cyrilzakka/clinical-trials huggingface dataset:
Rutgers Pilot for PREDICT- Patient LAB Test

A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate Diagnostics)

Patients with upcoming dental appointments at the Oral Medicine clinic at Rutgers School of Dental Medicine were contacted to solicit interest in participating in a pilot study to assess feasibility of testing asymptomatic dental patients for SARS CoV 2 infection using an RNA RT-PCR assay. Interested subjects completed a previsit survey after confirming their interest electronically. Subsequently, they received kit to collect their saliva sample at home along with instructions on how to do so. They were directed to drop off their saliva samples for testing at the dental clinic and signed the consent form at that time. After confirming a negative result, the patients were subsequently triaged over the phone for any symptoms and the following day, presented for their dental visit.

On the day of their visit, they were triaged, completed their dental visit and were surveyed to get their feedback on the study procedures and their perceptions of safety.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit

Exclusion Criteria:

* Previous participation
Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

Eligibility Criteria:
Inclusion criteria:

* Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
* Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
* Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.

Exclusion criteria:

* Not received any investigational product within 30 days of enrolment into the study.
* Must not be pregnant.
* Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
* Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
* Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
* Must not have a history of peptic ulcer disease.
The Effect of Laughter Yoga on Psychological Well-Being

Brief Summary: The definition of individuals with disabilities, who are among the disadvantaged group, is defined by Law No. 5378 as "those who have difficulties in adapting to social life and meeting their daily needs due to the loss of their physical, mental, spiritual, sensory and social abilities at various degrees due to any congenital or subsequent reason; and a person who needs protection, care, rehabilitation, counseling and support services" (Law on the Disabled).

Due to the fact that the conditions and needs of physically disabled women are not well expressed, they have not benefited enough from services such as education and health and they have faced difficulties. No study has been found in the world or in our country that examines the effect of laughter yoga on physically disabled women and their relatives. In this study, it is thought that the practice of laughter yoga can increase the psychological well-being and quality of life of physically disabled women and their relatives.

Aim: This study was planned to measure the effect of laughter yoga on psychological well-being and quality of life in physically disabled women and their relatives.

Detailed Description: Method: The research was planned as a quasi-experimental study including pre-test, post-test and follow-up.

The research will be carried out by reaching physically disabled women and their relatives affiliated to Sinop Disabled Association.

Population and Sample: Disabled women living and their relatives in Sinop in the Sinop Disabled Association will form the universe of our study, and all individuals who have agreed to participate in the study and volunteered will form the sample.

How the research was conducted: Laughter yoga to be done will last eight weeks, once a week. Each session of laughter yoga is planned to be approximately 40 minutes. Personal Information Form, Psychological Well-Being Scale, SF-12 Quality of Life Scale Short Form, Psychological Well-Being Scale and SF-12 Quality of Life Scale as a post-test at the end of the laughter yoga were used for the physically disabled women and their relatives who agreed to participate in the study before starting the study. The Short Form and the Psychological Well-Being Scale and the SF-12 Quality of Life Scale Short Form will be administered again in the follow-up (one month after the application has ended).

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Being woman,
* Not being mentally handicapped
* Having a physical disability
* Being a relative caring for a woman with a physical disability.

Exclusion Criteria:

* Not being between the ages of 18-65,
* To being male,
* Being mentally handicapped
* Not having a physical disability
* Not volunteering to participate in the research.
Evaluation of Delefilcon a Contact Lenses

The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.

Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;
* Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);
* Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye.

Key Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
* History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;
* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.

Other protocol-defined inclusion/exclusion criteria may apply.
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
* Must be able to swallow oral medicines
* Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

* Known central nervous system (CNS) metastases
* Non-metastatic castration-resistant prostate cancer (CRPC) (biochemical or locoregional disease only) is excluded from trial participation
* Evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s)
* Symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease
* Known disorder affecting gastrointestinal absorption
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device

Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). The purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the NICU.

Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine NICU care practices. Particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert NICU caregivers to important changes in patient status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the NICU, while allowing some transmission of low frequency sounds, such as a mother's voice.

Eligibility Criteria:
Inclusion Criteria:

* Neonate admitted to the Neonatal Intensive Care Unit
* Age greater than 12 hours and less than 2 weeks
* Informed consent from the parent(s)

Exclusion Criteria:

* Significant cranial trauma noted on admission
* Congenital anomalies of the head and/or neck
* Hemodynamic instability requiring pharmacologic intervention
* Recommendation by the attending neonatologist not to enroll the patient
Growth Hormone in Obese Cases With Covid-19

The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

It is well known that lymphoid organs such the thymus, the spleen and peripheral blood produce growth hormone (GH) and GH receptor is expressed on different subpopulations of lymphocytes. Many in vitro and in animal studies demonstrate an important role of GH in immunoregulation. GH stimulates T and B cells proliferation and immunoglobulin synthesis, enhances the maturation of myeloid progenitor cells and is also able to modulate cytokine response.

