cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration

Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration


Eligibility Criteria:
Inclusion Criteria:

1. Persistent low back pain with at least 3 months of non-surgical therapy at one suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized provocative discography protocol. The required discography protocol will be provided by the sponsor. Subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration. Historical provocative discograms may be used for screening purposes, with an expiry of 12 calendar months from the date performed. If the study treatment is not performed within those 12 calendar months, a new discogram will be required.
2. Oswestry Disability Index (ODI) for low back pain of 30 or greater
3. Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline

Exclusion Criteria:

1. Persons unable to have a discogram, CT, or MRI
2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
3. Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
4. Extravasation of contrast agent during the discogram, into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity)
5. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments
A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers

This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV) RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil kinetics data will be collected for all subjects up to Day 10 of the study. Following the last study visit on Day 10, all subjects will attend two further safety follow-up visits on Day 28 and Day 56.


Eligibility Criteria:
Inclusion Criteria:

* Male aged between 18 and 65 years inclusive
* Healthy as determined by screening assessments
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Non-smoker
* Must agree to use a barrier method of contraception supplemented with spermicide during the treatment period and for at least 150 days after the last dose of study drug

Exclusion Criteria:

* Participation in a clinical study with an investigational drug within 3 months or at least 5 half-lives (whichever is longer) prior to dosing
* Current or past history of smoking within 6 months
* Previous exposure to therapeutic monoclonal antibodies in the past 6 months prior to screening
* Current or clinically significant history of any condition that, in the opinion of the investigator, would: place the subject at undue risk; invalidate the giving of informed consent; interfere with PK or PD data; or interfere with the ability of the subject to complete the study
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Any recurrent infections; infection requiring antibiotic treatment in the 6 weeks prior to dosing; mononucleosis in the 6 months prior to dosing; known HIV, Hepatitis B, or Hepatitis C; or active infection at the time of screening
* Active tuberculosis (TB) requiring treatment within the previous 3 years.
* Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
* Primary or secondary immunodeficiency
* Autoimmune disease
* Use or dependence on substance of abuse
* Alcohol abuse or average weekly intake greater than 2 units per day
* Screening or baseline resting heart rate \< 45 or \>90 beats per minute
* Major surgery within 8 weeks prior to screening
* Major illness in the 3 months prior to dosing
* Biliary obstruction
* Current or past history of diverticulitis
Indoor Temperature and Sleep Apnea

The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea

Exclusion Criteria:

* Central sleep apnea
Efficacy of Esomeprazole in Patients With Frequent Heartburn

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant ,non-lactating females 18 years or older
* Experience heartburn at least 2 days a week
* Having heartburn that has responded to heartburn medication
* Must discontinue any current heartburn medications

Exclusion Criteria:

* Having a history of erosive esophagitis verified by endoscopy
* Having a history of GERD which was diagnosed by a physician
* Inability to take study medication or complete the study and all study procedures
* Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.

E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.

This is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC.

Subjects were randomly assigned to receive either E.coli Nissle 1917 (Mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared.

Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-ASA (Mayo score 3-9)
* Patient who signed the consent form

Exclusion Criteria:

* The extent of ulcerative colitis is limited to proctitis
* History of bowel resection
* History of using other medication than 5-ASA such as immunomodulators, steroid or biologics within 3months
* history of using antibiotics or probiotics within 2 weeks
* Pregnant or lactating woman
* Requiring hospitalization and imminent need for surgery
Blind Measurement in Fetal Weight Estimation

Woman who are expected to give birth in the next 72 hours will be allocated randomly to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. Accuracy of estimations will be compared between the groups.

Estimating fetal weight using ultrasound is an essential component in fetal medicine and prenatal treatment.

A study that was conducted as a part of the INTERGROWTH-21 project established international standards for fetal growth by documenting 3 measurements of biometry indices, which included head circumference, abdominal circumference, femur length and biparietal diameter (BPD). The measurements were not disclosed to the investigator in order to prevent bias.

In a recent study it was found that use of the average of the 3 biometric measurements compared with a single measurement for the purposes of estimating fetal weight, is more accurate. However, the measurements were disclosed to the investigator.

Currently, no studies have examined whether there blinded measurements are significantly better than non-blinded measurements.

The aim of this study is to compare blinded to non-blinded biometric measurements for estimation of fetal weight.

