cyrilzakka/clinical-trials huggingface dataset:
Effect of 12-week FW Programme on Sex Hormone Levels and Risk Factors for MS in Postmenopausal Women

Postmenopausal women were separated into two groups: one participating in a 12-week fitness walking programe as the fitness walking group, and the other maintaining their regular lifestyle as the control group. The study evaluated alterations in health markers and examined the correlation between metabolic syndrome risk factors and sex hormone levels before and after the intervention.

According to the inclusion and exclusion criteria, our study invlved postmenopausal women aged from 50 to 69 years old. After the selection process, baseline assessments were conducted, including evaluations of metabolic syndrome risk factors, body morphology measurements, sex hormone levels, and cardiopulmonary exercise testing. Participants were then randomly assigned to either the fitness walking group or the control group using a random number table. Participants in the fitness walking group completed a 12-week fitness walking program, while those in the control group maintained their usual lifestyle without any intervention. During the post-intervention assessment, all baseline measurements were repeated to evaluate changes in the previously measured indicators.

Eligibility Criteria:
Inclusion Criteria:

* (1) Participants were entirely voluntary and capable of completing the full 12-week intervention process.
* (2) Participants were postmenopausal women aged between 50 and 69 years.
* (3) Participants had been postmenopausal for over 12 months and had not received exogenous estrogen supplementation post-menopause.

Exclusion Criteria:

* (1) Participants had a history of acute or chronic musculoskeletal disorders, cardiovascular diseases, diabetes, or other conditions that might impact their ability to engage in the intervention.
* (2) Participants had recent hormone treatment, anti-inflammatory medication use, or other medications affecting blood indices.
* (3) Participants experienced unstable body weight (fluctuations exceeding 2.5 kg) in the past three months.
* (4) Participants were concurrently enrolled in other intervention studies or maintained regular exercise routines.
* (5) Participants had smoking or alcohol consumption habits.
Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults

This randomized controlled trial examines the effects of a transitional care clinic for high-risk patients at an academic medical center who had no trusted medical home. The trial will provide the first reliable evaluation of the Northwestern Transitional Care Clinic / Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.

It is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more likely to have a usual source of primary care 6 months after discharge.

The Northwestern Transitional Care Follow-up Clinic (NFC) was established in 2012 to improve the coordination of care for these patients following inpatient or Emergency Department discharge from Northwestern Memorial Hospital. Since 2012, the NFC has constructed an integrated team care approach, logging about 2000 post-discharge encounters with Medicaid or patients without insurance. The NFC model has evolved over the past 2 years in response to a need to address mental as well as physical health needs and to interface with community resources to address social determinants of health that might otherwise lead to frequent re-admission. By working with clinical partners and public payers like Medicaid and County Care, the NFC has also worked to transition patients to accessible primary care medical homes that will provide behavioral, physical, and preventive care. The current study will provide the first reliable evaluation of the clinic's impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.

Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for Northwestern Transitional Follow Up care post-discharge from Northwestern Memorial Hospital
* Adults (18 years of age or older)
* Patients referred by an Northwestern Memorial Hospital care provider for discharge coordination by the Northwestern Transitional Follow Up Clinic

Exclusion Criteria:

* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant Women
* Prisoners
Antimicrobial PK in Infants With Suspected or Confirmed Infection

The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.

Greater than 90% of infants born \<32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their NICU hospitalization. Most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. Dosing is based largely on pharmacokinetic data from older children or in some cases, adults. This study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. The sites of the NIH-sponsored Pediatric Pharmacology Research Network (PPRU) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will

1. Guide dosing of commonly used antimicrobial agents, and
2. Provide preliminary data for future industry and government trials in the nursery.

Eligibility Criteria:
Inclusion Criteria:

* Infants ≤32 weeks and 6 days EGA with high probability of receiving one of the antimicrobial agents listed are eligible for study.
* Age younger than 120 days
* Written informed consent from parent or legal guardian
* Infants likely to survive beyond 48 hours after enrollment

Exclusion Criteria:

* Failure to consent
A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Study Objective

To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Study Design

The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:

1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.

Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.

Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis

Exclusion Criteria:

* Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
* Patients with infection, sepsis, and osteomyelitis
* Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis
Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)

Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.

Aim: To evaluate the role of GIPR signalling in postprandial physiology, including lipid, bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the GIPR.

