cyrilzakka/clinical-trials huggingface dataset:
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an infection consistent with complicated skin and skin structure infections.

Exclusion Criteria:

* Known or suspected hypersensitivity to any study medication or other related anti-infective medication
* Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
* Previous enrollment in this study
* Treatment with any investigational drug within 30 days before enrollment
Rehabilitation of Finger Flexor Tendon Injuries

The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* ≥ 18 years old
* Understanding of the German language (written and oral)
* Single and multiple finger injuries
* Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
* Treated by the hand surgery department at the Inselspital Bern
* Treated with at least a 4-strand core suture

Exclusion Criteria:

* \< 18 years old
* Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
* Replantation of the injured finger
* Fracture of the injured finger
* Primary tendon reconstructions
Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.

Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.

Participants in this double-blind study will be randomly assigned to receive either placebo or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children will be followed and assessed until 4 years of age.

Eligibility Criteria:
Inclusion Criteria:

* General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
* ages 18-45 years
* prepregnancy BMI\>18 and \<45

Exclusion Criteria:

* Prior history of fetal death
* Current personal history of chronic infections, including HIV
* Current personal or family history out to first degree relatives of

  1. Trimethylaminuria
  2. Homocystinuria
* Primary language other than English or Spanish
* Evidence of noncompliance
Cold Plasma for Dental Restoration and Caries Prevention

The main objective of this entire research project is to develop a miniature atmospheric cold plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial portion of the study is to compare the longevity and durability of dental composite restorations created using the plasma brush, to that of the standard care in dentistry for treating dental cavities, and effects on caries prevention.

The study will be a randomized controlled trial (RCT) and be approved by the institute review board of the University of Tennessee Health Science Center. The study subjects will be composed of young adults 18-35 years old in order to control effects of age on caries. Also the subjects must be Caucasian or Africa American. Young adult patients will be recruited from the UTHSC dental clinics.The baseline visit include a dental exam by one of the investigators, standard preventive dental care (e.g cleaning, application of fluoride varnish), anthropometric measurements, oral health interview survey. 100 patients who meet all inclusion and exclusion criteria will be recruited after they sign an informed consent form. These patients will be randomly assigned to 1 of 2 study groups. Randomization assignment will be stratified by age and number of teeth with caries. Two study groups will be: 1.) plasma treatment group and 2) standard treatment group. For patients in standard treatment group, they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline. For patients in plasma treatment group, they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth. Standard preventive treatment and plasma treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction. Only one composite commercially available will be used during the study.

Eligibility Criteria:
Inclusion Criteria:

* subject must be Caucasian or Africa American, 18-35 years old, have written, completed, informed consent forms;
* be generally healthy;
* be able to participate in the study;
* have no diagnosed periodontitis and pericoronitis;
* have no active mucosal diseases such as aphthous ulcers and herpetic stomatitis.

They must also agree to follow study instructions.

The patients must meet the following specific entry criteria:

* 1-5 untreated caries and at least one class II caries.

Exclusion Criteria:

* each subject must have no diagnosed diabetes mellitus or any other endocrine diseases;
* no diagnosed cardiovascular diseases;
* no diagnosed immune-compromised diseases, such as HIV and AIDS;
* no other serious systemic diseases, such as cancer;
* no antibiotic therapy in the past 6 months;
* no use of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 3 months; and
* no reported use of illicit drugs.
Hyperglycemia and the Extra-pancreatic Effect of Incretins

Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion augment insulin secretion from the pancreas to help maintain glycemic control. Studies in vitro and in vivo have shown that these incretin hormones also have functional effects in other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate insulin secretion in a glucose-dependent manner, however the glucose-dependency of their extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology during euglycemic and hyperglycemic conditions we will test the hypothesis that extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* BMI 18-30 kg/m2
* Male
* Normal glycemic control (fasting glucose \<5.6 mM)

Exclusion Criteria:

* Evidence of chronic disease
* Smoking
* Active weight loss (\>2 kg in previous 6 months)
* Treatment with drugs known to affect our outcome varaibles
Combination Therapy of Different Antidepressants With Dietary Supplements

The aim of this clinical trial is to compare the effect of antidepressants in combination with different dietary supplements in patients with depression. Our main objective is to compare the efficacy of antidepressants in combination with either L-methyl folate, Vit B12, or magnesium) in patients with depressive disorders. The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.

