cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis

To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years
* Meet 1984 modified New York criteria for AS
* The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
* NSAIDs washout period of at least 5 days prior to randomization
* DMARDs washout period of at least 4 weeks prior to randomization
* Corticosteroids washout period of at least 4 weeks prior to randomization
* Biological agents washout period of at least 3 months prior to randomization.

Exclusion Criteria:

* Peptic ulcer
* Unstable cardiac diseases
* Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits
* Abnormal renal function with creatinine more than upper normal limit
* Hematologic disorders
* Psychosis
* Malignancy
* Allergic to LX drug.
Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.


Eligibility Criteria:
Inclusion Criteria:

* The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria:

* Renal disease
* Hepatic disease
* Neuromuscular disease
* Coagulation disorder
* Cardiopulmonary disease
Fresh Food Farmacy: A Randomized Controlled Trial

This trial investigates the value created by the highly innovative Fresh Food Farmacy (FFF) program at Geisinger Health. The program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. The program also provides education on how to prepare the food, and education on healthy living including diabetes self management. The research measures the effects of the FFF program on patient health and wellbeing.

This is a pragmatic, prospective, randomized controlled trial of Geisinger's Fresh Food Farmacy (FFF) program as the program expands to new sites. Qualifying subjects will be randomized 1:1 to receive either early participation in the FFF program (treatment group) or later participation (control group).

Approximately 500 Geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. The treatment group will begin the program soon after trial recruitment: the "Begin Now" group. The control group will begin the program after 6 months: the "Begin Later" group. Approximately 2000 household members will be included in the data-only portion of the research.

Outcomes will include clinical measures, such as HbA1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from EHR and paid claims data. These will be measured for subjects and their household members.

Eligibility Criteria:
Inclusion Criteria:

* Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months
* Food insecure based on a two-question survey instrument
* Age \> 17 \& Age \<86
* Living within geographic reach of the program (Lewistown, PA and Scranton, PA)

Exclusion Criteria:

* Already enrolled in FFF in Shamokin
* Not English speaking (working on changing this as the program evolves)
* On hospice or palliative care
* Acute or chronic psychosis
* Resides in a facility which provides meals
* Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including:

  * Cancer; active treatment
  * Steroid dependent asthma/ COPD/ emphysema
  * Steroid dependent Colitis
  * Chronic Kidney Disease with GFR\< 30 mg/mmol
  * Celiac disease
  * Cirrhosis
  * Steroid dependent arthritis
Single Center Food Allergy Oral Immunotherapy Study

The Primary Objective of the study is to develop a customized regimen for oral immunotherapy that reflects what the subject is allergic in a clinically significant way (i.e., the offending food allergen is defined as a food allergen with a positive skin test or positive specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and multiple food allergy subjects are included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
* Sensitivity to food allergen will be documented by a positive skin prick test result (see Appendix for details) or allergen specific ImmunoCAP IgE level with 7 kU/L as a lower limit of eligibility.

Exclusion Criteria:

* No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
* Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
Resistance Training and Sleep in the Elderly

Purpose: The objective of this study was to evaluate the influence of a session of resistance training on the sleep patterns of elderly people.

Methods: Forty men aged 65 to 80 years, sedentary and clinically healthy were divided into two groups: the control group (n=18) and the resistance group (n=22). Both groups underwent two polysomnography tests, one at baseline and another after either a resistance training session (One Repetition Maximum - Strength Test, resistance group) or without physical exercise (control group).

Upon completion of the baseline polysomnography (PSG), volunteers underwent body composition evaluations (total body mass, height and body mass index calculation) to characterize the sample. Three familiarization sessions were conducted with the exercise machines used in the study, and one repetition maximum test (1 RM) was completed in order to quantify the training session load. A PSG test was conducted on the same day of the exercise session for the resistance group, and the control group had a second PSG without exercise to compare the groups at both times.

The body composition assessment, the adaptations to the exercises and the training sessions were held at the Center for Psychobiology and Exercise Studies.

