cyrilzakka/clinical-trials huggingface dataset:
Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass

This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.

In this study, total 50 patients with low bone mass will be enrolled and divided into 5 dose groups. In the lowest dose group 6 subjects will be recruited, among whom 4 will receive SHR-1222 and the other 2 will receive placebo. In each of the other 4 groups, 11 subjects will be recruited, among whom 9 will be administered with SHR-1222 and the other 2 with placebo.

Levels of nitric oxide (NO), Endothelin-1 (ET-1), plasminogen activator inhibitor-1 (PAI-1) and hypersensitivity C-reactive protein (hs-CRP) will be detected in patients before and after the SHR-1222 injection.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Male or postmenopausal female;
* Age ≥45 and ≤59 years old;
* The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;
* T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris\>-2.5 and \<-1;
* The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication;
* No smoking, alcohol or drugs abuse.

Exclusion Criteria:

* Any disease affecting bone metabolism;
* Past medical history of cerebral infarction or cerebral arterial thrombosis;
* Past medical history of myocardial infarction;
* Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D\>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
* Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
* A bone fracture within the previous 6 months;
* A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;
* 3 months prior to screening involved in any drug clinical subjects;
* Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;
* Serious infection, trauma or major surgery in 4 weeks prior to screening;
* A surgery plan during the study;
* Blood donation and transfusion in 3 months prior to screening;
* Unstable thyroid dysfunction in 6 months prior to screening;
* Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
* Intolerant to venous blood collection;
* A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar；
* Subjects with any other situation should not be involved, which determined by the researchers.
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)

This is a gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec and delandistrogene moxeparvovec dystrophin expression in association with imlifidase, in participants with DMD with pre-existing antibodies to rAAVrh74 over a period of 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory per protocol specified criteria.
* Has a definitive diagnosis of DMD prior to Screening based on documentation of clinical findings and confirmatory genetic testing.
* Ability to cooperate with motor assessment testing.
* Has elevated rAAVrh74 antibody titers per protocol-specified requirements.
* A pathogenic frameshift mutation, nonsense mutation or premature stop codon or pathogenic variant in the DMD gene that is expected to lead to absence of dystrophin protein.
* Stable daily dose of oral corticosteroids for at least 12 weeks prior to Screening, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight).

Exclusion Criteria:

* Previous treatment with imlifidase.
* Presence of any other clinically significant illness, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, or behavioral disease, or infection or malignancy or concomitant illness or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risks for receiving the study drugs or a medical condition or extenuating circumstance that, in the opinion of the Investigator, might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability.
* Exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests.

Note: Other inclusion or exclusion criteria could apply.
Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)

The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.


Eligibility Criteria:
Inclusion Criteria:

* The primary source of pain is the study knee of one lower extremity
* Patient is willing to limit alcohol and caffeine intake
* Aside from osteoarthritis, patient is in generally good health
* Patient is capable of completing protocol specified walks
* Patient is able to understand and complete questionnaires in English
* Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen

Exclusion Criteria:

* Patient has another condition which could interfere with evaluating pain in the knee being tested
* Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen
* Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer
* Patient has a history or current evidence of dizziness, unsteadiness, or falling
* Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure
* Patient has a history of stomach, digestive track, or small intestine surgery
* Patient is unable to complete the study questionnaires in English
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)

The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.


Eligibility Criteria:
Inclusion Criteria:

* A high risk participant undergoing non emergency CABG surgery requiring CPB and cardioplegia.
* Age: \>=50 years
* At least one of the following risk factors:

  * Female (but not pregnant or lactating), or
  * History of prior CABG, or
  * History of myocardial infarction (MI), or
  * History of ischemic stroke, or
  * Left ventricular ejection fraction \<=30%, or
  * Diabetes mellitus requiring insulin and/or antidiabetic agents.
* Significant coronary artery stenosis

Exclusion Criteria:

* Planned valve replacement, carotid artery or aortic surgery, distal coronary endarterectomy,surgical ablation for cardiac arrhythmia, or ventricular aneurysmectomy, alone or with CABG surgery (repair for mild to moderate mitral valve disease with concomitant CABG is not excluded).
* Planned or staged major surgery within 30 days of CABG surgery
* CABG surgery using intermittent aortic cross clamping without cardioplegia.
* Minimally invasive surgery (ie, without use of CPB).
* MI within 5 days prior to surgery.
* Pre-operative or planned intra operative/postoperative use of intra-aortic balloon pump (IABP), ventricular assist device (VAD), extra-corporeal membrane oxygenator (ECMO), or other mechanical hemodynamic assist device.
* History or presence of gout or uric acid nephrolithiasis.
* Serum creatinine \>2 mg/dL (180 µmol/L).
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x Upper Limit of Normal (ULN).
* Adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and any cardioplegia solution containing adenosine, dipyridamole or lidoflazine within 24 hours before surgery:
* Dipyridamole within 2 days and allopurinol or febuxostat within 4 days before surgery
* Food and drinks containing caffeine, theobromines or methylxanthines (such as coffee, tea, colas, some 'energy' drinks or chocolate) within 12 hours before surgery.
* Pregnancy
Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.