This is an open-label study assessing the comparative efficacy of antidepressants in combination therapy of either L-methylfolate, mecobalamin, or magnesium in patients with Depressive Disorder. The plan is to enroll 84 patients with depression based on Patient Health Questionnaire (PHQ-9) score of 9 and above, which is a valid and reliable Structured Clinical Interview. The investigators will collect data from the enrolled patient populations. The participants will be able to receive their results, on request, upon completion of the study. The investigators hypothesize that depressive symptoms can be improved by the addition of above mentioned nutritional supplementations with antidepressant medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Depressive Disorder having PHQ-9 Score 9 and above
* Age 12 and above
* Patients having low/marginal and low normal levels for arms 2 and 3 of respective supplements
* Patients having low/normal serum magnesium for arm 4

Exclusion Criteria:

* Patients having psychiatric diagnosis other than Depressive Disorder according to the International Classification of Diseases 11th Revision (ICD-11)
* History of kidney disease, myasthenia gravis
* Mentally handicapped or terminally ill patients
* Age less than 12 years
* Patients already taking multiple nutritional supplements
* Patients on polypharmacy with potential interactions with antidepressants and supplements in this study.
Psychiatric Genotype/Phenotype Project Repository

The purpose of this project is to obtain DNA, brain imaging data, other biological samples (e.g., urine, serum), and a comprehensive clinical assessment on patients with schizophrenia and other psychotic disorders, bipolar disorder, major depression, and normal volunteer controls. Understanding the physical and genetic factors related to these disorders will help us make progress in fitting treatments to an individual's needs. Participants will take part in a detailed clinical assessment, two blood draws, and an MRI scan over two visits. Participants will also be asked to provide urine and saliva samples.

The links between psychiatric symptoms and underlying biological processes remain unclear at this time. Unipolar Major Depressive Disorder, Bipolar Disorder, and Schizophrenia are associated with major disruptions in functioning and quality of life. Understanding the causal physiological and genetic factors involved in each of these disorders would allow us to make great strides in tailoring treatment to the individual's needs. Because the etiology of these disorders are likely multifactorial in nature, a study examining a wide range of variables might best allow us to examine the interactions between different factors and to get a better sense of how genes and the brain interact to produce psychiatric disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 16 and 65
2. Able and willing to provide informed consent
3. Able to read and speak English sufficiently to provide consent and answer questions
4. Diagnosis of one of the following:

   * Unipolar Major Depressive Disorder of any subtype
   * Bipolar I, Bipolar II Disorder, or Bipolar Disorder NOS
   * Axis I Psychotic Disorder, which can include the diagnoses of Schizophrenia, Schizoaffective Disorder, Major Depression or Mania with Psychotic Features, Schizophreniform Disorder, Brief Psychotic Episode, or Psychotic Disorder NOS
   * Normal volunteer controls, individuals with no personal history of any Axis I disorder.

Exclusion Criteria:

1. Reported pregnancy or breastfeeding
2. Dementia or delirium
3. Any medical condition that would interfere with participation in the study. This would include, but not be limited to:

   * uncontrolled diabetes, hypothyroidism, Cushing's disease, or other significant endocrine condition (treated endocrine condition is allowed)
   * demyelinating disease
   * HIV infection
   * active hepatitis
   * CNS infection
   * clinically significant and unstable cardiovascular disease
   * any cancer involving the CNS (including metastatic disease)
4. Exclusion criteria for normal control subjects include any history of mental illness or psychotropic drug abuse.
5. Participants will be excluded from the imaging portion of the study if they have any condition deemed to interfere with PET or MRI scanning, such as but not restricted to extreme obesity, metal fragments in eyes, metal implants in the head, or cochlear implant. These participants may still take part in the portion of the study involving the clinical assessment and providing biological samples.
A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants

To evaluate the effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign informed consent, able to comply with the requirements of the study.
* Age 18-45 years old, both male and female;
* Weight: male ≥ 50 kg, female ≥ 45 kg, 19 kg/m\^2 ≤ BMI ≤26 kg/m\^2.
* 12-lead electrocardiogram (ECG) examination, 300 ms≤QTcF\<450 ms, 120 ms≤PR interval ≤200 ms, and QRS duration \<120 ms;
* The subjects (including male subjects) are willing to voluntarily take effective contraceptive measures within the next 3 months.

Exclusion Criteria:

* Have a history of risk factors for torsade de pointes, or have a family history of short QT syndrome, long QT syndrome, unexplained sudden death in young adulthood (≤40 years old), drowning or sudden infant death syndrome in first-degree relatives;
* Previous history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia;
* Subjects who had donated blood or lost ≥400 mL of blood within 3 months before screening;
* HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
* Women with positive blood pregnancy test (applicable to women) or lactating women;
* Subjects who have other factors that the investigator considers unsuitable for participation in the study.
Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.


Eligibility Criteria:
Inclusion Criteria:

* Complicated hepatitis C by HCC
* Complicated hepatitis C by liver cirrhosis
* Complicated hepatitis C by steatohepatitis
* uncomplicated hepatitis C

Exclusion Criteria:

* pre-portal fibrosis secondary to previous bilharzial disease
* pre-portal fibrosis secondary to alcoholic fatty liver
* The presence of hepatic malignancy other than HCC
* decompensated cirrhosis
* hepatorenal failure
* hepatic manifestations of congestive heart failure.
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery

The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery.