The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

Eligibility Criteria:
Inclusion Criteria:

* Obese with BMI \> 30

Exclusion Criteria:

* History of hypersensitivity to GH
Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump

This study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed.

The purpose of this study is to determine whether exclusively pumping mothers of hospitalized infants greater than or equal to 28 weeks gestational age can come to volume, defined as a minimum of 500ml/24 hours, while using the Ameda Pearl breast pump during the first 14 days postpartum.

The Ameda Pearl has a stimulation and expression mode, as well as separate speed (30-120 cycles per minute) and suction (-30 to -250 mmHg) push-button controls that are adjustable in each mode.

Study data will include daily milk volumes, suction pressures, pumping times, ending speeds and comfort by mothers of preterm infants to determine if the pump facilitates achievement of 'coming to volume' status.

Eligibility Criteria:
Inclusion Criteria:

* Delivered an infant \>28 weeks gestational age
* Infant is unlikely to be developmentally ready to breastfeed until \>2 weeks old
* Wish to initiate lactation and express breast milk for at least two weeks, exclusively using the study pump
* Started or plan to start pumping within six hours of delivery
* Agree to double pump with study pump to express breast milk at least 8 times per 24 hours for a minimum of 15 minutes each session during the study participation period
* Read and understand the English language
* Adults, over or equal to the age of 18 are being recruited in this study so consent can be given by the participant directly. These potential participants could be included in the study if their infants were born in the third trimester, greater than or equal to 28 weeks gestational age, and were unable to breastfeed due to prematurity, developmental stage and/or physical anomalies preventing their ability to breastfeed directly at the breast.

Exclusion Criteria:

* Have had breast reduction surgery
* Have a history of low milk production
* Have any medical or physical condition that in the opinion of the investigator would prevent them from participating in the study
* Are currently breastfeeding another child
* Fail the initial Investigator Breast Tissue Assessment (Attachment #4)
* Have begun breast pumping with another breast pump to express breast milk
* Are taking any medications or supplements that are meant to alter milk supply volume
Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department

Objective: The purpose of this study is to determine if administering ketamine as an intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse drug reactions without attenuating its analgesic effects.

Study design: prospective, randomized, controlled, double-blind trial.

Objective: The purpose of this randomized, controlled, double-blind trial is to evaluate if sub-dissociated dose ketamine given as an infusion versus an intravenous (IV) push over 1 minute has fewer and/or less severe adverse drug reactions and provides equivalent analgesia for patients with moderate to severe pain in the emergency department (ED).

Study design: Prospective, randomized, controlled, double-blind trial

Participants: Research assistants will recruit patients ≥18 years old with moderate to severe pain (NRS≥5) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed based on prior data which suggests that 60% of IV push arm and 20 % of infusion arm will have adverse drug reactions. investigators assume an alpha of 0.05 and a power of 0.8, which results in 56 patients needing to be enrolled.

Intervention: After a trained research assistant obtains written informed consent, pharmacists will randomize the participants to the IV push or IV infusion arm of the study. All patients will be placed on a cardiac monitor. All patients will receive and IV push over 1 minute and a 100 mL normal saline minibag over 15 minutes.

In the IV push arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 10 mL syringe and a 100 mL normal saline minibag. The nurse will start the minibag of normal saline and then administer the IV push of ketamine over 1 minute.

In the IV infusion arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 100 mL normal saline minibag and a 10 mL syringe of normal saline. The nurse will start the minibag of normal saline and then administer the IV push over 1 minute.

Data collection: The trained research assistant will collect data on the patients' pain scores, adverse drug reactions (presence, severity, and how bothersome they are), and vital signs.

Statistical analysis: Investigators will perform descriptive statistics, compare the proportion of patients with side effects, compare the severity of the side effects scores, and compare how bothersome the side effects.

