cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Body-worn Multimodal Hand Hygiene System. Impact on Health-Care Associated Infections

Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit environment and evaluate any impact on health care associated infections.

Deploy and utilize a novel body worn hand hygiene system that incorporates provider and group specific feedback allowing hand hygiene to occur directly within the patient environment. We hypothesize that by improving provider hand hygiene we will reduce health-care associated infection rates.

Eligibility Criteria:
Inclusion Criteria:

* All ICU patients

Exclusion Criteria:

* Patient is not in an ICU at our Institution
Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients

Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a sustained response with viral loads becoming undetectable and staying undetectable, but do not have an increase in their CD4 counts to levels greater than 500. Adding maraviroc to the treatment regimen of these patients may result in an increase in their CD4 counts. As the patient would be continuing their prior regimen, they will likely continue with full control of viral replication.

This is a prospective, open-label, non-controlled, non-randomized, single center study of the effect of adding the antiretroviral Maraviroc to the antiretroviral treatment regimen (HAART)of patients who have achieved a sustained virologic response to HAART but have had a sub-adequate immunologic response to treatment. Patients who have had a full virologic response (as defined by HIV-1 viral loads of \< 48 copies/mL) for 12 months or more are defined as having a sub-adequate immunologic response if their CD4 lymphocyte count has not gone above 500.

This pilot study will contain up to 30 patients who will be followed over a period of 12 months starting from the date of enrollment and addition of maraviroc to their current highly active antiretroviral therapy regimen. The main outcome to be followed is the CD4 lymphocyte counts at baseline and after 12 months of treatment with the addition of maraviroc.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 positive.
2. Receiving highly active antiretroviral therapy (HAART).
3. HIV-1 viral load of \< 48 copies for 12 months or more.
4. CD4 lymphocyte count that has not gone above 500. -

Exclusion Criteria:

1. Severe hepatic impairment (cirrhosis) or active Hepatitis C with liver transaminases \> 5 times normal.
2. Severe renal impairment (creatinine clearance \< 30 ml/min) or end-stage renal disease (ESRD) who are taking potent CYP3A4 inhibitors or inducers.
3. Receiving certain necessary medications that have the potential for serious drug-drug interactions with maraviroc. -
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).

This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone \<4 mIU/mL at the Month 6 study visit of the lead-in study.
* Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
* Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
* In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.

Exclusion Criteria:

* Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
* Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
* Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
* Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
* Current therapy with medroxyprogesterone acetate.
* Current therapy with growth hormone.
* Current therapy with insulin-like growth factor-1 (IGF-1).
* Current use of an estrogen preparation.
* Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
* Subject has a positive pregnancy test.
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 20.0 and 28.0 kilogram per square meters (kg/m\^2) inclusive (BMI=weight/height\^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg
* Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
* Nonsmoker (not smoked for 3 months prior to screening)
* A woman must have a negative serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test on Day -1 of each Period
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study intervention administration

Exclusion Criteria:

* Cardiac arrhythmias or other cardiac disease, hematological disease, hypertension, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, glaucoma, epilepsy or any other illness that the Investigator considers should exclude the participant
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies at screening visit
* Drinks, on average, more than 5 cups of tea/coffee/cocoa or 8 cans of cola per day
* Clinically significant acute illness within 7 days prior to each study intervention administration
* History of clinically significant drug and/or food allergies including known allergies, hypersensitivity, or intolerance to JNJ-54135419 or its excipients
Photographic Posture Analysis in Children With Cerebral Palsy

Cerebral palsy (CP), which is the largest group of patients among pediatric neuromuscular diseases, is a non-progressive permanent disorder that affects muscle control, movement, posture and balance. The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.Children with CP were included in the study according to the following criteria; aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS. Postural evaluation was done using the photographic method. Trunk control was evaluated with Trunk Control Measurement Scale,Motor performance of children was evaluated with Gross Motor Function Measure-88. ICC values for photographic posture analysis was found to be highly reliable.

Sitting position is of great importance in the development of upper extremity functions, orthogonal functional skills, personal care, cognitive, perceptual and social skills in children with cerebral palsy and these kids spend most of their time in a sitting position.There are goniometer, inclinometer, flexicurve, spinal mouse, and modified head posture spinal curvature ınstrument tools for posture analysis in the sitting position.However, none of these measurement tools have been validated for validity and reliability studies of head and trunk posture measurement in the sitting position in children with CP. Methods such as magnetic resonance (MR) and x-ray used in posture evaluation provide clear images of reference points and are the gold standard in the literature. However, they are not preferred much because they are expensive and contain radiation.Photographic posture analysis can be considered as a measurement method such as posture analysis methods using the gravity line. It is a digital, more objective measurement method that measures linear distances and angles using anatomical reference points using specially designed software. Clinical use of photographic posture analysis is recommended in the literature, as it is an accurate and objective method, preventing radiation exposure.The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5-12 years,
* Diagnosed as spastic diplegia or hemiplegia,
* Having a level of "I, II, III" according to GMFCS

Exclusion Criteria:

* Children who could not cooperate,
* Have undergone spinal surgery, had botulinum toxin (BoNT) and surgical treatment in the last 6 months
* Had another neurodevelopmental or congenital disease other than CP
Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 years old. The effects of prior infection and or prior season vaccination will be examined. Children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).

All children will have baseline blood samples drawn and will then be vaccinated with licensed and approved influenza vaccines. Following the recommendation from the Advisory Committee on Immunization Practices, children 5-8 years old will preferentially receive live attenuated influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed influenza vaccine will be excluded from the study.