Eligibility Criteria:
Inclusion Criteria:

Males/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Harmonica Playing Improves Quality of Life in Patients With COPD

15 patients who have completed the Baylor Martha Foster Lung Center Pulmonary Rehabilitation Program at least six months ago will be selected to participate in a 12 week training program with six months of follow up.

Subjects will be consented and evaluated prior to beginning the Harmonica Training. Subjects will undergo spirometry testing, six minute walk testing and inspiratory capacity, inspiratory and expiratory respiratory muscle strength will be measured. A music therapist will evaluate their ability to assess the participant's ability to play the harmonica and offer assistance during the training. Subjects will complete a self-reported depression, shortness of breath, and quality of life questionnaire. All evaluations and questionnaires will be completed before and after the 12 week program and six months after the training program.

They will be trained to play the Harmonica and practice as a group during a twelve week program, for one hour a day, one day a week with the Instructors, one is a Registered Respiratory Therapist and the other is a music therapist, who will evaluate their ability and offer assistance. The music therapist will meet individually with each study participant at the beginning of the study to assess participants' harmonica playing ability.

They are required to practice at home (individually) in between classes for 30 minutes five days a week outside the formal training hour with the group. They may use oxygen as prescribed by their physician during the training. The training booklet includes information to help the subject with COPD understand how this program is designed to help them. They will also be given instructions on how to clean the harmonica and infection control measures to use during the program to prevent infections that could occur using the harmonica.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to attend 12 weeks of harmonica training for one hour a day per week
* Practice playing at home 30 minutes x 5 days a week
* Documented diagnosis of COPD
* Ability to perform spirometry, IC, MIP, and MEP maneuver and 6 minute walk
* Willing to complete depression, quality of life, shortness of breath, functional evaluation questionnaires
* Willing to perform in a group setting

Exclusion Criteria:

* Current COPD exacerbation
* Inability to perform spirometry, IC, MIP and MEP maneuver
* Inability to commit to weekly one hour sessions for 12 weeks and practice for 5 days/week.
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients

The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. The investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.

Understanding the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of an antibiotic can provide insight into developing appropriate dosing regimens. It is even more imperative at the present time to maximize PK/PD parameters since there are no new novel antimicrobial agents to treat resistant gram-negative infections. This approach allows us to achieve superior PD parameters and treat bacteria that would have been resistant to standard dosing due to higher minimum inhibitory concentrations (MICs).

Doripenem exhibits time-dependent bactericidal activity and the pharmacodynamic parameter predicting clinical and bacteriologic outcomes is the percentage of the dosing interval that free drug concentrations remain above the minimum inhibitory concentration (T \> MIC) of the infecting pathogen Sepsis is known to influence drug pharmacokinetics and pharmacodynamics as a result of changes in hemodynamics, capillary permeability, third spacing, acid-base status, serum proteins, and organ function. Moreover, trauma patients tend to be younger with fewer comorbidities. They are hypermetabolic and are often given aggressive fluid resuscitation resulting in increased renal clearance of drugs and a larger volume of distribution. As a consequence of these differences in PK parameters, the calculated PD parameters will likely differ resulting in sub-optimal T\> MIC. For time-dependent antibacterial agents such as doripenem, the T \> MIC is one of the most important pharmacodynamic parameters in predicting clinical efficacy, therefore it is imperative to evaluate the PK parameters in this particular population.

Eligibility Criteria:
Inclusion Criteria:

* Patients are 18 years of age or older
* Admitted to Emory surgical intensive care unit (ICU) service
* Have a diagnosis of sepsis that requires empiric antimicrobial therapy
* Obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure

Exclusion Criteria:

* Surgical ICU length of stay less than 24 hours
* Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated creatinine clearance of less than 50 mL/min)
* Pregnancy
* Known allergy to beta-lactam antibiotics
* Non-English-speaking patients
PNF Techniques Versus Stabilization Exercises of Trapezius Muscle PNF Techniques Verus Stabilization Exercises of Trapezius Muscle

This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. The population sample will be 50 divided randomly into two groups by concealed envelop method. Then I will collect data from the social security hospital Physiotherapy department, Lahore. Group A was given stretching exercises and Group B was given stabilization exercises (25 stretchings and 25stabilization). NDI and NPRS were used as an outcome measure to quantify the upper trapezius on pain, range of motion, and functional disability with non-specific neck pain.