Eligibility Criteria:
Inclusion Criteria:

* Pain NRS ≥5
* Anticipated stay in ED ≥1 hour

Exclusion Criteria:

* Pregnant or breast feeding
* Vital sign abnormalities (SBP \<90, SBP \> 180, HR \< 50, HR \> 150, RR \<10, RR \> 30, weight \<45 kg, weight \> 115 kg)
* Arrhythmias
* Altered mental status (active psychosis/delirium)
* Administration of opioid pain medication in previous 1 hour
* history of acute head or ocular trauma
* presence of known intracranial mass or vascular lesion
Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain

the purpose of this trial is to investigate and compare between lumbopelvic stabilization and pilates exercises on gait cycle phases and maximum peak pressure on the foot in chronic nonspecific low back pain?

LBP is the leading cause of activity limitation, results in significant losses in productivity at work, and incurs billions of dollars in medical expenditure annually So, the aim of physical therapy treatment in the patient with chronic nonspecific low back pain is more effective in improving gait cycle phases and maximum peak pressure on the foot and help LBP patients to walk normally as much as possible, also this will improve our body of knowledge about the best modalities for treating LBP. The finding of this study may help LBP patients avoid exposure to complications due to altered gait cycle phases and maximum peak pressure on the foot. Also, it will help physiotherapists to know which treatment will be effective in improving gait cycle phases and maximum peak pressure on the foot. one hundred patients with mechanical low back pain will be allocated randomly to three groups; group A will receive pilates, group B will receive lumbopelvic stabilization exercise and group C will receive strengthening exercises for the abdominals, back, and hip muscles

Eligibility Criteria:
Inclusion Criteria:

1. Their age between 20 and 40 years
2. patients is required to have chronic nonspecific LBP (more than12 weeks), deﬁned as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line).
3. Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes

Exclusion Criteria:

1. subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour),
2. subjects with neurological involvement (radiculopathy, myelopathy),
3. subjects with previous spinal surgery
Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing elective breast surgery
2. Age 18-75 years old
3. ASA-PS grade I or II
4. Those who voluntarily participate in the research and sign the informed consent

Exclusion Criteria:

1. Cognitive impairment (MMSE \<27) before the operation
2. The patients received adjuvant chemotherapy before the operation
3. At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs
4. Known or treated patients with obstructive sleep apnea
5. Patients with other cancers
Access to Care and Prognosis in Elderly With Cancer (INCAPAC Study)

The growing incidence of cancer associated to an aging population represents an epidemiologic reality that requires questioning access to care and prognosis in elderly with cancer, for which disparities have been highlighted. However, generally speaking, studies are limited in that they overlook geriatric-specific factors. The aim of this work was to study sociodemographic, socioeconomic and clinical determinants of access to care (cancer stage, cancer treatment) and prognosis (functional decline, survival) in elderly cancer patients.

The French department of Gironde (1.5 million inhabitants) is covered by cancer registries. In addition, three cohorts were initiated in Gironde on cerebral and functional aging that enrolled subjects aged 65 years and over: the PAQUID study (1988), the 3-City study (1999), and the AMI study (2007). In these cohorts, a large amount of individual data on the participants has been collected longitudinally at different follow-up visits, conducted every two or three years.

Using cancer registries, older subjects with cancer were identified in the cohort studies. Subjects were included if they presented the following: i) aged 65 years and over from one of the three cohorts, ii) alive on January 1st 2005 (common start date for tumor recording) and resident in Gironde, and iii) with a validated cancer diagnosis recorded in one of the cancer registries from January 1st 2005 to December 31st 2014. All tumors for which data is annually sent by cancer registries to the International Agency for Research of Cancer were included: invasive malignant tumors and benign tumors of the central nervous system. As the incidence of skin tumors in older cancer patients is high, they were also included. For patients with multiple tumors, only one was considered: either the first one diagnosed if there were several tumors with a minimum of a 6 months interval between their diagnosis, or the one with the worse prognosis if there were several tumors diagnosed within 6 months.

In order to not consider information concerning patients' characteristics that was too old, subjects with a delay between the last completed cohort follow-up visit before the cancer diagnosis and the diagnosis of cancer equal or superior to 6 years were excluded.

Variables were extracted from cohorts and registries at different times: cohort inclusion, pre-diagnosis visit, cancer diagnosis or registries follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Alive on January 1st 2005 ( PAQUID or 3-City cohorts) or included in the AMI cohort study
* Cancer diagnosis recorded in one of the cancer registries in Gironde, French department
Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients

The investigators aim to determine the complications and risk factors related with peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer patients.

The purpose of this study is to determine the complications and risk factors related with peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* all adult cancer patients with central venous catheters (CVCs) or peripherally inserted central catheters (PICCs) placed at BeijingHCH.

Exclusion Criteria:

* without written informed consent