The children will have their blood drawn between 2 and 4 times total over the course of two months in order to test their immune response to the vaccine. Between approximately December and April, study participants will be contacted weekly to monitor for any new respiratory illnesses with cough, and if present, nasal and throat swabs will be collected to test for influenza.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)
* Enrolled in either the immune response study or the vaccine effectiveness study conducted at the site in the 2013-14 influenza season
* If enrolled in the vaccine effectiveness study the previous season must have either been vaccinated and infected with influenza or unvaccinated and uninfected with influenza

Exclusion Criteria:

* Children with contraindications to either the quadrivalent live attenuated influenza vaccine or to the trivalent inactivated influenza vaccine will be excluded.
* Anyone unwilling or unable to complete all required study activities including informed consent
* Subjects who already received the influenza vaccine for the 2014-15 season
Personalized Immunotherapeutic for Antibiotic-resistant Infection

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure.

Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures.

SAB Biotherapeutics, Inc. (formerly Sanford Applied Biosciences, LLC) located in Sioux Falls, SD, have developed transchromosomic (Tc) cows containing human immunoglobulin (Ig) heavy (IgH) and light (IgL) chain loci in the setting of inactivated bovine IgH and Ig lambda loci. To date, SAB Biotherapeutics (SAB) has several products in development that have been tested in animal models, but to date no human trials.

Investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow, purify antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

M. A. is a highly educated person with full decision making capacity and is well aware of the uncertainties and risks associated with this treatment. This proposal is designed to offer this patient an alternative and perhaps curative approach to his disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments.

Exclusion Criteria:

* None
Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects

The aim of this study is to evaluate clinically and radio-graphically the efficiency of "Tent- Pole "grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane.

Various techniques have been described for the reconstruction of large vertical defects before implant placement . In this study we assessed the efficacy of tenting the periosteum and soft tissue matrix with titanium screws maintaining a space for the graft material in order to augment large vertical defects of mandibular ridge (anterior or posterior region) using data from 12 patients . After 6 months we assessed the increase in bone height and density.

Eligibility Criteria:
Inclusion Criteria:

* Patients with missing lower tooth or teeth and have a related large vertical bony defect .
* Patients with about 7mm residual bone hight and requiring about 5 mm increase in the vertical height of the mandibular alveolar ridge for future prosthetic rehabilitation.
* Patients with an acceptable oral hygiene and willing to improve it

Exclusion Criteria:

* Presence of infection or local lesions.
* Parafunctional habits.
* Current chemotherapy or radiotherapy.
* Heavy smokers.
* Alcohol or drug abuse.
* Medically compromised patients with diseases that affect passively the clinical procedure or result.
Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

Currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily combined. This phase I trial will evaluate the safety and tolerability of weekly topotecan in combination with pemetrexed in patients with advanced solid tumors.

Three patients will be accrued at each of 5 dose levels. Dose escalation will only proceed if none of the additional 3 patients experience DLT. The highest dose level that generates DLT in 0/3 or 1/6 patients will be the maximum tolerated dose (MTD) or the doses recommended for subsequent studies. A total of 10 patients will be treated at the MTD to further assess the toxicity of the dosing regimen and its suitability for use in subsequent trials. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered. Treatment cycles will be repeated every 21 days. The protocol is also designed to enroll an additional 10 patients at the maximum tolerated dose to increase the confidence in the safety and suitability of the doses that are chosen for subsequent studies.

* Topotecan Day 1 and 8
* Pemetrexed Day 1

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven advanced solid tumors
* Measurable or evaluable disease
* Age ≥ 18 years
* Karnofsky performance status ≥ 80% (ECOG 0 or 1)
* Adequate liver, bone marrow and kidney function

Exclusion Criteria:

* More than 3 prior chemotherapy regimens in the metastatic setting
* Prior treatment with topotecan or pemetrexed
* Clinically significant third space fluid present at the time of treatment
* Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs
* Inability to take steroid premedications or vitamin supplementation
* The presence of active brain metastases
* Prior radiotherapy within 4 weeks prior to the first day of treatment
* Prior surgery within 3 weeks prior to the first day of treatment
* Prior chemotherapy within 3 weeks prior to the first day of treatment
Intern Health Study 2022 and 2023

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.

The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility Criteria:
Inclusion Criteria:

* Medical intern during the 2022-2023 or 2023-2024 internship years
* iPhone or Android phone user
* Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year

Exclusion Criteria:

* None
Comparing the Effectiveness of Written Vs Verbal Advice for First Degree Relatives of Colorectal Cancer Patients

CRC patients were enrolled and asked about their FDR contacts These FDRs were telephoned and enrolled and randomized to receive either written advice and verbal advice about their cancer risk and screening methods. These FDRs were telephoned after 2 weeks to evaluate their knowledge about CRC risk and method of screening to see which method of giving advice was better.

1. Colorectal cancer patients in a tertiary referral hospital who had first degree relatives in the screening range were enrolled into the study.
2. CRC patients and their FDRs were randomized after enrollment into written advice and verbal advice arms
3. CRC patients were asked to give the documents or verbal advice to FDR within 2 wks.
4. A telephone check was done to see if CRC patients had given or sent the advice their FDR.
5. FDR were telephoned to see if they received the document and assessed their knowledge of FDR risk, screening methods, previous screening and other knowledge about CRC.
6. FDRs were given information over the telephone about CRC risk and screening and then asked whether they wanted to have screening or not.

Eligibility Criteria:
Inclusion Criteria:

* First degree relatives of patient with colorectal cancer

Exclusion Criteria:

* First degree relatives whom already diagnosed of colorectal cancer
* First degree relatives whom have colorectal cancer from genetic disease