Twelve healthy men (age 18-70 years, BMI 19-27 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin\[9-39\], C) GIP-A + Exendin\[9-39\], or D) saline (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication, Diabetes type 1 or 2, BMI \> 27, first degree relatives with Type 2 Diabetes
Registry on Hypomethylating Agents in Myeloid Neoplasms

This registry is set up to collect real-world experience in the management of patients with myeloid neoplasms, in particularly in patients with MDS, CMML or AML, treated with hypomethylating agents in Austria and potentially other participating countries. This registry will collect data in a retrospective as well as in a prospective manner at various sites. The aim is to gain valuable insights on both efficacy and toxicity of these drugs in a routine clinical setting in patients with various comorbidities.


Eligibility Criteria:
Inclusion Criteria:

Patients with MDS, CMML, and AML

* who begin with or already have received treatment with with a hypomethylating agent
* who are willing to provide informed consent

Exclusion Criteria:

* Due to the non-interventional design of this program there are no specific exclusion criteria.
Cannabis' Impact on Alcohol Consumption

This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo.

The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.

This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant (0.35% THC and 11.27% CBD) dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly to obtain the final sample of 200 with complete data. Participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. Findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 50
* English-speaking
* cannabis smoking in past two months
* heavy drinking in past two months
* in good physical health and weighing \< 250 lbs
* zero breath alcohol at each visit

Exclusion Criteria:

* positive pregnancy test
* nursing
* positive urine toxicology screen for drugs other than cannabis
* interest to quit or receive treatment for cannabis or alcohol use
The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach

The study evaluates wether deep neuromuscular block during entire surgical procedure to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach results in less muscular damage to the deltoid muscle and therefore less post-operative pain and an earlier functional recovery..


Eligibility Criteria:
Inclusion Criteria:

• Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach

Exclusion Criteria:

* Inability to consent because of mental status
* Open injuries involving the deltoid muscle
* Previous open surgery on the shoulder joint.
* American Society of Anaesthesiologists (ASA) physical status \>II
* Age \<18 or \>85 year old
* Body mass index (BMI) \<18.5 or \>35 kg/m2
* Renal insufficiency (glomerular filtration rate \<40 ml/min)
* Impaired liver function (hepatic cirrhosis, cholestatic jaundice)
* Neuromuscular disease
* Pregnancy
* Breastfeeding
* Predicted difficult airway
* Patients receiving medications known to interact with neuromuscular blocking agents
* Allergy to any drug included in the anesthetic protocol
Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered

The purpose of this study is to evaluate the effects of multiple doses of verapamil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and verapamil.


Eligibility Criteria:
Inclusion criteria :

1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
2. Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria :

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease

Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. This study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.

At their admission in Raymond Poincaré hospital in the long-term ventilation unit for a ventilation check-up, patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease will be included in the study if they have no sign of pneumonia and no contact with a hospital structure within a month. These exclusion criteria allow to focus on non-decompensating patient with a respiratory flora not hospital-acquired and not modified by antibiotics.

The doctor in charge of the patient will fill a questionnaire with the help of the patients or the patient's family with several items as date of tracheostomy, history of respiratory infections, history of hospitalization, characteristics of ventilation (presence of a cannula, frequency of change of filter, type of water use in the humidifier...). Beside, a tracheal aspirate will be collected and send to the microbiology laboratory for bacterial culture. The tracheal aspirate will be supported as a usual clinical tracheal aspirate but each bacterial specie will be quantify and identify by mass spectrometry. Antimicrobial susceptibility testing will be performed only for potential pathogenic species with a cut-off at 105.

Eligibility Criteria:
Inclusion Criteria:

* Patient of majority age who signed the information note
* Tracheostomized patient for more than 6 months for a neurological or neuromuscular disease leaving in the community and hospitalized in Raymond Poincaré hospital for less than 48 hours

Exclusion Criteria:

* Refusal to take part of the study
* Not membership in a national insurance scheme
* Patient under guardianship or curatorship
* More than 48 hours hospitalization before tracheal aspirate
* Hospitalization in the previous month
* Evolutionary pneumonia at the admission or in the previous month (fever \>38.4°C with respiratory signs of pneumonia as cough, increase of the dyspnea, increase of expectorations associated with radiological opacities of recent appearance)
* Non-chronical antibiotic treatment in the previous month
* Patient already included during a previous hospitalization
A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers

The purpose of this study is to investigate the absorption (the way the drug enters the body), metabolism (the way the drug is broken down in the body), and excretion (the way drug leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed.

