cyrilzakka/clinical-trials huggingface dataset:
The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old

Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks.

Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score
* female and male, BMI ≥ 30 to 39.9 kg/m2
* age between 18 and 40 years
* stable weight for 3 months before the beginning of the study
* sedentary lifestyle

Exclusion Criteria:

* previous weight loss surgery
* pregnancy or intent to become pregnant
* breastfeeding
* chronic diseases
* drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
* diabetic type 1 and 2 individuals
* anyone physically active to reduce the influence of confounding covariates
Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment

Medication overuse headache is the chronicity of headaches, which occurs more than 15 days a month, as a result of frequent use of painkillers, opioids or migraine attack drugs (ergotamine, triptan) in individuals with pre-existing primary headache disease.

In the treatment of this headache, two ways can be followed as slow drug discontinuation or sudden drug discontinuation. The most commonly used method is the sudden discontinuation of the overused analgesic agent, the initiation of prophylactic treatment, and then the application of bridge therapy for 6-10 days. Intravenous hydration, steroids, antiemetics, neuroleptic drugs and local anesthetic drugs such as lidocaine can be used in bridge treatment.

In our clinic, we routinely apply intravenous 1.5 mg/kg lidocaine, intravenous prednisolone and intravenous saline treatments as bridge treatment to patients diagnosed with medication overuse headache. In this study, we aimed to compare the efficacy of intravenous lidocaine, intravenous steroids and intravenous hydration therapy, which were used as bridge therapy after the cessation of analgesic use in patients with medication overuse headache.

Patients who applied to the algology outpatient clinic and who were diagnosed with drug overuse headache and treated were evaluated by dividing them into 3 different groups. It was planned to include 15 patients in each group. The first group consists of patients who were given 500 cc of intravenous saline for 1 hour in the service. The second group consisted of patients who were given 80 mg intravenous prednisolone for the first 4 days and then gradually reduced doses of prednisolone in the following days. The third group includes patients in whom 2 mg/kg intravenous lidocaine was administered as a 1-hour infusion, monitored in the ward.

Pain intensity will be evaluated by visual analog scale (VAS) in all patients after treatment, at 1 month and 3 months. In addition, the number of days with pain and the number of analgesics used in the 3-month period after the end of the treatment will be evaluated and the Quality of Life Scale will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Medication overuse headache
* Chronic migraine

Exclusion Criteria:

* Other headaches will not accompany (tension-type headache, cluster...)
* Pregnancy
* Epilepsia
* Heart disease
* Bradikardia
* Hypertension
* Diabetes mellitus
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD

The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.

Although often considered to be a disease of adults, complications of autosomal dominant polycystic kidney disease (ADPKD) begin in childhood. While ADPKD causes the continued growth of multiple kidney cysts that ultimately result in loss of kidney function, the leading cause of death among patients with ADPKD is cardiovascular disease. Treatment options to prevent cardiovascular disease in adults with ADPKD are limited, thus childhood may be an important time to reduce risk. Curcumin is a safe, naturally occurring substance found in the Indian spice tumeric, which is in curry powder. The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with ADPKD. The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* ADPKD diagnosis
* Normal renal function (estimated glomerular filtration rate \>80 mL/min/1.73m\^2)
* Ability to provide informed consent

Exclusion Criteria:

* Currently taking a curcumin supplement
* Current smoking or history of smoking in the past 12 months
* Marijuana use within 2 weeks prior to FMDBA and aPWV testing
* Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and aPWV testing and for the duration of the study
* Alcohol dependence and abuse
* History of hospitalization within the last 3 months
* Active infection or antibiotic therapy
* Pregnancy, lactation, or unwillingness to use adequate birth control
* Body-mass index \>95th percentile in ages 6-17 or \>40 kg/m2 in ages 18-25
* Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study

This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the breast (seeTNM staging Appendix I) that is ER and/or PR positive as determined in local laboratories at each investigator site (central verification of ER status will be performed after the patient starts treatment
* A tissue block from either the metastatic or primary tumor site is required.
* WHO performance status (PS) 0-2
* Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as:
* natural menopause with last menses \> 1 year ago,
* radiation induced oophorectomy with last menses \> 1 year ago,
* chemotherapy induced menopause with 1 year interval since last menses, or
* serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution.
* bilateral oophorectomy

Exclusion Criteria:

* Patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
* Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
* Treatment with LH-RH analog.
* Laboratory values as follow Bilirubin \>1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) \>2.5 times the ULN if no demonstrable liver metastases, or \>5 times the ULN in the presence of liver metastases
* Bone marrow function: WBC \<1500 mm3
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Requirement for a primary unilateral bunionectomy
2. Has an American Society of Anesthesiologists Physical Status of I, II, or III.
3. Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block
4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block
5. Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.