Eligibility Criteria:
Inclusion Criteria:

* male gender
* sedentary lifestyle
* age between 65 and 80 years
* clinically good health (able to practice physical exercise)

Exclusion Criteria:

* known diseases of the cardiovascular, pulmonary, and musculoskeletal systems, diabetes
* profession in the field of physical exercise
* use of sleep medication
* disqualification based upon the clinical examination
Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis

This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion ≤80; with atopic lesions on arms, legs, trunk and neck;
* Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening;
* Males, non-fecund females, or females of child-bearing potential using 2 independent highly effective barrier methods of birth control when used correctly for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits.

Exclusion Criteria:

* Chronic pruritus due to conditions other than atopic dermatitis (AD) including the following conditions: Prurigo nodularis, Lichen simplex chronicus, Bullous pemphigoid;
* Acute superinfection of AD.
Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome

Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.

We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men.


Eligibility Criteria:
Inclusion Criteria:

* CPSS III
* symptomatic \>3 months
* NIH-CPSI total score =/\>15
* NIH-CPSI pain =/\>8

Exclusion Criteria:

* post void residual \>100mL
* urinary tract infection
* urethral stricture
* age \<18 years
Reduce Speed Limits From 90km/h to 80 km/h on French Roads: Impact on Mortality

On the first July 2018, the French government lowered the maximum authorized speeds on two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of road deaths.

The objective of the measure is to reduce the number of deaths on the roads concerned by encouraging the reduction of the average speed practiced by drivers.

The analysis deals with a comparison of the number of killed persons on the network concerned, before and after the reduction of the speed limits. The "before" period is 2015-2017. The "after" period is from July 2018 to June 2019.

The data used are extracted from the national bodily injury accident file (BAAC). The police fills this file for each road accidents occurring on a road open to public traffic and causing at least one victim (i.e., one user requiring medical care and involving at least one vehicle).

This measure was intended general and concerns a type of roads in its entirety. The rest of the road network is too heterogeneous (urban, highways ...), leading to an accidentology very far in terms of severity, users concerned and families of accidents to allow the establishment of control groups that would not be affected by a reduction in the speed limit. As a result, the principle of an assessment of "before-and-after" effects has been retained.

Eligibility Criteria:
Inclusion Criteria:

* people who circulate on French non-motorway non-urban roads during the period of the study
* any person who dies in a road accident on this network during the period of the study, who either dies instantly or within 30 days of the accident, due to the consequences of the accident

Exclusion Criteria:

* all persons involved in an accident on a private road
* all persons involved in a road accident without a motor vehicle
Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients

DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated cortisol may contribute to the development of type 2 diabetes.

To maintain the blind in Protocol DIO-502, subjects will be re-randomized at Study Visit 1 to one of three doses of DIO-902: 150, 300 or 450 mg QHS. All subjects receiving DIO-902 placebo and 50% of subjects receiving DIO-902 will be re-randomized to one of three DIO-902 doses. The remaining 50% of subjects receiving DIO-902 will be assigned to their original DIO-902 dose. The re- randomization will be performed by a group independent of study conduct to ensure the treatment status of the subject while in Protocol DIO-502 remains blinded. In addition, subjects will continue on the same dose of metformin that they had been taking during the conduct of Protocol DIO-502. Subjects will continue on atorvastatin 10 mg for the first 4 weeks of this protocol. Thereafter, at Study Visits 3 and 4, the dose of atorvastatin may be increased up to a maximum of 40 mg daily in order to achieve LDL-cholesterol/non-HDL cholesterol goals specified within the protocol. In addition, after Study Visit 4 (Week 12) subjects with HbA1c levels of \> 7.5% (0.075 Hb Fract.) will undergo a one time titration of their oral hypoglycemic regimen as per the algorithm provided in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Participated in DIO-502

Exclusion Criteria:

* Did not participate in DIO-502
Performance Study of Targeted Sequencing Technology for VAP

Main purpose: To evaluate the feasibility of tNGS for pathogen detection and drug resistance analysis in VAP patients.

Research site and research population:

This study is planned to be conducted in hospitals, targeting VAP patients. Perform clinical routine testing and tNGS testing on lower respiratory tract samples (BALF) from VAP patients, and collect patient clinical information. Clinical routine testing includes culture (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on positive culture samples as needed. Finally, compare the consistency of tNGS detection results with clinical culture, comprehensive diagnosis, and drug sensitivity results. Further validation was conducted on consistent negative or inconsistent samples through PCR and mNGS.