Woman who are expected to give birth in the next 72 hours will be asked to participate in the study. After singing an informed consent, participants will be randomly allocated to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. Estimation of fetal weight will be performed using the Hadlock-4 formula in triplicate measurements. In the study group the measurement will be blinded from the sonographer and measurements will be revealed only upon completion of all measurements. In the control group, the same measurements will be conducted without blinding of the measurements during the assessment. Accuracy of estimations will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age between 37 and 41 weeks
* Expected delivery within 72 hours

Exclusion Criteria:

* Major Malformations
* Active labor
Effect of Local Anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) Cream and Reduction in Dose, Pain and Intravenous Analgesic During Permanent Pacemaker Implantation

The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing pacemaker implantation

Exclusion Criteria:

* Dementia Patients
* Psychiatric Patients
* Unconscious Patients
* Patients with sensitivity to EMLA
Restoring Neural Oscillatory Communication in Developmental Dyslexia

Developmental dyslexia (DD) is a multifactorial disorder that hampers the education of about 10% of individuals across cultures and is associated to both phonological and visual deficits. The latter have been linked to a deficit in the magnocellular-dorsal (M-D) visual stream, that has a critical role in guiding the activity of ventral visual stream areas where letters identity is extracted. Here, we will test the efficacy of transcranial alternate current stimulation (tACS) of the M-D stream combined with reading trainings in adult participants with DD, assessing the neurophysiological underpinnings of these new trainings with EEG and fMRI/DTI.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age between 18 and 35)
* Official Diagnosis of Developmental Dyslexia (DD)
* Normal or corrected-to-normal vision and hearing
* Normal motor skills

Exclusion Criteria:

* Participants that cannot sign the consent form
* Participants unable to read or understand and correctly complete the procedures foreseen by the study
* Participants with a diagnosis or personal history of epilepsy or patients with a positive family history of epilepsy
* Pregnant or breastfeeding patients
* Participants with major psychiatric or neurological disorders and/or currently in psychopharmacological treatments.
* Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants.
* Participants with claustrophobia (only for fMRI)
CBT for Insomnia in Primary Brain Tumor Patients

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology, as well as the preliminary potential benefits of this intervention on brain tumor patients' sleep, fatigue, mood, quality of life, and chronic inflammation. This may lead to improvements in treating insomnia in primary brain tumor patients.

The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things:

* Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, lasting 90 minutes each. Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention.
* Complete \~20-minute online surveys before the program, immediately after the program (6 weeks), and at follow-up (3 months). Questions will ask about subjective sleep, fatigue, mood, and quality of life. The follow-up time point will also ask about the patient's satisfaction with the CBT-I program.
* Complete a brief (15 minute) cognitive evaluation before and immediately following the program.
* Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention.
* Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw. THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years old
* Confirmed primary brain tumor diagnosis
* \>/= 1 month removed from radiation therapy (if applicable)
* Able to readily read and understand English
* Meeting DSM-V diagnostic criteria for insomnia as measured by the Structured Clinical Interview for DSM-5
* Sleep Disorders (SCISD) insomnia subsection
* Cognitively intact as measured by a score \>20 on the Telephone Interview for Cognitive Status (TICS)
* Have a stable internet connection and video-capable device for Zoom sessions

Exclusion Criteria:

* Inability to attend weekly group in-person meetings
* Patients must also meet the inclusion criteria listed above.
Treatment of Late-life Anxiety in Primary Care Settings

The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years
* a DSM-IV diagnosis of GAD
* able to read English.

Exclusion Criteria:

* current psychotherapy
* a DSM-IV diagnosis of alcohol or substance abuse
* a diagnosis of dementia or global cognitive impairment operationalized as a score of \< 24 of the Mini-Mental Status Examination
* psychotic symptoms
* active suicidal ideation
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases

This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

OBJECTIVES:

I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional setting with central quality control for children and young adults with metastatic tumors in the lungs.

II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation by comparing treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this study.

III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT at a minimum period of six months after IMRT.

OUTLINE:

Patients undergo cardiac-sparing whole lung IMRT.

After completion of study treatment, patients are followed up for 1-5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients may have a Wilms tumor, Ewing Sarcoma, Rhabdomyosarcoma or any other metastatic pediatric malignancy; patients may have a single or multiple pulmonary metastases at the time of diagnosis or at the time of recurrence; a pulmonary metastasis may be defined as one pulmonary nodule \>= 1 cm or more than one pulmonary nodules \>= 0.5 cm; a biopsy of the nodules may be considered in case of doubt
* The Karnofsky performance status must be \>= 50 for patients \> 16 years of age and the Lansky performance status must be \>= 50 for patients =\< 16 years of age
* Patients must not have received prior radiation therapy to any part of the thorax
* Adequate cardiac function defined as:
* Shortening fraction of \>= 27% by echocardiogram, or
* Ejection fraction of \>= 50% by radionuclide angiogram