This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. The population sample will be 50 divided randomly into two groups by concealed envelop method. Then I will collect data from the social security hospital Physiotherapy department, Lahore. Group A was given stretching exercises and Group B was given stabilization exercises (25 stretchings and 25stabilization). NDI and NPRS were used as an outcome measure to quantify the upper trapezius on pain, range of motion, and functional disability with non-specific neck pain. Single blinding of accessor was done at the time of recording of outcome measures pre and post-treatment Baseline was 4th week and 8th week. Eighty female participants and twenty male participants in each group. The duration was 9 months. The 18-30 years age range of both males and females were considered. There was not any statistically significant difference between the two groups as p \> 0.05. But within-group changes show that there was a significant change in baseline, 4th week, and 8th-week readings for NDI, NPRS, and ROM with p \< 0.05.

Eligibility Criteria:
Inclusion Criteria

* Male and female, age range 18-30years with non-specific neck pain.

  * Permanently mobile users spent more than 8 hours per day using their mobiles
  * Participants are willing to participate in the research.
  * Having constant or frequent neck pain of more than 4weeks duration.

Exclusion Criteria:

* Specific disorders of the cervical spine, such as disc prolapse, spinal stenosis, postoperative conditions in the neck and shoulder areas.

  * History of severe trauma, instability, spasmodic torticollis, migraine (frequency more than twice per month).
  * Peripheral nerve entrapment, fibromyalgia, hypermobility syndrome, shoulder diseases (tendonitis, bursitis, capsulitis).
  * Inflammatory rheumatic diseases, severe psychiatric illness, and other diseases that prevent physical loading, pregnancy, and other on-going therapies.
Effects of Mineral Water Consumption on Serum Lipid Parameters

The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as based on medical history and physical examination
* Fasting serum LDL cholesterol \> 100 and/or fasting serum triglyceride \> 100
* Willing to drink mineral water for 12 weeks
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype) or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it ended with the patient's death few years later. No neuroprotective treatment has shown a real efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication of dopamine neuromediator pathway in integration and modulation of pain. Several studies suggest the existence of various influences with dopamine implication in the appearance of painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA and PD could be due to a decrease of pain appearance threshold, secondary to a lost of control of sensitizes centres, to Parkinson control.

It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold and to characterise the levodopa effect on the patient's pain threshold. Better physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care. Because the efficacy of others treatments is low, it's important to improve the research for a better comfort of patients with a better understanding, analysing and treating of the pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 50 to 80 years old (Male and female)
* Patients suffering of a diagnosis possible or probable MSA-P with the international criteria (2008).
* Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB (Gibb et Lees, 1988; Hughes et al, 1992)
* Patients with no cognitive troubles
* Patients who give their informed and signed consent.
* Patients affiliated to a social protection program

Exclusion Criteria:

* Patient suffering from an other parkinson syndrome than MSA and PD, by example progressive supranuclear palsy, corticobasal degeneration...
* Patient suffering of a diagnosis possible or probable MSA-C with the international criteria
* Patient suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies...)
* Patient under tutelage, curatella or law protection
Text4Father Pilot Feasibility, Acceptability Study

This study evaluates the feasibility, acceptability, and preliminary efficacy of Text4Father among first-time lower income fathers. Half of the participants will receive Text4Father - a text messaging educational program - from mid-pregnancy through 2 months of postnatal age, while the other half will receive usual care.

Text4Father, a multi-modal text messaging program, is designed to increase first-time lower income fathers' knowledge, self-efficacy, and behavioral engagement on infant care and parenting. Text4Father consists of 48-weeks of twice weekly texts written at a 5th grade reading level. Texts include resource links and instructions to support behavior change (e.g., videos, infographics), starting mid-pregnancy and continuing through 2 months of postnatal age. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.

Usual maternity care does not involve expectant fathers in education. Further, while father engagement is widely advocated, few public health and clinical approaches aim to engage expectant fathers during the prenatal period and first months after birth - a critical window of opportunity that has been insufficiently leveraged to promote father engagement when fathers describe being unsure of father role.

Eligibility Criteria:
Inclusion Criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Self-reported expectant father and pregnant partner (expectant mother)
* Aged ≥18 years
* In a romantic relationship and expect to continue to be in this relationship during the study period
* Able to speak English
* Lower socioeconomic status (SES) (e.g., high school/general education or vocational/trade school or less; or qualify for Medicaid/public insurance, WIC, SNAP, food stamps)
* Access to necessary resources for participating in a technology-based intervention (i.e., cell phone) and willing/able to receive/send texts

Exclusion Criteria:

* Individuals who are not able to provide informed consent.