The investigators plan to include 150 VAP patients in the ICU. Lower respiratory tract samples (BALF) from VAP patients were routinely tested and tNGS tested, and clinical information was collected. Routine clinical tests include culture (necessary), microscopic examination, serology, PCR, etc., and drug sensitivity tests are performed on positive culture samples as required. Finally, the consistency of tNGS test results with clinical culture, comprehensive diagnosis and drug sensitivity results was compared. The uniformly negative or inconsistent samples were further verified by PCR and mNGS.

Eligibility Criteria:
Inclusion Criteria:

* (1)VAP patients (2) Patients can collect the required test information

Exclusion Criteria:

* (1) Clearly diagnosed as non-infectious patients

  (2) Insufficient samples or patients unwilling to participate

  (3) Life expectancy is less than 24 hours

  (4) Patients' clinical information cannot be obtained
Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts in Patients Who Undergo Bilateral Tubal Ligation

The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any possible links between the clinical changes and pathophysiologic mechanisms. One hundred and thirteen patients were randomly divided into two groups (neural therapy and control). Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one year after the treatment. The visual analog scale (VAS) were noted in both groups, also discomfort and gynecologic symptoms are recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo bilateral tubal ligation

Exclusion Criteria:

* Previous abdominal surgery
* Patients with diseases that could have neurologic complications (DM, SLE ...)
Psilocybin Therapy for Depression in Parkinson's Disease

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 80
* Comfortable speaking and writing in English
* Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
* Currently experiencing depressive symptoms
* Able to attend all in-person visits at UCSF as well as virtual visits
* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating

Exclusion Criteria:

* Psychotic symptoms involving loss of insight
* Significant cognitive impairment
* Regular use of medications that may have problematic interactions with psilocybin
* A health condition that makes this study unsafe or unfeasible, determined by study physicians
Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma

RATIONALE: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma.

OBJECTIVES:

Primary

* Assess whether treatment with topotecan hydrochloride, vincristine, and doxorubicin hydrochloride can achieve a satisfactory response rate in pediatric patients with stage 4 neuroblastoma that failed to respond to rapid first-line treatment.

Secondary

* Determine time to progression in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and vincristine IV continuously and doxorubicin hydrochloride IV continuously over 48 hours on days 5 and 6. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve partial response (PR) after two courses of treatment receive an additional two courses. Patients who achieve complete response or very good PR are treated according to the standard therapy in protocol SIOP-EUROPE- HR-NBL-1. Patients who fail to achieve PR after 2 courses receive further treatment at the physician's discretion.

Patients are followed periodically for at least 3 years.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage 4 neuroblastoma
* Failed to achieve adequate metastatic partial response after first-line therapy while enrolled on protocol SIOP-EUROPE-HR-NBL-1

PATIENT CHARACTERISTICS:

* Neutrophil count \> 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.36 mg/dL
* Bilirubin ≤ 2.92 mg/dL
* AST and ALT \< 2.5 times upper limit of normal
* Glomerular filtration rate ≥ 60 mL/min
* Normal cardiac function on echocardiography
* No severe organ dysfunction
* No active hepatitis C or hepatitis B virus positivity
* No HIV infection

PRIOR CONCURRENT THERAPY:

* No anti-tumor chemotherapy within the past 10 days
* No radiotherapy within the past 30 days
* No other investigational drugs within the past 30 days
* No prior doxorubicin hydrochloride
Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)

This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol

This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals:

1. Tablet/capsule administration - up to 20 healthy volunteers will be recruited to the study. The tablet/capsule will be administered as a single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
2. Gel administration - the gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female and aged 18-65 years
* BMI - 19-24
* Subject is not pregnant and is not nursing
* Signed Informed Consent Form

Exclusion Criteria:

* Current use of multivitamin or mineral complexes (washout of 4 days before Visit 2 is permitted)
* Participants with known vitamins or mineral deficiencies
* Diabetes Type II
* Smoking
* Subjects who have undergone surgery within the last 3 months.
* Subjects with a clinically significant (during last 3 months) infectious, immune-mediated or active malignant disease.
* Subjects who are receiving an elemental diet or parenteral nutrition.
* Subjects who are treated with insulin.
* Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
* Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
* Known sensitivity to any ingredients in the study product
* History of addiction or drug abuse
* Alcoholic regular use