This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single dose, single center study to investigate the absorption, metabolism, and excretion of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. On Day 1, all volunteers will receive a single oral dose of radiolabeled 14C-canagliflozin which contains 196 mg of canagliflozin and approximately 40 microcurie (1480kBq) of radioactivity. The International Commission on Radiological Protection considers this amount of radioactivity to be acceptable for this type of study. The radioactivity allows the amount of canagliflozin and its metabolites (break-down products) to be more precisely measured in blood, plasma, urine, and feces samples, which will be collected from each volunteer. The total duration of the study is approximately 5 weeks (including screening and follow-up); this time will be increased by 6 days in volunteers who have a slower rate of excretion of canagliflozin.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2
* Non-smoker

Exclusion Criteria:

* Exposure to radiation for professional or medical reasons (except dental x-rays and x-rays of thorax and bone skeleton, excluding spinal column) in the past 12 months
* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
DASH Diet Intervention for Systemic Hypertension in Adolescents

Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.

Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.

Eligibility Criteria:
Inclusion Criteria:

Age 12 to 17 years of age at baseline visit Elevated blood pressure or hypertension

-

Exclusion Criteria:

Inability to eat by mouth Secondary hypertension
Study on Antiviral Therapy for HBeAg-positive Chronic Hepatitis B Patients Aged 1-16 Years

The purpose of this study is to provide theoretical and real world evidence for the optimization of antiviral treatment by IFN combined with Nucleosides analog in HBeAg positive chronic hepatitis B patients aged 1-16 years，so that the functional cure could be achieved in the greatest extent in pediatric patients

This research is a national multicenter, randomized, prospective study. The planned sample size is 200 subjects in 1-16 years pediatric patients with HBeAg positive Chronic Hepatitis B (CHB). These subjects will be randomized (1:1) to group A(treated with NAs + IFN for 96 weeks) and group B(treated with NAs for 48 weeks, then NAs combined with IFN for 96 weeks).Meanwhile, 1-6 years and 7-16 years patients should be distributed by 1:1 ratio by random method in both groups. Regularly Blood cell count, biochemical test, hepatitis B viral markers test, and lymphocyte subsets test were exerted. To compare the curative effect of group A and group B, The primary monitoring indicator is HBsAg clearance rate, and the secondary monitoring indicator is hepatitis B virus (HBV) DNA clearance，HBeAg seroconversion in these patients,. So that we can make the optimal antiviral treatment strategy for 1-16-year-old children with CHB，and try to find out the possible influencing factors of function cure

Eligibility Criteria:
Inclusion Criteria:

1. Aged 1 to 16 years old.
2. Chronic Hepatitis B (CHB) patients or HBsAg positive \> 6 months patients who are line with the diagnostic criteria for chronic hepatitis B infection.
3. ALT:40～400 U/L.
4. HBeAg positive.
5. HBV DNA\>2×104IU/L.
6. Liver histology: G\<3.
7. Agree to sign the Informed Consent Form (Children aged 1-6 years may be signed by the guardian; children between the ages of 7 and 11 are in principle signed by the child and the guardian; those over the age of 12 must be signed by the child and the guardian)

Exclusion Criteria:

1. white blood cell (WBC)\< 3.5×109/L，PLT\< 80×1012/L，Pt A\<60%，total bilirubin (TBIL)\>34umol/L，ALB\<35g/L，Cr\>133umol/L.
2. Combined with HAV、HCV、HDV、HEV or HIV-infected persons.
3. Patients combined with other causes of liver disease：alcoholic or non-alcoholic liver disease，thyroid disease，autoimmune liver disease，genetic metabolic liver disease，bile duct diseases，or Parasitic infection of hepatobiliary tract.
4. Patients with decompensated cirrhosis，including ascites.
5. Received the following medications（Immunosuppressant and Systemic cytotoxic drugs）in six months.
6. Patients who are allergy to IFNs and NAs;
7. Patients with other severe or active psychosomatic diseases （kidney, heart, lungs, vascular, neurological, digestive including history of pancreatitis, metabolic diseases including diabetes, thyroid and Adrenal disease, adrenal disease or tumor), Researchers believe which affect the treatment, evaluation or compliance of patients with the study plan.
8. Patients who unable to comply with the study arrangement judged by researcher.