Key Exclusion Criteria:

1. Previously dosed with this formulation of MR-107A-02.
2. Subjects with a contralateral foot bunionectomy in the past 6 months.
3. Subject has a concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the bunionectomy, and which may confound the postoperative assessments.
4. Known hypersensitivity to aspirin, NSAIDs or other medication used in the study.
5. Body mass index (BMI) \>40 kg/m2 at screening.
6. Body weight of \<43 kg at screening.
7. History of GI bleeding or peptic ulcer disease.
8. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
9. A history of bleeding disorders that may affect coagulation.
10. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.
Metabolic Diet for Relapse Prevention in Anorexia Nervosa

This is an interventional study that will test the safety, tolerability, and efficacy of the Metabolic Diet, which was designed as a treatment for women with anorexia nervosa to remain weight-stable after they have been restored from low weight. Participants will be adult women with anorexia nervosa who have been recently restored to normal weight and adult women with no history of eating disorders. After enrollment, participants will start meeting weekly with a registered dietitian to implement the Metabolic Diet in their daily lives, and will receive medical monitoring for adherence, side effects, changes in metabolic or psychological parameters, and weight stability.

The study plan to enroll a total of 20 subjects from the broader New York City area into an 8-week eating behavioral program. Of the 20, 10 will be weight-restored patients with anorexia nervosa (WR-AN) and the other 10 will be age-, sex-, and body mass index (i.e. weight) matched healthy controls (HC).

The primary study intervention is an eating behavioral program called, Metabolic Diet, which is aimed to change the proportion of macronutrients in their meals to incorporate higher fat content and lower the carbohydrate content to limit fluctuations in circulating blood glucose levels throughout the day, which may contribute to a relapse in anorexia nervosa. Participants will be guided to start the Metabolic Diet following the first 2 individual study visits, and the duration of the primary intervention is for 8 weeks. As part of the intervention, each subject will keep a food log and measure the urinary ketones at home, which they will discuss with the study providers during weekly visits. Each subject will meet individually with the Study Dietician and with the Study Physician on a weekly basis. At these visits, food logs and ketone logs will be reviewed so that subjects' adherence to the Metabolic Diet can be assessed and facilitated.

Surveys and lab work are completed during screening, week 4 and week 8.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age at least 18 and not over 40
* BMI at or above 18.5 kg/m2
* Speaks English
* Medically stable, as cleared by a licensed physician, with vital signs and initial blood draws
* History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only)
* Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only)

Exclusion Criteria:

* Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders
* Active DSM-5 substance use disorders
* On medications that could affect metabolism

  \*Subjects are to be free of any medications that could affect metabolism, as discussed with study physician, for 2 weeks prior to primary study visit for glucose function testing.
* History of suicide attempt within previous 6 months or acute suicide risk
* Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy
* Current/lifetime diagnosis of DSM-5 eating disorders (HC only)
* Active DSM-5 depressive disorders (HC only)
Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

This study was terminated on 08 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
* 18 years of age or greater
* Two methods of birth control one of which must be barrier if of childbearing potential
* Willing to discontinue pain medication except as permitted per protocol

Exclusion Criteria:

* Pregnancy or wishing to be pregnant during the course of the study, lactating women
* Body Mass Index (BMI) greater than 39
* Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
* Previous exposure to a Nerve Growth Factor (NGF) antibody
Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time

The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin and using a shorter course of therapy.

This study will be a pilot study of the efficacy of 750 mg of levofloxacin once daily for 5 days in the treatment of complicated urinary tract infection.