The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery receiving our institution's standard dual prophylactic antiemetic therapy in combination with intraoperative acupuncture and postoperative acupressure compared to those receiving only the standard dual prophylactic antiemetic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy ASA 1 and 2 Patients
* Age 2 to 18 years old
* Undergoing Outpatient Middle ear surgery

Exclusion Criteria:

* ASA 3 and above
* Patients with underlying pro-emetogenic disease
* Patients currently taking antiemetic agents
* pregnant women
* Cognitively impaired adults
* prisoners
* History of bleeding disorder
* Age less than 2 or greater than 18
Rollover Study of VX-770 in Cystic Fibrosis Subjects

The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.

This open-label, rollover study of orally administered VX-770 was conducted in participants with CF to evaluate the safety and efficacy of long-term VX-770 treatment. Participants who were previously enrolled in Study 102 (VX08-770-102/NCT00909532) and Study 103 (VX08-770-103/NCT00909727), and met certain criteria were eligible to enroll in this study (Study 105/VX08-770-105/NCT01117012).

Eligibility Criteria:
Inclusion Criteria:

1. Participants who have completed the assigned study treatment in Study 102 or Study 103
2. Participants who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770)
3. Participants who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator
4. Participants of child bearing potential and who are sexually active must meet the contraception requirements
5. Participants must sign the informed consent form (ICF), and where appropriate, assent must be obtained

Exclusion Criteria:

1. Participants with a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
2. Participants with a history of study treatment intolerance as observed in their previous VX-770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject
3. Participants who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements
4. Participants taking any inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), including certain herbal medications (for example, St. John's Wort) and grapefruit/grapefruit juice
Effect of Mulligan Technique Versus Core Stability Exercises on Low Back Pain in Post Menopausal Women

This study will be conducted to compare the effect of Mulligan technique and core stability exercises on low back pain in post menopausal women.

Low back pain is a major health problem affecting majority of the people at some point of their life.

Mulligan techniques can correct positional faults that occur in the spine and, thus, once the pain generator is released, normal function returns and the muscle guarding around the affected joint is resolved. Several studies have reported that along with the biomechanical changes, certain neurophysiological changes exist that occur at the spinal level after applying Mulligan techniques, including changes in descending pain inhibitory systems and changes in central pain processing mechanisms.

Core stability exercises are usually used to strengthen the muscles around the abdominal, lumbar, and pelvic regions, because the muscles of these regions play an important role in stability as well as in controlling the lumbar posture by using tonic or postural muscles during whole-body exercises.

So, this study will be conducted to provide new evidence and information about the efficacy of Mulligan technique versus core stability exercises on low back pain in postmenopausal women, to manage this problem for these women and add new information to the field of physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Sixty postmenopausal women (at least one year after stoppage of menses).
* Their age will be ranged from 50 to 60 years.
* All of them are diagnosed with chronic low back pain.
* Their BMI will be less than 30 kg/ m2.
* All of them are of sedentary lifestyle.
* The score of pain will be 2 or more in a VAS.

Exclusion Criteria:

* Participants will be excluded from the study if they have:
* Spinal fractures or any other neurological disorders.
* Lumber disc herniation or spondylolithesis
* Body mass index more than 30 kg/m2.
* Pelvic pathology
* Gynecological diseases as chronic pelvic pain, uterine prolapse or retroversion flexion of the uterus.
Perceptions of Health Professionals Confronted With Palliative Situations

Hospitals, doctors and caregivers, who take care of increasingly heavy patients, are faced with ever more complex situations, particularly in the case of severe, progressive, and incurable pathologies.

Thanks to their willingness and expertise, these care providers try to guarantee the continuity and quality of care for both patients and patients in a palliative situation. Nevertheless, these same actors testify to the complexity they encounter in the care of patients in advanced or terminal stages, especially since the concept of "palliative care", which was often erroneously reduced during the Any end of life and therefore death, remains a source of questions, contradictions, even resistances.

In this context, how do physicians and caregivers appropriate palliative care? How do they react to the complexity and intensity of certain situations? Do they have specific expectations of help or support in the face of certain difficulties? Are there actions to be carried out and developed to make the aid given to these actors of the palliative approach more efficient?

These are the topics that the HUS palliative care service proposes to explore through a study of physicians and caregivers working in HUS services for adult patients with LISP.


Eligibility Criteria:
Inclusion Criteria:

* Major hospitals, doctors and caregivers, who take care of increasingly heavy patients

Exclusion Criteria:

* Patient under 18 years