  * Female patients of childbearing age must have a negative pregnancy test
  * Female patients who are lactating must agree to stop breast-feeding
  * Sexually active patients of childbearing potential must agree to use effective contraception

Exclusion Criteria:

* Patients enrolled on Children's Oncology Group protocols cannot be treated with whole lung IMRT on this study
* Patients who have a prior history of radiation therapy to the thorax or adjacent regions cannot be entered on this protocol
* Patient with Hodgkin's Lymphoma are not eligible for this study
* Patients with mediastinal masses or other pulmonary masses requiring additional mediastinal or lung irradiation beyond the whole lung irradiation (WLI) doses stated in this protocol are ineligible for this study
* Patients who may require concurrent or sequential irradiation to sites beyond the chest such as the neck, flank, abdomen or liver are eligible for this study
A Family-Based Alcohol Preventive Intervention for Latino Emerging Adults

The purpose of the proposed study was to develop a family-based drinking prevention intervention for Latino emerging adults (EAs) and Latino parents of EAs. Although drinking rates for Latinos are lower than those for Whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for Latinos, especially those 18-23 years old. The investigators developed a brief (4 session) intervention for each of EAs and parents focused on identity development and parent support for EAs, respectively.

The purpose of the proposed study was to develop a family-based drinking prevention intervention for Latino emerging adults (EAs) and Latino parents of EAs. The investigators specifically targeted EAs aged 18-23. Although drinking rates for Latinos are lower than those for Whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for Latinos, especially those 18-23 years old.

The intervention program included four sessions with emerging adults (EA) in a group setting, and four sessions with groups of parents of EAs. This dual-site project was developed in Oregon and Florida in three phases: (1) development of the intervention components; (2) initial pilot testing and focus group feedback (including modifying the intervention and revising the manuals); and (3) a randomized pilot study. The EA component was developed by integrating identity-based intervention strategies that have been used successfully with adolescents and EAs, ensuring that they are developmentally and culturally appropriate. The parenting component was developed by adapting efficacious parenting strategies used with adolescents so that the activities were developmentally and culturally appropriate for parents of EAs. As the pilot study launch coincided with the start of the COVID-19 pandemic, the investigators adapted the original in-person approaches for online delivery.

Eligibility Criteria:
Inclusion criteria:

Emerging adult criteria:

* Between the ages of 18 and 23 years old upon recruitment
* Identify as Latina/o, Hispanic, Chicana/o, or have been born or descended from a parent or grandparent from Mexico or another nation in Central or South America or the Spanish-speaking Caribbean
* Intend to remain in the area for the four months following their recruitment into the study in order to participate in the intervention, if selected

Parent criteria:

* Have a child between the ages of 18 and 23 years old
* Identify as Latina/o, Hispanic, Chicana/o, or have been born or descended from a parent from Mexico, or a nation in Central or South America or the Spanish-speaking Caribbean
* Speak and understand Spanish

Exclusion Criteria:

Emerging adult criteria:

• EAs are not themselves a parent or stepparent
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy

OBJECTIVES:

I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences.

II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam.

III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

PROTOCOL OUTLINE:

This is a randomized, double blind study.

Patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. Sedative doses may be reduced if necessary. Treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced.

Patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.

Eligibility Criteria:
* Patients admitted to the Rainbow Babies and Children's Hospital Pediatric Intensive Care Unit who require mechanical ventilation and sedation therapy
* Mean COMFORT score must be greater than 26 after 3 consecutive scores are obtained at 2 minute intervals over 6 minutes
* No other concurrent sedative therapy
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides

The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

1. Serum triglycerides
2. Serum lipids and lipoproteins
3. Safety and tolerability

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with high triglyceride levels
* Male or female subjects between age 18 and 65 years, inclusive

Exclusion Criteria:

* History of drug abuse
* Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life
* Blood donation of more than 500ml blood in the previous 3 months
* Any confirmed significant allergic reaction against any drug or multiple allergies
Family Planning Ahead

Family Planning Ahead is a study that aims to improve decision-making about postpartum contraception. Family Planning Ahead will test two different strategies: a patient decision aid and a patient information leaflet.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
* Between 28 and 38 weeks' gestation at the time of enrollment
* Estimated due date in March, April, May, or June 2018
* 15 years or older
* Can read and write English
* Live in the United States
* Share a valid email address for study purposes

Exclusion Criteria

* Not currently pregnant
* Less than 28 weeks' or more than 38 weeks' gestation at the time of enrollment
* Estimated due date earlier than March 2018 or later than June 2018
* Under 15 years
* Can not read and write English
* Do not live in the United States
* Do not share a valid email address for study purposes