The specific objectives include:

1. To describe clinical and microbiological outcome at short and long term follow-up with 5 days levofloxacin in subjects with acute symptomatic complicated urinary infection, both with and without indwelling catheters.
2. To determine the tolerability of levofloxacin 750-mg once daily in patients with complicated urinary infection.
3. To describe some characteristics of the resolution of the inflammatory response with treatment of complicated urinary infection as demonstrated by changes in urine proteins.
4. To identify any emergence of resistant organisms in recurrent urinary infection following therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract.
2. Pre-therapy urine culture \> 105 cfu/ml (\> 108 cfu/L) of at least one urinary pathogen.
3. Age 18-80 years, male or female.

Exclusion Criteria:

1. Prior allergic reaction to any fluoroquinolone antimicrobial.
2. Known infection with a fluoroquinolone - resistant organism.
3. Requiring parenteral therapy because of severity of illness or unable to take oral medications.
4. Women who are pregnant or breastfeeding.
5. Requiring additional antimicrobial therapy for infections elsewhere.
The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU

Aim of the study is to determinate the frequency of acute renal failure in COVID-19 patients, its relationship with the severity of COVID-19 disease in ICU, and the ability to take precautions against these factors.


Eligibility Criteria:
Inclusion Criteria:

Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study.

Exclusion Criteria:

there is no exclusion criteria
Morning Bright Light to Improve Sleep Quality in Veterans

One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.


Eligibility Criteria:
Inclusion Criteria:

* Veterans

Exclusion Criteria:

* History of bipolar disorder
* History of macular degeneration
* Non-English speaking
* Decisionally impaired
* Currently using a light box
Human Sodium Balance Study

The overall objective of this study is to examine how dietary sodium is used by the body. In a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. This has implications for how investigators interpret studies that use urine biomarkers of sodium. Study findings about tissue sodium storage also have implications for managing hypertension and related conditions.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old;
* Diagnosed with high blood pressure or pre-hypertension (systolic blood pressure (SBP) \> 120 mm Hg or diastolic blood pressure (DBP) \> 80 mm Hg);
* Taking no more than two medications for high blood pressure;
* Currently has a primary care provider;
* Willing to eat all meals provided by the study for two 14-day feeding periods;
* Willing to complete study measurement procedures.

Exclusion Criteria:

* Diabetes;
* Smoker;
* Serious food allergies;
* Currently pregnant or planning to become pregnant
The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program

This study uses a randomized controlled design to evaluate the efficacy of a new mobile app, Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based mobile health application that can be accessed through mobile smartphones and computers. Pulse was designed to increase highly effective birth control use and reproductive and sexual health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of women with the following characteristics at study enrollment: aged 18-20, not pregnant or trying to become pregnant, has daily access to a smartphone, currently living in the United States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to enroll up to 1,300 participants over a one-year enrollment period using social media, including Facebook, Instagram, and Twitter.

Users access Pulse autonomously, on their own terms, and in their own time and place. The app consists of 6 sections and includes 3 hours of unique content. It does not require the user to follow a specific sequence of content viewed; however, all users will receive a monetary incentive after registering with the apps. Youth randomized to the intervention condition are given access to Pulse indefinitely and receive daily text messages related to sexual health for 6 weeks. Control participants are directed to a free general health/fitness web-based mobile application, also called Pulse, and receive text messages related to general health for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain different content. Participants in both the intervention and comparison groups receive a baseline survey and a 6-week follow-up survey. Participants will also receive incentives once they complete the baseline and post-intervention survey. Both surveys are conducted online via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Female
* Age Limit: 18-20
* Must have daily access to a smartphone that receives text messages and can access to the Internet
* Must speak English or Spanish
* Must live in the United States or a U.S. territory

Exclusion Criteria:

* Currently pregnant or trying to get pregnant
Interventional Sonography Guided by Image Fusion

The purpose of this study is to register the precision of image fusion between live sonography and CT, MRI or PET/CT of liver lesions and other focal lesions in the abdomen. To test whether it will be possible to biopsy guided by image fusion.


Eligibility Criteria:
Inclusion Criteria:

* Focal liver lesion seen on CT, MRI or PET/CT
To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension

To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers.
* Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
* Have a body mass index (BMI) ≥19 and ≤30

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
* Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
* Daily use of nicotine containing substances.