

The overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.

Human subjects will be enrolled into the study from NYU Langone Health and Bellevue Hospital Center. When orthopaedic surgery is consulted for management of a fracture, the patient will be offered enrollment into the study. The collected data will be assigned a letter and number associated for references with the patient's age, type of fracture, and time since original injury to thermal imaging scan. If any patient receives a thermal imaging scan at their initial injury evaluation, then he or she will also receive thermal imaging scans at all follow-up appointments to track changes in temperature over the healing process. No obtunded or unresponsive patients will be enrolled into the study. The goal will be to have to thirty patients enrolled into both acute fracture and non-union arms of the proposal for a total of sixty subjects. Age, gender, ethnicity, smoking status, medical history, and surgical history will be recorded for future confounding analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 to 95
* Have fracture injury

Exclusion Criteria:

* Subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness
* Those with a concomitant fracture
* Subjects with no specific medical history or surgical history
* Subjects who cannot provide informed consent
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* operable cataracts in at least one eye

Exclusion Criteria:

* Endothelial Cell Count (ECC) ≤1500cells/mm2
* Intraocular Pressure (IOP) \> 21mm Hg
* previous ocular inflammation
* systemic or ocular conditions affecting corneal endothelium
PROTECT-TIMI 30 Trial

The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.

Platelet inhibitor drugs

Eligibility Criteria:
Inclusion Criteria:

* Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:

  * diabetes
  * elevated cardiac proteins in the blood (indicating acute coronary syndrome)
* Be willing and able to give informed consent

Exclusion Criteria:

* uncontrolled hypertension
* cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
* prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
* any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read
Ultrasonic Wound Debridement vs. Standard Sharp Debridement

A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.


Eligibility Criteria:
Inclusion Criteria:

* Chronic wound needing debridement \>3 cm2
* Ulcer history \>4mo
* Adequate arterial blood flow (ABI\>0.7)
* Venous, Inflammatory, Pressure, Diabetic

Exclusion Criteria:

* Bleeding disorder
* ABI\<0.7
* Uncontrolled diabetes
* Taking systemic corticosteroids
* Chemotherapy
* Participating in another study
* Treatment with Apligraft, Dermagraft, or Regranex within 90 days
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair

Arthroscopic rotator cuff repair is described as being a successful procedure. These results are often derived from clinical general shoulder examinations, which are then classified as 'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications vary and sometimes modified scores are used.

Arthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease specific health-related quality of life patient-administered questionnaires are needed. The WORC is a quality of life questionnaire designed for patients with disorders of the rotator cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair specifically.

The aim of this study is to investigate reliability, validity and responsiveness of WORC in patients undergoing arthroscopic rotator cuff repair.

An approved translation of the WORC into Dutch is used. In this prospective study three groups of patients are used: 1.Arthroscopic rotator cuff repair; 2.Disorders of the rotator cuff without rupture; 3.Shoulder instability.

The WORC, SF-36 and the Constant Score are obtained twice before therapy is started to measure reliability and validity. Responsiveness is tested by obtaining the same tests after therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* written informed consent
* diagnosis for group 1, 2 or 3

Exclusion Criteria:

* lack of understanding the Dutch language
* not able to complete questionnaires independently
* additional shoulder pathology like adhesive capsulitis, AC-pathology and osteoarthritis
* previous shoulder surgery
The Effect of Heating on Thermal Comfort and Anxiety

This study with a randomized, pretest - posttest controlled experimental design was conducted to determine the effects of active and passive heating methods applied in different parts of the perioperative process on thermal comfort, anxiety and vital signs. The study was conducted with the patients who were hospitalized for open abdominal surgical interventions in the Department of Obstetrics and Gynecology, of Selcuk University Medical Faculty Hospital, between the dates of 1 October 2018 and 10 January 2019. The study included 99 patients in two control groups and one experimental group. The patients in group A were dressed with hot air blowing patients scrubs in both preoperative and postoperative periods, while patients in group B were dressed with hot air blowing patients scrubs only in the postoperative period. The control group continued routine practice. In the preoperative period, vital signs, thermal comfort, and anxiety levels of the patients were evaluated. In the intraoperative period, vital signs and thermal comfort levels of the patients were evaluated. Thermal comfort level of the patients was re-evaluated prior to the induction of anesthesia. Once the patients were transferred to the post-anesthesia care unit, among the vital signs of the patients, body temperature was measured in the temporal region, and other signs were measured using the monitors. Thermal comfort and anxiety levels of the patients were re-evaluated after they got dressed.

"Perioperative hypothermia," which is defined as a decrease below 36 °C in the body temperature 1 h prior to anesthesia and up to 24 h following anesthesia is a common problem in patients undergoing surgery. Perioperative hypothermia leads to many problems.

Given the negative effects of increased anxiety and deterioration in thermal comfort due to perioperative hypothermia (such as decreased satisfaction and increased pain) hypothermia poses a problem that should be highlighted and prevented. It is also important for nurses to understand hypothermia and the complications associated with it and take effective measures. In the present randomized controlled trials, gowns blowing warm air; heated blankets, fabrics, and liquid; and self-heating blankets were used for increasing thermal comfort. No common heating technique or heating area was used in these studies In this context, the primary purpose of the present study was to determine the effects of active (gown blowing warm air) and passive (heated blanket) heating on thermal comfort and anxiety in preoperative and postoperative periods in patients scheduled for open abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Being scheduled for open abdominal surgery
* Being an inpatient in the obstetrics and gynecology ward
* 2-4 h surgery duration
* 1 and 2 ASA scores
* Being able to speak Turkish
* Being 18-65 years of age

Exclusion Criteria:

* Mental retardation and psychiatric disorder,
* The presence of severe lesions or wounds on the skin
* Being an alcohol and drug addict